Prescription Shortages

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Your comments, suggestions, and research topics are greatly appreciated via the comment button below. A friend of mine sent me a note about his difficulties obtaining heart medication. Let’s look into it.

Drug Shortages

A friend of mine recently wrote to me about a problem he was having refilling a critical cardiac prescription. He was shocked to learn that the drug he needed was in short supply. He is not alone and the problem requires attention.

I spent some time looking into it and found that problem of drug shortages has a long history. Here is what I learned.

According to a recent CNN article, new drug shortages in the US increased nearly 30% between 2021 and 2022, according to a report commissioned by the Senate that was published in March 2023.

At the end of 2022, drug shortages experienced a record five-year high of 295 active drug shortages, according to the report.

It also found that while the average drug shortage lasts about 1.5 years, more than 15 critical drug products have been in shortage for over a decade.

Here is an AMA article on persistent drug shortages. They identified 5 critical areas that typically experience shortages.

1. Central nervous system drugs,

2. Fluids and electrolytes,

3. Antimicrobials,

4. Chemotherapies, and

5. Hormones

While identifying which drugs are hardest to obtain is fairly straightforward, figuring out precisely why that’s the case is another matter entirely. A drug-shortage task force established by the Food and Drug Administration reported that supply disruptions caused by economic factors played a key role in triggering shortages.

The FDA does track drug shortages. There are currently 141 drugs on the FDA shortage database. However, the database does not provide any insight into the cause of the shortage. Only that it exists.

The problem of shortages has many facets. For instance, when new drugs are in high demand it may be difficult for manufacturing to keep up. Drugs like Ozempic, used to control diabetes and for weight loss, experienced shortages last year.

Many drugs and key ingredients for drugs are manufactured overseas and there is little visibility into those portions of the supply chain. If there are labor or supply or cleanliness issues, we have virtually no visibility and it is hard to be proactive.

Some manufacturers use just in time manufacturing to limit expenses and increase profit. This entails having materials ready for the manufacture of the product just when you need them and not spending extra to warehouse or transport a stockpile. It works really well until it doesn’t and then the process comes to a halt. We saw this elsewhere during the pandemic - like in computer chips. PS my friend’s medication made by Pfizer went through this kind of disruption in 2008.

Generic drugs have their own problems often related to Pharmacy Benefit Managers and middlemen. On December 5th of this year the Senate held hearings on drug shortages. A lot of their attention was on the generic drug market.

Senator Ron Wyden, D-Oregon, spoke on this topic during hearings. His remarks are here. He noted that although there is money to be made in generics, it’s primarily going to pharmacy middle men – drug wholesalers and pharmacy benefit managers or PBMs – rather than to manufacturers. “There are many companies that manufacture generics, but they must compete for the attention of highly consolidated middle men,” Wyden said. He noted that there are three drug wholesalers that control 90% of the nation’s pharmaceutical market. The generic manufacturers that are awarded contracts by these middle men do so by offering penny-on-the-dollar prices and with such low prices, companies don’t earn enough to invest in capacity or in equipment that’s key to making reliable high-quality medicines. The result is a race to the bottom price for generics that leads to quality control problems and factory shutdowns.

Recommendations:

An AMA article on drug shortages and national security suggested we:

1. Consider drug shortages to be an urgent public health crisis. Recent shortages have had a dramatic and negative impact on the delivery and safety of appropriate health care to patients.

2. Find a way to make manufacturers be more transparent about their production locations of drugs and provide more detailed information regarding the causes and anticipated duration of drug shortages to the FDA.

3. Involve the Department of Homeland Security and consider drug shortages as a national security initiative and include vital drug production sites in the critical infrastructure plan. Hold that thought.

Here are recommendations from the March 2023 Senate Report on Drug Shortages.

1. Invest in domestic advanced manufacturing capabilities for critical generic drug products regularly in shortage:

2. Conduct regular inter-agency medical supply chain risk assessments:

3. Require manufacturers of life-supporting and life-sustaining drug products to report increased demand and export restrictions to the FDA:

4. The FDA should take steps to ensure its supply chain data can be used to monitor supply chain vulnerabilities and conduct predictive modeling:

5. Streamline private and public efforts to predict and mitigate potential supply chain vulnerabilities:

6. Provide the FDA with mandatory recall authority for all drug products:

Keeping track of shortages and why they occur is important. Maintaining key reserves of life saving medications in the event of market or supply chain disruptions is a good idea, and of course reigning in pharmacy benefit managers to control their undue influence in creating shortages for their own economic benefit would help.

All of this would be much easier with Universal Healthcare. We would know what medications are most critical and could arrange for those strategic reserves. As the single most important purchaser of drugs we could have more visibility into the supply chain to keep more people healthy. This is, after all, a key part of the American Infrastructure.

ACTION

Drug shortages are something Congress can address. This is not a political issue - all of us get sick and all of us deserve to have access to the medicine that will help us.

Let’s let our Members of Congress and Senators know this is serious business and they can have a positive effect on the health of all Americans. Their contact info is in the Resources Section below.

Here is a link to the March 2023 Senate report on drug shortages for them https://www.hsgac.senate.gov/wp-content/uploads/2023-06-06-HSGAC-Majority-Draft-Drug-Shortages-Report.-FINAL-CORRECTED.pdf

Let’s ask them to read it and act on it and while we have their attention they can reform pharmacy benefit managers operations to stop the shortages of generics that they are creating. Think of S. 1339, the Pharmacy Benefit Reform Act.

You can also text SIGN PPCWAC to 50409 to send this message to them via RESISTBOT from your cell phone.

“I am your constituent and I want you to know that we all deserve a healthcare system that works for all of us. That includes being able to access the medications we need, when we need them. We have been having critical shortages of drugs in the US for more than a decade. Lifesaving medicines are held hostage by, supply chain disruptions here and overseas (with little transparency), pharmacy benefit managers driving short supply by squeezing the generics manufacturers, and a lack of strategic reserves of critical lifesaving medicines. All of this puts the lives and health of Americans at risk. I want you to read this Senate Report https://www.hsgac.senate.gov/wp-content/uploads/2023-06-06-HSGAC-Majority-Draft-Drug-Shortages-Report.-FINAL-CORRECTED.pdf and then take action. By the way - this is not the time to restrict the FDA. They are the ones we need to help fix the shortages and keep us healthy.

While we are thinking about it I want you to also consider reforming PBMs as with S. 1339. The Pharmacy Benefit Manager Reform Act, too. Thank you.”

RESOURCES

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Contact State and Federal Representatives

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• https://www.usa.gov/elected-officials

Important Healthcare Resources

League of Women Voters Healthcare Reform Toolkit

Organizations to Contact

National Nurses United Medicare4All

Physicians for a National Health Program

One Payer States

Healthcare Now

Reproductive Health

NARAL - Pro Choice America

Charley. chatbot abortion resource - make sure to use a secure incognito browser if you live in a state that has banned abortion

Planned Parenthood

Miscarriage and Abortion Hotline has references about where to procure abortion medications. They also assist women in the process of self managed abortion or miscarriage by phone or text and will respond in an hour. Details and hours of operation at their website.

United State of Women Reproductive health page (bottom of the page) has important resources such as medical support, access to Telehealth, prescriptions by mail, and legal support references.

Practice careful communications - The Digital Defense Fund has a number of tips to keep texts, calls, and internet use private. Here is their site.

If you need financial help with an abortion try abortionfunds.org

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Appeal a Healthcare Decision

Appeal/Negotiate a Hospital Bill

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Cybersecurity Infrastructure Security Agency

Library of Advice

Specific Advice

Save Democracy

Chop Wood, Carry Water by Jessica Cravens

RESISTBOT

Link to the RESISTBOT site to learn more

Link to Chop Wood, Carry Water RESISTBOT write up

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