Top tips for quality and safety in Unlicensed Medicines
With pharmacies playing an integral role in driving patient safety, we put a spotlight on the responsibilities pertinent to pharmacy staff to ensure unlicensed medicines are obtained efficiently and safely. In our guide, we focus on how to protect patients‘ safety through quality standards and the documentation that should be supplied with every unlicensed medicine.
With the focus squarely on risk and safety, how can pharmacy staff be sure they are getting their unlicensed medicines from a reputable source?
As the demand for unlicensed medicines has increased, so too has the range of suppliers. While speed of service, product range and value for money must be considered, it is important that pharmacists base their purchases on quality and safety above all else.
Protecting patients through GMP and GDP
The production and distribution of medicines is an intricate process and the MHRA requires manufacturers to conform to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements.
GMP demands a quality assurance (QA) system is built to guarantee quality at every stage of the manufacturing process. It is especially important when producing bespoke unlicensed medicines, where the risk of error increases due to the unique nature and unlicensed status of each hand-made preparation.
GMP and GDP requirements can overlap. This is to guarantee product quality from the manufacturing stage through to the point where it is released from the site. GDP should be considered equally as important as GMP, and provides more detail specifically for warehouse operations.
Your continued responsibility
Pharmacy teams should ensure that both the patient (and carers), and any other healthcare professionals involved, closely monitor patients‘ treatment and report any associated adverse events. A key way to maintain patient safety and quality standards is to ensure that unlicensed medicines come with the appropriate paperwork.
Unlicensed medicines which are individually produced, should come with a Certificate of Conformity (CofC). The CofC confirms that the final product conforms to the specification supplied by the pharmacist and should be signed by a suitably authorised person. They should also come with a batch number, which is documented on the CofC, which allows traceability back to the manufacturing record.
If an unlicensed medicine is supplied as a batch, then a Certificate of Analysis (CofA) should accompany the order. The CofA confirms that a sample of the final product has been tested and levels of active ingredients have been retrospectively verified.
A CofA should:
- Confirm the laboratory/ organisation issuing it
- Be authorised by a Qualified Person (QP) i.e. Quality Assurance or Quality Control personnel and include their signature
- Show the specific batch number that matches the medicine supplied
- Indicate exactly who performed the tests and the date
- State the specification against which the tests were performed
- Give the required test results and the actual results - a result in full or ‘complies‘ may be shown.
Right treatment, right patient, right time
As patient care is a pharmacist‘s first concern, developing professional knowledge, maintaining competence and taking responsibility for their working practices allows them to ensure the best standard of care is delivered to patients, and they continue to make safe choices.
By taking the appropriate steps to demonstrate that the unlicensed medicines supplied meet all the relevant standards, patients are safeguarded and pharmacists can protect their status as a trusted healthcare professional.
When it comes to our products, we take quality seriously. All of our processes are built with safety and quality in mind to give our customers peace of mind. To understand how we do this, read how our quality processes drive patient safety, or alternatively, contact 01207 279 400 or firstname.lastname@example.org.