Interruption in manufacture and delivery for vital products can hit all pharmacies hard, in both health systems and the community. The patient is the last link in the supply chain, but pharmacists are a vital connection to ensuring continuity of medications and supplies.
What makes the devastation to Puerto Rico so destructive to this supply chain is the concentration of drug and medical device manufacturing there; about 50 companies that make pharmaceuticals and another 40 that make a variety of medical devices including pacemakers, insulin pumps, and blood collection devices.1 About 8% of medicines used in the United States by dollar value are made in Puerto Rico, as are about 25% of all drugs exported from the United States.
Americans don’t realize the extent to which pharmaceutical production is concentrated on Puerto Rico, said David Friend, MD, MBA, Managing Director and Chief Transformation Officer at the BDO Center for Healthcare Excellence and Innovation, a consulting firm that advises health-care organizations on clinical and financial performance. “I don’t think people understood. I’ve been in this space for 40 years and I didn’t realize that we had so many sole-source operations out of Puerto Rico.”
Supply chain disruption is a public safety concern, according to a BDO Knows Healthcare Alert.2 The question is not if, but when a natural disaster will break the chain.
“This is a decades-old problem that we experienced before,” said Fred Pane, RPh, FASHP, formerly an Administrator of Pharmacy at Lehigh Valley Health Network in Pennsylvania. “Every time there is a natural disaster, we think about the impact on the supply chain and what it means to the patient. Our number one priority in hospitals and pharmacy is taking care of patients and if we don’t have drugs, supplies, medical devices, etc., we can’t take care of patients.”
In the wake of the hurricanes, government agencies have expressed alarm. In his testimony before a Congressional subcommittee, Scott Gottlieb, MD, head of the FDA, called Hurricane Maria “an epic event of historic destruction” that would require sustained commitment from the agency.
The FDA is closely monitoring about 30 products that are critical and made only or primarily in Puerto Rico, he said. Of those, 14 are “sole-source products,” which means they are made in only one location and there are no good alternatives that can be used, he added.1
One member of the subcommittee had a personal story of the supply chain disruption. Rep. Diana DeGette (D-CO) stated: “If anybody has any concern this is impacting all American families, my daughter who is a Type 1 diabetic just got a letter from Medtronic last week saying her insulin pump was not going to arrive because of the problems in Puerto Rico.”
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