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 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literature such as reports of clinical trials, and from unpublished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 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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