The efficacy of personalised medicine has been shown in numerous medical disciplines – especially in the oncology setting. According to the American Food and Drug Administration (FDA), the overarching aim of personalised medicine is ‘to elevate benefits and reduce risks to patients by targeting prevention and treatment more effectively’.1
Mathur and Sutton state that personalised medicine has the potential to reduce healthcare costs as well as drug-development costs and time.1
A key component to a personalised approach is compounded medicine. The concept of compounding dates back centuries and was used up to the late 1960s when the mass production of medicines became more common.2,3
What is compounding?
The FDA describes compounding as the ‘combining, mixing, or altering of ingredients to create a medication tailored to the needs of a patient’. The United States Pharmacopeia describes compounding as ‘the preparation, mixing, assembling, altering, packaging, and labelling of a drug … in accordance with a licensed practitioner’s prescription …’4,5
The South African Medicines and Related Substances Act, 1965 defines compounding as preparing, mixing, combining, packaging, and labelling a medicine by a pharmacist, pharmacist intern or pharmacist's assistant practising in accordance with the Pharmacy Act for an individual patient and prescribed by a licensed person (section 22C [1] [a]).6
Furthermore, the act states that a pharmacist or other person licensed to compound a medicine for sale shall only compound a quantity that is intended to be used by a patient for not more than 30 consecutive days from the date of compounding. The date of compounding and the statement ‘use within 30 days’ have to be clearly indicated on the label. Any compounded medicine may not be advertised or displayed for sale.6
The process of compounding
As alluded to above, before the mass production of medicines, they were mixed, formulated, or compounded by independent pharmacists based on the prescribing information provided by a healthcare professional for use by an individual patients.4
Today, compounding combines the ancient art of mixing/formulating or compounding ingredients to prepare customised medication, with the latest medical knowledge and state-of-the-art technology.1
Compounded medicines may be made using approved brand or generic agents as well active pharmaceutical ingredients (APIs) and other inactive components. Benefits of compounding from APIs include the avoidance of binders, and the possibility of accessing pharmaceutical substances that are not available in suitable commercial forms for the intended use of the compounded medicine.5
Furthermore, compounding allows for the creation of alternate dosage strengths or forms and omit components of approved drugs to which a patient may be allergic to (eg peanut oil or lactose) or to provide a liquid dosage formulation for a child who is unable to swallow tablets. In addition, additives such as dyes, sugar, or alcohol can be omitted. 2,4
Compounded medicine can be prepared either as:4
- Sterile preparations: formulations are prepared in a clean-room environment using antiseptic techniques to ensure they are free of micro-organisms. Sterile compounding is used primarily for injectable, implant, and ophthalmic preparations
- Nonsterile preparations: formulations are prepared in a clean environment but without aseptic techniques required. Nonsterile compounding is used primarily to prepare oral and topical (skin) formulations: capsules, solutions, suspensions, ointments, creams, and suppositories.
Who is likely to benefit from compounding medicine?
Compounded medicines offer alternatives for patients with unique medical needs that cannot be met by mass produced medicines (eg discontinuation of an approved medication).4
Compounded medicines are used to treat a wide spectrum of diseases and conditions across a range of therapeutic areas, including men's and women's health, pain management, sports medicine, dental care, paediatrics, hospice care, allergy, dermatology, immunology, otolaryngology, oncology, ophthalmology, neurology, and rheumatology.4
Patient populations that have traditionally benefited from customised compounded formulations include paediatric patients, people at the end of life who may have difficulty swallowing pills or capsules, or people with certain specific medical conditions for which a current approved medication does not exist.4
Sterile and non-sterile compounding for patients with rare diseases include: infusion bags for total parenteral nutrition (neonates with inborn errors of metabolism), medicines and placebos for phase 1 clinical trials with designated orphan drugs, radioactive and other drugs with stability limitations in pharmacokinetic/pharmacodynamic studies for rare disorders, repurposed medicaments awaiting orphan drug authorisation or withdrawals (drug shortages), masking of taste and smell in medicines for babies with metabolic disorders, and medicinal products for special populations such as paediatrics.7
Conclusion
The increasing demand for personalised medicine has resulted in a resurgence in the interest in compounded medicine. According to marketing reports, the estimated global market revenue for compounded medicine in 2018 was between R30bn and R135bn. It is predicted that the revenue will increase between 3%-7% in the next few years.4
For more information, contact The Compounding Pharmacy of South Africa on 011 463 0310 or send an e-mail to: pharmacist@compounding.co.za.
