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Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.
Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Although drug compounding fills a critical need for many patients, it has also given rise to significant drug safety concerns, fraud, and anticompetitive practices. Every year, many patients experience harmful side effects and even death from compounded drugs that are contaminated or made in excessive potency because of pharmacist error. The ability of pharmacies to make and dispense drugs outside of the typical channels has also given rise to extensive fraud. In addition, some rogue pharmacies earn significant profits by mass-producing compounded drugs that are essentially copies of commercially-available drugs. Many of the drug safety problems, fraudulent practices, and anti-competitive behaviors are facilitated by regulatory gaps in the oversight of drug compounding. Traditional drug manufacturers must prove that their drugs are safe and effective and manufactured in accordance with current good manufacturing practices (CGMPs) in order to obtain FDA approval. In contrast, compounders need not obtain FDA approval for their drugs before selling them, and most compounders do not have to produce drugs in accordance with CGMPs. Moreover, traditional drug manufacturing facilities are subject to routine inspection by the FDA to ensure they are in compliance with CGMPs and that there are no other safety or quality concerns. In contrast, most compounders are not primarily overseen by the FDA but by state boards of pharmacy that are less consistent in their oversight -- fewer than half of the states even conduct routine inspections of compounding pharmacies. Finally, whereas traditional manufacturers are required to report adverse events involving their drugs to the FDA, most compounders do not have to report adverse events to either the FDA or state regulatory authorities. This Article explains the regulatory gaps in drug compounding that give rise to drug safety problems, fraud, and anti-competitive behavior and proposes various measures that could be taken to close the gaps in order to protect patients, payors, and innovation.
Supplementary videos demonstrating various dispensing procedures can be viewed online at www.pharmpress.com/PCDvideos. --Book Jacket.
"Compunding has always been part of pharmacy practice. Today, the need for compounding is growing, with the prevalence of drug shortages, outsourcing of compounding services by hospitals, and patients' needs for individualized preparations. Compounding pharmacies now have the opportunity to obtain accreditation. The Art, Science, and Technology of Pharmaceutical Compounding presents all the information a student needs to understand the purpose and processes of compounding. It includes the essential information on establishing, equipping and operating a compounding pharmacy. It discusses all aspects of good manufacturing practices for compounded medications and it features quality control measures for all aspects of compounding. For practitioners who already compound prescription medications, the book is a ready reference featuring more than 200 sample formulations, including bases, vehicles and ingredient-specific preparations. Each formulation lists the necessary ingredients and gives step-by-step instructions for preparing the product. A new chapter emphasizes the importance of knowing the purity and form of all ingredients to ensure that the proper dose of a compounded product is delivered."--Publisher.
The authors have been teaching Dispensing and Compounding practice for a very long period. One of the challenges in their carrier was the lack of a proper, user friendly and comprehensive reference in compounding to use for teaching and instructing students as well as in hospital pharmacy practice. This book was constructed with this challenge in mind, and therefore simply presents such a reference. It is simply written, covers a wide spectrum of compounding practice with many formulae. The book is also useful for entrepreneurial individuals interested in small scale manufacturing of extemporaneous products.
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
An award-winning investigative journalist's horrifying true crime story of America's deadliest drug contamination outbreak and the greed and deception that fueled it. Two pharmacists sit in a Boston courtroom accused of murder. The weapon: the fungus Exserohilum rostratum. The death count: 100 and rising. Kill Shot is the story of their hubris and fraud, discovered by a team of medical detectives who raced against the clock to hunt the killers and the fungal meningitis they'd unleashed. "Bloodthirsty" is how doctors described the fungal microbe that contaminated thousands of drug vials produced by the New England Compounding Center (NECC). Though NECC chief Barry Cadden called his company the "Ferrari of Compounders," it was a slapdash operation of unqualified staff, mold-ridden lab surfaces, and hastily made medications that were injected into approximately 14,000 people. Once inside some of its human hosts, the fungus traveled through the tough tissue around the spine and wormed upward to the "deep brain," our control center for balance, breath, and the vital motor functions of life. Now, investigative journalist Jason Dearen turns a spotlight on this tragedy--the victims, the heroes, and the perpetrators--and the legal loopholes that allowed it to occur. Kill Shot forces a powerful but unchecked industry out of the shadows.