Author Rizvan Faruk Batha MPharm, Superintendent Pharmacist and Director of Operations at Specialist Pharmacy, discusses how compounding pharmacies have a critical role to play in the future of personalised medicine, allowing prescribers to control and mitigate medical conditions better than ever.
Every human is unique, so it stands to reason that a standard set dosage of a medication is not necessarily the right one for each patient. That’s where personalised dosage comes into its own.
With many licensed medications only available in set dosages, some people suffer from unnecessary side effects. A personalised dosage often produces better results. Prescribers can improve results and the prognosis for their patients in certain circumstances by using compounded personalised doses. In other words, combining, mixing or altering two or more active pharmaceutical ingredients to create compounded medication that is tailored to the individual.
Did you know that 6.5% of all hospital admissions in the UK are due to side effects from a prescribed medication?
The NHS’s second biggest cost is medication, yet 90% of drugs only work for 30-50% of the patients . So there is a strong case for personalised doses and dosage forms in order to get the best treatment response for a patient, improve adherance and at the same time, try to reduce side effects due to high doses or adverse reactions to certain excipients or ingredients found in standard formulations.
The general healthcare strategy practised in both general practice and hospital environments relies heavily on a ‘one size fits all’ policy. This can cause numerous issues for patients due to for example, adverse drug reactions or unpleasant side effects, patient reluctance to take medication due to poor taste or inability to swallow a solid dosage form which can then lead to poor treatment outcomes. These two issues can be resolved with compounded, personalised medication.
How does compounding work?
Compounding was the recognised process of making medication from the times of the ancient Egyptians right up to the late 1960s when the mass production of medicines became more common. Personalisation of doses and dosage forms is still common across many healthcare sectors, including paediatrics, clinical nutrition and oncology, and is an accepted practice within the NHS.
Compounding pharmacies are regulated by the General Pharmaceutical Council (GPhC). Section 10 of the Medicines Act 1968 and Regulation 4 of the Human Medicines Regulations 2012 allows a pharmacist to prepare and supply unlicensed medicines. Pharmacists acquire this knowledge and skill during their initial education and training prior to registration with the General Pharmaceutical Council. So it is not new, and it is highly regulated; it is therefore important that a pharmacy practising compounding follows the strict regulations regarding quality and safety and working to the same level as an MHRA regulated unit.
The pharmacist and the prescriber work closely together in a patient centric approach 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/ intolerant to an ingredient or excipient. Compounding offers a personalised solution and therefore improves compliance.
Let’s take Utrogestan as an example. This is bioidentical progesterone in a licensed form, available on the NHS. However, it is only available in 100mg capsules. For some women, this dose is too high and intolerable and may result in nausea, drowsiness and bleeding, causing them to stop 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 (like a rapid dissolve tablet) if, for example, the patient struggles to swallow capsules.
Regardless of how the medication is prepared, the labelling will still include the standard information that is required by law for all named-patient prescription-only-medicines i.e., 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) and a beyond-use date that is accurate to the day.
A patient information leaflet is provided with each prescription that provides safety information, ingredients, practical advice on dosing delivery and any potential side effects as required by principle 4.3 of the GPhC’s Guidance for Registered Pharmacies Preparing Unlicensed Medicines
Medicine is moving away from a ‘one size fits all’ approach to the personalised treatment and care of patients to one which uses the knowledge of a prescriber and the expertise of a pharmacist to achieve the best outcome for the patient. This benefits both the patient in the outcome achieved and the prescriber in managing their condition more effectively. This is especially effective where licensed medicines are unable to achieve the desired outcome .
There is still a stigma attached to compounded medication. This stems from unscrupulous/unregulated online pharmacies and providers offering medication without prescriptions and 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. The general pharmaceutical council guidance explicitly mentions that patients have a right ‘when an unlicensed medicine is prepared by, or under the supervision of, a pharmacist in a registered pharmacy, it is of an equivalent quality to any licensed medicine they will receive (such as those produced by a regulated and licensed manufacturer)’. Therefore, compounding pharmacies are expected to ensure that they can maintain these high standards and are regularly inspected by the GPhC.
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 and meets the requirements found in established pharmacopeias.
The patient comes first
There are many different prescribers who use compounding pharmacies including private GPs, aesthetic doctors, dermatologists, veterinary practitioners, pain clinicians, endocrinologists and prescribing nurses to name a few. They are able to use their knowledge of the conditions they are treating and their individual patient circumstances to personalise compounded medicines in conjunction with a specialist compounding pharmacist.
Whether the patient needs an alternative method of delivery to make taking medication less stressful, a vegan alternative or has religious beliefs that prevent ingestion of specific ingredients, personalised medication improves patient compliance with the prescribed treatment and helps to improve outcomes for the patient.
Patients are able to source information online so are much more aware of the options available to them. Personalised medicine is becoming more mainstream, as DNA and RNA sequencing becomes more widespread. The future will see a move away from trial-and-error treatment to a tailored approach.3 Personalised vitamins, (using blood samples to recognise deficiencies) with tailored micronutrients designed specifically for the individual, are already widely available and people are more active in monitoring and maintaining their health. This increased awareness means they are more likely to demand medication that will deliver treatment that is tailored to their specific needs.
Compounding pharmacies have a critical role to play in the future of personalised medicine, allowing prescribers to control and mitigate medical conditions better than ever. The future of medicine is already offering exciting opportunities to deliver an enhanced health service.
- The Lancet. (2018) Personalised medicine in the UK.
2. 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
3.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 . 06/11/21