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Compounding pharmacy is the process of mixing drugs by a pharmacist or physician to fit the unique needs of a patient. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose needed. It may also be done for voluntary reasons, such as adding favorite flavors to a medication.

Contents 1 History 2 Uses 2.1 During research and development 2.2 In the community pharmacy 3 Regulation 4 Controversies 5 See also 6 References 7 External links

History

Before mass production of medications became normal, compounding was a routine activity among pharmacists. Community pharmacists who have experience with compounding techniques are now less common.

The art of pharmaceutical compounding has ancient roots. Hunter-gatherer societies had some knowledge of the medicinal properties of the animals, plants, molds, fungus and bacteria as well as inorganic minerals within their environment. Ancient civilizations utilized pharmaceutical compounding for religion, grooming, keeping the healthy well, treating the ill and preparing the dead. These ancient compounders produced the first oils from plants and animals. They discovered poisons and the antidotes. They made ointments for wounded patients as well as perfumes for customers.

The earliest druggists were familiar with various natural substances and their uses. These drug artisans compounded a variety of preparations such as medications, dyes, incense, perfumes, ceremonial compounds, preservatives and cosmetics. Drug compounders seeking gold and the fountain of youth drove the Alchemy movement. Alchemy eventually contributed to the creation of modern pharmacy and the principles of pharmacy compounding. In the medieval Islamic world in particular, Muslim pharmacists and chemists developed advanced methods of compounding drugs. The first drugstores were opened by Muslim pharmacists in Baghdad in 754,^[1] while the first apothecary shops were also founded by Muslim practitioners.^[2]

The modern age of pharmacy compounding began in the 19th century with the isolation of various compounds from coal tar for the purpose of producing synthetic dyes. From this one natural product came the earliest antibacterial sulfa drugs, phenolic compounds made famous by Joseph Lister, and plastics.

During the 1800s, pharmacists specialized in the raising, preparation and compounding of crude drugs. Crude drugs, like opium, are from natural sources and usually contain multiple chemical compounds. The compounding pharmacist often extracted these crude drugs using water or alcohol to form extracts, concoctions and decoctions.

Pharmacists began isolating and identifying the active ingredients contained within these crude drug concoctions. Using fractionation or recrystallization, the compounding pharmacist would separate the active ingredients, like morphine, and use it in place of the crude drug. During this time modern medicine began.

With the isolation of medications from the “raw materials” or crude drugs came the birth of the modern pharmaceutical company. Pharmacists were trained to compound the preparations made by the drug companies, but they weren’t able to do it efficiently on a small scale. So economies of scale, not lack of skill or knowledge, produced a market for the modern pharmaceutical drug companies (Pharma).

With the turn of the 20th century came greater government regulation of the practice of medicine. These new regulations forced the drug companies to prove that any new medication they brought to market was safe.

Pharmacy compounding was still common in the 1930s, with over 80% of the prescriptions dispensed being compounded by the dispensing pharmacist.^{citation needed} With the discovery of penicillin, modern marketing techniques and brand promotion, the drug manufacturing industry came of age. Pharmacists continued to compound most prescriptions until the early 1950s when the majority of dispensed drugs came directly from the large pharmaceutical companies.

From the 1950s to the 1980s, pharmaceutical compounding became less common because it was less necessary. Mass-produced and often pre-packaged drugs could be more cheaply and reliably ordered directly from the manufacturer, saving the pharmacist's time. However, some pharmacies still offer this service for at least some drugs. In 2006, over 30 million compounded prescriptions were dispensed, not counting all the admixtures and injectable drugs compounded in America’s hospitals.^{citation needed}

Uses

During research and development

Pharmaceutical compounding is a branch of pharmacy that continues to play the crucial role of drug development. Compounding pharmacists and medicinal chemists develop and test pharmaceutical formulations for new drugs so that the active ingredients are effective, stable, easy to use, and acceptable to patients.

In the community pharmacy

Physicians may prescribe an individually compounded medication for a patient with an unusual health need. This allows the physician to tailor a prescription to each individual. Compounding preparations are especially prevalent for:

• Patients requiring limited dosage strengths, such as a very small dose for infants
• Patients requiring a different dosage form, such as turning a pill into a liquid or transdermal gel for people who can't swallow pills due to disability
• Patients requiring an allergen-free medication, such as one without gluten or colored dyes
• Patients who need drugs that have been discontinued by pharmaceutical manufacturers because of low profitability
• Patients who are taking bioidentical hormone replacement therapy, specifically the Wiley Protocol
• Children who want flavored additives in liquid drugs, usually so that the medication tastes like candy or fruit
• Veterinary medicine, usually for a change in dose

Regulation

Compounding pharmacies are licensed and regulated like all other pharmacies.

In the United States, The Pharmacy Compounding Accreditation Board was created in 2006 as a voluntary accreditation body by pharmacy organizations to establish high quality standards for compounding pharmacies. The FDA does not register or inspect compounding pharmacists because they are not considered drug manufacturers.

Controversies

There is currently a controversy over who should regulate compounding pharmacies. The FDA is concerned that many large compounding pharmacies are actually acting as large-scale manufacturers of new drugs, and therefore should be subject to normal pharmaceutical regulation. The FDA has repeatedly asserted that all compounded drugs are new drugs and are thus illegal, but it will exercise its “enforcement discretion.”^{citation needed} The International Academy of Compounding Pharmacists states that "Congress, the U.S. Supreme Court, and each of the 50 state boards of pharmacy that regulate compounding have long recognized the value of pharmacy compounding, yet the FDA has contended for nearly 20 years that compounded medications are illegal. Compounded medications are not new, unapproved drugs and pharmacies dispensing them act only under a doctor’s prescription. To the extent that there are patient safety issues, state boards of pharmacy are well-equipped to deal with them.”^{citation needed} Recent court rulings, such as Medical Center Pharmacy v. Gonzales (2006) support the position taken by IACP.^{citation needed}

Compounding pharmacy has been caught up in the recent controversy over hormone replacement therapy.^[3] Synthetic hormones, manufactured by large drug companies such as Wyeth Pharmaceuticals, were found to lead to increased rates of heart disease, breast cancer and stroke in the Women’s Health Initiative study, halted in 2002. As an alternative to synthetics, many physicians prescribe bioidentical hormones for patients suffering from menopausal symptoms. These hormones are mixed in a compounding pharmacy. There is no evidence that bioidentical hormones are safer than synthetic hormones for this purpose, and groups such as the North American Menopause Society have raised concerns about the marketing of these drugs.

See also

• Gluten-free diet
• Plastic compounding

References

External links

• International Journal of Pharmaceutical Compounding

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• This page was last modified on 7 August 2008, at 14:47.

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