FIP Congress 2006
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Jane Nicholson reports from a session that she co-chaired,
organised jointly by the Pharmacy Information and Industrial Pharmacy
Sections
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 The World Congress of Pharmacy and Pharmaceutical Sciences,
the 66th International FIP Congress, was organised by the International
Pharmaceutical Federation in association with the Federal
Council of Pharmacy of Brazil.
It took place in Salvador da Bahia from August 26 to 31, 2006
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Medicines information for consumers on the web — where are we now?
There are a number of well documented barriers that patients may encounter
in obtaining satisfactory information on their medicines and on their
general health. One of these is dubious or simply inappropriate information
obtained from the internet.
Pharmacists need to be able to discuss such
information with their patients and be able to point them in the direction
of good quality web-based information.
Setting the scene, Theo Raynor, of the University of
Leeds, UK, asked, “why
web-based information?” The general public is increasingly seeking
and using more information about their medicines. Spoken information
is usually brief and easily forgotten while web-based information is
more flexible than paper-based information in terms of potential for
access and customisation.
Since 2000, there has been a huge upturn in
the accessibility of the internet and health information is one of the
most popular topics, particularly for people seeking sensitive health
information.
However, we are only just scratching the surface with web-based
information, commented Professor Raynor, with current content often simply
the leaflet transposed to the screen. The real benefits will come with
the personalisation and interactivity that are possible on the web.
Professor Raynor suggested that paper-based information, such as patient
information leaflets (PILs), is “too negative, too narrow, too general and too late”.
Rather than focusing on the contraindications and side effects, more positive
information is essential. As people want information on the various options
available, PILs focusing on single products should be embedded within a wider
information source, said Professor Raynor.
Patient package leaflets include information irrelevant to many people and
the future should be towards personalised information. It is not sustainable
only to provide information after decisions about the patient’s medicines
have been made. The advantages of web-based information are that it is up to
date, can be personalised and is accessible before, during and after a consultation.
It can include videos, such as those used for inhaler use, it can produce information
in large print and it can generate sound for people with sight impairment.
Professor
Raynor noted that health-related internet searches are carried out both before
a consultation (the patient is deciding whether to
manage their care independently or request professional help) and after the
consultation (the patient wants reassurance or is not satisfied with the
information provided).
Health professionals respond in one of three ways.
Either they feel
threatened and reply defensively with their “expert opinion” or
the professional and patient collaborate in obtaining and analysing the information.
Alternatively, the professional guides the patient to a reliable and accurate
site for further information.
Professor Raynor said his group had conducted a search in Google for “ibuprofen” and “naproxen” and
evaluated 17 sites which contained more than 100 words on the two medicines.
The information was then compared with the approved PIL and the mean score
for completeness was only 50 per cent, with a range of 20 to 80 per cent. Eight
inaccuracies were found, including four serious ones related to dose.
His group is also collaborating with the UK Cancer Research Campaign. Visitors
to their website are invited to take part in research to assess different
ways of expressing the risk of side effects.
Under “challenges for the future”, Professor Raynor suggested the
pharmaceutical industry might be one of a range of information sources for
patients. Although not currently allowed in the EU, a pilot study has been
proposed by the European Commission for the industry to provide direct-to-patient,
non-promotional information on medicines for HIV/AIDS, diabetes and asthma.
Health Commissioner Markos Kyprianou has stated that the EU needs to adjust
its position and patients need to be made more aware.
Other challenges include how to make consumers more discerning, how to gain
web access for patients from the developing world, how to help older patients
and special groups such as the deaf, and those with sight loss or low literacy
to use web-based information.
In conclusion, Professor Raynor described the ideal source of medicines information
as accurate, up to date, reliable, practically useful, available at different
levels of detail, informative about conditions as well as treatments and
linked to other reliable sources of information. Shifting patient power
Steve Mott, of Datapharm Communications, UK, told the congress that
Datapharm is a not-for-profit organisation funded through subscriptions
from
130 pharmaceutical companies. Its website contains non-promotional
information that is open to the public and six million documents are
downloaded each year. It provides a mechanism for gaining a position
in search engines.
Research in 1977 had shown that 50 per cent of patients do not take
their medicines properly — and nothing much has changed since then, said
Mr Mott. The aim of the Medicines Information Project is a shift in patient
power to allow them to make informed decisions about their own health,
be more involved in treatment choices and to make the best use of their
medicines.
The project is a collaboration between patients, doctors, pharmacists,
professional bodies, the Department of Health, the Medicines and Healthcare
products Regulatory Agency and the industry. It is a bridge between the
health information provided by the NHS, patient groups’ online
services and the industry’s regulatory information (summaries of
product characteristics and patient information leaflets).
Medicines
Guides link the information about the disease and treatment options and
act as navigation aids to information on individual medicines. Key project
elements include producing a clearly defined plan, a pilot, proof of
concept, feedback funding (£2m development and ongoing £500,000
per year) and delivery on time. The organisation includes a board consisting
of all interested parties, an operations team, a reference group and
an advisory group.
The independent authors are pharmacists or medical
doctors who follow a charter and write to agreed guidelines, structure
and to a developed glossary. A Medicines Guide takes an average of
one day to write. How Medicines Guides will be presented has not yet
been
decided. The aim is to provide an interactive glossary, animations,
audio presentations, larger font sizes and special case side effects.
Navigation is via NHS condition codes and the underlying code is JavaScript.
In future, filtering and individual configuration will allow personalised
information.
Web-log analysis indicates 200,000 page views per month by 42,000 users.
Mr Mott emphasised the importance of the search engines in gaining
traffic, as three-quarters of hits are currently from Google and 80
per cent of
the time a Medicines Guide will appear in the top 10 within three weeks
of being written.
Adopting a progressive approach, in small manageable,
deliverable steps, not trying to solve all problems at once but standardising
the source information gives a stable base and limits the use of
experiential information. Exciting new developments are in the areas
of risk/benefit
analysis, user configured information such as interaction warnings
and potential links to patient records, said Mr Mott. Customised information
“My own drug information leaflet, customised according to who
I am and what I use and what is relevant for me to know”, was the
definition of personalised consumer medicines information (PCMI) provided
by Han
de Gier, of the Health Base Foundation and the University of Groningen,
the Netherlands.
As a first step, a leaflet containing the name and address
of the patient, instructions on how to use the medicine, with precautions,
practical information for special conditions and a selection of appropriate
sections from the PIL using age and gender of the patient, should be
printed in the pharmacy. The next step is presenting a full medication
record based on dispensed medicines, an personalised indication for use
with accessibility for people with special needs.
A 2003 survey among 170 Dutch community pharmacists using the Pharmacom
Information System had shown that most pharmacists (80 per cent) believe
patients should receive more relevant information and that they want
more personalised information on medicines.
A recent survey of 190 patients
visiting seven community pharmacies in Groningen and 29 patients in a
focus group was undertaken to identify the conditions that allow pharmacists
to use the options available. Patients were asked whether they would
like access to their medication records in the secure environment of
the pharmacy and to select one of their medicines to download as PCMI.
Eighty-three per cent of patients preferred the PCMI to the statutory
PIL in the pack. The PIL was read only at the first dispensing of the
medicine.
Of 10 pharmacists questioned, four thought PCMI to be a good idea for
patient empowerment, provided the PIL text was also available to prevent
mistakes. Four pharmacists had no particular opinion and two thought
it was a bad idea, because it is easy to make mistakes during a personal
consultation and the pharmacist would be held liable.
The patients’ opinions on PCMI were captured in focus group discussions,
explained Professor de Gier. Patients did not want too much information
to read in leaflets and the most useful information was considered to
be clear instructions for use and information on indications and side
effects.
As well as whether pharmacists and patients are ready to move forward,
important questions to be answered are who is responsible for the integrity
of the data base and who will pay for web-based PCMI, he noted. Confused picture in US
To explain the rather confused picture in the US, Gerald McEvoy, of
the American Society of Health-System Pharmacists, described the Food
and
Drug Administration’s moves to regulate patient package inserts,
medication guides and consumer medicines information over the past
40 years.
In 1996, a steering committee of health care professional
associations, consumer groups, voluntary health agencies, publishers,
the pharmaceutical industry and other stakeholders developed an action
plan for the provision of useful prescription medicines information
(the Keystone Guidelines). This plan was approved by the US Secretary
of Health and precluded the FDA from regulating CMI in the US, pending
achievement of some key goals by the private sector. The key aspects
were that information must be useful, scientifically accurate, unbiased,
non-promotional and up to date.
Unfortunately, the FDA’s interpretation
of the guidelines has resulted in a strong bias to explain the risks
rather than the benefits. In the FDA’s mandated 2000 assessment,
only community pharmacy CMI was evaluated; mail order and hospital
clinic CMI were not assessed. Last month, nearly 10 years later, the
FDA finally issued an interpretive guidance document for CMI although
it is not legally enforceable.
As a result of the above, almost all CMI in the US is provided by private
publishers, explained Dr McEvoy. Written CMI leaflets are generated automatically
in the pharmacy with the container label and handed to the patient. They
may be customised to the extent of patient name, specific dosage instructions
and features such as photo images of the medicine.
However, the actual
content of the CMI is rarely customised except by the ASHP’s MedTeach
software. This produces the only form of CMI subject to content and format
usefulness, standards embodied in the Keystone Guidelines. Web-based
access to ASHP’s CMI is via its
own website or those hosted by the National Library of Medicine
or Consumer
Reports
The FDA does not currently produce or regulate CMI but the US Secretary
of Health could ask it to do so if the goal of “95 per cent useful” is
not met.
The FDA publishes patient drug safety information but it is a confusing
array of documents with no standards for content, format or usefulness.
Patient package inserts and medication guides are part of the manufacturers
labelling approval process by the FDA but potentially confuse patients
relative to other risks and instructions and are distributed by printed
tear off sheets as the FDA has resisted permitting pharmacies to generate
them by current electronic pharmacy systems.
Unfortunately, because of
the resultant disruption in usual work flow, this information may not
be received by the patient with their prescription. Patient information
sheets, yet another form of medicine safety information, have been
introduced by the FDA as a result of the problems with Vioxx and contain
alerts
on drug safety information. Their effect on patient behaviour is unknown.
An industry perspective on consumer medicines information in Australia
Susan Parker, of Pfizer, Australia,
presented her personal view of the industry perspective on web-based
medicines
information. Consumer
medicines information, based on “usability” guidelines
and agreed with consumer organisations, has been available in Australia
since 1994.
Guidelines follow the process laid down by an advisory
committee and core information is available for the various therapeutic
classes. Mild and common adverse events are included, as are serious
side effects with patient friendly descriptions, including instructions
to the patient on what to do if one occurs.
The consumer medicines information documents are required at the
point of supply and pharmacists receive a small payment per prescription.
The document can be electronic, a pack insert or a paper leaflet
but web-based information alone is insufficient to meet the legislation.
Consumer
medicines information is available via dispensing and prescribing
software that is available to the majority of community
and hospital
pharmacies. The regulatory authorities do not hold consumer medicines
information on their website and manufacturers are able to alter
texts without the approval of the regulatory authorities, explained
Ms Parker.
Health care professionals indicate some problems with provision
of consumer information. Dispensary work flow is interrupted
and the
documents are considered too long and alarmist. Also, there is
no method of providing 100 per cent coverage and some consumer
medicines
information has been found to be out of date.
However, an evaluation
of the programme for the provision of medicines information
to the consumer was generally positive and further support material
can
be provided by companies after the prescribing decision has
been
made. Such information is password-protected, must be non-promotional
and include disease state information and compliance advice.
The advantages of web-based information are that it is available
when it suits the consumer and it is easy to maintain currency.
The font size can be adjusted for legibility, it is searchable
and in
future it could be personalised, said Ms Parker.
She concluded
that there will always be problems of literacy and comprehension
among
patients and consumer medicines information is designed as
a further aid to counselling and not as a replacement to
the pharmacist
or
other health care professionals. |
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The
Pharmaceutical Journal