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The Pharmaceutical Journal
Vol 278 No 7438 p173
10 February 2007


Society summary

 Law and Ethics Bulletin

An occasional feature, prepared in the Royal Pharmaceutical Society’s Professional Standards Directorate, to highlight problems and inquiries currently being handled

Law and Ethics Bulletin, 2001 to present

• Metropolitan Police investigations and release of patient confidential data
• Medication error logs


Metropolitan Police investigations and release of patient confidential data

The Metropolitan Police is currently investigating a serious major crime that may have implications nationally. It is possible that individual pharmacists in a number of areas across the country may be approached by the Metropolitan Police in respect of patient confidential information they hold regarding the supply of particular prescription items. Before any patient confidential information is supplied, the investigating officers should serve on the individual pharmacist the relevant authority in the form of a request under Section 29(2) of the Data Protection Act 1998, which should be signed by an officer of inspector rank or above.

Investigating officers from the Metropolitan Police have been in contact with senior members of staff from the Society and can confirm that the information that may be requested is justified and its release is in accordance with Society guidelines.

To be in accordance with Society guidelines any disclosure of patient confidential information must comply with both the legislation and the pharmacists’ Code of Ethics, which states the circumstances in which a pharmacist may disclose information without a patient’s consent. Paragraph (b)(v) below would apply in the circumstances described above.

C. Confidentiality
The public expects pharmacists and their staff to respect and protect confidentiality. This duty extends to any information relating to an individual which pharmacists or their staff acquire in the course of their professional activities. Confidential information includes personal details and medication, both prescribed and non prescribed.

Pharmacists must ensure that:

(a) the confidentiality of information acquired in the course of their professional activities is respected and protected, and is disclosed only with the consent of the individual other than in the circumstances defined below in (b).

(b) information is disclosed without the patient’s consent only in the following circumstances:

(i) where the patient’s parent, guardian or carer has consented to the disclosure and the patient’s apparent age or health makes them incapable of consent;

(ii) pharmacists should be aware that information about services provided to adolescents should not normally be disclosed to their parents;

(iii) where disclosure of the information is to a person or body empowered by statute to require such a disclosure;

(iv) where disclosure is directed by a coroner, judge or other presiding officer of a court, Crown Prosecution Office in England and Wales and procurator-fiscal in Scotland;

(v) to a police officer or NHS Fraud Investigation Officer who provides in writing confirmation that disclosure is necessary to assist in the prevention, detection or prosecution of serious crime;

(vi) where necessary to prevent serious injury or damage to the health of the patient, a third party or to public health; …

The decision to disclose patient confidential details remains with the pharmacist who consents to the release of the data and patient confidential information may only be disclosed without the patients’ consent in one of the above circumstances. A copy of any written request for disclosure provided by the police under Section 29(2) of the Data Protection Act 1998 should be retained in the pharmacy in the event of any query.

If you are approached by the Metropolitan Police during the course of this investigation and have any concerns about disclosure of patient confidential information, please contact the Society’s legal and ethical advisory service on 020 7572 2308 for further guidance.

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Medication error logs

30 June 2007
As a result of recent developments and changes in the way that single dispensing errors are to be dealt with by the Society it is now necessary to revise and replace this Law and Ethics Bulletin on medication error logs

The maintenance of medication error logs is seen as good practice in pharmacy and, in line with clinical governance arrangements, should be included in pharmacy standard operating procedures.

Medication error logs are intended to be used as a risk management tool and information from the logs should be regularly reviewed, analysed and discussed within the pharmacy in order to identify risk areas associated with the dispensing and checking process. Appropriate action to review systems and procedures with a view to minimisation of future risk should be taken, where necessary.

Pharmacy owners and individuals may be apprehensive that information contained in medication error logs could be used as a basis for disciplinary action by the Society. However, the existence and regular audit and review of such logs is considered to be indicative of good practice and robust risk management. Their use is therefore encouraged.

During routine pharmacy inspections, Society inspectors may ask to see evidence that a system is in place to deal with dispensing errors, including the maintenance and use of medication error logs. However, inspectors will not ask to look at any of the actual records or any of the specific information held within those logs. Further information on the inspection of error logs during routine visits is contained in a monitoring and inspection checklist for inspectors (PDF 90K).

If the Society receives a complaint about a dispensing error, the inspector may, as part of the investigation, ask to see the specific error log which relates to the complaint under investigation. Evidence of the maintenance of an error log by the pharmacy (where the pharmacy has been made aware of the error) can be seen as evidence of good practice. It may be particularly helpful if the error log describes any review of systems carried out at the pharmacy in light of the incident.

On rare occasions where serious concerns have been raised about a particular pharmacy or about the fitness to practise of an individual, it may be necessary for error logs to be examined. This action would only be considered in extreme circumstances, where there was genuine cause for concern about public safety.

For further information on the handling of dispensing errors please refer to the document “Dealing with dispensing errors” (PDF 120K).

Those without access to the internet can obtain copies of the above-mentioned documents by contacting Seema Khan, Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN (tel 020 7572 2236; e-mail seema.khan@rpsgb.org

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