Pharmacopoeia
A pharmacopoeia is a comprehensive resource that provides detailed descriptions and standards for various pharmaceuticals, aimed at ensuring the quality and safety of medications. Typically published by professional organizations or governmental bodies, pharmacopoeias have historical roots dating back to ancient civilizations, including works from Greek scholar Pedanius Dioscorides and Egyptian texts like the Edwin Smith Papyrus. These resources serve crucial functions in public health by establishing regulatory standards that drug manufacturers must adhere to, thereby preventing the use of inferior or harmful ingredients in medications.
In the United States, the United States Pharmacopoeia (USP) plays a significant role in drug regulation, working alongside the National Formulary (NF) to set standards that the Food and Drug Administration (FDA) utilizes to identify and eliminate adulterated drugs from the market. The rapid pace of pharmaceutical development presents ongoing challenges for pharmacopoeia organizations, which must continually update their standards to keep pace with new discoveries and formulations. Additionally, discussions around the legal standing of pharmacopoeial standards, such as those from the British Pharmacopoeia, highlight the complexities and varying practices in pharmaceutical regulation across different countries. This ongoing dynamic underscores the importance of pharmacopoeias in facilitating safe trade and ensuring consumer protection in the global pharmaceutical market.
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Pharmacopoeia
A pharmacopoeia is an information resource that gathers together descriptions of how many different pharmaceuticals can be identified. The entity publishing this information is usually either a professional organization devoted to medical care, or a state or national government seeking to compile drug data for the safety of those living in the region. The word itself is Greek in origin, and can be translated roughly as "the making of drugs." There are examples of pharmacopoeia dating as far back as the time of the ancient Egyptians, Greeks, and Romans. One of these was written by the Greek scholar Pedanius Dioscorides, and is called De Materia Medica. De Materia Medica has proven to be an incredibly long-lived work, and was regularly in use as a reference as recently as the seventeenth century. Other well-known works include the Edwin Smith Papyrus from Egypt and a pharmacopoeia written by Pliny of Rome. In the United States, the Food and Drug Administration (FDA) uses the standards of the United States Pharmacopoeia (USP).
Brief History
Pharmacopoeia are intended to serve several different functions in support of public health. The primary purpose served is to establish standards for the composition and quality of medicines within the regional scope covered by the pharmacopoeia, which could be an entire country or even a multinational region such as Europe. Because the pharmacopoeia description of a medicine conclusively defines what compounds are to be included within a drug, drug manufacturers have a standard that they are held to. Without this, an unscrupulous pharmaceutical manufacturer could substitute cheaper, less effective, or completely nonstandard ingredients into its formulation for a drug, which could result in consumers purchasing the drug under the assumption that it is has been manufactured according to traditional practices and standards.
A second purpose furthered by the use of pharmacopoeia is the support of trade in pharmaceutical products. This type of trade is particularly important in the modern, globalized economy, where ingredients for a medication might come from three different countries, be combined in a fourth country, and then transported to a fifth country for sale and consumption. Each of these countries represents a separate set of regulations and standards for the production of medicines, so there is a great need for a uniform set of standardized definitions to make it possible for agents in the pharmaceuticals market to conduct business with one another.
Overview
In the United States, the United States Pharmacopoeia (USP) is a nonprofit organization that was founded in 1820 in order to promulgate drug standards. The USP does this in conjunction with the National Formulary (NF). The USP has trademarked its USP-NF label, to ensure that only drugs and drug components that follow the requirements of the USP are permitted to be sold under the USP-NF label. This gives consumers an independent "stamp of approval" that they can trust instead of having to rely on drug manufacturers’ representations. There is also a legal component to the USP, because the Food and Drug Administration (FDA) uses the standards of the USP to identify drugs that it describes as adulterated. Adulterated medicines may not be sold under FDA regulations, so by enforcing the USP requirements the FDA is able to protect consumers by banning nonstandard drugs.
One of the greatest challenges faced by the organizations charged with developing and maintaining pharmacopoeia is the rapid rate of drug development and research, and its distributed nature. Companies and university research facilities all around the world are constantly working to develop new medications to treat a vast array of medical conditions. As these drugs navigate through the approval processes within their particular jurisdiction, pharmacopoeia must struggle to keep up with the frenetic pace being set by profit-driven companies with substantial private funding.
This situation is further complicated in some countries, where the regulatory power of the pharmacopoeia is less clearly established than it is in the United States. In the United Kingdom, for example, there has been a substantial amount of discussion about whether the contents of the British Pharmacopoeia are legal requirements that pharmaceutical manufacturing companies must follow or are more akin to "helpful suggestions" intended primarily to provide useful information to drug makers to use if they wish. Surprisingly, the latter argument has been found to hold some merit, as the British Pharmacopoeia contains entries for substances beyond commercially manufactured drugs, such as gum arabic, beeswax, and linseed oil. This lends support to the argument that the British Pharmacopoeia is intended to serve as a reference work rather than as an encyclopedia of legal requirements. This has prompted many to call for the revision and updating of not only the British Pharmacopoeia but also the legal basis, if any, that it has in the sphere of medical regulation. Not surprisingly, these calls are often resisted by pharmaceutical manufacturers, who prefer to have greater amounts of latitude in how they conduct business and how they manufacture their products.
Bibliography
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