The
Pharmaceutical Journal Vol 266 No 7131 p89-92January 20, 2001
The
Pharmaceutical Journal Vol 266 No 7131 p89-92
January 20, 2001
AIM
• To determine the attitudes, hopes and concerns of community pharmacists in
Great Britain about the proposed deregulation of emergency hormonal contraception
(EHC) at a time when the change was becoming increasingly likely.
DESIGN • Postal questionnaire survey with two mailings.
SUBJECTS AND SETTING • 1,827 community pharmacists in community
pharmacies in Great Britain (691 independents, 464 owners, but supported as
part of an alliance, and 672 working for pharmacy multiples).
OUTCOME MEASURES • Self-reported Likert-scale for 31 attitudinal
statements and thematic analysis of qualitative data from open responses.
RESULTS • The response rate was 66 per cent (1,205/1,827). Pharmacists
were in broad agreement with EHC deregulation as indicated by the responses
to the statements. Most pharmacists (96 per cent) wanted to be paid a fee for
providing this service although opinion was divided on whether women should
pay for this product themselves. Pharmacists also felt that the provision of
this product would increase their role within the wider primary care team, something
which many of them actively sought. A number of important practical and service
issues were raised.
CONCLUSION • The majority view was that EHC is suitable for over-the-counter
sale and pharmacists seem ready to take on this task. What will be needed is
comprehensive organisation and evaluation of the service in terms of providers,
users and stakeholders.
The arguments for deregulating emergency hormonal contraception (EHC) have
now been well expounded professionally and publicly. These arguments include
unplanned conception and consequent termination rates (especially in teenagers),1–3
barriers to obtaining emergency contraception when needed,4,5
and safety and efficacy of the product.6–8 While
the practical debate continues, a number of initiatives have been suggested9,10
and several pilot projects are in progress.11 In
addition, within the United Kingdom, the introduction of a progesterone-only
EHC product (Levonelle-2), in the wake of the pivotal World Health Organisation
(WHO) study,12 has accelerated activity.
The proposition in the UK at the time of the study was that EHC be made available
over the counter as a pharmacy (P) medicine. Originally, the idea was for a
combined method product. However, it became increasingly clear over the year
that the progesterone-only product would be put forward. This change in status
took place in the past three weeks. In the UK, the steady flow of deregulations
from prescription only medicine (POM) to P status has presented new challenges
for pharmacists.10,13
However, some would argue that the deregulation of EHC raises issues and presents
challenges not seen with previously deregulated drugs.
It is vital that community pharmacists have a voice in this debate, but there
is limited published information about their attitudes towards deregulation
of EHC. A recent study using a questionnaire, with a response rate of 38.6 per
cent, found that three-quarters of respondents were happy to issue EHC through
the pharmacy, although they had some clinical and practical concerns.14
In contrast, two other studies found that most pharmacists were opposed to deregulation.15,16
They identified a number of areas of concern, ranging from the broad and practical
to issues which were specific and often personal. There was also a feeling of
disapproval towards women requesting EHC. However, factors such as small sample
size, low response rate or sample selection, limit the generalisability of these
studies. Towards the end of 1999, we therefore undertook this study with the
aim of describing the current views of UK community pharmacists on EHC deregulation.
A postal questionnaire was sent to 1,827 community pharmacists in Great Britain.
Pharmacists were asked to indicate their degree of agreement with 31 attitudinal
statements on a five-point Likert-scale. The questions were identified and chosen
in the light of previous research and the public debate around deregulation
of EHC. In most cases, the questions were asked in terms of EHC generally rather
than in relation to a specific product. Demographic details were requested (available
from the authors). Respondents were asked how much they thought a pharmacist
should be paid for providing an EHC service and they were given an opportunity
to make additional comments.
The target population included three groups: independent pharmacists, independent
pharmacists working as part of an alliance, and a branded multiple. The questionnaires
were sent out in March, 2000, with one reminder which included a duplicate of
the original questionnaire. Quantitative data were entered into Microsoft Access
and analysed using the Statistical Package for the Social Sciences (SPSS). Qualitative
data were analysed using the constant comparative method for thematic content.
Completed questionnaires were received from 1,205 pharmacists (response rate
of 66.0 per cent, n=1,827). For the three groups in the sample population individual
response rates were 39.4 per cent for independents, 79.4 per cent for independent
alliance pharmacies and 83.0 per cent for branded multiples.
The mean age of respondents was 39 years (SD 10.76). Fifty-five per cent of
respondents were male.
Median scores for each of the attitudinal statements are given in Table 1.
When asked how much pharmacists should be paid for providing this service,
most suggested a fee of from £5 to up to just under £15 (Table 2).
Four broad themes were identified using content analysis of the open comments.
Considerations of cost Overwhelmingly, pharmacists wanted to be paid a professional fee for providing EHC. However, they were divided on whether women should pay for the product themselves. This uncertainty revolved around the need to make it accessible to all without making it appear to be an “easy” choice. Comments included:
Status and role There was a strong feeling that pharmacists were undervalued and that they desired greater recognition. In general, it was felt that taking more clinical responsibility was an appropriate extension of their role with a number supporting a further move to pharmacy prescribing. Comments included:
Practicalities The pharmacy was generally seen as an acceptable setting for providing EHC. In taking on this new responsibility, the pharmacy “environment” and training were seen as the main areas to be addressed, with time seen as much less of an issue. Few pharmacists expressed personal or ethical difficulties and several felt that the profession should simply “get on with it”. Some of those who would not participate on personal grounds (invoking the “conscience clause”) could still see the benefits of the service. Although there was some uncertainty about the influence of the change on sexual behaviour and contraceptive choice, the consensus was that neither of these issues would be significantly influenced in a negative manner. A recurring view was that records should be kept and that ideally the woman’s general practitioner should be aware of her accessing the service. Comments included:
Abuse Concerns were expressed regarding “abuse” of the service. Three clear categories of abuse emerged: the younger user, the repeat user and surrogate supply. The related issue of premeditated purchase or storage was also raised. Dealing with a request from teenagers and age verification were of great concern. Single or rare use was felt to be appropriate, but regular use inappropriate. Pharmacists expressed the fear that the product might not be used by the person to whom it was supplied. Within the attitudinal statements, respondents generally disapproved of women keeping a pack for emergencies. But those who chose to comment on this issue were more positive. Comments included:
This study shows that generally pharmacists favour a change in the legal status
of emergency hormonal contraception. They clearly want to have an active role
in shaping such a service. It was seen as an appropriate service for pharmacists
to undertake and a way of engaging with the wider primary care team.
The response rate was high for a postal questionnaire and the range of pharmacists
represented was broad in terms of work environment, geographical location and
type of pharmacy. The age and gender breakdown was comparable to that of the
Royal Pharmaceutical Society’s 1996 manpower survey.14
In addition, 27 per cent of respondents were from the black and minority ethnic
groups, which also seems representative of British pharmacy, although no public
data are available for comparison. Responders therefore seemed to be representative
of the wider pharmacy community.
The pharmacy was perceived to be an appropriate setting for providing EHC although
space and privacy were important issues when considering handling a request.
Pharmacists felt that they had the time to do it but identified a clear need
for training before starting. However, there was also a feeling that new tasks
and responsibilities were migrating in their direction without professional
or financial recognition. These are clearly issues that need to be addressed.
A principal issue in proposing a pharmacy service is speed of access. This is
important in the context of the efficacy of the product. The overall effectiveness
in preventing expected pregnancies with the Levonorgestrel-only regimen is estimated
at >85 per cent in the first 24 hours, falling to 58 per cent when the first
dose is taken between 48 and 72 hours after intercourse.12
Pharmacists thought it unlikely that this service would lead to increased sexual
activity or a decrease in condom usage, although concerns were more likely to
be expressed about the younger age group. The majority of pharmacists had no
ethical problems with providing EHC and several commented that they had changed
their opinion on the subject. Even those who expressed the opinion that they
would “opt out” could understand the need for such a service. Except for some
comments about younger women, there were very few negative or judgmental comments
made, in contrast to the findings of earlier studies.15,16 Attitudes in all
of these areas may reflect a softening with time as a consequence of public
and professional debate. However, concerns remain to a great extent about repeat
use and to a lesser extent about prepurchase and storage of EHC.
Pharmacists want to be paid for providing EHC. Within the written comments this
was couched in terms of parity with the cost of a GP or nurse consultation.
In contrast, there was less certainty as to whether women should pay for the
product. If an overall impression can be gained by the data it is that a pharmacy
EHC service should attract a fee for the pharmacist and that the patient should
pay a small fee.
Events overtook the questionnaire in that the debate on deregulated EHC moved
towards Levonelle 2. However, most of the questions relate to EHC in general
and pharmacists would have had some experience of issuing the new product at
the time of participating in the survey. This was reflected in comments made
by several pharmacists who identified Levonelle 2 as a more appropriate product
for deregulation than Schering PC4 due to its greater efficacy over time and
better side effect profile.
At the same time as this study, two pilots of EHC provision via selected pharmacies
began and continue in Manchester and South London.11
These were funded through health action zone monies. Both of these pilot studies
and the PATH (Program for Appropriate Technology in Health [www.path.org])
initiative in the United States17 deal with the
supply of EHC by the pharmacist acting as a “dependent prescriber” under patient
group directions not as a “pharmacy” supply as would occur under deregulation.
This has important implications in applying findings from these evaluations.
Pharmacists had concerns about litigation in the current and previous attitudinal
studies which are not relevant in “dependent prescribing”.
Although this study supports deregulation of EHC, it also identifies areas requiring
consideration and action along with such a change. A suitable training programme
needs to be devised and implemented. Pharmacy premises may need adapting and
an appropriate level of remuneration has to be agreed. A decision has to be
made about record keeping and lines of communication; this will need to be explicit
and publicly understood. There will also need to be agreement on who will be
legally responsible for the product and its effects.
Perhaps more difficult are the issues of who obtains deregulated EHC and why.
Is repeat use a sign of disorganisation or pragmatism? In terms of preventing
expected pregnancies, both forms of EHC are effective, but repeat users are
likely to get “caught out” at some stage. Is there a problem in women storing
the product for later use? A small study has reported positively on a cohort
of women who were given a pack of Schering PC4 to use in an emergency.18
After all, we do not worry about barrier methods of contraception or the patient’s
ability to make appropriate decisions about when to use other P or general sale
list (GSL) products. Clearly, there will need to be public education and promotional
campaigns on the appropriate usage of EHC if the desired effect is to be achieved.
There are also wider public health issues to be considered in this debate. The
Government’s strategy for health, as published in the national plan,19
relies on Government-wide action and shared responsibility to which pharmacists
have always contributed. The increasing availability of EHC, whether via patient
group directions or deregulation to pharmacy medicine status, raises many issues
that need careful consideration in order to ensure that the public is clearly
educated and supported to prevent further increases in sexually transmitted
infections.20
Levonelle-2 has now been granted a pharmacy licence in the United Kingdom. This
survey indicates that pharmacists will broadly welcome the change and that there
is a readiness among them to take on the task of providing an emergency hormonal
contraception service. In the end, however, there is no way of being sure about
what will happen in practice. What will be needed is a comprehensive evaluation
of the service in terms of providers, users and stakeholders.
Acknowledgments
We particularly thank the following staff at Pharmacy Alliance who were involved
in printing and mailing the questionnaire, setting up the database, entering
data and commenting on drafts of the paper: Pam Sandhu, Ziba Rajaei-Dehkordi
and Marilyn Ewan (service development pharmacists), Russell Goodwyn (data analyst),
Lee Bailes (data assistant), and Sarah Eager and Nathalie Pedrono (administration).
We also thank the pharmacists who participated in the study.
Dr Wearn is clinical lecturer and Dr Gill
is clinical senior lecturer, health inequalities research group, in the department
of primary care and general practice, University of Birmingham. Mr Gray is service
development director, Pharmacy Alliance. Professor Li Wan Po is director, centre
for evidence-based practice, department of pharmacy, at Aston university.
Correspondence to Dr Wearn, Department of Primary Care and General Practice,
Medical School, University of Birmingham, Birmingham B15 2TT (e-mail a.m.wearn@bham.ac.uk)
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