Friday, August 18, 2023

Where are my meds? How safe are they?

Some 90% of the medications we take are generic. Generic drugs are dramatically less expensive than their branded equivalents and generally similar to the branded products in all but price. Unfortunately, generally does not mean always. Two large healthcare systems tested all the generics sold through their pharmacies and found that 10% had potential quality issues.

A major source of medications sold in this country and elsewhere are manufactured in India and China. The $50 Billion pharmaceutical industry is a leading source of exports and foreign earnings for India. While most Indian pharmaceutical plants are of good quality, many, especially the smaller ones, are not.

The FDA tries to inspect overseas plants whose products are imported to the U.S. In 2019, the FDA reported to Congress that India had the lowest percentage of acceptable inspections of any country. 17% of the plants it inspected had major failings. And, due to the pandemic, the number of inspections the FDA conducted fell dramatically for 2020-22.

You may recall the news stories of children in Gambia and Uzbekistan dying in 2022 due to contaminated cough syrups from Indian manufacturers. This was only the tip of the iceberg. Less dramatic but important are issues of contamination, uneven content of pills and capsules and poor formulation causing poor absorption of medication. These will not kill you, but may well make the medication less effective.

The Department of Defense is sufficiently concerned that they have contracted with an independent testing lab to test the drugs it purchases for our military and evaluate the manufacturers. Kaiser Permanente has been doing the same thing for the past three years.

What can you do? If you look at the prescription label, in small print you will find the name of the manufacturer. You can do an Internet search on the company and see where they are located and also get an idea of how ”legitimate” they seem. If you find that your medication was made by an obscure Asian company, you can ask your doctor to contact the pharmacy about changing to another manufacturer. You can also make your elected representatives aware of this issue.

A seemingly unrelated problem that has been recently making headlines is shortages of important medications. A recent survey of hospital pharmacists found that virtually all reported some drug shortages, and that 83% were rationing some medications. Key shortages have been notable in generic cancer drugs that are the mainstay of many chemotherapy regimens.

Why is this? Do you remember the baby formula crisis last year? The issue is similar: concentration in a small number of manufacturers and a convoluted supply chain. As of mid-August, 48% of the injectable medications made by Pfizer were in short supply. The generic cancer drugs are low-profit and so do not get priority when companies are deciding on what products to manufacture.

The solution here is not in our hands as individuals – it demands that the federal government strongly encourage in-sourcing manufacture of key medications. Just as we cannot depend on Asia to make crucial electronic components and ship them half-way around the world, we cannot outsource the manufacturing of crucial medications.

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