1. Clinical governance is an essential service in the new contract and is built around seven components: patient and public involvement, clinical audit, risk management, clinical effectiveness, staff management, training and development, and use of information
2. All pharmacies will be expected to participate in two clinical audits each year
3. Patient safety incidents (not just dispensing errors) will need to be recorded, reported, monitored, analysed and learnt from
4.Standard operating procedures will be needed for many of the pharmacy’s functions
5. All staff should be trained or be undergoing training, and pharmacists should undertake continuing professional development
Complying with clinical governance requirements is an essential service in the new pharmacy contract. The clinical governance service is built around seven components: patient and public involvement, clinical audit, risk management, clinical effectiveness, staff management, training and development, and use of information.
An explanation of these seven components was given in last week’s Contract 2005 (PJ, 9 October, p519). The new contract sets out the requirements for pharmacy for each of these components. One, patient and public involvement, was covered in last week’s article. This article describes the requirements of the other six components.
In order to comply with the clinical audit section of the clinical governance service, contractors will be expected to participate in two clinical audits each year. One is likely to be a practice-based audit. The other will be a multidisciplinary audit, determined by primary care trusts, through which it is hoped team working will be developed. Both must have a clear outcome so that they can be used to help develop patient care.
Although details of how long the audits will be expected to take are yet to be finalised, it will be necessary for PCTs to give contractors reasonable notice of any meetings required for the multidisciplinary audit.
To meet risk management requirements, contractors will need to ensure that procedures are in place to guarantee that stock is procured and handled properly and that equipment is maintained appropriately.
Maintaining a log of patient safety incidents at all stages of the medication process, not just dispensing errors, will be a requirement of the new contract. The information collected will be used to fill the mandatory fields of the reporting form in the National Patient Safety Agency’s national reporting and learning system.
The national reporting and learning system will allow any NHS staff to report patient safety incidents and near misses anonymously. The information will be analysed by the NPSA so that patterns can be identified and solutions developed. The system was explained in a series of articles last year (PJ, 22 November 2003, p719).
The NPSA is currently exploring how it can provide anonymised feedback to the PCT in which the pharmacy is located. It is also hoped that, in future, pharmacists will report incidents directly to PCTs. In order for this to happen, reporting systems will need to be non-punitive, confidential and be based on open disclosure, ie, on telling patients when something has gone wrong.
Contractors will have to demonstrate that they are not only recording incidents but also monitoring, analysing and learning from them. Critical incidents should be analysed by the whole pharmacy team to inform both individuals and the organisation. To assist with this, pharmacists should be competent in risk management, including root cause analysis. The Centre for Pharmacy Postgraduate Education is planning to produce a distance learning pack on risk management next year.
Brian Jolley, of Park Pharmacy in Lowestoft, has successfully written and implemented a number of standard operating procedures. “The key message is keep it simple, keep it flexible and review it regularly,” he says.
To write a SOP, he suggests writing a step-by-step description of the process and then asking a member of staff to test it. “When you adopt a SOP, monitor it monthly initially and alter it if you identify a problem.”
Contractors should have standard operating procedures in place, covering the areas specified by the Royal Pharmaceutical Society as a minimum. SOPs should also be produced for advanced and enhanced services.
Waste disposal systems will need to be developed for clinical and confidential waste. All confidential paper waste should be considered, from paperwork associated with services to unused labels which state patients’ names.
Contractors will have to comply with other guidance, including health and safety legislation, and local and national guidance relating to child protection procedures.
Finally, each pharmacy will need one member of staff to become its clinical governance lead. This person does not necessarily have to be a pharmacist.
To ensure that standards of clinical effectiveness are met in the provision of self-care advice, SOPs or other protocols will have to be put in place. Another way in which pharmacists will contribute to improving clinical effectiveness is through the medicines use review service.
The first requirement of the staff management section is for contractors to ensure that all staff and locums are given appropriate induction training on issues such as confidentiality, health and safety, and security. Furthermore, all staff should be trained or be undergoing training, and contractors should identify and support the ongoing developmental needs of staff.
The qualifications of all staff should be checked and references taken. For pharmacists, this will be supported by the introduction of PCT-held lists. This list will be called a “supplementary list” and will be in addition to the main pharmaceutical list which contains the names of contractors and company directors. All employed pharmacists and locums will have to register on one PCT’s supplementary list in order to work in pharmacies providing NHS services in England.
Training and development
To fulfil training and development requirements, pharmacists will have to be able to demonstrate a commitment to continuing professional development using a CPD record. They will also have to obtain any necessary accreditation before providing enhanced or advanced services.
Use of information
In terms of information requirements, contractors will have to provide access to up-to-date reference sources (such as the BNF and the Drug Tariff) and appropriate IT links to electronic reference sources.
To protect patient data, confidentiality policies will need to be in place for all staff. Records should be made of interventions and advice given, as well as basic recording of medication supplied.
Contractors will also have to ensure that the PCT and NHS Direct are aware of the pharmacy’s actual working hours so that these organisations can provide accurate information to the public.