How Specials manufacturers support community pharmacists
APSM member companies dedicate their resource and expertise to this very specialist area of medicines manufacture. They are an essential partner to pharmacists and can streamline the process from assessing the formulation, through quality manufacture to timely delivery. Most pharmacists are only called upon to dispense a handful of specials prescriptions each month. A specials manufacturer can help pharmacists to navigate the complexities of supply and avoid issues with reimbursement.
The following summarises the ways in which APSM member processes align with RPS guidelines1
1. ESTABLISH THE OPTIMAL TREATMENT FOR THE PATIENT
“All treatment options are evaluated. Prescribers and pharmacists work together to ensure that Specials are only supplied when the patient has a special clinical need that cannot be met by an available licensed medicine (this special clinical need does not include reasons of cost, convenience or operational need’
A special can only be supplied when and if a licensed alternative is not available and so the very first thing a specials manufacturer will do is to check this. APSM members report that it is quite often the case that they reject an order for this reason, instead providing the pharmacist with details of the licensed preparation.
The Guideline underlines the importance of Prescriber and Pharmacists working together to agree medication and formulation. However, the Specials manufacturer also plays an important role in this process. As a requirement of membership, APSM members have expert and knowledgeable customer service teams whose role it is to provide advice and expertise about any aspect of a specials prescription.
2. UNDERSTAND THE PATIENT’S EXPERIENCE AND MAKE A SHARED DECISION
“The patient’s needs, values and preferences are discussed to ensure that the implications and practicalities of supplying and using Specials are understood, and that patients (or carers) are supported to adhere to their medicines”.
APSM companies undertake to provide clear labelling on their specials. If necessary, they can advise on alternative formulations that might be more acceptable to patients, for example, flavouring.
As a requirement of membership, APSM members have expert and knowledgeable customer service teams whose role it is to provide advice and expertise about any aspect of a specials prescription.
3. IDENTIFY A PREPARATION AND A SUPPLIER
“When procuring and supplying a Special, pharmacists ensure that patients receive medicine that is of appropriate quality, is appropriate for the patient’s condition and personal circumstances, with minimal clinical risk.”
Quality commitment from a licensed Specials manufacturer
APSM members have invested more than £150 million in quality and infrastructure in the last 5 years.
All members should offer:
· Premises inspected by MHRA for compliance to GMP (Good Manufacturing Practice)
· A pharmaceutical quality assurance system, e.g. pharmacopoeial monograph, stability tests
· Batch testing / Certificates of Analysis provided
· Certificates of Compliance (for single products)
· Best practice labelling
· Customer support line
· Unique codes on all products
· Innovation – e.g. clearer patient labelling
· Yellow card adverse event reporting
· Investment in facilities for medicines manufacture
In the UK, the majority of Specials are manufactured and prepared by Specials manufacturers who are licensed, regulated and inspected by the MHRA and must comply with the principles of Good Manufacturing Practice (GMP) adopted by the EU Commission.
These licensed manufacturers provide additional assurances of quality. A certificate of analysis is provided for batch manufactured Specials as evidence that critical parameters have been met through physical, chemical or microbiological analysis of the final product. Where individual or bespoke Specials are prepared, the manufacturer will provide a certificate of conformity to show that the product meets the specification.
In addition, (ALL) APSM members voluntarily undertake to apply the Yellow Card reporting scheme for their Specials (unlicensed medicines). This is the same pharmacovigilance process adopted by manufacturers of licensed pharmaceuticals.
Pharmacovigilance involves the continuous monitoring of medicines for any adverse side effects. In the UK, this process is managed under the Yellow Card scheme whereby patients, doctors and health professionals can report any potential side effects.
In this way, any adverse events related to unlicensed medicines produced by APSM members would be brought to the attention of the MHRA and therefore fully monitored and investigated in the same way as any licensed medicine.
Specials manufacturers have streamlined order processes to the extent that on receipt of the product request, the manufacturer manages the process through to verification of requirements, prompt delivery and provision of supporting paperwork.
4. MONITOR THE PATIENT AND REVIEW THE NEED FOR A SPECIAL
“The appropriateness of continued prescribing of a Special is reviewed to ensure that it remains the best option and ongoing supply is justified by the patient’s continued special clinical need.”
The APSM can support this review process, offering advice about formulations and if necessary advising if a licensed alternative has subsequently become available.
5. ENSURE EFFECTIVE GOVERNANCE IS IN PLACE
“Governance arrangements are in place to support the safe and effective procurement and supply of Specials in order to provide consistently safe and effective Specials to treat patients.”
Clinical governance for the pharmacy contractor is defined as ‘about being accountable, taking professional responsibility, having the right systems and processes in place and about continuously improving what we do.’ This is very reflective of the ethos of all APSM member companies for a number of pharmacy governance processes, either directly or indirectly.
- Adverse events monitoring – all APSM members also monitor and report AEs
- MURs – advice about a special, or, if there is a problem with the pharmaceutical form of a medicine, what options might be available for a special.
- Out of stock – is there a special alternative available that could be prescribed?
- Special obtains – sourcing niche or difficult to obtain licensed products is often a service provided by specials manufacturers
- Specials procurement Information about shelf-life and stability – certificates of conformity and certificates of analysis
For a list of APSM members and services provided visit Specials Suppliers
1. PROFESSIONAL GUIDANCE FOR THE PROCUREMENT AND SUPPLY OF SPECIALS (2015). Royal Pharmaceutical Society