Select Committee on Health Written Evidence


APPENDIX 7

Memorandum by the Association of Information Officers in the Pharmaceutical Industry (PI 15)

1.  INTRODUCTION

  The Association of Information Officers in the Pharmaceutical Industry (AIOPI) is the professional organisation for individuals in the pharmaceutical industry who are involved in the provision and management of information. It represents members from most pharmaceutical companies in the UK, including all the major research-based companies. Members are involved in a range of roles, but the following are of particular relevance to the Health Committee's inquiry:

        Medical Information

        Medical Information departments provide evaluated information on clinical aspects of medicines to healthcare professionals (eg, physicians, pharmacists and nurses) and to patients. The information provided is obtained from published literature such as reports of clinical trials, and from unpublished data held by the company, such as details of the formulations of medicines.

          Pharmacovigilance

        Pharmacovigilance is the process of monitoring the safety of medicines and collecting and analysing reports of possible side-effect. Pharmacovigilance departments provide information to healthcare professionals to aid safe and effective use of medicines.

  AIOPI is making this submission in order to provide information relevant to the Health Committee's terms of reference concerning the pharmaceutical industry's role in:

    —  the provision of drug information and promotion;

    —  professional and patient education;

    —  regulatory review of drug safety and efficacy.

2.  PROVISION OF INFORMATION ABOUT MEDICINES AND PROMOTION

  Medical Information and Pharmacovigilance departments in pharmaceutical companies provide factual, verifiable information about medicines to healthcare professionals, and to patients when appropriate. Information is usually supplied in response to inquiries; it is not sent proactively as a form of promotion.

  Research-based pharmaceutical companies have more information about the medicines that they market than any other source. They have information about the efficacy and safety of these medicines from the pre-clinical studies, clinical trials, and safety studies that have been carried out and they may have access to information from studies still in progress. It is essential for the appropriate and safe use of medicines that health professionals have access to all relevant information. It is a difficult and time-consuming task for them to find the information that they need from the many medical and scientific journals in which clinical trials, case reports, reviews, adverse event reports and other clinical information are published. In addition, especially when a new medicine is first available, some of the information may not yet have been published. Medical Information and Pharmacovigilance departments play a crucial role in supporting health professionals by finding and supplying the published information and unpublished data that they need. In this way they also help to ensure safe, appropriate use of medicines for patients' benefit.

  The value of these information services has been confirmed in surveys carried out by NHS hospital pharmacists of pharmaceutical companies' Medical Information departments (1). In the most recent survey, performed in 2003, pharmacists across the country contacted company Medical Information departments on 239 occasions on a single day (see http://www.aiopi.org/attachments/UKMIExec.pdf). The most common reasons for contacting the Medical Information departments were:

    —  the company was the only source of the information needed (47% of cases);

    —  the company was a more comprehensive source of information than other sources (37% of cases);

    —  it was quicker to obtain information from the company than from alternative sources (10% of cases).

  The importance of the service provided by Medical Information departments is emphasised by the fact that in over 70% of cases, the information requested by pharmacists in this survey directly or indirectly affected patients' treatment. Pharmacists rated the knowledge and competence of the Medical Information departments as excellent or good in 86% of cases.

  Medical Information and Pharmacovigilance departments operate to high standards. The activities of Pharmacovigilance departments in collecting and reporting details of possible side-effects of medicines are governed by statutory and regulatory requirements and are subject to regular audits to ensure compliance. Appropriate standards for the provision of information services by Medical Information and Pharmacovigilance departments are set out in AIOPI's UK Guidelines on Standards for Medical Information Departments (see Annex). A fundamental principle, which also accords with the ABPI Code of Practice, is that information supplied must be accurate, fair, objective, unambiguous and up to date and must reflect all the available evidence clearly.

  Particular care is taken in dealing with requests from patients. AIOPI's Guidelines on Standards for Medical Information Departments state that such inquiries must be answered with care and judgement. Departments may provide factual, non-promotional information about a medicine. However, if a patient requests advice about his or her treatment, or information outside the scope of the relevant Summary of Product Characteristics or Patient Information Leaflet, he or she will be recommended to consult a doctor, pharmacist, or other healthcare professional as appropriate.

  It should be clear from the above that pharmaceutical companies, through their Medical Information and Pharmacovigilance departments, provide non-promotional information about their medicines that is essential for the safe, effective and appropriate use of those medicines.

3.  PROFESSIONAL AND PATIENT EDUCATION

  The pharmaceutical industry plays an important role in educating health professionals and patients about medicines. As discussed in the previous section, research-based companies have more information about their medicines than any other source. It is appropriate that this information is made available in the form of educational programmes and materials to help health professionals to use medicines appropriately.

  Medical Information and Pharmacovigilance departments have a role in many companies in the production of educational items such as monographs and other factual material on new products for health professionals. They may also be involved in production of material for patients such as patient information leaflets.

  The aim of educational materials is to provide evidence to health professionals to help them in assessing a medicine, or to provide helpful information to patients who have been prescribed the medicine. As is the case when handling inquiries, Medical Information and Pharmacovigilance departments operate to high standards and the information in educational materials must be factual and must reflect the available evidence.

4.  INFORMATION PROVIDED IN THE REVIEW OF DRUG SAFETY AND EFFICACY

  Pharmacovigilance departments play an essential role in the review of the safety of medicines. They are responsible for collecting case reports of possible side-effects (adverse events) and for submitting such reports to the Medicine and Healthcare Products Regulatory Agency (MHRA) in the UK and equivalent bodies in other countries. Companies' Pharmacovigilance departments analyse these reports in order to assess any risks associated with a medicine, identify new side-effects or detect altered patterns of side-effects. This information is provided to health professionals to help ensure that patients are not exposed to unnecessary risks. If severe side-effects are discovered, or if the risk/benefit profile of the drug is altered a company will act promptly to notify the MHRA and doctors.

  It is a key requirement of Pharmacovigilance departments that they act ethically and in accordance with statutory requirements. There are requirements in the UK and other countries that companies must report serious side-effects to the relevant regulatory bodies promptly within specific deadlines. Companies devote much effort to ensure that these requirements are observed. They have standard operating procedures to ensure that staff understand their responsibilities, and all staff involved in pharmacovigilance undergo extensive training.

  Pharmaceutical companies do not wish patients to be harmed by their medicines. The information provided by Pharmacovigilance departments to health professionals can help to ensure that risks are minimised and that, if side-effects do occur, the best available information is provided to help the health professional and patient decide on the most appropriate course of action.

5.  CONCLUSION

  The information services provided by the pharmaceutical industry through its Medical Information and Pharmacovigilance departments are of significant help to the NHS. They provide factual information that may be difficult or expensive to find through other sources or that may not be available elsewhere. These departments operate to high professional standards in accordance with the AIOPI guidelines, the ABPI Code of Practice and statutory requirements.

  The industry advertises its products and promotes their appropriate use. Such promotion is governed by the requirements of the Medicines Act and the ABPI Code of Practice. The activities of Medical Information and Pharmacovigilance departments are non-promotional in nature and their value to healthcare professionals has been endorsed by the UK Medicines Information Pharmacists Group within the NHS.

REFERENCE

  (1) Standards Working Party of the Association of Information Officers in the Pharmaceutical Industry. A survey by medicines information pharmacists of the medical information services provided by drug companies. Pharmaceutical Journal 2001; 267: 66-7.



 
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Prepared 26 April 2005