by Kimberly Allen, RN
It’s been almost 6 months since the deadly fungal meningitis outbreak began and there are still people reporting infections caused by the contaminated steroids responsible for the outbreak. According to the CDC, so far the outbreak of fungal meningitis has killed 48 and caused over 700 people to become ill. Many of the newly reported infections are occurring in people who were known to have received the contaminated doses of methylprednisone but had previously been examined with MRI’s or lumbar punctures that indicated there was no infection. This has lead the CDC to issue another health alert urging doctors and health care professionals to remain alert and watchful for new infections even in people with mild or no symptoms.
Dr. Tom Chiller of the CDC states that some people have very long incubation periods. This means people are still getting infections months after their injections. This incubation period is now longer than the 2002 outbreak when a patient became sick 5 months after receiving a steroid injection leaving doctors wondering how long the incubation period for this outbreak will be.
Six months ago, when the outbreak of fungal meningitis began, there were approximately 14,000 people in 23 states that had been exposed to the contaminated steroids with approximately 11,000 having actually received injections for back or neck pain. At that time, the CDC believed the highest risk of developing the dreaded fungal meningitis was in the first 6 weeks after receiving the injections. This lead people to believe that the crisis would end after the first week of November. However, that has not been the case as people are continuing to become ill 6 months later. Most of the new infections are not meningitis but are either abscesses or arachnoiditis, a condition where the nerves of the spine are inflamed.
One of the concerns of health officials is that these infections tend to be unknown because some people have not continued to get close medical follow up care or they do not recognize the symptoms indicating a localized infection. Officials are also encouraging clinicians and health care workers to be open to considering MRI examinations to discover any unseen infections. The problem is that these infections are serious and left untreated they will get even worse. Infections that are left untreated sit and simmer and spread. They can spread to the soft tissue and bone as well as the central nervous system which poses serious consequences including death.
Because of the long incubation period and the seriousness of the infections many are asking how long should patients already infected continue to be treated. Some patients were originally told 3 months which was then increased to 9 months and then to a year. The drugs that are currently being used to treat these infections are not only expensive but highly toxic with a wide range of side effects from hair loss and liver problems to hallucinations. Most patients receiving treatment describe it as “hell.” They complain of extremely severe headaches, constant vomiting and incredible pain.
Many of the victims of this infection as well as their families are hoping that two upcoming Congressional hearings on the investigation into this incident will focus on their plight and hopefully change regulations regarding compounding pharmacies.
Pharmaceutical Compounding Compounds the Problem
Pharmaceutical compounding is the practice of creating medications to fit the specific needs of a specific individual. For example, if a person is allergic to one of the ingredients in a medication the doctor wants to prescribe the doctor can contact a compounding pharmacy to have him/her create the medication without the allergen, or if a child needs a smaller dose of a medication in liquid form but it’s only available in an adult dose tablet the compounding pharmacist will create the medication in the correct dose for the child and in liquid instead of tablet form. Many years ago, before drug companies began mass producing medications, the majority of medications were compounded by a pharmacist. When medications started being mass produced, they were no longer made for individual patients but for the general population. Therefore, when a situation arises where a patients medical condition prevents him/her from using one of these mass produced medications, the doctor is able to prescribe a medication that is specific to the needs of his/her patient using a compounding pharmacist.
Today there are approximately 7,500 compounding pharmacies that specialize in advanced compounding services. Approximately 3,000 of those make sterile medications. The steroid injections that were made by NECC, the company responsible for the recent outbreak of fungal meningitis, were supposed to be sterile. All injectible medications are supposed to be sterile because they are being injected into a sterile environment unlike most oral medications which follow the same pathway as food do not need to be sterile as they are not entering a sterile environment.
Recently I watched a report about compounding pharmacies on CBS’s 60 minutes and was stunned by what I saw and heard. Like most people, including many doctors, I thought all pharmaceutical medications and pharmacies were regulated by the FDA. However, along with many others, I found out that because these compounded medications are prescribed specifically for an individual patient they are not subject to FDA approval. They are not supposed to be produced in mass amounts. However, the offending compounding pharmacy got “greedy and sloppy.” I’m not sure which is more alarming, that doctors and hospitals knowingly participated and encouraged this compounding pharmacy to produce large quantities of compounded medications by providing prescriptions with obviously fake names or that the salesman for the company was more than willing to accept them knowing they were false.
Unfortunately, NECC is not the only compounding pharmacy that has had serious issues with safety and sterility. In 2009, another compound pharmacy produced medications that killed 21 polo horses. The pharmacist received a fine and reprimand. Then only 3 years later, 47 people developed fungal eye infections from medications made at the same pharmacy. Currently compounding pharmacies are under the regulation of state boards, the FDA only regulates the “integrity of the drugs.” In 1997 a law was passed giving the FDA authority over compounding pharmacies which was then struck down by the Supreme Court in 2002. Now the FDA is pushing again for new laws that provide federal oversight on these pharmacies. However, Congress has expressed little interest in cooperating with the FDA.
For those compounding pharmacies that are willing, the Pharmacy Compounding Accreditation Board (PCAB), which is an independent agency will provide its official seal of approval to those pharmacies that pass strict inspections as well as follow other stiff requirements. Of the approximately 7,500 compounding pharmacies in the US only approximately 180 of them have PCAB accreditation and as you would expect the NECC is not one of them. So if your Dr recommends a compounded medication check to see if the pharmacy is PCAB accredited to be sure you’re getting a safe medication.
Kimberly Allen is a registered nurse with an AND in nursing. She has worked in ACF, LCF and psychiatric facilities, although she spent most of her career as a home health expert. She is now a regular contributor to HealthAndFitnessTalk.com, dispensing advice and knowledge about medical issues and questions. You can reach her with any comments or questions at firstname.lastname@example.org.