TY - JOUR
AU - Desmond, Jeffrey, S
AB - collaboration, compliance, regulatory, safety, sterile compounding, training Sterile compounding is one of the essential job functions of a health-system pharmacy department. It is a vital service that is required to ensure patient safety and help produce successful patient outcomes. Noncompliance with sterile compounding regulations has led to serious adverse events in facilities across the country.1,2 One such event occurred at New England Compounding Center, where negligent compounding practices directly led to 64 deaths and hundreds of additional infections.2 This unfortunate event could potentially be replicated at any compounding facility that does not set forth and emphasize a standardized system that enables employees to strictly follow best practices. The Michigan Medicine department of pharmacy has been certified for medication compounding by the Joint Commission, and thus members of the department considered themselves to be compliant with regulations and following best practices in optimizing this aspect of the patient care experience. However, following a Food and Drug Administration (FDA) inspection in 2016 and a subsequent external consultant review, we learned about increased rigor related to sterile compounding compliance and the diligence needed to meet that rigor. Prioritizing sterile compounding and the techniques, procedures, and processes necessary to truly create a controlled compounding environment has led to many questions about and changes in the compounding services provided. More stringent requirements from pharmacy regulatory boards have made creating and maintaining a sterile environment complex.3 The primary issues that were identified at our institution, with the help of external experts and our internal compounding compliance team (CCT), included determining which pharmacy personnel are responsible for each aspect of sterile compounding compliance, what training should consist of, who and how often team members should be trained, and how to maintain a sterile environment once established. These issues were identified by completing a gap analysis of current requirements vs existing practices. It was determined that the institution had room for improvement in order to consistently become one of the top compounding programs in the nation. Throughout the resulting transformation, we developed internal expertise and competency where we did not have it previously and built structures to maintain that expertise and sustain the operational changes. It took time, extensive communication, understanding, education, and resources. This focus on sterile compounding and compliance has ultimately led to positive changes in patient safety. This article conveys perspectives on sterile compounding from leaders at 3 different levels: a front-line manager; a pharmacy executive; and senior leadership members, the chief medical officer and chief compliance officer. A review of Michigan Medicine’s organizational and operational information and a more detailed background on regulatory findings was previously published.3 Pharmacy operations manager’s perspective Prior to 2016, newly hired pharmacy technicians received roughly 1 week of sterile compounding training. Training consisted of watching a 3-hour video on aseptic technique, practicing compounding techniques, passing gloved fingertip and media fill tests, and pairing up with another technician team member in the operational sterile production environment. More emphasis was placed on how to read labels, dilute vials, and use the supporting equipment (syringes, needles, and fluid bags) rather than how to complete the process with optimal sterile technique. Pharmacists did not receive training on sterile compounding practices other than how to check a prepared product and/or how to garb to enter an ISO-7 environment (ie, a cleanroom that meets class 7 requirements of the International Organization for Standardization). Each new team member’s training was variable and dependent on the abilities of the trainer, both technically and as a teacher. There were no consistent job aids, work procedures, or a robust training program to ensure we were training everyone consistently and with a fundamental understanding of the importance of sterile technique in compounding. Sterile compounding technique and proper use of compounding and cleaning logs were not discussed with regularity or emphasized to new employees. This suboptimal training approach introduced opportunities that may have resulted in patient safety events had we not changed our practices. Since implementation of the compounding vigilance initiative described here, a day does not pass without hearing something related to sterile compounding. Our pharmacy department has made sterile compounding compliance a top priority. In order to achieve the outcomes we desire, a compounding compliance team (CCT) was formed.3 Among other roles, the CCT helped the department develop a robust training program backed by specific policies and procedures. CCT members became content experts and are relied on to help standardize workflow of making sterile preparations as safe as possible for our patients.3 A group of pharmacy leaders met with a consulting group with recognized expertise in sterile compounding to help us understand best practices, and then a subgroup met weekly to help customize a purchased portfolio of new pharmacy compounding policies and procedures. These sterile compounding−related changes were incorporated into practice in a phased approach consisting of training sessions and several different attestations indicating that a compounding team member has read and understands the new policies and procedures. In addition, a quiz on the policies and procedures was administered, with team members required to achieve a passing score (90%). These were supplemented by “eLearning” sessions, with assessments conducted at the end of each module. Today, every sterile compounding team member has been through the training, and all new team members—both technicians and pharmacists—go through the program during the onboarding process.4 Additionally, physical observation of compounding personnel is conducted semiannually during media fill challenges. While the importance of the training cannot be stressed enough, standardized training has not been accomplished without operational challenges for front-line team members, supervisors, and managers. Implementing the new policies and procedures was challenging in some areas of our institution, as not all compounding locations were adequately constructed to help support the changes. Team members found it difficult to comply with the time-sensitive demands of customers (physicians, nurses, and patients) while still supporting safe and aseptic technique. When technician staffing levels were not sufficient or there was especially high demand for compounded products, it was reported that some staff felt their aseptic technique was being compromised in order to meet demand. Further, all new pharmacists and technicians must pass a media fill and gloved fingertip test before they are allowed to compound or check sterile preparations. This is a lengthy process that can take multiple weeks. Our vigilance with regard to cleaning has also increased dramatically. Different categories of cleaning of the primary engineering controls and surrounding areas take place daily, weekly, and monthly. We have worked with our environmental services team and helped train them in cleaning pharmacy-specific areas, including both cleanroom and segregated compounding areas. The documentation of these tasks was historically completed on paper; to facilitate cleaning log use, we pilot tested an online tool. This online tool has been used in many pharmacy areas to date, and we hope to implement electronic documentation at all of the health system’s compounding locations in the future. To help with documentation compliance, we asked team members to double document (both electronically and on paper) until we had achieved consistent compliance with online documentation. During project planning documentation was not directly taken into account in determining the timing of workflow, but it should be considered due to its importance. Another cleaning task that has been operationally difficult in some areas, specifically the segregated compounding areas, is cleaning of vials that are brought into the area with a sporicidal agent. We started this practice because we were seeing bacterial growth on our media fill plates after cleaning them with sterile alcohol alone. To help operationalize this aspect of the compliance project, nonmembers of the compounding team wipe down all medication vials before placing them into storage bins. If compounding team members were asked to do this, they would need to change their gloves in between cleaning the vials and preparing the final sterile product. Further, the 3-minute dwell time required for use of the sporicidal agent would result in additional delays in the preparation phase if product decontamination must be completed in real time. Prior to preparation for pursuing a certificate in medication compounding and an FDA inspection in 2016, we did not have additional audits or checks to make sure team members were adequately using sterile technique and following policies and procedure, with the exception of the media fill requirements. With the help of our CCT as well as senior technicians and supervisors, we have developed an audit program that is helping to assess team member’s aseptic technique and adherence to policies, proper use of equipment, materials handling and dating, and facilities cleaning. We set a goal to complete 5 audits of every compounding location every month. On top of this, we have a member of the CCT audit our areas twice a month to share opportunities for improvement as well as document any findings of compounding practices that run counter to policy or use of inadequate technique while compounding. The audits ensure all areas are in a state of regulatory readiness by improving compounders’ skills and knowledge of the subject matter. The time required to garb and the supplies needed for personal protective equipment have increased and changed over time. We used to allow our technicians to wear scrubs brought from home while compounding in the cleanroom and our pharmacists to wear street clothes into the cleanroom while checking product. We previously required that three-quarter-length gowns be donned over a technician’s scrubs and a pharmacist’s street clothes, in addition to use of a mask, hair bonnet, sterile gloves, and booties. Now, we require all cleanroom team members to wear hospital-laundered scrubs that are donned at the facility, as well as a mask, hood, booties, coveralls with cuffed ankles and a tall collar, and sterile gloves. Because we require team members to wear hospital-laundered scrubs, an additional 10 minutes of changing time is allotted at the beginning of each shift. This changing time needs to be accounted for when creating work processes, including determining break schedules. Implementation of intravenous (i.v.) workflow systems is an additional step towards providing safe patient care while compounding. We currently use software to help manage many hazardous compounds and will soon implement additional technology so that all sterile preparation activities are captured with this system; this would include both patient-specific and non–patient-specific preparations. Further, robotic systems should be analyzed to determine if they have the right capabilities for the institution. Important items to consider include workflow limitations, space needs, and financial implications. We have decided to incorporate i.v. workflow systems first and will consider the use of robotics in the future. With the implementation of new systems comes additional training in use of these technologies and the consideration that these new workflows, while safer, may take additional time and effort. The additional steps to prepare a sterile compound may include barcode scanning, weighing preparations, and taking pictures, among other steps. Team members take great pride in the advancements of our sterile compounding requirements and hold each other and our cleaning partners accountable to adhere to high standards. This culture took time to build, and it is important for leaderships to continue to focus on improving workflow where there is opportunity to do so. Chief pharmacy officer’s perspective Improving compliance with compounding regulations can be challenging for pharmacy executives in several ways. First, a health system’s executives typically assume that a pharmacy department’s staff and practices are compliant with regulations. To learn otherwise can be a surprise to them. Therefore, when faced with significant budget requests for capital improvements or personnel, or both, effective communication is crucial. The pharmacy leader must be able to articulate efficiently and effectively as to why additional resources are required; this can often be done by referencing new standards, preparing a before-and-after comparison document, and pointing to articles published in journals familiar to the organization’s leaders. Communicating the importance of compliance to the pharmacy staff is critical. Pharmacy departments are often faced with minimal staffing levels. It can be difficult for cleanroom team members to meet compounding expectations (eg, slow, deliberate movements; more frequent environmental monitoring; increased record keeping) while trying to meet service expectations of nursing staff and patient needs. The pharmacy executive must be able to explain why these changes in practice are required and help the staff determine how new and improved processes can be completed. This process will entail an analysis and prioritization of job duties in order to make time for required compounding work. This can actually be an effective exercise, forcing a department to consider which functions actually provide value. Spending time on achieving compounding compliance can mean that resources, both financial and human, are diverted away from reaching other department goals related to expanding clinical services or optimizing drug therapy. A new priority that causes the delay of other initiatives may decrease employee engagement. Therefore, it is important to help other pharmacy leaders understand that noncompliance with regulations can fundamentally undermine the department and organization. Reprioritization of work in the department can also challenge front-line pharmacy managers. The most basic concern is ensuring that staff receive the proper initial training and can demonstrate competence in their compounding duties. Training applies not only to those involved in the direct compounding of the product but also staff involved in final checking of the prepared drugs and observing compounding technique and conducting audits. In a large organization this may mean several hundred individuals—pharmacy technicians, pharmacists, and pharmacy managers. The logistics of arranging this training, as well as conducting competency assessments, can be time consuming and logistically difficult. While the commercial, online system that we use facilitates staff members’ completion of training modules when it is convenient for them, it often results in overtime expense, because the 25 or so hours required for completion of all modules can seldom be accommodated in work schedules. Another challenge for front-line managers is ensuring that sufficient staff are in place to perform the work according to defined procedures and expectations while still meeting demands of patient care. The compounding standards require that compounding personnel move in a “slow and deliberate” fashion; this is often in conflict with clinician demands for medications that are needed immediately or the volume of compounding that must be completed over the course of a shift. Slower movements result in less efficiency and the need for additional personnel. Department managers must also ensure that staff, once trained, maintain their competence. This can be difficult in work environments where staff rotate positions and do not frequently compound medications. Conversely, in those areas where a staff member’s full-time job is compounding, there is a risk of repetitive motion injuries. The implications of increased compounding rigor for the pharmacy profession are significant. For the pharmacy technician workforce, a higher level of knowledge—and potentially skill—is required. In fact, national certification exams are now specifically separated into compounding and noncompounding certifications. In an already tight technician labor market this makes recruitment more difficult in those states that require certification as part of registration or licensure. For pharmacists, these changes mean that greater depth of both knowledge and expertise are required. In fact, the Board of Pharmacy Specialties recently approved “compounding” as a certified credential. While compounding knowledge and skills are technical in nature, they also must be very detailed and voluminous; this is leading to further specialization at both the technician and pharmacist levels, and it may also impact residency training programs, such as rotations in sterile compounding. Our professional organizations and colleges of pharmacy must ensure that educational and training opportunities exist for their members and students, respectively. Such opportunities may include more sterile compounding training and, eventually, different standards to govern who is allowed to prepare a sterile compounded product. Leaders of pharmacy departments are expected to allocate both financial and human resources to provide pharmacy services. These resources are limited, and demand for services is increasing. The role of the pharmacist has increased with regards to ensuring appropriateness of drug therapy. There are ever-increasing demands for more clinical involvement of pharmacists, yet leaders often find themselves having to direct more human resources to the compounding function; this generally detracts from job satisfaction for many pharmacists who have been trained and often prefer to provide direct patient care services and can result in increased professional staff turnover. The increased level of control and rigor required by recently adopted compounding standards and regulations provides greater assurance that compounded sterile products will be contaminant-free. Regardless of the resource commitment and debates on where to spend department budgets, pharmacy leaders need to convince their staff that compliance to compounding regulations is important for patient safety. It is impossible to point out all of these challenges without mentioning costs. While the details of all additional costs involved are beyond the scope of this article, suffice it to say they are extensive and fall into the following categories: Personnel—compounding personnel (including training time), compliance team, facilities staff, housekeeping staff, etc Facilities—renovation costs, increased maintenance costs, environmental monitoring, etc Supplies—sterile wipes, more expensive garb, sterile marking pens, dedicated cleaning supplies, etc We were fortunate to have the full support of our organization’s leadership in the provision of resources needed to become fully compliant. It may be difficult for many pharmacy leaders to obtain this level of financial support. Successfully overcoming these challenges was achieved by creating a compounding compliance report and reporting the status of each issue area on a monthly basis. These reports took the form of a table categorized into 4 sections: regulatory issues, personnel issues, facilities issues, and policy and/or procedure issues. Each area of focus included a description of the activities currently underway, progress to date, obstacles encountered and/or resources needed, and a color-coded status designation (red, yellow, or green) (see Figure 1 for an example). This report to the senior leadership was the basis for having necessary resources allocated in order to achieve compliance. Figure 1. Open in new tabDownload slide Example of monthly executive summary provided by Michigan Medicine pharmacy department detailing the status of various facilities-related activities of the compounding compliance team. Figure 1. Open in new tabDownload slide Example of monthly executive summary provided by Michigan Medicine pharmacy department detailing the status of various facilities-related activities of the compounding compliance team. Organizational leadership perspective The organizational leader to whom the head of the pharmacy department reports should expect to learn in some detail the level of rigor that compounding regulations require. Minimally, reading a few articles as well as the basic regulations would be appropriate. In addition, getting a guided tour of the compounding areas will provide valuable insight to an administrator who needs to make resource allocation decisions. Communication to other leaders in the organization is also important. The need for resources (operational, capital, and personnel) that may be directed away from other programs requires explanation and justification. Compounding process changes, as well as construction projects, may affect response times and turnaround times required to serve patients in different areas; that needs to be communicated to other providers. Ongoing communication with the executive leadership about construction and compliance progress is also important. One of the strategies a leader naturally considers when faced with a situation such as that described here is obtaining compounded products from an outside source. Key questions may be asked: Do we need to compound drugs at all? Why not outsource all compounding? It may be quickly learned that many drugs required for patient care are not commercially available, nor are they available from intermediate companies such as 503B outsourcing facilities. Many drugs have impractically short stability periods and would therefore expire before they could be used; some of these drugs are primarily used in urgent care scenarios. Moreover, there are many drug shortages that force hospital pharmacies to compound drugs. Thus, it becomes apparent that in-house compounding is required to safely support patient care. Compliance with regulations is something that leaders at the top of any health system expect from all professional service departments, including the pharmacy department. Pharmacy department managers are expected to be knowledgeable of standards and regulations. In addition to compliance, products and services must be provided in a safe manner consistent with contemporary practice standards. In fact, patient safety and high-quality care are usually at the top of every health system’s priority list. In general, compliance is achieved by having appropriate policies and procedures in place along with strong training programs and sufficient staff to comply with the expected policies. Occasionally an investment in technology or software is required, but technology investment is usually not extraordinary. Compounding regulations, such as those listed in United States Pharmacopeia chapters 797 and 800, Joint Commission standards, and state regulations, are intended to ensure patient safety and quality of care.5 These regulations, however, have taken resource consumption to a new level. As leaders learn about the details and associated costs of these requirements, compounding quickly garners attention. Difficult choices regarding allocation of resources often must be made. Investing in facilities construction and other aspects of meeting compounding requirements, as opposed to other patient care services, can prove challenging. Executives should be prepared for significant costs associated with compliance with sterile compounding regulations. A typical hospital cleanroom that requires new and/or controlled heating, ventilation, and air conditioning systems, with additional outlays for a specialized construction consultant and architectural fees, could easily cost $1 million (depending on the age of a building and in-house expertise). In addition to capital costs, there are new ongoing operational expenses for cleaning supplies, garb, environmental monitoring, educational and/or training materials and software, and (potentially) additional personnel. The cost of these investments must be balanced against the risk of being found noncompliant. Noncompliance with regulations places all of the functions of the organization at risk. Not only is clinical care potentially compromised, but compliance issues can impact research funding, result in financial penalties, and—perhaps most important—damage the reputation of the organization as a trusted provider of healthcare services. One of the concerns of a corporate officer is whether outside vendors are actually doing excellent work. The fact that a vendor is not doing a job as expected sometimes only becomes apparent when a government or other regulatory agency conducts an inspection. In our case, for example, it was assumed that the company certifying our cleanrooms was doing a good job. However, it was learned after a Joint Commission inspection occurred that some HEPA filters had holes so large that they did not pass inspection. Ways to prevent these disappointments include having strong contract language, conducting periodic internal audits, and requiring more solid evidence of compliance. Whether it is compliance with state or federal compounding regulations or another area of practice, there continues to be increased scrutiny by external regulatory and accreditation agencies. Organizations must be proactive in identifying these risks to the health system and make plans to mitigate the risk. It is always better (and less expensive) to prevent noncompliant practices than to react to them in response to an inspection or patient care event. Compliance and risk management groups and departments can be very helpful and must support pharmacy departments in this regard. In many ways, this heightened level of regulation is a new way of life for healthcare organizations. Summary With an organizational commitment to training and resources, front-line team members are more confident in their technique and knowledge of sterile compounding, and supervisors and managers are more aware of regulatory standards and how to achieve and maintain them. Pharmacy department and hospital leaderships must be engaged and supportive in terms of resources necessary to meet new regulations in practice. Making this commitment has allowed us to improve our compounding practices every day and positioned our organization for continued success in the future. Disclosures The authors have declared no potential conflicts of interest. References 1. Myers CE . History of sterile compounding in U.S. hospitals: learning from the tragic lessons of the past . Am J Health-Syst Pharm. 2013 ; 70 : 1414 - 1427 . Google Scholar Crossref Search ADS PubMed WorldCat 2. US Food and Drug Administration . New England Compounding Center pharmacist sentenced for role in nationwide fungal meningitis outbreak [news release] . https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/january-31-2018-new-england-compounding-center-pharmacist-sentenced-role-nationwide-fungal. Published January 31, 2018. Accessed October 20, 2019 . 3. Chaffee BW , Tharp JC, Clark JS, et al. A compounding compliance team at an academic medical center . Am J Health-Syst Pharm. 2020 ; 77 :885-895. OpenURL Placeholder Text WorldCat 4. Penzien CE , Tharp JC, Mulzer K, et al. Development of a sterile compounding training and competency program at a large academic medical center . Am J Health-Syst Pharm. In press. OpenURL Placeholder Text WorldCat 5. General chapter <797> Pharmaceutical compounding–sterile preparations. In: United States Pharmacopeia–National Formulary . Rockville, MD : US Pharmacopeial Convention, Inc ; 2008 . Google Scholar Google Preview OpenURL Placeholder Text WorldCat COPAC © American Society of Health-System Pharmacists 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)
TI - Impact of enhanced compounding vigilance: Three perspectives
JF - American Journal of Health-System Pharmacy
DO - 10.1093/ajhp/zxaa097
DA - 2020-06-23
UR - https://www.deepdyve.com/lp/oxford-university-press/impact-of-enhanced-compounding-vigilance-three-perspectives-7PJo8NLKr2
SP - 1071
EP - 1077
VL - 77
IS - 13
DP - DeepDyve
ER -