Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.”1 The recent outbreak was caused by steroid shots contaminated with so much fungus that in some cases the fungus particles were visible to the naked eye.2 A single compounding pharmacy in Framingham, Massachusetts, the New England Compounding Center, “shipped 17,676 vials of … potentially contaminated [steroid] solution to 75 clinics in 23 states.”3 As of March 4, 2013, the Centers for Disease Control and Prevention (CDC) had linked 720 cases of meningitis or other complications, including forty-eight deaths, in twenty states to the epidural steroid injections that all originated from the New England Compounding Center.4
However, the New England Compounding Center is a relatively small compounding pharmacy, with $32.4 million in annual sales for 20125 in comparison to estimates that there are “between 800 and 900 compounding pharmacies with sales in excess of $2 billion a year.”6 Additionally, the contaminated steroid solution linked to the current fungal meningitis outbreak is not an isolated incident, as historically more than “one million doses of compounded drugs have been recalled for bacterial or fungal contamination.”7
Currently, compounding is a matter for individual state pharmacy boards to regulate.8 State compounding pharmacy oversight regimes vary widely in terms of requirements and resources, and the proliferation of Mail-Order and Internet pharmacies whose patients are often across state lines has stretched the regulatory abilities of the state pharmacy boards.9 Therefore, Congress should resuscitate the Safe Drug Compounding Act of 2007 to give the Food and Drug Administration (FDA) the power to regulate large-scale compounding pharmacy operations to prevent future outbreaks like the recent fungal meningitis outbreak from occurring.
In 2007, Senators Edward Kennedy, Richard Burr and Pat Roberts proposed the Safe Drug Compounding Act of 2007, which would have increased the FDA’s role in regulating compounded drugs.10 The twenty-four page draft bill11 proposed amending the Federal Food, Drug, and Cosmetic Act to allow the FDA to regulate compounding pharmacies, restrict interstate distribution of compounded products, and establish federal requirements for sterile compounding.12. Enacting the proposed Safe Drug Compounding Act of 2007 would thus enable the FDA to fill in the gaps left by state pharmacy boards. The bill was opposed by pharmacy trade groups including the International Academy of Compounding Pharmacists because of the perception that such regulation would limit patient access to medically necessary compounded prescriptions.13 The bill never came to a vote in the Senate.14
However, FDA regulation would primarily target larger-scale interstate operations like the New England Compounding Center rather than, for example, the pharmacist who compounds the occasional prescription for an infant who needs a smaller dose than is commercially produced. The Safe Drug Compounding Act of 2007 explicitly preserved the ability of pharmacists and physicians to compound drug products for an identified individual patient.15 Therefore, the draft text does not deny patients medically necessary compounded drugs.
Under the Safe Drug Compounding Act of 2007, state pharmacy boards can continue regulating compounded drugs prepared for individual patients. Bringing large-scale compounding pharmacies under federal oversight will heighten manufacturing standards and subject drugs compounded in large batches to FDA inspection. Further, restricting the interstate distribution of such drugs will ensure that future outbreaks because of contamination will be limited in scope. In other words, having a federal regulatory regime in place for large-scale compounded drugs could have prevented or severely limited the ongoing outbreak of fungal meningitis. Therefore, in light of the tragic outbreak of fungal meningitis, Congress should enact the Safe Drug Compounding Act of 2007 to improve the safety of large-scale compounded drugs.
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2 comments:
The author, a student at the university, has missed some key points. I am not sure where she got her statistics from but not even the FDA says there are 800-900 compounding pharmacies doing over $2 billion of sales. She has also missed the fact that the FDA has declared compounding to be illegal. How would that not limits access for the patients?
If you take FDA generated statistics and look at the number of deaths per prescription by medication errors of manufactured drugs versus compounded drugs you would find that patients are 50,000 times more likely to die from an FDA approved product. We don't want any mistakes and are trying to minimize them. But don't make the assumption that FDA over-site is safer. We have a long way to go before that is the case.
The author is a student because it is a note written for a law review journal. Those are typically written by law students. Each of her statements is supported by a footnote as required in law review articles. I have not checked her underlying supporting authority for her statement. In the past the FDA may have declared compounding illegal but that is not their current position. As with all administrations of the federal government, policies and positions change over time. I have no doubt you are correct about the number of prescription deaths. I believe I have done a post on that in the past. You are also correct that just because there is FDA over site does not necessarily mean safer products. Everyone must play a role to make the system work.
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