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IV nitroglycerin shortage concerning, but manageable


Although every drug shortage is a concern to healthcare professionals, the shortage of IV nitroglycerin that the New York Times first reported on, is especially concerning: Unlike with the IV saline shortage, in dealing with refractive chest pain and hypertensive crisis in the emergency room, there is no substitute or direct alternative for IV nitroglycerin.

Nitroglycerin is used to treat chest pain. Spray and tablet forms of the drug are typically used to treat patients with heart disease, who might take medication to keep their condition stable or before exercise or other strenuous activities to prevent chest pain from occurring. These forms of nitroglycerin are not in short supply.

For patients who are experiencing myocardial Infarction and other types of heart decompensation, IV nitroglycerin is the best choice, according to Marvin Finnefrock, PharmD, divisional vice president, clinical services at Comprehensive Pharmacy Services (CPS), a pharmacy management services.

“There is no direct substitute for [IV nitroglycerin] and to date, none of the manufacturers can provide an estimate of when they expect to return to normal production of IV nitroglycerin, leading us to conclude—just like we did with the IV saline situation—that health facilities should prepare for a protracted shortage of IV nitroglycerin,” Dr Finnefrock said. “Even if it appears that the shortage is easing up, we often do see a reoccurrence of the shortage several months or even years after the initial event.”

Supply shortages rather than increased demand, is responsible for the shortage of IV nitroglycerin, according to Dr Finnefrock.

“Two of 3 US manufacturers have had manufacturing difficulties and the third [Baxter], while still producing nitroglycerin, issued a recall on some of their IV nitroglycerin back in November,” he said. “Currently, the sole manufacturer is unable to meet demand for the product and has resorted to rationing in order to ensure that all hospitals receive some of what they typically order. According to public reports, FDA is trying to secure IV nitroglycerin from international sources to help meet demand until US supplies can be fully restored.”

 

Formulary managers play a very important role in managing an effective supply chain of medications.

“In general they should become aware of the drugs most at risk of becoming short in supply, and develop protocols for managing such shortages, including conversions to acceptable substitutions, and if no substitutions are available then working as a team with clinical staff to identify treatment and procedural alternatives,” Dr Finnefrock said. “How these issues are communicated is the key to maintaining supply and confidence at our hospital sites.”

CPS has made efforts to mitigate the shortage of IV nitroglycerin in its 400 hospital and healthcare facilities clients in the United States and advises others to do the same, specifically:

  • Inventory Control: Immediately conduct a usage review in all areas where IV nitroglycerin is routinely used. Set up basic guidelines leading to conservation of a limited resource. For 24-hour pharmacies, relocate supply and dispense from the main pharmacy.

  • Substitution: There is no direct substitution. Alternative routes can include topical, under the tongue and oral use where clinically indicated.   

  • Communication: Implement a timely communication plan to all clinical staff involved in ordering or administering IV nitroglycerin, keeping them informed of the status of the shortage and supplies available to the facility. The goal of the communication is to engage staff in inventory efforts and keep them informed of actions planned by clinical leadership to mitigate shortage challenges.

“It is necessary to ensure that our supply chain is reliable, for all drugs that are used to care for patients in hospitals and healthcare settings, Dr Finnefrock said.

Currently, there are more than 300 drugs in short supply; 30% of those are in short supply because of manufacturing issues, according to the American Society of Health-Systems Pharmacists. FDA reportedly is taking steps to encourage manufacturers to step-up production of drugs that are currently in short supply. However, it cannot force a company to produce a drug or increase production of a drug.

“Healthcare facilities throughout the United States should expect continued and possibly broadening shortages of important medications, and they should plan for it,” Dr Finnefrock said. "They need to put protocols in place that include identifying most at risk drugs for shortages, creating an early warning system to detect potential shortages, establishing predetermined substitutions, and building a rapid response communications system so that the facility can pivot quickly to address future shortages. In the meantime, FDA will no doubt continue to play a central role in dealing with shortages on the public health and safety front.” 

 

FDA approved dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

Critically ill patients requiring mechanical ventilation in an intensive care unit (ICU) may be at increased risk of a new psychiatric illness and medication use following hospital release, according to a report published March 19 in JAMA.


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Apr 21, 2014