Drug shortages are always a frustrating situation for everyone involved in patient medical healthcare: the physicians, the nurses, the pharmacists and obviously the patient. The pharmacist certainly cannot fill the prescription for a medication that is unavailable, the nurse in clinical settings cannot administer to their patients what the pharmacy can’t supply to them, the patients cannot get the medicine that they need for their specific individual medical condition, and the doctor or physician can’t utilize the chosen and preferred method for helping to treat his or her patient in receiving the highest possible level of acceptable and preferred medication to ensure that the his/her patient receives the very best treatment that there is. Many times the pharmacist, doctor and, worst of all, the patient is forced to settle for the “next best” treatment that’s available. Then add into the “equation” the lost and wasted time that both the patient and druggist will usually spend on trying to locate the medication elsewhere. Additionally, the stress and anxiety this causes to everyone is something that you cannot even associate a monetary price to. Lastly, keeping in mind that the patient is already ill and suffering from a treatable condition that now cannot be therapeutically alleviated with the best possible medication (if at all without it!), and one can clearly see the dramatic and almost “domino like” negative effects that a drug shortage may potentially result in.
In attempt to put this in its proper perspective, according to one recent survey by Vizient, Inc. , hospitals alone in the U.S. lose over $350 million a year due to drug shortages, plus that more than an additional 8.5 million hours of people’s time are wasted annually.
What Statistics are there on Drug Shortages?
Drug shortages in the USA are documented and monitored by the ASHP (The American Society of Health-System Pharmacists), a professional organization of over forty-five thousand members that’s primarily comprised of pharmacists, pharmacy interns and students. Their most recent update on drug shortages in the United States was released just a week ago on January 24th of 2020. Note that this annually updated statistical report even includes the data from last year or 2019.
The January 24, 2020 report released by the ASHP included numerous statistics and data to analyze for those experts that enjoy doing that, but there were five key statistics and takeaways from the recent drug shortage report.
- There were 166 new drug shortages in 2019. This is actually lower than the number of shortages that the were documented by the ASHP in 2018 when there was a grand total of 186 for the year. Below are the yearly drug shortage counts that were document by the ASHP in the United States annually over the past two decades (from 2001 to 2019):
Although down from last year, and well short of the drug shortage record of 267 that were seen in 2011, there were 166 situations last year where a shortage did occur and resulted in the negative consequences caused by drug shortages that we discussed previously.
- Keeping in mind that the drug shortages we are discussing are NEW shortages, perhaps a better number to put this in its proper perspective is the total number of ACTIVE shortages. These include, quite obviously, the new ones each year added to the existing ones that are still in play. When we look closely at the total active drug shortages by year, perhaps we can all get a better appreciation of how drastic the drug shortage situation currently is. Plus it is actually growing each year!
In 2018 the total number of active shortages was 915. At the end of 2019 the total number of active shortages was 1,087. Perhaps there was a drop in new ones, but the real point is that the total active and ongoing number has steadily been increasing every year! In fact, even though the number of new shortages decreased in 2019 when compared to 2018, the number of active shortages increased by almost 20%. Perhaps that helps explain why the NCBI (The US National Institutes of Health) has called the drug shortages a Crisis in the United States!
- Greater than half of the drug shortages (approximately 60%) were for non-injectable medications.
- Central nervous system drugs (included are drug treatments in patients with anxiety, insomnia, stress, etc.) comprised the therapeutic class of drugs that accounted for the most drug shortages in 2019. These were followed by:
– Electrolyte replacements (including IV electrolyte replacement treatments)
– Cardiovascular medications (including blood pressure and heart disease drugs)
– Chemotherapy medications
– Gastro-intestinal, Hormonal, and EENT medications were all relatively about even and comprised the rest of the therapeutic classes of the 2019 drug shortages list.
- For the 2019 list regarding the causes of the new drug shortages, the majority were classified as “unknown cause” (over 80%). However, this inflated number was repudiated by by FDA Drug Shortage Task Force report that documented that greater than 60% of all the new shortages in 2019 were attributed to quality and/or manufacturing issues by the manufacturers, suppliers, and/or distributors. The FDA’s report also stated that the ASHP report’s number was askew and incorrect due to the fact that a “significant number of manufacturers, distributors and suppliers of the drugs” simply refused to provide a reason for the shortage on the ASHP report.
What Do Drug Shortages Mean to a Pharmacy Manager or Owner?
In what is now known as “The Age of Documentation” in the pharmacy business, updating your Policy and Procedure manual is a must. This manual must contain the required policies and reflect the actual operational procedures of the pharmacy. So how your pharmacy handles these drug recalls requires a customized and detailed policy be a part of your P&P, plus additionally, the documented procedures or steps undertaken to make sure that the policy is properly implemented and carried out by your staff. In addition to what most pharmacy managers and owners would consider the “normal” policies and procedures that are expected, how you deal with these drug shortages must include both Drug Recalls and Drug Shortages now. Also, training for your staff on how to address drug shortages (and documenting that you do have such training and that every employee receives it) is also a must!
Healthcare Consultants is a leading national Pharmacy Consulting company offering expertise in all areas of pharmacy consulting. Known for being one of the nation’s leading pharmacy staffing agencies for over three decades, HCC has been in the business of Pharmacy Consulting for 31+ years now. Known nationally as one of the industry leaders in providing a full range of professional pharmacy consultation services to its vast array of clients, HCC is owned and operated by pharmacists. We can provide proven expertise and experience in all facets of pharmacy operations, including retail, hospital and all specialty pharmacy venues.
Don’t overlook the fact that the mishandling of drug recalls and shortages can result in serious problems and issues to your pharmacy business. As the old cliché goes – “An ounce of prevention is worth a pound of cure!” Contact us online now or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.