Specials quality guide
We aim at shedding light on the quality considerations relating to Specials and to provide additional insight to help pharmacists choose the right manufacturer.
With the top Specials manufacturers now able to receive a bespoke medicine order before they process, make and deliver it back to a pharmacist in just 24 hours, how can you be sure that such speed is not at the expense of product quality?
First and foremost, always check the licenses and credentials of a supplier, especially if ordering for the first time. Even if it’s a supplier you have used for many years, there is no harm in checking licenses are up-to-date and relevant. Check how the supplier is manufacturing – either under an MHRA licence or under section 10. MHRA-licensed specials suppliers (listed on the MHRA’s website) will be inspected regularly by the MHRA guaranteeing that the manufacturing unit will have met the high standards of the MHRA.
It’s also worthwhile checking how long the manufacturer has been around to ensure they have the correct experience to make such products. With an increasing number of specials suppliers in the industry, pharmacists should order from a reputable partner with a track record of reliably delivering high quality unlicensed medicines to pharmacies either in your region or across the UK.
Secondly, all Specials must comply with Good Manufacturing Practice (GMP). This ensures a Pharmacist will check the product complies with GMP regulations to verify stability, labelling and shelf life. This helps assure the product supplied to you for your patient is made to the highest possible standards, in the right type of facility/environment and by the people with the right experience and qualifications.
Thirdly, following on from the latter point, don’t be afraid to ask about staff qualifications and experience to ensure those making your Specials are the people qualified to do so. Numerous pharmacists and pharmacy technicians with experience across retail, hospital and industry are always a good signs. A supplier who commits to training of all personnel and has a bank of regularly updated Standard Operating Procedures (SOPs) is also a good sign. Suppliers should be able to provide knowledge and support that can help verify the specification of each order and ensure product quality at all times.
Next, appreciate the manufacturing process. Enquire about quality checking from your Specialsmanufacturer to understand its production process. Every item should go through several quality checks throughout the order and manufacturing process to certify the accuracy and safety of each formulation.
Finally, ask for back-up data to ensure what’s on the label is in the bottle. The production of every Special should include the creation of a unique batch manufacturing record (BMR) and a Certificate of Conformity (CofC) as a minimum, so manufacturers (and you) can check, track and retrace the production of every individual item. Being able to obtain the correct documentation is vital and in keeping with the MHRA’s guidance around record keeping for Specials, pharmacists should also keep documents such as records of purchase and supply for each order, quantities supplied and batch numbers, which again should be supplied by your chosen manufacturer on request.
In the hectic environment of a busy dispensary, verifying all of the above might seem extreme. However, don’t forget that the pharmacist is the one that is responsible for ensuring a Special is the right product made to right standards and meets the specific needs of the patent.
With less emphasis on price and quality covered in detail above, here is a quick summary of the other important factors that pharmacists should bear in mind when deciding who to make that special call to.
The nature of Specials means there can literally be thousands of variations of formulas and dosage forms. For this reason, it is unlikely to find a Specials supplier that can provide every possible unlicensed medicine. However, it is worth utilising the services of a supplier that can manufacture a comprehensive range of quality products and ideally holds a Wholesale Dealers Licence to source imported and sterile items.
It is important to remember that some products do require the same formulation to be administered for repeat prescriptions due to bioavailability issues – if you have a product that you think meets this criteria, check with the GP/Hospital before ordering.
Needless to say, but leadtime and customer service should of course be major considerations. A supplier that answers the phone when you call, provides you with updates on your order and responds to a query clearly value your custom. With a patient at the end of every single order, getting a Special as quick as possible is essential. Top level suppliers are geared up for and should be consistently providing 24 hour delivery. Pharmacists should expect this level ofleadtime turnaround on a consistent basis.
In summary, be sure to choose a supplier that can both reliably deliver your Specials in a timely manner, consistently to the quality required, to help meet the needs of your patient.