CURRENT POLICY

Did you know? Under current policy, the FDA cannot require a pharmaceutical company to disclose details of why a drug shortage occurs. Limitations of the FDA include:

• Cannot require a company to produce a drug

• Cannot require a timeline of manufacturing a drug

• Obtain information on how much and whom the drug is distributed

Access to Drugs

The American Society of Health-System Pharmacists defines a drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”

The ASHSP serves the medical community to share information about shortages. In 2019, through July, 80 new drugs have already been added to the drug shortage list.

DRUG SHORTAGE IMPACTs

Across America, the impacts of the drug shortage crisis is largely unquantified; however, recent reports indicate increased out of pocket costs, rates of drug errors, adverse events, mortality, and complaints during times of shortage.

Patients have reported increased burdens such as travel, expenses, emotional distress and concern of replacement drug effects.

8 Out of 10 DRUGS

Used in treating the most common childhood cancers have been temporarily unavailable in the past ten years.

The list of physician specialities that are affected by drug shortages include oncology, pediatrics, psychiatry, neurology, cardiology, gastroenterology, anesthesiology and more.

Despite the broad impact, centralized regulation for supply has not been developed.