TY - JOUR
AU1 - Wertheimer, Albert, I
AB - I have been a pharmacist for just over 50 years. I have lectured or consulted in over 70 countries and have guided master’s, PhD, and postdoctoral students from about 30 countries, so I feel qualified to discuss global pharmacy with you today. Pharmaceutically speaking, I come from a backward country. I will explain that statement in a few minutes. In the United States, we are taught that we are at the top and do things as leaders and set examples for the rest of the world. In some areas that is true. However, in pharmacy it is not so accurate. I have learned over and over a simple lesson that the problems surrounding and within the profession are quite the same all over the world, whether in Swaziland or Switzerland. It is true that the solutions vary, but not the problems and issues. And it should not be any surprise to us that there are some very smart and clever people everywhere who often devise solutions that are equal or superior to those practiced in the United States. What are some of these universal dilemmas within and surrounding the pharmacy profession? One of the most important is the image of the pharmacist and the subsequent lack of professional opportunities due to stereotyping of pharmacists. Many physicians, hospital administrators, and others view the pharmacist as a seller or dispenser of medications. Fortunately, this is a declining population, since our clinical pharmacist colleagues have proven their worth all over the world. The naysayers are either threatened by the new skills and abilities of pharmacists or are in the group of people in every domain who refuse to recognize change and progress. These are the same persons who deny the progress made by physician assistants and nurse practitioners. One way to fight this image is for pharmacists to loudly proclaim their professional imperatives and refuse to practice in settings where they are unable to offer valuable cognitive services, such as medication therapy management and patient education. Most physicians recognize the importance of pharmacists reviewing patients’ medication orders and participating in other patient care activities. If we offer such services with persistence and confidence, always keeping the patient’s best interests in mind, there is no question as to the pharmacist’s inevitable success as a full member of the healthcare team. Pharmacists in every country face similar challenges, irrespective of the country’s level of development, wealth, educational level, political system, geography, or climate. However, the solutions will differ even though the goals are the same. Finding solutions to access problems. Don’t you find it baffling that the United States spends nearly twice as much on healthcare as a percentage of gross domestic product (GDP)—17% or more—than nearly all other countries on this planet? Our Western European neighbors spend 8% to 10% of GDP and have similar health status outcomes. We rank 14th worldwide in maternal child deaths and lower than that in life expectancy. There is no reason to be baffled by these numbers. We have 2 societies: one with employment and health insurance and one without. The former group has access to world-class care, nutrition, and other services. Members of the latter group visit a hospital on the day of giving birth for the first time during their pregnancy, or they postpone seeking care until age 65, when they will be eligible for Medicare benefits. There is a “permanent underclass” in the United States. You might say that we have a national program to assist the medically indigent, called Medicaid. However, many physicians will not accept Medicaid patients due to low reimbursement rates. In addition, Medicaid has enrollment limitations based on patients’ assets and income. Let us assume a person locates a physician and receives a prescription for an effective medication. A typical brand-name medication may cost $200 for a month’s supply. Needless to say, many people do not have an extra $200. The literature time after time tells us that drug prices in the United States are among the highest in the world. This is because there is no government involvement in price setting in this country, as opposed to nearly all other countries, where the government reviews not only the safety and efficacy of medications but also their prices. In the United States, the price of a medication is determined by the marketplace. Residents of Europe have access to healthcare services through a single-payer (government-operated) system, and no one goes bankrupt due to healthcare expenses. These same people have access to nearly zero-cost university education and government-provided old age pensions. Please understand that my goal is not to criticize the United States but rather to point out how some other nations deal with the identical problems that we face. ALBERT I. WERTHEIMER, PHD, BSPHARM, MBA, is Professor at the Nova Southeastern University College of Pharmacy in Fort Lauderdale, FL, and a Visiting Professor at the Touro College of Pharmacy in New York City. Before joining the faculty at Nova Southeastern, Wertheimer held academic positions at the University of Minnesota, Philadelphia College of Pharmacy, and Temple University. He also was a Vice President at First Health, a pharmacy benefits management company, and Director of Outcomes Research and Management at Merck & Co. He has also served as a pharmacoeconomics and outcomes research consultant for numerous companies. Much of Wertheimer’s professional interest has been in international pharmacy. He served for 4 terms as President of the International Pharmaceutical Federation (FIP) Academic Section, 2 terms as an FIP Vice President and Council member, and 2 terms as Chair of the FIP Social and Administrative Pharmacy Section. He has also served on numerous FIP working groups, task forces, and committees. He is an Adjunct Professor at colleges of pharmacy in Mexico, Taiwan, Slovenia, China, Malta, and Turkey and serves as an external PhD dissertation reviewer in several countries, including Qatar, Kuwait, Pakistan, and New Zealand. A sought-after speaker and consultant, Wertheimer has lectured and offered consulting services in nearly 60 countries. He is the author or editor of 43 books and an author or coauthor of more than 400 articles in professional and scientific journals. He has directed 90 PhD students and nearly 100 MS degree students in the discipline of social and administrative pharmacy. Wertheimer earned his bachelor’s degree in pharmacy at the University of Buffalo. He earned an MBA degree at the State University of New York at Buffalo, and a PhD at Purdue University. He also completed a 1-year postdoctoral research fellowship at the department of social medicine at St. Thomas Medical School of the University of London. I called the United States a pharmaceutically backward nation. Why did I say that? Well, we are nearly alone in not using the metric system. Much of Africa uses it as well as all of Europe, Asia, and our North American neighbors to the North and South. Instead we continue on, mystifying international visitors with mention of grains, quarts, pints, gallons, pounds, ounces, feet, and yards. Finding innovative ways to advance pharmacy practice. The United States has had a major impact on advancing pharmacy practice through introducing the concept of clinical pharmacy, which was pioneered by Donald Francke, Harvey Whitney, Donald Brodie, Paul Parker, and many others, at US hospitals and universities in the 1960s and 1970s. The American idea of patient-centered practice was revolutionary in replacing the product-oriented focus of the past. Today, clinical pharmacy, under many different names, is the dominant form of pharmacy practice throughout the world. This basic change made the pharmacist relevant and truly a member of the healthcare team. In fact, had we not adopted this advance, we might find pharmacy in 2019 run by technicians with little need for someone to make flawless emulsions or having the ability to synthesize active ingredients. Pharmacy educators and professional society leaders recognized the need for us to become consultants to prescribers and patients alike and to provide cognitive services. Mandatory continuing pharmacy education (CPE) emerged in the United States. It has been improved in the last 30-plus years and is very likely responsible for today’s better prepared pharmacists. The CPE concept has been adopted in many other countries. However, some argue that CPE is neither continuing nor education. Leaders in the profession are giving consideration to periodic competency testing to maintain licensure status. I can envision a required, universally applied, practical test offered every 10 years. If one passed the test, he/she would maintain licensure for a 10-year period; those who failed would have up to 4 or 5 years to retake and pass the examination. Only through a scheme such as that can we truly convey to patients that practicing pharmacists maintain current competency even if they graduated 40 or more years ago. Finding better approaches to drug development and distribution. The future should be better than the present, and an ideal future should most likely be a hybrid or amalgam of the best features seen in the United States and the best features observed in the rest of the world, blended together thoughtfully to optimize our professional contributions to improve the lives of our fellow citizens. Let’s begin by borrowing something from the European Medicines Agency (EMA), now located in Amsterdam, which is the European counterpart to our Food and Drug Administration (FDA). In the United States, a clinical trial of a candidate drug is conducted to compare the drug to a placebo, and we learn whether the new drug cures or controls a condition without causing serious harm. But that only tells us if the new drug is superior (or not) to an inert substance. EMA tests the new drug against a popular drug already on the market, enabling it to determine whether the new agent is superior, equal, or inferior to the currently used medication. That is an improvement. Let’s also borrow innovations in unit-of-use packaging from the Europeans. When we in the United States dispense an antihypertensive medication, we count out the required 30 or 60 or 90 tablets and place them in a bottle. A prescription could also be for 45 or 50 or 75 tablets—all to be counted out in the pharmacy. In Europe medications come from the factory in the appropriate package size for a single course of therapy, such as 30 or 90 tablets. The carton contains a great deal of information, and should there be unused dosages, they can be returned and used by another patient, since the blister package is sealed and displays the expiration date and batch number for each tablet. Needless to say, the counting process used in the United States is not always clean, facilitates contamination, and is time consuming. Pharmacovigilance (also called Phase IV or postmarketing research) in the United States specifies rules for when clinicians should submit reports to FDA or to the manufacturer. In Europe reporting of adverse drug reactions is mandatory, yielding far more reports than the pharmacovigilance methods used in the United States, where such reporting is voluntary. Mandatory reporting can be expected to unearth previously unknown adverse drug events rapidly and enable pharmacists and physicians to be on the lookout for such possible problems. When a new drug application (NDA) is approved in the United States, the drug can be sold indefinitely unless a most serious problem is detected. It is difficult to remove a drug from the market once it is approved. However, Japan and several other countries employ a novel approach. They approve a new drug for a limited period of time, such as 3 years; at the end of that period, the manufacturer must reapply for marketing authorization for a further time period. This system enables the regulatory authorities to review the risk-benefit data and adverse event reports to make a determination for the follow-up period. A side benefit for the manufacturer occurs if the product was not a commercial success during its first 3 years in the market, as the manufacturer can decide to not attempt to secure a second period license and thereby cut costs or losses. Within FDA, the Center for Drug Evaluation and Research (CDER) is responsible for initial NDA approval. This same division is also responsible for removing drugs from the market. This dual role can create a difficult or awkward situation, because in deciding to remove a drug from the market CDER staff must at least indirectly acknowledge that they made a poor decision earlier when they decided to approve the medication. It would make sense to have a different FDA body in charge of drug removal from the market, as this would address some of these potential conflict-of-interest problems. A number of European countries use an “on call” system in which the community pharmacies in a city or suburban area divide up and assign overnight and weekend hours of operation; each pharmacy might be open every fourth Saturday or Sunday and overnight once or twice a month. There are signs posted in all of the pharmacies informing patrons about which pharmacies are open each night and on weekends. This eliminates a great deal of costly duplication resulting from maintaining staffing at every pharmacy every day. Many years ago, Norway introduced a regulation called the Need Clause. The Norwegian Medicines Agency can refuse to review a new drug application if a robust number of entries in the same drug class are already on the market. For example, if there are already 8 statins available and a ninth agent that offers no significant clinical advantage is presented for review, the agency can simply state that there is no need for such an additional product and refuse to consider it. Norway also created a government chain of drug wholesalers. This innovation stemmed from the country’s experience during the Second World War. At the time Norway imported nearly all of its pharmaceutical needs, and the war cut off normal transport and delivery services, creating very serious shortages. As community pharmacies are privately owned, it would not be fair to require them to keep in inventory enough medication for 3 months of typical consumption. Therefore, the government opened a series of wholesale depots that keep in stock enough medicines to cover a potential 3-month shortage. Donald E. Francke Medal CURRENT AND PAST RECIPIENTS 2019 Albert I. Wertheimer 2018 Abdul Latif Sheikh 2017 Marianne F. Ivey 2016 Lee C. Vermeulen 2015 Roberto Frontini 2014 Andrew Lofts Gray 2013 Eduardo Osvaldo Savio Quevedo 2012 Henri R. Manasse, Jr. 2011 Barry R. Goldspiel 2010 Agathe Wehrli 2009 William A. Zellmer 2008 Jacqueline Surugue 2007 Toshitaka Nabeshima 2006 Philip J. Schneider 2006 Thomas S. Thielke 2005 Colin R. Hitchings 2004 Dwight R. Tousignaut 2003 Toby Clark 2001 Joaquin Ronda Beltran 1996 Carl D. Lyons 1995 Gloria N. Francke 1986 Joseph A. Oddis 1978 T. Douglas Whittet 1971 Donald E. Francke See more at www.ashp.org/ About-ASHP/Awards/Board-of- Directors-Awards/ASHP-Donald- Francke-Medal In Europe the location of pharmacies is governed by rules and regulations. In the United States it is possible for 4 different pharmacies to occupy the 4 corners of an intersection, with only market realities governing such location. The regulations in Europe function via 1 of 2 possible avenues. One system is to permit a pharmacy license when the applicant shop owner can show that there are 5,000 unserved persons; he or she must point to new residential development and growth or show how a new expressway has made access to existing community pharmacies problematic. The other strategy is to have regulations requiring a minimum distance of 500 meters between licensed outlets; in high-density city center locations, where there are many more than 5,000 persons per 500 meters, more outlets are permissible. Both schemes reduce excess capacity, lowering operating and dispensing costs and resulting in lower prescription prices as well as increased profitability for owners. Innovating to meet drug shortage and pricing challenges. Recently, FDA entered into reciprocity agreements with EMA for mutual recognition of some policies. The benefit and meaning for US residents are clear: If there is a drug shortage in the United States and an available supply in Belgium or the Netherlands, for example, a drug product may be legally imported into the United States to help with the shortage situation. This is the case even if the European supplier has never filed an NDA in the United States. The opposite is also possible. Pharmaceuticals are generally less costly in Europe and elsewhere in the world; this is because the national government is, for the most part, the sole buyer of pharmaceuticals. This arrangement provides the government with great leverage and allows it to negotiate with drug manufacturers until the parties arrive at a mutually agreeable price. Another reason for lower foreign drug prices is a system referred to as reference pricing. This system allows a government to evaluate the prices for a given drug product in neighboring countries or in a group of countries with similar income and wealth levels; a typical strategy is to aim for the center of an identified range of prices. Today, there is almost no production of active pharmaceutical ingredients in the United States. Most of our drug supply comes from China, with additional amounts from India and other Asian countries. In light of concerns surrounding drug shortages, it is not comforting to know that the vast majority of our essential drug supply comes from other nations, some of which are our competitors and, in some cases, too often affected by internal disruptions. A cautionary note about US pharmacy education. The United States has no control over the number of pharmacy schools or of their enrollment numbers. Most other countries have a licensure process that considers the need for additional pharmacists in a particular geographic area. With no such controls, the number of pharmacy schools in the United States has gone from about 80 several decades ago to nearly 140 today. The creation of a surplus of pharmacists lowers wages and makes the study of pharmacy less attractive. Then shortages can be expected to ensue in a pendulum-effect reaction, making pharmacy more attractive sometime in the future. The profession of medicine controls the number of practitioners through the rate-limiting step of controlling the number of residency openings, which is increased only gradually over time. Fortuitous meetings. I have been very fortunate in my pharmacy career. I had the good luck to work with Dr. Francke in the International Pharmaceutical Federation (FIP), for which I served as a Council member and as vice president and president of both the Academic Section and the Social and Administrative Pharmacy Section. I have met so many talented and hardworking colleagues, many of whom became personal friends. I learned so much from Dr. Joe Oddis, Dr. Francke, and so many others. It all began in 1969, when as a graduate student I attended my first FIP meeting. I knew no one there, and it seemed that the Germans spoke to the Germans, the French to the French, etc. I was alone and decided that would be my last FIP meeting. Then a community pharmacist from Portsmouth, England, sat down next to me at a lunch and invited me to come to a committee meeting that afternoon. I accepted Jimmy Bloomfield’s invitation and met 6 or 8 of his colleagues. They invited me to join the committee and introduced me to their friends and colleagues, a process that has continued over 40-plus years until today, and I have met and dealt with thousands of colleagues and friends from every continent. Many have visited my home, as I have visited theirs. Now when I see a pharmacist sitting alone at a conference, I think of my 1969 experience and introduce myself and chat. Who knows where that can lead? Even if I can encourage involvement in only 10% of these situations, my impact is compounded by all of the other attendees those solitary individuals will encounter, and we can look forward to a surge of eager, enthusiastic pharmacists involved in international pharmacy activities. Lastly, I want to offer my most sincere gratitude to the ASHP Board of Directors for selecting me as the 2019 Francke Medalist. I’m no Donald Francke, but I promise that I will do everything in my power to prove that I warranted this high honor. Thank you so much. Editor’s note: The following was adapted from the author’s onstage remarks in acceptance of the 2019 ASHP Donald E. Francke Medal on December 9, 2019, at the ASHP Midyear Clinical Meeting and Exhibition in Las Vegas, NV. © 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 - Thinking globally to meet pharmacy’s universal challenges
JF - American Journal of Health-System Pharmacy
DO - 10.1093/ajhp/zxaa098
DA - 2020-06-23
UR - https://www.deepdyve.com/lp/oxford-university-press/thinking-globally-to-meet-pharmacy-s-universal-challenges-CSKs8107w9
SP - 1066
EP - 1070
VL - 77
IS - 13
DP - DeepDyve
ER -