Geographical Location: The U.S.A., 2011
Chronicle of event: The U.S. is experiencing an increasing
frequency of drug shortages, which have caused many difficulties for Drug
stores, Hospitals, patients and the regulators. Drug shortages have had a serious
and widespread impact on the quality of health care in the U.S. and have
created significant hurdles.
Breakdown of the event: Drug shortages are caused by
many factors, including difficulty in acquiring basic materials, manufacturing
issues, regulatory issues, and business judgments and many other vagaries within
the supply chain. Distributors are also sometimes inconsistent in providing
information to the system regarding any issues.
Consequences of the event: This adversely affected
patient care by causing substitution of safe therapies with alternative
treatments; compromising or delaying medical procedures or causing medication
errors, sometimes life threatening.
Policy remedy: Ideally, there would be an early
warning system for future drug shortages that would provide abundant time to
prepare for any implications that might arise due to the shortage.
Manufacturers are required to give the FDA six months advance notice when they
plan to stop producing a single-source, medically necessary drug. Pharmacists
need to have credible and timely information to enable them to successfully
manage drug shortages. Some industry experts blame the drug shortage problem on
increased carelessness by the FDA, because the agency has made drug safety a
higher priority after being criticized for being too lax. However, FDA
officials dispute that increased government oversight is a major factor in
causing drug shortages.
Comment: While dealing with an important issue related to
health, proper care should be taken while determining the problem at hand and
coming up with strategies to deal with that. Solving such complex issues is a
long-term process and well planned and coordinated efforts are must for solving