On daily basis, hospitals run out of medicines such as cardiovascular medications, anticancer drugs, antihypertensive drugs and even antibiotics which when in short supply affect patient care and the overall outcome of therapy. A common practice during a medicines shortages issue is to select an alternative medicine, however, when alternate medications are procured there may be unintended consequences, including adverse effects, medication errors, less efficacious, more toxic or even more expensive and may therefore compromise patient safety especially if healthcare providers are not familiar with the mode of administering the substitute drug. Thus, patient care may suffer significantly as a result. Delayed and cancelled care have been reported from medicines shortages. (McLaughlin M et al, 2013). In fact 90 percent hospitals in the United States reported they have experienced at least one shortage in the past six months that affected patient safety and 99 percent of medicine shortages forces them to purchase a more expensive alternative with the result of an increase in health care cost.
By definition, a medicine shortage is a drug supply issue requiring a change that impacts patient care and requires the use of an alternative agent. Furthermore, the U.S. Food and Drug Administration FDA defines a shortage as a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the projected demand at the user level (FDA, 2012). The American Society of Health Systems Pharmacists ASHP defines a shortage as a supply issue that affects how pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent (Fox, et al., 2009). The International Pharmaceutical Federation FIP defined medicines shortages as: “a drug supply issue requiring a change. It impacts patient care and requires the use of an alternative agent” (FIP, 2018)
A shortage of anti-anxiety medication, Buspirone, has recently been reported. The medication is indicated for the management of anxiety. The shortage of this medication has left patients in the lurch with physicians having to scramble for substitute medicines. This medication is therefore indispensable for patients who cannot tolerate other agents.
Buspirone exhibits a unique pharmacologic mechanism of action since it helps anxiety without depressing the central nervous system. That is, without causing sedation or functional impairment and does not promote abuse or physical dependence. In fact, the mechanism of action of Buspirone in helping to alleviate anxiety had been said to have challenged the notion that only one neurotransmitter mediates anxiety. Furthermore, Buspirone does not have the addiction potential of the benzodiazepines. Hence, shortages of Buspirone will have a potential clinical impact.
There are many potential reasons for medicines shortages including demand and supply issues, disturbances within the supply chain, regulatory issues including long timelines of approval and inadequate incentives. Shortages of raw materials, endemic diseases, natural disasters are also potential causes of medicines shortages. Reports gathered have indicated that the recent shortages of Buspirone is due to production issues. It has been reported that Mylan pharmaceuticals recently interrupted its supply of Buspirone and roughly a third of the supply of Buspirone is manufactured by Mylan pharmaceuticals.
Shortages of this drug may have a significant clinical impact although measures are already in place to ensure the availability of the drug.