International Summit on Medicine Shortage, Toronto, Canada

I am here in Toronto attending the International Summit on Medicine Shortages. This two-day Summit is co-hosted by the International Pharmaceutical Federation (FIP) and the Canadian Pharmacists Association. It is sponsored by Pfizer, Interpharma and Canada’s Research-Based Pharmaceutical Companies. The goal is to examine causes for the increasingly severe worldwide shortage of medicines, and recommend solutions. At the first session yesterday I gave opening remarks from the physician perspective. Michel Buchmann, President of FIP, represented pharmacists. Suzanne Nurse, PhD from the International Association of Patients’ Organizations (IAPO) spoke for patients.

The following are my remarks.

“The World Medical Association (WMA) is the global federation of National Medical Associations in 102 countries representing the millions of physicians worldwide. Acting on behalf of patients and physicians, the WMA endeavors to achieve the highest possible standards of medical care, ethics, education and health-related human rights for all people.

It is in support of this endeavor of achieving the highest possible standards of medical care that I am pleased to be here representing the WMA to provide a physician perspective on the subject of medicine shortages.

First, on a personal note, I have vivid recollections of rounding on the wards at Grady Memorial Hospital in Atlanta while a medical student at Emory University some decades ago.

We were treating especially virulent infections caused by coagulase positive staphylococcus aureus – a bacterium that was quickly becoming resistant to the major antibiotics in our armamentarium at that time – penicillin, streptomycin, sulfa and tetracycline. And we were worried we would run out of antibiotics that were effective.

We would be doomed. Today of course we call that MERSA, and we are still predicting doom – as Mark Twain famously said – a little prematurely. That was a time when our armamentarium of medications was limited, not just in antibiotics but also for treatment of many diseases.

In my career in general internal medicine, over the years I have been continually amazed and awed by advances in science. The tests, treatments, medications and vaccines – that flow in an ever-building torrent from the laboratories and clinics of inquisitive and imaginative scientists have been and continue to be breathtaking.

Today, rather than be limited by the lack of an effective treatment, we are faced with a different problem that has intensified over the last several years – shortages of known effective medicines. The patient with pernicious anemia unable to obtain parenteral vitamin B12 so essential to his health and well-being. IV Calcium Gluconate and IV cortisone for hospital patients – two other examples. The challenge now is how to assure a reliable supply of those medications we have come to rely on to relieve suffering, cure disease and save lives.

Shortages of medicines have always been present to some degree in the US, but over the last decade the number of drugs in short supply has surged dramatically. The American Society of Health-System Pharmacists’ web site currently lists more than 230 drugs and vaccines in short supply.

In the US shortages are concentrated in several areas – treatments for cancer patients, infectious disease, cardiovascular disease, and emergency care have been impacted, as well as drugs used in surgery and pain management. Recently shortages have surfaced for commonly used electrolytes and components of parenteral nutrition admixtures. The majority of drug shortages in the US are sterile injectables, accounting for nearly 75% of the total.

However, although much of my remarks relate to the US, the problem is not limited to the US. WHO reports medicine shortages in Australia and Canada. On a global scale other markets are challenged with shortages in medication for treating diseases such as tuberculosis, malaria, and HIV/AIDS. A recent commentary in a Belgian pharmacy journal lists 21 countries with a variety of supply problems.

So what does that mean for patients?

At the just completed annual meeting of the American Society of Clinical Oncology in Chicago a survey of 245 cancer specialist doctors was reported. 83 percent reported a shortage of drugs within the past six months, and 93 percent said patients’ care has been affected. In the presence of being unable to provide the most appropriate drug – at any price – they reported having to make painful choices.

• 79 % switched chemotherapy regimens, which may be less effective.
• 43 % delayed treatment, which can give cancers more time to spread.
• 37 % chose among patients leaving some patients to go without a critical medication.
• 29 % omitted doses, which can reduce the chance of controlling cancer.
• 20 % reduced doses, which also may harm a patient’s chances of surviving.
• 17 % sent patients to other doctors.

Similar issues have been reported in surveys of U.S. anesthesiologists.

Painful choices.

There is no single cause for shortages. In 2012 in the US 54 percent of shortages of “medically necessary” drugs were equally divided between issues of quality and delays/capacity. 13 percent were from product discontinuation and 9 percent were from problems with availability of raw materials. The causes for 20 percent of the shortages were not identified or reported. You will shortly hear more details about the dynamics of drug shortages in the US from Kasey Thompson of the American Society of Health-system Pharmacists (ASHP).

At the annual meeting of the American Medical Association in Chicago earlier this week, its Council on Science and Public Health gave an update on drug shortages in the U.S. The report explains various ways in which the FDA is attempting to address drug shortages in the US. One tactic is to approve a drug for importation from a foreign manufacturer. This process has been used infrequently, in part, because of the global dynamics of drug shortages.

The report concludes that drug shortages continue to be a significant problem for hospitals, ambulatory care centers, physicians and their patients. Some improvement in the number of new shortages affecting “medically necessary drugs” is apparent although the overall number of shortages remains elevated.

The majority of drug shortages are due to manufacturing quality issues, often related to aging infrastructure or production equipment. High market concentration of manufacturers and limited spare production capacity contribute to scenarios promoting drug shortages.

The exercise of regulatory discretion by the FDA has been beneficial in mitigating individual drug shortages. However, this approach will not be as effective as company-based improvements in infrastructure, processes, and manufacturing lines.

Some new efforts are underway in the U.S. An upcoming GAO report is designed to shed more light on the real world causes of drug shortages, including market driven and economic variables, and to recommend solutions in light of root cause analysis. A more comprehensive and dedicated strategic plan for mitigating and resolving drug shortages will be forthcoming from the FDA.

Some options include incentives for manufacturers to upgrade facilities and expand production capacity, or to enter the market in the first place. Additionally, creation of a qualified manufacturing partner program is an option. The latter, could for example coordinate the development and provide end-stage funding for products to be stored in a national stockpile once overall manufacturing capacity is increased.

In the meantime, additional resources for the FDA from the Generic Drug User Fee Act have the potential to expedite application reviews and inspections. The FDA also should work to improve communication about existing drug shortages in a transparent fashion in order to promote confidence in their entire process.

Medicine shortages have serious life-threatening consequences for those who are ill. The physician faced with a shortage of medications necessary to care for patients, is frustrated and angry. The patient who finds out that the best drug for his or her treatment is not available is frightened – and frustrated and angry.

Speaking as a member of the World Medical Association, recognizing the ongoing nature and clinical implications of global drug shortages, there is urgency in monitoring this issue and working to prevent and mitigate drug shortages.

I look forward to the next two days in which we tackle this challenge.

Thank you”

WMA President Cecil. B. Wilson, MD travels around the world talking about the WMA’s work representing the millions of physicians worldwide. Acting on behalf of patients and physicians, the WMA endeavors to achieve the highest possible standards of medical care, ethics, education and health related human rights for all people. This blog will chronicle these travels and important issues.