Survey: Hospital Drug Shortages Hurt Patient Care
Hospital Pharmacists Must Divert Time From Patients in Order to Manage Drug Shortage Problems
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Why Drug Shortages Occur
According to the FDA web site, many shortages involve older, sterile injectable drugs.
The shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, and drugs needed for emergency medicine.
The manufacture of sterile injectable drugs is particularly complex, according to the FDA. That is because there are multiple steps in the process. So it increases the things that can go wrong.
Shortages also occur due to discontinuation of drugs, according to the FDA.
The FDA works with a company when shortage issues involve quality or manufacturing. However, a company does not have to notify FDA of shortages.
A company does need to notify the FDA of their plan to discontinue a drug six months in advance if it is medically necessary and it is the sole source.
Proposed Legislation on Drug Shortages
In February, proposed legislation known as the Preserving Access to Life-Saving Medications Act was introduced.
It proposes to give the FDA new power to work with shortages. It would require manufacturers to report to the FDA if a shortage is expected, among other measures.
The bill has been referred to the Senate Health, Education, Labor and Pension Committee, according to Linden Zakula, a spokesperson for Sen. Amy Klobuchar, D-Minn. She introduced it with Sen. Bob Casey, D-Pa.
Kate Connors, a spokeswoman for the Pharmaceutical Research and Manufacturers of America (PhRMA), says the industry group would not comment on pending legislation.
In a news release, PhRMA Deputy Vice President Karl Uhlendorf says many factors can contribute to drug shortages. These include natural disasters, shortages of raw material, and decisions to discontinue medicines.
He says the group's member companies work with the FDA when shortages occur.