Modern medicine delivers miracles every day, but there are challenges, too. At any given time, 300 or more drugs bloat the FDA’s shortage list. Many of these medicines, including life-saving cancer drugs, don’t get to the patients who need them.
Drug shortages have a variety of causes, including contamination at pharmaceutical plants, major storms, supply chain issues, or runs on important vaccines. The Wall Street Journal blames downward pressure on drug prices.
Shortages of vital prescription drugs are nearing all-time highs, with more than half of hospital pharmacists facing critical shortages of chemotherapy drugs. Hospital pharmacists also report that significant drug shortages exist for steroids, hormonal drugs, and oral liquids, such as amoxicillin, and lidocaine.
Nearly one-third (32%) of hospital pharmacists characterize the overall current state of drug shortages as “critical,” meaning they are rationing, delaying, or canceling treatments or procedures. The government has called drug shortages a national security risk, and this is creating issues for today’s pharmacists on the front lines.
Heavy impact on hospitals
Let’s look at how pharmacies are forced to mitigate drug shortages.
When a hospital checks the FDA list, scrolls through hundreds of meds and learns of a drug shortage, the pharmacy staff scrambles to research what else is available on the market. The replacement might be the very same drug in a different container (e.g., larger or smaller), a different form factor (tablet, capsule, solution), or a different manufacturer. These are good options. Generic equivalents in the same concentration are the next best thing and prevent provider and patient impacts.
If a substitute formulation is available but in a different concentration, however, things get more complicated. The pharmacy needs to conduct an internal communication campaign to ensure that all relevant personnel – pharmacy technicians, prescribers, nurses, informatics specialists, pharmacy buyers, and medication safety teams – understand the replacement solution is different and the volume of medication, or number of tablets needs to be adjusted. This campaign might need to reach hundreds of clinicians whose first priority is providing patient care, not checking e-mail. In the worst-case scenario, a clinician misses this news and administers a potentially dangerous wrong dose.
On many occasions, no direct substitute for the originally prescribed medicine is available, and the pharmacy must find a clinically equivalent drug that has the same or similar function as the original – say, doxycycline instead of erythromycin. When you force a patient to take a different medicine, however, this can deviate from the standard of care recommended for the patient. Clinicians suddenly find themselves dealing with different medications from the ones they are used to, meaning different doses, dosing schedules and durations of therapy. All of which can potentially confuse at best, or a medication error at worst.
Whatever the strategy, mitigation involves a lot of change management. These are valuable hours that clinicians can’t spend treating patients. Industry figures say pharmacy teams must devote three hours of busy work for every drug shortage, but insiders say that’s a gross underestimate. Managing drug shortages costs U.S. hospitals nearly $360 million annually in labor costs alone, according to one survey.
Finally, substitute drugs routinely cost more than the original medicines, adding on more costs to pharmacies. On the whole, drug shortages are regular events and major headaches for pharmacies, clinicians, and administrators.
Red tape, risk, and rationing
When a drug shortage occurs on the manufacturing or distribution side, the hospital pharmacy team may have only two weeks maximum to activate a mitigation strategy, depending on their inventory and usage rate. In many cases, two weeks isn’t enough time. If a potential medication substitution is involved, administrators need to call an ad hoc pharmacy and therapeutics committee meeting to decide whether the substitution is acceptable and under what conditions. They must decide whether to modify orders in EHRs and/or create some sort of service level agreement for the future where the pharmacy department can automatically substitute the drug during the next drug shortage. And, as always, everyone who touches the drug needs to know the details.
Too often, the solution to a drug shortage involves a very tough decision: rationing the original medication. Pharmacies are left with no choice but to restrict the medicine only to the patients for whom it is most important, thereby extending the life of one’s inventory.
What does that look like? Consider a hospital that administers IVs to every sick or injured emergency room patient on arrival, or prescribes a prophylactic for deep-vein thrombosis (DVT) to every patient. If a sudden shortage forces the hospital to ration the treatment to a subset of patients, the hospital is assuming new risks and potentially legal exposure.
New tech solutions help pharmacies focus, strategize, and execute
Although shortages show no signs of relenting, hospitals and systems can mitigate the harm through smart technology decisions.
Technology providers are starting with the biggest problems first – shrinking the problem to a manageable size. Of the 300 drugs that may be short worldwide at any one time, a hospital system might purchase and use only 20 of them. And of those 20, only 12 are likely to be short given the hospital’s purchasing history. New technology can spotlight the dozen relevant drugs and answer the request, Tell me what I need to focus on. If the hospital doesn’t need to be distracted by the other 288 shortages, that’s a tremendous benefit.
Hospitals are getting help funneling these lists of relevant medications to a dashboard by integrating data from purchasing histories with the FDA and American Society of Health-System Pharmacists databases to identify impending shortages at the earliest opportunity. Real-time alerts give pharmacies more lead time to strategize mitigation than if they had to discover shortages manually.
These emerging mitigation solutions also pull from wholesaler lists to present pharmacies with ideal substitutes for each short medicine – meaning if the same drug in the same concentration is available, pharmacy staff can simply point and click to order it. The system also provides relevant, context-sensitive clinical guidance from ASHP around potential substitutions.
Better dashboard solutions let the pharmacy buyer see information about options, cost impact, supply levels, local inventory levels, and usage histories all on one screen to support optimal decisions. Careful software development makes the relevant information exportable in formatted emails, intranets, and SharePoint to start the clinician communications campaign. All decisions are captured for continuous reference and analysis.
What the future holds
It would be ideal for technology to learn of drug shortages long before they occur, giving pharmacies more than a week or two to plan and execute mitigation strategies. Such advance notice is within the realm of possibility given the advent of artificial intelligence and machine learning, but the industry needs to proceed with caution. No predictive technology is 100% accurate. A pharmacy can’t afford false positives. Crying wolf would destroy its credibility with clinicians and warnings could also trigger hoarding, creating drug shortages that wouldn’t have otherwise been so serious.
Unfortunately, drug shortages are here to stay for the foreseeable future, and they cause great distress to health systems, their staff, and their patients. The good news is that new technologies, when creatively applied, will help us treat the condition. Hopefully, a solution is around the corner.
About AJ Rivosecchi
AJ Rivosecchi, PharmD is a senior product manager at Bluesight, the medication intelligence company and former inpatient pharmacy operations manager.
