Purpose of aseptic services
Aseptic manipulation is a high-risk method of medicine preparation. The consequence of errors or contamination can be severe when medicines are administered by injectable routes. Aseptic manipulation should only be used when licensed, sterile ready-to-administer presentations are not available.
However, a significant number of essential medicines, for example chemotherapy, parenteral nutrition, radiopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs), are not available in a ready-to-administer form, so require aseptic manipulation.
Pharmacy aseptic services are an essential support service for critical clinical services by preparing safe, high-quality medicines in a ready-to-administer form. This reduces risks for patients, releases nursing time to care, and protects staff from exposure to hazardous medicines.
The article on aseptic manipulation of injectable medicines (SPS page) provides more detail about these risks.
Regulation
Aseptic services must comply with national standards and regulations to prevent serious harm to patients.
NHS pharmacy aseptic services may operate under
- the Section 10 exemption from the Medicines Act 1968 (via Regulation 4 of HMR 2012)
- a Medicines and Healthcare products Regulatory Agency (MHRA) Manufacturing Specials (MS) authorisation
These two frameworks provide the regulatory basis for making and supplying unlicensed medicines. The article Regulations for NHS aseptic services (SPS page) provides more information.
Assurance of quality in aseptic services
‘Quality’ in aseptic service means that all products made should be
- free from microbial, particulate and chemical contamination
- of the correct content, for example the right drug in the right concentration
Aseptically made medicines cannot be tested without destroying the product, so assurance of quality relies on preventing contamination and errors during processing.
The person responsible for releasing the product cannot know for certain that a product is free from contamination or error. They must therefore have sufficient evidence to make a professional judgment that the product is of the required quality and fit for purpose. This includes documented evidence that
- facilities are well designed and operating correctly
- processes are well designed, have been followed correctly and have been appropriately supervised
- the workforce is appropriately trained, competent and authorised
This forms part of the pharmaceutical quality system (PQS). The article Assuring quality in NHS aseptic services (SPS page) provides more information about pharmaceutical quality systems, and how they are designed.
Chief Pharmacist responsibilities
Pharmacy aseptic services are resource intensive and require significant time, expertise, and infrastructure to build, maintain and operate safely and effectively.
Chief Pharmacists must be able to assure themselves, the Trust senior managers and regulators that their pharmacy aseptic service is operating in a state of control. The Chief Pharmacist must therefore ensure regular review of key quality and performance indicators to ensure they have oversight of the unit’s performance. Attendance at quality meetings is one way in which Chief Pharmacists can gain this assurance.
Some key areas of the Chief Pharmacist’s responsibility are outlined below. For further details see the Royal Pharmaceutical Society’s guide for Chief Pharmacists.
Provide adequate facilities
Facilities must be compliant with relevant standards, for example
- Royal Pharmaceutical Society’s Quality Assurance of Aseptic Preparation Services (QAAPS)
- Annex 1 to Good Manufacturing Practice (available from the European Commission)
- NHS England’s Health Technical Memoranda
A programme of planned preventive maintenance (PPM) is necessary to ensure all facilities and equipment operate correctly, and that defects are identified promptly. PPM may be undertaken by a combination of Trust Estates personnel, aseptic service personnel, and external outsourced engineers. All PPM must be overseen by the aseptic service management irrespective of who carries out the work.
All facilities and equipment should be included in Trust capital replacement plans to ensure timely refurbishment or replacement. A mechanism is required for timely escalation of risks associated with the facilities or equipment to Trust senior management.
Provide adequate workforce
The Chief Pharmacist is responsible for ensuring that there are sufficient staff available for all aspects of the aseptic service. Staff should be trained, competent and act in accordance with the relevant standards. It is essential that robust succession plans are in place. Vacant roles must be filled quickly and effectively to minimise disruption and maintain operational stability.
Control aseptic capacity and demand
The Chief Pharmacist holds ultimate responsibility for the adequate resourcing of the pharmacy aseptic service. An effective system must be in place to ensure that the aseptic unit can meet clinical demand without compromising quality or safety. This is recorded in a capacity plan. There needs to be resource for both production and quality related activities and services should look at capacity both prospectively and retrospectively.
The capacity limits should not be breached due to the high-risk nature of aseptic preparation and risk to patient safety. It is therefore important that the capacity plan is accepted by senior management external to pharmacy. Any breaches must be risk assessed, investigated and appropriate action taken, for example invoking contingency arrangements.
Ensure service resilience
Contingency arrangements must be in place to minimise risk of disruption to the supply of medicines to patients.
The contingency plan should include all the information that would be required to make risk-based decisions about service provision in the event of unplanned service disruption or acute unplanned surges in demand.
The contingency plan should cover both unexpected events and planned down-time, and should include plans for short term (days) and long term (months) disruption.
Considerations will include, but are not limited to
- severe weather
- infrastructure failure
- equipment and facility problems
- staffing shortages
- loss of key personnel
- pandemics
Oversee the audit programme
Audit is of vital importance for determining whether the aseptic service is currently operating in a state of control, and to drive continuous improvement.
External audit
Chief Pharmacists are expected to attend the opening and closing meetings of external audits and inspections. They are responsible for ensuring action plans are implemented and that the auditor or inspector is informed of any slippage.
The article Preparing for audits and inspections of aseptic services (SPS page) provides more advice.
Internal audit (self-inspection)
Chief Pharmacists should ensure there is an effective programme of internal audit, that is on schedule, and that action plans to correct deficiencies are created and on target. This is because external audit and inspection can only ever be a ‘snapshot’ of one or two days each audit cycle.
Establish key relationships
It is vital that the Chief Pharmacist maintains key relationships with Trust senior managers to ensure that they can fulfil their responsibilities.
The Chief Pharmacist should also ensure that the pharmacy aseptic unit maintains close working relationships with the rest of the Pharmacy department and other Trust departments. This may include wards, other clinical areas, estates departments and Trust senior managers.
This ensures
- mutual understanding of available capacity
- effective forward planning for changes in service demand
- clear understanding of mutual responsibilities for maintenance and replacement of facilities and equipment
- clear and effective escalation pathways in place for emerging risks or issues identified by the aseptic services team
The Chief Pharmacist is also responsible for establishing external communication channels with
- the MHRA, for aseptic services with a Specials licence
- their Regional Quality Assurance team (SPS, in England)
- their regional Chief Pharmacist