Rizvan Faruk Batha MPharm, PGDip GPP, IPresc, MRPharmS, Superintendent Pharmacist and Director of Operations at Specialist Pharmacy, examines the benefits of compounded and personalised medication.
With many licensed medications only being available in set dosages, which for many can lead to unnecessary side effects, personalised dosage can often give better results, often by administering a lower dosage. Prescribers can actually get better results and prognosis for their patients by using compounded medication but they should be sure the compounded pharmacy they are using follows strict regulations on quality and safety.
Adverse drug reactions are unwanted and harmful side effects which occur after administration of a drug make up a staggering 6.5% of all hospital admissions in the UK. If we consider the fact that the drugs budget is the NHS’s second biggest cost, yet 90% of drugs only work in 30-50% of the patients, we can begin to see where a case for personalised doses can be made. The aim of personalised medicine is to gain the best treatment response for a patient, with the highest safety margin.
Standard approaches to healthcare rely heavily on a ‘one size fits all’ policy which can cause numerous issues for patients, such as adverse drug reactions, compliance issues and poor treatment outcomes, which of course impacts on their clinicians.
What is compounded and personalised medication?
Compounding is the process of combining, mixing or altering two or more active pharmaceutical ingredients to create compounded medication that is tailored to the individual. This was the recognised process of making medication right up until the late 1960’s, which is when the concept of licensing was introduced, so this is not a new process. It is common across many healthcare sectors, including paediatrics, clinical nutrition and oncology, and is an accepted practice within the NHS.
The act of compounding medication is regulated by the General Pharmaceutical Council (GPhC) and a pharmacist’s right to compound medication has actually been maintained through the Medicines Act 1968 and re-confirmed through the Human Medicines Regulations 2012. The process allows the pharmacist to work with a prescriber to meet the individual needs of the patient. It may be that the patient needs their medication in a dosage form or strength that is not available in a licensed medication, or it may be that the patient cannot swallow capsules/tablets or is allergic or intolerant to an ingredient or excipient, so compounding offers a personalised solution and therefore improves compliance.
We can take Utrogestan as an example. This is bioidentical progesterone in a licensed form, available on the NHS, however it is only available in one dose, 100mg and one form, capsules. This dose is often too high for many women to tolerate and may result in nausea or drowsiness, for example, causing them to cease taking the medication. A compounding pharmacy can use exactly the same raw material (bioidentical micronized progesterone) and compound it into capsules in lower strengths or into a more tolerable formulation if, for example, they are unable to swallow capsules.
The labelling of all extemporaneous preparations includes the standard information that is required by law for all named-patient prescription-only-medicines – the exact name, strength, form, quantity of medication and accurate dosing instructions. In addition, labelling information includes a serial number for full process traceability (raw materials and accuracy checks along the way) and a beyond-use date that is accurate to the day. A patient information leaflet is provided with each prescription which provides safety information, ingredients, practical advice on dosing delivery and any potential side effects as per Principle 4.3 of the GPhC’s Guidance for Registered Pharmacies Preparing Unlicensed Medicines.
Put simply, this is moving away from a ‘one size fits all’ approach to the treatment and care of patients with a particular condition, to one which utilises the knowledge of a prescriber and the expertise of a pharmacist to achieve the best outcome for the patient in the management of their condition, especially where licensed medicines are not able to achieve the desired outcome.
There can be some stigma faced around compounded medication, as there have been cases where unscrupulous online pharmacies are offering medication without prescriptions using questionable ingredients.
It is important to use a GPhC registered (and regulated) compounding pharmacy which uses state-of-the-art computer-controlled processes to eliminate any errors and uses high precision equipment to ensure that each and every prescription meets exacting standards. Any respectable compounding pharmacy will source all ingredients and packaging from reputable pharmaceutical suppliers who are compliant with Good Manufacturing Practice (GMP) standards, as recognised by the UK & EU. This means that each and every medication can be traced back to its original formula, lab technician and ingredient source. Certificates of analysis should also be obtained, so that the pharmacist can be assured of the raw materials they are working with.
How can compounding pharmacies benefit prescribers?
There are many different prescriber types who use compounding pharmacies, from private GPs, aesthetic doctors, dermatologists to endocrinologists and non-medical prescribing nurses. They are able to better utilise their knowledge of the conditions they are treating and their individual patient circumstances to personalise compounded medicines in conjunction with a specialist compounding pharmacist. From changing the route of delivery, to making vegan options or accommodating religious beliefs, it all helps to improve patient compliance with a treatment and obtain optimum results and outcomes.
The future of personalised medicine
Patients are becoming more aware of the treatment options available, in part due to information available online. Personalised medication is becoming more mainstream, as DNA and RNA sequencing becomes more widespread, meaning a future where we move away from ‘trial and error’ treatment to a far more tailored approach. Personalised vitamins, (using blood samples to recognise deficiencies) which can provide tailored micronutrients designed specifically for the individual, are already flooding the market. This is giving consumers a more participatory role in their health, empowering them to demand diagnostic testing that will deliver treatment that is tailored to their specific needs.
This approach holds great potential and an exciting opportunity to improve individualised healthcare and therefore prevention and treatment of disease and disorders. Compounding pharmacies have a critical role to play in the future of personalised medicine, allowing us to control and mitigate medical conditions better than ever.
 The Lancet. (2018) Personalised medicine in the UK.(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)33261-0/fulltext). 06/11/21
 NHS England. (2016). Improving Outcomes Through Personalised Medicine. https://www.england.nhs.uk/wp-content/uploads/2016/09/improving-outcomes-personalised-medicine.pdf 06/11/21
 Bayer, (2021). Personalised Medicine- from a one-size fits all to a tailored approach. https://www.bayer.com/en/news-stories/personalized-medicine-from-a-one-size-fits-all-to-a-tailored-approach?gclid=Cj0KCQjw5oiMBhDtARIsAJi0qk2KFVyUtOpziDiVHRR2wZJCMvVDFYoauUc4RqYgiSwTkxCVsYoD8GQaAlXPEALw_wcB&gclsrc=aw.ds