Shortages of Pharmaceuticals Bring New Medical Risks

SHORTAGES OF PHARMACEUTICALS BRING NEW MEDICAL RISKS

By AMFS Expert #E03151
Physician – Emergency Medicine

The American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP) issued a joint release in June 2010 concerning shortages of pre-filled epinephrine syringes and the potential for serious and potentially fatal dosing errors.  A look at their website, www.ashp.org/DrugShortages/Current/, reveals a staggering list of medications, some critical, that may be missing from hospital pharmacies.  When alternative medications must be employed, physicians and hospital employees may be unfamiliar with dosing, routes for administration, drug interactions, length of effect and adverse side effects.

The June 2010 alert concerning epinephrine pre-filled syringes reported that the drug was generally available only in a dilution of 1 mg/ml, ten times the concentration of pre-filled syringes commonly used in cardiac arrest situations.  The alert went out 12 days after a man went to an emergency department in Maine with an allergic reaction and died after administration of a dose of epinephrine 10 times the appropriate amount.

In November, ASHP and ISMP, along with the American Society of Anesthesiologists and the American Society of Clinical Oncology, sponsored a summit conference on the crisis.  The ISMP published a survey of 1800 health care practitioners, 68% pharmacists, concerning the effects of shortages, and 64% of all respondents believed that the shortages posed a risk of adverse patient outcomes.

In the February 2011 issue of Annals of Emergency Medicine an article entitled, “Hospital Pharmacists Scrambling Amid Vast Drug Shortages” stated, “supplies of multiple drugs that are crucial to clinical medicine dwindled to critical levels”.

The Annals article details medication errors reported caused by shortages of propofol, succinylcholine, heparin, and multiple antibiotics.

The reasons for the shortages are not clear, as manufacturers have released little information other than “manufacturing delays” and “unanticipated increased demand” but there are economic pressures leading manufacturers to keep lower inventories on hand and take low-return drugs off the market.

The Food and Drug Administration (FDA) has asked manufacturers to give them advanced notice when drugs are likely to be in shortage, and they are legally required to give 6 months notice before discontinuing production of a “medically necessary” drug, but there is no statutory definition of “medically necessary”, and no penalty if the firm doesn’t notify the FDA.  While manufacturers are required to notify the FDA of quality problems, taking a drug off the market for economic issues is a business decision in which the FDA has no say.

Medical-Legal Considerations

Medication shortages can clearly cause bad outcomes.  The challenge for the plaintiff’s attorney will be to identify the cause:  Was a substituted drug responsible for a bad outcome?  Was an inappropriate drug given?  Was the dosage or route of administration incorrect?  Was the error on the part of the physician, pharmacist, or nurse?  If a drug substitution was made, was the hospital’s pharmacist negligent in pursuing a supply of the medication or was a manufacturer at fault?

For the defense attorney, displacing responsibility from the physician to the hospital or from the hospital to a drug firm, may exonerate the client or bring in other parties to share the burden of an adverse outcome.