angry doctor

There is an epidemic of drug shortages in the U.S. It has been going on for years. The reasons are often hard to pin down. Drug company consolidation has contributed. The big fish swallow the smaller fish until only a couple of companies make a particular medication.

The FDA also notes that:

“A major reason for these shortages has been quality/manufacturing issues…Discontinuations are another factor contributing to shortages. FDA can’t require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs.”

We recently wrote about charges of collusion and price fixing within the generic drug industry (at this link). Accusers have suggested that some companies divided up the marketplace to reduce competition. If only one company makes a critical medicine and then gets into trouble with the FDA because of “manufacturing issues,” there are bound to be drug shortages.

Now add Hurricane Maria’s devastation to Puerto Rico as another contributing factor to drug shortages.

The Fragile Drug Supply Chain:

Drug shortages have bedeviled doctors and hospitals for several years. Our pharmaceutical supply chain is far more fragile than most people realize. Hurricane Maria has made this ongoing disaster far more precarious.

Decades ago Congress passed legislation to encourage pharmaceutical companies to locate manufacturing facilities in Puerto Rico. Although those incentives have expired, there are still many drug and device companies with key manufacturing plants on the island. That’s due in part to the availability of a skilled and affordable work force. Annual sales are nearly from the island are estimated around $15 billion.

Hurricane Maria changed everything when it destroyed much of the island’s infrastructure. Being without power, water, food and communications has had a devastating impact on the population. It has also affected manufacturing.

The Big “Proprietary” Secret:

Because pharmaceutical companies do not like to tell people where their medicines are made, it is hard to anticipate all the drugs that could become in short supply over the coming months. This kind of information is considered a proprietary secret.

We think that is a mistake. Hospital, physicians, pharmacists and patients need to plan for ways to cope with potential shortages. We have heard from readers who have had to deal with “standard” drug shortages:

Cheryl in California is outraged:

“This shortage of atenolol is a joke! But not funny to people who have been on it for forty years! Just read about a recall from Zydus. Really? This is for your heart, not your toenails!”

Atenolol is a beta blocker heart and blood pressure medicine. Millions of prescriptions are filled for this drug every year.

Elizabeth in Wyoming had a similar concern:

“I’ve been on Atenolol since 1983 for high blood pressure following the birth of my 2nd son. I had post-partum toxemia. I was ok on that med until recently. There is now a shortage and the pharmacy recommended my doctor give me a new prescription, which is metoprolol.

“Now I have to address new side effects along with the fact that my blood sugar is now higher than it should be…and I’m following the same diet routine I have for years, as well as the same medication for diabetes. What a pain…”

How Serious is the Puerto Rican Debacle?

Drug companies have tried to downplay the severity of the situation. But in testimony to Congress, FDA Commissioner Dr. Scott Gottlieb said:

“We understand that manufacturing is running at minimal levels, and certainly far from full production. We have surveyed firms and can anecdotally relate that reports of manufacturing running below 50 percent are common, with many firms operating around 20 percent capacity, and some even less. We have found no firm operating above 70 percent of their normal operation.”

Dr. Gottlieb also pointed out that this drop in manufacturing capacity may result in drug shortages on the mainland:

“…there are hundreds of drugs manufactured on the island and many of these drugs made on the island are critical medicines. We are monitoring closely a list of about 30 products that are critical and either manufactured solely or primarily in Puerto Rico. Of those 30 products, 14 are sole-source products, meaning there are no alternative drug products available.”

Where to Turn For Crucial Meds?

Shutting down or significantly reducing the manufacture of sole-source products means there is nowhere else to get these medications. That can cause a lot of disruption as doctors and pharmacists hunt for alternatives.

The New York Times (Oct. 23, 2017) pointed out that one product now in very short supply is a Mini-Bag of IV solution, which allows for safe and sterile administration of essential drugs. According to the Times:

“Now, hospital pharmacists across the country are racing to find alternatives — which themselves are becoming scarce…”

It is likely that critical medicines will also become hard to find in coming weeks. The FDA has not revealed the names of all the drugs that could soon be in short supply. Putting two and two together, though, we are concerned that Humira (a drug for rheumatoid arthritis), methotrexate (a medicine for childhood leukemia and other cancers) and Xarelto (an anticoagulant) might be affected.

Could It Get Worse?

The nonprofit organization insightUS recently reported on its “Viva Puerto Rico Project.” The article has this headline:

Some of These 101 Prescription Drugs – Made in Puerto Rico Before Hurricane Maria – May Soon Be Unavailable

These investigators note that:

“So far, neither FDA nor the companies involved have provided a comprehensive list of the specific drugs that are manufactured in Puerto Rico) and that are thus at risk of shortages). By reviewing hundreds of government and industry documents we’ve assembled that list. It illustrates yet another reason why mainland Americans should care about Puerto Rican recovery: because the mainland and the island both depend upon one another.”

The sleuths at The Viva Puerto Rico Project have listed “101 drugs manufactured in whole or part in Puerto Rico.”

Here are just a few they included in their table:

Actonel (for osteoporosis)

Advicor (for lowering cholesterol)

Avandia (for diabetes)

Benadryl (for allergies)

Biaxin (antibiotic for infections)

Cardura XL (for high blood pressure)

Celebrex XL (for pain and inflammation)

Cialis (for erectile dysfunction)

Concerta CR (for ADD/ADHD)

Crestor (for lowering cholesterol)

Cymbalta (for depression and neuropathic pain)

Enbrel (for rheumatoid arthritis)

Evista (for osteoporosis)

Forteo (for osteoporosis)

Humalog (for type 1 diabetes)

Humira (rheumatoid arthritis, inflammatory bowel disease, colitis)

Januvia (type 2 diabetes)

Levaquin (antibiotic for infections)

Lipitor (for lowering cholesterol)

Lyrica (for fibromyalgia, neuropathic pain)

Go to this link for the entire list.

People’s Pharmacy Perspective:

We have no way of knowing whether any of the above drugs will be hard to obtain in the weeks and months ahead. We only wish the FDA and the drug companies would come clean on whether drug shortages might impact patients.

We need to help the people of Puerto Rico rebuild their infrastructure. Not only are people suffering and dying there, but soon people in the rest of the world may be affected by the long-lasting impact of Hurricane Maria.

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