Compounding pharmacies can help resolve drug shortages - - Drug Topics

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Compounding pharmacies can help resolve drug shortages


Drug Topics
Volume 155, Issue 12

Key iconKey Points

  • Compounding pharmacists and pharmacies that have the resources to compound sterile injectable formulations and other forms of drugs are being called on to help deal with these shortages.
  • PCCA is urging its member physicians and hospitals to help reduce the problem of drug shortages - which has been going on for years, according to John Preckshot, RPh, an independent compounding pharmacist in Peoria, Ill.

More than 200 medications crucial in fighting conditions such as leukemia, breast and colon cancer, and infectious diseases are in short supply in the United States. As a result, compounding pharmacists and pharmacies that have the resources to compound sterile injectable formulations and other forms of drugs are being called on to help deal with these shortages.


John Preckshot
Professional Compounding Centers of America (PCCA) is urging its member pharmacists to continue working with physicians and hospitals to help reduce the problem of drug shortages — which has been going on for years, according to John Preckshot, RPh, an independent compounding pharmacist in Peoria, Ill. Now, however, the situation "is finally reaching epidemic proportions."


John Herr
Compounding pharmacists already help to supply otherwise unobtainable drugs, said John Herr, RPh, FIACP, president, International Academy of Compounding Pharmacies (IACP) and owner of Town and Country Pharmacy in Ridgewood, N.J. "We have traditionally been called upon to provide meds that were never available." Now, he said, compounding pharmacists are being asked to provide products that used to be available but cannot currently be obtained as drug shortages increase.

"Most healthcare providers are not aware of the high level of sophistication that exists in pharmacy compounding," said Preckshot. "There may be healthcare providers who are aware of [pharmacists] making a cream or a capsule, but the high level of sophistication that is required for sterile work is not a well-known concept."

Consequences

The shortages have made some drugs completely unavailable, which allows compounding pharmacists to step in, since compounding is permissible only for commercially unavailable products. Prices for other drugs that are in short supply have skyrocketed. The situation has delayed some clinical trials because experimental treatments are often tested against older medications that are subject to shortage.

The American Society of Health-System Pharmacists keeps a list of the drugs that are in short supply or that are completely unavailable at http://www.ashp.org/shortages. The list includes injectable vancomycin hydrochloride, injectable dexamethasone, and injectable fluorouracil. Shortages of veterinary medications are also being reported. "It is not like these are unusual drugs," Herr said. "We are talking about gentamicin and tobramycin, drugs that every hospital and surgery center would keep in stock."

Compounders

Most pharmacies do compounding, and if they don't, they can refer clients to a local pharmacy that does, said Herr. Preckshot noted that Peoria has 3 compounding pharmacies. However, he added, not all compounding pharmacists have the equipment or a clean room in which to compound injectables.

Both Herr and Preckshot have pharmacies with clean rooms, and both frequently compound sterile injectables. Preckshot noted that his pharmacy now compounds batches of sterile injectables 2 and 3 times every day, quite a difference from before the rise of shortages, when most days it compounded only 1 batch. He primarily compounds injectable products for local surgery centers and for physicians to use in their offices, he said.

Executive order

On Oct. 31, President Obama issued an executive order addressing the drug shortages. The order instructs FDA to broaden reporting of potential shortages of certain prescription drugs, to speed reviews of applications to begin or alter production of these drugs, and to provide more information to the Justice Department about possible instances of collusion or price gouging, a move aimed largely at wholesalers who mark up prices during shortage. The order attempts to alleviate shortages, but the White House called it just 1 step in solving the problem.

IACP represents more than 2,000 pharmacists and technicians concerned with the practice of pharmacy compounding. PCCA membership includes more than 3,900 independent community pharmacists in the United States, Canada and Australia. An assessment tool to help healthcare providers locate nearby compounding pharmacists is available at the IACP website ( http://www.iacprx.org/).

Valerie DeBenedette is a medical news writer in Putnam County, N.Y.

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Drug Topics is a monthly news magazine, guided by a board of pharmacy leaders, reporting on all phases of community, retail, and health-system issues and trends. We cover managed care and professional, national, and state activities as well as new therapies involving prescription and OTC drugs.
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