Meningitis Watchdog Group - Public Citizen

Meningitis Outbreak could spark new legislation

The catastrophic meningitis outbreak has brought on efforts to enact new legislation regarding the inspection and regulation of compounding pharmacies. Although the states have the ultimate authority in the matter of policing compounding pharmacy practices, the FDA has been called upon to review the pharmacies that have, in the past, violated best practices.

The watchdog group, Public Citizen, sent a letter to the FDA asking that agents be sent to six compounding pharmacies that have received warning letters from the years 2003 to 2012. The violations that caused the issuance of the warning letters included:

• Creating and distributing vast quantities of drugs
• Creating and distributing drugs without individual patient prescriptions
• Fabricating copies of drugs that are commercially available
• Manufacturing drugs using ingredients that are not FDA approved
• Maintaining improperly sanitized facilities and equipment
• Employing improperly trained staff

According to the letters issued by the FDA to the offending pharmacies, there have been examples of patients being sickened or even killed by solutions of dextrose that had been contaminated by microorganisms, and one inspection uncovered a pharmacy using an ingredient found in industrial cleaners in an injectable drug.

The letter also requests that all documentation and reports concerning the inspection of compounding pharmacies be released to the public for review. This includes not only the pharmacies that have received warning letters, but all 483 reports since 2003.

There are other areas that might merit further investigation, namely Medicaid and Medicare coverage policies. Public Citizen, a nonprofit organization that acts as a people’s advocate, sent a letter earlier in November, 2012, suggesting that reimbursement policies for compounding pharmacies created by Medicare and Medicaid were actually financial incentives. Because the Centers for Medicare and Medicaid services routinely cover compounded drugs, compounding pharmacies were able to create large scale manufacturing operations that might not have been otherwise possible. According to the letter, the following areas warrant examination:

• The fact that the Centers for Medicare and Medicaid services (CMS) guidance documents prohibit covering compounded medications that have not been approved by or in violation of the FDA, yet later state that Medicare and Medicaid can continue coverage until either the FDA or CMS specifically take action against reimbursement.
• The fact that the CMS denies coverage of compounded inhalation drugs but not other large scale compounded drugs.
• The fact that some CMS carriers have approved coverage for compounded drugs that are administered near the spine by an implanted pump.

According to Dr. Michael Carome, the deputy director of Public Citizen’s Health Research Group, the CMS policies have actually encouraged compounding pharmacies to produce large quantities of dangerous drugs. “An independent investigation is necessary to determine exactly how these policies contributed to the current meningitis outbreak and to prevent a similar tragedy from happening in the future,” he says.

Unregulated Compounding Pharmacies

Sometimes, tragedy has to strike before action is taken

For the past two decades, the United States congress has been pressured to enact regulations on compounding pharmacies that act as manufacturers of specialty medications. Rather than submitting to the same regulations as standard drug manufacturers, compounding pharmacies were not seen as “manufacturers,” even though they were creating pharmaceuticals for distribution to medical facilities.

How is it different? Both manufacturers and compounding pharmacies are supplying medications to the public for consumption. However, compounding pharmacies are not supposed to be making large batches of medications and distributing them as substitutions for FDA approved pharmaceuticals—and yet, that is exactly what these pharmacies were doing.

Unregulated Compounding Pharmacies

Before the deadly meningitis outbreak, before it became clear that numerous unregulated compounding pharmacies were operating under questionable and, sometimes, downright unsanitary conditions, compounded medications were seen as a perfectly legitimate and less expensive alternative to standard brand-name drugs. Many members of congress and several advocacy groups touted compounding pharmacies as a trustworthy alternative to big drug companies. During drug shortages, compounding pharmacies were often called upon to mix alternative versions of needed medications. As the practice became more commonplace, and the option of cheaper and easily accessible compounded drugs became more enticing, compounding pharmacies became small-scale manufacturers. Eventually, they were accused of copying legitimately manufactured drugs and distributing them cheaply. The reason for the disparity in price was due to the fact that compounding pharmacies use ingredients from unapproved sources.

There have been previous examples of contaminated or dubious medications from compounding pharmacies; a compounding pharmacy in South Carolina was responsible for several illnesses and one death from a batch of contaminated medication; in 2001, the FDA examined samples from 12 different pharmacies and discovered that 30% did not pass quality tests.

Because compounding pharmacies are not under the jurisdiction of the FDA, the FDA has no power to regulate them. State boards of health are responsible for policing them, but often choose not to; only two states—Texas and Missouri—issue random tests of compounded drugs. The only way a compounding pharmacy is made to follow FDA regulations is if that pharmacy is found to be manufacturing drugs. The only way the FDA can determine whether or not a pharmacy is manufacturing drugs is to look at records of the volume of compounded drugs shipped, which the pharmacies insist that the federal government has no right to do. In fact, often the only way the FDA even becomes aware of tainted products from compounding pharmacies is to read about pharmaceutical related illnesses in the news, or if the victims report to them directly. Unlike drug manufacturers, compounding pharmacies are not obligated to report instances of product causing patients harm.

Unregulated Status of Drug Compounding Pharmacies

Dangers of Improperly Handled Medications

Compounded drugs are nothing new. Doctors prescribe compounded drugs to treat specific conditions on an individual patient basis. For example, pharmacists compound certain drugs to reduce their potency in order to be administered to children, or change the method of drug delivery from tablet to patch form for patients that have trouble swallowing. However, the unregulated status of drug compounding pharmacies has alerted us to the dangers of improperly handled medications because of the tainted steroid medication that went on to be injected into patients and infect them with aggressive meningitis. It is important to educate ourselves about the ways in which our medications are processed in order to prevent serious infections and even worse.

Do not order drugs from overseas online pharmacies

The high cost of prescription medications has forced many patients to purchase their medicines from unregulated overseas pharmacies. It was reported by the National Association of Boards of Pharmacy that fully 97% of 10,000 online pharmacy websites that were investigated do not operate under United States pharmacy laws and regulations . These medications may seem as though they are the same as those that are acquired through hospitals and licensed clinics, but the batches of drugs distributed from these illegal operations might put users at great risk. Investigators found instances of tampering, improper handling and storage, expired drugs that were re-labled with inaccurate expiration dates and counterfeit medications. If an online pharmacy doesn’t require a prescription or medical history, then that pharmacy is operating illegally.

Ask your physician where the prescription medication came from, and if it was compounded

If you are prescribed medication by your doctor, ask him or her if it was compounded, and why. If there are standard FDA approved drugs available in a form that is ready to use, opt for that instead, although it will be very likely more expensive. Very often, physicians will choose the less expensive compounded form of a drug in lieu of the brand name drug. If your medication must be compounded, ask where it must be done; many hospitals compound drugs on site.

Do not allow a pharmacy to compound drugs for you without a specific doctor’s order

Many pharmacies will suggest compounding drugs that are problematic for the patient. Allowing a pharmacist to mix special versions of a medication that was prescribed by a doctor might have an effect unforeseen by the pharmacist that may compromise either the efficacy of the drug or the patient’s health; an effect a physician might catch if alerted to it. If you are having trouble taking medications for any reason, consult your doctor before allowing a pharmacist to make adjustments.