The unfolding hurricane damage is a terrible tragedy for the people of Puerto Rico. Being without power, water, food, transportation, communication and other critical services is a calamity of enormous proportions. What the vast majority of mainland citizens do not yet realize, however, is that the ongoing crisis in Puerto Rico could have a direct impact on their own lives because it is leading to drug shortages.
We received a phone call yesterday from a prominent cardiologist at one of the world’s most prestigious medical centers. He said that his hospital is experiencing shortages of intravenous potassium chloride, a critical electrolyte that every hospital must have on hand. In his opinion, this is a direct result from the hurricane that hit Puerto Rico. He warned us that we might anticipate more drug shortages as a result of the catastrophic disruption in Puerto Rico.
Puerto Rico and Drug Manufacturing:
Historically, Puerto Rico has been a major drug manufacturing location. That’s because pharmaceutical companies used to get substantial tax benefits for making medicines in Puerto Rico. That was eventually phased out, but many drug companies still have plants there.
At last count, there are more than 80 drug, device and related manufacturing facilities on the island. Their annual sales approach $15 billion. An article in the New York Times (“Hurricane Damage in Puerto Rico Leads to Fears of Drug Shortages Nationwide”) notes that:
“Its factories make 13 of the world’s top-selling brand-name drugs, from Humira, the rheumatoid arthritis treatment, to Xarelto, a blood thinner used to prevent stroke, according to a report released last year.”
FDA Concerned About Drug Shortages from Puerto Rico:
The commissioner of the FDA, Dr. Scott Gottlieb, immediately recognized the potential scope of the disaster for the mainland and the rest of the world. He traveled there to assess the potential risk of drug shortages from Puerto Rico.
At last count, there are at least 40 drugs that the FDA is concerned about. Of that number, 13 are only made in Puerto Rico. As far as we can tell, however, the FDA has not revealed the names of the 40 medicines that could soon be in short supply. Nor has the FDA identified the 13 medications that are only made in Puerto Rico. According to Dr. Gottlieb:
“These are critical medicines. These are not drugs for which there are therapeutic substitutes.”
“Some of these products are critical to Americans. A loss of access could have significant public health consequences.”
The Impact on Puerto Rico:
Dr. Gottlieb has noted that the impact of Hurricane Maria on the population of Puerto Rico is devastating. He also reported that:
“This is both a short- and long-term issue. We need to ensure access to these critical treatments for the Americans who need them, but also recognize the important role that the medical product industry plays in helping Puerto Rico sustain its economy and help in its recovery. The pharmaceutical industry in Puerto Rico is responsible for nearly 90,000 jobs, and the island will need them to recover and rebuild.”
Almost three fourths of all the exports from Puerto Rico are pharmaceutical. Equally important are U.S. drug exports to the rest of the world. According to reports, one fourth of all the pharmaceutical exports from the mainland originate in Puerto Rico. Before long, drug shortages from Puerto Rico could affect the health of the world.
What Drugs Are Involved?
As mentioned, we could not find a comprehensive list from the FDA of the 40 or so drugs involved. We have, however, uncovered reports potentially affecting the following:
- Humira (for rheumatoid arthritis)
- Methotrexate (used for childhood leukemia and other cancers)
- Potassium chloride (IV bags)
- Sterile saline bags for mixing medicines
- Xarelto (an anticoagulant used to prevent blood clots)
Where’s the Transparency on Drug Shortages from Puerto Rico?
Drug companies do not like to tell people where they make their medicines. This is considered a proprietary secret. The FDA also tends to be very secretive about such information. The agency has not shared the names of the 40+ drugs that could be affected. We think that is short-sighted. Physicians, pharmacists and patients need to prepare for drug shortages caused by the hurricane damage in Puerto Rico.
Our hearts go out to the people of this ravaged island. When we hear reports that it could take months for power to be restored, we are dumbfounded. This is a crisis that requires enormous resources from all over the world.
The entire infrastructure of the island must be rebuilt and quickly. Not only are the people of Puerto Rico suffering and dying, people in the rest of the world may soon experience a public health crisis because of a lack of critical medicines. The damage to the island will impact millions of people around the world. Let’s get busy helping with the recovery!