Dealing with Drug Shortages
As has been widely reported in the media, the U.S. is experiencing the most severe drug shortages in decades. These shortages are affecting many consumers. Community pharmacists are being asked frequent questions about shortages and why they exist. To best serve customers, some pharmacists are actively looking for alternative medications.
After 54 drug shortages in 2004, there were almost 200 in 2010 and 267 in 2011.
While many of the drugs for which shortages have occurred are used in hospitals for surgery, emergency care or cancer treatment, there have been dozens of shortages for prescriptions filled through retail pharmacies. Examples include drugs for high blood pressure, ADHD, Parkinson’s disease, asthma, arthritis, poison ivy, pain relief and the shingles vaccine.
Many pharmacists say these are the worst shortages they have ever seen and they don’t expect the problems to be resolved in the near future. They see this as a long-term problem that will last for years.
What’s Behind These Shortages?
On December 15, 2011, the Government Accounting Office released a report titled “Drug Shortages, FDA’s Ability to Respond Should Be Strengthened.” This report identified the following factors as causes for drug shortages:
- Disruption in the supply of raw materials. Manufacturers are sometimes unable to obtain the raw materials used in producing a drug, including the active pharmaceutical ingredients (API). The majority of APIs in FDA-approved drugs are imported from foreign countries, which may add challenges to their availability.
- Manufacturing problems. These may be problems identified by a manufacturer or by the FDA during an inspection. This is the number one reason for shortages among sterile injectable drugs.
- Manufacturers’ business decisions. Many shortages occur because a drug manufacturer decides to no longer produce a product, perhaps due to lack of profitability.
- Industry consolidation. Mergers and acquisitions in the drug industry have reduced the number of manufacturers making drugs. Many drugs in short supply are produced by only a few manufacturers. With few manufacturers for some drugs, if a manufacturer experiences a supply disruption, a manufacturing problem, or decides to no longer make a drug, there may not be other suppliers to pick up the slack.
- Unexpected increases in demand. Changes in clinical practice can unexpectedly boost demand for a drug, which can occur without a corresponding increase in supply.
- Natural disasters. Disasters can cause shortages when they affect manufacturing facilities, the availability of raw materials or supply chains.
- Unstable supply chain. Changes in supply-chain management have made drug supply chains more efficient and cost effective, but have lessened the capacity to respond to supply disruptions. Factors affecting supply chains include the creation of complex global supply chains, consolidation of facilities and elimination of redundancy, and lean inventory systems that result in smaller amounts of inventory.
Strategies Pharmacies Are Using
In reviewing articles and speaking with pharmacists, the following strategies were cited in the pharmacy industry:
- Monitoring. When community pharmacies have customers who need a drug for which a shortage exists, they closely monitor potential shortages. (Resources to monitor shortages are provided below.)
- Seeking alternatives. To serve customers, pharmacists and physicians are looking for suitable alternatives for drugs where there is a shortage.
- Communicating. Pharmacists are communicating with their staff and customers about the situation. Communication helps customers understand that the shortage is not the pharmacy’s fault. Instead of being viewed as part of the problem, good communication will help customers view their community pharmacy as part of the solution.
These strategies are consistent with an alert from the Institute for Safe Medication Practices (ISMP) titled, “Weathering the Storm: Managing the Drug Shortage Crisis.” ISMP recommends several steps including:
- Learn more about drug shortages to understand the reasons behind them
- Identify drug shortages
- Assess inventory of drugs on hand
- Identify potential alternatives
- Develop communications plans for staff, providers and patients
What’s the Federal Government Doing about Shortages?
The federal government is aware of the drug shortage problem, and in just the past few months the following activity has occurred:
- Congressional Hearings. Since September 2011, two House committees and a Senate panel have held hearings on drug shortages.
- Executive Order. On October 31, 2011, President Obama issued an executive order that directed the FDA to take steps to prevent future shortages; required manufacturers to provide adequate notice of manufacturing discontinuances that could lead to shortages; ordered an expedited regulatory review process to avoid shortages; and ordered the FDA to review practices such as stockpiling or price gouging.
- GAO Report. Published on December 15, 2011, this report outlined the causes of drug shortages and offered recommendations to address them.
- Interim Final Rule. On December 19, 2011, the FDA issued a rule requiring the sole manufacturer of a drug to provide notification at least six months before discontinuing a drug.
- Pending Legislation. Legislation was introduced in Congress that would require notification by manufacturers when they expect a shortage.
- GAO Report on Drug Shortages: www.gao.gov/products/GAO-12-116
- FDA Drug Shortages Page: www.fda.gov/cder/drug/shortages
- CDC Vaccines in Short Supply: https://www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html
- ISMP Medication Safety Alert: Managing the Drug Shortage Crisis, 10/7/10: http://www.ismp.org/Newsletters/acutecare/articles/20101007.asp