Patient information on prescribed drugs
BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d1924 (Published 03 May 2011) Cite this as: BMJ 2011;342:d1924
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We have had product inserts in Australia for many years. Generally
the same blurb is reproduced in commercial drug lists such as MIMS. I do
not think anyone monitored any changes in behaviour or health demands when
this was introduced almost 30 years ago.
From a clinical aspect the major problem seems to arise from the way
infomration is presented. The content seems to be driven by legal
imperative where in most cases adverse reactions are listed if they EVER
have been reported with no attempt to indicate how often they occur in
comaprison to placebo. This seems to increase the level of adverse
reaction anxiety in susceptible patients, and maps to psychogenic
reactions quite often.
Much of the medication consuming public has had very poor science
education and they regard active mondrugs as equivalent to inactive
polydrugs (placebos), microdose active polydrugs (i.e. herbs),and even
water (homeopathic remedies) and similar forms of magical remedies
fraudulently flogged to the gullible in all countries.
I doubt that the EC will have any adverse outcome from providing
information provided it is presented scientifically with a health, and not
legal imperative.
Competing interests: No competing interests
It is unfortunate that the debate following Joanne Shaw's editorial
has turned personal. This should not, however, distract us from the
reasoned discussion needed on this important issue. We know a number of
things:
(a) Patients want access to a range of information sources. (1)
(b) There is no such thing as unbiased information - all information, even
that from patient groups, comes from a particular standpoint.
(c) Patients in Europe currently access pharmaceutical company websites
based outside Europe - which contain information that may not be
appropriate for an EU citizen. (2)
The latter point in particular means that doing nothing is not an
option. Patients who wish to do so, need to be able to access patient-
facing EU-based company websites, but with the appropriate safeguards -
which I believe the proposed legislation provides. The two key safeguards
are:
(a) Companies will be limited in the extent to which they can provide
information. In addition to statutory documents (such as the package
leaflet for the patient), they may make available information on prices,
pack changes, adverse-reaction warnings, instructions for use (including
moving images which patients find particularly useful for devices like
inhalers), clinical trial information and finally 'frequently asked
questions'. These must be pre-vetted by the regulatory authorities.
Nothing can go out without prior approval.
(b)Previous iterations of the draft text used the term 'disseminate' which
I pointed out as being inappropriate at a workshop of the EU 'Environment,
Public Health and Food Safety' committee in 2010, and suggested instead
the term 'make available', which has now been adopted in the text. (2)
So companies can 'make available' a restricted amount of information that
has to be pre-vetted by the regulatory authorities. A further positive
point from the proposals (not mentioned by Shaw) include the addition in
the package insert of a short paragraph setting out the benefits and
potential harm of the medicine. A frequent complaint of patients is that
the leaflet is too focused on harm information and they want more balanced
information which includes the possible benefits of the medicine (1).
Looking at Shaw's editorial and subsequent correspondence, I broadly
support Shaw's views, and reject most of the criticism aimed at it.
However, she clearly comes from a particular viewpoint (which does appear
to have been clearly stated), as do correspondents Mintzes and Alves. I do
not agree with Shaw that the proposed legislation 'does nothing to
facilitate the provision of credible information from reputable
providers'. It is clear to me that rapporteur Fjellner has got it pretty
much right, in framing the legislation in terms of the patients right to
information being made available. I do not agree that the 'dead hand' of
the regulators is strengthened - it is right that they be the arbiters.
Mintzes described Shaw's 'enthusiastic endorsement', but the
editorial is measured in my view. Less measured is Mintzes' claim
regarding the ' increased leeway to produce either overtly or covertly
promotional web based information that raises a red flag, whether or not
these materials are to be pre-vetted by regulators' . The safeguards
mentioned above will not allow this and so the sites that companies will
produce will not be 'promotional websites'. Shaw does not use the word
'advertising' because nothing she mentions IS advertising. The Canadian
example that Mintzes uses is not well chosen, as the media she describes
(a television advert) is expressly forbidden in the draft legislation.
Alves is correct that the European Council could significantly amend the
draft - there may still may be 'a slip between cup and lip'. In the mean
time the time is ripe for influencing the package leaflet - one of the
main sources of information for patients across the EU. The Commission is
tasked, in the EU Pharmacovigilance legislation passed recently, to
prepare a report on the shortcomings of the leaflet and present proposals
for improvement to better meet patients' needs. We should take this
opportunity to shape what remains the most important written information
source for patients about their medicines.
(1)Raynor DK, Blenkinsopp A, Knapp P. A systematic review of
quantitative and qualitative research on the role and effectiveness of
written information available to patients about individual medicines.
Health Technol Assess 2007; 11: 1-160. www.hta.ac.uk/execsumm/summ1105.htm
(2)Proceedings: Workshop 'Information to patients on prescription
medicines' Brussels 4 March 2010.
www.epha.org/IMG/pdf/workshop_summary_information_to_patients_PE_433_440...
Competing interests: Dr Raynor is Professor of Pharmacy Practice at the University of Leeds, and Director of Luto Research, which develops, improves and tests patient information materials.
Dr Mintzes' concern to protect the public from covert drugs promotion
is admirable and I support it. But her fear and loathing of the
pharmaceutical industry has blinded her to the realisation that the
control of information by well intentioned health professionals is deeply
unhelpful to patients.
Research by academics such as Professor Theo Raynor at Leeds, shows
that health professional (doctor, nurse and pharmacist) assumptions about
what information patients want about medicines are consistently wrong.
British patients and public prefer to be able to get medicines
information from a range of providers than from one single approved source
- in the ratio of about 80/20 (Medicines Partnership research).
The German situation shows they are right to be suspicious of a
single authorised version. The German consumer drug bulletin mentioned by
Dr Mintzes, 'Gute Pillen - Schlechte Pillen' [Good Pills - Bad Pills] is a
great publication but it's a magazine, not a reference source. German
patients are still hugely frustrated at their inability to access basic
information about medicines for their conditions.
Inevitably, failure to allow companies to provide regulated,
objective information in European languages drives more confident patients
to US sites - 24% of German web users and 22% of Italian, according to
Datamonitor, while leaving less confident ones in an information black
hole.
I'm sorry that Dr Mintzes thought I was trying to conceal my
affiliations. I clearly identified myself as Chairman of Datapharm
Communications, which publishes the Medicines Guides referred to in the
article. But she is of course right when she notices a familiar ring
about my editorial. In 2009, I wrote one which highlighted the similarity
between doctors of today and the Catholic priesthood of pre-reformation
Europe. Despite her good intentions, priests like Dr Mintzes, who seek to
control access to information, no longer reflect what most people want or
need from their health professionals.
Competing interests: Chairman of Datapharm Communications, which publishes Medicine Guides
The new draft European legislation on information to patients, which
Joanne Shaw so enthusiastically acclaims, is far from being a masterpiece.
Designed to conceal its true nature, the legislative piece does
little to meet the real needs of patients and consumers across the
European Union, but goes a long way to soothe the requests of "reputable
information providers" such as the pharmaceutical industry. No wonder then
that consumer, public health, non-profit social insurance organizations,
health professional associations and some patient groups have been
critical of the use of the term 'patient information' to disguise a
proposal that includes substantial amendments which will affect medicines
advertising.
The main criticism is that the proposals do not provide patients and
consumers in Europe with unbiased, comparative information on health and
medicines, or address inequities in information access across EU Member
States. Useful patient therapeutic information should be comparative, so
that patients, consumers and healthcare professionals can learn about the
different treatments available and what to expect from them, in order to
make an informed choice (or to participate in the decision-making).
Intriguingly, the author appears to have missed a tiny detail and
overlooked the legislative co-decision procedure. The fact is that this
legislation has not been adopted into law. While the legislative draft has
been endorsed by the EU Parliament, it is now being revisited by the
European Commission and will need, subsequently, to be discussed by the
Council. The same European Council, composed of EU Member States, which
expressed concerns about the proposal, stating that: "... many delegations
hold that the distinction between "information" and "advertising" is not
sufficiently clear and therefore fear that the proposals will not provide
sufficient guarantees that the prohibition of advertising of prescription-
only medicinal products to the general public will not be circumvented.
"(1)
It would be wise to wait for further developments before declaring
victory too soon. The Council is very likely to hear the concerns of the
'demanding public' and just say no.
(1) - Council of the European Union. Press release: 2947th
Employment, Social Policy, Health and Consumer Affairs Council meeting.
Luxembourg 8-9 June 2009. Available at:
www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/108380.pdf.
Competing interests: No competing interests
As someone who has been following the heated debate on proposed
changes to European pharmaceutical advertising legislation, I cannot help
but notice a familiar ring to Joanna Shaw's enthusiastic endorsement of
European Union's 'patient information' initiative. Shaw welcomes
companies' expanded scope, but is concerned that in its current form, the
initiative does not go far enough.
The initiative's provisions to make approved patient leaflets,
monographs and EPARS more accessible are uncontroversial. Whether these
materials are posted directly by the regulator on a national website, or
by manufacturers, easier access is a boon. It is the increased leeway to
produce either overtly or covertly promotional web-based information that
raises a red flag, whether or not these materials are to be pre-vetted by
regulators.
Shaw castigates opponents as "uncomfortable with the idea of
empowered patients", without noting just how universal this opposition is
among non industry funded European consumer and patient groups, the very
sector that has championed consumer rights in health care.
Her many uses of the words 'information', 'factual' and 'regulated'
and the infrequent mention of the word 'advertising' will be familiar to
anyone who has been following this debate. Although she does not declare
any competing interests, Shaw is chairman of DataPharm Communications Ltd,
which states on its website that it is funded by "about 190 pharmaceutical
companies." <http://www.datapharm.org.uk/Pages/about-
datapharm#funding> No other funding source is listed.
Shaw 's main argument appears to be that the proposal does not go far
enough in allowing companies to provide information to consumers about
their products in a variety of ways, due to "anxiety to restrict the drug
industry".
Why be anxious? It may be worth looking at whether any other
jurisdictions have had trouble with advertisements sneaking into their
airwaves, news, or digital media in the name of 'information' from
pharmaceutical companies about their medicines.
Canada is a good example of a country that has succumbed to industry
pressure and partially subverted its ban on prescription drug advertising
to the public, turning a blind eye to certain forms of advertising (excuse
me, "information"), including branded 'reminder ads' and disease-awareness
advertisements.[1]
Examples have included a television spot with men dancing to, "We are
the Champions", ending with a large Viagra (sildenafil) pill and the
suggestion to talk to your doctor. Or the www.flupill.ca website that
accompanied the launch of oseltamivir, with a chilling account of the
Spanish flu pandemic and enthusiastic endorsement of an unnamed new,
effective flu treatment. Or, more recently, the www.40over40.ca Lilly
website and its much exaggerated 40% prevalence rate for erectile
dysfunction in men over 40.
At a January 2011 consultation on proposed changes to Canadian
pharmaceutical legislation, neither industry spokespeople nor regulators
used the word 'advertisement' to describe these forms of persuasive
communication. Instead, they were called, "name, price and quantity".
These "name, price and quantity" never mention the product's price. They
appear to be named after the unfortunate 1975 price advertising regulation
that has provided the loophole for this form of pharmaceutical advertising
from the year 2000 onwards.
It is no less imaginative, although perhaps a bit less of a tongue
twister, to call manufacturer's product-specific websites, "objective
balanced information to combat the dangers of unregulated content online."
Based on my experience to date, I'd recommend calling them promotional
websites.
Shaw highlights Germany as a country in which patients can currently
only access information about drugs through health professionals or in
websites that are either in English or of poor quality.
Germany has an excellent consumer drug bulletin, 'Gute Pillen -
Schlechte Pillen' [Good Pills - Bad Pills], which provides the public
with independent comparative medicines information, based on rigorous
systematic reviews but presented in a user-friendly format with personal
stories, interviews and a focus on questions consumers have raised. The
methods used, and the independence from any party with a financial stake
in the products that are being reviewed, lend the bulletin its
credibility. Rather than weakening the legislation on pharmaceutical
advertising, the EU and national governments could do much to further
patients' drug information needs by providing support to similar
independent drug information initiatives.
[1]Gardner DM, Mintzes B, Ostry A. Direct-to-consumer prescription
drug advertising in Canada: Permission by default? CMAJ 2003 169: 425-427.
Competing interests: I have no competing financial interests. The German drug bulletin I have mentioned is a member of the International Society of Independent Drug Bulletins (ISDB). My organization, the Therapeutics Initiative, is also a member of ISDB.
Concerns re industry developed information are not misplaced
1. Shaw J. Patient information on prescribed drugs. BMJ 2011;342:d1924. (3 May.)
2. Mintzes B. Patient information on drugs: Is patient information on prescribed drugs just another form of advertising? BMJ 2011;343:doi:10.1136/bmj.d4899 (Published 2 August 2011
3. Moynihan R, Heath I, Henry D. Selling sickness: the pharmaceutical industry and disease mongering. BMJ 2002;324:886-891 doi:10.1136/bmj.324.7342.886 (Published 13 April 2002)
4. Raynor DK, Blenkinsopp A, Knapp P. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess 2007; 11: 1-160. www.hta.ac.uk/execsumm/summ1105.htm
Competing interests: No competing interests