MANUFACTURER DRUG SHORTAGES
Pharmaceutical manufacturers, distributors, group purchasing organizations, and regulatory bodies have a responsibility when making decisions regarding manufacturing and distribution that may create drug product shortages, to prevent those decisions from compromising the quality and safety of patient care.
The Illinois Council of Health-System Pharmacists (ICHP) supports the following principles with regard to pharmaceutical manufacturer shortages:
- Healthcare systems establish policies and procedures to secure products in times of acute shortages, such as formal arrangements with other pharmacies for borrowing.
- Healthcare systems establish policies and procedures to ensure the quality of products obtained from alternative distribution sources, for instance, verification of appropriate regulatory compliance.
- The FDA establishes a rapid and reasonable mechanism to respond to changes in demand of products that require allocation from the FDA.
- The FDA strongly considers in its definition of “medically necessary” drug products the patient safety risks created by use of alternate drug products.
- The FDA investigates the causes of the shortages for potential questionable motives.
- Manufacturers, wholesalers and other distributors give priority distribution to providers caring for patients at the highest risk of an adverse outcome without the product that is in short supply.
- Manufacturers and wholesalers provide timely communication regarding shortages and potential shortages, including projected time frames for resolution.
- Laws and regulations should be enacted that require pharmaceutical manufacturers to notify the appropriate government body at least 12 months in advance of voluntarily discontinuing a drug product and at least 6 months before the interruption of supply of life-sustaining medication.
- Pharmacists and technicians assist in the identification and implementation of clinical and operational plans when products are not available so as to minimize the risk of adverse events.
- Pharmacists utilize national guidelines and technical assistance bulletins, and other resources including the ASHP drug shortages website and the FDA drug shortages website.
- Pharmacists communicate with national professional organizations and governmental agencies to assist in identification of shortages and potential consequences and recommend alternative strategies.
- Pharmacies avoid stockpiling inventory beyond reasonable patient care needs.
- Health systems engage information technology in the dissemination and coordination of handling a drug shortage situation.