Drug shortage strategies
Darshan Kulkarni
Kulkarni law firm
This is intended to be a discussion of how healthcare providers are dealing with drug shortages. This blog will give a front line view of what is happening on the front lines.
Shortages
Drug shortages have tripled to 278 in 2010 from just 61 in 2005 (Current List from ASHP). So, the FDA decided that if a company is the only supplier of a drug, it legally must notify the FDA six months before it anticipates a shortage of the medication. Still, the law lacks teeth. If a company fails to inform the FDA of a looming shortage, it faces no legal consequences.
Impact
Managing drug shortages has cost the healthcare system $216 million annually. A survey from the Institute for Safe Medication Practices, as reported in November, found that 25% of physicians said an error had occurred because of drug shortages. Seven U.S. anesthesiologists have reported that drug shortages resulted in deaths of their patients, according to a new survey from the American Society of Anesthesiologists.
Systemic impact
Impact of Shortages
As it currently stands, healthcare providers and hospitals now conduct weekly drug shortage meetings in addition to formulary committee meetings, looking not only at which drug will be approved but also which drug will remain in supply. While pharma and life sciences companies believe that decisions are based on cost, availability is starting to play a larger role in what will stay on formulary. For example, metoprolol (which used to be the mainstay for IV blood pressure control) has spent a significant portion of the previous year going on and off shortage. This has resulted in several hospitals and healthcare organizations deciding to switch over to alternative drugs like propranolol. However, some prescribers do not have adequate experience with this new drug, resulting in an unsafe prescribing environment.
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"Drug shortages have tripled to 278 in 2010 from just 61 in 2005..."
Stability &, sterility
Additionally, prescribers have now started looking at medications in a different way. They used to consider package labelling to be sacrosanct. However, prescribers are now looking at single use products and seeing if they can be used over short durations for multiple patients or doses. This allows a drug to be used multiple times, not for the sake of saving money, but in the interest of being able to meet patient needs.
Alternative sourcing
There have been news reports of physicians looking at the gray market to see if they can get access to a drug. There has been a problem where certain wholesalers and distributors get access to a large quantity of drugs, resultantly putting the drug “on shortage”. As a result of the shortage, these same wholesalers and distributors may then offer to sell the previously purchased products at multiples of their acquisition cost. Facilities will pay such costs because they need access to that drug. These prices are often not able to be passed on, and facilities (like hospitals and pharmacies) are starting to bear the burden of such costs.
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"...certain wholesalers and distributors get access to a large quantity of drugs, putting them at a shortage..."
Compounding
Several hospitals and other facilities have also started looking at compounds of other medications that were received from other manufacturers. For example, morphine, ativan, and fentanyl, were traditionally obtained directly from manufacturers. The vials were only pierced at times of necessity. Unfortunately, now these products are often being compounded by specialty compounding facilities who may be able to provide extended stability and sterility data and hence afford greater availability of products. This may be a win-win situation for the manufacturer, compounding facility, and healthcare providers, but often results in the cost being increased for providers and facilities.
Extended stability &, sterility dating
In line with compounding, healthcare facilities are now looking at whether there is data to support using products beyond their expiration date. There are several intravenous medications that have traditionally been assumed to be stable for only 24 hours. In light of shortages, several healthcare facilities have looked at conducting their own tests to see if there is extended stability on these compounded medications. This may help prevent waste. However, if the data is not appropriately vetted, this may result in increased costs and inappropriate use on patients.
DISCLAIMER: The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and / or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney-client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.
About the author:
Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance / Regulatory Affairs, and a Juris Doctorate degree. He works with and for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory and / or compliance needs.
Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products- Regulatory Considerations.
You can follow him on twitter at @FDALawyers or visit him at the Kulkarni Law Firm.
How can we prevent drug shortages?
