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Drug Shortages In Health Care

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n The U.S. is experiencing a rapidly increasing frequency of drug shortages, which have caused numerous difficulties for clinicians, health care facilities, patients, and federal regulators.1 Drug shortages are caused by many factors, including difficulties in acquiring raw materials, manufacturing problems, regulatory issues, and business decisions, as well as many other disturbances within the supply chain.1,2 They adversely affect patient care by causing substitution of safe and effective therapies with alternative treatments; compromising or delaying medical procedures; or causing medication errors.2 Drug shortages also significantly burden health care provider and health care facility finances and personnel.2 A management strategy that …show more content…
morphone, furosemide, amino acids, and others.6 Shortages can also extend to medical supplies, such as technetium99m, which was in short supply when the Canadian nuclear r eactor that produces it temporarily closed down for repairs in 2007.9 Lack of an Advanced Warning System Is the Main Cause of Problems Ideally, there would be an early warning system for impending drug product shortages that would provide ample opportunity to prepare for all implications of the shortage.2 Manufacturers are required to give the FDA six months’ a dvance notice only when they plan to stop producing a singlesource, medically necessary drug.2,4 However, even this requirement has been criticized as being “soft,” since “medically necessary” is not statutorily defined; therefore, the manufacturer is free to decide whether or not notification is required.12 Also, the manufacturer isn’t penalized in any way if it fails to provide the required notification.12Manufacturers are required to notify the FDA of quality problems; however, drug shortages or discontinuations are often caused by a business decision or other factors that don’t require FDA notification.12 Therefore, manufacturers either routinely don’t provide any notice of an impending drug shortage or provide little advance notice and no estimate of the projected duration.12 Without advanced warning of an impending drug supply problem, the FDA can become engaged only when a shortage begins.6 Some drug manufacturers do voluntarily alert the FDA …show more content…
resources from manufacturing to research and development, loss of production and compliance personnel, and many others.2 Changes in a product’s formulation and limited production capabilities can also delay product availability.2,5The FDA also approves a specific manufacturing line to produce a specific drug at a specific facility.14 Therefore, pharmaceutical manufacturers can’t just set up production of a drug in short supply somewhere else in a facility.14Manufacturers also often use the same manufacturing equipment for many drug products, so it is difficult to increase production of one product without causing manufacturing shortages and delays for another.5 Consequently, sometimes it is possible to increase drug production only by buying more equipment or contracting with other companies to produce the drug.5 However, this isn’t an easy solution, because there is often a significant lag between a supply shortfall and a production increase at another facility.13 Antitrust laws may also prevent companies from sharing manufacturing

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