Drug Shortages: An Unavoidable Problem
Backordered products have become a common and frustrating challenge to institutional pharmacies. Temporary backordered products that were expected to be available within weeks, have often been difficult to obtain for months from manufacturers and wholesalers. More than 45,000 different prescription drug products are on the market today, originating from about 1,400 different manufacturers. Most common among the list of shortages are injectable generics, chemotherapy drugs, surgical sedatives and standard remedies used in the emergency department setting.
The Negative Impact of Drug Shortages
A shortage in the supply of a prescription drugs can have serious implications for patient care. In the hospital setting, a shortage may result in the delay of medical procedures. Substitution of therapeutic or similar medications, if available, may lead to medication errors and preventable adverse events especially when prescribers are not as familiar with the alternative products’ dosing and potential for adverse interactions with other drugs. Some second or third choice products may also be less clinically effective. In addition, faced with limited or no supply, some hospital pharmacies may even revert to alternative sources such as “gray market” vendors. Such vendors obtain products in short supply in order to resell them at substantially higher prices. Concerns arise about the reliability of the source of the drugs, which may be outside the U.S., and whether they have has been properly handled throughout the chain of custody. The growing problem of drug shortages is also costly to hospitals and to the healthcare system as a whole. Steps needed to respond to shortages can divert important resources away from improving care. The cost in time and money can be especially high when hospitals and other providers face shortages in drugs that are needed to respond to new treatment guidelines and to treat victims of natural and other catastrophes where disease outbreaks, for example, threaten large numbers of people.
What Causes Drug Shortages to Happen?
Medications may become unavailable for a variety of reasons. Some of the culprits are:
- Back-ordered due to a manufacturing problem
- Discontinued due to decreased usage or declining manufacturer profits, which may be related to the introduction of a newer drug
- Drugs may also be withdrawn from the market due to health risks, and we do not compound medications that were discontinued due to safety concerns.
Often cases arise in which although there is not a shortage, mass-market medications may need to be adjusted to fit the patient’s need:
- Formulations of a commercially available medication is required in a lower dose or specific vehicle form.
- Flavors can be added to medication for pediatric patients.
- If the medication is for a veterinary patient, it may need to be compounded to be more palatable.
What We Can Do About It
As a compounding pharmacy, we help to alleviate these problems by providing doctors and patients a readily available source for backordered products and compounded medications. Filling this void is just one of the reasons why compounding pharmacies are a vital component of the healthcare system. As shortages occur manufacturers inform the FDA, who then post it to their FDA website drug shortage list. Communication between the FDA and the public is an essential component of preventing and mitigating drug shortages. The current list is posted online in the FDA Current Drug Shortage Index.