AUTH/2198/1/09 - Primary Care Trust v Solvay

Patient identification programme

  • Received
    14 January 2009
  • Case number
    AUTH/2198/1/09
  • Applicable Code year
    2008
  • Completed
    09 December 2009
  • Breach Clause(s)
    2, 18.1 and 18.4
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Advertisement
    Audit of company’s procedures
    Public reprimand
    Re-audit
  • Appeal
    No appeal, report from Panel to Appeal Board
  • Review
    February 2010

Case Summary

The assistant medical director of a primary care trust (PCT) complained that a service provided to a general practitioner by Solvay had led to the inappropriate prescribing of Omacor (omega 3-acid ethyl esters 90).

The complainant explained that the GP had met the Solvay representative who promoted Omacor. The GP thought that patients would benefit from the medicine and he signed an agreement with Solvay which provided an unconditional financial grant to audit patients with cardiovascular risk factors and review their long term management. The agreement named a nurse who would do the audit. The GP had been introduced to the nurse by the Solvay representative and although he might have been shown a protocol by the nurse no copies were kept and so nothing was known about it. The GP thought the nurse was identifying patients who had a history of cerebrovascular or coronary heart disease or hypertension or abnormal lipids. The nurse had access to the medical records, identified 'suitable' patients and put Omacor on repeat prescriptions. The GP signed the prescriptions and the letters explaining why the medicine was prescribed. The complainant did not know if the GP was offered any inducement.

The complainant submitted that the matter raised concerns about the nurse and the GP; it had also identified issues relating to Solvay's promotion of Omacor. Breaches of the Code were alleged.

The detailed response from Solvay is given below.

The Panel considered that it was not necessarily unacceptable for pharmaceutical companies to sponsor audits in general practice. The supplementary information to the Code prohibited switch programmes but genuine therapeutic reviews which aimed to ensure that patients received optimal treatment following clinical assessment were acceptable. The decision to change or commence treatment must be made for each individual patient by the prescriber and every decision to change an individual's treatment must be documented with evidence that it was made on rational grounds.

The Panel noted Solvay's submission that it had given the GP unconditional grants to audit patients at increased cardiovascular risk to review their therapy between November 2006 and June 2007. Approximately £1,700 had been given to cover the cost of a nurse to do the audits. As part of the agreement the GP was offered template letters to recall patients for review. It was not clear whether all the patients prescribed Omacor following the audit met the licensed indications.

The Panel noted that the details of that audit were unknown to Solvay. It appeared that the company had no way of knowing if it was paying for a clinically robust audit. This was unacceptable. In the Panel's view, pharmaceutical companies sponsoring third parties, particularly individuals, must be reasonably confident that their proposed activities were clinically sound and complied with the Code. In addition to funding and agreeing that the audit be performed by an external healthcare practitioner, Solvay had, in letters to the GP, stated that the audit would be performed by a named nurse. Solvay had, in effect, provided the nurse to do the audit who the company understood had some expertise in similar audits. Again the Panel considered that this was unacceptable; if the company was recommending staff to carry out the audit it should be sure that they had the necessary expertise. In the Panel's view, by introducing the nurse to the practice, Solvay had to assume some responsibility for her actions.

The Panel was concerned about the representative's role. Although Solvay stated that the representative had sought authority for financial support to be given, it appeared that no regional sales manager or healthcare development manager had discussed the project with the GP as recommended in guidance issued to the field force. The representative had provided the GP with the contact details of the nurse and had arranged for the GP to sign the agreement regarding the support to be provided by Solvay. The representative had delivered the cheque which represented the fee to be paid to the nurse for conducting the audit. In the Panel's view the delivery of cheques to doctors by representatives in this way gave a very poor impression; it might be perceived by some to be an inducement to prescribe the company's products given the prime role of a representative was to promote medicines.

The Panel noted Solvay's involvement with the audit and subsequent therapy review and considered that it was inextricably linked to it. The company had given the GP approximately £1,700 but had had no oversight of the protocol; it had, in effect, provided a nurse to do the audit although it appeared to have no evidence that she was suitably experienced to be able to conduct the audit or knowledge of what she was going to do. The Panel considered that the vague arrangements which existed were wholly unacceptable; the arrangements were such that Solvay had no way of ensuring that the grant which it had given to the GP would be used for an appropriate purpose. The Panel considered that the arrangements were such that they did not constitute a bona fide medical andeducational good or service. The Panel ruled a breach of the Code.

The Panel noted that data provided by the complainant showed that the prescribing of Omacor in the practice in question greatly exceeded the prescribing of Omacor in the other practices in the area. The Panel further noted that shortly after receiving each letter from Solvay regarding the provision of more money (November 2006, January, April and June 2007) prescribing of Omacor in the practice in question increased. The Panel also noted the complainant stated that following the meeting with the representative the GP considered his patients would benefit from Omacor and he signed an agreement with Solvay. The Panel noted its concerns about the role of the representative. The Panel considered that on the balance of probabilities the delivery of cheques by a representative in association with an unacceptable service amounted to an inducement to prescribe Omacor in breach of the Code. The Panel had no evidence that the grants constituted the disguised promotion of Omacor. No breach of the Code was ruled in that regard.

The Panel was very concerned about the overall arrangements set out above. The Panel further considered that given its involvement in the process, Solvay's failure to assume any responsibility for the audit which it facilitated meant that the conduct of employees had fallen short of competent care such as to bring discredit upon or reduce confidence in the pharmaceutical industry. A breach of Clause 2 was ruled.

The Panel was extremely concerned that Solvay appeared to have no procedures in place for ensuring that grants given to facilitate general practice audit were spent on valid audits/therapy reviews and the like. The Panel was also concerned that Solvay would recommend third parties to perform the audits/reviews, without knowing their relevant qualifications or experience to perform such tasks, but take no responsibility for their actions. The Panel decided to report Solvay to the Code of Practice Appeal Board in accordance with Paragraph 8.2 of the Constitution and Procedure. In accordance with Paragraph 7.1 of the Constitution and Procedure, the Panel further required Solvay to suspend the provision of grants for patient identification programmes and the like such that no new agreements were signed.

Solvay accepted all of the Panel's rulings of breaches of the Code.

The Appeal Board was very concerned that Solvay had provided grants in the form of cheques via its representative to the GP on four separate occasions. The Appeal Board considered that it was inappropriate for a representative to hand over money to a doctor. The company had no processes to enable it to check that the money was used to pay a nurse to conduct an audit and how long that would take or that the audit itself was appropriate.Further there was no assessment of the first audit before providing a cheque to the same doctor for the next audit. The Appeal Board did not accept that the payment to the doctor was unconditional as submitted by Solvay. It was provided for a specific reason – ie an audit. The Appeal Board was further concerned that the nurse, introduced to the GP by Solvay and employed by him to undertake the patient identification programme, had not been assessed by the company with regard to her ability to carry out the task for which she was to be paid. There was a failure of management.

The Appeal Board further noted that there appeared to be a marked consequential increase in the prescribing of Omacor by the GP concerned and it queried whether, as a result, patients had been put at risk.

The Appeal Board decided in accordance with Paragraph 11.3 of the Constitution and Procedure to require an audit of Solvay's procedures in relation to the Code to be carried out by the Authority. The audit should be conducted as soon as possible. On receipt of the audit report the Appeal Board would consider whether further sanctions were necessary. In addition the Appeal Board decided that Solvay should be publicly reprimanded.

Upon receipt of the audit report the Appeal Board noted with concern that some of Solvay's policies still needed to be changed so as to ensure compliance with the Code. The Appeal Board decided, in accordance with Paragraph 11.3 of the Constitution and Procedure, to require a further audit of Solvay's procedures in relation to the Code to be carried out by the Authority. The audit should be conducted in November 2009 when the Appeal Board expected Solvay's standard operating procedures (SOPs) to be completed. On receipt of that audit report the Appeal Board would consider whether further sanctions were necessary. In accordance with Paragraph 13.6 of the Constitution and Procedure the Appeal Board decided that an interim case report should be published on the PMCPA website.

Upon receipt of the re-audit report the Appeal Board noted that Solvay had made much improvement since the audit on 5 June 2009. The Appeal Board decided that on the basis that the recommendations from the re audit were either implemented or ongoing no further action was required.