UK GUIDELINES ON STANDARDS FOR MEDICAL INFORMATION
DEPARTMENTS (REVISED 2004)
High quality up-to-date information about medicines
is essential for their safe and effective use in treating patients.
Pharmaceutical company medical information departments are a leading
source of such information, including information that is not
available from other sources. The importance of this role is recognised
in the ABPI Code of Practice
(Clause 13) which states that companies must have a scientific
service which is responsible for information about medicines which
Appreciating the need for high standards in
the provision of medical information, AIOPI has drawn up the following
guidelines after consultation with key customers. The original
guidelines were written in 1995 with the latest revision in 2004.
Adherence to the guidelines is necessarily voluntary.
They are however recommended to all companies as representing
practicable standards indicative of a high quality of service
in medical information.
Companies must have a clearly identified
resource to deal with medical, pharmaceutical and technical enquiries.
The telephone number(s) of the medical
information service should be advertised in appropriate publications
such as the ABPI Medicines Compendium, MIMS, the British National
Formulary (and their electronic versions), and the UK Company
website. Where appropriate, a direct-dial number to Medical Information
should be used.
Any medical information provided
via either an open or password protected website should comply
with these guidelines and with the ABPI Code of Practice.
Procedures should be in place to
ensure that customers are routed to the appropriate department
as rapidly as possible.
Procedures should be in place for
answering enquiries from healthcare professionals, from patients
and the public, and from other groups, eg press, police, coroners
Letters, faxes and e-mails must be
read promptly and dealt with appropriately. Where possible e-mails
should be acknowledged promptly.
A standard procedure should be in
place for handling telephone calls covering:
Speed of responsecalls
should be answered with minimal delay. The use of answering machines,
voice-mail and interactive voice routing (IVR) systems to deal
with medical information enquiries should be avoided. However,
if direct-dial answering machines or voice-mail systems are used,
there must be an automatic re-routing facility or alternative
number for callers to obtain an immediate response in emergencies.
If IVR systems are used, the menus should be kept to a minimum.
Identification of the person
answering the callit must be made clear immediately
to the caller whether he/she is talking to a person who will be
able to answer the enquiry or to someone who will take a message.
Where company policy permits, it is recommended that medical information
staff identify themselves to customers by first name only.
telephone calls must at all times be helpful, courteous and easily
should be appropriately trained and/or use prompt lists when taking
details of telephone enquiries to help ensure that they are properly
understood and that sufficient details are taken.
calls inconveniences callers and should be avoided or, if essential,
kept to the absolute minimum (ideally no more than one transfer
within or from the department). Relevant details should be provided
to the recipient of the call.
Putting customers "on
hold"if it is clear that it may take longer than
two minutes to answer the customer's question, then he/she should
be told this and given the option of holding or being rung back
by an agreed time.
a return call has to be made to the enquirer a deadline for this
must be agreed and adhered to.
be a procedure to ensure that appropriate staff are available
or can easily be contacted throughout office hours, including
lunch times, and that deputies are available when staff are out
of the office eg during holiday periods. An appropriate procedure
must also be in place to deal with emergency out-of-hours enquiries
(evenings, weekends, public holidays etc).
All reasonable steps must be taken
to identify enquirers, who should be answered in accordance with
their status or profession.
A policy should be agreed with the
company's legal department on the length of time, types of enquiries
and what level of detail should be retained for legal, regulatory
audit and potential litigation purposes. Such records may include:
details of the enquirer;
the nature of the enquiry;
referral to other departments
details of information provided;
who provided the information
Companies should have a procedure
to ensure the most current prescribing information is displayed
in relevant hardcopy and electronic publications. Details of changes
to Summaries of Product Characteristics (SmPC) and Patient Information
Leaflets (PIL) should be sent to publications such as the electronic
Medicines Compendium website (www.medicines.org.uk), MIMS and
electronic MIMS (www.emims.net), BNF, Chemist & Druggist,
and Pharmaceutical Journal. Additional methods of supplying SmPCs
and PILs to healthcare professionals and the public (eg post,
via representative, e-mail, Internet) may be used as appropriate
and as permitted by current legislation and codes of practice.
To facilitate safe dispensing of
products, all healthcare professionals involved in dispensing,
including community pharmacists, require prior warning of new
product launches. It is standard practice for companies to send
letters to wholesalers, after licence but before launch, to enable
stock purchase. Companies should also circulate wholesaler letters
to groups such as the National Pharmaceutical Association (www.npa.co.uk)
and the UK Medicines Information network (www.ukmi.nhs.uk). All
letters should be accompanied by full prescribing information
and PIL where possible.
When products are discontinued, changed
or divested, medicines information centres (www.ukmi.nhs.uk) must
be promptly notified directly or via the pharmaceutical press.
In the case of divested products a procedure must be agreed for
transfer of information to the new owner to enable that company
to maintain an adequate medical information service. For discontinued
products, the DoH/ ABPI Best Practice Guidelines for discontinuation
should be followed (www.doh.gov.uk/discontinuedmedicines/discontinuedmedicines.pdf)
A procedure should be in place to
notify appropriate medical staff and pharmacists of urgent important
information, eg availability, contra-indications, warnings and
adverse effects. All such letters/notices should be sent to all
UK Medicines Information centres.
Requests from external customers
for information relating solely to another company's product should
be referred promptly to that company.
In response to a request for advice
on the treatment of an individual patient using a prescribed medicine,
factual information may be given. The decision about treatment
remains the responsibility of the patient's prescriber. Medical
information departments should be aware of the needs of healthcare
professionals and should be as helpful as possible in sharing
expertise, knowledge and information to aid decision-making. If
a medical opinion is required the enquirer should be referred
to a company medical adviser or other medically qualified person.
Information provided should normally
be within the terms of the product licence. However, information
may be supplied in response to enquiries from appropriate health
care personnel on an unlicensed drug or on the use of a licensed
drug outside the terms of the product licence, provided it is
made clear to the enquirer that use of the product in this way
is unlicensed and remains totally the responsibility of the prescriber.
Information on new drugs before marketing
or on unlicensed products may be provided to healthcare personnel
on request. Information may also be provided pro-actively to those
involved in planning the introduction of new products provided
that this complies with the supplementary information to clause
3.1 of the ABPI Code of Practice.
People are increasingly aware of
and involved in their own medical care, and information of a medical
nature is becoming more accessible (eg via NHS Direct or the Internet).
This means that patients who are already well informed about their
condition and its treatment may be contacting companies. Their
current level of knowledge about their treatment should be assessed
before any information is given.
Enquiries from the public, including
patients, must be handled in accordance with the requirements
of the ABPI Code of Practice (specifically Clause 20). Such enquiries
must be answered with care and judgement, and a decision must
be taken in each case as to whether the company can responsibly
answer the enquiry.
Factual information about a medicine
may be given, but anyone requesting information or advice outside
the scope of the relevant SmPC or PIL should be recommended to
consult their doctor, pharmacist, or other healthcare professional
Many health information and patient
organisations now exist and it may be appropriate to give details
to members of the public so that they may obtain more information
about specific conditions. There are also a number of publicly
available documents which might be appropriate eg SmPCs, PILs,
EPARs (European Public Assessment Report).
Additional information may be provided
in response to public enquiries about General Sales List (GSL)
or Pharmacy only (P) products. As the public are exposed to claims
about efficacy, relevant factual information can be provided depending
upon company procedures. However, the information provided must
not be promotional or be seen to be making any promises regarding
efficacy and safety. Any enquiries regarding the use of GSL/P
products in patients with concomitant illness or taking other
medicines should be referred to their doctor, pharmacist, or other
In some situations when people request
information on personal medical matters it may be appropriate
to provide information directly to their doctor such that they
can discuss it at their next visit. Under such circumstances permission
must be obtained from the patient. The nature of the enquiry and
the limitations placed on the company in supplying information
directly to the patient must be explained to the doctor.
Some enquiries from the public may
alert the company to possible adverse reactions that have occurred
in association with the use of a specific product. In such situations
permission must be sought from the patient to contact their doctor,
and the company's usual pharmacovigilance procedures must be initiated.
Enquiries about adverse reactions,
overdose or use during pregnancy concerning any of the company's
products may require involvement of the company's pharmacovigilance
function. If the enquiry is of a general nature, and no patient
has experienced an adverse reaction with a specific product nor
has it been used in a pregnant patient, the enquiry should be
handled in accordance with the usual methods for answering enquiries
of a clinical nature.
Adverse reactions or overdose:
it should be established whether the enquiry concerns the clinical
use of any of the company's POM, GSL and P products, and devices.
If so, details of the adverse event(s) should be taken, and the
company's pharmacovigilance procedure followed. The National Poisons
Information Service may be an additional resource for enquirers
dealing with overdoses.
Use during pregnancy: it should
be established whether the enquiry involves use of any of the
company's products in a pregnant patient. If so, details should
be taken and the case followed up in accordance with the company's
usual process for obtaining such information; companies should
actively seek information about the outcome of pregnancies following
use of any of their products.
The answer and any subsequent follow-up
should be supplied within a deadline agreed with the enquirer.
If a response cannot be supplied by the deadline, the enquirer
should be notified that there will be a delay and should be given
the reason and a new deadline.
In the absence of an agreed deadline,
enquiries should be answered as quickly as possible. A reasonable
standard may be five to 10 working days depending on the nature
and complexity of the enquiry. The enquirer should be notified
if there will be a delay.
A procedure must be in place to ensure
that urgent requests on safety or other issues are expedited.
Medical information departments must
have a minimum set of up-to-date information resources to enable
them to provide comprehensive information on all the products
for which they are responsible. Further guidance on recommended
textbooks and electronic sources is provided by AIOPI (see www.aiopi.org.uk).
Medical information departments must
be able to easily identify published references on the products
for which they are responsible. They must also have access to
relevant unpublished information where it exists, including adverse
reaction reports, pharmaceutical information such as stability
studies, and clinical data.
Information professionals must have
(or have ready access to) detailed knowledge on the products supplied
by their company. There should always be someone available to
provide a knowledgeable response in the absence of the recognised
A procedure must be in place to ensure
that information resources are kept up to date.
For discontinued products only concise
product histories (eg alternative suppliers where appropriate)
need to be kept.
Medical information departments often
receive enquiries via third parties such as company representatives.
Departments should therefore ensure that such third parties are
briefed on the appropriate use of the services provided. Third
parties should have a thorough understanding of the services that
can be provided and the standards and regulations to which the
Medical information professionals
should have suitable qualifications or experience. This would
normally be a degree in pharmacy, pharmacology or a life science
or an appropriate equivalent qualification or experience.
All medical information professionals
must receive training appropriate to the level of their responsibilities.
They should have an up-to-date working knowledge of the following
subjects if they have not been covered in previous training, academic
studies or job experience:
pharmacy and pharmacology;
areas of medicine related to
products for which they are responsible;
information sources and information
evaluation of information;
communication skills and written
presentation of information;
regulations and codes of practice;
health economics and evidence-based
public relations and marketing
AIOPI endorses the MSc/Diploma in
Pharmaceutical Information Management run by the City University
London as well as the MSc/Diploma in Pharmacovigilance run by
the University of Hertfordshire.
Medical information staff must demonstrate
high standards of customer care, with a helpful and responsible
attitude, and effective communication skills.
Medical information departments must
set and monitor compliance with quality standards, which should
include the following:
information supplied must be
accurate, fair, objective, unambiguous and up to date and must
reflect all the available evidence clearly;
comparisons between products
must be based on an objective review of all the evidence and must
reflect that evidence fairlydifferences between products
must not be exaggerated;
information must be relevant
to the enquiry and the specific needs of the enquirer;
any additional product-related
information supplied that is not directly relevant to the enquiry
must be treated as promotional material, must comply fully with
the ABPI Code of Practice and must be appropriately certified;
for those enquiries requiring
a literature search, a search record should be maintained and
details should be provided to the enquirer if appropriate;
the term "Medical Information"
must not be used to describe promotional materials or materials
used for promotional purposes;
companies should put into place
a procedure to encourage feedback and deal with complaints about
their medical information service.
Medical information departments must
have appropriate systems in place to monitor their performance
and should carry out audits at regular intervals. Appropriate
performance indicators include the following:
telephone calls should be answered
quickly (within five rings);
during office hours appropriate
staff must be available to deal with telephone enquiries at all
times or must be able to be reached with minimal delay (no more
than five minutes) when information is required urgently;
enquiries requiring a written
response should be answered in a timely manner or by a deadline
agreed with the enquirer. In the absence of an agreed deadline,
a reasonable standard may be five working days for straightforward
enquiries and 10 working days for more complicated enquiries;
customers' views of the quality
of service and information provided should be assessed periodically,
for example by questionnaires relating to specific enquiries or
surveys. An industry standard questionnaire should be used to
encourage benchmarking. Additional questions can be added to the
for appropriate enquiries, feedback
should be obtained from the enquirer on the value of the information
providedhow it was used and what actions/decisions were
taken because of it.
For the current version of this document, please
consult the AIOPI website (www.aiopi.org.uk)
18 The Code of Practice reflects the requirement
for a scientific service in charge of information laid down in
the European Directive on Advertising of Medicinal Products for
Human Use (92/28/EEC) and the UK Medicines (Advertising) Regulations