Medication Quality Issues in the U.S. Are Very Real

Problems can stem both from violations of FDA guidelines and from within broad allowable ranges of variability

Medication quality issues are much more prevalent than most people realize and the effects can easily be missed or blamed on other factors. People take medications to help with a condition, so when the condition worsens or fluctuates it is very rare that the medication itself is ever investigated.

Medication quality issues, both in violation of FDA guidelines and within the allowable ranges, are of increasing concern now that the percentage of prescriptions in the U.S. that are for generics has increased to 90%. While generic drugs are of great value and allow millions of Americans to save thousands on prescriptions, there are times when cutting corners in manufacturing of drugs may come at too steep of a price.
The $2 trillion global pharma supply chain is incredibly complex and medications can touch 10-20 hands before reaching the consumer. Drugs are typically tested for quality only at the manufacturer that self-reports the results, if they’re tested at all. It is common industry practice to “skip-test,” meaning testing is only performed on a subset of batches on a production line. The FDA very rarely tests medications itself.

Is Current FDA Oversite Enough to Protect Consumers?

The FDA, which is in charge of maintaining quality in everything from our food to our medical devices to our drugs, is inadequately equipped to oversee the manufacturing of every drug at every facility, particularly manufacturing plants in India and China where 80% of all drug ingredients are made. It is estimated that approximately 1,000 facilities have never even been inspected by the FDA.

In a 2015 white paper, the FDA acknowledged that “product recall and defect reporting data demonstrate unacceptably high occurrences of problems attributed to inherent defects in product and process design; these data further indicate failures in the implementation of manufacturing process as well as routine production.” Furthermore, the “FDA has no formal means for quality surveillance except through inspections,” and “inspection findings have not been a reliable predictor of the state of quality.”

Weaknesses in this system have become particularly evident with the multitude of recalls of sartan class drugs, which are taken by tens of millions of Americans. The problem which went undetected for four years has since been traced back to poor manufacturing practices primarily in China.

Oftentimes even your doctor isn’t aware of these manufacturing issues, which can contribute to changes in a patient’s care, as underscored by Cleveland Clinic cardiologist Harry Lever, who stated in a recent Bloomberg video that, “I’ve had patients who come to see me. They’re not feeling well, and I look them over, and the only change I make is I change the manufacturer of the drug.  And not everybody, but a good number of them get better when I change the manufacturer because something wasn’t right with the original drug they were taking.”

Allowed Variability Is a Serious Concern

Even when a drug is not in violation of FDA guidelines, the variability lot-to-lot or manufacturer-to-manufacturer can be much more significant than many people realize. For most drugs, whether brand or generic, the concentration of active ingredient is allowed to vary to a maximum range of 20% or +10%/-10%. Variability can get even broader when a drug goes generic.When a brand-name drug’s patent expires, significantly cheaper generic versions are permitted to be launched into the market. For a manufacturer to obtain approval for making a generic medication they need to perform one self-reported study of “bioavailability.” This is a test for how well a drug is absorbed into your body, usually measured as concentration in blood.

The FDA allows for the bioavailability of a generic drug to vary from the brand anywhere from a minimum of 80% to a maximum of 125%. This allowable variance of up to 45% (+25%/-20%) from one generic to another can be of particular concern for people who take medications for high blood pressure, depression, thyroid conditions and others.
The problem with such large allowed variability is that the simple act of refilling your prescription could result in significant differences in the medication, especially when the manufacturer changes.

A good example comes from the roughly four million epileptic patients in the U.S. taking antiepileptic drugs. With epileptics, it is very clear when your meds are off: you suffer a seizure. A Harvard Medical School study was able to show that just the batch-to-batch variability of simply refilling your meds was associated with a 2.3-fold increased chance of having a seizure.

It is common practice for drugs to be sourced from different manufacturers as pharmacies often purchase from the manufacturers with the lowest market price of the day. Therefore, even if one manufacturer has stayed relatively consistent, switching to another can put you in a very different place within the broad allowable range. At Valisure, we strive to bring consistent quality regardless of fluctuating prices by batch testing all medications and striving to keep our suppliers consistent.

Medication quality issues are certainly quite real and the recent drive to significantly increase generic drug approvals while total FDA inspections are going down definitely raises concerns that these issues will only get worse. It is now all the more important to increase vigilance throughout the pharma supply chain all the way to the individual patient.

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