Pharmaceutical compounding has been an important part of medical care since the earliest recorded history. It is impossible to determine when humans first began to mix and concoct preparations for therapeutic effect. However, it is known that a range of ancient civilizations compounded medical preparations from animal, vegetable and mineral sources. For example, societies of ancient Egypt, Greece, Rome and Arabian cultures all developed sophisticated levels of medical knowledge, integrating various aspects of medicinal compounding.
Over time, the practise of compounding continued despite the disintegration of the ancient civilizations and emergence of the dark ages. Great practitioners of the ancient world left written works containing information on drugs, medicines and compounding which formed the basis of therapeutics well into the 17th Century.
During the 18th Century in Britain, recognition of a need for structured, professional training and regulation saw the development of existing professional associations into the more structured Pharmaceutical Society of Great Britain along with a framework of Legislation under which pharmacy and pharmaceutical compounding could be practised. This included the standard of proficiency, educational standards, and the registration of pharmacists. These standards have continued to develop and expand to the present time.
During the 1940’s and 1950’s, the world saw the advent of large scale manufacturing or mass production of medicines. This never seen before large scale access to a broad range of medicines pushed compounding to the background. However, over the last 25 years a number of factors have renewed the interest in, and demand for, compounding.
- Patients and their medical practitioners are insisting on a more personalised or individualised approach to healthcare. The mass production model does not offer the flexibility to meet all patient needs in a growing number of cases.
- Patients and their medical practitioners are also becoming aware of medication use in other parts of the world that are not produced or available in Australia.
- The internet is driving access to information and uniting likeminded individuals hungry for knowledge, sharing their experiences and demanding more personalised care and attention.
- Medication shortages and discontinuation have been increasing in recent years, perhaps due to unavailability of imported raw materials, the small size of the Australian market, just-in-time manufacturing or miscalculation of actual drug usage rates.
- Medical practitioners may have patients who would benefit from new formulations or new drug applications. Preparation of such one-off medicine applications is not feasible for large scale manufactures.
- Rapid advances in technology have also provided compounders access to laboratory equipment once only available to large manufacturers. Compounders now also have easy access to sophisticated databases, information, technical support and professional training from organisations such as PCCA (Professional Compounding Chemists of Australia) and Medisca.
This increased interest in compounding has resulted in the Pharmacy Board of Australia recently rewriting and expanding their compounding guidelines to ensure product quality, safety and efficacy. In addition, many state regulators are in the process of reviewing their legislation that relates to compounding as well as their ongoing monitoring and inspection of compounding facilities and their staff.
Just as compounding receded to the background with the advent of pharmaceutical mass production last century, educational focus on the art and skills of compounded also diminished. Only recently have some Schools of Pharmacy started to consider enhancing their educational offer in this area.
Fortunately for Australia, professional organisations such as PCCA and the more recent entrant, Medisca, provide a range of training packages for pharmacists and technicians. These courses range from basic to advanced, from general compounding to complex specialty areas within compounding. Additionally, they provide exceptional technical support, advice and a broad range of high quality ingredients and equipment.
It is now up to the various Universities to update the curriculum of their pharmacy courses and incorporate additional medicinal and pharmaceutical chemistry, pharmaceutics, pharmacy calculations, and many other activities directly relevant to compounding.
Recognised continuing education courses with laboratory experience needs to be developed for pharmacists in practise who did not receive adequate compounding training or wish to enhance their skills. Many pharmacists wish to incorporate compounding into their practise but lack the basic or advanced skills to do so.
In the next Newsletter, I would like to discuss in more detail the Legislative framework under which we operate in terms of working with a compounder, as well as quality in compounding. It is important that you understand what steps are required to ensure consistent quality in compounding and how your compounding pharmacist is operating.