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Pharmaceutical Services Negotiating Committee

General News

Quintiles audits for adjustment to quota allocations

PSNC has been concerned to hear reports from pharmacies that Quintiles have been requesting access to confidential prescriber and sensitive patient data from patient medication records in order for pharmacies to adjust their allocation of medicines under manufacturer-imposed quota arrangements.  PSNC has been in contact with Quintiles who have stated that the audit serves a dual purpose: to ensure pharmacies have accurate information about their stock requirements, and to ensure the drug manufacturers have accurate information concerning pharmacy stocking requirements.  Quintiles describe this as a free of charge, (i.e. funded by the pharmaceutical supplier) legitimate service facilitating these mutual objectives.

Patient medication records, which contain the patient’s sensitive data, are amongst the most confidential matters that pharmacies handle. Patients, the Information Commissioner and the NHS would expect their disclosure only where explicit consent has been given, or in the absence of consent, where there is an over-riding provision to allow lawful disclosure.

The arrangements in question, so far as we understand them, are that a nurse employed by Quintiles would visit the pharmacy to examine the records.  An ‘honorary’ contract is signed between the contractor and the nurse, purporting to employ the nurse for the duration of their visit.  It has been suggested that this would allow the nurse to have access to the same information as any other member of staff.  Quintiles stress that the nurses have professional as well as contractual obligations of confidentiality, and that the ‘honorary contract’ is in fact a legally binding tri-partite agreement between Quintiles, the nurse and the pharmacy.

PSNC believes that such an arrangement to allow access to individual patient records, without explicit patient consent on the grounds that pharmacy employees would normally have access to the PMRs would not be acceptable to the Information Commissioner or the NHS.  But we also question whether even a member of staff would have a right to examine the medication record for an individual patient for a purpose such as this, which is unrelated to the treatment of that individual patient.  We do not believe that it would be justifiable for the pharmacy to disclose a patient’s sensitive information to a third party to satisfy an audit of stock usage, carried out on behalf of a manufacturer.
We have raised our concerns with Quintiles, and they have agreed that their auditors will not in future request to see any patient identifiable information.  They will, however, request evidence from the PMR of the dispensing of the drugs they are auditing.  Pharmacists will need to ensure that during this process, there is no disclosure of patient’s details (such as name or address).  Disclosure of the details of prescriptions dispensed, omitting patient data, would be acceptable.
Quintiles has also indicated that it wishes to see details of the prescribers of the items that they are auditing.  Practice level prescribing information is publically available, but prescribers may consider that their individual prescribing should be treated as confidential information, and not be disclosed to an auditor funded by a pharmaceutical supplier.  Pharmacists who are to be visited by an auditor may wish to seek the views of the local prescribers before deciding whether to allow access to individual prescriber details.

Quintiles have also advised that they will continue to work with an Honorary Contract, which they believe makes clear their obligation not to disclose any sensitive information their audit staff may come across in the course of their audit work.  PSNC is not supportive of this system, and reminds contractors that the clinical governance requirements in the terms of service impose significant obligations on contractors when they employ or engage staff – such as checking registration and qualifications, taking up references, supporting CPD, identifying training needs, providing training on safeguarding, Information Governance (including confidentiality), and the SOPs in use in the pharmacy.  To protect any confidential information that may be seen during the course of the audit (for example, prescription volume, or overheard conversations about the clinical care provided to patients) the contractor may instead prefer to enter into a direct confidentiality agreement with Quintiles and their representative – but this is a matter for contractors.
There is good practice guidance agreed for products in short supply, to allow manufacturers and pharmacies to reach agreement over the supply of stocks subjected to quotas, but this does not include any requirement to disclose sensitive information.

For further information please refer to:
PSNC Information governance web page
‘Best Practice’ for supply
‘NHS Confidentiality: Code of Practice’

Posted 29 April 2013

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