Medication Shortages Update

By Michael G DeBusk, PharmD, MBA system director - Pharmacy Operations - Premier Health

Medication shortages are a serious public health crisis. Quality issues are listed as a major cause of sterile drug shortages. However, aging manufacturing infrastructure, regulatory compliance, discontinuation of items with low margin, industry consolidation, and unpredictable significant weather events disrupting production and distribution are also of significance.

The American Society of Health System Pharmacy has identified 131 current medication shortages¹. Manufacturers have voluntarily recalled 54 medications in the past two months, compounding the issue. Many of the recalled medications were already on the drug shortage list. The top five therapeutic categories of medications listed on the current FDA drug shortages list² (accounting for 50 percent of the shortages) are:

• Chemotherapy
• Antibiotics
• Cardiovascular drugs
• Central nervous system agents (including pain and anesthesia medications)
• Injectable electrolytes and nutritional products.

Ongoing IV fluid shortages have escalated due to the impact of hurricane damage in Puerto Rico. Medication exports from Puerto Rico (where 80 drug manufacturers have plants) make up 72 percent of the island’s economy³. Premier Health Supply Chain recently announced critically low levels of Lactated Ringers (LR) available within the system. Wholesale distributors and suppliers are unable to meet demand. This has strained the already challenged (and in short supply) IV Normal Saline, and Dextrose 5 percent fluid status, which are on allocation status from manufacturers and wholesalers. Allocations are not guaranteed and are designed to prevent hoarding by end user clients.

Cumulatively, medication and IV fluid shortages have created an acute crisis, particularly for hospitals, since many of the medications in short supply are sterile injectable products used in treatments either prior to hospitalization (i.e. by emergency medical services) or within hospitals (e.g. for emergency care, surgical procedures, or other serious acute conditions). The lack of so many medications and IV fluids fundamental to care has had significant implications for patients, clinicians, and hospitals, including treatment delays and increased costs.

There have been ongoing and increasing frustrations and concerns expressed by physicians, pharmacists, nurses, supply chain officials, and others about the clinical effect that shortages have on patients and the tremendous strain on resources required to address shortages every day. Ongoing management strategies have included identifying alternative therapies when possible, load leveling between facilities, buying off-contract (or branded) medications if available, EPIC Alternative Alerts, criteria based restrictions, education about alternatives, frequent communication with wholesalers/distributors to obtain and maximize allocations, etc. A list of medications and IV fluid shortages can be found at the American Society of Health-System Pharmacists  (ASHP) .

¹https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?page=CurrentShortages
²Drugs that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. Does not include radiopharmaceuticals.
³The New York Times 10-4-2017 https://nyti.ms/2xTQwwF 

Back to the November 2017 issue of Premier Pulse