Compounded medicines fulfil a critical role in healthcare by providing personalised treatment options for patients with specific medical requirements and even can help to alleviate drug shortages. However, there is a lack of understanding and misconceptions about the role and regulation of compounded medications.
In this article we answer some of the most frequently asked questions about compounded medications and compounding pharmacies, aiming to provide clarity for both doctors and patients.
Are compounding pharmacies and compounded medications regulated?
In the UK, the right of a pharmacist to compound extemporaneous preparations is enshrined in the Human Medicines Regulations 2012 and compounding pharmacies are regulated by the General Pharmaceutical Council (GPhC).
Compounded medications are only prepared in response to a valid prescription from a doctor for an individual patient and are not stock items.
Typically, pharmacies will follow rigorous quality assurance processes, including the use of pharmaceutical-grade raw materials, meticulous preparation in controlled environments, and thorough documentation. Each step is designed to ensure the safety and efficacy of the compounded medication.
What’s the difference between compounded and licensed medications?
Licensed medications undergo extensive trials and testing to ensure they are safe and effective. These trials can cost millions of pounds, are resource intensive and it can take years for a pharmaceutical product to achieve regulatory approval and market use. While no medicine is completely free of side-effects, a license indicates that the medicine treats the condition for which it is intended and the benefits are believed to outweigh the risks.
However, sometimes to ensure the best possible treatment for a condition this one-size-fits-all approach does not accommodate everyone, and it may be necessary for unlicensed medicines to be prescribed.
Compounded medications are tailored to fit individual needs, offering a level of customisation that licensed products cannot. For example, a patient with a skin disorder, may require a specific topical combination not available in standard treatments. Compounding pharmacies can create a formulation that precisely matches the patient’s requirements, ensuring better treatment outcomes.
Whilst it is also possible to compound by altering the form of licensed medication (e.g. crushing a tablet), we only work with pharmaceutical-grade active ingredients thereby avoiding enteric coatings, fillers and preservatives, where possible.
How do compounded medications differ from other unlicensed drugs?
Compounded medications are a subset of unlicensed medicine. They are customised for individual patients based on specific needs that cannot be met by mass-produced, licensed medications. This personalisation is crucial for patients who may have allergies to certain ingredients or require unique dosages not available in standard formulations.
However, unlicensed products include any products that have not been licensed at all, have been licensed outside of the UK or that have been licensed in the UK for a purpose other than which the medication is being used (often called ‘off-license use’).
As a pharmacy operating in the strongly regulated UK market, we are unable to accept prescriptions for unlicensed medication from prescribers who are not registered here.
Compounded medications are unlicensed and cannot be advertised as products to prescribers or patients.
How are patients informed about the implications of compounded medications?
At Roseway Labs we are committed to prescriber and patient education. At our pharmacy, every compounded medication is accompanied by a patient information leaflet detailing ingredients, potential side effects, and instructions for reporting any adverse reactions through the MHRA’s Yellow Card Scheme. This transparency ensures that patients are fully aware of what they are taking and can make informed decisions about their treatment.
We also advise all patients to only buy from reputable sources and manufacturers in countries with strong regulatory regimes, check the conditions under which it is transported and the duration of time that they must wait for it, to make sure they are comfortable with the quality of the product that they receive.
What quality control procedures and safety measures do compounding pharmacies follow?
To ensure the quality and consistency of compounded medications, compounding pharmacies like Roseway Labs will employ robust quality assurance processes, including:
- Clinical checks: Comprehensive clinical checks are performed to check that formulations are safe and appropriate for patient use.
- Traceability: All ingredients are fully traceable thanks to our electronic prescribing system, which records the prescription, ingredients, formulation and method, and enables dispensing. This allows for efficient recalls if necessary.
- Purity and quality: We use pharmaceutical-grade raw materials from reputable suppliers and obtain certificates of analysis to verify their quality and origin.
- Precision: Compounding takes place in controlled laboratory environments with laminar-flow cabinets to protect both the medication and the staff members. We meticulously weigh and measure ingredients to ensure precise formulations.
- Documentation: Each compounded medication is documented, including formulation methods and ingredient sources, ensuring transparency and accountability.
- Final product checks: Thorough final product checks are conducted to confirm that the finished product meets the specified standards in terms of weight, appearance, smell, and texture.
Roseway Labs empowers patient choice
At Roseway Labs we aim to empower patients to make informed choices about their treatment options, ensuring they receive the best possible care tailored to their needs.
Compounded medications play a vital role in personalised healthcare, addressing the unique needs of patients that standard medications cannot. While they are subject to stringent regulations and quality controls, it is essential for both doctors and patients to understand their benefits and limitations.