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International Academy of Compounding Pharmacists
Pharmaceutical compounding is a skill dependent on the expertise of those who perform it. Compounded preparations address the medical needs of those ill-served by mainstream mass-produced pharmaceuticals: children, the elderly, patients who require drugs discontinued from the market, hospice patients, hospitalised patients who must receive intravenous admixtures or total parenteral nutrition, and those for whom the standard dosages of commercial drugs are inappropriate or unacceptable. Without the skill of a competent compounding pharmacist, such patients have few options for successful treatment.
In the mid-1950s, the availability of massproduced drugs diminished the practice of pharmaceutical compounding.(1) During the last 20 years, however, compounding has experienced a resurgence, and physicians often request that medications be tailormade to answer the medical needs of individual patients.(2) Increasing numbers of clinicians are
realising that, because patients respond very differently to medications, the “cookbook” approach to prescribing is not always appropriate and that drugs prescribed according to a patient’s weight, age and medical characteristics are often more effective than standardised dosages.(3)
Safety of compounded preparations in the USA
During the past decade, intermittent media coverage has been devoted to injury or death caused by US compounding pharmacists who have failed to implement necessary safeguards that ensure product sterility. In the early 1990s, the US federal government and influential pharmaceutical associations such as the United States Pharmacopeia and what is now the American Society of Health-System Pharmacists (ASHP) called for stronger regulations for compounded sterile preparations.(4) A 1995 survey of the effects of compliance with those standards indicated an improvement in the quality of pharmacy-prepared sterile compounds.(4) In spite of this, occasional problems with compounded medications still surface. In June 2001, contaminated betamethasone from a compounding pharmacy in California was administered to 38 people, three of whom died.(5) Several other recent adverse drug events involving compounded products have been traced to pharmacies in Missouri, Georgia, Tennessee, Illinois and Virginia.(6,7)
As the need and demand for individualised medications in the USA increase, is the practice of compounding changing to improve preparation safety? According to Loyd Allen, editor-in-chief of the International Journal of Pharmaceutical Compounding, the answer is yes. Allen has monitored the resurgence in and subsequent evolution of US compounding for the past 15 years. “Compounded products generally have a good safety profile, especially in comparison with errors that occur in healthcare overall,” he said. “There have been some unfortunate events over the last several years, but those occurrences may be related to the rapid growth of compounding in the United States. Twenty-five years ago, minimal compounding was performed (except in hospitals), but because more commercially manufactured medications are being withdrawn from the market for economic reasons or are in short supply, compounding is becoming much more important. Today, between 1% and 11% of all prescriptions written in the United States are compounded. Of those, a very small number of compounded dosage units have caused problems. When compared with the massive drug recalls by the pharmaceutical industry, the rate of compounding errors is insignificant. Mistakes will occur; there’s no question about that. But we also read about medical errors, surgical errors, and nursing errors; they happen all the time.”
Linda McElhiney agrees. McElhiney is a compounding pharmacist at Clarian Health Partners, a merger of three hospitals in Indianapolis, Indiana. “The media focus is usually on unusual incidents,” she said. “Thousands of compounds are prepared in the United States each day, and very few adverse effects result. You never hear about the formulation that saved a patient’s life or improved quality of care.” Most of the compounded prescriptions for patients in the 1,000-bed Clarian system are for children, and compounding for those patients is not an option. “More than 80% of the FDA-approved drugs do not have paediatric indications,” McElhiney said, “and most are not available in dosage forms that children can take. Compounding for the Clarian hospitals, which has increased about 25% in the last five years, is an essential part of our pharmacy practice.” McElhiney emphasised that safety is a priority in the Clarian compounding pharmacy. All measures and final products are double-checked, and sterility testing has been performed since the passage of the Food and Drug Modernization Act (FDAMA) in 1997. End-product testing is also an established part of the compounding protocol.
Improvements made, challenges still to face
Ensuring the safety of compounded medicines depends on pharmacists’ awareness (and implementation) of good compounding practices like those followed in the Clarian system. Some experts on pharmaceutical compounding remain concerned about certain aspects of current practice. Eric Kastango is president of Clinical IQ, LLC, a US company that specialises in process redesign and consulting in sterile product preparation, medical device manufacturing and sterile product outsourcing. “Problems can occur in a number of areas,” he said. “Some compounding pharmacists still don’t have the equipment necessary to prepare sterile products properly, and compounding staff may not be properly trained. Policies and procedures appropriate for the level of compounding performed may not be in place, or staff may not follow those practices. Validated methods of compounding may not be used, and preparations may be dispensed before their sterility or stability has been evaluated. Aseptic technique may not be used for sterile product compounding, and there may be a lack of understanding about the segregation of preparations. The overall problem is ignorance. People don’t know what they don’t know, and learning in this field never stops.” Kastango agreed that education is the answer to many issues of compounding safety. “Pharmacists must maintain their knowledge base, especially with respect to sterile product preparation,” he said.
High-tech compounding improves quality
The greater availability of automated equipment, which is used extensively in hospital and community pharmacies, can improve the quality of compounded preparations. Many US compounding pharmacies are now equipped with unit-dose packagers, electric mixers, ointment mills and capsule-filling machines. The electronic mortar and pestle produces a preparation of better uniformity and quality. The interface of the electronic balance with computer software programs for compounding ensures the accuracy of formulations, and metering pumps facilitate the prepackaging of formulations such as respiratory inhalation solutions. As Linda McElhiney noted, however, the use of high-tech equipment requires checks and balances. “We have an automated dispensing system that reads barcodes,” she said, “but its accuracy depends on that of the operator who has previously barcoded the drugs. Human error is still possible, even when the most reliable automated equipment is used.”
Continuing education prevents errors
Education, then, is the key to preventing the dire consequences of problems caused by pharmacy prepared medications, and acting on that knowledge is essential. As the demand for compounded medications increases, pharmacists must re-educate themselves and must often upgrade their pharmacy equipment and facility to the level required for the type of compounding performed. Pharmacy organisations such as the ASHP, the National Association of Boards of Pharmacy, and the International Academy of Compounding Pharmacists, call for such reform. “Our goal is to decrease the number of compounding errors, and we’re doing that by placing a greater emphasis on the quality of the preparation, on the education and training of pharmacists and their compounding staff, on upgrading facilities and equipment, on adherence to proper standard operating procedures, and on the proper testing of compounded products,” Loyd Allen said.
The future of compounding
The need for pharmacy-prepared preparations is increasing as compounding techniques become more effective and specialised equipment is more available. If pharmacists respond to the demands of their profession, the future of compounding is bright and patients will benefit. More options for education and obtaining information on good compounding practices are becoming available, and, as biotechnology and nanotechnology evolve, compounding pharmacy will become an even more integral part of healthcare practice.