Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA), requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg. Sometimes it takes a disaster to spur the adoption of appropriate regulation. Today, compounding pharmacies are at the center of a controversy after a rare outbreak of . . .
Small pharmacies that produce and package (or repackage) specific drugs for individual patients are an important part of the medical landscape. These so-called compounding pharmacies formulate therapeutic and diagnostic products for physicians in practice and those engaged in research. They make individualized chemotherapeutic agents, noncommercial formulations (e.g., a liquid rather than a tablet) and doses, preservative-free and dye-free products, flavored products, combination products, products without specific allergens, diagnostic agents, and other customized products. These pharmacies are essential if our health care system is to serve populations with particular needs. Recently, the valuable role that such pharmacies fill has been eclipsed . . .
Background Fungal infections are rare complications of injections for treatment of chronic pain. In September 2012, we initiated an investigation into fungal infections associated with injections of preservative-free methylprednisolone acetate that was purchased from a single compounding pharmacy. Methods Three lots of methylprednisolone acetate were recalled by the pharmacy; examination of unopened vials later revealed fungus. Notification of all persons potentially exposed to implicated methylprednisolone acetate was conducted by federal, state, and local public health officials and by staff at clinical facilities that administered the drug. We collected clinical data on standardized case-report forms, and we tested for the presence of fungi in isolates and specimens by examining cultures and performing polymerase-chain-reaction assays and histopathological and immunohistochemical testing. Results As of October 19, 2012, more than 99% of 13,534 potentially exposed persons had been contacted. As of December 10, there were 590 reported cases of infection in 19 states, with 37 deaths (6%). As of November 26, laboratory evidence of Exserohilum rostratum was present in specimens from 100 case patients (17%). Additional data were available for 386 case patients (65%); 300 of these patients (78%) had meningitis. Case patients had received a median of 1 injection (range, 1 to 6) of implicated methylprednisolone acetate. The median age of the patients was 64 years (range, 16 to 92), and the median incubation period was 20 days (range, 0 to 120); 33 patients (9%) had a stroke. Conclusions Analysis of preliminary data from a large multistate outbreak of fungal infections showed substantial morbidity and mortality. The infections were associated with injection of a contaminated glucocorticoid medication from a single compounding pharmacy. Rapid public health actions included prompt recall of the implicated product, notification of exposed persons, and early outreach to clinicians.
From a survey of compounding pharmacists, specific questions regarding compounded menopausal hormone therapy were used to estimate compounded hormone therapy (CHT) prescribing in the United States.
Understanding mechanisms of neuropathic orofacial pain, targets of treatment, and basic pharmacology and working with informed compounding pharmacists may result in significant benefit for patients. The clinical significance of topical medications is improvement of quality of life for patients by providing a unique medication delivery system for neuropathic orofacial pain and other dental and extraoral conditions. The use of this route of administration has decreased or minimized side effects compared with other methods and is especially useful in medically compromised and elderly patients. These innovations, supported and improved by ongoing research, will augment the armamentarium of the clinician treating orofacial pain disorders.
ABSTRACT Compounding pharmacies serve a critical role in modern health care to meet special patient care needs. While the Food and Drug Administration (FDA) has clearly delineated jurisdiction over drug companies and products manufactured under Good Manufacturing Practice (GMP) regulations to ensure quality, potency and purity, compounding pharmacies are regulated by the State Boards and are not registered by the FDA. In the recent years, some compounding pharmacies acted like a manufacturer, preparing large amounts of injectable drugs with interstate activities. Multiple outbreaks have been linked to compounding pharmacies, including a recent outbreak of fungal meningitis related to contaminated methylprednisolone, exposing more than 14,000 patients in multiple states. This tragedy underscores the urgency of addressing safety related to compounding pharmacies. There is a call for action at the federal and state levels to set minimum production standards, impose new labeling conditions on compounded drugs, and require large scale compounders be regulated by the FDA. “Industrial” compounding must come under FDA oversight, require those pharmacies to meet GMP standards, and ensure quality and safe products for patient use. Moreover, compliance with the Institute for Safe Medication Practices 2011 recommendations that any type of sterile compounding must be in compliance with the United States Pharmacopoeia Chapter 797 guidelines will reduce the risk of patient harm from microbial contamination. Finally, other critical factors that require close attention include addressing injectable products compounded in hospitals and other outpatient healthcare centers. The FDA and State Boards of Pharmacy must be adequately funded to exercise the oversight effectively.
- Pain practice : the official journal of World Institute of Pain
- Published about 5 years ago
Compounding pharmacies play an increasing and increasingly important role in our healthcare system, but recent media attention has exposed limited regulatory control over these organizations at the same time their role is expanding. Compounding pharmacies are not regulated in the same manner as pharmaceutical companies and are governed largely by Chapter <797>, a monograph on the pharmaceutical compounding of sterile products, issued but not enforced by the U.S. Pharmacopeial Convention. Not all states require adherence to Chapter <797>, and those that do may choose not to enforce it stringently. Furthermore, Chapter <797> is not a strong standard-for example, it does not require documentation of drug lot numbers or cross-references for patient identification. Thus, there have long been many potential quality issues associated with compounding pharmacies. As these compounding pharmacies provide important products and services, better regulation is urgently needed. Moreover, clinicians should be better aware that some injectable products they use may have been prepared by a compounding pharmacy.
Fungal endophthalmitis is a rare but serious infection. In March 2012, several cases of probable and laboratory-confirmed fungal endophthalmitis occurring after invasive ocular procedures were reported nationwide. We identified 47 cases in 9 states: 21 patients had been exposed to the intraocular dye Brilliant Blue G (BBG) during retinal surgery, and the other 26 had received an intravitreal injection containing triamcinolone acetonide. Both drugs were produced by Franck’s Compounding Lab (Ocala, FL, USA). Fusarium incarnatum-equiseti species complex mold was identified in specimens from BBG-exposed case-patients and an unopened BBG vial. Bipolaris hawaiiensis mold was identified in specimens from triamcinolone-exposed case-patients. Exposure to either product was the only factor associated with case status. Of 40 case-patients for whom data were available, 39 (98%) lost vision. These concurrent outbreaks, associated with 1 compounding pharmacy, resulted in a product recall. Ensuring safety and integrity of compounded medications is critical for preventing further outbreaks associated with compounded products.
Pharmaceutical compounding preparations, produced by (hospital) pharmacies, usually do not have marketing authorization. As a consequence, some of these pharmaceutical compounding preparations can be picked-up by a pharmaceutical company to obtain marketing authorization, often leading to price increases. An example is the 3,4-diaminopyridine slow release (3,4-DAP SR) tablets for Lambert-Eaton Myasthenic Syndrome (LEMS). In 2009 marketing authorization was given for the commercial immediate release phosphate salt of the drug, including a fifty-fold price increase compared to the pharmaceutical compounding preparation. Obtaining marketing authorization for 3,4-DAP SR by academia might have been a solution to prevent this price increase. To determine whether the available data of a pharmaceutical compounding preparation with long-term experience in regular care are adequate to obtain marketing authorization, 3,4-DAP SR is used as a case study.
Adherence to a gluten-free diet (GFD) demonsrates various difficulties, including the high cost of the diet. The present study aimed to (i) compare the cost of gluten-free products (GFP) from supermarkets and pharmacies with the cost of their conventional counterparts and (ii) estimate the weekly economic burden of a GFD.