Sam Uretsky

When States Drop the Ball, It’s No Time to Cut the FDA

Before World War II, the practice of pharmacy was pretty much a matter of mixing up the dried plants to make liquids, capsules and ointments. There were plenty of companies making proprietary drugs and patent medicines, but the corner druggist was still mixing up combinations of eight or a dozen ingredients — all labelled in Latin and measured in drachms and minims. These skills are still taught, although a chain store pharmacist may go through life without lifting a pestle, and the only time anybody looks at the apothecary balance is when a state inspector drops in.

But, compounding pharmacy is back – not quite the quaint calendar illustration, but filling needs where the commercial manufacturers can’t or don’t make an appropriate form, when a patient needs several intravenous drugs and the goal is to reduce the fluid load, or when the patient can’t tolerate one of the components in a commercial product. A lot of this is innocuous, but recently there has been an outbreak of fungal meningitis responsible for 14 deaths and 170 cases in 10 states.

According to an update from the International Academy of Compounding Pharmacists (IACP), “The outbreak is linked to tainted methylprednisolone acetate steroid injections from the New England Compounding Center (NECC) in Framingham, Mass. Contaminants were found in an unopened vial during an inspection of NECC. Three lots of single-dose vials (17,676 single vials) of methylprednisolone acetate sent to 76 facilities in 23 states were recalled.” This raises a number of questions – one of which is whether the pharmacy is acting as a compounder or a manufacturer. Manufacturers are regulated by the Food & Drug Administration, pharmacies by the various states. Because of the economy, income shortfalls and budget cuts, neither level of government may have been able to provide the inspections and oversight needed for public safety.

Compounding has traditionally been thought of as filling individual prescriptions and drug orders, written by physicians for individual patients. The volume of activity reported from NECC minimally places it in a grey area, and most people would go well beyond that. Unfortunately, the FDA doesn’t seem to have the ability to distinguish between pharmacies that are filling prescriptions for skin creams, and which for drugs like the methylprednisolone injection, which was injected around the spinal cord, bypassing the body’s natural defenses.

The risks involved with contamination of sterile pharmaceuticals are so great that the very highest standards of care should always be used. A safe product can be produced in a physician’s office, and in a multinational pharmaceutical manufacturer’s plant.

The difference is that it’s a lot easier to make mistakes in an office or pharmacy. For example, a hospital pharmacy will be doing compounding under a hood, and all manipulations should be done at the rear of the hood, closest to the source of sterile air. Move to the front of the hood, the open section, and there’s risk of contamination from room air. In a well designed manufacturing plant, all the air entering the room is sterile, so there is no comparable risk. Still, even in the largest facilities there are risks of contamination.

Although manufacturers have more money to spend on sterile facilities, their products aren’t perfect. On Oct. 5, there was a recall of one lot of lactated ringer’s solution, an intravenous product from a traditionally reliable manufacturer, due to mold growth. On April 2, a different manufacturer recalled cyanocobalamine injection because of contamination risks.

Good hardware is essential, but it has to be accompanied by perfect technique. The challenge of the NECC recall is the size of the recall, and the tragic severity of the reaction. Because the fungi responsible for the outbreak (Exserohilum and Aspergillus) are slow-growing, it’s impossible to estimate how many people will become infected before this is over. This could become a public health problem as great as the Elxir Sulfanilamides and Thalidomide tragedies of the past.

While there are issues of jurisdiction between state and federal authorities, it seems basic that any pharmacy routinely making sterile products, intravenous solutions, eyedrops, should be monitored. The problem is about money. The Food & Drug Administration, the federal agency responsible for monitoring drug manufacturing, has a total annual budget of around $4 billion, but as much as half of that is in the form of user fees paid by pharmaceutical manufacturers. This system makes the manufacturers, not the public, the customers. That’s bad.

The Obama Administration’s budget request for 2013 called for a 17% increase in the FDA budget, including $253 million for a food safety program. In response, the House Appropriations Committee recommended a budget cut of about $285 million. Further cuts are possible under Congress’ mandatory cutbacks scheduled for January.

The Center for Communicable Disease Control (CDC) has issued a quote from John Jernigan, MD, MS, Clinical Team Lead of the Multistate Meningitis Outbreak, “Given that fungal infections of this kind have never been seen before, the doctors caring for these patients are going to need guidance. CDC has convened the nation’s top clinical fungal experts to work with us in developing diagnostic and treatment guidance for physicians caring for these patients. Patients who are concerned about whether they were exposed to a potentially contaminated product should contact the physician who performed their injection.”

Maybe the House Appropriations Committee should consider giving back some of the money.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y. Email sdu01@ mail.com.

From The Progressive Populist, November 15, 2012