NPA Response

Thank you for giving the National Pharmacy Association (NPA) the opportunity to comment on the draft guidance on the strengthened governance arrangements for the safe management of controlled drugs.

The NPA represents the interests of community pharmacies. We have, in voluntary membership, around 11,000 community pharmacies, which comprises the majority of the 12,000 pharmacies in the UK. The NPA provides a representative voice for its members as well as a range of services to help them with both commercial and professional aspects of running their businesses.

Views on whether the right balance has been achieved between strengthening controls and ensuring patient access to the drugs they clinically require

The NPA welcome the strengthening of the governance arrangements for the safe management of controlled drugs and believe the right balance has been achieved. The strengthened controls should not obstruct patients from getting the drugs they require and the sharing of information between organisations will act to increase patient safety.

Views on whether the new arrangements make best use of existing mechanisms

Inspections

We welcome the proposal that controlled drug arrangements should be inspected as part of the existing inspection procedures, and agree that inspections should be standardised. The pharmacy should be told in advance that an inspection is going to take place. In order to carry out the inspection correctly, the RPSGB inspector should be allowed access to the self assessment form before the visit. A more detailed inspection will take more time and inspectors should allow for this and ensure there is minimal disruption to the running of the pharmacy.

If a controlled drugs review is carried out by the PCT, the NPA believe the results of this should be passed to the RPSGB. This will ensure there is no duplication of inspection and will minimise disruption to the pharmacy.

The NPA are concerned about the manner in which inspection teams investigating serious concerns may enter pharmacies as this could cause concern to patients. Any inspection must be done in a discreet way.

Care homes inspection

The NPA welcome the inspection of care homes controlled drugs arrangements by the CSCI pharmacist inspector as they are best placed to understand the issues surrounding Controlled Drugs. This inspector should report any concerns to the Accountable Officer.

Recording of errors

The NPA support the recording of errors and informing the NPSA of any adverse incident. Pharmacists are already recording errors as part of their NHS contract and therefore there would be no extra burden on pharmacists doing this.

Views on self assessment by practices

While the NPA welcome the increased transparency on use of controlled drugs, we are concerned that completing a self assessment form could be time consuming for pharmacists. In addition if PCTs are allowed to develop their own forms, there will be little consistency across the country. A national template should be developed for all primary care providers to use and its use should become mandatory.

We are also concerned that the guidance states that pharmacies with NHS contracts should return their form to the PCT, whilst "private pharmacies" should return theirs to the RPSGB. This could lead to confusion within the pharmacy profession and make it difficult to advise pharmacists on the correct course of action. We suggest that all pharmacies should return their self assessment form to the RPSGB, with contracted pharmacies also sending a copy to the PCT. The RPSGB and PCT should then work together, with the PCT allowing the RPSGB to inspect in the first instance.

Views on the role of the Accountable Officer

The NPA agree this role should not be carried out by someone involved in the day to day use of Controlled Drugs. The role could be carried out by a pharmacist employed by the PCT as they have wide experience in dealing with the management of Controlled Drugs. However, we feel confusion could arise between this role and the role of the RPSGB inspector and it should be made clear to pharmacists who they should contact if they experience problems.

The size of the population that each Accountable Officer will cover must be carefully considered particularly with the proposed merging of PCTs which may lead to each Accountable Officer being responsible for large numbers of primary care providers.

The NPA agree there should be local networks which can share information on CDs and this should include inspectors from all agencies.

Arrangements on disposal of CDs

The NPA propose that as part of the arrangements for the disposal of CDs, it should be mandatory for destruction of patient returns to be recorded. Guidance on the disposal of CDs in patients’ homes should be issued along with the guidance on strengthening the governance arrangements to ensure consistency of approach.

Views on sharing of data

We welcome the anonymising of data and agree patients should give their consent before their data is shared. Organisations should be encouraged to comply with the Data Protection Act and confidentiality principles.

Data on national trends

While it is welcomed that national data be available, we are concerned that this may mean that pharmacists will be asked to submit data which could increase paperwork. Instead prescription data could be used as this information is already available.

Investigation of serious concerns

The NPA believe any investigation into the fitness to practice of a pharmacist, especially where patient safety is an issue, should involve the RPSGB. Other agencies should be involved as appropriate. Of paramount importance during an investigation is to ensure patient access to drugs will not be restricted and that pharmacy services are not disrupted.

Summary

The NPA welcome the introduction of measures which will lead to improved patient safety and believe the measures proposed should have minimal impact on access to CDs for patients. Any paperwork should be kept to the necessary minimum and pharmacists should be permitted to use support staff where possible to complete paperwork. There is a danger that the work of inspectors may be duplicated resulting in additional inspections and paperwork for pharmacies. Measures should be taken to ensure there is adequate communication between agencies to ensure this does not happen.

Further clarification is required on the implications of the new arrangements for drug misuse services. The consultation does not mention how drug misuse organisations such as shared care co-ordinators and Drug Action Teams etc will be involved in the new arrangements. It is important that the Accountable Officer fully understands the role and provision of drug misuse services in their area if they are to be responsible for monitoring this service.

The NPA fully support the strengthening of governance arrangements for the safe management of controlled drugs however we are concerned that any increase in regulatory burden may incur costs for community pharmacy. We believe that any increase in costs must be considered and reflected in Government decisions regarding the costs of the community pharmacy service.