American Journal of Health-System Pharmacy

doi: 10.1093/ajhp/63.14.1298pmid: N/A

Development and Clinical Outcomes of Pharmacist-Managed Diabetes Care Clinics Patients whose diabetes mellitus was managed by pharmacists at special naval medical clinics were more likely than the general population of patients with diabetes in health plans to achieve national targets for glycemic control and low-density-lipoprotein cholesterol. Even annual retinal and microalbuminuria screenings occurred at higher rates at the two pharmacist-managed diabetes care clinics. Open in new tabDownload slide Comparison of glycosylated hemoglobin (HbA1c) and low-density-lipoprotein (LDL) cholesterol values of patients in diabetes care clinics (DCCs) with the national averages of patients with diabetes. Open in new tabDownload slide Comparison of glycosylated hemoglobin (HbA1c) and low-density-lipoprotein (LDL) cholesterol values of patients in diabetes care clinics (DCCs) with the national averages of patients with diabetes. A PHS Pharmacist Team’s Response to Hurricane Katrina For two weeks in September 2005, eight Public Health Service pharmacists who normally work apart teamed up to establish and run a fully functional pharmacy in a military aircraft hangar. Their clientele? Patients in the hangar’s new 480-bed federal medical station, Navy and Coast Guard families evacuated from the Mississippi gulf coast, and, in a special off-site program, hurricane victims at a local free clinic. Impact of United States Pharmacopeia Chapter 797: Results of a National Survey Since the initial publication of the United States Pharmacopeia chapter on standards for compounding sterile preparations, hospital pharmacies have made or plan to make many changes, according to a national survey of directors. But some of the standards, such as daily validation of the accuracy of automated compounding devices, have met firm resistance. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

Young,, Donna

doi: 10.2146/news050088pmid: 16809748

When FDA on December 1 lifts a six-year stay on a rule that requires wholesalers to forward to buyers a pedigree—a drug product’s complete sales history—regulators are hoping the action will help protect the U.S. supply chain from counterfeit drugs. But loopholes remain in the Prescription Drug Marketing Act (PDMA) of 1987 that leave the drug market vulnerable to counterfeiters. Congress passed the law to help stop counterfeit, adulterated, misbranded, and expired drugs from entering the distribution system. However, it took FDA more than a decade to issue PDMA regulations. After the secondary distributor community and some lawmakers objected to certain pedigree requirements, regulators in May 2000 put a hold on the pedigree rule, which was scheduled to be implemented by the end of that year. FDA stayed implementation of the rule four more times, most recently in February 2004. Secondary wholesalers—companies that generally buy prescription drug products from other wholesalers—argued that FDA’s pedigree regulations would shut out many wholesalers from the distribution system, leaving small pharmacies that rely on them underserved. Because PDMA does not require authorized distributors of record (ADRs)—those companies that generally buy prescription drugs directly from manufacturers—to pass on a pedigree to the next buyer, smaller wholesalers contended that companies that do business with ADRs are not able to meet the law’s requirements. PDMA defines an ADR as a wholesaler that has an “ongoing relationship” with the manufacturer to distribute the drug. However, Congress left it up to FDA to define what constitutes an ongoing relationship. Regulators determined that an ADR has an ongoing relationship with a manufacturer when the two entities have a written agreement under which the wholesaler is authorized to distribute the manufacturer’s products. Secondary wholesalers can be ADRs, noted Ilisa Bernstein, FDA’s director of pharmacy, as long as those companies meet the regulation’s requirements. “ADR status is granted by the manufacturer with the agreement between the wholesaler and the manufacturer,” she said. However, most direct buying from manufacturers is done by the nation’s three largest wholesalers: McKesson, Cardinal Health, and AmerisourceBergen. When an ADR buys drugs from a non-authorized distributor and sells the product to another wholesaler or a pharmacy, there is the potential for a break in the pedigree’s chain. FDA has maintained that counterfeit drug products have entered the distribution chain through secondary wholesalers that obtained products without complete pedigrees listing all transactions. Secondary wholesalers have argued that it is PDMA’s ADR exemption that is to blame for incomplete pedigrees, which, they claimed, have allowed unscrupulous wholesalers to take advantage of the secondary market. Nonetheless, Bernstein said, PDMA requires companies that buy from an ADR to be responsible for the pedigree and for including information in the document about each prior sale going back to the manufacturer. But, she added, even though ADRs are not required to pass on the pedigree or provide prior sales information to buyers, “we believe that it’s in the best interest of the public health in order to ensure a safe and secure supply chain that they do provide this information to everybody further on down the supply chain, whoever they sell their product to.” However, Bernstein noted, FDA cannot force ADRs to provide pedigrees to buyers since it was Congress that wrote the ADR exemption into the pedigree provision. The agency’s regulations, she explained, can only reflect what is in the law. “We can’t impose anything beyond what the law says,” Bernstein declared. But unless ADRs provide pedigree information, there is a gap in a drug’s transaction record. Some of the larger ADRs have pledged to limit or stop buying from the secondary market. AmerisourceBergen announced in September 2005 that it would purchase all of its branded and generic pharmaceuticals for distribution in the United States only from manufacturers. However, the company stated, in the “rare instances” in which a manufacturer requires purchasing products from an exclusive distributor, “Amerisource-Bergen will follow the manufacturer’s requirements.” Cardinal Health announced in May 2005 that it was closing its subsidiary that bought and sold discounted and overstocked drugs in the secondary market. McKesson did not publicly issue an announcement about its policies dealing with the secondary market. But in a November 11, 2005, e-mail to the father of a victim of counterfeit drugs—New York resident Timothy Fagan—the company’s general counsel said that McKesson “on a going forward basis” would purchase prescription drugs “directly from the manufacturer or from the manufacturer’s designated sole distributor.” The company has a June 7 statement that includes similar information, which organizations can request, according to McKesson spokesperson James Larkin. Fagan had sued AmerisourceBergen and CVS’s specialty pharmacy division PharmaCare, alleging that the companies should be held accountable for a counterfeit injectable that reached Fagan. The product, which was labeled as Amgen’s epoetin alfa product Epogen 40,000 units/mL, actually contained 2,000 units/mL of the active ingredient. The suit was settled out of court and a stipulation of dismissal was filed March 1 in the U.S. District Court Eastern District of New York to all parties, said Fagan’s attorney Eric Turkewitz. The Fagan case spurred legislation designed to toughen criminal penalties for counterfeiters and grant greater powers to FDA to investigate and recall counterfeit drugs. The Counterfeit Drugs Enforcement Act of 2005 is pending. A state of confusion FDA’s stay of the pedigree rule has led to much confusion about what is required of wholesalers and pharmacies. For instance, when FDA announced in February 2004 that it was again staying the rule—for the fifth time—the agency’s Counterfeit Drugs Task Force stated in its report that it “encourages wholesalers to provide pedigree information,” leaving the impression that the pedigree was an option rather than a requirement. When the government in 2004 charged RxBazaar Inc., an Ohio-based wholesaler, and its wholly owned subsidiary, FPP Distribution Inc., with failing to provide customers with a complete pedigree, company executives said that FDA’s stay of the pedigree rule led them to believe that the requirement was not in effect. An FDA spokesperson said that “the fact [that] regulations have not been implemented does not nullify the law.” Ignorance of the law or lack of criminal intent, regulators said in an August 27, 2004, statement, “is no defense.” The companies each pleaded guilty to one misdemeanor charge under the Federal Food, Drug, and Cosmetic Act for failing to forward a pedigree and were sentenced to five years’ probation and a $100,000 fine. Once the stay is lifted, Bernstein maintained, pedigree requirements will be better clarified for wholesalers. Are electronic pedigrees the solution? The last time FDA stayed implementation of the pedigree rule, officials said the reason was to give the drug industry time to adopt electronic technologies, such as radiofrequency identification (RFID), to track drugs through the supply chain. Regulators contended that if widely adopted, RFID could create a de facto electronic pedigree that would document the sale of a drug product from the place of manufacture through the U.S. drug supply chain to the final dispenser. “FDA has concluded that this approach is a much more reliable direction for assuring the legitimacy of a drug than paper record-keeping requirements, which are more likely to be incomplete or falsified, and that it is feasible for use by 2007,” the agency’s Counterfeit Drugs Task Force said in its February 2004 report. However, this past February, FDA admitted that the 2007 prediction might have been too optimistic. In a report issued June 9, FDA’s task force said that the agency would not issue a new forecast or target date for the widespread adoption of electronic pedigrees “because we do not have enough information to do so at this time.” The task force recommended that FDA continue to work with the drug industry to develop a time frame for widespread use of an electronic pedigree, adding that members of the drug supply chain should be able to implement the necessary technology “in the very near future.” “We’re hoping that industry will continue to move forward with some speed to get the e-pedigree in place as quickly as possible,” Steve Niedelman, assistant commissioner of regulatory affairs at FDA, said during a June 9 media telebriefing. FDA continues to believe that RFID is the “most promising” technology for tracking and tracing drugs in the supply chain, said Randall Lutter, FDA’s associate commissioner for policy and planning. The task force mentioned that other technologies, such as two-dimensional bar codes, should also be considered. Lutter admitted that FDA is unaware of any instance when a counterfeit drug was stopped from entering the supply chain through a company’s use of RFID or other track-and-trace technology. Paper pedigrees Until electronic pedigrees are widely adopted, wholesalers would be required to keep paper pedigrees, regulators said. However, paper pedigrees are highly vulnerable to forging. New York resident Gregory Broccoli admitted in a New Jersey courtroom on May 25 that from 2002 to 2004, he created fraudulent pedigrees as part of a conspiracy with other secondary wholesalers to sell stolen injectable somatropin, a product used for the treatment of AIDS-wasting syndrome, or cachexia. Broccoli pleaded guilty to five counts of conspiracy in connection with his operation of a New Jersey-based pharmaceutical distribution company that sold the stolen products. The total value of the prescription drug transactions involved in the scheme exceeded $7.3 million, according to the U.S. Attorney’s Office for the New Jersey District. Broccoli is scheduled to be sentenced on September 5. He faces a maximum statutory prison sentence of five years and a $250,000 fine for each count of conspiracy. Guidance FDA on June 9 also issued a draft compliance policy guide to clarify for regulators and the drug industry how the agency intends to prioritize its enforcement of the pedigree requirements over the next year. The guide describes a “phased-in” approach for enforcing the pedigree provision. Regulators plan to focus enforcement efforts on expensive drugs, medications that are in short supply or high demand, and drugs that have a history or a reasonable probability of being counterfeited or diverted, Niedelman explained. “By providing guidance on the types of drugs that are currently of greatest concern to FDA, we believe that wholesale distributors will have a better idea of where and how to focus their initial energies as they implement systems to come into complete compliance” with PDMA, the guide states. “We believe that the phased-in approach reflected in the FDA’s draft compliance policy guidance will allow the agency to prevent the introduction of counterfeit drugs into the U.S. drug supply chain by concentrating on the risk factors of drugs that are currently of greatest concern,” said Gary Stein, director of regulatory affairs for the American Society of Health-System Pharmacists (ASHP). ASHP, he added, supports FDA’s decision to lift the stay on the pedigree rule. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

Young,, Donna

doi: 10.2146/news050089pmid: 16809749

Regulators and pharmaceutical makers need to be transparent, direct, forthcoming, and willing to acknowledge scientific and medical uncertainties about risks associated with drug products, said Dennis Paustenbach, president of ChemRisk, a San Francisco health and environmental risk assessment firm. “Humility about the limits of science is critical to enjoy the trust and respect of the public,” he told FDA officials, drug industry executives, and scientists at a recent two-day Institute of Medicine forum about the risks and benefits of medications. If pharmaceutical firms and regulators try to hide suspected problems about a drug from the public, Paustenbach warned, trust in FDA and the industry will continue to erode. To be credible, he added, regulatory decisions must be “grounded in science.” FDA has been widely criticized in recent years for being too slow to act on safety concerns of certain drugs, most notably antidepressants and cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs. Members of Congress have suggested that FDA’s relationship with the drug industry is too cozy. Regulators have also been under fire for postponing a decision last year on Barr Laboratories’ application to make its emergency contraceptive Plan B available to women age 16 years or older without a prescription. Some lawmakers have contended that FDA’s delay was based on ideology and not science. Most recently, members of Congress have focused on FDA’s April 2004 approval of telithromycin, an antiinfective marketed as Ketek by Sanofi-Aventis, which has been linked to severe liver damage. Lawmakers have questioned why regulators allowed erroneous and fraudulent study data to be presented at a January 8, 2003, meeting of the agency’s Anti-Infective Drugs Advisory Committee and withheld from the panel the fact that there was an ongoing investigation into the integrity of the study’s data. “The Ketek case demonstrates the urgent need for reform at the FDA and in the pharmaceutical industry,” Representative Henry A. Waxman (D-California) said in a May 1 statement. “FDA approved the drug on flimsy data without resolving the safety issues, and it failed to penalize Aventis,” he said. “Americans deserve more vigilance from FDA and from the companies that make critical medical treatments.” Poor communication Americans, Paustenbach noted, are playing a more active role in their medical decisions and are increasingly insistent about being informed of potential risks. Unfortunately, he said, FDA and the pharmaceutical industry have done a poor job of communicating drug risk–benefit information to patients and health care practitioners. He cited technically worded and lengthy prescription drug labeling and misleading advertisements as examples of drug makers’ reluctance to provide clear information to clinicians and the public. Technical language FDA is partly to blame for the lack of clear risk–benefit information, asserted Steven Woloshin, professor of community and family medicine at Dartmouth Medical School in Hanover, New Hampshire. In fact, he noted, the original wording in the federal Food, Drug, and Cosmetic Act of 1938 declared that prescription drug labeling should appear “only in such medical terms as are not likely to be understood by the ordinary individual.” Many of the experts at the meeting agreed that most physicians have difficulty understanding information in prescription drug labeling. “And they are the experts who provide patients with this information,” charged forum cochair Jeffrey Leiden, a physician and former president of Abbott Laboratories. Steven K. Galson, director of FDA’s Center for Drug Evaluation and Research, noted that drugs approved on or after June 30 are required to use a new labeling format in which companies must summarize warnings in a “Highlights” box at the top of the package insert. The new format is intended to make it easier for prescribers to access, read, and use the information, according to regulators. But many meeting attendees were skeptical that the new labeling format would improve risk–benefit communication, especially for patients, since package inserts are intended for prescribers and pharmacists and not the general public. Only a handful of physicians at the forum acknowledged that they had ever read a drug product’s full labeling information. Direct-to-consumer ads Many direct-to-consumer (DTC) drug advertisements make assertions about efficacy without providing data to support those claims, Woloshin contended. Data often provided in DTC advertisements make declarations about a drug’s popularity rather than support claims of efficacy, he added. Warnings and precautions in print DTC advertisements are too complex for most consumers to understand, Woloshin said. He urged FDA to require pharmaceutical firms to put risk–benefit information in DTC advertisements in a tabular format similar to the nutrition facts box used on food products. Accepting risks Too much emphasis has been placed on ensuring that patients receive risk information, Leiden argued, reminding regulators that “there is a benefit side to this equation” that often is not communicated. Most patients will accept certain risks if they understand how those risks compare with the benefits of taking a needed medication, Paustenbach maintained. Pharmaceutical firms need to better communicate to patients the risks of not taking a drug or how a disease may progress if left untreated, he said. Drug companies, Paustenbach said, also need to be clear about the risks and benefits of taking prescribed medications with other drug products and the patient’s role in the “total approach to dealing with their illness,” such as the importance of diet and exercise. Leiden acknowledged that the issue of risk–benefit communication goes beyond FDA’s authority. “It’s not the FDA’s job to make the decision” about which medications are prescribed to patients, he said. Ultimately, Leiden said, physicians and patients must decide together whether a drug can be safely used by the patient. But, Leiden said, he is often “astounded” about how little most practicing physicians understand about evaluating the risks and benefits of medication use for their patients. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

Traynor,, Kate

doi: 10.2146/news050090pmid: 16809750

A congressionally mandated panel whose mission is to discover what ordinary people want from the health care system has called for the creation of a basic package of benefits for all Americans by 2012. “Americans should have a health care system where everyone participates, regardless of their financial resources or health status,” states the interim recommendations from the Citizens’ Health Care Working Group. These health benefits should be “sufficiently comprehensive to provide access to appropriate, high-quality care without endangering individual or family financial security,” according to the panel’s findings. The recommendations, released June 1, are intended to represent the voice of the American people as presented to the 14-member citizens’ panel online, in writing, and during public meetings held across the nation this past winter and spring. In all, the panel made six main recommendations: A public policy, established in law, should guarantee affordable health care for all Americans. A national core package of physical, mental, and dental health benefits should be defined using evidence-based principles. Everyone should be shielded from very high health care costs. The federal government should support integrated community health networks and coordinate the support of the health care safety net. The federal government should promote evidence-based improvements in health care quality and efficiency. The financing and provision of end-of-life care should be restructured to improve access to palliative services for those with incurable conditions. “These recommendations outline a vision and a plan for achieving broad-based change in health care in America,” the interim document states. “We recognize that the issues involved are complex and challenging, and that it will take time and a great deal of technical expertise, as well as political will, to make the changes we think are necessary.” The committee’s full recommendations are available at www.citizenshealthcare.gov. The panel is accepting public comments on the recommendations through August 31. All public comments on the interim recommendations are to be posted online. In general, the public’s comments on the interim recommendations so far represent a wide range of views on what kind of health care system currently exists in the United States, how or if the health care system needs to be fixed, and who should pay for changes to the system. After the comment period ends, the panel will produce final recommendations for the President, who is required by law to review and comment on the recommendations in a report for Congress. The President is also obligated to suggest legislation and administrative actions related to the panel’s findings, if appropriate. Within 45 days of receiving the President’s recommendations, two Senate and three House committees must begin hearings evaluating those recommendations and the panel’s work. Health care policy expert Shoshanna Sofaer of Baruch College in New York City said that although she was disappointed that the report lacked direct quotes from the public, she was pleased by most of the recommendations in the document. “They’re good recommendations,” Sofaer said. She added that she was particularly pleased that the group tackled end-of-life care, a topic that is usually covered by “policy wonks,” not the broader public. Sofaer was a member of the Institute of Medicine (IOM) Committee on the Consequences of Uninsurance, which issued a series of reports from 2001 to 2004. The committee’s final report had recommended that universal health care coverage be available to Americans by 2010. But Sofaer doubted that her group’s recommendations or those of the citizens’ panel will be adopted by their target dates. “The political planets have to be in alignment [for universal coverage], and they aren’t now,” Sofaer said. “And they won’t be until we get leadership on both the executive branch and the legislative branch at the national level.” The citizens’ committee did not provide a detailed plan for financing universal coverage but proposed a combination of enrollee contributions and income taxes, value-added taxes, and so-called sin taxes. The group explained that “large majorities” of the American public have said they are willing to pay more to support the expansion of access to high-quality health care. The interim report also stated that health care spending “needs to be considered in the context of other societal needs and responsibilities.” About 18% of Americans under age 65 years—more than 45 million people—lacked health insurance in 2004, according to the most recent data from the nonprofit Kaiser Family Foundation. The remainder of the so-called nonelderly population relies on employer-sponsored insurance plans, private plans, or public programs like Medicaid and Medicare for coverage of medical costs. Publicly financed insurance coverage through the Medicare program is available to people age 65 years or older and to certain disabled Americans. Medicaid coverage is available mostly for low-income households with children. Nearly three-fourths of adults in childless households with earnings below the federal poverty level receive no assistance from Medicaid, and nearly half lack insurance coverage from another source, according to Kaiser. Some of the comments on the interim report that have been posted to the panel’s Web site expressed a belief that Medicaid and Medicare coverage is universally available to meet the health care needs of the poor. Other commenters have stated that Americans already have access to universal care because hospitals cannot turn people away when they seek emergency services. Language creating the citizens’ panel was included in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 at the behest of Senators Ron Wyden of Oregon and Orrin Hatch of Utah. Panel members were chosen in February 2005 by U.S. Comptroller General David Walker from a pool of more than 530 applicants. Panel members have different backgrounds, and health care lobbyists or politicians were ineligible for the committee. Health and Human Services Secretary Michael Leavitt is part of the committee by statute and will be formally presented with the group’s final recommendations. Leavitt did not participate in formulating the interim recommendations, according to the June report. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

doi: 10.1093/ajhp/63.14.1320apmid: N/A

Aripiprazole orally disintegrating tablets (Abilify Discmelt, Otsuka America Pharmaceutical): 10-, 15-, 20-, and 30-mg orally disintegrating tablets, with creme de vanilla flavoring and aspartame, were added to the product line. The tablets must not be split. Doxycycline capsules (Oracea, CollaGenex Pharmaceuticals): The antibiotic, prepared in a combination of immediate- and delayed-release beads, is indicated for the treatment of rosacea papules and pustules in adults. The recommended dosage is 40 mg taken once daily in the morning on an empty stomach, but with adequate amounts of fluid, at least one hour before or two hours after a meal for 16 weeks. Oracea will be available in 40-mg capsules containing 30 mg of doxycycline in immediate-release beads and 10 mg of the antibiotic in delayed-release beads. Fluticasone propionate and salmeterol hydrofluoroalkane inhalation aerosol (Advair HFA, GlaxoSmithKline): An inhalation aerosol, indicated for the long-term maintenance treatment of asthma in patients 12 years of age or older, was added to the product line. The recommended initial dosage in patients not already receiving corticosteroid therapy by inhalation is two inhalations twice daily from the lowest- or medium-strength canister; in patients whose asthma has not been adequately controlled with inhaled corticosteroids, consult the table in the FDA-approved labeling for the recommended dosage of fluticasone–salmeterol by inhalation. Advair HFA will be available in three strengths that deliver, from the actuator, 21 μg of salmeterol and 45, 115, or 230 μg of fluticasone propionate. Papillomavirus quadrivalent recombinant vaccine (Gardasil, Merck): The vaccine, containing virus-like particles from four types of human papillomavirus (HPV), is indicated for the prevention in girls and women ages 9–26 years old of cervical cancer, genital warts, cervical adenocarcinoma in situ, grades 2 and 3 vulvar and vaginal intraepithelial neoplasia, and grades 1–3 cervical intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18. The recommended dosage is a series of three 0.5-mL doses administered by i.m. injection, with the first dose given at age 9–26 years of age and the other doses given two and six months afterward. Gardasil will be available as single-dose vials and ready-to-use syringes that must be stored at 2–8 °C. Prednisolone sodium phosphate orally disintegrating tablets (Orapred ODT, BioMarin Pharmaceutical): Grape-flavored orally disintegrating tablets containing 10, 15, or 30 mg of prednisolone were added to the product line, which is owned by Alliant Pharmaceuticals. Selegiline hydrochloride orally disintegrating tablets (Zelapar, Valeant Pharmaceuticals): The monoamine oxidase inhibitor is indicated for adjunct therapy of Parkinson’s disease in patients not receiving as much benefit as before from levodopa–carbidopa therapy. Use of the product is contraindicated in patients receiving dextromethorphan, meperidine, methadone, propoxyphene, tramadol, or another selegiline-containing product. The recommended initial dosage is 1.25 mg once a day before breakfast and without liquid; this dosage may be increased after six weeks to 2.5 mg once a day. Zelapar will be available in 1.25-mg tablets with grapefruit flavoring and aspartame. Somatropin for injection (Omnitrope, Sandoz): The hormone, which has an amino acid sequence identical to growth hormone produced by the human pituitary, is indicated for the long-term treatment of children whose failure to grow at a normal rate is due to inadequate secretion of endogenous growth hormone. The drug is also indicated for long-term replacement therapy in adults with growth hormone deficiency. Use of the product is contraindicated in children with fused epiphyses; patients with Prader-Willi syndrome who are severely obese or have a severe respiratory impairment, patients with an acute critical illness due to complications after open-heart or abdominal surgery or multiple accidental traumas, patients with acute respiratory failure, and patients in whom there is evidence of tumor growth. The recommended dosage in children is 0.16–0.24 mg/kg a week, divided into daily doses administered by s.c. injection. In adults, the initial dosage should not exceed 0.04 mg/kg a week, divided into daily s.c. doses; this dosage may be increased at intervals of four to eight weeks to a maximum of 0.08 mg/kg a week. Omnitrope will be available in drug–diluent sets: a vial containing 1.5 mg of lyophilized somatropin accompanied by a vial of sterile water for injection; or a vial containing 5.8 mg of lyophilized somatropin accompanied by a vial of bacteriostatic water for injection. The somatropin vials must be stored at 2–8 °C. Zoster vaccine live for injection (Zostavax, Merck): The vaccine is indicated for the prevention of herpes zoster in persons 60 years of age or older. Use of the product is contraindicated in patients receiving immunosuppressive therapy or who have active untreated tuberculosis or a history of primary or acquired immunodeficiency or anaphylactic reaction to gelatin or neomycin. The recommended dosage is 0.65 mL administered once by s.c. injection into the upper arm. Zostavax will be available in single-dose vials of lyophilized vaccine accompanied by vials of diluent. The vaccine vials must be stored at −20 °C or colder during shipment and at an average temperature of −15 °C or colder by the end user. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

doi: 10.1093/ajhp/63.14.1320pmid: N/A

• Christopher W. Crank, Pharm.D., BCPS with Added Qualifications in Infectious Diseases, was recognized as preceptor of the year by Midwestern University Chicago College of Pharmacy and Purdue University School of Pharmacy and Pharmaceutical Sciences in West Lafayette, Indiana. Crank is the clinical specialist in infectious diseases for the pharmacy department at Rush University Medical Center in Chicago. • Rear Admiral Robert E. Pittman received the 2006 Flag Officer Award from the American Indian and Alaska Native Commissioned Officers Advisory Committee. Pittman is the principal pharmacy consultant for the Indian Health Service and chief pharmacist officer for the U.S. Public Health Service Commissioned Corps. The award recognizes contributions that have proven invaluable to the Commissioned Corps. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

Carro,, George

doi: 10.2146/ajhp060202pmid: 16809751

This interview was conducted February 24, 2006, with George Carro, senior director of oncology pharmacy services at Evanston Northwestern Healthcare. Carro was interviewed by Donna Young, news writer for the American Journal of Health-System Pharmacy. The questions are focused on the effects of the changes in the Outpatient Prospective Payment System, under which medications provided in areas such as infusion suites, cancer centers, and stress laboratories will be reimbursed. For many drugs, the reimbursement will decrease to the average sales price (ASP) plus 6%, which will result in health systems losing margin on many products and may require service-line evaluation and tighter controls on patient precertification and the reimbursement cycle. Q: Please describe your organization and the areas that are being affected by the ASP pricing model. A: Evanston Northwestern Healthcare is an 858-bed three-hospital system located in Chicago’s northern suburbs. Each facility has an outpatient cancer center. The three Kellogg Cancer Care centers provide chemotherapy treatment to about 120 patients per day. Our pharmacies prepare about 400 doses of chemotherapy and associated medications per day, 200 of which are prepared at Evanston Hospital, the largest of the three hospitals, in Evanston, Illinois. Our health system is fully equipped with computerized prescriber-order-entry and electronic medical records systems. Of the health-system’s departments, oncology has been affected the most by the new ASP pricing model. Q: Have you identified the drugs that are at the highest risk because of this new pricing? A: Pegfilgrastim, or Neulasta, and docetaxel, sold under the trade name Taxotere, are the two that really stand out. We are paying about 10% to 15% more for them than Medicare will reimburse. That additional amount comes out of the health-system’s budget, which is something that administration does not want to hear. So you ask yourself, how can this happen? We are not a huge institution, but we are not small either. Does Medicare have the price wrong, are the companies selling it to somebody else a lot cheaper, or is the data flawed somewhere? When you ask the drug companies, they say that Medicare has the wrong data. Q: How did you obtain the data that showed which drugs were higher reimbursement risks than others with the new ASP pricing? A: Under the old system of using the average wholesale price, every year beginning in December, I would identify our top 20 drugs based on cost and put together a spreadsheet looking at the use of those drugs and what our Medicare reimbursement was for that year. Based on that information, I estimate what our costs and reimbursements for the coming year will be. I have been doing this for several years now. The process is a little easier this year because the ASP numbers are published without further calculations required. The ASPs will change quarterly. However, Medicare’s ASP data are three quarters behind. So, you are looking at the figures that they got three quarters ago for what you are being reimbursed now, which may or not be accurate. This past December, we used the reimbursement amounts that physicians in private practice were getting to try to predict which drugs were going to be the loss leaders, what drugs were going to be okay, and what the overall effect was going to be. Q: What steps have you taken to ensure that your health-system’s administration is aware of how this change in pricing will affect your organization? A: We explain to administration how much overall our Medicare reimbursement will change, that is, how much approximately it will go down this year compared with last year. However, with some drugs, even though the reimbursement has decreased, the price has also gone down. For example, our average cost last year for carboplatin was higher than it will be this year. So, while the reimbursement for that drug has gone down, the price has also decreased. Q: Has there been much communication with physicians or physicians’ groups about the effect ASP pricing will have on the relationship between patients, physicians, and hospitals? A: There has been a lot of communication with physicians. We publish a monthly oncology newsletter in which we always include something about reimbursement and costs. We have found that physicians want to know what the costs are to the patient for a lot of our medications. Whenever a new drug comes out, we usually include in the newsletter the dose, how to administer the drug, the approximate cost to us, and the cost to the patient on a monthly basis. The physicians appreciate the information. They are very good about asking us what drug would be best for the patient and if it is the most cost-effective option. I have been impressed that our physicians really want to know what the costs are and have taken a very active role in this regard. Q: Has there been feedback from nursing on how this will affect their practice settings? A: We try to make the nurses aware of any medications that may increase the financial risk to the patient. Our nurses are very dedicated patient advocates and often identify patients with insurance and reimbursement concerns, and they work with us to initiate patient assistance. Q: How have you educated pharmacy staff about the new procedures in managing patients on high-cost medications to help ensure reimbursement? A: It has been an ongoing process for over a year. We have spent a lot of time making our pharmacists more aware of new coding and compliance issues. The pharmacy ends up doing a lot of the research on behalf of the patient. We call the insurance company to find out if the patient is going to be covered, and if not, explore all of the patient-assistance options. So, in many instances, we have become the advocate. Patients use the pharmacists to try to help them figure out what their costs are going to be for their oral medications at home and their medications here at the hospital. There is a group of patients who are underinsured or have lifetime caps on their insurance, and you worry about them because with some of these treatments, the patient reaches that cap very soon. Essentially, we try to help patients in any way we can (e.g., compassionate care, patient-assistance programs) to cut their costs. We spend a lot of time trying to advocate for the patient by signing them up with patient-assistance programs. Unfortunately, those programs have become more complicated this year, mostly with the high-cost drugs. We have also had good success appealing to the fiscal intermediary from Medicare for many treatments that are not listed in the indications. We have written letters, including patient-specific information, along with three articles supporting the use of a particular drug for a particular indication. Q: Does your facility require any type of preauthorization for patients receiving outpatient drug therapy? A: We have a preauthorization process for transplant recipients, but we do not require preauthorization for our cancer patients. Q: Has your hospital considered discontinuing any service lines due to the reimbursement changes? A: No. While the changes in reimbursement are negative, we would not change our service lines. If we did, we would abandon Medicare patients and patients whose treatments are “financial losers.” It is quite a dilemma, and it has become a clinical dilemma. But our medical staff is wonderful. They are very open to the possibility of substituting drugs for some patients when possible, such as changing from pegfilgrastim, which is a sustained product, to filgrastim, which requires more injections. Some patients are given prescriptions for pegfilgrastim to be filled out of the hospital if they have someone who can administer the drug for them, such as a family member who is a nurse or physician. So far, we have successfully worked with patients to meet their needs. Q: Have you seen any changes in behavior from insurance companies since ASP pricing went into effect? A: We spend a lot more time petitioning insurance companies to support a patient’s treatment. One way we do that is to send articles published in professional journals to them to support the particular use of a drug for a patient. Q: What are some of your concerns over the next year as a result of this new ASP pricing? A: I am concerned that the decrease in Medicare reimbursement will affect the comprehensive oncology pharmacy services that we currently provide. Author notes The Medicare Modernization Act (MMA) Q&A, coordinated through the Section of Home, Ambulatory, and Chronic Care Practitioners, is a series of interviews with pharmacy practitioners who describe different aspects of the MMA and discuss how they are implementing and adjusting to practice changes and challenges brought about by the MMA. This forum presents viewpoints and experiences expressed by the practitioner during a single interview and may not reflect the developing landscape of the MMA over time. Information provided in the MMA Q&A is not an official interpretation of any laws or regulations, nor does the forum offer direct information from payers, prescription drug plans, or the Centers for Medicare and Medicaid Services. ASHP hopes you will find this forum a useful tool for interpreting and implementing the portions of MMA that affect your practice. Please direct comments or suggestions for this column to David Chen, director of ASHP’s Section of Home, Ambulatory, and Chronic Care Practitioners, at [email protected]. After this interview was conducted, Amgen worked with Medicare to increase the ASP, and it has decreased the cost of pegfilgrastim. The reimbursement from Medicare is now greater than the cost of the drug. This change was effective April 1 and included an increase in ASP payment and a decrease in the cost of pegfilgrastim. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

Morello, Candis, M.;Zadvorny, Emily, B.;Cording, Margaret, A.;Suemoto, Ryan, T.;Skog,, Jilian;Harari,, Amir

doi: 10.2146/ajhp050430pmid: 16809752

Abstract Purpose. The development and outcomes of two pharmacist-managed diabetes care clinics (DCCs) are described. Methods. Retrospective data analysis was performed to determine the outcomes for patients with type 2 diabetes mellitus who were treated in two pharmacist-managed DCCs. Primary outcome measures included changes in glycosylated hemoglobin (HbA1c), fasting plasma glucose, body mass index, low-density-lipoprotein (LDL) cholesterol, high-density-lipoprotein cholesterol, triglycerides, and blood pressure and documented annual retinal and micro-albumin screening. Secondary outcome measures included the use of aspirin and kidney-sparing agents and annual screening for thyroid-stimulating hormone. Results. Data from 113 patients in the DCCs were analyzed. After one year, the mean reduction in HbA1c levels was 1.3%, with a mean HbA1c of 7.8%. HbA1c goals were based on the institution’s HbA1c normal range of 4.1–6.5%. Compared with baseline, over one third of patients met the HbA1c and blood pressure goals of <7.5% and <130/80 mm Hg, respectively. Mean LDL cholesterol concentration decreased from 110 to 94 mg/dL. The mean concentration of triglycerides decreased from 243 to 178 mg/dL. Mean systolic blood pressure decreased from 136 to 132 mm Hg. Whereas the national average for uncontrolled diabetes (HbA1c > 9.5%) was 36.9%, only 3.5% of patients at the pharmacist-managed DCCs had uncontrolled diabetes. Attainment rates of LDL cholesterol goals and annual retinal and microalbumin screenings were significantly higher in clinic patients compared with national averages. Three-year postclinic inception data revealed similar favorable outcomes, most notably an average HbA1c of 7.6% and 55% of patients meeting their target HbA1c goal of <7.5%. Conclusion. Compared with national averages, DCCs managed by clinical pharmacists achieved higher screening rates and attained treatment goals more often. Ambulatory care, Clinical pharmacists, Diabetes mellitus, Interventions, Pharmaceutical services An estimated 20.8 million Americans have diabetes mellitus, accounting for 7% of the U.S. population.1 By 2050 or possibly sooner, the number of Americans living with diabetes is projected to more than double.2,3 Type 2 diabetes mellitus represents approximately 90% of patients with this disease.1 In 2002, the total cost for treating diabetes in our country was an estimated $132 billion, with the majority spent on treatment of long-term complications.4 Poor glycemic control manifests in costly, lifelong morbidities, including blindness, kidney failure, amputations, and cardiovascular disease. The economic burden of treating long-term diabetes complications is well documented.4,5 Improving glycemic control in patients with type 2 diabetes mellitus can prevent or delay the onset, or slow the progression, of microvascular and some macrovascular complications.6,–9 Patients can benefit from an individualized approach to comprehensive diabetes care. Comprehensive care involves a multidisciplinary approach with evaluation and education from specialty practitioners, such as endocrinologists, pharmacists, exercise physiologists, diabetes educators, nurses, dietitians, podiatrists, and ophthalmologists. A cornerstone of diabetes treatment is drug therapy, often with complex regimens, including multiple oral and injectable agents. A collaborative agreement between physicians and pharmacists is an innovative strategy to treat patients with diabetes that takes advantage of pharmacists’ expertise in disease management and drug monitoring. Improved patient outcomes and reduced cost to health care systems are potential benefits of implementing an innovative ambulatory clinic model for diabetes treatment. The Naval Medical Center San Diego (NMCSD) treats over 5000 patients with diabetes. NMCSD is a 500-bed comprehensive teaching hospital with more than 20 general and specialty ambulatory care clinics. In mid-1999, ambulatory care pharmacist specialists were specifically hired to expand the current pharmacist-managed ambulatory care services in anticoagulation and lipid clinics and to create new clinics. This article describes the development of two pharmacist-managed diabetes care clinics (DCCs) established at NMCSD and the diabetes-related outcomes of enrolled patients, comparing these outcomes to national averages. Methods Clinic development In early 2000, the ambulatory care pharmacist team at the NMCSD developed two DCCs for patients in the endocrinology and primary care clinics. Working in collaboration with a board-certified endocrinologist and primary care physicians, clinical practice guidelines and treatment algorithms were created based on national standards of care for diabetes and related comorbidities, including hypertension and hyperlipidemia.10,–13 Patient encounter notes, care flow sheets, and patient care plan documents were developed.14 All pharmacist providers had similar educational backgrounds. Each held a doctor of pharmacy degree and completed at least one year of pharmacy practice residency in addition to undergoing significant scrutiny to attain prescribing privileges at the NMCSD to provide disease management under physician-approved protocols. Prescribing privileges are medical-center-approved guidelines authorizing pharmacists to perform specific clinical tasks related to patient care (e.g., prescribe medications, place and interpret laboratory orders, order various medical procedures). Moreover, the clinical pharmacists attended additional diabetes training courses held by the American Association of Diabetes Educators. Two pharmacist-managed DCCs were created: (1) a primary care DCC, managed by two pharmacists, and (2) an endocrinology DCC, managed by one pharmacist who was also a certified diabetes educator. Initial outcomes analysis One year after clinic inception, a continuous-improvement report was required to analyze the effectiveness of the pharmacist-managed DCCs. Hence, we conducted a retrospective chart review from April 2000 through May 2001. Patient-identifying information was not collected. Data from patients with type 2 diabetes mellitus who were enrolled in the pharmacist-managed DCCs and had two or more clinic encounters with a clinical pharmacist were analyzed. The few patients with type 1 diabetes mellitis, who received care in the endocrinology DCC, were excluded from data analysis. Primary outcome measures were changes from baseline (at clinic enrollment) in diabetes-related markers, including glycosylated hemoglobin (HbA1c), fasting plasma glucose, body mass index (BMI), low-density-lipoprotein (LDL) cholesterol, high-density-lipoprotein (HDL) cholesterol, triglycerides, and blood pressure. The numbers of patients receiving retinal and microalbumin annual screenings were also recorded. HbA1c, LDL cholesterol, and annual retinal screening and microalbumin screening clinical markers were benchmarked against available corresponding national averages of patients being treated for diabetes.15 The National Committee for Quality Assurance (NCQA) reported the mean percentages of patients achieving specified outcomes from combined data available from commercially accepted plans of the NCQA Health Plan Employer Data and Information Set (HEDIS) from 2000 through 2003. The NCQA HEDIS 2001 data set supplied the national averages to which DCC outcomes were compared. The American Diabetes Association (ADA) HbA1c target of less than 7.0% is less than 1% above the upper normal limit of 4.0–6.0% when measured by a Diabetes Control and Complications Trial-based assay.10,16,17 ADA’s HbA1c goal is based on data from prospective randomized clinical trials showing that a reduction in the average HbA1c to approximately 7% (approximately 1% above the upper limit of normal) was associated with fewer long-term complications.6,7,16 Since no standardized HbA1c assay existed, each laboratory based its normal HbA1c range on its nondiabetic population and the particular assay used. During our study, the normal HbA1c range of nondiabetic patients at NMCSD was 4.1–6.5%. Using ADA’s target goal for HbA1c (<1% above the upper limit of normal), the target HbA1c was set at <7.5% for NMCSD’s diabetic patients. Secondary outcome measures included the percentage of patients who (1) received aspirin for cardioprotection, (2) had microalbuminuria or proteinuria and were taking a kidney-sparing agent (e.g., angiotensin-converting-enzyme inhibitor, angiotensin-receptor blocker, or calcium channel blocker), and (3) received annual thyroid-stimulating hormone (TSH) screening by study end. Statistical analysis Patients served as their own control for within-patient comparisons of outcome variables. All comparisons for continuous variables were analyzed using a two-tailed paired t test. Chi-square analysis was used to analyze categorical data. The α level was set at 0.05. Outcomes from the study cohort were compared with corresponding national averages obtained from NCQA.15 Follow-up outcomes analysis To assess sustainability of the initial outcomes, a cross-sectional assessment of outcome measures was conducted three years after DCC inception. All patients with type 2 diabetes mellitus enrolled in both DCCs as of March 2003 were included. Outcomes measures collected and summarized included HbA1c, BMI, triglycerides, LDL and HDL cholesterol, and systolic and diastolic blood pressure. Results Clinic implementation Even though other ambulatory care programs were successfully operating at NMCSD, collaborative work in a disease requiring such comprehensive management as diabetes was unfamiliar at NMCSD. Because initial pharmacist-managed DCC development met with some resistance from physicians, particularly the primary care DCC, a physician-mandated level of care specifying the extent of care that a pharmacist could provide was conceived and implemented. After several iterations with physician input, we developed three levels of diabetes care from which referring physicians could select. Each level indicated the care each physician was comfortable with the pharmacist providing and did not reflect the severity of patients’ diabetes and co-morbid conditions. Depending on the scope of the referral, clinical pharmacists provided patients with one of the following care levels: diabetes self-care education and counseling (level 1), level 1 care plus diabetes treatment and monitoring (including evaluation, laboratory monitoring, and modification of pharmacotherapy) (level 2), and level 2 care plus education, treatment, and monitoring of comorbid conditions (including hypertension and hyperlipidemia) (level 3). The pharmacists performed limited physical assessments for level 2 and level 3 patients, including blood pressure measurements and foot examinations. The primary care DCC enrolled level 1–3 patients, and the endocrinology DCC enrolled only level 3 patients. In the primary care DCC, a physician could choose to move a patient from one level to another at any time. As their comfort level increased with the pharmacist-provided care, physicians advanced the majority of their patients to level 3 care. Because of the dynamic nature of this process, the number of patients at each level was constantly changing. Therefore, a clean comparison among levels of care could not be achieved. A designated physician oversaw and participated in the collaborative effort of each pharmacist-managed DCC. Patients who were not meeting their metabolic goals or who needed in-depth disease education and counseling were referred to the DCCs from the internal medicine and primary care clinics. After a 90-minute initial visit, patients met with a DCC pharmacist every 4–12 weeks (45–60 minutes per session) for individualized diabetes education, monitoring, and pharmacotherapy assessment and treatment. The frequency of visits and telephone follow-up were determined by each patient’s specific needs (e.g., evaluation of dosage adjustment or drug tolerability). Physicians were located in the same clinic space, so patients were immediately evaluated if the pharmacist identified acute symptoms requiring physician evaluation or diagnosis. Individualized treatment plans were created with patient input to emphasize the patient’s role in the process and to empower participants to take control of their diabetes. Comprehensive patient education focused on diabetes and long-term complications, identification and self-treatment of hypoglycemia and hyperglycemia, self-monitoring of blood glucose and pattern management, the importance of preventive care, proper foot and skin care, and nutrition and physical activity guidelines. Pharmacists referred patients to other health care providers when indicated (e.g., ophthalmologists, podiatrists, exercise physiologists, dieticians, urologists, nephrologists, cardiologists). Once patients met all of their metabolic targets, they were referred back to their primary care physicians for ongoing management. Initial outcomes analysis A total of 113 DCC patients with type 2 diabetes mellitus met the inclusion criteria, with 36 patients referred to the endocrinology DCC and 77 to the primary care DCC. Sixty-three patients (56%) were women. The mean age was 55.5 years, and the mean time since diabetes diagnosis was 9.1 years. Baseline and final primary clinical outcome measures are reported in Table 11. Improvements were realized in most clinical markers, particularly glycemic control, with a 1.3% reduction in HbA1c and an average end-of-study HbA1c of 7.8%. Table 1. Primary Clinical Outcomes for All Patients Treated in Diabetes Care Clinics Variablea Mean Baseline Value Mean Final Value Change aBecause some patients did not receive level 3 comprehensive diabetes care, including treatment of blood pressure and lipid levels, n differs per variable. bHbA1c = glycosylated hemoglobin, FPG = fasting plasma glucose, BMI = body mass index, LDL = low-density-lipoprotein, HDL = high-density-lipoprotein, SBP = systolic blood pressure, DBP = diastolic blood pressure. cFor HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. HbA1c (%)b,c (n = 113) 9.1 7.8 –1.3 FPG (mg/dL) (n = 113) 175 142 –33 BMI (kg/m2) (n = 113) 30.9 31.0 0.1 Total cholesterol (mg/dL) (n = 83) 208 182 –26 LDL cholesterol (mg/dL) (n = 75) 110 94 –16 HDL cholesterol in men (mg/dL) (n = 39) 44 45 1 HDL cholesterol in women (mg/dL) (n = 43) 61 58 –3 Triglycerides (mg/dL) (n = 83) 243 178 –65 SBP (mm Hg) (n = 87) 136 132 –4 DBP (mm Hg) (n = 87) 75 73 –2 Variablea Mean Baseline Value Mean Final Value Change aBecause some patients did not receive level 3 comprehensive diabetes care, including treatment of blood pressure and lipid levels, n differs per variable. bHbA1c = glycosylated hemoglobin, FPG = fasting plasma glucose, BMI = body mass index, LDL = low-density-lipoprotein, HDL = high-density-lipoprotein, SBP = systolic blood pressure, DBP = diastolic blood pressure. cFor HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. HbA1c (%)b,c (n = 113) 9.1 7.8 –1.3 FPG (mg/dL) (n = 113) 175 142 –33 BMI (kg/m2) (n = 113) 30.9 31.0 0.1 Total cholesterol (mg/dL) (n = 83) 208 182 –26 LDL cholesterol (mg/dL) (n = 75) 110 94 –16 HDL cholesterol in men (mg/dL) (n = 39) 44 45 1 HDL cholesterol in women (mg/dL) (n = 43) 61 58 –3 Triglycerides (mg/dL) (n = 83) 243 178 –65 SBP (mm Hg) (n = 87) 136 132 –4 DBP (mm Hg) (n = 87) 75 73 –2 Open in new tab Table 1. Primary Clinical Outcomes for All Patients Treated in Diabetes Care Clinics Variablea Mean Baseline Value Mean Final Value Change aBecause some patients did not receive level 3 comprehensive diabetes care, including treatment of blood pressure and lipid levels, n differs per variable. bHbA1c = glycosylated hemoglobin, FPG = fasting plasma glucose, BMI = body mass index, LDL = low-density-lipoprotein, HDL = high-density-lipoprotein, SBP = systolic blood pressure, DBP = diastolic blood pressure. cFor HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. HbA1c (%)b,c (n = 113) 9.1 7.8 –1.3 FPG (mg/dL) (n = 113) 175 142 –33 BMI (kg/m2) (n = 113) 30.9 31.0 0.1 Total cholesterol (mg/dL) (n = 83) 208 182 –26 LDL cholesterol (mg/dL) (n = 75) 110 94 –16 HDL cholesterol in men (mg/dL) (n = 39) 44 45 1 HDL cholesterol in women (mg/dL) (n = 43) 61 58 –3 Triglycerides (mg/dL) (n = 83) 243 178 –65 SBP (mm Hg) (n = 87) 136 132 –4 DBP (mm Hg) (n = 87) 75 73 –2 Variablea Mean Baseline Value Mean Final Value Change aBecause some patients did not receive level 3 comprehensive diabetes care, including treatment of blood pressure and lipid levels, n differs per variable. bHbA1c = glycosylated hemoglobin, FPG = fasting plasma glucose, BMI = body mass index, LDL = low-density-lipoprotein, HDL = high-density-lipoprotein, SBP = systolic blood pressure, DBP = diastolic blood pressure. cFor HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. HbA1c (%)b,c (n = 113) 9.1 7.8 –1.3 FPG (mg/dL) (n = 113) 175 142 –33 BMI (kg/m2) (n = 113) 30.9 31.0 0.1 Total cholesterol (mg/dL) (n = 83) 208 182 –26 LDL cholesterol (mg/dL) (n = 75) 110 94 –16 HDL cholesterol in men (mg/dL) (n = 39) 44 45 1 HDL cholesterol in women (mg/dL) (n = 43) 61 58 –3 Triglycerides (mg/dL) (n = 83) 243 178 –65 SBP (mm Hg) (n = 87) 136 132 –4 DBP (mm Hg) (n = 87) 75 73 –2 Open in new tab For non-glycemic-related laboratory test values, the number of patients varies since not all patients received comprehensive level 3 care. LDL cholesterol values were not reported in seven patients due to excessively elevated triglyceride levels, and the LDL and HDL cholesterol levels of one patient were not available due to laboratory error. A significantly higher proportion of patients achieved a Joint National Committee (JNC) VI blood pressure goal of <130/80 mm Hg and an ADA HbA1c goal of <1% above the upper limit of normal after treatment in the DCCs than at baseline (Figure 11). Figure 1. Open in new tabDownload slide Achievement of glycemic and blood pressure targets. For HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. Of the patients evaluated for achievement of the American Diabetes Association goal for glycosylated hemoglobin (HbA1c) (n = 113), 20 (18%) and 41(36%) had an HbA1c of <7.5% at baseline and study end, respectively (p < 0.01, χ2 test). Of the 87 patients evaluated for achievement of the Joint National Committee’s blood pressure goal for diabetic patients, 18 (21%) and 30 (34%) had a blood pressure reading of <130/80 mm Hg at baseline and study end, respectively (p < 0.05, χ2 test). Figure 1. Open in new tabDownload slide Achievement of glycemic and blood pressure targets. For HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. Of the patients evaluated for achievement of the American Diabetes Association goal for glycosylated hemoglobin (HbA1c) (n = 113), 20 (18%) and 41(36%) had an HbA1c of <7.5% at baseline and study end, respectively (p < 0.01, χ2 test). Of the 87 patients evaluated for achievement of the Joint National Committee’s blood pressure goal for diabetic patients, 18 (21%) and 30 (34%) had a blood pressure reading of <130/80 mm Hg at baseline and study end, respectively (p < 0.05, χ2 test). In addition to achieving glycemic and other diabetes-related clinical goals, patients in the DCCs received other comprehensive preventive care. After the first year of the study, 77% of patients were taking aspirin daily for cardiovascular protection. Patients not taking aspirin included those who had a relative or absolute contraindication to therapy. Of the 53 patients with microalbuminuria or proteinuria, 98% were treated with a kidney-sparing antihypertensive agent at study end. The 2% of patients not taking a kidney-sparing medication had a relative or absolute contraindication to therapy with these agents. Within the previous 12 months, TSH screening had been performed on 94% of patients. Laboratory tests were ordered for the few patients who did not have a TSH screening, but due to laboratory error or patient choice, blood was not analyzed for the TSH evaluation. National average comparisons To put the DCC outcomes in perspective, DCC initial outcomes data were compared with corresponding national averages. After one year of DCC operation, substantially fewer DCC patients had poor glycemic control (HbA1c > 9.5% defined by HEDIS 2001), with only 4 of 113 DCC patients (3.5%) reaching this threshold, compared with 36.9% of patients nationally (p < 0.001) (Figure 22). HEDIS 2001 set an LDL cholesterol goal of <130 mg/dL, whereas the target goal for the DCCs was the more stringent target established by the National Cholesterol Education Program (NCEP) (<100 mg/dL).12 A greater number of patients in the DCCs achieved an LDL cholesterol concentration of <100 mg/dL, despite the more rigorous goal (Figure 2 2). Almost 87% (98 of 113) of DCC patients received annual retinal screening compared with a national average of 52.1% of diabetes patients (p < 0.001). Annual testing for diabetic nephropathy was performed by DCC pharmacists more than twice as frequently as reported nationally (109 of 113 patients [96.4%] versus 46.3%, respectively) (Figure 33). Figure 2. Open in new tabDownload slide Comparison of glycosylated hemoglobin (HbA1c) and low-density-lipoprotein cholesterol values of patients in diabetes care clinics (DCCs) with the national averages of diabetic patients. For HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. Significantly fewer patients in the DCCs had poor glycemic control (4/113 [3.5%]) compared with the national average (36.9%) (p < 0.001, χ2 test). Despite the more rigorous LDL cholesterol goal set by the DCCs, a higher proportion of DCC patients (49/75 [65.3%]) achieved substantially better LDL cholesterol control when compared with the national average (49.8%) (p < 0.01, χ2 test). Figure 2. Open in new tabDownload slide Comparison of glycosylated hemoglobin (HbA1c) and low-density-lipoprotein cholesterol values of patients in diabetes care clinics (DCCs) with the national averages of diabetic patients. For HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. Significantly fewer patients in the DCCs had poor glycemic control (4/113 [3.5%]) compared with the national average (36.9%) (p < 0.001, χ2 test). Despite the more rigorous LDL cholesterol goal set by the DCCs, a higher proportion of DCC patients (49/75 [65.3%]) achieved substantially better LDL cholesterol control when compared with the national average (49.8%) (p < 0.01, χ2 test). Figure 3. Open in new tabDownload slide Comparison of the number of patients in pharmacist-managed diabetes care clinics (DCCs) who received annual retinal and microalbumin screenings with national averages. Most DCC patients received annual retinal screening (98/113 [86.7%]) compared with the national average of 52.1% (p < 0.0001). Annual testing for diabetic nephropathy (microalbumin screening) was performed by DCC pharmacists more than twice as frequently (109/113 [96.4%]) as reported nationally (46.3%) (p < 0.0001). Figure 3. Open in new tabDownload slide Comparison of the number of patients in pharmacist-managed diabetes care clinics (DCCs) who received annual retinal and microalbumin screenings with national averages. Most DCC patients received annual retinal screening (98/113 [86.7%]) compared with the national average of 52.1% (p < 0.0001). Annual testing for diabetic nephropathy (microalbumin screening) was performed by DCC pharmacists more than twice as frequently (109/113 [96.4%]) as reported nationally (46.3%) (p < 0.0001). Subset analysis of endocrinology DCC Unlike the primary care DCC, which was run by two pharmacists, the endocrinology DCC was managed by one clinical pharmacist. Moreover, all patients in this clinic received comprehensive level 3 diabetes care. To determine if large differences in patient outcomes existed between the two DCCs, a subset comparison of the endocrinology DCC to the larger group was performed (Table 22). Of the 113 patients, 36 were enrolled in the endocrinology DCC. Of these, 20 (56%) were female. The mean ± S.D. age was 51.8 ± 10.8 years, and the mean ± S.D. time since diabetes diagnosis was 9.3 ± 8.4 years. Six patients, who were referred to the pharmacist for intense insulin regimen or other co-morbid evaluation, achieved the HbA1c goal at referral and maintained this threshold throughout the study and were therefore excluded from the analysis. Results were similar to those for all DCC patients. Patients achieved significantly improved glycemic control, with a 1.2% reduction in HbA1c and a mean final HbA1c of 8.0%. In addition, preventive care outcomes were similar to the larger group. By study end, 29 of 36 patients (81%) were taking aspirin daily, 35 (97%) had an annual TSH screening, and 32 (89%) had retinal screening. Annual microalbumin screenings were completed for 35 patients (97%), and all patients (100%) who tested positive for microalbuminuria or proteinuria received a kidney-sparing antihypertensive agent. Table 2. Primary Clinical Outcomes for Level 3 Endocrinology Diabetes Care Clinics Mean ± S.D. Value Endpoint Baseline Final Change pa aTwo-tailed t test. b HbA1c = glycosylated hemoglobin, FPG = fasting plasma glucose, BMI = body mass index, NS = not significant, LDL = low-density-lipoprotein, HDL = high-density-lipoprotein, SBP = systolic blood pressure, DBP = diastolic blood pressure. c For HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. HbA1c (%)b,c (n = 30) 9.2 ± 1.7 8.0 ± 0.8 –1.2 <0.001 FPG (mg/dL) (n = 36) 165 ± 71 140 ± 53 –25 <0.05 BMI (kg/m2) (n = 36) 31 ± 4.6 31.1 ± 4.5 0.1 NS Total cholesterol (mg/dL) (n = 36) 202 ± 58 182 ± 40 –20 <0.05 LDL cholesterol (mg/dL) (n = 36) 109 ± 35 95 ± 31 –14 <0.05 HDL cholesterol in men (mg/dL) (n = 16) 45 ± 13 46 ± 10 1 NS HDL cholesterol in women (mg/dL) (n = 20) 61 ± 17 59 ± 14 –2 NS Triglycerides (mg/dL) (n = 36) 209 ± 187 166 ± 68 –43 NS SBP (mm Hg) (n = 36) 138 ± 15 132 ± 14 –6 NS DBP (mm Hg) (n = 36) 74 ± 9 75 ± 10 1 NS Mean ± S.D. Value Endpoint Baseline Final Change pa aTwo-tailed t test. b HbA1c = glycosylated hemoglobin, FPG = fasting plasma glucose, BMI = body mass index, NS = not significant, LDL = low-density-lipoprotein, HDL = high-density-lipoprotein, SBP = systolic blood pressure, DBP = diastolic blood pressure. c For HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. HbA1c (%)b,c (n = 30) 9.2 ± 1.7 8.0 ± 0.8 –1.2 <0.001 FPG (mg/dL) (n = 36) 165 ± 71 140 ± 53 –25 <0.05 BMI (kg/m2) (n = 36) 31 ± 4.6 31.1 ± 4.5 0.1 NS Total cholesterol (mg/dL) (n = 36) 202 ± 58 182 ± 40 –20 <0.05 LDL cholesterol (mg/dL) (n = 36) 109 ± 35 95 ± 31 –14 <0.05 HDL cholesterol in men (mg/dL) (n = 16) 45 ± 13 46 ± 10 1 NS HDL cholesterol in women (mg/dL) (n = 20) 61 ± 17 59 ± 14 –2 NS Triglycerides (mg/dL) (n = 36) 209 ± 187 166 ± 68 –43 NS SBP (mm Hg) (n = 36) 138 ± 15 132 ± 14 –6 NS DBP (mm Hg) (n = 36) 74 ± 9 75 ± 10 1 NS Open in new tab Table 2. Primary Clinical Outcomes for Level 3 Endocrinology Diabetes Care Clinics Mean ± S.D. Value Endpoint Baseline Final Change pa aTwo-tailed t test. b HbA1c = glycosylated hemoglobin, FPG = fasting plasma glucose, BMI = body mass index, NS = not significant, LDL = low-density-lipoprotein, HDL = high-density-lipoprotein, SBP = systolic blood pressure, DBP = diastolic blood pressure. c For HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. HbA1c (%)b,c (n = 30) 9.2 ± 1.7 8.0 ± 0.8 –1.2 <0.001 FPG (mg/dL) (n = 36) 165 ± 71 140 ± 53 –25 <0.05 BMI (kg/m2) (n = 36) 31 ± 4.6 31.1 ± 4.5 0.1 NS Total cholesterol (mg/dL) (n = 36) 202 ± 58 182 ± 40 –20 <0.05 LDL cholesterol (mg/dL) (n = 36) 109 ± 35 95 ± 31 –14 <0.05 HDL cholesterol in men (mg/dL) (n = 16) 45 ± 13 46 ± 10 1 NS HDL cholesterol in women (mg/dL) (n = 20) 61 ± 17 59 ± 14 –2 NS Triglycerides (mg/dL) (n = 36) 209 ± 187 166 ± 68 –43 NS SBP (mm Hg) (n = 36) 138 ± 15 132 ± 14 –6 NS DBP (mm Hg) (n = 36) 74 ± 9 75 ± 10 1 NS Mean ± S.D. Value Endpoint Baseline Final Change pa aTwo-tailed t test. b HbA1c = glycosylated hemoglobin, FPG = fasting plasma glucose, BMI = body mass index, NS = not significant, LDL = low-density-lipoprotein, HDL = high-density-lipoprotein, SBP = systolic blood pressure, DBP = diastolic blood pressure. c For HbA1c, the upper limit of normal for the nondiabetic patient population at the Naval Medical Center San Diego (NMCSD) was 6.5%. The American Diabetes Association’s target HbA1c is <1% above the upper limit of normal; therefore, the target HbA1c at NMCSD was <7.5%. HbA1c (%)b,c (n = 30) 9.2 ± 1.7 8.0 ± 0.8 –1.2 <0.001 FPG (mg/dL) (n = 36) 165 ± 71 140 ± 53 –25 <0.05 BMI (kg/m2) (n = 36) 31 ± 4.6 31.1 ± 4.5 0.1 NS Total cholesterol (mg/dL) (n = 36) 202 ± 58 182 ± 40 –20 <0.05 LDL cholesterol (mg/dL) (n = 36) 109 ± 35 95 ± 31 –14 <0.05 HDL cholesterol in men (mg/dL) (n = 16) 45 ± 13 46 ± 10 1 NS HDL cholesterol in women (mg/dL) (n = 20) 61 ± 17 59 ± 14 –2 NS Triglycerides (mg/dL) (n = 36) 209 ± 187 166 ± 68 –43 NS SBP (mm Hg) (n = 36) 138 ± 15 132 ± 14 –6 NS DBP (mm Hg) (n = 36) 74 ± 9 75 ± 10 1 NS Open in new tab Three-year follow-up data Compared with 2001, the 2003 cross-sectional clinical outcomes evaluation of the DCCs showed similar favorable outcomes, with some improvement in glycemic control, triglycerides, and blood pressure. In March 2003, 133 patients with type 2 diabetes mellitus were enrolled in the DCCs, with an average HbA1c of 7.6%, and 55% of patients (73 of 133) met the target HbA1c goal of <7.5%. Mean BMI was 32 kg/m2. Patients’ average triglyceride concentration was 168 mg/dL, and the percentage of patients achieving a systolic blood pressure of <130 mm Hg and a diastolic blood pressure of <80 mm Hg was 65% (86 of 133) and 77% (102 of 133), respectively. Overall LDL and HDL cholesterol concentrations were 107 and 41 mg/dL, respectively. Discussion The goal of this project was to determine if pharmacist providers in the NMCSD DCCs, working collaboratively with physicians, could improve diabetes-related outcomes. As with all new clinical pharmacy programs, continuation of services should be justified with outcomes data. Pharmacist-managed diabetes clinics in ambulatory clinic and community pharmacy models have shown positive outcomes when pharmacists are involved in the care of patients with diabetes.18,–22 One-year outcomes data from the NMCSD DCCs demonstrated that pharmacist involvement in caring for patients with type 2 diabetes mellitus significantly improved clinical out-comes. For this time period, the over-all mean reduction in HbA1c was 1.3%. These outcomes remained consistent or improved three years post-clinic inception, with an average HbA1c of 7.6% and the majority of patients achieving a target HbA1c of <7.5%. A large study at a staff-model health maintenance organization found a cost saving of $685–$950 per patient whose HbA1c declined by at least 1% for the first year and continued improvement for the additional three years of the study.5 Based on this model and accounting for pharmacist time and salaries, the estimated cost avoidance to NMCSD was $17,157 per year. When extrapolated to the entire NMCSD diabetes population, cost avoidance analysis indicated a potential annual saving of $616,000–$735,000. Other diabetes-related markers, including blood pressure and lipid values, also improved in the DCC patients. All final mean cholesterol values were within the NCEP goals at the time of the initial outcomes study. Although the mean HDL cholesterol in female patients decreased by 3 mg/dL, the final HDL cholesterol mean of 58 mg/dL was well above the NCEP target goal. While improved glycemic control due to increased oral diabetes medication or insulin use may result in weight gain, patients managed in the DCCs maintained their BMI without significant weight gain at the end of year 1. The results of the subset analysis of the 36 endocrinology DCC patients indicate that outcomes of the larger group were similar to the outcomes of the endocrinology DCC patients receiving level 3 care and that similar improvements were seen in patients at all levels of treatment intensity. The cross-sectional assessment of outcome markers three years after DCC inception shows that the pharmacist-managed DCCs can provide sustained outcomes in glycemic, blood pressure, and lipid control. Moreover, outcomes measures achieved in our DCCs were superior to HEDIS national averages. These successful outcomes justified continuation of the pharmacist-managed DCCs at NMCSD. Offering different levels of care allowed referring physicians to dictate the degree of pharmacist involvement in diabetes management in the primary care DCC. One year after clinic inception, most physician referrals were for level 3 care, the most comprehensive care offered. By 2003, approximately 90–95% of patients were referred for level 3 care. This suggests an increasing level of comfort on the part of physicians for this collaborative model, likely due in part to our successful outcomes. We also found that working collaboratively with physicians in a clinic setting and having multidisciplinary team members available for consultation were valuable. Some study limitations included the retrospective nature of data collection and evaluation, the lack of a control group, and multiple pharmacist providers. However, patients served as their own control since previous care came from their primary care providers who made referrals to the DCCs when their patients were not achieving target metabolic goals. Increased physician confidence in the pharmacists’ abilities demonstrated that the changes seen in clinical markers were valued. Another possible confounder was that patients were provided different levels of care by multiple pharmacist providers in two clinics; however, subset analysis revealed that patients receiving the more comprehensive care achieved similar clinical outcomes to the larger patient group across clinic settings and treatment levels. Thus, having multiple pharmacist providers did not seem to affect overall care and clinical outcomes. With the recent implementation of Medicare Part D and the growth of medication therapy management services, pharmacists will become acknowledged as patient care providers for diseases such as diabetes, asthma, hyperlipidemia, hypertension, and congestive heart failure. With their extensive education and pharmacotherapy expertise, pharmacists can help patients achieve clinical goals. Conclusion Compared with national averages, DCCs managed by clinical pharmacists achieved higher screening rates and attained treatment goals more often. References 1 Centers for Disease Control and Prevention. National diabetes fact sheet. General information and national estimates on diabetes in the United States, 2005. www.cdc.gov/diabetes/pubs/factsheet05.htm (accessed 2006 Apr 12). 2 Boyle JP, Honeycutt AA, Narayan KM et al. Projection of diabetes burden through 2050: impact of changing demography and disease prevalence in the U.S. Diabetes Care. 2001 ; 24 : 1936 –40. Crossref Search ADS PubMed 3 Wild S, Roglic G, Green A et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care . 2004 ; 27 : 1047 –53. Crossref Search ADS PubMed 4 Hogan P, Dall T, Nikolov P, for the American Diabetes Association. Economic costs of diabetes in the U.S. in 2002. Diabetes Care . 2003 ; 26 : 917 –32. Crossref Search ADS PubMed 5 Wagner EH, Sandhu N, Newton KM et al. Effect of improved glycemic control on health care costs and utilization. JAMA . 2001 ; 285 : 182 –9. Crossref Search ADS PubMed 6 UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998 ; 352 : 837 –53. [Erratum, Lancet. 1999; 354:602.] Crossref Search ADS PubMed 7 UK Prospective Diabetes Study Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998 ; 352 : 854 –65. [Erratum, Lancet. 1998; 352:1558.] Crossref Search ADS PubMed 8 Stratton IM, Adler AI, Neil HA et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ . 2000 ; 321 : 405 –11. Crossref Search ADS PubMed 9 Knowler WC, Barrett-Connor E, Fowler SE et al., for the Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med . 2002 ; 346 : 393 –403. Crossref Search ADS PubMed 10 American Diabetes Association. Clinical practice recommendations 2000. Diabetes Care . 2000 ; 23 (suppl 1): S1 –116. Crossref Search ADS PubMed 11 The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Arch Intern Med. 1997 ; 157 : 2413 –46. [Erratum, Arch Intern Med. 1998; 158:573.] Crossref Search ADS PubMed 12 National Cholesterol Education Program. Second report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation . 1994 ; 89 : 1333 –445. Crossref Search ADS PubMed 13 American Association of Clinical Endocrinologists. AACE medical guidelines for clinical practice for the diagnosis and treatment of dyslipidemia and prevention of atherogenesis. Endocr Pract . 2000 ; 6 (2): 163 –213. 14 Morello CM, Suemoto RT. Diabetes. In: Blair MM, Blake EW, Harris IM, eds. Ambulatory care survival guide. Kansas City, MO: American College of Clinical Pharmacy; 2004 :125–30. 15 National Committee for Quality Assurance. The state of health care quality: 2004. www.ncqa.org/communications/SOMC/SOHC2004.pdf (accessed 2006 Apr 12). 16 Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med . 1993 ; 329 : 977 –86. Crossref Search ADS PubMed 17 American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2005 ; 28 (suppl 1): S4 –36. [Erratum, Diabetes Care. 2005; 28:990.] Crossref Search ADS PubMed 18 Garrett DG, Bluml BM. Patient self-management program for diabetes: first-year clinical, humanistic, and economic outcomes. J Am Pharm Assoc . 2005 ; 45 : 130 –7. Crossref Search ADS 19 Leal S, Glover JJ, Herrier RN et al. Improving quality of care in diabetes through a comprehensive pharmacist-based disease management program. Diabetes Care . 2004 ; 27 : 2983 –4. Crossref Search ADS PubMed 20 Irons BK, Lenz RJ, Anderson SL et al. A retrospective cohort analysis of the clinical effectiveness of a physician-pharmacist collaborative drug therapy management diabetes clinic. Pharmacotherapy . 2002 ; 22 : 1294 –300. Crossref Search ADS PubMed 21 Cioffi ST, Caron MF, Kalus JS et al. Glycosylated hemoglobin, cardiovascular, and renal outcomes in a pharmacist-managed clinic. Ann Pharmacother . 2004 ; 38 : 771 –5. Crossref Search ADS PubMed 22 Cranor CW, Christensen DB. The Asheville Project: short-term outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc . 2003 ; 43 : 149 –59. Author notes The authors acknowledge CAPT Richard Daly, M.D., CDR B. Jill Pettit, Pharm.D., BCPS, Linda Reynolds, Pharm.D., Rheta Sandoval, Pharm.D., and Christopher Abbott, M.D., for their help in initial clinic and protocol development; Keith Agent, M.S., for helping with statistical analysis; and Brookie Best, Pharm.D., and Kim E. Barrett, Ph.D., for reviewing the manuscript. Presented in part at the ASHP Midyear Clinical Meetings in New Orleans, LA, December 6, 2001, and December 8, 2003. The views expressed in this article are those of the authors and do not reflect the official policy or position of the Department of the Navy, Department of Defense, or U.S. government. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

Velazquez,, Lydia;Dallas,, Scott;Rose,, Lisa;Evans, Krista, S.;Saville,, Rebecca;Wang,, Jialynn;Bradley, Sean, K.;Bona, James, D.

doi: 10.2146/ajhp060020pmid: 16809753

Abstract Purpose. The challenges and victories that a team of Public Health Service (PHS) pharmacists experienced in establishing pharmacy operations at a federal medical station and conducting outreach missions are described. Summary. The Gulf coast of Mississippi and southeast Louisiana were struck on August 29, 2005, by Hurricane Katrina, which caused widespread infrastructure damage, flooding, and loss of life. A team of 70 officers, which included 8 pharmacists, arrived on September 3 and 4 to establish a 480-bed federal medical station in an aircraft hangar at the naval air station (NAS) in Meridian, Mississippi. Numerous challenges were encountered, including identifying a secure space for a pharmacy, determining how to manage the immediate shortage of medications, devising a dispensing system specific to controlled medications, handling personal medications brought in by patients, and maintaining adequate pharmacy staffing to provide for hospital needs. Two outreach efforts were also undertaken. The first was to assist the NAS pharmacy department, which was overwhelmed with nearly 800 Navy and Coast Guard personnel who were displaced to the Meridian NAS. The second outreach effort was to augment the staff at a local free clinic in Meridian, which needed help to set up their clinic so they could handle the influx of hurricane victims who were arriving daily. Conclusion. A team of PHS pharmacists established a pharmacy, provided pharmaceutical care, and conducted outreach programs to aid victims of Hurricane Katrina. Controlled substances, Disasters, Dispensing, Drug distribution, Personnel, pharmacy, Pharmaceutical care, Pharmaceutical services, Pharmacists, Public Health Service, Volunteers The Gulf coast of Mississippi and southeast Louisiana were struck on August 29, 2005, by category 4 hurricane Katrina, which caused widespread infrastructure damage, flooding, and loss of life. Teams of commissioned officers of the U.S. Public Health Service (PHS) were deployed to the affected and neighboring areas to provide relief assistance.1 Our team arrived on September 3 and 4 to establish a 480-bed federal medical station (FMS) in an aircraft hangar at the naval air station (NAS) in Meridian, Mississippi. The purpose of the FMS was to (1) provide a medically supervised location where low-acuity hospitalized patients could receive care until discharge or until additional care necessitated transport to another medical facility and (2) care for evacuees with special health care needs. Staffing of the FMS was provided by a multidisciplinary detachment of 79 PHS officers. Surrounded by structural damage and widespread debris, we were tasked with meeting a multitude of new public health challenges. Establishing a makeshift pharmacy As a team of eight pharmacists, we were to establish a fully functional pharmacy and provide services to patients and staff. Before our clinical skills could be put to work, we had to address certain issues, namely the cleaning of an aircraft storage and repair area that was identified as a suitable structure for our hospital. The FMS was located on a naval base, so establishment of hospital security was not an issue. Part of the team that had arrived a day earlier took on the grueling job of cleanup, with assistance from the Navy. Rank, degree, and title were put aside, with the primary goal of establishing an area that could receive displaced hurricane victims within 48 hours. Our FMS was a prepackaged unit of field hospital equipment purchased by the Centers for Disease Control and Prevention (CDC) from a vendor specializing in disaster response. The FMS was established and accepted its first hurricane victims on September 5. The pharmacy received a limited supply of pharmaceutical products from the Strategic National Stockpile (SNS). This supply had been predetermined and compiled according to past disaster experiences. Unfortunately, supplies were not specifically tailored to the type of patients we expected to serve. There were very small amounts of insulin and no tetanus toxoid vaccines or any other vaccines. Basic pharmacy supplies used for dispensing were not available, except for one medication counter, a spatula, and some labels and zip-lock bags, insufficient to support a 480-bed FMS. We faced numerous challenges when establishing the FMS, including the following: Identify a secure space for a pharmacy, Establish interdisciplinary communication to avoid duplication of efforts, Determine how to manage the immediate shortage of medications, Obtain shelving for medications, Handle the absence of prescription forms for providers to order medications from the pharmacy, Provide a concise list of medicines for patient care that was available to health care workers, Lack of medical reference materials, Devise a dispensing system specific to controlled medications, Provide refrigeration for certain medications in a 100 °F+ hangar, Establish a dispensing area, Work without telephone services, electricity, and sufficient lighting, Obtain accurate medication information from patients who arrived in a tired, confused, and scared state, Handle personal medications brought in by patients that may be laced with toxins from flood waters, Identify personal medications not in their original containers, Establish a safety system for pharmacists to follow when handling such packages and medications, Track individual inpatient drug therapies, Provide medication regimen continuity when all of our patients would eventually be relocated to different parts of the country, and Maintain adequate pharmacy staffing to provide for hospital needs. With little time to prepare for our first wave of casualties, the pharmacy team began to brainstorm and prioritize solutions to these challenges. It became an ongoing project that changed daily, depending on the situation at hand. Early on, we recognized that maintaining flexibility was key to the successful development of pharmacy operations. Points of contact were established with identified team leaders who would be responsible for communicating with other groups and the command staff. A lockable caged area within the aircraft hangar was identified by the first pharmacy officer who arrived in Meridian as the most secure space for a pharmacy. The NAS provided us with additional medications, shelving, tables, and chairs. An order of controlled medications later arrived from the SNS. Controlled drugs were obtained under an umbrella Drug Enforcement Administration number, and a list of providers’ names with signatures was obtained by the pharmacy to be filed as a reference. A system to reorder medications through a national wholesaler was established, with a representative on-site to meet our needs and train the pharmacy staff in online medication ordering once we had Internet access. Purchases made by the NAS from local vendors aided in the procurement of additional administrative supplies, including a printer/copier/scanner/fax machine. A laptop computer became the information technology station for our pharmacy. We created standard operating procedures for many pharmacy functions and prescription forms for providers to use, with a specially designed form for Schedule II medications. Procedures for picking up medication orders and delivering prescriptions quickly followed. At the next staff meeting with the command staff, such procedures were further developed and adopted by providers and nursing staff. A pharmacy and therapeutics committee was formed and meetings among pharmacy, medical, and nursing staffs were conducted periodically to discuss processes for requesting additional cost-effective medications not currently covered by our formulary. Additional meetings were held to determine how self-administration versus nursing administration of medications would be tracked, how to ensure medication security at the nursing stations, and how many days of medication would be dispensed to each patient since we had limited supplies. Tackle boxes secured with bicycle locks and chains were purchased locally to secure controlled substances at the nursing stations. Additional issues resolved at such meetings included the development of a patient triage system and a system to minimize medication and treatment order transcription and duplication errors. Because we were treating elderly patients with chronic illnesses, including cardiac-related diseases, the availability of crash carts and all the necessary medications and equipment for advanced cardiac life support became a critical priority. Several backpacks were purchased because of their easy access and mobility, and they were stocked with most of the i.v. medications and equipment necessary to support a cardiac emergency and distributed to central locations within the hangar. The original formulary was refined as our inventory grew to meet the needs of the facility and included the generic and brand names of each drug, dosage forms, strengths, medication expiration dates, and onhand quantity information. Two versions of the formulary were created: one was sorted in alphabetical order by generic drug name and the other by therapeutic category to facilitate medication substitution and help with identifying medications available within a specific therapeutic class. Both were quickly distributed to the entire staff and nursing stations for reference. The formulary was updated daily as new medications arrived from wholesalers and dated daily to help staff determine whether they had a current version. This was necessary until most of the medications needed by the medical staff had arrived. Two refrigerators soon arrived, along with the insulin that had been ordered. Additional lighting was provided by the NAS, as was an electric typewriter to use instead of handwriting patient medication labels. Personal medical references brought in by pharmacy officers were initially our only means of referencing information to answer medication-related questions until we obtained Internet access. Once that was accomplished, we could contact the local poison control center and subscribe to Identidex (Thomson Micromedex, Greenwood Village, CO) to help identify unknown medications. Through the Internet, we acquired a free subscription to the Micromedex health care series to use as an additional medical reference. Managing medication administration As part of the triage and admission processes for incoming patients and evacuees and their families, the pharmacy developed a standard operating procedure for handling personal medications brought in by patients. As patients and their caregivers and families arrived, they were triaged by a clinician before admission. General information from the patients was obtained at the admissions desk, and patients then moved to the pharmacy triage area. Since the majority of patients were expected to require intermediate care, we anticipated that they would be on multiple medications and have many of these medications with them upon arrival. Assessment and monitoring of the patients were critical to maintaining safety and order within the FMS. Some of the patients who arrived were disoriented and confused, making resolution of medication questions difficult. Interpretation of prescription labels was often difficult since many bottles were wet. If the labels were legible, many of the phone numbers listed were not in service or no longer existed. Thus, it was impossible to resolve medication questions directly with patients’ providers. Regardless of these setbacks, the pharmacy triage area obtained all the self-administered medications the patients had in their possession. All medications and narcotics were examined, counted, and recorded by the pharmacy staff in front of each patient or caregiver. In some cases, medication identification was necessary since some medications were not in their original container. It was the pharmacy’s decision whether a particular medication was still safe for patient use. All pharmacists exercised universal safety precautions when handling seemingly contaminated containers and medication bags. During triage, pharmacists were responsible for interviewing patients and creating a medication log containing directions for medication use as provided on the prescription bottles. Nonprescription medications and patient drug allergies were recorded on the medication and treatment history sheet that we had designed. Pharmacists also provided recommendations for patients’ current drug regimens for use by hospital staff during admission. Later, pharmacy patient discharge procedures were developed in collaboration with social workers and nursing staff. Since many of the patients were ambulatory and lucid, and because of our limited nursing staff, some patients were allowed to administer their own noncontrolled medications. These medications were placed in labeled bags and tied to their bed for easy access. To reduce the amount of work required by the limited nursing staff, nurses had to document only the time at which these patients took their medications. Logbooks for this purpose were placed at the nursing stations, along with all the narcotics secured in the tackle boxes. Patients or their caregivers and families received counseling from pharmacists if the patients were admitted with a myriad of medications and would thereby benefit from the establishment of a medication regimen. We provided drug education and dispensed medication boxes to help establish a routine that patients could follow based on their lifestyle. When discharged from the FMS, patients and their caregivers and families received specific pharmacy discharge written and oral instructions to ensure that they had a clear understanding of changes that may have been made to their medication regimen. This allowed them to relay this information to their next health care provider upon relocation. Outreach efforts The first outreach effort was to assist the NAS pharmacy department. Because of the hurricane, a number of Navy and Coast Guard family homes were destroyed on the Mississippi Gulf coast, and nearly 800 personnel were displaced to the Meridian NAS. The increased workload of extra patients placed a large burden on the NAS pharmacy staff. They requested assistance for their pharmacy department, and three PHS pharmacists volunteered and assisted the NAS staff for five days. The second outreach program began when the FMS received a request from the city of Meridian to augment the staff at a local free clinic called Wesley House. Two pharmacy officers volunteered to help. Wesley House had been providing food, clothing, counseling, and medical services to displaced hurricane victims and local citizens, since many members of the community were now homeless. Upon our arrival at the clinic, the full-time staff requested help in setting up their clinic so they could handle the influx of hurricane victims who were arriving daily. Some of the tasks we accomplished at Wesley House included (1) the cleaning and setup of a medication closet and arrangement of medications in alphabetical order by generic name, trade name, and therapeutic category for cross-reference, (2) establishing a dispensing area within the medication closet with all necessary equipment to count, label, and dispense medications within arms’ reach, and (3) providing education to the clinic staff on the importance of monitoring the temperature in the refrigerator used to store medications. Not all medications necessary for complete patient care were available at the clinic since it relies on donations of medications from local pharmacies and drug companies. Local pharmacies were contacted, and the services they were able to provide to Katrina victims free of charge were documented. All volunteers received a pharmacy information table upon arrival, which contained the contact information of the pharmacies providing free services and the names of pharmaceutical manufacturers willing to absorb costs if their products were distributed by local pharmacies. After the establishment of these procedures, the operation was turned over to another FMS group, which was attached to the Air National Guard. The initial assessment and setup performed by our FMS group allowed approximately 200 patients to be treated in the first three days of clinical efforts at the facility. The NAS FMS later used the pharmacy information table originally developed for the Wesley House clinic when patients began being discharged from our facility. Completing the mission Our field pharmacy and hospital continued to operate until September 16. A decision was made to relocate the facility to an area closer to the damaged Gulf coast. On September 14, the hospital staff began disassembling the pharmacy and hospital, which involved inventorying and packing all supplies and medications onto trucks for delivery to Baton Rouge, Louisiana, where a new FMS was to be established in the parking lot of a local hospital. The pharmacy provided copies of all forms and standard operating procedures that had been developed at the NAS FMS. All of our patient records, medication inventories, and controlled drug records were turned over to the administrative officers of the FMS for safekeeping. By September 17, we had successfully completed all phases of our mission. This experience challenged us all and made us grow both personally and professionally. Team effort and good communication were key to the success of the mission. The medical staff provided us with great insight and communicated their needs and expectations of the pharmacy in a way that helped us succeed and be effective. References 1 Young D. Public Health Service evolves to meet nation’s needs: pharmacists play pivotal roles in PHS history. Am J Health-Syst Pharm. 2006 ; 63 : 194 ,196–7. News. Crossref Search ADS PubMed Author notes Special thanks to the U.S. Navy, who provided many resources and assistance in the mission and demonstrated a spirit of cooperation. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.

Candy, Timothy, A.;Schneider, Philip, J.;Pedersen, Craig, A.

doi: 10.2146/ajhp050447pmid: 16809754

Abstract Purpose. The initial response of the pharmacy profession to United States Pharmacopeia (USP) chapter 797 and the current state of hospital pharmacy practice as it relates to implementing this chapter were studied. Methods. A stratified random sample of 600 hospital pharmacy directors across the nation were surveyed by mail. Results. A total of 251 surveys (41.8%) were returned. Larger hospitals (≥200 staffed beds) were more likely than smaller hospitals (<200 staffed beds) to have read USP chapter 797 (80.0% versus 45.8%, respectively) and have a copy of the chapter (94.6% versus 78.0%, respectively). Overall, respondents felt that chapter 797 would negatively affect workload and pharmacy’s ability to provide sterile preparations in a timely manner. Conversely, respondents replied that the new standard would have a positive effect on the quality of care provided by the hospital. Overall, 45.3% of respondents reported plans to build a clean-room, and 21.7% reported plans to obtain new equipment to comply with chapter 797. Furthermore, 42.3% of respondents had decreased the quantity of high-risk compounding. Respondents also reported that their pharmacy’s budget had increased in order to comply with chapter 797. The most common requirements with which respondents were not willing to comply were validating the accuracy of automated compounding devices, sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting use of cosmetics by staff. Conclusion.USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in the compounding of high-risk preparations, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall. Aseptic areas, Automation, Budgets, Compliance, Compounding, Control, quality, Data collection, Disinfectants, Equipment, Pharmacists, hospital, Pharmacy, institutional, hospital, Quality assurance, Standards, Sterile products, United States Pharmacopeia, Workload On January 1, 2004, chapter 797 of the United States Pharmacopeia (USP) became the nation’s first enforceable standard for the compounding of sterile preparations.1,2 This new standard was developed in response to a growing demand to hold pharmacies more accountable for preparations that are compounded outside of a controlled environment. For example, although the Food and Drug Administration (FDA) requires that drug manufacturers adhere to current good manufacturing practices (cGMPs), a pharmacy that prepares the same product is not held to that same rigorous standard.3,4USP chapter 797 is intended to provide a more rigorous standard for pharmacy operations since cGMPs cannot be applied to compounding in pharmacies. Not only does FDA consider USP chapter 797 an enforceable standard, but the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is using USP chapter 797 when surveying hospitals.1 To assist pharmacies in complying with this new standard, JCAHO has developed a recommended timeline for implementation of specific requirements of chapter 797.5 From the public’s perspective, recent incidents of contaminated sterile products causing patient harm and death have given the profession of pharmacy a negative reputation.6,–11 These incidents occurred because recommended published compounding guidelines were not followed, particularly guidelines addressing quality assurance and personnel training. Chapter 797 was developed to eliminate the risk of patient harm due to improperly compounded sterile preparations, but it is unknown how an enforceable standard will influence the changes that FDA, JCAHO, and the public demand. Past national surveys have shown that hospital pharmacies do not routinely comply with published guidelines for compounding sterile preparations.12,–15 In the most recent national survey evaluating compliance with the American Society of Health-System Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products, only 5.2% of pharmacies were fully compliant with garb attire requirements for compounding low-risk preparations.12 Furthermore, only 4.7% of hospital pharmacies were fully compliant with documentation procedures for high-risk preparations. The national surveys have also found that larger hospitals are more compliant with guidelines than are smaller hospitals.12,–15 Since there are more smaller hospitals in the country than larger hospitals, implementing chapter 797 will be a significant challenge for the profession of pharmacy. This study was designed to determine the response of the pharmacy profession to USP chapter 797 and to report on the current state of hospital pharmacy practice as it relates to implementing chapter 797. Methods Survey design A survey instrument was created to measure the impact of chapter 797 on budgetary concerns, the building of clean-rooms, the acquisition of new equipment, and the operation of satellite pharmacies. The questions were grouped into four categories: (1) current opinions, (2) current compounding practices, (3) impact of chapter requirements, and (4) budget and resource allocation. A four-page, 20-question survey instrument in a multiple-choice format was developed. The survey instrument was field tested with three different pharmacy managers from various sizes of hospitals and modified according to reviewers’ comments. The study design, including the final survey instrument, was approved by The Ohio State University’s investigational review board. Study sample Using the SMG database (Verispan, Yardley, PA), demographic characteristics were obtained, including the number of beds, U.S. Census Bureau region, ownership, U.S. Census Bureau metropolitan statistical area (MSA) status, and medical school affiliation status. Of the 6837 hospitals in the United States, 4963 general and children’s medical–surgical hospitals were included in the sampling frame. Specialty, federal, and Veterans Affairs hospitals were excluded. Based on the number of staffed beds, hospitals were stratified into the following six categories: <50, 50–99, 100–199, 200–299, 300–399, and ≥400 staffed beds. One hundred pharmacy directors were randomly sampled from each strata, yielding a total of 600 mailed surveys. Data collection Data collection followed a slightly modified Dillman16 method. The surveys were mailed to the randomly selected pharmacy directors with a letter describing the intent of the survey and a self-addressed, stamped return envelope. Participants were assured that their responses would be kept confidential and that only aggregate data would be reported. Reminder postcards were sent approximately one week later. Approximately four weeks after sending the first survey, a duplicate survey with a self-addressed, stamped return envelope was sent to all of the pharmacy directors who did not initially respond. Data collection occurred between February and May of 2005. Data analysis Each participant was assigned a unique identification number that allowed the survey response to be matched with hospital characteristics in the SMG database. Because of the stratified random sampling procedure, it was necessary to employ a design-based analysis.17 This technique produces population estimates that are much more accurate by accounting for the complex sampling design and improves the reliability of the estimates for each subdomain (e.g., hospital size). Data were entered using SPSS, version 12.0 (SPSS Inc., Chicago, IL), and converted to an Intercooled Stata, version 7 (StataCorp LP, College Station, TX), readable format using DBMS Copy version 7 (Statistical Solutions, Saugus, MA). All non-design-based analyses were conducted using SPSS, version 12.0. All design-based analyses were conducted using Stata, version 7, with the set of survey commands. To account for oversampling the largest hospitals, weights were assigned to participants to adjust their contribution to the population estimate. The calculated weights assigned were as follows: 24.295 for hospitals with fewer than 50 beds, 9.652 for 50–99-bed hospitals, 14.913 for 100–199-bed hospitals, 8.215 for 200–299-bed hospitals, 4.075 for 300–399-bed hospitals, and 4.407 for hospitals with 400 or more staffed beds. Descriptive statistics were used extensively. Chi-square analysis and analysis of variance or regression were used to examine how responses differed as a function of hospital characteristics. The a priori level of significance was set at 0.05. Results Of the 600 mailed surveys, 262 surveys were returned, yielding a response rate of 43.7%. Eleven surveys were not usable, which adjusted the returned sample to 251 surveys, with an adjusted response rate of 41.8%. Of the 11 unusable surveys, 7 were returned by pharmacy directors stating they were not familiar with USP chapter 797. The remaining 4 surveys were not usable because one hospital was closing down, two hospitals did not compound sterile preparations, and one hospital had a policy that disallowed participation in national surveys. Table 11 shows the size, location, ownership, and affiliation status of the respondents’ hospitals, the nonrespondents’ hospitals, the surveyed hospitals, and the 4963 general and children’s medical–surgical hospitals with pharmacies in the SMG hospital database. The characteristics of the surveyed hospitals are presented to highlight the complex sampling design used in this survey. Respondents and nonrespondents did not significantly differ in MSA status, ownership, or medical school affiliation. Hospitals with fewer than 50 staffed beds were underrepresented, as were hospitals in the West and South. As a design-based analysis was employed, these slight differences were adjusted for in the population estimates. Table 1. Size, Location, Ownership, and Affiliation of Hospitalsa Respondents Nonrespondents Surveyed Population Characteristic n %b n %b n %c n %d aFrom the SMG hospital database; MSA = metropolitan statistical area. bCalculated as a percentage of all hospitals surveyed in the category. cCalculated as a percentage of all hospitals surveyed. dCalculated as a percentage of all hospitals. eχ2 = 14.09, df = 5, p = 0.015. fχ2 = 12.08, df = 3, p = 0.007. All hospitals 251 41.8 349 58.2 600 100.0 4963 100.0 Staffed bedse     <50 28 28.0 72 72.0 100 16.7 1482 29.9     50–99 54 54.0 46 46.0 100 16.7 859 17.3     100–199 43 43.0 57 57.0 100 16.7 1193 24.0     200–299 41 41.0 59 59.0 100 16.7 649 13.1     300–399 43 43.0 57 57.0 100 16.7 379 7.6     ≥400 42 42.0 58 58.0 100 16.7 401 8.1 Regionf     West 41 38.0 67 62.0 108 18.0 933 18.8     Midwest 71 51.1 68 48.9 139 23.2 1444 29.1     South 88 35.3 161 64.7 249 41.5 1872 37.7     Northeast 51 49.0 53 51.0 104 17.3 714 14.4 MSA status     Within an MSA 166 41.8 231 58.2 397 66.2 2752 55.5     Outside an MSA 85 41.9 118 58.1 203 33.8 2211 44.5 Ownership     For profit 29 42.0 40 58.0 69 11.5 605 12.2     Nonprofit 222 41.8 309 58.2 531 88.5 4358 87.8 Medical school affiliation     Yes 83 42.3 113 57.7 196 32.8 1182 24.4     No 166 41.4 235 58.6 401 67.2 3654 75.6 Respondents Nonrespondents Surveyed Population Characteristic n %b n %b n %c n %d aFrom the SMG hospital database; MSA = metropolitan statistical area. bCalculated as a percentage of all hospitals surveyed in the category. cCalculated as a percentage of all hospitals surveyed. dCalculated as a percentage of all hospitals. eχ2 = 14.09, df = 5, p = 0.015. fχ2 = 12.08, df = 3, p = 0.007. All hospitals 251 41.8 349 58.2 600 100.0 4963 100.0 Staffed bedse     <50 28 28.0 72 72.0 100 16.7 1482 29.9     50–99 54 54.0 46 46.0 100 16.7 859 17.3     100–199 43 43.0 57 57.0 100 16.7 1193 24.0     200–299 41 41.0 59 59.0 100 16.7 649 13.1     300–399 43 43.0 57 57.0 100 16.7 379 7.6     ≥400 42 42.0 58 58.0 100 16.7 401 8.1 Regionf     West 41 38.0 67 62.0 108 18.0 933 18.8     Midwest 71 51.1 68 48.9 139 23.2 1444 29.1     South 88 35.3 161 64.7 249 41.5 1872 37.7     Northeast 51 49.0 53 51.0 104 17.3 714 14.4 MSA status     Within an MSA 166 41.8 231 58.2 397 66.2 2752 55.5     Outside an MSA 85 41.9 118 58.1 203 33.8 2211 44.5 Ownership     For profit 29 42.0 40 58.0 69 11.5 605 12.2     Nonprofit 222 41.8 309 58.2 531 88.5 4358 87.8 Medical school affiliation     Yes 83 42.3 113 57.7 196 32.8 1182 24.4     No 166 41.4 235 58.6 401 67.2 3654 75.6 Open in new tab Table 1. Size, Location, Ownership, and Affiliation of Hospitalsa Respondents Nonrespondents Surveyed Population Characteristic n %b n %b n %c n %d aFrom the SMG hospital database; MSA = metropolitan statistical area. bCalculated as a percentage of all hospitals surveyed in the category. cCalculated as a percentage of all hospitals surveyed. dCalculated as a percentage of all hospitals. eχ2 = 14.09, df = 5, p = 0.015. fχ2 = 12.08, df = 3, p = 0.007. All hospitals 251 41.8 349 58.2 600 100.0 4963 100.0 Staffed bedse     <50 28 28.0 72 72.0 100 16.7 1482 29.9     50–99 54 54.0 46 46.0 100 16.7 859 17.3     100–199 43 43.0 57 57.0 100 16.7 1193 24.0     200–299 41 41.0 59 59.0 100 16.7 649 13.1     300–399 43 43.0 57 57.0 100 16.7 379 7.6     ≥400 42 42.0 58 58.0 100 16.7 401 8.1 Regionf     West 41 38.0 67 62.0 108 18.0 933 18.8     Midwest 71 51.1 68 48.9 139 23.2 1444 29.1     South 88 35.3 161 64.7 249 41.5 1872 37.7     Northeast 51 49.0 53 51.0 104 17.3 714 14.4 MSA status     Within an MSA 166 41.8 231 58.2 397 66.2 2752 55.5     Outside an MSA 85 41.9 118 58.1 203 33.8 2211 44.5 Ownership     For profit 29 42.0 40 58.0 69 11.5 605 12.2     Nonprofit 222 41.8 309 58.2 531 88.5 4358 87.8 Medical school affiliation     Yes 83 42.3 113 57.7 196 32.8 1182 24.4     No 166 41.4 235 58.6 401 67.2 3654 75.6 Respondents Nonrespondents Surveyed Population Characteristic n %b n %b n %c n %d aFrom the SMG hospital database; MSA = metropolitan statistical area. bCalculated as a percentage of all hospitals surveyed in the category. cCalculated as a percentage of all hospitals surveyed. dCalculated as a percentage of all hospitals. eχ2 = 14.09, df = 5, p = 0.015. fχ2 = 12.08, df = 3, p = 0.007. All hospitals 251 41.8 349 58.2 600 100.0 4963 100.0 Staffed bedse     <50 28 28.0 72 72.0 100 16.7 1482 29.9     50–99 54 54.0 46 46.0 100 16.7 859 17.3     100–199 43 43.0 57 57.0 100 16.7 1193 24.0     200–299 41 41.0 59 59.0 100 16.7 649 13.1     300–399 43 43.0 57 57.0 100 16.7 379 7.6     ≥400 42 42.0 58 58.0 100 16.7 401 8.1 Regionf     West 41 38.0 67 62.0 108 18.0 933 18.8     Midwest 71 51.1 68 48.9 139 23.2 1444 29.1     South 88 35.3 161 64.7 249 41.5 1872 37.7     Northeast 51 49.0 53 51.0 104 17.3 714 14.4 MSA status     Within an MSA 166 41.8 231 58.2 397 66.2 2752 55.5     Outside an MSA 85 41.9 118 58.1 203 33.8 2211 44.5 Ownership     For profit 29 42.0 40 58.0 69 11.5 605 12.2     Nonprofit 222 41.8 309 58.2 531 88.5 4358 87.8 Medical school affiliation     Yes 83 42.3 113 57.7 196 32.8 1182 24.4     No 166 41.4 235 58.6 401 67.2 3654 75.6 Open in new tab The sampling design ensured approximately equal distribution of hospitals by number of staffed beds. Mirroring the population, nearly two thirds of the respondents’ hospitals were in the South or the Midwest. Most respondents worked for nonprofit organizations (88%), were not affiliated with a medical school (67%), and were located within an MSA (66%). Information gathering In larger hospitals (≥200 staffed beds), the most common methods of learning about USP chapter 797 were reading the actual chapter (80.0%) and reading the ASHP Discussion Guide on chapter 797 (80.0%). In smaller hospitals (<200 staffed beds), respondents referred to the ASHP Discussion Guide (54.8%) and other summaries from secondary sources (47.5%) more often than the actual chapter (45.8%). Respondents from larger hospitals were more likely to attend a live presentation (64.7%) or read postings on Internet bulletin boards, listservers, or e-mails (40.4%) than respondents from smaller hospitals (37.3% and 27.4%, respectively) (p < 0.001 and p = 0.0459, respectively). Respondents from smaller hospitals tended to use word-of-mouth as a means to learn about USP chapter 797 more often than respondents from larger hospitals (45.8% versus 37.0%, respectively) (p = 0.187). Larger hospitals were more likely to have a copy of the published standard than were smaller hospitals (94.6% versus 78.0%, respectively) (p = 0.0002). Overall, 61.8% of survey respondents reported learning more about chapter 797 because JCAHO is using the standard when surveying hospitals. Current opinions Respondents reported that chapter 797 will negatively affect the (1) workload of pharmacy technicians, (2) workload of pharmacists, (3) overall efficiency of operations, (4) pharmacy’s ability to provide compounded sterile preparations in a timely manner, and (5) pharmacy’s ability to provide excellent customer service (Table 22). Respondents agreed that the new standard exceeds what they think is necessary for hospital pharmacy practice. Conversely, respondents believed that chapter 797 will positively affect the quality of care provided to patients. Table 2. Respondents’ Opinions About United States Pharmacopeia (USP) Chapter 797a Survey Questions Mean (95% CI) aUSP = United States Pharmacopeia, CI = confidence interval. b1 = very negative or restrictive effect, 2 = somewhat negative effect, 3 = neutral or no effect, 4 = somewhat positive effect, 5 = very positive or helpful effect. c1 = strongly disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = strongly agree. Rate the effect that USP chapter 797 will have on theb     Workload of pharmacy technicians (n = 251) 2.10 (1.99–2.21)     Workload of pharmacists (n = 251) 2.14 (2.02–2.25)     Overall efficiency of operations (n = 249) 2.08 (1.96–2.19)     Pharmacy’s ability to provide compounded sterile preparations in a timely manner (n = 251) 2.11 (1.99–2.24)     Pharmacy’s ability to provide excellent customer service (i.e., nursing satisfaction) (n = 251) 2.41 (2.28–2.54)     Quality of care provided to your hospital’s patients (n = 251) 3.57 (3.44–3.70) Rate your agreement with the following statementc:     The rigor of USP chapter 797 exceeds what is necessary for hospital pharmacy practice (n = 250) 3.86 (3.69–4.03) Survey Questions Mean (95% CI) aUSP = United States Pharmacopeia, CI = confidence interval. b1 = very negative or restrictive effect, 2 = somewhat negative effect, 3 = neutral or no effect, 4 = somewhat positive effect, 5 = very positive or helpful effect. c1 = strongly disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = strongly agree. Rate the effect that USP chapter 797 will have on theb     Workload of pharmacy technicians (n = 251) 2.10 (1.99–2.21)     Workload of pharmacists (n = 251) 2.14 (2.02–2.25)     Overall efficiency of operations (n = 249) 2.08 (1.96–2.19)     Pharmacy’s ability to provide compounded sterile preparations in a timely manner (n = 251) 2.11 (1.99–2.24)     Pharmacy’s ability to provide excellent customer service (i.e., nursing satisfaction) (n = 251) 2.41 (2.28–2.54)     Quality of care provided to your hospital’s patients (n = 251) 3.57 (3.44–3.70) Rate your agreement with the following statementc:     The rigor of USP chapter 797 exceeds what is necessary for hospital pharmacy practice (n = 250) 3.86 (3.69–4.03) Open in new tab Table 2. Respondents’ Opinions About United States Pharmacopeia (USP) Chapter 797a Survey Questions Mean (95% CI) aUSP = United States Pharmacopeia, CI = confidence interval. b1 = very negative or restrictive effect, 2 = somewhat negative effect, 3 = neutral or no effect, 4 = somewhat positive effect, 5 = very positive or helpful effect. c1 = strongly disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = strongly agree. Rate the effect that USP chapter 797 will have on theb     Workload of pharmacy technicians (n = 251) 2.10 (1.99–2.21)     Workload of pharmacists (n = 251) 2.14 (2.02–2.25)     Overall efficiency of operations (n = 249) 2.08 (1.96–2.19)     Pharmacy’s ability to provide compounded sterile preparations in a timely manner (n = 251) 2.11 (1.99–2.24)     Pharmacy’s ability to provide excellent customer service (i.e., nursing satisfaction) (n = 251) 2.41 (2.28–2.54)     Quality of care provided to your hospital’s patients (n = 251) 3.57 (3.44–3.70) Rate your agreement with the following statementc:     The rigor of USP chapter 797 exceeds what is necessary for hospital pharmacy practice (n = 250) 3.86 (3.69–4.03) Survey Questions Mean (95% CI) aUSP = United States Pharmacopeia, CI = confidence interval. b1 = very negative or restrictive effect, 2 = somewhat negative effect, 3 = neutral or no effect, 4 = somewhat positive effect, 5 = very positive or helpful effect. c1 = strongly disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = strongly agree. Rate the effect that USP chapter 797 will have on theb     Workload of pharmacy technicians (n = 251) 2.10 (1.99–2.21)     Workload of pharmacists (n = 251) 2.14 (2.02–2.25)     Overall efficiency of operations (n = 249) 2.08 (1.96–2.19)     Pharmacy’s ability to provide compounded sterile preparations in a timely manner (n = 251) 2.11 (1.99–2.24)     Pharmacy’s ability to provide excellent customer service (i.e., nursing satisfaction) (n = 251) 2.41 (2.28–2.54)     Quality of care provided to your hospital’s patients (n = 251) 3.57 (3.44–3.70) Rate your agreement with the following statementc:     The rigor of USP chapter 797 exceeds what is necessary for hospital pharmacy practice (n = 250) 3.86 (3.69–4.03) Open in new tab Overall, 77.6% of respondents believed that wastage of sterile products would increase because of the new beyond-use dating recommendations. Current compounding practices Overall, 79% of respondents’ hospitals had performed a gap analysis (Table 33). Larger hospitals are more likely to have completed the gap analysis. Only 35% of respondents’ hospitals had a cleanroom in the central pharmacy that met chapter 797 standards. Of those, 72% met the more stringent International Organization for Standardization (ISO) class 7 standard (<10,000 particles per cubic foot). Table 3. Current Compounding Practices % Hospitals, by Staffed Bed Size Current Practice <50 (n= 28) 50–99 (n= 54) 100–199 (n= 43) 200–299 (n= 41) 300–399 (n= 43) ≥400 (n= 42) Overall aUncorrected χ2 = 65.81, design-based F(3.43, 840.14) = 12.36, p < 0.0001. bA cleanroom is described as a specific room designated solely for the compounding of sterile preparations, separated from the outside environment by a door. The cleanroom maintains at least an International Organization for Standardization (ISO) class 8 (100,000 particles per cubic foot) environment and has a line of demarcation designating one section of the room as the anteroom area and the other section of the room as the buffer zone, whereby the laminar-airflow workbench is located. cSterile products made from nonsterile ingredients (e.g., bulk powders) or preparations using sterile ingredients in nonsterile devices before sterilization. dUncorrected χ2 = 29.78, design-based F(3.53, 860.59) = 5.70, p = 0.0003. eUncorrected χ2 = 24.13, design-based F(3.67, 894.32) = 5.13, p = 0.0007. Compound sterile preparations in satellite pharmacies 7.1 5.6 16.3 22.0 51.2 76.2 19.9a Hospital pharmacy has a cleanroomb in the central pharmacy area that meets chapter 797 standards 28.6 35.2 34.9 36.6 48.8 45.2 35.2 Of those with a central pharmacy cleanroom, the hospital pharmacy’s cleanroom meets ISO class 7 standards 85.7 76.5 57.1 78.6 80.0 57.9 72.5 The hospital pharmacy compounds high-risk preparationsc 10.7 5.6 14.0 20.0 30.2 54.8 16.9d The hospital has performed a gap analysis to identify any deficiencies in complying with chapter 797 64.3 72.2 83.7 97.5 93.0 95.2 79.3e The hospital uses chapter 797 to evaluate nursing practice in preparing sterile doses in patient care areas 39.3 35.2 51.2 55.0 55.8 57.1 46.2 % Hospitals, by Staffed Bed Size Current Practice <50 (n= 28) 50–99 (n= 54) 100–199 (n= 43) 200–299 (n= 41) 300–399 (n= 43) ≥400 (n= 42) Overall aUncorrected χ2 = 65.81, design-based F(3.43, 840.14) = 12.36, p < 0.0001. bA cleanroom is described as a specific room designated solely for the compounding of sterile preparations, separated from the outside environment by a door. The cleanroom maintains at least an International Organization for Standardization (ISO) class 8 (100,000 particles per cubic foot) environment and has a line of demarcation designating one section of the room as the anteroom area and the other section of the room as the buffer zone, whereby the laminar-airflow workbench is located. cSterile products made from nonsterile ingredients (e.g., bulk powders) or preparations using sterile ingredients in nonsterile devices before sterilization. dUncorrected χ2 = 29.78, design-based F(3.53, 860.59) = 5.70, p = 0.0003. eUncorrected χ2 = 24.13, design-based F(3.67, 894.32) = 5.13, p = 0.0007. Compound sterile preparations in satellite pharmacies 7.1 5.6 16.3 22.0 51.2 76.2 19.9a Hospital pharmacy has a cleanroomb in the central pharmacy area that meets chapter 797 standards 28.6 35.2 34.9 36.6 48.8 45.2 35.2 Of those with a central pharmacy cleanroom, the hospital pharmacy’s cleanroom meets ISO class 7 standards 85.7 76.5 57.1 78.6 80.0 57.9 72.5 The hospital pharmacy compounds high-risk preparationsc 10.7 5.6 14.0 20.0 30.2 54.8 16.9d The hospital has performed a gap analysis to identify any deficiencies in complying with chapter 797 64.3 72.2 83.7 97.5 93.0 95.2 79.3e The hospital uses chapter 797 to evaluate nursing practice in preparing sterile doses in patient care areas 39.3 35.2 51.2 55.0 55.8 57.1 46.2 Open in new tab Table 3. Current Compounding Practices % Hospitals, by Staffed Bed Size Current Practice <50 (n= 28) 50–99 (n= 54) 100–199 (n= 43) 200–299 (n= 41) 300–399 (n= 43) ≥400 (n= 42) Overall aUncorrected χ2 = 65.81, design-based F(3.43, 840.14) = 12.36, p < 0.0001. bA cleanroom is described as a specific room designated solely for the compounding of sterile preparations, separated from the outside environment by a door. The cleanroom maintains at least an International Organization for Standardization (ISO) class 8 (100,000 particles per cubic foot) environment and has a line of demarcation designating one section of the room as the anteroom area and the other section of the room as the buffer zone, whereby the laminar-airflow workbench is located. cSterile products made from nonsterile ingredients (e.g., bulk powders) or preparations using sterile ingredients in nonsterile devices before sterilization. dUncorrected χ2 = 29.78, design-based F(3.53, 860.59) = 5.70, p = 0.0003. eUncorrected χ2 = 24.13, design-based F(3.67, 894.32) = 5.13, p = 0.0007. Compound sterile preparations in satellite pharmacies 7.1 5.6 16.3 22.0 51.2 76.2 19.9a Hospital pharmacy has a cleanroomb in the central pharmacy area that meets chapter 797 standards 28.6 35.2 34.9 36.6 48.8 45.2 35.2 Of those with a central pharmacy cleanroom, the hospital pharmacy’s cleanroom meets ISO class 7 standards 85.7 76.5 57.1 78.6 80.0 57.9 72.5 The hospital pharmacy compounds high-risk preparationsc 10.7 5.6 14.0 20.0 30.2 54.8 16.9d The hospital has performed a gap analysis to identify any deficiencies in complying with chapter 797 64.3 72.2 83.7 97.5 93.0 95.2 79.3e The hospital uses chapter 797 to evaluate nursing practice in preparing sterile doses in patient care areas 39.3 35.2 51.2 55.0 55.8 57.1 46.2 % Hospitals, by Staffed Bed Size Current Practice <50 (n= 28) 50–99 (n= 54) 100–199 (n= 43) 200–299 (n= 41) 300–399 (n= 43) ≥400 (n= 42) Overall aUncorrected χ2 = 65.81, design-based F(3.43, 840.14) = 12.36, p < 0.0001. bA cleanroom is described as a specific room designated solely for the compounding of sterile preparations, separated from the outside environment by a door. The cleanroom maintains at least an International Organization for Standardization (ISO) class 8 (100,000 particles per cubic foot) environment and has a line of demarcation designating one section of the room as the anteroom area and the other section of the room as the buffer zone, whereby the laminar-airflow workbench is located. cSterile products made from nonsterile ingredients (e.g., bulk powders) or preparations using sterile ingredients in nonsterile devices before sterilization. dUncorrected χ2 = 29.78, design-based F(3.53, 860.59) = 5.70, p = 0.0003. eUncorrected χ2 = 24.13, design-based F(3.67, 894.32) = 5.13, p = 0.0007. Compound sterile preparations in satellite pharmacies 7.1 5.6 16.3 22.0 51.2 76.2 19.9a Hospital pharmacy has a cleanroomb in the central pharmacy area that meets chapter 797 standards 28.6 35.2 34.9 36.6 48.8 45.2 35.2 Of those with a central pharmacy cleanroom, the hospital pharmacy’s cleanroom meets ISO class 7 standards 85.7 76.5 57.1 78.6 80.0 57.9 72.5 The hospital pharmacy compounds high-risk preparationsc 10.7 5.6 14.0 20.0 30.2 54.8 16.9d The hospital has performed a gap analysis to identify any deficiencies in complying with chapter 797 64.3 72.2 83.7 97.5 93.0 95.2 79.3e The hospital uses chapter 797 to evaluate nursing practice in preparing sterile doses in patient care areas 39.3 35.2 51.2 55.0 55.8 57.1 46.2 Open in new tab Overall, only 46% of hospitals used USP chapter 797 to evaluate nursing practices in preparing sterile doses in patient care areas. Larger hospitals were more likely to evaluate nursing and pharmacy practices than were smaller hospitals. Larger hospitals were also more likely to compound sterile preparations in satellite pharmacies and compound high-risk level preparations than were smaller hospitals. Impact of chapter requirements Table 44 summarizes the action plans of pharmacy directors for 14 requirements specifically stated in chapter 797. The most common requirements that respondents were not willing to comply with were validating the accuracy of automated compounding devices (ACDs), sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting cosmetic use by staff. The most common requirements that were addressed with a long-term action plan (>12 months to implement) included sterilizing products and equipment before entering the cleanroom, performing end-product bacterial endotoxin testing on all high-risk preparations, and prohibiting nurses and other health care providers from making nonemergent sterile preparations outside of the central pharmacy. The most common requirements that were addressed with a short-term action plan (≤12 months to implement) included initially and annually validating aseptic technique skills of personnel who compound sterile preparations by using media-fill tests, regularly using settle plates to monitor environmental conditions of the cleanroom over time, sanitizing the i.v. cleanroom floors daily, and addressing garb attire requirements for pharmacy staff working in the i.v. cleanroom. Table 4. Compliance with United States Pharmacopeia Chapter 797 Requirements and Future Plans % Hospitals Specific Standard Does Not Meet Standard; No Plans To Change (n= 251) Does Not Meet Standard; Long-Term Plans To Change (n= 251)a Does Not Meet Standard; Short-Term Plans To Change (n= 251)b No Changes Needed; Currently Meets Standard (n= 251) aPlans for change after 12 months were considered long term. bPlans for change before or in exactly 12 months were considered short term. The pharmacy validates the accuracy of automated compounding devices on a daily basis 35.7 8.4 14.8 41.2 The pharmacy sterilizes products and equipment (e.g., carts) prior to entering the cleanroom 29.9 29.1 34.4 6.7 The pharmacy regularly rotates the type of disinfectants used in the i.v. cleanroom 28.5 23.9 38.1 9.5 The pharmacy has a policy in place prohibiting makeup for staff working in the i.v. cleanroom 26.8 20.6 32.1 20.5 The i.v. cleanroom floors are sanitized on a daily basis 15.8 21.0 44.7 18.5 The pharmacy uses settle plates on a regular basis (i.e., at least monthly) to monitor environmental conditions of the cleanroom 15.7 23.4 49.4 11.5 The pharmacy uses a cleanroom to compound sterile preparations 13.6 22.3 41.0 23.2 Hospital policy prohibits nurses and other health care providers from making nonemergent sterile preparations outside of the central pharmacy 12.7 24.4 26.7 36.2 The pharmacy utilizes specific garb attire requirements for the pharmacy staff who work in the i.v. cleanroom 11.3 13.6 43.3 31.9 The pharmacy performs end-product bacterial endotoxin testing on all high-risk preparations 11.1 27.2 35.2 26.5 The pharmacy uses the recommended beyond-use dating for products that do not undergo end-product sterility testing 9.0 9.3 22.9 58.8 The pharmacy performs end-product sterility testing on all high-risk preparations 6.6 18.0 41.0 34.5 Initially, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations 6.4 16.9 49.5 27.2 Annually, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations 6.4 17.5 53.6 22.5 % Hospitals Specific Standard Does Not Meet Standard; No Plans To Change (n= 251) Does Not Meet Standard; Long-Term Plans To Change (n= 251)a Does Not Meet Standard; Short-Term Plans To Change (n= 251)b No Changes Needed; Currently Meets Standard (n= 251) aPlans for change after 12 months were considered long term. bPlans for change before or in exactly 12 months were considered short term. The pharmacy validates the accuracy of automated compounding devices on a daily basis 35.7 8.4 14.8 41.2 The pharmacy sterilizes products and equipment (e.g., carts) prior to entering the cleanroom 29.9 29.1 34.4 6.7 The pharmacy regularly rotates the type of disinfectants used in the i.v. cleanroom 28.5 23.9 38.1 9.5 The pharmacy has a policy in place prohibiting makeup for staff working in the i.v. cleanroom 26.8 20.6 32.1 20.5 The i.v. cleanroom floors are sanitized on a daily basis 15.8 21.0 44.7 18.5 The pharmacy uses settle plates on a regular basis (i.e., at least monthly) to monitor environmental conditions of the cleanroom 15.7 23.4 49.4 11.5 The pharmacy uses a cleanroom to compound sterile preparations 13.6 22.3 41.0 23.2 Hospital policy prohibits nurses and other health care providers from making nonemergent sterile preparations outside of the central pharmacy 12.7 24.4 26.7 36.2 The pharmacy utilizes specific garb attire requirements for the pharmacy staff who work in the i.v. cleanroom 11.3 13.6 43.3 31.9 The pharmacy performs end-product bacterial endotoxin testing on all high-risk preparations 11.1 27.2 35.2 26.5 The pharmacy uses the recommended beyond-use dating for products that do not undergo end-product sterility testing 9.0 9.3 22.9 58.8 The pharmacy performs end-product sterility testing on all high-risk preparations 6.6 18.0 41.0 34.5 Initially, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations 6.4 16.9 49.5 27.2 Annually, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations 6.4 17.5 53.6 22.5 Open in new tab Table 4. Compliance with United States Pharmacopeia Chapter 797 Requirements and Future Plans % Hospitals Specific Standard Does Not Meet Standard; No Plans To Change (n= 251) Does Not Meet Standard; Long-Term Plans To Change (n= 251)a Does Not Meet Standard; Short-Term Plans To Change (n= 251)b No Changes Needed; Currently Meets Standard (n= 251) aPlans for change after 12 months were considered long term. bPlans for change before or in exactly 12 months were considered short term. The pharmacy validates the accuracy of automated compounding devices on a daily basis 35.7 8.4 14.8 41.2 The pharmacy sterilizes products and equipment (e.g., carts) prior to entering the cleanroom 29.9 29.1 34.4 6.7 The pharmacy regularly rotates the type of disinfectants used in the i.v. cleanroom 28.5 23.9 38.1 9.5 The pharmacy has a policy in place prohibiting makeup for staff working in the i.v. cleanroom 26.8 20.6 32.1 20.5 The i.v. cleanroom floors are sanitized on a daily basis 15.8 21.0 44.7 18.5 The pharmacy uses settle plates on a regular basis (i.e., at least monthly) to monitor environmental conditions of the cleanroom 15.7 23.4 49.4 11.5 The pharmacy uses a cleanroom to compound sterile preparations 13.6 22.3 41.0 23.2 Hospital policy prohibits nurses and other health care providers from making nonemergent sterile preparations outside of the central pharmacy 12.7 24.4 26.7 36.2 The pharmacy utilizes specific garb attire requirements for the pharmacy staff who work in the i.v. cleanroom 11.3 13.6 43.3 31.9 The pharmacy performs end-product bacterial endotoxin testing on all high-risk preparations 11.1 27.2 35.2 26.5 The pharmacy uses the recommended beyond-use dating for products that do not undergo end-product sterility testing 9.0 9.3 22.9 58.8 The pharmacy performs end-product sterility testing on all high-risk preparations 6.6 18.0 41.0 34.5 Initially, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations 6.4 16.9 49.5 27.2 Annually, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations 6.4 17.5 53.6 22.5 % Hospitals Specific Standard Does Not Meet Standard; No Plans To Change (n= 251) Does Not Meet Standard; Long-Term Plans To Change (n= 251)a Does Not Meet Standard; Short-Term Plans To Change (n= 251)b No Changes Needed; Currently Meets Standard (n= 251) aPlans for change after 12 months were considered long term. bPlans for change before or in exactly 12 months were considered short term. The pharmacy validates the accuracy of automated compounding devices on a daily basis 35.7 8.4 14.8 41.2 The pharmacy sterilizes products and equipment (e.g., carts) prior to entering the cleanroom 29.9 29.1 34.4 6.7 The pharmacy regularly rotates the type of disinfectants used in the i.v. cleanroom 28.5 23.9 38.1 9.5 The pharmacy has a policy in place prohibiting makeup for staff working in the i.v. cleanroom 26.8 20.6 32.1 20.5 The i.v. cleanroom floors are sanitized on a daily basis 15.8 21.0 44.7 18.5 The pharmacy uses settle plates on a regular basis (i.e., at least monthly) to monitor environmental conditions of the cleanroom 15.7 23.4 49.4 11.5 The pharmacy uses a cleanroom to compound sterile preparations 13.6 22.3 41.0 23.2 Hospital policy prohibits nurses and other health care providers from making nonemergent sterile preparations outside of the central pharmacy 12.7 24.4 26.7 36.2 The pharmacy utilizes specific garb attire requirements for the pharmacy staff who work in the i.v. cleanroom 11.3 13.6 43.3 31.9 The pharmacy performs end-product bacterial endotoxin testing on all high-risk preparations 11.1 27.2 35.2 26.5 The pharmacy uses the recommended beyond-use dating for products that do not undergo end-product sterility testing 9.0 9.3 22.9 58.8 The pharmacy performs end-product sterility testing on all high-risk preparations 6.6 18.0 41.0 34.5 Initially, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations 6.4 16.9 49.5 27.2 Annually, the pharmacy uses media-fill testing methods to validate the aseptic technique skills of personnel who compound sterile preparations 6.4 17.5 53.6 22.5 Open in new tab Overall, 45.3% of respondents stated that their hospital obtained approval to build a cleanroom because of USP chapter 797. Of those, 60.8% stated that chapter 797 was the sole reason for obtaining approval, and 22.2% stated that the new standard had a very large influence on obtaining approval. Only 8.8% of respondents indicated that the chapter had no influence on obtaining approval for a new cleanroom. Of the respondents who did receive approval to build a new cleanroom, 57.3% stated that the new cleanroom would meet ISO class 7 standards. Only 21.7% of respondents had obtained new equipment for compounding sterile preparations (e.g., laminar-airflow hood, barrier isolator, ACD). Of those who did, 58.9% indicated that USP chapter 797 was the sole reason for obtaining the new equipment, and 33.4% stated that the chapter largely influenced the decision to obtain new equipment for compounding sterile preparations. No respondents stated that the new standard had little or no influence on obtaining the new equipment. Larger hospitals more commonly had satellite pharmacies preparing sterile products, compared with smaller hospitals (50% versus 9.6%, respectively) (p < 0.001). In response to USP chapter 797 requirements, 19.9% of respondents shifted all compounding to the central pharmacy, 45.7% shifted some compounding to the central pharmacy, and 34.4% did not shift any compounding to the central pharmacy. When asked about high-risk preparations, 42.3% of respondents were decreasing the quantity of these preparations being compounded because of chapter 797. Of the hospital size most commonly associated with compounding high-risk products (≥400 staffed beds), 65.2% of hospitals were decreasing the quantity of high-risk preparations being compounded because of chapter 797. Overall, 22.6% of respondents said that their staffing changed because of USP chapter 797, either by shifting existing full-time-equivalent (FTE) employees or adding new FTEs to perform functions related to compounding sterile preparations. Only 16.3% of hospitals with fewer than 200 staffed beds stated that their staffing changed, compared with 38.5% of hospitals with 200 or more staffed beds (p = 0.0002). Budget and resource allocation Overall, 75.1% of hospitals had total pharmacy budget increases for the next fiscal year as a result of changes necessary to comply with USP chapter 797. I.V. room supplies and equipment were the most common increase in resource allocation. Furthermore, 51.0% and 44.8% of hospitals were increasing the budget to purchase point-of-care activated i.v. medication devices and manufacturer-premade or frozen sterile products, respectively (Table 55). Table 5. Effect of United States Pharmacopeia Chapter 797 on Resource Allocation Budgeted Resource % Hospitals That Have Increased Allocation aFTEs = full-time equivalents. I.V. room supplies or equipment 87.2 I.V. cleanroom floors sanitized on a daily basis (similar to how operating room suites are sanitized) 69.9 Manufacturer-premade or frozen compounded sterile products 51.0 Point-of-care activated devices (e.g., Add-Vantage, Mini-Bag Plus) 44.8 Pharmacy technician FTEsa 31.9 Pharmacist FTEs 20.8 Budgeted Resource % Hospitals That Have Increased Allocation aFTEs = full-time equivalents. I.V. room supplies or equipment 87.2 I.V. cleanroom floors sanitized on a daily basis (similar to how operating room suites are sanitized) 69.9 Manufacturer-premade or frozen compounded sterile products 51.0 Point-of-care activated devices (e.g., Add-Vantage, Mini-Bag Plus) 44.8 Pharmacy technician FTEsa 31.9 Pharmacist FTEs 20.8 Open in new tab Table 5. Effect of United States Pharmacopeia Chapter 797 on Resource Allocation Budgeted Resource % Hospitals That Have Increased Allocation aFTEs = full-time equivalents. I.V. room supplies or equipment 87.2 I.V. cleanroom floors sanitized on a daily basis (similar to how operating room suites are sanitized) 69.9 Manufacturer-premade or frozen compounded sterile products 51.0 Point-of-care activated devices (e.g., Add-Vantage, Mini-Bag Plus) 44.8 Pharmacy technician FTEsa 31.9 Pharmacist FTEs 20.8 Budgeted Resource % Hospitals That Have Increased Allocation aFTEs = full-time equivalents. I.V. room supplies or equipment 87.2 I.V. cleanroom floors sanitized on a daily basis (similar to how operating room suites are sanitized) 69.9 Manufacturer-premade or frozen compounded sterile products 51.0 Point-of-care activated devices (e.g., Add-Vantage, Mini-Bag Plus) 44.8 Pharmacy technician FTEsa 31.9 Pharmacist FTEs 20.8 Open in new tab Discussion Past studies have shown a general lack of compliance with guidelines for compounding sterile preparations in hospitals.12,–15 This may be related to a lack of enforceable standards similar to cGMPs that the pharmaceutical industry must follow. Before 2004, most pharmacy directors used ASHP guidelines to learn how to develop and maintain a high-quality sterile compounding program.12,18,19 Lack of funds to comply with ASHP guidelines may be related to capital cost justification: investment in compounding sterile preparations will not generate increased revenue for the hospital. State boards of pharmacy are using USP chapter 797 to guide the development of regulations for compounding sterile preparations, and JCAHO is using chapter 797 during accreditation surveys. The consequences of not meeting regulatory and accreditation standards are likely to prompt administrators to support full compliance with chapter 797. The results of this survey, however, indicate that many institutions are not planning to change processes despite the enforceable nature of chapter 797. One factor related to compliance with USP chapter 797 is hospital size. Small hospitals may not have the volume of sterile preparations to justify the cost of building a cleanroom. While there is evidence that hospitals of all sizes are trying to implement changes to meet chapter 797 requirements, results from this survey suggest that smaller hospitals are more reluctant to changing practices compared with larger hospitals. This is an important finding because 71% of all general and children’s medical–surgical hospitals in the United States are smaller hospitals with fewer than 200 staffed beds (Table 11). More than one third of respondents stated that they were not going to change their noncompliant practice of validating the accuracy of ACD daily. This is alarming considering the critical condition of patients receiving total parenteral nutrition (TPN) and the effect that an improperly calibrated TPN machine could have on patients. Undetected errors when compounding highly potent medications using an ACD could lead to adverse drug events for many patients. Another factor limiting change is a lack of information about chapter 797 among smaller hospitals. Of hospitals with fewer than 200 staffed beds, 45.8% of respondents had read USP chapter 797, compared with 80% of respondents in larger hospitals (p < 0.0001). All seven surveys returned by respondents stating that they were not aware of chapter 797 came from facilities with fewer than 50 staffed beds. Another reason for reluctance to implement changes to meet chapter 797 requirements is related to how pharmacy directors feel about the chapter. If a pharmacy director is under pressure to improve the department’s productivity, efficiency, and timeliness, there may be a reluctance to implement changes that would detract from those goals. More than three fourths of the respondents felt that the beyond-use dating standards would increase wastage, which would decrease efficiency and deter a pharmacy from implementing the new requirements. The survey results also demonstrated that respondents felt that chapter 797 requirements exceed what is necessary for hospital pharmacy practice. Despite the reasons that pharmacy directors may have for not implementing chapter 797, the survey did show that the chapter is having a positive impact not realized with previously published guidelines. The biggest impact of this chapter has been on the sterile preparation compounding environment. Chapter 797 emphasizes the importance of a controlled environment wherever compounded sterile preparations are prepared. One of the best ways to ensure a safe, controlled environment is a cleanroom.2 Almost half of the respondents reported that they had built or were building a cleanroom, and almost two thirds of these respondents stated that chapter 797 was the sole reason for this construction. USP chapter 797 has also had a significant effect on high-risk compounding procedures. The standards for compounding high-risk preparations are much more stringent than those for low- and medium-risk preparations. These more stringent standards seem to be forcing hospital pharmacy directors to either decrease the amount of high-risk preparations that are compounded or increase compliance with quality assurance measures and facility requirements. USP chapter 797 strongly emphasizes the importance of training and validating aseptic technique.2 One component of validating aseptic technique is media-fill testing, which requires a trainee to pass a rigorous series of sterile transfers without contaminating the media before compounding sterile preparations. More than 70% of respondents indicated that there were plans to implement annual media-fill testing; 22.5% of respondents were already compliant with this standard. USP chapter 797 also emphasizes the importance of continuous monitoring of environmental quality. This chapter reintroduces the practice of using settle plates, which contain a growth medium that is exposed to the air at critical points in a clean-room.2 Almost three fourths of the survey respondents stated that there were plans to use settle plates. Particle counts are necessary to ensure compliance to the requirements for an ISO class 8 cleanroom.2 More than two thirds of respondents stated that their particle counts met ISO class 7 cleanroom requirements. The impact of chapter 797 on practices for monitoring the environmental quality is evidenced by comparing the current survey results with those from the 2002 quality assurance compliance survey, in which only 35.5% of hospitals measured particle counts in the cleanroom and only 6.3% of hospital pharmacies met ISO class 7 requirements.12 One area of pharmacy practice not specifically addressed in chapter 797 is satellite pharmacies. Even though sterile preparations can still be compounded in a satellite pharmacy and meet chapter 797 requirements, the chapter seems to have resulted in pharmacies compounding more preparations in the central pharmacy. Two thirds of respondents stated that they have shifted some or all of the compounding in satellite pharmacies to the central pharmacy. USP chapter 797 seems to have slightly affected staffing. Almost 40% of hospitals with more than 200 staffed beds indicated that the pharmacy changed its staffing model to better comply with chapter 797 requirements. This change can be attributed to shifting more FTEs to compounding functions and adding more responsibilities to technicians and pharmacists to meet new requirements. Chapter 797 has resulted in more human resources being assigned to compound sterile preparations, whether through shifting existing FTEs or by adding new FTEs. This was not associated with a compensatory decrease in other budgetary items, as three quarters of the respondents reported that the overall pharmacy budget increased due to USP chapter 797. The results of this survey are limited in that the data collected were self-reported. It is possible that the directors’ responses do not reflect actual practices. However, many responses were opinion based, and this report captures respondent opinions. In addition, nonresponse can be a concern in survey research. In this survey, hospitals with fewer than 50 beds had a decreased response rate compared with larger hospitals. However, because a design-based analysis was used to account for the stratified random sampling procedure, our population estimates should not be affected by this underreporting. Conclusion USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in high-risk compounding, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall. References 1 Thompson CA. USP publishes enforceable chapter on sterile compounding. Am J Health-Syst Pharm . 2003 ; 60 : 1814 –7. News. Crossref Search ADS PubMed 2 Pharmaceutical compounding—sterile preparations (general information chapter 797). In: The United States pharmacopeia, 27th rev., and The national formulary, 22nd ed. Rockville, MD: United States Pharmacopeial Convention; 2004 : 2350–70. 3 Vivian J. Pharmacy compounding and the FDA. US Pharm . 2003 ; 28 : 32 –45. 4 Food and Drug Administration. 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Am J Health-Syst Pharm . 2000 ; 57 : 1150 –69. Crossref Search ADS PubMed Author notes The assistance and guidance of Sam Augustine and Firouzan “Fred” Massoomi are acknowledged. The assistance of ASHP is acknowledged for the use of the SMG database. This survey was funded by OSU’s Latiolais Leadership Program. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved.