Compounding in Dermatology

Introduction

Since at least 2000 BC and throughout history, compounding has been an integral part of pharmacy and medical practice. Throughout the nineteenth century, until the start of the industrial revolution in the United States, all drugs were compounded. In the 1930s 75% of all written prescriptions were compounded medications. By the early 1970s, less than 1% of prescriptions were compounded.

The trend for compounding prescriptions started to change in the 1980s and 1990s. By 1995, approximately 11% of all prescriptions were compounded. According to the US Food and Drug Administration (FDA) from early 2000, 250 million prescriptions per year are written for compounded medications, accounting for 1% to 8% of all prescriptions. Q69.1 Health practitioners and patients have realized that the “one-size-fits-all” approach to treatment offered by the commercially available drug products is becoming less practical because of increases in patient’s allergies to some of the ingredients in these products and the growing number of patients that require special dosage forms or medications that are not commercially available. Drug shortages by the manufacturers also contribute to the need for compounding, so that patients can continue their conventional treatments without interruption or delays.

Topical preparations, particularly in the area of dermatology, represent a large percentage of compounded medications. There are many reasons why physicians may choose to prescribe a compounded medication over a commercially available drug product. For example, a patient may need a medication in a different strength or dosage form that is not commercially available. Some patients are allergic to preservatives and need a preservative-free dosage form. Some drugs may not be chemically or physically stable and must be prepared just before dispensing or use. Compounding allows the practitioners, with the expertise of the pharmacists, the ability to be flexible and tailor drug therapy to meet the specific needs of the patient. Vehicles for dermatologic preparations can be chosen to increase the absorption of the drug(s). Combination preparations can be compounded to improve patient compliance too.

There has been controversy surrounding the use of some compounded drug preparations. A few advocacy groups and governmental agencies have tried to ban, or severely restrict, compounding activities in pharmacies because of a few unfortunate adverse events (AE). In September 2012, a compounding facility, which went beyond the scope of traditional pharmacy practice, prepared thousands of fungal-tainted corticosteroid injections that sickened over 800 patients and 76 patients died. Q69.2 Opponents of compounding claim that the pharmacy specialty is unregulated and the compounded preparations are not properly tested. However, the standards for the practice of compounding are set by the United States Pharmacopeia (USP), which is legally recognized by federal law and enforced by many state boards of pharmacy. In fact, the USP continuously revises all of the chapters regarding pharmacy practice, drug manufacturing, and compounding. Since the New England Compounding Center (NECC) tragedy, stricter standards have been written to minimize major risks in compounding, particularly with sterile preparations, improve the quality of compounded medications, and to protect the compounders themselves from exposure to harmful substances. On November 27, 2013, President Barack Obama signed into federal law the Drug Quality and Security Act (DQSA). This law created a distinction between a 503B outsourcing facility, which can produce compounded medications in large quantities that can be distributed to healthcare facilities or practitioners without a patient-specific prescription or order, if they are registered with the FDA and follow strict current Good Manufacturing Practice (cGMP) guidelines. The DQSA also defines what a traditional 503A pharmacy may compound pursuant to a practitioner’s order or prescription. Further legislation is being considered to further clarify the DQSA and the state boards of pharmacy, who regulate traditional pharmacies, are currently rewriting their regulations with regards to compounding medications. The stricter regulations could potentially limit practitioners’ and patients’ access to compounded medications. However, although the practice of pharmacy is regulated by the state boards of pharmacy, access and restrictions will vary from state to state.

The USP also sets the standards for drug manufacturers and is committed to ensuring that both commercial products and compounded preparations meet high quality standards for the patients’ safety. Following, are four major principles summarizing the approach to treat patients using compounded drug preparations. These principles encompass the compounding triad and include the ability to develop, prescribe, and monitor treatment outcomes. Overall, 15 principles are defined and illustrated in the entire chapter. The goals of these principles are to:

• 1.

  Establish and maintain the professional relationship between the patient, physician, and pharmacist, which is called the compounding triad ;

• 2.

  Develop a stable compound formula based on clinical evidence to meet the individual needs of the patient;

• 3.

  Properly write the prescription so that the compound is prepared according to the physician’s specifications; and

• 4.

  Monitor the patient for positive and adverse outcomes so that future changes can be made in the compounded preparation to maximize therapy.

In the following sections, each of the 15 principles is illustrated by examples and tables. There is also a general discussion at the end of the chapter on compounded drug therapies for a variety of dermatologic conditions.

The Compounding Triad

According to the National Association of Boards of Pharmacy, compounding is defined as ‘the preparation of Components into a Drug product as the result of a Practitioner’s Prescription Drug Order based on the Practitioner/Patient/Pharmacist relationship in the course of professional practice.’ The DQSA confirms that compounding medications is allowed as long as a practitioner prescribes the compounded medication for a specific patient and it is prepared by a pharmacist or practitioner for that patient’s home use. Q69.3 This professional relationship between: (1) the patient, (2) the pharmacist, and (3) the physician is also known as the ‘compounding triad,’ and each person must interact adequately with the other two individuals in this triad ( Fig. 69.1 ). The triad must remain intact to provide safe and effective compounded medications. It is also the legal basis that distinguishes compounding from manufacturing and is thus an essential component to prescribing and preparing compounded medications. A break in the compounding triad relationship can result in poorly prepared compounded medications and may compromise treatment outcomes and patient safety.