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Susan C Winckler
RPh, Esq
Vice President
Policy and Communications
Staff Counsel
American Pharmacists Association
Washington, DC
USA
E:[email protected]
With the continued dominance of manufactured medications in pharmacy practice, the value of pharmacy compounding is often overlooked. But compounding is essential to today’s contemporary hospital pharmacy practice, providing tailored medications for individual patients. As changes in healthcare take place, compounding should also continue to occupy an important part of pharmacy practice and remain vital to the profession’s efforts to improve medication use and advance patient care.
Extemporaneous compounding of medications has been a significant component of the practice of pharmacy and medicine since these practices began. As AC Wooten said in Chronicles of Pharmacy, “Pharmacy, or the art of selecting, extracting, preparing and compounding medicines from vegetable, animal, and mineral substances, is an acquirement that must have been almost as ancient as man himself on earth.”(1) A staple of early medical and pharmacy practice, nearly every patient today still benefits from compounding at some point in their healthcare experience. However, because compounded medications are a small proportion of all medication used, these vital products (and the skills necessary to prepare them) are often overlooked. This article provides a brief history of compounding practice, as well as an overview of the prevalence of the practice in our profession’s societal contributions.
Compounded pharmaceuticals
Compounding emanates from the physician/pharmacist/ patient relationship, with these different people working together to individualise care for maximum patient benefit. Compounding is most frequently performed by a licensed pharmacist, although physicians or other qualified healthcare professionals may also engage in the practice. These healthcare providers formulate individualised treatment in response to a prescription or the expected needs of individual patients. Compounding is performed on the site of the pharmacy for nearly immediate dispensing and use by, or administration to, the patient. Compounding does not encompass the preparation of massive amounts of a drug product with the contemplation of distribution to a mass market of unknown users in unknown venues.
Compounding has always been a basic part of pharmacy practices; the drugs, dosage forms, equipment and techniques have changed as pharmacy practice has advanced. The early practice of pharmacy required the compounding of virtually all medications, because there were few, if any, commercially available products. As pharmaceutical companies were founded, there was less need for compounding the most widely used products, although the need to compound still exists.
Physicians and pharmacists recognise that some individuals and their healthcare needs do not always fall in the windows of commercially available dosage strength and formulations, and that large-scale manufacturers cannot tailor-make a medication in a cost-effective manner. Many patients need custom-made medication dosages to solve specific medical problems. Paediatric or geriatric patients may need extremely small doses, cancer patients may need specific combinations of chemotherapy drugs to treat their disease, or special dosage forms may be necessary to care for patients with AIDS, chronic pain or other maladies. Pharmaceutical manufacturers recognise the need for compounding, because they include instructions for compounding specialised dosage forms, such as oral suspensions, in some of their package inserts, which are the instructions for use that accompany any drug product and must be approved before distribution by the FDA. Some therapies, such as parenteral nutrition, are provided predominantly in compounded dosage forms.
Compounding may involve different activities in different practice settings. It may mean the preparation of oral liquids, topicals or suppositories; the conversion of one dosage form into another; the preparation of selected dosage forms from bulk chemicals; the preparation of intravenous admixtures or parenteral nutrition solutions; the preparation of radioactive isotopes; or the preparation of cassettes, syringes and other devices for drug administration in the home setting. Some of the most commonly compounded products include lotions, ointments, creams, gels, suppositories, intravenously administered fluids and medications, total parenteral nutrition products, oral suspensions and troches.
Some therapies, such as hyaluronidase injection (used to increase dispersion and absorption of other drugs injected under the skin), must be compounded because they generate insufficient revenue to pharmaceutical companies to justify large-scale manufacturing. Additionally, some medications may not have sufficient stability to withstand the commercial distribution process and, therefore, need to be prepared at the time of dispensing (such as radioactive drugs used to diagnose or treat disease). Many manufactured “finished pharmaceutical” products are only “finished” in the sense of being ready to ship and then store in the pharmacy. The products must still be compounded to provide a dosage form suitable for a patient’s treatment. In providing compounding services, pharmacists work hand-in-hand with physicians to solve problems not addressed by commercially available drugs and develop a special and unique relationship with the patients they serve.
One of the most important clinical needs for compounding occurs in the care of patients with cancer. Almost all chemotherapy involves drugs and drug combinations that are compounded by pharmacists. It is imperative that patients receive the correct drug dosage based upon their body size, the type of cancer, the size and type of tumour and their clinical condition. This can only be accomplished using compounded patient-specific medication preparations.
The compounding of paediatric dosage forms is also an area of extensive activity, particularly in paediatric hospitals, because many drugs used in paediatric treatment are not available in dosage forms appropriate for paediatric patients. Consequently, commercial products manufactured for use in adults must be modified and compounded for use in children. It has been estimated that more than 40% of doses given in paediatric hospitals require compounding to prepare a suitable dosage form. Indeed, utilisation of compounded medications is essential for the provision of medical care to hospitalised children.
Hospice care, or care of the terminally ill, is another practice involving extensive compounding. Hospice pharmacists devise drug therapy protocols that establish optimal pain and symptom control, often using compounded dosage forms. Their goal is to enhance patient compliance through education and monitor outcomes in a supportive and humanistic fashion.(2) Medications to alleviate pain and control nausea and vomiting are common prescriptions for patients in the hospice setting. If commercial products that provide the precise dose(s) are not available, they can often be supplied by extemporaneous compounding. Patient-specific formulations and dosage forms are constantly being developed by compounding pharmacists to meet the needs of these patients, for example when pain medications are not manufactured in the required dosages. Additionally, patients often are not physically capable of swallowing the number of commercially manufactured tablets required. A pharmacist can compound a stronger product by transforming a tableted dosage form into a liquid that is easily swallowed.
Conclusion
As noted by these examples, compounding continues to fill a valuable niche in patient care: filling the void when manufactured products are not appropriate for an individual patient. As healthcare evolves, our profession must continue to provide quality compounding services and work with patients to make the best use of those medications.
References
- Wooten AC. Chronicles of pharmacy. Quoted in Jordan DG. Pharmacist compounding v. veterinarian compounding: similarities and differences. JAVMA 1994;205:256.
- Hospice Care and the Pharmacist. Special Issue. Int J Pharm Compounding 1997:11.
