In last month's Diagnote, we asked the question, "How do our clients recognize that we care?" The answer includes facets such
as our speech, empathic rather than reactive listening, showing kindness and being trustworthy. This month, we examine the
recent phenomenon of prescription drug shortages and their relationship to patient healthcare.
What's causing the shortages?
According to Erin Fox, manager of the University of Utah Drug Information Service, a severe shortage of prescription drugs,
including injectables, chemotherapy agents and antimicrobial drugs, is endangering the welfare and lives of human (and probably
The American Society of Health-System Pharmacists lists the following factors as contributing to recent medication shortages:
- Bulk material, raw material or supply shortage
- Manufacturer's voluntary recall due to contamination
- Production delay due to FDA inspection findings
- Reallocation of resources to other products
- Reduction in number of available products due to merger of manufacturers
- Stock-piling of drugs prompted by the likelihood of impending shortages.
The FDA has put forward the following reasons as responsible for the drug shortages:
- Manufacturing delays
- Increase in demand
- Market withdrawals
- Uneven product distribution
- Inadequate finished drug supply to support current market demand
- Shortages due to active ingredient constraint
- Change in manufacturing sites
- Higher than anticipated market demand
- Discontinuation of unprofitable drugs
- Capacity constraints
- Market recalls
- Backorders due to shortages.
The cost of the shortage
As a result of drug shortages, hospitals are being forced to purchase drugs from secondary suppliers at exorbitant prices
because they can't get them in a timely fashion in any other way. Hospitals that buy scarce medicines from the "gray market"
are taking a gamble. The drugs may be stolen, improperly stored, adulterated or beyond the manufacturers' expiration date.
So far in 2010, about 210 drugs have been added to the list of drugs in short supply, compared with 70 per year from 2003
to 2006. The average price markup on drugs sold by secondary distributors was 670 percent (as reported by Premier Health Alliance).
According to a panel of experts, in the last 15 months, at least 15 human deaths have been recorded as a result of this problem.
However, many hospital injuries and deaths are not recorded.
An example in veterinary medicine
As veterinarians, we are faced with similar issues related to shortage of a variety of pharmaceutical agents. For example,
one expensive drug, 2-mercaptopropionylglycine (2-MPG), was manufactured in Japan and distributed in the United States. In
clinical trials performed at the Minnesota Urolith Center, this drug in combination with a therapeutic diet was effective
in dissolving cystine uroliths.
Because cystinuria is an inherited disease requiring therapy for an indefinite period, and because of limited supply of 2MPG
in the United States for treatment of cystinuria (both human and veterinary medicine), the pharmaceutical company tried to
minimize the problem by purchasing the right to manufacture and distribute 2-MPG under the watchful eye of the FDA. As a result,
the drug was not available in the United States for an extended period. The lack of access to this expensive drug led to the
death or euthanasia of an untold number of dogs with cystinuria.
The shortages involving widely used generic drugs that ordinarily are inexpensive have delayed surgeries and cancer treatments
leaving patients in pain. This situation has often resulted in the use of less effective treatments, complications and longer
periods of hospitalization.
In next month's Diagnotes, we will discuss the pharmacists' and the veterinarians' role in identifying drug shortages and
protocols to minimize drug-related adverse events. Correction of client misperception will also be discussed.
Dr. Osborne, a diplomate of the American College of Veterinary Internal Medicine, is professor of medicine in the Department of Small
Animal Clinical Sciences, College of Veterinary Medicine, University of Minnesota.
Dr. Nwaokorie recently completed his MS and is pursuing a PhD at the University of Minnesota.