SUPPLY AND DEMAND: Dealing with Drug Shortages
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Supply and Demand: Dealing with Drug Shortages
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Up Close & Personal: International Academic Fellowship Committee
Global Connections is published twice-yearly by the American Urological Association Education and Research, Inc. (AUA). The AUA believes that the information in this newsletter is as authoritative and accurate as is reasonably possible and that sources of information used in preparation are reliable, but no assurance or warranty of completeness or accuracy is intended or given, and all warranties of any kind are disclaimed. This newsletter is not intended as legal advice, nor is the AUA engaged in rendering legal or other professional services. For comments or questions email us at communications@AUAnet.org.
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Social Media: Impacting Practice and Helping Providers Stay Connected
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AUA Education Around the World
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Around the world in 2012, some of the biggest news stories for the health care community centered on drug shortages, and one would be challenged to identify an area of health care not impacted at some level by scarcity of key agents used to treat patients. For urologists and urologic oncologists, one therapy in short supply was Bacillus Calmette-Guerin (BCG), used in our field to treat patients with bladder cancer. But urologists were not alone. Around the globe, anesthesiologists, medical oncologists, cardiologists and pharmacists also grappled to balance supply with demand – which led to strong collaborations between organizations and agencies and some very difficult conversations with patients. G LO B A L CO N N EC T I O N S • VO L U M E 5
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Though different regions of the world may vary in terms of which agents are in short supply, a 2011 commentary in one Belgian pharmacy journal claimed that the problem stretched from Afghanistan to Zimbabwe and listed 21 countries impacted by shortages. 1 In February 2013, the U.S. Food and Drug Administration (FDA) listed nearly 120 drugs on its shortage list. The American Society of Health-System Pharmacists (ASHP) listed more than 230 active drug shortage bulletins. Drugs on these lists include both generic and non-generic varieties, and include widely used anesthesia drugs (such as propofol and succinylcholine chloride), antibiotics (such as doxycycline) and oncologic agents like BCG and methotrexate. In the United States, shortages are centered primarily on five key areas: anti-infectives, oncology, pain management, cardiovascular and central nervous system. Earlier this year, the Canadian Medical Association, the Canadian Pharmacists Association and the Canadian Society of Hospital Pharmacists released results of a joint survey on shortages that demonstrated more than half the physicians surveyed reported a worsening of the issue since 2010. “The survey confirms that the health and well-being of patients is being negatively affected and that physicians and pharmacists are devoting a significant amount of time dealing with shortages, time that could be better
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spent improving patient care,” the groups said in a statement. Leaders estimate that, in 2011, there were 220 drugs in short supply in Canada.
CAUSES AND IMPACTS Shortages in drugs and biologics are caused by a variety of factors, ranging from manufacturing and/or quality control issues to scarcity of raw materials or components to simple economic underlying factors like reduced production or discontinuation. Laws of supply and demand, as well as mergers/acquisitions, creation and closing of facilities, and the overall financial market can all impact the availability of drugs and biologics. As companies consolidate resources, supply can be impacted – either temporarily or permanently. For instance, if the production of an active pharmaceutical ingredient (API) is negatively impacted, so then is the manufacturing time. The overall economy can also play a role in a company’s production of drugs and biologics. There are a number of factors for a firm to consider, including, but not limited to, generic competition, declining use of a drug due to newer alternatives, the cost of the manufacturing process and, of course, the product’s profit margin. In an already depressed economy, some
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companies around the world are keeping less of a reserve on hand for particular agents. Having less product in reserve makes it harder to meet demand in the face of shortage, particularly for a drug that has a longer-than-average production time. The world health care community is closely watching a number of widespread supply shortages, particularly those drugs for tuberculosis, malaria and, in some cases, antiretroviral medications.
‘...PHYSICIANS AND PHARMACISTS ARE DEVOTING A SIGNIFICANT AMOUNT OF TIME DEALING WITH SHORTAGES, TIME THAT COULD BE BET TER SPENT IMPROVING PATIENT CARE’
They are not worried whether the usual anesthetics are going to be available to put the patient to sleep. They are typically not curious if the usual vasopressor agent is available in case something goes wrong on the table. They do not have a list of backup drugs in case their agent of choice is on back order. Unfortunately, the medical community has to start worrying about these things.
For some urologists around the world, however, it isn’t a shortage in anesthesia drugs that is causing an issue, but rather, postoperative pain management agents. Nigerian urologist Dr. E. Oluwabunmi Olapade-Olaopa shared this information: We have reasonable access to most anesthetic drugs (except the newest ones), but most of our pelvic procedures are done under combined epidural and spinal anesthesia so it is not much of a problem. However, we do have an issue with opiate analgesics, which are in short supply due to attempts at curbing the illegitimate narcotic market. We cope with the shortages by using the drugs when available until the supply is exhausted. In those times (more often), we use alternative medications that are less effective and, yes, oftentimes this means our pain control is inadequate. CO N T I N U E D O N P G 8 ▼
With complex manufacturing processes and long lead times, sterile injectable drugs are among those particularly vulnerable to shortages. In some cases, even the slightest glitch can have a serious impact on supply, leading doctors, pharmacists and patients in pursuit of a “plan b.”
ANESTHESIA: A GROWING CONCERN The international anesthesia community is one of the hardest hit when it comes to drug shortages. Limited supplies of commonly used anesthesia drugs, such as propofol and succinylcholine chloride, can necessitate clinicians’ use of alternative agents, comparable in efficacy but different in terms of half-life, adverse effects and/or drug interactions. In situations where propofol isn’t available, midazolam or dexmedetomidine are viable substitutes but have different times for onset and offset and level of sedation. However, midazolam has a longer duration (one to four hours) than propofol and, though dexmedetomidine’s duration of action is comparable to propofol, the drug has an increased association with bradycardia and hypotension, as well as a higher cost. In a 2011 article in Orthopedics, authors Tara Mullins and Aaron Cook, PharmD, BCPS, cautioned readers to be aware of these shortages: Before stepping into the operating room, surgeons should be concerned with sterile garbing, proper hand-washing techniques, and the procedure they are about to perform.
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BCG In 2009, a shortage of the antitumor antibiotic mitomycin-C, a sterile injectable agent made from natural products produced by the fungus steptomyces, resulted in an increased number of urology patients with intermediate-risk bladder cancer being treated with courses of BCG. However, three years later when the specialty faced a global shortage of BCG, managing the problem wasn’t as easy. In the summer of 2012, a manufacturing issue caused one of the world’s largest producers of BCG to temporarily suspend all manufacturing of BCG at their facility. The impact was broad. “The mitomycin shortage was as severe as or more severe than BCG, but BCG is a crucial drug in bladder cancer treatment while [mitomycin-C] is not usually a game changer” said Edward Messing, MD, FACS, a professor of urology at the University of Rochester Medical Center and the president of the Society of Urologic Oncology (SUO). Shortly after the manufacturing issues were announced, U.S. regulators, manufacturers and key stakeholders, including physician groups and patient advocates, convened to address the issue and share information, including input from a second manufacturer of the drug. In the case of BCG, a second manufacturer was able to begin releasing product and increase production. But that did not mean that patients weren’t impacted. “The lack of availability of BCG, although brief, led some patients to lose their bladder who might not have needed to,” Dr. Messing said. “Fortunately, its extreme scarcity was relatively brief, although the problem isn’t over yet.”
‘THE L ACK OF AVAIL ABILIT Y OF BCG...LED SOME PATIENTS TO LOSE THEIR BL ADDER WHO MIGHT NOT HAVE NEEDED TO’ In the United States, the FDA works with manufacturers to communicate supply issues and works to ameliorate the impact of shortages by working with companies who manufacture the same drugs. By serving as a “middle man,” the FDA can ask other companies to increase production; in cases where this is not possible, the FDA serves as the key agency in working to obtain pharmaceuticals and biologics from international sources to meet patient needs.
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The reduction in supply of BCG in 2012 was fairly universal. Dr. Messing, as president of the Society of Urologic Oncology (SUO), engaged with international groups – including those in Europe and Japan – to share information on managing patients with bladder cancer during the shortage. For Dr. Marcelo Wroclawski, MD, MsC, a urologist in Brazil, there were limitations on BCG availability, where the drug is produced by a governmental institute, and is distributed by the state with no charges. “At the end of 2012, BCG distribution was instable, with some patients complaining of the difficulty to acquire the medication,” he said. “This fact occurs every now and then, but usually it does not last for a long time. Since November 2012, the situation seems to be solved.”
STAY INFORMED, BE PREPARED Although the issue with BCG is currently resolved, in the United States, the FDA reported on nine biologic agents that had supply issues and, to date, only the BCG issue has been resolved. The issue with biologics may be particularly difficult as the shortage may be due to production problems identified by either the company or the FDA. Therefore, it is important for organizations to maintain close contact with federal regulating agencies so that impending shortages can be identified early and alternatives communicated to providers. In addition, it is critical that other issues (economic, manufacturing, etc.) surrounding critical drugs be recognized by government agencies that may be required in the future to subsidize the production of such drugs that no longer remain profitable for drug companies. In the United States, this is partly accomplished through the “orphan drug” program, where the development and production of drugs used to treat rare conditions are supported by the federal government. Still, providers need to report any shortages quickly to their specialty organizations so that early communication with agencies can be used to provide solutions as quickly as possible and minimize impacts on patient care. ●
REFERENCES 1 Beerten E, Bonheure F. Autour due monde – des indisponsibilites de medicaments. Annales Pharmaceutiques Belges 2011; Nov 15: 11-14.
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INTERNATIONAL ACADEMIC FELLOWSHIP COMMITTEE AUA’s Academic Exchange Programs* offer promising young urologists the opportunity to spend time at academic institutions in another country and attend that organization’s annual meeting. The programs give participants the opportunity to gain a global perspective in urology while broadening their cultural horizons. Participants, selected through a competitive process, include urologists from Brazil, China, Europe, India, Japan, Mexico, South America and the United States. An important aspect of these programs is the work of the International Academic Fellowship (IAF) Committee. The IAF Committee is made up of past AUA academic exchange participants who have firsthand experience traveling internationally, many of whom have hosted international scholars at their own institutions. In preparation for the international exchanges, the Committee carefully reviews applications from North American junior faculty and selects participants for each international academic exchange program based on several important criteria. The Committee also assists AUA staff with the promotion and communication of the programs to young urologists throughout the year. Perhaps most importantly, the Committee advises AUA staff and leadership on the changing landscape of urology for junior faculty and makes improvements to the exchange programs to ensure their continued success. Recently, Global Connections reached out to the Chair of the IAF Committee, Dr. Daniel Lin, and IAF Committee member Dr. Sam S. Chang to ask them about their work on this unique AUA committee.
Name: Daniel W. Lin, MD (IAF Committee Chair) Hospital and Professional Position: Chief of Urologic Oncology Professor, Department of Urology Bridges Endowed Professorship in Prostate Cancer Research University of Washington Year of AUA Academic Exchange: 2008 (Europe) Name: Sam S. Chang, MD, FACS (IAF Committee Member) Hospital and Professional Position: Professor of Urologic Surgery Department of Urologic Surgery Vanderbilt University Medical Center Year of AUA Academic Exchange: 2006 (Europe)
AUA:
What is the IAF Committee’s mission?
Lin:
The mission of the IAF Committee is to facilitate the identification of appropriate exchange fellows, to provide oversight for the experiences of the various exchange programs and to dialogue with the AUA Executive Board on issues surrounding global urologic endeavors.
Chang:
Match the best and the brightest with academic, social and personal opportunities in the international arena that are mutually beneficial.
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AUA:
What value do you see in the exchange programs? Are you still experiencing benefits from your exchange experience?
Lin:
The primary value is the interchange of ideas, values, urologic practice patterns and delivery of health care among the diverse cultures across the globe. Academic collaborations and lifelong friendships emerge from these experiences, and I am still reaping the benefits to this day.
Chang:
This is a win-win. Everyone learns from each other, and this learning involves a variety of avenues, from the mundane of how cases are scheduled to the nuances of palliative care for advanced prostate cancer patients. The give-and-take is based on honest curiosity as well as experience from both sides. It is an eye-opening experience that reinforces our appreciation of the U.S. system but also exposes us to many specifics of medical care that we can improve. The personal relations are important and continue to this day.
AUA:
How is the IAF Committee different than other committees at the AUA?
Lin:
The IAF Committee is more intimate and perhaps more interactive than other committees in the AUA.
Chang:
Chang:
Although competitive, everyone interested should apply. Do NOT be put off by concerns regarding lack of experience or area of expertise. The AUA understands the importance of establishing and strengthening international relations.
AUA:
How do you see the exchange programs evolving in the future?
Lin: I would hope that other countries would see the value in these exchange programs, and the AUA would work towards fostering mutual exchange programs in other venues.
Chang:
Although it is difficult to improve on the excellent programs currently in place, I am hopeful other countries and locales will become involved and partner with the AUA.
AUA:
Dr. Lin, as the chair of the IAF Committee, how would you like to contribute to or improve the exchange programs?
Lin:
I believe that increased communication of the opportunities and vast benefits of these programs will improve the overall scope of the program in years to come, as this will foster increased applicants, interest, and perhaps number of exchange programs.
The IAF Committee is a smaller committee with personal experiences impacting our decisions.
AUA:
How does the IAF Committee select exchange program participants?
Lin:
The Committee carefully considers the overall merits of applicants, primarily evaluating the candidate’s motivation and goals, track record of accomplishment and letters of reference.
Chang:
There is a thoughtful evaluation of the applicant’s academic achievements, stated goals, personal statement and recommendation letters.
AUA:
How has being on the IAF Committee changed your perspective on the exchange programs?
Lin:
I have seen more fully the breadth of opportunities for international exchange within the AUA and the importance that the AUA places on these endeavors.
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For more information about AUA’s Academic Exchange Programs, go to www.AUAnet.org/Exchange * AUA’s 2013 Academic Exchange Programs are made possible through an educational grant by
Social Media IMPACTING PRACTICE AND HELPING PROVIDERS STAY CONNECTED By Benjamin Davies, MD and Jennifer Larche Social media in recent years has received a great deal of attention in the realm of medical practice, revealing a global shift in how the health care industry interacts. Study results provided by QuantiaMD show that more than 20 percent of clinicians use two or more social media sites for both personal and professional use. It is these “connected clinicians” that will be the group to push the boundaries of how social media can be applied to improve health care and build momentum towards understanding this social movement. In a 2012 survey of more than 500 international AUA members, 70 percent answered “yes” to using social media sites such as Facebook, Twitter, YouTube and LinkedIn. Physicians have long understood the importance of staying connected to their patients and colleagues; social media is now giving them a new way to interact with these critical communities across the globe instantly. CO N T I N U E D O N P G 12 ▼
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WHY SOCIAL MEDIA? For many urologists, social media (Twitter in particular) has been a benefit. It is the quickest way to see new articles published from many medical journals and, more importantly, how urologists react to the articles — this being germane to quality patient care. This is also true for routinely monitoring trends in care; it lends advantages like being able to remain current on drug approvals. Some urologists also believe in the use of social media for international connection. When Dr. Henry Woo, a practicing urologist in Sydney, Australia, initiated an international Twitter journal club, physicians quickly supported Dr. Woo’s efforts and began to use their own Twitter pages to do so. The Twitter journal club is where urologists internationally debate, discuss and critique in real time the importance of articles. It is here that physicians can learn more regarding international differences in approach to problems and attitudes. An increasing phenomenon taking urology conferences by storm is conference tweeting. Twitter is all about immediacy — the cutting-edge facts and realtime discussions are just a few reasons why physicians are using Twitter to stay connected during conferences.
“...WITH THE INITIATION OF SOCIAL MEDIA, IT HAS BECOME INCREASINGLY EASIER TO CONNECT WITH THE ‘WHO’S WHO’ OF UROLOGY.”
Online communities, social media sites such as Facebook and Twitter, and blogging are just a few of the methods that enhance the connection with peers, patients and the urologic community worldwide. Dr. John Samuel Banerji, associate professor of urology at the Christian Medical College, Vellore, in Tamil Nadu, India, said that with the initiation of social media, it has become increasingly easier to connect with the “who’s who” of urology.
REALIZING THE VALUE Social media can also provide value to physicians in ways some never thought. One of the obvious benefits on both a personal and professional level is that these outlets give physicians a voice; they now have the opportunity to procure the best health care information and share it with their network. Today’s patients are turning to the Internet to self-diagnose and avoid faceto-face visits with their doctors. Particular to the specialty of urology, promoting the message of “having the conversation” is crucial in encouraging patients to take that first step and talk to a urologist. Many patients suffering with urological issues are at times hesitant and too embarrassed to communicate about them. Creating a professional Facebook page, a Twitter account or a blog to share relevant, valuable medical information may provide these patients with additional support needed to talk to their doctor, all the while improving patient relationships and increasing practice traffic — but, at the very least, it’s known that the information obtained is from a reliable source. Other benefits from embracing a social media presence include increasing referrals and becoming Internet information curators. Dr. Banerji finds that social media “has become a platform for surgeons to discuss interesting cases or something with a message, from which learning can take place.” Overall, it is a lowcost medium that allows physicians to educate patients on things like treatment outcomes and choices, as well as communicate with their specialty’s community quickly and broadly. In addition to being an outlet to share and express individual opinions and progressing the method of physician education, one of the key benefits of having a social media presence is being able to improve effective communication with patients and, in turn, providing the best quality care. Physicians are encouraged to determine the goal of their social media presence, whether it is promoting their practice, promoting themselves and speakers, or advocating for issues they are passionate about. Dr. Yi Zhang, associate professor of surgery at Capital University of Medical Sciences in Beijing, China, says, “I personally use social media for education, promoting to potential patients and connecting with colleagues. Airing of my own view is encouraging to network with urologists worldwide. I also use Linked-In for discussion groups on laparoscopy, endourology, etc.”
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BEHIND THE CURTAIN Social media goes beyond front-runners like Facebook and Twitter — many physicians have seen valuable benefits from blogging. One pediatrician from Kansas City, Dr. Natasha Burgert, has been using social media for the last three years to communicate with her patients to be a “source of reliable, real medical information.” She blogs as KC Kids Doc, and authored an entry specifically on How Social Media has Changed My Medical Practice; in this she mentions that selectively following leaders in the field of pediatrics has allowed her to refresh and update knowledge, and she can get help for her patients across the country through online professional connections. Another successful physician-blogger, Kevin Pho, MD, an internist in private practice in Nashua, New Hampshire, discusses breaking medical news. His blog, KevinMD.com, averages 310,000 page views per month and has launched him to superstar status in the realm of physician bloggers. Dr. Pho’s online presence has expanded to popular social networking sites, and he is regularly sought out for commentary in national media. According to Dr. Pho, social media has made health care more transparent. “By definition, social media encourages a two-way interaction so it gives patients a voice. Not only can patients look behind the curtain and see what a physician thinks, but they can also
“...SOCIAL MEDIA HAS MADE HEALTH CARE MORE TR ANSPARENT” respond to it,” he said. “There is a lot more interaction, and that barrier between the patient and health care provider has come down with the advent of social media.” Dr. Pho shares interesting findings and updated clinical guidelines on Facebook and Twitter; anyone can view his professional Facebook page, while his personal account is limited to family and friends. Physicians are not alone in their increasing use of social media. Professional associations, including the American Urological Association (AUA), are also finding these media to be effective communication tools with their members and constituents, allowing for real-time information-sharing. The AUA has compiled a list of “physician tweeters;” at the top are Drs. Benjamin Davies, Mathew Cooperberg, and Alex Kutikov, who have found social media extremely effective in creating awareness around critical issues, such as prostate-specific antigen testing and sustainable growth rate (the list can be accessed through the AUA’s Twitter profile). CO N T I N U E D O N P G 14 ▼
GETTING STARTED: After urologists ensure their online reputation is suitable for a social media presence, the following tips may help with how to get started, return on investment (ROI) strategies, and how to protect their efforts for long-term success:
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Creating a Facebook page and/or Twitter account is a great start without becoming overwhelmed; when creating a Twitter handle (e.g., Dr. Benjamin Davies is @daviesbj), use names applicable across many platforms. Start posting and communicating.
2
Follow the AUA on Facebook (www.facebook.com/AmerUrological) and Twitter (@AmerUrological), and use its list of urology physician tweeters to build a following/followers base.
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Learn more about Search Engine Optimization (SEO) and the basics of medical SEO — Google search is the most cost-effective and popular social media tool available so it’s important to become ranked on the first page. Register on Twitter Doctors – this is the international directory of doctors who tweet; they can also be featured as a “Twitter doc of the week,” which is an excellent marketing tactic.
Protect your social media ROI — Google your website, articles and your name – often.
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UROLOGISTS ON TWITTER A number of leading urologists are active on Twitter. If you’re wondering who you should follow, this list is a good starting point. Find more at www.Twitter.com/AmerUrological. Timothy Averch - @Tdave Professor of Urology and Director of Endourology at the University of Pittsburgh School of Medicine Matt Cooperberg - @cooperberg_UCSF Urologic oncologist specializing in prostate cancer at the University of California, San Francisco Cancer Center and the San Francisco VA Medical Center. Benjamin Davies - @daviesbj (self-proclaimed ”King of the urology Twitterverse”) Assistant Professor of Urology at the University of Pittsburgh and Chief of Urology, Shadyside Hospital UPMC Alexander Kutikov - @uretericbud Associate Professor of Urologic Oncology at Fox Chase Cancer Center in Philadelphia, PA Mike Leveridge - @_TheUrologist_ Assistant Professor in the Departments of Urology and Oncology at Kingston General Hospital in Kingston, Ontario. Declan Murphy – @declangmurphy Urologist and Director of Robotic Surgery, Peter MacCallum Cancer Centre in Melbourne, Australia David Penson - @Urogeek Professor of Urology at the Vanderbilt University Medical Center and Director, Vanderbilt Center for Surgical Quality and Outcomes Research Quoc-Dien Trinh - @qdtrinh Director of the Center for Outcomes Research and Analytics at the Vattikuti Urology Institute at Henry Ford Health System in Montreal, Canada Carl Wijburg - @roboturoloog Urologist specializing in prostate and bladder cancers, at Rijnstate in Arnhem, Netherlands Henry Woo - @DrHWoo Associate Professor of Surgery at University of Sydney in Sydney, Australia
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Using social media does have many benefits but, when maintaining an online presence, it is important for physicians to acquire certain strategies to manage their online reputation. Whether physicians are using social media as a personal or a professional network, some remain cautious about engaging with patients and are wary of the challenges it may bring for medical professionalism. In November 2012, the American Medical Association (AMA) created a policy about professionalism in the use of social media. Its guidelines include maintaining standards of confidentiality, using privacy settings to safeguard personal information and maintaining appropriate boundaries of the patient-physician relationship. The AMA policy also encourages physicians to consider separating personal and professional content and routinely monitoring their reputation by ensuring the information posted about them by others is accurate and appropriate. Dr. Kevin R. Campbell, a cardiac electrophysiologist and blogger, put it best when he said that his “digital footprint has opened many doors and provided many new opportunities to educate and serve patients both at home and across the world.” ● Benjamin Davies is Assistant Professor of Urology at the University of Pittsburgh; Program Director, Urologic Oncology Fellowship and Chief, Division of Urology Shadyside Hospital. He is also the prolific tweeter behind @daviesbj, and blogger for BJU International at bjui.com.
REFERENCES 1 Doctors, Patients and Social Media. Mary Modhal, QuantiaMD. Accessed Jan 21, 2013, @ www.quantiamd.com/q-qcp/DoctorsPatientSocialMedia.pdf
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Visit www.AUAnet.org/Academy for more information.
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AUA Education Around the World The American Urological Association (AUA) is a globally engaged organization with more than 19,000 members, one-quarter of whom practice in over 100 countries, representing the world’s largest collection of expertise and insight into the treatment of urologic disease. Since its inception in 1902, the AUA has worked to advance urologic education and the highest standards of urologic care through exceptional educational offerings, publications, research, policy and philanthropic initiatives. The AUA values opportunities to collaborate with the global urologic community and recognizes that the interchange of urological skills, expertise and knowledge is critical to the continued success of urology worldwide. The AUA would like to thank our international colleagues and partners for their friendship and collaboration to increase AUA education around the globe. For more information on AUA’s International Programs or to find a program near you, please visit the AUA International Academy at www.AUAnet.org/Academy.
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