The Ideal Pharmacopeia

Nov 02, 2008

There are currently more than 30 pharmacopeias operating in the world, according to the World Health Organization (WHO) (1). Some of these organizations have been in existence for quite a long time—in some cases more than 100 years—while others were recently created. Pharmacopeias, in general, are national, meaning that they provide standards for a particular country (e.g., United States Pharmacopeia [USP], Japanese Pharmacopoeia [JP]) and others serve as regional bodies (e.g., European Pharmacopoeia [Ph. Eur.]) or even global bodies (e.g., the WHO's International Pharmacopoeia [Ph. Int.]). Their standards are published in a wide variety of languages to meet the needs of those using them. In terms of updates, several pharmacopeias have active processes for revision, with new editions and supplements published on a regular basis, but not all pharmacopeias have the resources to publish revisions as frequently.

Clearly there are differences between pharmacopeias, but there are also important similarities such as their purpose and content of their publications. Given today's global pharmaceutical environment, it is instructive to consider the current pharmacopeial situation with a goal of defining the "ideal" state. This concept was jointly discussed in May 2006 between industry representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). This article presents the conclusions from that discussion, with further development by PhRMA's Compendial Liaison Team.It is hoped that the industry vision provided herein will stimulate further discussion to ensure a continued beneficial role for pharmacopeias in our global healthcare system.

A pharmacopeia's purpose

A pharmacopeia includes published, public quality standards for pharmaceutical ingredients and dosage forms. A standard may include acceptance criteria as well as test methods for determining the conformance of an ingredient or dosage form to the standard. The existence of a pharmacopeia is often a legal mandate, referenced in national law and enforced by governmental bodies. The fundamental purpose of the pharmacopeia is to promote public health, as stated in the mission and preface to USP 31, the preface to JP 15, and in the following text from the introduction of Ph. Eur. 6.0 (2–4):

"The purpose of the European Pharmacopoeia is to promote public health by the provision of recognized common standards for use by healthcare professionals and others concerned with the quality of medicines. Such standards are to be appropriate as a basis for the safe use of medicines by patients and consumers."

The Ph. Eur. introduction continues by noting that Ph. Eur. is widely used internationally, and that its standards are developed by working with all users of the pharmacopeia to satisfy their needs and facilitate cooperation.

Pharmacopeias, along with regulatory agencies and pharmaceutical manufacturers, play a role in supporting the availability of safe, effective, and quality medicines worldwide. The ultimate beneficiaries of pharmacopeial standards are healthcare professionals and patients. However, it should be recognized that physicians, pharmacists, and patients do not directly use the pharmacopeias. With the exception of a few general chapters aimed specifically at pharmacists (e.g., USP General Chapters <795> and <797>, which address pharmaceutical compounding), the benefit to these parties is indirect through the published pharmacopeial standards that are implemented by the pharmaceutical industry and enforced by regulatory authorities. The direct impact of the large majority of pharmacopeial standards is on industry and regulators; this direct impact is key to the discussion of an ideal pharmacopeia.

Historical perspective

To establish characteristics associated with the ideal pharmacopeia, it is helpful to have some historical perspective of the initial creation and purpose of the pharmacopeias. The early history of USP serves as an illustrative example. In 1820, a small group of physicians met in the US Capitol building to "create a compendium of the best therapeutic products, give them useful names, and provide recipes for their preparation" (2). The resulting Pharmacopeia of the United States was intended to meet a critical need that existed at that time, when there was little consistency in the ingredients, preparation, and quality for drugs that were typically compounded by physicians and apothecaries. The early pharmacopeia provided standards to ensure uniformity for medicines to benefit patients and practitioners, whether they lived in New York, Boston, or any other city in the nation.

Today's situation is quite different. In our modern, global healthcare environment, medicines are typically manufactured by pharmaceutical companies in highly controlled facilities operating under current good manufacturing practices (CGMPs). New drug applications are reviewed by regulatory agencies throughout the world to ensure the products are safe, effective, and of appropriate quality. Regulators inspect manufacturing facilities to ensure compliance with agreed-upon quality standards. While uniformity for medicines remains an important goal, the scope has changed dramatically. It is now essential to have safe, effective, and high-quality medicines available for patients and practitioners in New York, Paris, Tokyo, or any other city in the world.