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Return to PJ Online Home Page The Pharmaceutical Journal Vol 266 No 7137 p293-296
March 3, 2001

Original Papers

Over-the-counter emergency hormonal contraception: a survey of pharmacists' and general practitioners' knowledge, use and views

By Rachel D'Souza, MB BS, MRCOG, and Walli Bounds, SCM

Aim ? To ascertain the knowledge, use and views of community pharmacists and general practitioners (GPs) on emergency contraception, in particular progestogen-only emergency contraception (POEC), and its availability over the counter (OTC). To evaluate the effectiveness of circulating educational material

Design ? Cross-sectional postal questionnaire, utilising closed, open and scaled questions

Subjects and setting ? All registered GPs and practising community pharmacists within Camden and Islington (C&I), and Merton, Sutton & Wandsworth (MS&W) health authorities. The Faculty of Family Planning and Reproductive Health Care (FFP) guidelines were sent four weeks in advance to all of the above in C&I only, with MS&W serving as a control.

Results ? Response rates were 56% for GPs and 50% for pharmacists, with GP respondents showing a good knowledge of POEC, but reluctance to use it. Although virtually all GPs had reservations about the availability of emergency hormonal contraception (EHC) over the counter, 55% were in favour. Pharmacists had less knowledge of EHC, but were keener (75% in favour), and expressed fewer reservations to it becoming available OTC, although one-fifth expressed a conscientious objection to providing EHC. The FFP guidelines had been read by 60% of C&I GPs but only 37% of C&I pharmacists. Knowledge of POEC was greater among those GPs who had read the guidelines, with younger, female and academically better qualified doctors being particularly well informed. Yet there was no difference in knowledge and attitude to OTC availability between the two health authorities.

Conclusion ? Overall, there is considerable support from pharmacists and GPs for OTC availability of EHC, but training and pharmacy facilities need to be addressed. Conscientious objection to provision needs to be evaluated formally. Circulating guidelines requires careful targeting to be of benefit.



Accessibility to emergency hormonal contraception (EHC) is currently highly topical and controversial. It has been suggested that widespread use could prevent up to 70 per cent of unwanted pregnancies in those circumstances where a woman realises she is at risk after unplanned intercourse or condom failure.1 In England and Wales almost half of all pregnancies are unplanned,2 and a total of 183,200 pregnancies were terminated in 1999.3 The Government has a target to halve the rate of conceptions among under 18s by 2010.4

Use of EHC depends both on a woman's knowledge of its availability and time-scale for effective use, and on user-friendly accessibility. Accurate knowledge among the general population about EHC is limited, but appears to be improving.5 However, owing to United Kingdom licensing regulations in force at the time of our survey, accessibility was under the control of doctors, with prescribing usually only after an episode of unprotected sexual intercourse. It should be noted that some women and providers have ethical concerns regarding its use, although legally it is not abortive, since EHC acts prior to implantation.

With the aim of increasing accessibility to EHC, the British Pregnancy Advisory Service has, since July, 1999, allowed women to purchase Schering PC4 in advance, in preparation for a contraceptive failure, especially in view of recent evidence that prompt EHC use offers greater effectiveness.6 As from January, 2001, availability has been further improved by a change in licensing status, allowing purchase of POEC (as Levonelle) directly from pharmacists.

There is still considerable uncertainty as to the appropriateness of these changes. The knowledge and views of both general practitioners and community pharmacists are highly relevant to this debate. Yet few studies have addressed these, and related issues, such as the impact on GP prescribing practices of the realisation of POEC's superiority to combined oral emergency contraception (Schering PC4).6

Our aim was to assess current attitudes, knowledge and prescribing of EHC, and in particular POEC, within both general medical and community pharmacy practice. We also decided to assess the effectiveness of general circulation of relevant educational material. It should be noted that, at the time of questionnaire circulation, POEC was unlicensed in the UK, although it was available as multiple progestogen-only pills (such as 25 Microval tablets, repeated after 12 hours), or in some centres as the two-tablet preparation Postinor.

Method

Setting In January, 1999, all registered GPs and community pharmacies in Camden and Islington health authority (C&I) were sent by post (within the C&I mailing system) a copy of "Recommendations for clinical practice: emergency contraception" produced in November, 1998, by the Faculty of Family Planning and Reproductive Health Care (FFP guidelines)7. Letters to community pharmacies were addressed to a named pharmacist.

Four weeks later, all GPs and all community pharmacies in C&I and also in Merton, Sutton and Wandsworth health authority (MS&W) were requested to complete a postal questionnaire. The latter acted as a control group, not having received the FFP guidelines (unless they happened to be a member of the FFP). Questionnaires were sent directly from the research unit with Freepost return envelopes. Eight weeks later, repeat questionnaires were sent to non-responders and anonymous responders.

Questionnaire design Both GPs and pharmacists were asked their gender, age and qualifications, the number of colleagues in their practice or pharmacy, and about their current practice in providing EHC. Knowledge of POEC was scored out of 10, using questions with categorised answers. Nine concerns about OTC availability of EHC were listed, and all respondents rated their personal views using a five-category ordinal scale; thus the maximum possible cumulative score was 45. Pharmacists were requested to agree or disagree with six statements concerning changes deemed necessary for safe OTC supply of EHC.

All respondents were asked if they felt their own knowledge of EHC to be adequate, where they had obtained such knowledge, and whether they had read the FFP guidelines. Other comments were encouraged throughout.

Statistical analysis Responses were transcribed into, and analysed with the aid of, the Statistical Package for the Social Sciences (SPSS) software package. Responses from GPs and community pharmacists in C&I were compared against those in MS&W. In comparisons of categorical data, chi-square analysis was performed, whereas continuous data were compared using the univariate analysis of variance. For all statistical analyses p<0.05 was considered significant, and confidence intervals (CI) are quoted at the 95 per cent level.

Percentages quoted in the Tables are based on the number of responses given to each question.


Results

Questionnaires were sent to 541 GPs (201 in C&I and 340 in MS&W) and to 256 community pharmacies (110 in C&I and 146 in MS&W). The details below relate to the 56 per cent of GPs and to the 50 per cent of community pharmacists who replied.

General practitioners Fifty per cent were male, and all received requests from the public for EHC, 62 per cent at least weekly. When asked which methods of emergency contraception the GPs would offer, where appropriate, 64 per cent stated they would never prescribe POEC, and 41 per cent would never offer a copper intrauterine device (IUD). Where appropriate, only 5 per cent would usually offer POEC, in contrast to 95 per cent offering Schering PC4.

Overall the GPs had a good knowledge of POEC (Table 1) with a mean score of 5.8 out of 10 (CI 5.5?6.1). There was a straight-line inverse relationship (p<0.0001) between the knowledge score and the age of the GP (Table 2). Female GPs scored significantly better than their male colleagues (mean 6.3 [CI 5.9?6.7] v mean 5.4 [CI 5.0?5.8], p=0.008). The mean knowledge scores were also significantly related to qualifications held (Table 3).

Not surprisingly, the 70 per cent who perceived their knowledge of EHC to be adequate did better on the knowledge score compared with the 13 per cent stating inadequate knowledge (mean 6.2, [CI 5.9?6.6] v mean 5.0 [CI 4.2?5.8], p=0.001).

Although the FFP guidelines were circulated to all in C&I, only 60 per cent claimed to have read them. This compared with 43 per cent of MS&W respondents, who presumably had received the guidelines directly from the FFP (p=0.052). Post-hoc comparisons (with Bonferroni corrections) show that mean actual knowledge score was significantly greater if the FFP guidelines had been read rather than not read (Table 4) (p<0.0001).

Regarding EHC availability over the counter, 55 per cent of GPs supported this, yet all but three GPs expressed one or more concerns (see Table 5). Those who felt EHC should not be available from pharmacists were significantly more likely to express concerns (p<0.0001).

Pharmacists Sixty-six per cent were male, with only 32 per cent having received requests at least weekly to provide EHC over the counter. Twenty-one per cent expressed a conscientious objection to providing EHC (compared with 3 per cent of the responding GPs, p<0.0001).

The mean for the POEC knowledge score was 3.6 out of 10 (CI 3.2?4.0) as compared with 5.8 for responding GPs (p<0.0001) (Table 1). Knowledge of contraindications to POEC was poor. Unlike for the GPs, there was no significant relationship between the knowledge score obtained and either the age, gender or qualifications of the pharmacists.

In total, only 27 per cent stated they had read the FFP guidelines. This included 37 per cent of C&I respondents (ie, having been sent the guidelines), compared with 25 per cent of MS&W respondents (who presumably obtained the guidelines from another source) (p=0.069). Unlike with the GPs, there was no significant relationship between reading of the guidelines and either qualifications held or the knowledge score obtained. Significantly more pharmacists than GPs felt their knowledge of EHC to be inadequate (33 per cent v 13 per cent), with 42 per cent assessing their knowledge as adequate.

Regarding OTC availability, 25 per cent were against any form of EHC being available OTC, whereas 68 per cent were in favour of Schering PC4 (including 35 per cent who also favoured POEC). Only 8 per cent would support POEC instead of Schering PC4, and these pharmacists scored significantly higher on the POEC knowledge score than those stating no form of EHC should be available (mean 5.9 [4.6?7.1] v 3.3 [2.6?4.0], p<0.0001).

All pharmacists expressed one or more concerns about EHC becoming available OTC (Table 5), but overall fewer concerns than the GPs (mean score 28.8 [27.7?30.0] v 30.3 [29.6-31.1] out of a possible total of 45, p=0.034). All pharmacists felt that at least some changes were necessary in the UK for EHC to be safely available OTC (Table 6).


Discussion

Response rates were as expected for a postal questionnaire. We appreciate that our results may be biased in that respondents may represent those more interested in and thus possibly more knowledgeable about EHC, or those with more concerns about OTC provision of EHC. Nevertheless, we feel they give a valuable insight into GPs' and pharmacists' views and concerns.

At the time of the survey, provision of POEC generally involved prescribing an unlicensed combination of multiple progestogen-only contraceptive pills. Not surprisingly then, knowledge about POEC was significantly better among the GPs than the pharmacists, who would only have had experience with issuing Schering PC4. In view of this, it was surprising that only one third of pharmacists felt that they had inadequate knowledge to administer EHC, although this corresponded poorly with the feeling of most that more training was necessary.

Circulation of the FFP guidelines, although apparently ignored by many recipients, had more influence on the knowledge of the GPs than the pharmacists, possibly because, at that time, the latter group considered them less relevant.

Our observation that knowledge of POEC was greater among younger, female, and better qualified GPs suggests these were better at keeping up to date with the publicity surrounding POEC. Female GPs have previously been found to know more about EHC and to prescribe it more readily than their male colleagues.8 Practices including female and younger GPs have been found also to have lower teenage pregnancy rates.9

Usage of EHC depends on numerous factors, including willingness of doctors, specialist nurses and pharmacists to provide it. Maxwell et al10 found that as many as 50 per cent of accident and emergency departments and 42 per cent of GPs in the North West region were not willing to provide emergency contraception. Yet only 3 per cent of our responding GPs expressed a conscientious objection. That one in five of pharmacists in our survey expressed a conscientious objection to providing EHC contrasts sharply with the findings of Blackwell et al,11 where only 2.6 per cent of respondents cited moral objections among concerns related to deregulation. More recently, Wearn et al12 reported that, of their 1,205 respondents, "few pharmacists expressed personal or ethical difficulties" with providing EHC, and that several commented that they had changed their opinion on the subject. It is possible that a misunderstanding as to the mode of action of EHC may have contributed to the high level of conscientious objection in our survey. Ethnicity may also have played a part. If representative of pharmacists overall, this issue needs to be addressed. Alternative provision would need to be made (particularly where pharmacists are few in more rural areas).

Over half of our respondents felt EHC should become available OTC, which should encourage those involved in facilitating such a provision. Blackwell's survey11 also found just over three-quarters of pharmacists to support over-the-counter EHC, but with safety issues the most frequently-stated concerns, whereas moral and ethical barriers seemed also important to our respondents. Compared with the pharmacists, the GPs were significantly more cautious, and agreed more strongly with the concerns about OTC supply listed in our questionnaire. Yet they were more positive than the GP cohort in Ziebland's telephone survey, published in 1988.13 Ziebland found that only 15 per cent were enthusiastic about OTC availability. Appropriate training of pharmacists, together with space and privacy in pharmacies for appropriate consultation, will be important to take account of the considerable concern about possible misuse. Finances would need to be available for all the above, together with remuneration for the pharmacists for the extra time spent in consultations. Anxiety about lost opportunity for contraceptive awareness and sexual health education may be partially alleviated by the availability of suitable free leaflets at pharmacies.

Concerns expressed in our survey relating to safety and compliance were not substantiated in a recent study by Glasier et al,14 where women were randomised to either be given an advance supply of EHC, or expected to follow routine practice of seeking EHC after the event. Of the study group, 98 per cent used the EHC correctly, only 2 per cent admitted to having taken contraceptive risks, and unintended pregnancies were fewer than in the control group (although the study did not have the power to show statistical significance). The researchers found no difference between the groups in the use of regular ongoing contraception, and no serious adverse events were observed.

In the past four years, various pilot studies have been initiated to enable the supply of EHC directly from pharmacists. These have utilised patient group directions (PGDs), the pharmacists working to a group protocol, with a medical doctor taking overall responsibility. The designated pharmacists were required first to undertake a specified training programme and examination. A two-year pilot study in Washington State, completed in July, 1999,15,16 involved 130 pharmacies, and over 90 per cent of participating pharmacists reported being either satisfied or very satisfied with their collaborative agreements. Of the women using the facility, 36 per cent stated that, if EHC had not been available, they would otherwise have taken no further action to obtain it; instead they would have awaited menstruation. Nineteen per cent did not know what they would have done. Most women received the Schering PC4 within 24 hours of unprotected intercourse, many attending the pharmacy on weekends or after normal business hours. The women reported satisfaction with the quality of care received, and appreciation of the accessibility.

More recently, UK trials involving community pharmacists supplying EHC under a group protocol have commenced in Manchester, south west London, Derbyshire and elsewhere. Results of these pilot studies are awaited with interest.

The recent change in the UK in the licensing of POEC (as Levonelle) to a pharmacy medicine should lead to a gradual implementation of OTC supply in selected pharmacies. Such supply is not dependent on PGDs, as is favoured by some. For example, of the approximately 150 pharmacists who attended the Unichem convention in September, 2000, 86 per cent said they were prepared to supply EHC, and, of these, 69 per cent said that supply should be by PGDs rather than by pharmacy sale.17

Concerning training issues, raised by a large proportion of pharmacists in this and other surveys, these are already being addressed by the Royal Electronicjuice. This includes a detailed information and training booklet, prepared and distributed by the Centre for Pharmacy Postgraduate Education (CPPE),18 and the setting up of workshops throughout Britain. The Society's Council has also approved five professional standards for the sale of EHC as a pharmacy medicine, setting the mandatory requirements to be adopted by all pharmacists,19 and has issued practice guidance.20 While these developments are welcome, also crucial will be a comprehensive evaluation of the service in terms of providers, clients and the impact on reducing unwanted pregnancies.

Conclusion

This survey has demonstrated considerable support from pharmacists and GPs for OTC supply of EHC, which has since become a reality. It has also highlighted the need for numerous issues to be addressed (particularly training, facilities and staffing) for this to occur safely and without compromise to ongoing contraceptive needs. That nearly a quarter of pharmacists expressed conscientious objections requires further evaluation.

To be of benefit in training, the use of educational material, such as the FFP guidelines, needs careful targeting, and content must be appropriate to the intended readership. Concurrent publicity to, and education of, the general public would also be essential, as would careful monitoring of the service.

Acknowledgments
We are grateful to all the GPs and pharmacists who participated in this survey. We also wish to thank Tess Harris for her input into the questionnaire design, Amanda Sacker for her statistical input, and Alison Orr, Sophie Molloy and Jennie Franklin for administrative help. Professor John Guillebaud's support and helpful critique are much appreciated.

This study was funded by the Margaret Pyke Memorial Trust.


Rachel D'Souza is clinical research fellow and Walli Bounds is principal research fellow at the Margaret Pyke Centre research unit, department of obstetrics and gynaecology, University College London. Correspondence to Dr D'Souza at Margaret Pyke Centre Research Unit, 73 Charlotte Street, London W1T 4PL


References

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4. Social Exclusion Unit. Teenage pregnancy (Cm 4342). London: Stationery Office; 1999.
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11. Blackwell D, Cooper N, Taylor G, Holden K. Pharmacists' concerns and perceived benefits from the deregulation of hormonal emergency contraception. Br J Fam Planning 1999;25:100?4.
12. Wearn A, Gill P, Gray M, Li Wan Po A. Pharmacists' views on deregulating emergency hormonal contraception. Pharm J 2001;266:89?92.
13. Ziebland S, Graham A, McPherson A. Concerns and cautions about prescribing and deregulating emergency contraception: a qualitative study of GPs using telephone interviews. Fam Pract 1998;15:449?56.
14. Glasier A, Baird D. The effects of self-administering emergency contraception. N Engl J Med 1998;339:1?4.
15. Emergency contraception collaborative agreement pilot project. Available at www.path.org/resources/ec_better_access_ to_ecps.htm. Accessed February 9, 2001.
16. Wells ES, Hutchings J, Gardner JS, Winkler JL, Fuller TS, Downing D, et al. Using pharmacies in Washington state to expand access to emergency contraception. Fam Plann Perspect 1998;30:288?90.
17. Pharmacists oppose P sales of EHC. Pharm J 2000;265:584.
18. Centre for Pharmacy Postgraduate Education. Emergency hormonal contraception: information booklet. Manchester: CPPE; 2001.
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20. Guidance on pharmacy supply of EHC. Pharm J 2000;265: 890?2.

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