In 2011, the pharmaceutical industry set a rather dubious record: 267 separate drug shortages were recorded throughout the year.1 This number exceeded the prior records set each of the four preceding years and served as further evidence of substantial issues with the reliability of the pharmaceutical supply chain.1 This growing crisis has garnered the attention of physicians and other clinicians, the media, the lay public, patient advocacy groups and last but not least, the federal government. Multiple pieces of legislation have been proposed to address various aspects of the drug shortage crisis, ranging from the need for advanced notification of impending shortages to increased monitoring of “gray market” distributors who charge greatly inflated prices for products in limited supply.2-5 Regardless of the final legislation enacted, the end result will be increased monitoring expectations for the Food and Drug Administration and increased regulation of pharmaceutical suppliers.
As has been noted in previous articles within this journal, the reputation and public perception of the pharmaceutical industry has been harmed by negative publicity related to the substantial financial penalties levied against many pharmaceutical organizations for both civil and criminal liabilities.6 The drug shortage crisis has added to this negative perception in a very tangible way, as these product shortages can have a dramatic impact on the health status of a particular patient and their family. In numerous public forums, critically ill patients, often pediatric and/or oncology patients have detailed how the added burden of drug shortages contributed to their already difficult struggle against disease. The inability of any one entity to bring about substantial improvement to these personal trials has created an environment of frustration and a need to assign blame. Often, both the FDA and the pharmaceutical industry are the most frequent recipients of this criticism.
An Opportunity for Greater Disclosure
The pharmaceutical industry, along with many other stakeholders, is working on multiple possible solutions to mitigate the current flood of shortages. However, beyond these strategies and regulatory fixes, there exists a public relations opportunity for the industry to define itself in more positive terms, especially in relation to the transparency of communication about its products.
The following charts reflect one of the discrepancies that contribute to skepticism regarding the ethical behavior of pharmaceutical manufacturers. The first graph characterizes the reasons given by manufacturers to health care organizations regarding the factors contributing to shortages.
In contrast, the second chart reflects information disclosed by the FDA regarding the factors contributing to shortages over a similar period of time.
According to the first chart, the primary cause of shortages is “unknown.” However, according to the FDA’s chart, manufacturing issues most frequently contribute to product shortages.
While this variation may seem minor, it does contribute to the impression that certain participants in the pharmaceutical industry are unwilling to disclose complete information to physicians, nurses, pharmacists, and other health care providers. As a result, these clinicians have little ability to provide further explanation to patients as to why certain pharmaceuticals are unavailable and why therapies have to be modified or delayed. In an attempt to answer patient questions, providers may be inclined to speculate as to why a product as short. These interpretations may bear little resemblance to the chain of events that actually led to a supply issue. The absence of accurate, clarifying information may prompt clinicians to lend less credence to proposed timelines for resolution of supply issues.
While some issues must remain confidential, it does appear that pharmaceutical suppliers could disseminate information about supply interruptions more clearly and with greater detail to the end users, the clinical community of practitioners trying to deliver care. If suppliers could be more open to the acknowledgement of issues and increase the accuracy of their projections for improvement, some of the frustration related to the current crisis of shortages could be minimized.
Ethical Communication in Health Care
Many factors contribute to the current rash of shortages. However, within the health care environment, accurate and timely communication, even about unexpected or undesirable events, is of utmost importance for all participants. The premise of health care is that strategic clinical interventions, such as the administration of therapeutic pharmaceuticals, will result in an improvement in the health status of the patient receiving treatment. Conversely, the absence of needed critical medications can have a negative consequence on a patient’s condition. Published data have documented the increasing incidence of patient harm (e.g. adverse drugs events, medication errors, worsening conditions) associated with delayed therapy or the use of less effective therapeutic alternatives to products that are in limited supply.7 Limited access to information regarding the reasons for supply interruptions or unreliable projections regarding the resolution of shortages only further complicate a difficult clinical practice environment.
Early Adoption Better than Forced Adherence
Congress is currently evaluating multiple pieces of legislation, many of which demand more detailed accounting for the reasons and circumstances related to drug shortages.2-5 Given the overall efforts related to reauthorization of the Prescription Drug User Fee Act, it appears quite likely that some form of drug shortage-related legislation will be approved in 2012, expanding the expectations for both FDA and industry to bring about more rapid resolution of supply issues. Since requirements for disclosure are likely to increase, pharmaceutical suppliers could position themselves in a more favorable light by initiating efforts to educate both the clinical community and the public about the functioning of the pharmaceutical supply chain and by demonstrating additional leadership in ensuring improved communication, even during shortage events.
Participation in the health care supply chain necessitates ethical behavior and commitment to accurate and timely communication on many levels. The current drug shortage crisis is an opportunity for the pharmaceutical industry to demonstrate that commitment to an expanding audience of patients and clinicians.
- Statistics provided by the University of Utah Drug Information Center, January 2012.
- Blass J. The Financial Case for a Deeply Embedded Ethical Culture. Pharmaceutical Compliance Monitor. February 21, 2012.
- ISMP. Drug shortages: National survey reveals high level of frustration, low level of safety. ISMP Medication Safety Alert 2010;15:1-6.