August 24, 2017
Drug shortages are the new normal and pharmacists have become all too familiar with spending hours on end communicating with drug manufacturers, managing pharmacy inventories, and identifying alternative therapies to ensure limited supplies of medications don’t impact patient care. The labor costs associated with managing drug shortages reaches a couple hundred million dollars each year and frustration can mount among prescribers, pharmacists, and patients when needed therapies are unavailable.
There’s no easy answer to solving the drug supply problem, but pharmacists must proactively prepare for the next shortage instead of reacting when drug supplies dwindle, according to Milena McLaughlin, PharmD, MSc, BCPS-AQ ID, AAHIVP, an assistant professor of pharmacy practice at Midwestern University in Chicago. Dr. McLaughlin took some time to talk about the many challenges pharmacists face in securing doses of critical medicine when supply can’t keep pace with demand.
How common are drug shortages and are there agents that are in constant short supply?
Shortages come and go in cycles. They were prevalent roughly 7 years ago, and that’s when the issue got a lot of press and attention. Now shortages are ever-present. It’s still a huge issue, but doesn’t get as much immediate attention because we’re dealing with it on a daily basis and putting systems in place to prevent shortages from impacting patient care. A generic injectable medication is more likely to be on shortage than a tablet, especially if the medication has only one manufacturer, but there is no one drug that’s been on shortage for a very long time.
What’s the best way to prepare for shortages?
They’re very difficult to predict. In the past, drug manufacturers had to alert the FDA if they were planning on stopping production of a medically necessary agent. But that requirement was loosely defined, so there was really no consistent method for notifying clinicians of a coming shortage. Pharmacy purchasers ended up being told agents weren’t available when they attempted to place multiple orders.
Pharmacists around the country are now developing management methods to monitors drugs on back order and review current inventories to determine if supply levels are dwindling and need to be managed more closely. They need to be proactive when monitoring inventory levels and implement usage restrictions, so drugs in short supply are reserved for patients who truly need them or prescribers use alternative agents whenever possible. A lot of healthcare systems have been good about putting prospective inventory management plans in place since shortages have become commonplace.
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How much does managing drug supplies and shortages add to the daily workload of pharmacists?
That depends on the size of the health system. I work at a very large institution where we’re lucky to have pharmacy technicians and pharmacy students who are dedicated to managing shortages. Smaller institutions might have only one pharmacy purchaser who’s trying to manage drugs in short supply and who might spend entire days trying to figure out how to get critical medications in stock. There’s been a lot of time spent and a lot of funds allocated to dealing with shortages, which increase overall healthcare burdens. There’s no perfect system, and we’re all trying to streamline responses, because shortages are a problem that’s not going away.
Is the rising cost of generics contributing to the shortage problem?
Actually, the more expensive medications are less likely to go on shortage, because manufacturers are making money off of them and want to keep production levels high. It’s the drugs that manufacturers are not able to charge enough for that are likely to have limited availability. I’ve talked to many pharmacists who are willing to pay a little more for a drug if it means the agent wouldn’t go on shortage. Consider what happened several years ago when supplies of the generic drug leucovorin were limited and the much more expensive levoleucovorin was the available alternative therapy. Institutions would have been willing to pay a little extra for leucovorin to guarantee it was in stock instead of being forced to pay significant more for levoleucovorin.
What can be done to obtain essential medications that are in short supply?
There should be some type of cooperative plan in place so needed medications can be transferred between institutions. Cooperative agreements ensure patients receive the best possible care in the hospitals where they’re receiving treatment instead of having to go where medications are available. Pharmacists must also keep close tabs on when suppliers are allocating drugs and keep the lines of communication open with suppliers so they know how to secure drugs when shortages occur.
When Bactrim was on short supply many years ago, pharmacists had to approach the manufacturer with specific cases and spell out exactly why it was the drug of choice for a particular patient. Because Bactrim is a weight-based drug, the manufacturer would literally ship the exact amount needed for an individual patient’s course. We’d have an urgency stock to get the patient started on the therapy and would hopefully get the full supply approved and received from the manufacturer. That process shows why knowing how to obtain medications during shortages is very important.