A national study examining the effect of making emergency hormonal contraception available without prescription

S.R. Killick1,2 and G. Irving1

1 Institute of Postgraduate Medicine in association with Hull York Medical School, Academic Department of Obstetrics and Gynaecology, Women and Children’s Hospital, Anlaby Road, Hull HU3 2JZ, UK

2 To whom correspondence should be addressed. e-mail: s.r.killick{at}hull.ac.uk


    Abstract
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
BACKGROUND: In January 2001, emergency hormonal contraception was made available for women over the age of 16 years directly from a pharmacist without prescription. It is of interest whether this change in the UK has led to any improvements or deterioration in the service provided for the women who need it. METHODS: Self- completed, anonymous questionnaires were distributed to women requesting emergency hormonal contraception through a single group of pharmacies located throughout England, Wales and Scotland. RESULTS: A total 419 women returned completed questionnaires. A greater proportion of women were able to take emergency contraception within 24 h when they obtained their tablets directly from a pharmacy without a prescription (64% versus 46%, P = 0.029). Women who obtained their drugs directly from the pharmacist were just as well informed, just as likely to arrange regular follow-up and generally preferred this system, although they disliked having to pay. CONCLUSION: Making emergency hormonal contraception available without prescription has improved services to women who need them, but these improvements are quantitatively minimal, preventing only five additional pregnancies per 10 000 users.

Key words: emergency contraception/patient group direction/pharmacy status/questionaire


    Introduction
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Emergency hormonal contraception (EHC) has been available on prescription in the UK since 1984, and the annual number of scripts increased to over a million by 1999 (Schering Health Care Ltd in-house statistics). Even so, this must represent only a small proportion of the occasions on which inappropriately unguarded intercourse takes place, judging by the fact that >200 000 terminations of pregnancy are performed each year.

The introduction of a progestogen-only EHC method (Levonelle-2, Schering Health Care Ltd) represented a significant advance with regard to both the efficacy and the incidence of side effects (Ho and Kwan, 1993Go). Studies by the World Health Organization (World Health Organization, 1998Go; Piaggio and von Hertzen, 1999Go) have demonstrated a 95% success rate if the first 750 µg tablet is taken within the first 24 h after intercourse. However, this figure falls to 58% if therapy is delayed to 48–72 h.

Hence there is a strong incentive for a system by which women can obtain supplies of EHC as quickly as possible. The act of obtaining an appointment to see a GP or family planning doctor and anxieties about the subsequent consultation have been identified as probable hurdles to young women obtaining EHC (Free et al., 2002Go) and many have argued that access to EHC without the need for prescription would lead to a greater availability for those women who need it (Glasier, 1993Go; Drife, 1993Go; RCOG/FFPRHC, 1995Go).

This argument was accepted by the Government (Department of Health, 2000Go) and, in January 2001, EHC was given ‘P status’, that is to say, it was made available for women over the age of 16 to buy directly from a pharmacist without prescription (usual cost is ~£20, this compares with a free UK prescription for contraceptives). For a comprehensive review, see Schenk (2003Go). France and, more recently, several states in the USA have introduced similar systems. Also in the UK, a system of Patient Group Direction has been used in some areas, whereby women (in various categories according to the local Patient Group Direction scheme) can be prescribed their EHC free of charge after a full consultation with a pharmacist with specific training (National Pharmaceutical Association, 2001Go; Bacon and Savage, 2003Go). In the UK, therefore, women currently obtain their EHC supply by one of three methods depending on their preference: via a prescription from their GP, via a Patient Group Direction or by simply buying it from a pharmacist.

There are, however, a number of concerns about P status (see Table I). Most importantly, it remains to be proven whether the change in status will indeed make EHC more accessible and lower the numbers of unwanted pregnancies.


View this table:
[in this window]
[in a new window]
 
Table I. Potential advantages and disadvantages of the availability of emergency contraception without prescription
 

    Methods
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Questionnaires were distributed to EHC users through a single chain of high street pharmacies (Moss Pharmacy, the third largest pharmacy group in the UK with >820 outlets nationwide) throughout England, Scotland and Wales in an attempt to include areas with different population profiles such as urban and rural, low socio-economic and high socio-economic.

Pharmacists were asked to Branch stamp their questionnaires and to indicate whether that pharmacy supplied the EHC as a prescription only medicine (POM), as part of a Patient Group Direction or under P status. We asked that each client receiving EHC be handed a questionnaire and invited to complete and return it in a pre-paid envelope.

The questionnaire was totally anonymous. A record of the postcode of the pharmacy and the postcode of the client was necessary to assess local availability and local use of services. EHC users were asked a series of questions to determine how soon after unprotected intercourse they were able to take EHC and how much knowledge and understanding they had about their tablets, as well as their previous, current and planned future contraceptive use. They were also asked for comments about the system of supply and any difficulties they had encountered. The Flesch–Kincaid Reading Level of the questionnaire was 7.1 (www.timetabler.com/reading.html), Flesch Reading Ease 62.3 (Flesch, 1948Go). Questionnaires were piloted with small groups of young women and questions modified to reduce ambiguity. The questionnaire is available as Supplementary data at Human Reproduction Online.

The study was designed originally to detect a 10% increase in the proportion of women receiving their first EHC pill within 24 h after intercourse, for which we calculated we required 2300 completed returns. A total of 5000 questionnaires were therefore posted to 764 pharmacies. In order to minimize the work of the pharmacy and to maximize confidentiality, we chose a method that did not allow us to calculate the rate of return because we remained unaware of how many questionnaires were passed on to clients.

Ethical approval was obtained from Yorkshire Multicentre Research Ethics Committee.


    Results
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
A total of 419 completed questionnaires were returned from 112 different pharmacy outlets. It became apparent part way through the study that many of the 764 pharmacies to which questionnaires were sent were unable to hand out the questionnaires for a variety of reasons (religious beliefs of pharmacist, use of locum staff unaware of study, time constraints, sensitivity issues, unwillingness to add to administrative burden), and only a minority of the original 5000 were passed on to EHC users.

EHC users varied in age from under 16 to over 39 years, the mode being within the range 20–24 years. In all, 143 (34%) obtained their EHC via a prescription and 274 (65%) directly from their pharmacist, 64(23%) of these by means of a Patient Group Direction, 210 (77%) by paying for it. Similar proportions of women requesting EHC either by prescription or directly were first time users (39 and 38%). However, females under 20 years of age were more likely to access their EHC directly from a pharmacy (<20 years 72%; 20–29 years 64%; >29 years 66%).

Time to first tablet
Figure 1 shows how long after unprotected sex women reported taking their first tablet. Only one woman reported having taken the first tablet at 72 h (the recommended maximum time limit); no woman reported taking her first tablet beyond the recommended time limit.



View larger version (39K):
[in this window]
[in a new window]
 
Figure 1. Time after unprotected sex when first tablet of EHC was taken according to status of supply.

 
Most (64%) of the women who obtained their EHC directly from a pharmacy (either Patient Group Direction or P status) were able to take their first tablet within 24 h compared with only 46% of the women who obtained their EHC via a prescription from their doctor ({chi}2 = 17.084, P = 0.029).

Difficulties obtaining EHC
There were considerable differences in the day of the week on which EHC was taken (Figure 2). The greatest proportion of women (123, 29%) took their EHC on a Monday, whilst only seven women (2%) reported taking their EHC on a Sunday. This seems to indicate that women may still have problems accessing EHC on Sundays despite its availability over the counter at a pharmacy. Qualitative data (open text responses) validate this to some extent, in that women commented on the problems of access:



View larger version (78K):
[in this window]
[in a new window]
 
Figure 2. The day of the week when the first tablet of EC was taken.

 
‘Could not get emergency contraception on a Sunday’

‘Bank Holiday Monday and Sunday couldn’t find a chemist open!’

‘A problem getting this at the weekend (when most people will need it)’.

Very few women, even when asked specifically, reported difficulties finding out where they could obtain their EHC or travelling to obtain it. Fifteen percent experienced some embarrassment when asking for EHC from their pharmacist, and 15% reported difficulty with payment. The most frequently reported problem, however, was difficulty obtaining an appointment to see a doctor, which was cited by nearly a third of respondents.

Knowledge and understanding
Individual respondents were given a knowledge score by being given one point for each correct response to a series of eight questions about EHC use (see Table II). The knowledge scores were cross-tabulated against status of supply to assess whether women who had seen a doctor for EHC would be better informed about the tablets they were taking. Knowledge was in general very good and there was no difference between groups. Ninety-two percent of women visiting a doctor had knowledge scores of >5, compared with 95% for women going directly to a pharmacist ({chi}2 = 15.634, P = 0.111, not significant). Knowledge scores therefore seem to indicate that women who received their EHC through a pharmacy were given equally sound advice to those seeing a doctor.


View this table:
[in this window]
[in a new window]
 
Table II. Which of these statements do you know to be true about EHC?
 
The results were a little different when women were asked specifically if they were satisfied with the way in which they had received information from either their doctor or their pharmacist. The respondents in our study were more likely to be satisfied with information from their pharmacist about side effects (91% versus 58%, {chi}2 = 67.189, P < 0.001), about how to take the tablets (97% versus 90%, {chi}2 = 10.220, P = 0.006) and about their effectiveness (87% versus 63%, {chi}2 = 38.684, P < 0.001). Once again, the comments were supportive.
‘The chemist made sure I was well informed—he didn’t just hand it over’

‘Pharmacist more helpful than GP, knew more’

‘Lady at the counter was very understanding, made me feel OK"

‘The chemists where I got the EC were most helpful and they gave me a good consultation’

‘The procedure at the chemist was similar to the GP’

Future contraceptive plans
Overall, 56.6% (237) of the women indicated that they intended to see their doctor about future contraception. There were no significant differences in the proportion of women intending to visit their doctor in the POM, P status or Patient Group Direction groups (60, 55 and 58%, respectively). However, only 31 women (7.4%) reported actually having made a follow-up appointment.

Payment for emergency contraception
A total of 210 women reported that they had paid for their EHC. Charges ranged from £6 to £24. A total of 152 women thought they had paid too much for their contraception; 52 thought the charge was ‘about right’ and one woman thought she had paid too little.

The women most likely to pay for their EHC were in their 20s (49%); only 20% of females under the age of 20 paid for their tablets and 31% of those aged over 30 years.

Free text responses commonly referred to cost.

‘It doesn’t matter where you get them as long as they are free’

‘A prescription is cheaper than buying it over the counter’


    Discussion
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
There has been strong debate about the desirability of supplying emergency contraception under P status. Table I lists some potential advantages and disadvantages. The Catholic Doctors Guild has published an eloquent criticism (http://www.catholicdoctors.org.uk/By_Topic/Abortion/levonelle_critique.htm) highlighting the possible dangers to EHC users, pharmacists and society in general. The Society for the Protection of the Unborn Child raised a legal challenge on the grounds that the use of EHC constitutes an illegal abortion, but this challenge has now been dismissed in the High Court (http://www.doh.gov.uk/ehc/judicialreview.htm).

There have been systems for making EHC available without prescription in the USA since 1998 (e.g. the Eastern Washington ECP Access Project) and in France from 1999. The early evaluations of these systems have been positive, but quantitative assessments of their usefulness are lacking.

Our study provides evidence that making emergency contraception available without a prescription enables a greater proportion of women to use EHC more quickly and therefore reduces the risk of unwanted pregnancy. This increased availability was achieved without compromising the knowledge and understanding that women obtained about EHC use or reducing their intention to take regular contraception in the future.

Such a favourable result for pharmacy provision should, however, be considered with some caution. It was not possible to calculate a response rate for EHC users, although this was probably low, as might be expected from such a group. Pharmacies that were unable to distribute the questionnaires most commonly quoted non-permanent pharmacy staff as the reason why they had not done so. It is possible, therefore, that our study received responses preferentially from those pharmacies that were better staffed and more organized and possibly more able to cater for the information needs of EHC users.

Further consideration of the numbers involved also suggests the magnitude of the effect is disappointingly small, despite a 28% increase in the proportion of women accessing EHC within 24 h of coitus. Using the published efficacy rates of EHC at differing times after intercourse (World Health Organization, 1998Go), we calculate that 85% of pregnancies would have been prevented in our group who obtained their EHC via a prescription whereas 90% would have been prevented in the group who obtained their EHC via P status. This roughly equates to five additional pregnancies prevented for every 10 000 uses of EHC (95 failures rather than 100). Without EHC, we would expect somewhere in the region of 750 pregnancies from 10 000 random acts of intercourse (Dixon et al., 1980Go; World Health Organization, 1998Go).

It should also be noted that the WHO study (World Health Organization, 1998Go) is the only study so far to detect a relationship between time of treatment and efficacy. A more recent multicentre study of a similar size did not confirm the effect (Ellertson et al., 2003Go). A physiological explanation for the effect is also currently lacking.

Despite P status and Patient Group Directions improving the provision of EHC, major problems still exist, as evidenced by the difficulty users in our study had obtaining supplies on a Sunday and in paying for their tablets. It might be appropriate for a 24 h hotline to be established offering information on the availability of emergency contraception after hours and on Sundays (Ellertson et al., 2002Go; Trussell et al., 1998Go). One way in which EHC has been made available more promptly is by prescribing in advance in anticipation of a future contraceptive mishap (Glasier, 1993Go). Payment has been highlighted as a significant barrier in a previous study (Folkes et al., 2001Go). Improvements may lie with expansion of Patient Group Direction schemes to allow distribution to all groups of women and from a greater number of pharmacies, particularly those open on Sundays.

Conclusions
Making EHC available without prescription in the UK appears to have improved its accessibility without compromising the care of those who need to take it. However, quantitatively, these advantages are small and there are still significant barriers for some women, including Sunday access and the cost of the tablets.

Supplementary data
Supplementary data are available at Human Reproduction Online.


    Acknowledgements
 
We would like to thank Caroline Hayward of Moss Pharmacy for her support. The research was supported by an educational grant from Schering Healthcare Ltd.


    References
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Bacon L and Savage I (2003) Training and supporting pharmacists to supply progestogen-only emergency contraception. J Fam Plan Reprod Health Care 29,17–22.

Department of Health (2000) Wider Availability of Emergency Contraception. DoH, London.

Dixon GW, Schlesselman JJ, Ory HW and Blye RP (1980) Ethinylestradiol and conjugated estrogens as post coital contraceptives. J Am Med Assoc 244,1336–1339.[Abstract]

Drife JO (1993) Deregulating emergency contraception. Br Med J 307,695–696.[ISI][Medline]

Ellertson C, Heimburger A, Acevedo-Gacia D et al. (2002) Information campaign and advocacy efforts to promote access to emergency contraception in Mexico. Contraception 66,331–337.[CrossRef][ISI][Medline]

Ellertson C, Webb A, Blanchard K, Bigrigg A, Haskell S, Shochet T and Trussell J (2003) Modifying the Yuzpe regimen of emergency contraception: a multicentre randomised controlled trial. Obstet Gynecol 101,1160–1167.[Abstract/Free Full Text]

Flesch R (1948) A new readability yardstick. J Appl Psychol 32,221–233.

Folkes L, Graham A and Weiss M (2001) A qualitative study of the views of women aged 18–29 on the over-the-counter availability of hormonal emergency contraception. J Fam Plan Reprod Health Care 27,189–192.[ISI]

Free C, Lee RM and Ogden J (2002) Young women’s accounts of factors influencing their use and non-use of emergency contraception: in-depth interview study. Br Med J 325,1393–1397.[Abstract/Free Full Text]

Glasier A (1993) Emergency contraception: time for de-regulation? Br J Obstet Gynecol 100,611–612.[ISI][Medline]

Ho PC and Kwan MSW (1993) Prospective randomized comparison of levonorgestrel with the Yuzpe regimen in post coital contraception. Hum Reprod 8,389–392.[Abstract]

National Pharmaceutical Association (2001) Emergency Hormonal Contraception—Training Pack for Medicines Counter Assistants. National Pharmaceutical Association, London.

Piaggio G and von Hertzen H (1999) Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Lancet 353,721.[CrossRef][ISI][Medline]

RCOG/FFPRHC (1995) Joint Statement on Emergency Contraception. RCOG/FFPRHC, London.

Schenk KD (2003) Emergency contraception: lessons learnt from the UK. J Fam Plan Reprod Health Care 29,35–40.

Trussell J, Bull J, Koenig J et al. (1998) Call 1-888-NOT-2-LATE: promoting emergency contraception in the United States. J Am Med Women’s Assoc 53 (Suppl. 2),247–250.

World Health Organization (1998) Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. WHO Task Force on Postovulatory Methods of Fertility Regulation. Lancet 352,428–433.[CrossRef][ISI][Medline]

Submitted on September 11, 2003; accepted on November 21, 2003.