Table of Contents
Medicines Information Project
Medicine Guides
Roll out of the Project
Medicines Information Project
What is the Medicines Information Project? [Top 
]
The Medicines Information Project (MIP) exists to improve the quality of
medicines information for patients and the public. The project aims to provide
information that will encourage and enable patients and the public to make
informed decisions about their own health, be more involved in treatment
choices and make the best use of medicines. The MIP is taking a significant
step towards this vision by developing a new, structured source of information
linking medical conditions, major treatment options and individual medicines,
aimed at patients and the public.
How did the MIP come about? [Top ]
The vision and momentum for the MIP came originally from the AAMW Executive1.
With a growing awareness of the gap in the provision of high quality, reliable
and patient-friendly medicines information, the AAMW Executive brought together
a number of organisations that were already committed to improving medicines
information for patients. A common vision was agreed through this collaboration
and the MIP developed through a pilot phase to the current stage of planning a
comprehensive future rollout.
What is the main objective of the MIP? [Top ]
The MIP aims to encourage and enable patients and the public to make informed
decisions about their own health, be more involved in treatment choices and
make best use of their medicines. To facilitate this, the MIP aims to deliver
high quality, accessible and reliable information about medicines and treatment
options to patients and public.
What evidence is there for the need to improve patient information?
[Top ]
There are many research studies and national surveys that demonstrate patients'
information needs are not being met. For example in a MORI survey of 1864
adults conducted for Medicines Partnership in 2004, 44% of people who had been
prescribed a new medicine over the previous year felt that they did not know
enough about other possible medicines or treatments. And one in three people
surveyed thought that there is not enough information available about the risks
and benefits of medicines.
There is also well documented evidence about the limitations of the statutory Patient Information Leaflets, which many patients describe as difficult to
read, alarming and written for the benefit of company lawyers rather than
medicines users.
How is MIP funded? [Top ]
Funding for the production of Medicine Guides in the pilot phase was provided
by Datapharm Communications, with NHS Direct Online funding the development
of information on condition and treatment options.
On an ongoing basis, resources for the Medicines Information Project are being
provided from four sources:
- Central organisation of the project, including co-ordination of
the Board and the Advisory Group, is being provided by Medicines Partnership.
- Development of the NHS Direct Online content about medical
conditions and treatment options, linking to individual Medicine Guides, being
provided by NHS Direct Online.
- Funds for the development of individual Medicine Guides and
systems, processes and procedures to support them, provided by the
pharmaceutical industry, through a contribution from individual companies. The
funding model is based on a fee per product and contribution to development and
management costs based on companies' turnover.
- In addition to the financial resource, all partner organisations
involved are giving freely of their time and guidance in order to ensure this
project is delivered according to its guiding principles and within current
regulations for information provision. This support is of equal importance to
the financial resource required for implementation of the project.
What are the governance arrangements for the MIP? [Top ]
The project reports to the MIP Board, which represents key stakeholders in the
provision of medicines information. The Board has 17 members and meets
quarterly, with a supervisory remit for the project, giving it overall
direction and setting priorities.
How does the MIP link to other developments in medicines information? [Top ]
The project benefits from the input of an Advisory Group, drawn from experts in
the field of medicines information. Meeting 2-3 times a year, this group has a
strategic role, helping the project to gather new ideas and co-ordinate with
other developments.
Who writes the information for the MIP? [Top ]
NHS Direct Online have responsibility for the treatment and conditions sections
in the Health Encyclopaedia, overseen by their Editorial team. Additional
medicines content has been developed by working with a team of medicine
information pharmacists from the UK Medicines Information Pharmacists Group.
Individual Medicine Guides are authored by an independent team of clinicians.
There are clear standards and quality guidelines set out for authoring and the
process is overseen by Datapharm Communications.
How will the MIP be evaluated? [Top ]
Evaluation of the MIP includes:
- User feedback on the accessibility, content and format of the
information.
- Content testing by patients and patient groups.
- Assessment by organisations involved in the development and delivery of the
information.
- Assessment of the processes and guidelines by which the pilot
has been developed, e.g. whether the authoring system for the Medicine Guides
works and could be employed across a range of areas.
The NHS research and development programme is also considering a longer term
evaluation of the project, which will look at broader measures such as
behavioural change.
Was the pilot judged to be a success? [Top ]
Pilot Medicine Guides were produced for flu, epilepsy and cholesterol
medicines.
The pilot provided an opportunity to test the processes for authoring and
quality control of Medicine Guides,
to analyse the web traffic and to undertake some user testing.
Feedback collected over the course of the pilot was extremely encouraging:
- 90% of patients and 83% of health professionals found Medicine
Guides useful.
- 90% of patients and health professionals would use Medicine
Guides again.
- The majority of respondents who did not find the Guides useful
were looking for information on a condition other than epilepsy, flu or
cholesterol.
Feedback from patients during focus group sessions has been overwhelmingly
positive about the information, particularly as a resource when first
diagnosed. Some of the comments made by epilepsy patients are summarised below:
- 'This is the sort of information I spend ages looking for'.
- 'It is very factual, gives you what you want and treats you like
a grown up'.
- 'It is how it's written that makes me decide whether to
believe it or not... it's really good to have something attached to the NHS
with brand names of exactly what you're taking'.
How many people are currently accessing Medicines Guides? [Top ]
Our web user analysis shows that 34,000 requests for a Guide for either of the
pilot areas are being made each month. The majority of traffic is directed via
Google.
What disease areas were included in the MIP pilot? [Top ]
The pilot for the Medicines Information Project included epilepsy, colds and
influenza and cholesterol. Medicine Guides (which are for prescription
medicines only) have been developed for epilepsy, 'flu and cholesterol.
Why were these areas selected for the pilot? [Top ]
The pilot coincided with the NHS winter 'flu campaign and development of
Medicine Guides and information for influenza and colds supported this
campaign.
Epilepsy was selected as an area of health policy priority where there is a
clearly voiced need by patients for better information. It was also selected to
enable a more rigorous user evaluation in partnership with Epilepsy Action.
How can people access the MIP information? [Top ]
Information can primarily be accessed through the NHS Direct Online Health
Encyclopaedia (www.nhsdirect.nhs.uk)
and through the Datapharm website (www.medicines.org.uk).
The MIP is currently focused on the Internet as a production medium and
delivery mechanism. It exploits the flexibility and potential for customisation
offered by this medium, and also reflects growing trends in accessing health
information from online sources.
What about people who don't have access to the Internet? [Top ]
NHS Direct nurses will all have access to the pilot content on-line so will be
able to draw on the material in answering telephone queries from members of the
public.
The longer term vision for the project includes making the information available
in a number of formats and languages including Braille publications and audio
tapes, thereby reflecting the needs of different language speakers, those with
specific reading and learning abilities and with disabilities.
Isn't this a backdoor to Direct to Consumer Advertising? [Top ]
No. The project is focused on providing patients and the public with
information that is designed to encourage safe
and effective medicines use. The facts behind Medicine Guides come from
information already produced within
regulatory guidelines, which is available to the public in less user-friendly
forms. Medicine Guides are sought
out by ("pull") patients rather than being pushed at them through the normal
consumer advertising channels.
A condition of participation for organisations on the MIP Board is that the
project is non-promotional and non-prescriptive; no product is recommended
above another. In drawing up guidelines the Board has been careful to exclude
any element that might be construed as �promotion�. As a result information is
to a consistent standard for all medicines, old and new and comparative
information in relation to one medicine against another is excluded. Medicine
Guides are also linked to information that details the full range of treatment
options for each condition, which cover surgery and lifestyle as well as
pharmaceutical solutions.
How does this relate to European Regulations? [Top ]
Interpretation of the current regulations in the UK and Europe prohibit the
�promotion� of prescription only medicines by any entity. However, provision of
non-promotional information about medicines is permissible. The information
provided by the Medicines Information Project (including that in Medicine
Guides) is non-promotional. This core principle has been agreed by the Board
and clear standards are in place to prevent the recommendation of one product
over another.
Why is the industry involved? [Top ]
The MIP is an inclusive venture and has engaged all key stakeholders in the
provision of medicines information, including industry, in a groundbreaking
collaboration. Each partner in the project has a specific interest and is able
to add a unique dimension. The research-based pharmaceutical industry is the
generator of core information about its medicines and is therefore well placed
to provide a quality assurance role in the development of Medicine Guides that
ensures they are technically accurate and conform to the approved uses of
medicines.
Many changes occur each year that affect medicines information and the
manufacturer of an individual medicine is usually the first to have this
information. It is through industry involvement in the project that the
information included in individual Medicine Guides will be updated as quickly
as possible.
Is this just a front for the industry to sell more drugs? [Top ]
No. The aim is to provide patients with useful, objective and reliable
information to support them in making informed choices about their treatment,
without telling them what is best for them. The project is a significant
attempt to counter concerns over the quality of existing information and
responds to the increasing demands from the public for better sources of
reliable information.
The MIP is a broad based coalition involving government agencies, industry,
statutory bodies, healthcare professionals and patient groups with the ultimate
goal of improving public health. The MIP aims to be an unbiased and
non-prescriptive source of reliable information available in the public domain
and operating within existing regulatory guidelines.
Medicine Guides
What are Medicine Guides? [Top ]
Medicine Guides are electronic documents about individual medicines that can,
in the longer term, be presented in a number of formats and media. Medicine
Guides aim to help patients to understand their medicine better. The technical
content of the Guides is consistent with the content of the Patient Information
Leaflet and the Summary of Product Characteristics but they are not regulated
documents in the same way. They comply with a set of agreed Guidelines,
endorsed by the Medicines Information Project Board, which in turn will be
continuously developed to reflect the current legal framework for communication
about medicines to the public.
Why are Medicine Guides being produced? What is new about the Medicine
Guides in comparison to Patient Information Leaflets? [Top ]
Regulated information that patients receive about medicines is currently
limited to the Patient Information Leaflet (PIL) in the format of a medicines
pack insert. There are many issues over the organisation, scientific language
and terminology used in these documents. Many patients find them hard to read,
frightening and written for the benefit of company lawyers rather than
medicines users. In addition, they only cover one drug and can only be accessed
once a prescribing decision has been made.
Medicine Guides are potentially more useful to patients and the public than the
existing PIL because:
- They are flexible: users can tailor their Guides by using the
navigation system.
- They are linked to other information resources so the user can
'click-through' to explanations of the terms used in the Guide and to further
sources of help.
- They can be printed out in large size.
- They are easily available before a medicine is dispensed.
- They are linked to information about the medical condition
itself and different treatment options.
- As internet-based resources, they can form the basis of many
different formats and presentations.
Do Medicine Guides replace Patient Information Leaflets? [Top ]
No. Patient Information Leaflets (PILs) are designed to meet the labelling and
safety regulations laid down in European law. Medicine Guides are designed to
complement the PIL, expanding much of what constitutes the PIL in plain
language, to a consistent standard and in more formats than currently
available. The focus of Medicine Guides is to communicate important information
to the reader in a balanced and explanatory way that is often difficult given
the physical limitations of the pack insert. It is part of this programme�s
objectives to ensure that PILs develop alongside Medicine Guides.
How are issues on the presentation of risks and benefits being dealt with? [Top ]
The project has a working group on risk communication. This group is
collaborating with the CSM (Committee on Safety of Medicines) Patient
Information Working Group to identify options for improving the clarity of
communication about risks of adverse reactions.
Why are Datapharm producing the Guides? [Top ]
Datapharm is a not for profit company whose objective is to improve public
health through the provision of better health information. Datapharm has
already developed a substantial asset in the electronic Medicines Compendium
(www.medicines.org.uk) and the production and publishing of the Medicine
Guides, as part of the MIP is a logical extension of this facility.
Where does the information in Medicine Guides come from? [Top ]
Medicine Guides are based on technical data for the active ingredient or
medicine brand, (drawn from the electronic Medicines Compendium and consistent
with data in the Patient Information Leaflets and Summary of Product
Characteristics) and are put together using an authoring system that draws on a
vocabulary of terms and phrases that have been developed with the patient in
mind.
What input do pharmaceutical companies have to the production of the Guides? [Top ]
Pharmaceutical companies have the opportunity to review the technical data for
their brands and recommend changes. This is to ensure that Medicine Guides are
based on the most up-to-date information. The Medicine Guides Quality Assurance
Team review recommendations and decide whether it is appropriate to make
changes. The pharmaceutical companies only review the data - it is the authors
who decide on the wording and how best to present the information in a
user-friendly way.
Companies involved in the project are also invited to join Condition Scoping
Groups, along with other stakeholders such as patient organisations. These
groups give general input and advice relating to authoring Medicine Guides
across a whole condition, rather than commenting on individual Guides for
specific medicines.
Who makes the final decisions about content? [Top ]
As authors, owners and publishers of the Medicine Guides, Datapharm are liable
for their contents. Accordingly, Datapharm exercises the final editorial
decision on what is published.
When will Medicine Guides be available? [Top ]
The Medicine Guides for three pilot areas, epilepsy, flu and cholesterol have
been available online since October 2003. Guides for all other conditions will
become available over the course of the next 2 years.
What disease areas will the Guides cover? [Top ]
Datapharm is committed to developing Medicine Guides for all POM (Prescription
Only Medicine) status medicines by 2007 and the funding has been secured in
order to ensure this can be achieved.
Do Medicine Guides include all available products for a condition? [Top ]
The intention of the project is that Medicine Guides will be developed for all
available prescription medicines. This will include generic and branded
medicines so that the user can identify the product they have been given. There
will be a generic Medicine Guide for every product and branded Medicine Guides
will be developed for those companies who have supported the project
financially.
Have patient groups been consulted as part of the process of development? [Top ]
Patient organisations are represented on the MIP Board and play a key role in
steering the direction of the project with the user in mind. This includes
Epilepsy Action, who were consulted on the development of the Guides for the
pilot in epilepsy and played a key role in evaluation of the pilot. A
representative of the Long-term Medical Conditions Alliance also sits on the
MIP Board.
Patient organisations active in the area of hyperlipidaemia (high cholesterol)
have already been contacted and we look forward to closer involvement with
these organisations in the continuing improvement of Medicine Guides in this
area. A wider consultation of patient groups will commence this year, starting
with medical conditions that have been prioritised for the development of
Medicine Guides.
Roll Out of the Project
Which Medicine Guides will be made available next and when? [Top ]
Medicine Guides are currently being developed for all Prescription Only
Medicines licensed in the UK. For a publishing schedule please view the
Medicine Guides Roadmap.
How is the roll out of the project being funded? [Top ]
NHS Direct will continue to develop and fund the condition and treatment
options information.
Medicine Guides will be funded by the pharmaceutical industry with participating
companies contributing an amount based on their product portfolio and turnover.
Medicine Guides will be written for all medicines by generic ingredient.
Branded Guides will only be produced for those companies who have made a
financial commitment to support the project. Brand names will appear in the
list of available medicines but users will be re-directed to the generic
ingredient Medicine Guide if they click on a brand for which no Guide is
available.
Medicines Partnership is supporting the central co-ordination of the project
including the MIP Board and the Advisory Group.
In addition to the financial resource required to roll out the project, all
partner organisations involved are giving freely of their time and guidance to
ensure the project delivers against its guiding principles and within current
regulations for provision of information to patients. This support is of equal
importance to the financial resource required for implementation of the
project.
When will there be Guides for all medicines? [Top ]
Datapharm has committed to producing Medicine Guides for all Prescription Only
Medicines by 2007. If a condition has already been completed and a new medicine
is made available then a Guide will be written for that as quickly as possible
to ensure comprehensive information is available.
How will people know when Medicine Guides become available for the different
conditions? What are your plans to publicise them? [Top ]
To date there has been no specific publication of the Guides, and users have
found them largely by using search engines for a condition or medicine, via the
NHS Direct Online pages or via medicines.org.uk. The intention for the longer
term is to make the link to Medicines Guides more prominent within the NHS
Direct Online treatment section. We also anticipate that in the longer run
other information sources, for example patient support groups, will link to
this information resource.
There is also a longer term intention to make the core information available
through a range of channels, including touch screen kiosks, digital TV and
paper-based information as well as in different languages and formats such as
large print for the visually impaired.
1 AAMW is made possible through
the unique consortium of Doctor Patient Partnership (www.ddp.org.uk),
the Task Force on Medicines Partnership (www.medicines-partnership.org)
and the pecmi (promoting excellence in consumer medical information) working
group (www.pecmi.org)