APPENDIX 16
Memorandum by PharmacyHealthLink (PI 44)
ABOUT PHARMACYHEALTHLINK
PharmacyHealthLink (PHLink) is a registered
charity set up to improve the health of the public by conducting
research, providing training and information, and developing the
skills of pharmacists to promote the health of the public and
educate them in matters affecting their health. The beneficiaries
of the charity are the UK general public and specifically those
who use pharmacies or obtain pharmacy advice.
AN OVERVIEW
OF OUR
APPROACH TO
IMPROVING THE
PUBLIC'S
HEALTH
PHLink is dedicated to improving the public's
health by improving their access to high quality and effective
healthcare advice and provision of services through pharmacies
in all settings, but mainly community, hospital and primary care.
The Charity relies on reviews of published evidence and the opinion
of experts, pharmacy staff and the public to help inform its work.
THE INFLUENCE
OF THE
PHARMACEUTICAL INDUSTRY
ON PRESCRIBING
PRACTICE: EXAMPLES
FROM THE
FIELD OF
SMOKING CESSATION
Background
Our main evidence in this submission comes from
our experience of the field of smoking cessation. Reducing the
prevalence of adult smoking remains one of the Government's key
priorities for improving health[22]
and PHLink have been working closely with the Department of Health,
the NHS and other organisations to help them meet one of the key
public health targets[23]—specifically
"800,000 smokers from all groups successfully quitting at
the four week stage by 2006".
Since 1997 a number of policy initiatives have
been implemented to help reduce smoking prevalence. One was to
increase access to effective smoking cessation treatments—specifically,
bupropion hydrochloride (Zyban™) and nicotine replacement
therapy (NRT)—by making them available on NHS prescription.
This happened in June 2000 for buproprion and in April 2001 for
all NRT products. Many NRT products were already available to
the public before that time either as Pharmacy-Only (P) or as
General Sales List (GSL) medicines.
PHLink responded to the original consultations
from the (then) Medicines Control Agency (MCA) on these issues
and supported the proposal to make NRT reimbursable on the NHS
as well as the reclassification of certain NRT products to GSL
status. PHLink also submitted evidence into the technology appraisal
of smoking cessation treatments[24]
run by the National Institute for Clinical Evidence (NICE). Since
then it has been working with a range of healthcare organisations
to improve access to smoking cessation treatments on the NHS through
pharmacies, GP surgeries and other premises—this has been
primarily achieved through writing and distributing template Patient
Group Directions for Smoking Cessation Therapies.[25]
Issues arising from the supply of smoking cessation
therapies on the NHS
The main issues arising of relevance to the
Committee's Inquiry are as follows:
1. The influence that the pharmaceutical
industry has on prescribing practice in the NHS—via the
decisions individual companies make when applying for a licence
for its products, specifically:
(a) In deciding what category a medicine
should be placed in when applying for a licence (Prescription
Only—POM; Pharmacy Only—P; or General Sales List—GSL).
(b) In deciding what research to undertake,
and with which groups of individuals or patients, in determining
which medicines category to apply for a licence.
(c) In deciding, on the outcomes of the above,
which groups of individual or patients should be included/excluded
from the licensed supply of the product.
2. The role of the Medicines and Healthcare
products Regulatory Agency (MHRA) in "safeguarding public
health."
A brief outline only of each of these issues
will be made in the next few pages. PHLink is willing to submit
more evidence, either oral or written, in support of these statements
on request.
1. THE INFLUENCE
THAT THE
PHARMACEUTICAL INDUSTRY
HAS ON
PRESCRIBING PRACTICE
IN THE
NHS—VIA THE
DECISIONS INDIVIDUAL
COMPANIES MAKE
WHEN APPLYING
FOR A
LICENCE FOR
ITS PRODUCTS
As the Committee will no doubt be aware, some
of the most important decisions made in relation to the supply
of medicines on the NHS are made by individual pharmaceutical
companies during the process of submitting an application for
a product to be licensed by the Medicines and Healthcare products
Regulatory Agency (MHRA). These decisions affect key factors,
such as the category of medicine that the product is supplied
under (which has a huge influence on access to supply), the research
that is conducted to determine its safety and efficacy (and for
which groups of individuals/patients), and also the specific licensed
"indication" of the product which ultimately determines
its use and purpose.
Whilst PHLink accepts that strict confidentiality
is needed for commercial purposes by the pharmaceutical industry
when new products are being submitted for licence, the
Charity believes, that after an agreed period of time post-licensing,
or when competitor products have already been licensed for similar
purposes, there should be much greater scope for the advice of
external organisations, such as the NHS and health-related charities,
to influence subsequent revisions of the product licences.
This would further enhance patient safety as well as reduce bureaucracy
and cost in providing medicines on the NHS, particularly where
unnecessary licence restrictions are in place.
Using the example of smoking cessation treatments,
there are over 20 licensed NRT products currently available for
essentially the same licensed indication "the relief of nicotine
withdrawal symptoms as an aid to smoking cessation"[26].
Despite having some differences in method of delivery[27]
of the active agent (nicotine) these products are very similar
in terms of their pharmacological properties and physiological
effects. However, their Summary of Product Characteristics (SPCs)
vary in content, specifically with regards to contra-indications,
cautions, dosage, maximum length of use and other characteristics.
As a result, many health professionals are confused about product
safety and efficacy in certain patient groups and consequently
advise using NRT far more cautiously than clinically necessary
or is desirable to be effective. The Charity, and other healthcare
organisations, have made a number of (so far unsuccessful) approaches
to individual pharmaceutical companies and the MHRA to:
(a) remove unncessary restrictions on existing
product licences (eg supply of NRT to under 18 year olds);
(b) to extend the range of "therapeutic
indications" that NRT products are licensed for (eg to cover
temporary abstinence—not just treatment of dependence or
relief from withdrawal symptoms);
(c) to ensure consistency between existing
product licences (eg having similar contra-indications and recommendations
on maximum daily dosage).
Appendix 1[28]
to this submission illustrates this point in more detail by comparing
a "typical" SPC for a 2 mg nicotine gum with the proposed
revisions for an SPC that would both "harmonise" existing
SPCs as well as provide more accurate information on risk posed
by these products to both patients and health professionals.
Appendix 2[29]
to this submission illustrates the administrative "hoops"
that NHS organisations currently have to negotiate if they are
to increase access to supply of NRT on the NHS through professionals
other than doctors (Improving Access to Smoking Cessation Therapies
on the NHS through Patient Group Directions, PHLink, 2003). The
extra administration is primarily required as a result of having
to circumvent existing licence restrictions.
2. THE ROLE
OF THE
MHRA IN "SAFEGUARDING
PUBLIC HEALTH"
Despite the huge public health gains that could
be achieved with more smokers using effective smoking cessation
treatments as an aid to quitting, current attempts by NHS professionals
to persuade smokers to use NRT[30]
in cessation attempts are hindered by unnecessary licence restrictions,
which are beyond the power of the NHS to remove, but lie with
the relevant pharmaceutical companies and MHRA.
An outline of the role of the pharmaceutical
industry in submitting applications for product licensing to the
MHRA has already been made. However, the picture would be skewed
without also outlining the role of the MHRA in approving product
licences.
The area of smoking cessation is possibly a
unique area for the MHRA in that the "agreed approach"
they use in assessing the safety and efficacy of a medicine is
rendered inappropriate in this instance by the presence of a parallel
"nicotine market" in tobacco. Unfortunately the delivery
mechanisms for nicotine via tobacco use are much less regulated
but also "dirtier" (ie they contain recognised and regulated
toxins[31])
than delivery of nicotine through medicinal products. In order
to "safeguard public health"[32]
the MHRA needs to recognise the existence of this parallel "nicotine
market" and to adapt its regulatory approach to reflect the
real risks being posed to the public from these different nicotine
delivery devices. Unfortunately the MHRA has historically shown
very little interest in adapting its approach to deal with either
the existing inconsistencies in the regulation of nicotine products,
or the risks posed by new nicotine delivery devices entering the
tobacco market.
CONCLUSION
The role of the pharmaceutical industry and
(inseparably) its association with the MHRA has a major influence
on the supply and use of medicines within the NHS.
At present, the relationship between the two
players (from the outside at least) appears to be symbiotic in
that confidentiality over product licence applications and their
revision is maintained and there appears to be very little room
for external parties to influence proceedings (other than for
"equired consultations", for example, the reclassification
of a medicine). Whilst this is fully understandable for applications
for new product licences, it appears to be less appropriate for
established markets where relatively minor changes to product
licences to better suit the NHS and patients could be justifiably
made.
In addition, the role of the MHRA in smoking
cessation does not appear to sit easily with its current approach
to licensing medicines. If the MHRA was to change its approach
to better reflect its stated aim of "safeguarding public
health" then it might be appropriate for its role in regulating
product licences for smoking cessation to continue. Without that
change, however, it is likely to be more in the public's interest
for the regulation of nicotine and tobacco products to sit within
a different framework, which might be more concordant with the
approach of another regulatory body.
PharmacyHealthLink believes that the time is
right for a thorough (external) review of the methodology that
is currently used for licensing pharmaceutical products and the
degree of scrutiny that the process is currently subject to. In
our view, in line with developments in UK regulation elsewhere,[33]
there should be room for wider public and professional involvement,
particularly at the post-licensing stage. PHLink believes the
Health Select Committee Inquiry is ideally placed to conduct such
a review and make recommendations on how this process could be
"modernised" in line with other social and healthcare
developments.
http://www.hm-treasury.gov.uk/media//70320/sr04—psa—ch3.pdf
22 HM Treasury Spending Review 2004. Back
23
National Standards, Local Action: Health and Social Care Standards
and Planning Framework 2005-06-2007-08, Department of Health,
2004. http://www.dh.gov.uk/assetRoot/04/08/60/58/04086058.pdf Back
24
National Institute of Clinical Excellence. (2002, March). Technology
Appraisal Guidance-No 39. Guidance on the use of nicotine replacement
therapy (NRT) and bupropion for smoking cessation. London. Back
25
Improving Local Access to Smoking Cessation Therapies by Using
Patient Group Directions, PHLink, 2003. http://www.pharmacyhealthlink.org.uk/ Back
26
A few products (eg Nicotinell transdermal patches) state "the
treatment of nicotine dependence" as their therapeutic indication. Back
27
There are currently six different forms of NRT licensed for use:
chewing gum, transdermal patch, inhalator, nasal spray, lozenge
and sub-lingual tablet. Back
28
The use of NRT in cessation attempts is known to double the success
rate in quitting. Higher rates of success can be achieved if
the patient also receives specialist behavioural support during
their attempts to quit. Back
29
Nicotine Addiction in Britain. A report of the Tobacco Advisory
Group of the Royal College of Physicians (2000). Back
30
"Safeguarding public health" is the strapline of the
logo of the MHRA. Back
31
See, for example, Learning from Bristol: the Department of Health's
response to the Report of the Public Inquiry into children's heart
surgery at the Bristol Royal Infirmary 1984-95. http://www.dh.gov.uk/assetRoot/04/01/37/74/04013774.pdf Back
32
Not printed. Back
33
Not printed. Back
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