There has been increasingly frequent drug shortages in the U.S. during the past decade—and the problem has hit almost every drug class.
In a recent report from the International Society for Pharmaceutical Engineering, quality problems—like contamination—account for 46 percent of all drug shortages.
Only 54 percent of the members surveyed said they did have a drug shortage prevention program and only half of those said that prevented a shortage.
So, what is being done to help manage the problem?
Last year, Duke Medical Center adopted an approach based on models used in organ donations. For example, key drugs for cancer are distributed to patients with the greatest need and to those who could benefit most.
To help avoid shortages, Vanderbilt has increased their budget by half-a-million dollars to build up their drug supply on hand.
A South Texas Hospital System has opened its own multi-million dollar distribution center that allows it to buy drugs in bulk.
Healthcare professionals say that as of now, the shortages that are the most concerning include electrolytes, like potassium phosphate, and oncology medications. For a complete list of drug shortages, go to: http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm.
There do seem to be fewer shortages because in 2012, there were 117 compared to 251 in 2011, but the focus now is on the types of medicines.
In late October, the FDA announced a new proposal to try and head off more shortages of crucial medications. Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply, including plans to discontinue a product or manufacturing changes that could slow production.
BACKGROUND: Drug shortages have been a continuous problem in the United States. This issue demands the attention of not only the pharmaceutical companies, but generic drug manufacturers as well. These generic drug manufacturers sell their products to nearly 80 percent of the prescriptions sold in 2012. Healthcare providers, distributors, wholesalers, and pharmacies are also involved in this drug shortage. Often, generic drugs are the first medicines to expect a shortage, but biopharmaceutical drug companies are working to prevent any shortages from happening. (Source: http://www.phrma.org/drug-shortages)
HOW IT AFFECTS PATIENTS: Luckily patients who experience a medicine shortage are giving options until their care arrives. Doctor-patient communication is important when taking medicine to see if it is a popular drug. If so, then patients should check the FDA’s website to view the current list of drug shortages. Patients may also want to consider alternatives to their original medication. This can be a temporary change of medicine until the correct medication is available. (Source: http://www.phrma.org/drug-shortages)
WHY THIS HAPPENS: A drug shortage may occur for a variety of reasons, which are dimensional and complex. Some of them include:
• Natural disasters
• Raw material shortages
• Shifts in clinical practices
• Manufacturing challenges
• Changes in hospital and pharmacy contractual relationships with suppliers and wholesalers
• Wholesaler and pharmacy inventory practices
• Individual company decisions to discontinue specific medicines
• Adherence to distribution protocols mandated by the FDA (Source: http://www.phrma.org/drug-shortages)
PREVENTION: The FDA is working closely with health care providers, patients, and supply chain partners to ensure the accurate amount of supply needed of name brand medications. Pharmaceutical companies do their best to prevent shortages because once a shortage occurs; the “gray market” arises. This is when secondary wholesalers engage in price gouging. (Source: http://www.phrma.org/drug-shortages)
FOR MORE INFORMATION, PLEASE CONTACT:
U.S. Food and Drug Administration