Pharmacists’ views on deregulating emergency hormonal contraception

 
The Pharmaceutical Journal
Vol 266 No 7131 p89-92
January 20, 2001

Original Papers

By Andy Wearn, MMedSc, MRCGP, Paramjit Gill, DM, MRCGP, Mike Gray, MRPharmS, and Alain Li Wan Po, PhD, FRPharmS

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 suggested
^9,10 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.
^15,16They 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.

Method

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.

Results

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:

• Doctors get paid for contraceptive services; so should we.
• The fee should reflect the investment of time and space needed.
• Pharmacy shouldn?t take on any more tasks unless we are properly paid for them.
• Fee paid by [local health authority] on quarterly basis. No charge to customer …
• If they have to pay they?ll be more careful.
• If EHC is seen to be a free service then undoubtedly this will lead to more potential misuse of the system.
• Should be free at point of delivery …

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:

• This is a positive move for the profession …
• Deregulation will increase the standing of the pharmacist… . All too often we are ignored in favour of nurses and health visitors.
• EHC gives pharmacy the opportunity to develop a structured prescribing role -?not just another sale.
• A worthwhile development in becoming an accepted member of the primary health care team.
• It is a huge opportunity to expand our role.
• I feel in pharmacy we are more accessible and with the right training could make a meaningful difference.

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:

• This service should only be provided if private counselling areas are available.
• The provision of a private or confidential area … should be mandatory.
• Of paramount importance is training.
• It shouldn?t be advertised as an available product, but as a service that is subject to protocol.
• I personally would not wish to offer the service; however, I am not against the service in principle.
• Sadly, education has failed some sectors of society and accidents will happen. Any step to minimise the burden of unwanted pregnancy, preferably at an early stage, is a good step forward.
• We deal daily with sensitive issues and are fully trained already in drug related issues.
• The overuse and reliance that would develop with this medication is my major concern.
• Teenagers/others using it as first-line contraception will be a problem.
• There will need to be a system to check how often women are getting EHC.
• The patient must adhere to a strict protocol and must sign a declaration … one signed copy should be sent to the general practitioner to prohibit misuse.
• Also, I would want a means of record-keeping and informing of the patients GP to be compulsory
• As a working woman who finds it difficult to get time to go to regular appointments let alone for something which was unplanned I would welcome availability of EHC.

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:

• It?s a good idea [an EHC service], but definitely liable to abuse.
• I strongly feel that young women will be more promiscuous about having unprotected sex as a ?cure all? is available easily OTC.
• This is a much more complex issue than first thought. How do I refuse a supply to a distraught 12-year-old, or do I?
• Availability of EHC should be organised so that the teenagers do not become irresponsible about sexual activity.
• I think it should only be introduced to over 21-year-olds and if younger they should consult the GP.
• Many patients receiving EHC are teenagers who require advice and counselling which is often not given by the GP… . We are in an ideal position to promote safe sex and give advice and reassurance.
• How many times will they be allowed to obtain EHC?
• Safeguards against frequent usage.
• Some women will be embarrassed and send in a friend on their behalf.
• By allowing a woman to keep a supply ?just in case? turns it into a contraceptive.

Discussion

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 States
¹⁷ 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)

References

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