In a recent episode of Last Week Tonight, John Oliver explained drug compounding pharmacies and highlighted some of the problems they pose for regulators and the public.
The Role of Compounding Pharmacies
Drug compounders make medicine for people (and animals) whose medical needs cannot be met with FDA-approved products. Instead of obtaining drugs mass-produced by a pharmaceutical company, a patient can turn to a compounding pharmacy for custom-made medication.
Compounding pharmacies allow medication to be tailored to the specific needs of a patient. For example, they can prepare medication in a liquid form for persons who cannot swallow pills or produce medicine in lower concentrations than what’s commercially available. Oliver used the example of a parrot, which would need compounded medicine because drugs are not manufactured in dosages for birds.
Being able to turn to drug compounders for custom-made medication is helpful and necessary. As we have noted previously, however, compounding pharmacies are far less regulated than are pharmaceutical companies manufacturing FDA-approved drugs.
Problems with Drug Compounders
Oliver discussed, with his characteristic dark humor, some of the problems that have arisen with compounding pharmacies.
- Fraud – TRICARE, the military’s health insurance program, has spent nearly $2 billion on compounded pain creams. Not only is there little or no evidence that these creams work, compounding pharmacies have been adding very expensive ingredients to the creams and billing separately for each one.
- Ineffectiveness – Oliver reported that the failure rate for FDA-approved drugs is less than 2 percent. In contrast, the failure rate for compounded drugs is about 33 percent.
- Unsafe/Unsanitary Conditions – States regulate compounding pharmacies, not the FDA. Many states, as Oliver noted, do not have enough inspectors to prevent unsafe conditions at these facilities. He gave examples of a facility that kept medication in a refrigerator next to staff lunches and one that stored pills in a bathroom. He also highlighted the massive meningitis outbreak caused by unsanitary practices at the New England Compounding Center (NECC). The outbreak sickened hundreds of people and caused over 75 deaths.
- Bulk Production – Compounders are supposed to make small amounts of drugs for specific patients, like the old-fashioned pharmacist featured at the beginning of Oliver’s segment. Instead, some facilities mass-produce drugs and ship them around the country. In doing so, they are functioning like a drug manufacturer rather than a pharmacy, but without being subject to FDA regulation. To evade requirements that each drug produced have an individual prescription for a specific patient, some compounders have invented patient names, including – as Oliver points out – such obviously fake ones as “Bud Weiser” or names of celebrities.
Need for Closer Oversight
In response to the NECC disaster, Congress passed the Drug Quality and Security Act, which – among other things – created a category of drug compounders known as “outsourcing facilities.” Such facilities are subject to regulation by the FDA and stricter scrutiny than are small retail pharmacies. As Oliver notes (and as we have written about previously), registration as an outsourcing facility is voluntary.
Oliver reports that, to date, only 77 compounders have registered as outsourcing facilities while others carry on as before and are subject to regulation only by under-staffed state agencies. We agree with him that drug compounders should be regulated more closely. If you become aware of fraudulent or unsafe practices, we encourage you to contact us.
