Safety Standards in Pharmaceutical Compounding, Part 3: Fire Safety.

In pharmaceutical compounding, ensuring the safety of staff in the workplace is an issue of prime importance to pharmacy owners and managers and the focus of international, federal, state, and local agencies charged with enforcing adherence to the prevention of job-related injuries and illnesses. In this third article in a 3-part series on hazard communications, fire- and life-safety codes established by authorities having such jurisdiction over U.S. businesses (including compounding facilities) are discussed, safety inspections are described, required fire-safety equipment is reviewed, and an effective safety plan that includes building evacuation is presented.

Safety Standards in Pharmaceutical Compounding, Part 2: A Closer Look at Agency Information, Oversight, and Assistance.

In the U.S., compounding pharmacies are regulated primarily by state boards of pharmacy, which often collaborate with federal agencies such as the Drug Enforcement Administration or the Department of Health and Human Services. Other organizations, such as the U.S. Food and Drug Administration, the Occupat ional Safety and Health Administration, the Environmental Protection Agency, and state departments of agriculture or labor may also have jurisdiction over compounding pharmacies and their employees. In addition, compounding pharmacies are subject to the requirements of Section 503A of the Federal Food, Drug, and Cosmetic Act. Complying with requirements for training and competency and documenting adherence to various agency regulations may seem daunting, but guidance in doing so is available from independent organizations such as the United States Pharmacopeial Convention, Inc., and the Pharmacy Compounding Accreditation Board. In this second article in a series on safety standards in pharmaceutical compounding, we discuss the roles of several of those influential federal organizations and the benefits that guidance from independent agencies provides for compounding pharmacists. Questions of interest to pharmacists who seek to comply with established agency safety standards are also answered.

Safety Standards in Pharmaceutical Compounding, Part 1: The Occupational Safety and Health Administration.

Ensuring a safe working environment for employees is of paramount importance to all responsible compounding pharmacists, and adhering to safety standards established by the U.S. Occupational Safety and Health Administration renders achieving that goal more likely. However, information about such compliance (especially with respect to pharmaceutical compounding) may not be readily available. In this first article in a 3-part series, an overview of Occupational Safety and Health Administration standards that address employee safety in the workplace is provided and pertinent questions of interest to compounders are answered. In series parts 2 and 3, ensuring compliance with those standards is discussed in more detail and issues pertaining specifically to fire prevention in compounding facilities are addressed.

Quality Control: Hand and Glove Sanitizing in Sterile Compounding, Part 2.

Selecting an appropriate sanitizer (i.e., "rub") for application to hands and gloves before and, if necessary, during sterile compounding is as important as is its consistent and judicious use. Alcohols and chlorhexidine gluconate, which have long been recognized as safe and powerful biocides, are often essential ingredients in such sanitizing products. In this second article in a 2-part series on alcohol-based hand and glove sanitizers, we review the selection of and need for those rubs in sterile compounding, present considerations for their safe storage, compare the features of several appropriate sanitizing agents, and answer compounders' frequently asked questions about their use. Glove sanitizing is discussed as part of the hand-sanitizing process. In part 1 of this series, we explained, among other topics, the mechanism of action and composition of alcohol-based sanitizers and presented a protocol for their application to hands and gloves.

Quality Control: Hand and Glove Sanitizing in Sterile Compounding, Part 1.

In pharmaceutical compounding, strict adherence to a protocol for hand hygiene and glove sanitizing is essential to ensure the purity, safety, and effectiveness of sterile preparations; reduce patient morbidity and mortality; and decrease the cost of health care. Alcohols and chlorhexidine gluconate are among the most effective bactericides, virucides, and fungicides, and acquired resistance to those agents has not been shown in clinical practice. This article, which is part 1 in a series of 2, pertains primarily to alcohol-based hand rubs that are appropriate for use in sterile compounding (glove sanitizing is discussed as part of the handsanitizing process). In a brief overview of those products, we define pertinent terminology, examine the necessity of and requirements for the use of sanitizers, review their mechanism of action and composition, consider factors pertinent to their selection, and present a protocol for their application. In part 2 of this series, the topics examined include a comparison of various alcohol-based sanitizers and answers to compounders' frequently asked questions about their use.

Microbiologic Testing for 503A Sterile-Compounding Pharmacies.

Compounding pharmacists must ensure that the sterile preparations they dispense are free of microbiologic contamination. Working in a cleanroom under controlled conditions (proper differential air pressure, temperature, and humidity; acceptable levels of viable and nonviable airborne particles and surface counts, etc.) and testing the efficacy of cleaning and disinfecting practices via environmental monitoring (viable-air and surface testing, glove-fingertip-thumb testing, etc.) are essential to preparing contamination-free medications. Sterile-compounding pharmacists must understand how to monitor their cleanroom environment and, if they perform testing in house, to interpret the results of simple microbiologic tests (a skill helpful even when tests are outsourced to a contract laboratory). In this article, which pertains to 503A sterile compounding, and is based on the current version of United States Pharmacopeia (USP) Chapter <797>, basic concepts in microbiology and the microbial tests that can be performed and interpreted in house and those that must be outsourced are discussed. Streamlining communication with contract laboratory personnel is reviewed. Requirements for an inhouse microbiology laboratory are presented, and the advantages and disadvantages of inhouse and outsourced testing are examined. A list of suggested reading is provided for easy reference. In a subsequent article, environmental monitoring and analysis will be addressed in detail.

Performance Improvement in 503A Compounding Pharmacies: A PLAN FOR ASSESSMENT, IMPLEMENTATION, AND SUSTAINED SUCCESS.

Performance improvement is the continual effort to objectively assess current performance and then restructure the practices that support it to more closely achieve desired performance. A plan for performance improvement, unlike other approaches to correcting problems in job fulfillment, is a systematic method used to first find the root causes of areas of concern and then apply corrections to remedy those deficits. Implementing a performance improvement plan that can be easily adapted to ensure compliance with evolving and increasingly complex state and federal regulations is crucial to a successful compounding practice. In this article, we discuss the need for performance improvement in 503A compounding pharmacies, list the steps necessary to develop such a plan, and present three case reports of performance improvement plans in differing compounding settings.

Compounded pimobendan for canine chronic degenerative mitral valve disease and pulmonary hypertension.

Pimobendan (Vetmedin) is an effective treatment for canine chronic degenerative mitral valve disease and dilated cardiomyopathy. In an off-label use, it may also be of benefit for the treatment of pulmonary hypertension in dogs. In this report, we describe the effects of a palatable customized oral form of pimobendan used with both compounded and commercially manufactured conventional drug therapy to treat degenerative mitral valve disease and pulmonary hypertension in two small dogs. For those patients, who resisted many types of oral medication, the standard manufactured dose of pimobendan was inappropriate. Formulations of the preparations used to treat the patients described in this report are provided for easy reference. It should be noted that at the time of this writing, Boehringer Ingelheim GmbH (Ingelheim am Rhein, Germany), the manufacturer of pimobendan, has expressed concern about the stability of that agent in aqueous compounded form. To our knowledge, no current data confirming the stability or bioequivalence of compounded pimobendan exist.

Prophylaxis against exposure to bloodborne pathogens during compounding.

Unintentional exposure to biologic pathogens can occur when preparations that contain blood or its components are compounded. For example, autologous eye drops, which are not commercially manufactured, incorporate serum that must be handled by various staff members in a compounding pharmacy. In this report, we describe workplace practices and materials used to inform our staff members who handle or compound that preparation and other similar formulations about the safe and appropriate handling of blood or body fluids that could contain biologic pathogens. Compounding pharmacists who must develop and implement a standard operating procedure for managing exposures to bloodborne pathogens will find the prototype plan presented in this article of interest.

Autologous eye drops for the treatment of dry eye and neurotrophic keratitis.

Tears-which contain fibronectin, growth facors, and vitamins that support the migration, proliferation, and differentiation of the conjunctival and corneal epithelium-nourish, protect, and refresh the eye. An inadequate tear film produces a variety of symptoms (ocular irritation, itching, burning, eye strain or fatigue, photophobia, a foreign-body sensation, a sharp stabbing pain, blurred vision) that wax and wane in intensity and are characteristic of disorders such as dry eye (keratoconjunctivitis sicca) and neurotrophic keratitis. In patients for whom commercially manufactured eye drops fail to provide relief from the symptoms of those conditions, autologous serum eye drops (plasma eye drops, serum eye drops) have proven very effective. In this report, we examine the present case studies that reveal the efects of autologous serum eye drops on the signs and symptoms of both dry eye and neurotrophic keratitis. A procedure for preparing autologous eye drops is included.

Compounding for pediatric patients: case reports and formulations.

When no commercially available agent is appropriate for a pediatric patient, a compounded formulation often assures successful treatment. In the following case reports of five children, a pharmaceutical compound is an essential component of long-term therapy for a disorder best managed with customized medications and supplements.

Compounding for cancer in companion animals: therapeutic options and case reports.

Americans spend more than $20 billion per year on health care for their pets which are considered by many owners to be members of the family. In the past, the diagnosis of cancer in a companion animal could be considered a death sentence, but today, drugs designed for use in human patients offer a good quality of life and extended survival for many veterinary cancer patients. Often, the key to the success of that treatment is compounding, in which doses of manufactured drugs that would prove toxic to a cat or dog are reformulated into appropriate strenths or concentrations that provide beneficial therapy. In this article, two case reports describe the use of anticancer agents in dogs, and formulations for the compounding of several antineoplastic agents for veterinary patients are presented.

Tips for cleanroom construction and renovation.

The installation or renovation of a cleanroom is an increasing priority among compounders who, to offer sterile preparations, must comply with the most recent version of United States Pharmacopeia revised General Chapter 797 guidelines. To upgrade their pharmacy facilites, many compounders have worked successfully with a large-scale mechanical engineering firm or a specialized construction company dedicated to cleanroom installation. However, a qualified local mechanical contractor with design capability is a valuable and often overlooked resource for the construction of customized stae-of-the-art cleanrooms. In this report, we describe the installation of such a facility in a busy pharmacy and suggest ways in which compounding pharmacists can identify competent local contractors and control the cost of construction and upgrades. The addition of a cleanroom has enabled The Compounding Pharmacy in Hickory, North Carolina, to achieve accreditation from the Pharmacy Compounding Accreditation Board.

Transdermal Amlodipine Besylate in Lipoderm for the treatment of Feline Hypertension: A Report of Two Cases.

Primary hypertension may be more common in cats than prior research has indicated. Untreated feline hypertension damages organs nourished by a rich vascular supply, and kidney disease, ocular impairment and cardiac irregularites can be caused by this silent and progressive disorder. The effects of hypertension can be minimized with treatment, however, and the long-acting dihydropyridine calcium anatgonist amlodipine has been proven safe and effective in the management of high blood pressure in cats. Because anxiety can increase blood pressure even in normotensive cats, hypertensive feline patients must be protected as much as possible from the stress caused by forced medication. A compounded preparation of amlodipine in a transdermal gel can be easily applied to the feline pinna without subjecting the patient to the trauma of oral treatment. In this report, the potency and effectiveness of amlodipine besylate in Lipoderm transdermal gel for the treatment of feline hypertension are examined, and two case reports describing the outcome of treatment with that preparation in hypertensive cats are presented.