Access to medications when they are needed can mean the difference between life and death. Drug shortages occur frequently in the healthcare industry and may result in patient harm, especially a medication for a life threatening illness suddenly becomes unavailable. A drug shortage may mean that a particular product is available only in limited quantities, temporarily unavailable, or has been permanently removed from the market. Drug shortages are less serious when alternative or comparable treatment options are available. All drug shortages are inconvenient for patients and providers; may complicate patient therapy; are time consuming and expensive; and may result in significant patient distress.
Drug shortages pose a significant threat to healthcare and the frequency of drug shortages in the US has rapidly increased in the past ten years. Just this year an alarming forty-seven new drug shortages were reported between January 1 and March 31. Most drug shortages occur with little or no warning and its unpredictable nature makes this a challenging issue for the healthcare community. Nonetheless, healthcare providers may have better success in managing drug shortages if they:
What causes drug shortages?
The processes involved in manufacturing and suppling medications are complex. Drug supply is affected by multiple factors and shortages are rarely due to one specific cause. The following are some causes of drug shortages:
Problems with manufacturing: There are a variety of factors that may cause drug manufacturing difficulties. Manufacturers may face problems with equipment used in the manufacturing process. There may also be problems with maintaining enough staff that are adequately trained to work at the manufacturing factories. Financial hardships may also impact drug production. An example of a recent drug shortage due to manufacturing delays is the shortage of cefazolin injections which is an injectable antibiotic used to treat and prevent serious infections.
Shortage of raw materials: Medications are made from various ingredients. Shortage in the supply of any ingredient may impact the production of the drug. Shortage of raw materials is even more problematic when they are supplied by a single source or producer. Additionally, 80% of all raw materials used in the production of medications are imported from outside the US India, China, and European countries are top suppliers of raw materials. The supply of raw materials may be impacted if there are problems between the US government and any of the supplier nations. Also, supply may be disrupted by climate, environmental conditions, animal diseases, and product damage during transportation. The production of Heparin has been impacted by the shortage of quality raw materials that manufacturers were importing from China. A few years ago, Baxter, the major manufacturer of heparin in the US, voluntarily recalled a significant number of heparin products that were thought to be contaminated with tainted raw materials from a Chinese manufacturing plant.
Natural disasters: Floods, earthquakes, hurricanes, tsunamis, volcanic eruptions, and other natural disasters may impact the availability of drug products. Natural disasters may cause long term drug shortages if they damage the manufacturing facility. Natural disasters may also worsen drug shortages by creating demand for drugs that are required to treat disaster victims. For example, there was a shortage of the antibiotic gentamicin in 1997 when a hurricane in the Caribbean damaged the manufacturing plant.
Drug recalls: Drugs are recalled or removed from the market when there is reason to suspect that they may not be safe for human use. Recalls may be requested or mandated by the FDA, or manufacturers may voluntarily withdraw their drug. For example, the weight loss drug Meridia (sibutramine) was voluntarily removed from the US market by its manufacturer because clinical trial data showed that its use was associated with an increased risk of heart attack and stroke.
Failure to comply with regulatory standards: To ensure the safety of the public, the FDA closely monitors the process and procedures used in the manufacturing of drugs. The FDA has the power to stop the production of a medication if it has reason to believe that current good manufacturing practices (cGMPs) are not being followed. Resolution of such FDA compliance citations may take several months and may cause serious disruptions in drug supply.
Manufacturers decision to decrease production: There are times when drug manufacturers make the decision to decrease the production of certain drugs. Most manufacturers make more than one product and may occasionally decrease the production of a certain drug to use their resources to make other products. Also, when a generic product becomes available manufacturing of the brand name item may be decreased for business reasons. Furthermore, a manufacturer may decide to completely stop the production of a product because of a lack of financial return. Recently, Vertex announced that it will stop selling Incivek due to slow demand.
Unexpected increase in demand: A sudden increase in demand of a medication may temporarily cause a drug shortage until production is increased. This usually happens during disease outbreaks or when a product is newly approved to be used to treat multiple diseases. For example, in 2001 during the Anthrax outbreak the demand for the antibiotic Cipro (ciprofloxacin) skyrocketed and caused an unexpected drug shortage. Shortages of amphetamine salts for treating ADHD was partly due to increased demand.
Creation of artificial shortages by vendors: Some vendors may create artificial shortages by purchasing large quantities of selected products and later selling them at higher prices.
LIst of Drugs most vulnerable to shortages
Although any drug may face supply problems, some drugs are more likely than others to be affected.
Cancer treatments: Most cancer medications are injectable. Injectable medications have stricter manufacturing and safety regulations and are therefore more likely to be issued violations that may impact supply. In 2010, cancer medications including leucovorin, bleomycin, cisplatin, carmustine, cytarabine, doxorubicin, etoposide, mechlorethamine, chlormethine, vinblastine, busulfan, and vincristine topped the drug shortage list.
Injectable drugs: As already mentioned, the manufacturing of injectable drugs is complicated and impacted greatly by cGMP violations. Important drugs such as morphine and norepinephrine are impacted significantly by shortages. A report issued in 2010 cited product quality issues as the most common reason injectable drugs were removed from the market.
Generic drugs: Shortage of generic medications is more likely to occur because companies who make them have little financial incentive to keep up production. Shortage of generic antibiotics, cancer medications, and anesthetics has tripled since 2006.
How to manage drug shortages
Managing drug shortages is challenging and remains an area of concern for the healthcare industry. Although it may be unreasonable to prepare for every drug supply issue, proactive management and proper planning may decrease the adverse effects of drug shortages on patients and providers alike. Listed below are some strategies which may be used by healthcare providers to cope with problems associated with drug shortages.
Keep informed of drug supply trends: Pharmacists and other members of the pharmacy team should actively seek out information related to drug supply or availability. Pharmacies should track their order history and identify products which are on backorder, available in limited quantities, temporarily unavailable, or discontinued.
Identify alternative treatment options: Pharmacists should collaborate with physicians and other healthcare practitioners in identifying alternative treatment options for impacted drugs. Providers must act rapidly to find safe comparable treatments to avoid disruptions in patient care.
Notify the FDA of any disruptions in supply: The FDA’s Drug Shortage Program was designed to ensure that medications (prescription and over-the-counter) remain available to the public when needed. The FDA coordinates with the manufacturers to prevent and resolve drug supply issues.
Where to find information on drug shortages?
FDA Acts to Prevent More Drug Shortages. FDA Consumer Updates.
Fox E, Birt A, et al. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. ASHP REPORT.
Lee, Ventola C. The Drug Shortage Crisis in the United States; Causes, Impact, and Management Strategies. Pharmacy and Therapeutics.
Tyler L, Mark S. Understanding & Managing Drug Shortages. Abbott.