The introduction of Norplant® implants into the UK

The introduction of Norplant® implants into the UK

?he In r0duc i0n of 0rp]an Imp an s n;0 UE J o a n W a l s h a n d Toni Belfield BACKGROUND orplant®, the b r a n d name of a sub-dermal p r o g e s t...

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?he In r0duc i0n of 0rp]an Imp an s n;0 UE J o a n W a l s h a n d Toni Belfield BACKGROUND orplant®, the b r a n d name of a sub-dermal p r o g e s t o g e n - o n l y contraceptive implant, was launched in the UK in October 1993, an arrival which in theory presents a useful new contraceptive choice for women. Although the p ro d u c t has been marketed as a novel reversible m e t h o d of family planning, the Population Council initiated implant research and d ev el o p m en t 28 years ago, and Norplant implants have been available since 1983 in Finland, w h e r e they are currently manufactured. M o r e than 29 countries have n o w a p p r o v e d the m e t h o d for distribution, and over two million w o m e n have used it. In its current formulation, the m e t h o d provides contraceptive cover for up to five years. Within the next decade a variety of h o r m o n a l implants will be introduced, offering w o m e n a r an g e of h o r m o n e content and duration of contraceptive effect. Access to information and education on family planning and reproductive health issues is reg a r d e d as an essential part of preventative health care in the UK. Family planning clinics w e r e run independently by the Family Planning Association (FPA) for over 40 years until 1974, w h e n they b e c a m e part of the National Health Service (NHS). Family planning services are currently provided free at the point of care on the NHS. Contraceptives are available from general practitioners (GPs), community family planning clinics, some sexually transmitted disease clinics or from specialist non-profit agencies. Specialist family planning services are available for y o u n g people. Family planning qualifications are required for those wishing to work in community family planning clinics; no family planning qualification is required of GPs or nurses w h o work with them. Financial restructuring within the NHS in recent years has resulted in a dramatic reduction in the n u m b e r of clinics and clinic sessions t h r o u g h o u t the UK, with pressure to w a r d s

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increased family planning provision by GPs. It is t h o u g h t that about 70 per cent of w o m e n w h o use contraception n o w go to their GP for contraceptive services, and 30 per cent use co m m u n i t y family planning clinics. Less than half of GPs in the UK are trained to provide a full r a n g e of contraceptive methods. Of those w o m e n obtaining contraception from their GP the o v e r w h e l m i n g majority (95 p er cent) use oral contraceptives. W o m e n who attend clinics have access to specialist, fully trained staff and a w i d er variety of contraceptives, including barrier methods. There is evidence to suggest that w o m e n may use both types of service pragmatically, remaining registered with their GPs for routine provision, but also using specialist clinic services.

A SPECIALIST APPROACH Implants d e m a n d a specialist approach to contraceptive provision. This runs counter to trends t o w ar d s generalist family planning provision in the UK. While variants of existing contraceptive methods have b e c o m e available recently (such as the female condom, longer-lasting IUDs and n ew oral contraceptive formulations), implants are the first really n e w m o d e of contraceptive delivery to b e c o m e available in the UK for many years. Experience from outside the UK had given rise to concerns about the potential for discriminatory use of contraceptive implants, and raised a w a r e n e s s of the need to develop g o o d practice in professional and public information and clinical service provision. As a result, the introduction of Norplant implants in the UK has been acco m p an i ed by educational p r o g r a m m e s and supervised clinical training sessions for professionals, o r g an i sed and run by Roussel Laboratories, the UK distributor. These training p r o g r a m m e s emphasise that

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implants will only be accepted by w o m e n if appropriately promoted, discussed and prescribed by trained practitioners. Training in the insertion and removal of the implants is given free of charge to all GPs and family planning doctors wh o wish to provide them. Nurses are also eligible to be trained to insert and r e m o v e the implants, although doctors are given priority in the allocation of training places. It is encouraging that enquiries to the FPA from medical and nursing practitioners suggest that they have "taken on board" the need for specialised training, despite the fact that implant insertion and removal are, in medical terms, relatively m i n o r procedures. It is interesting to co m p a r e the introduction of contraceptive implants with that of the female condom, for which no medical intervention is required and which can be b o u g h t over the counter. Although it is r e c o g n i s e d that careful teaching in h o w to use the female c o n d o m is beneficial, no formal training has been provided for family planning professionals. It is perhaps the novelty of contraceptive implants, their cost, and the higher status aw a r d e d to contraceptives which require medical intervention, which have resulted in the expectation that practitioners must be specially trained to provide them. To date it is estimated that some 3,000 doctors in the UK have attended the first stage of Norplant implant training. This is a workshop lasting three hours, which covers the m e t h o d ' s mode of action, efficacy and reversibility, side effects, contra-indications and acceptability. The workshop also emphasises the need for contraceptive counselling to enable w o m e n to make an informed choice r e g a r d i n g the use of implants, and finally goes on to teach insertion and removal techniques, using a model arm. Doctors wh o subsequently wish to provide Norplant implants in clinical practice must contact Roussel, w h o ar r a n g e for an experienced clinical trainer to instruct and supervise during the first insertions. GPs must identify at least three w o m e n clients wh o definitely wish to use the m e t h o d before Roussel will a r r a n g e clinical supervision. So far no m o r e than 1,000 doctors in the UK have been clinically trained in implant insertion and removal. Between three and four thousand w o m e n in the UK have had the m e t h o d inserted since its introduction; few doctors have had any experience of r e m o v i n g it. Although

Roussel's p r o g r a m m e will only continue until implant insertion and r em o v al techniques have been fully integrated into training for family planning qualifications for doctors and nurses, the Roussel training scheme should set a p r e c e d e n t for the future.

W O M E N ' S VIEWS A n u m b e r of mistaken assumptions w e r e made r e g a r d i n g w h o w o u l d use Norplant implants prior to their introduction in the UK, despite k n ow l ed g e gleaned from ten years of clinical experience in other countries. A market research study in 1992, using a sample of 294 w o m e n attending family planning clinics and a review of 590 w o m e n seeking contraceptive advice f r o m 25 GPs, illustrates major differences b e t w e e n the type of w o m e n to w h o m doctors would spontaneously r e c o m m e n d implants and those w h o said they would definitely use the method. Doctors saw it primarily as a m e t h o d for w o m e n w h o had completed their families, and would usually r e c o m m e n d it only to older women. However, just over 40 per cent of w o m e n w h o r e s p o n d e d to a questionnaire w h o said they would use Norplant implants w e r e u n der age 25. Their perception was of a longt e r m m e t h o d to be used before choices about parenting w e r e made. 1 A MORI survey carried out before implants b e c a m e available in 1993 interviewed 1,258 w o m e n aged 16 to 49. The survey investigated w o m e n ' s attitudes t o w a r d s already available contraceptive m et h o d s and their reactions to the idea of implants. The w o m e n interviewed w a n t e d access to a r an g e of reversible contraceptive methods which w e r e highly effective, easy to use and not related to intercourse. The findings clearly d e m o n s t r a t e d that w o m e n from all age groups and a diversity of social backgrounds would consider using implants. 2 Research shows that Norplant implants cause significant disruption of bleeding patterns in about 60-80 per cent of w o m e n w h o use them, resulting in irregular and unpredictable menstruation, particularly in the first year of use. For this r e a s o n it is strongly r e c o m m e n d e d that contraceptive counsellors advise w o m e n that they are m o r e likely, rather than less likely, to experience disruption of the menstrual cycle. Studies have d e m o n s t r a t e d that w h e n w o m e n

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are well informed about this aspect of progestogen-only implant use and expect menstrual disturbance, they m o r e often remain satisfied with their choice. It is those w o m e n w h o are n o t given such information w h o m o r e often request removal of the implants.

AVAILABILITY AND COST Mass media c o v e r a g e has created a wide public awareness of the p r o d u c t in the UK; the d e m a n d for contraceptive implants has been beyond all expectation and continues to exceed supply. The UK FPA's information service helpline receives some 200,000 enquiries each year from the public and professionals. Analysis of calls about implants from O c to b e r 1993 to March 1994 shows that despite the information, education and training efforts outlined above, people cannot easily obtain information about contraceptive implants from sources such as GPs or community family planning clinics. Calls to the FPA also indicate that w o m e n w h o wish to use implants are having difficulty finding trained GPs, and that the initial cost of Norplant may be deterring GPs and clinics - w h o s e access to NHS funds is finite and m o n it o r e d annually, not five y e a r l y - from providing it. Some GPs also feel that they should be paid an enhanced 'item of service" fee for p r o v i d i n g Norplant, such as they currently receive for inserting IUDs. The surgical e q u i p m e n t needed to insert Norplant is provided free by the manufacturer. The cost of Norplant in the UK is £179 (about US$270), with discounts for bulk purchases. Payment is up-front; thus, while it may provide value for m o n e y over a five-year period, the price of the m e t h o d b eco m e s prohibitive if w o m e n subsequently request its early removal. This characteristic has resulted in g r e a te r recognition of the value of contraceptive counselling in increasing the likelihood that a contraceptive m e t h o d is truly the m e t h o d of choice for the client concerned, considering her current and foreseeable contraceptive requirements. Such recognition may in the long term be beneficial for all w o m e n wh o use contraception, if the insight gained from prescribing implants informs all contraceptive provision. Value for money, training needs, client counselling, c o n s u m e r information, quality of care and accessibility of services - all seem to have b e c o m e salient to

family planning as n ev er before. For now, however, the cost of Norplant to the NHS is making it difficult for w o m e n to obtain it, and the mismatch b et w een supply and d e m a n d has resulted in long clinic waiting lists in some areas of the country. The method is commonly not available from GPs because they are waiting to be trained. A further difficulty arises from d i s a g r e e m e n t r e g a r d i n g who should pay for the m e t h o d if a GP is unable or unwilling to provide it. For example, if a w o m a n ' s GP is not trained to insert the implants, but agrees that this is the contraceptive m e t h o d of choice for her, the w o m a n may be referred to a family planning clinic which has trained staff. But no clear guidelines have been established to determine w h o should pay for the m e t h o d under these circumstances, the GP or the clinic.

I M P L I C A T I O N S FOR SERVICE P R O V I S I O N The problems associated with the introduction of a new contraceptive m e t h o d with a high initial cost and which demands specialist training highlight a n u m b e r of issues for UK family planning provision. Unless contraceptive implants are made widely and freely available t h r o u g h readily accessible GPs, the m e t h o d will be unavailable to many w o m e n w h o may wish to use it. Inevitably, w o m e n w h o can afford to pay for private (non-NHS) treatment will be able to obtain Norplant, while p o o r e r w o m e n may not. In fact, it is by no means certain that family planning will remain entirely free at the point of care in the UK. In most European countries a fee is payable for contraceptive services, which may be subsidised by the state, as in Scandanavia, or repaid by health insurance, as in France and Holland. Current proposals suggest that the UK g o v e r n m e n t is reconsidering the principle of free contraceptive provision. If ch eap er methods of contraception such as older pilt formulations, IUDs and d i a p h r a g m s continue to be provided free, while m o r e expensive m et h o d s such as implants are not available on the NHS, there will not only be repercussions for the accessibility of existing contraceptives, but also for the research and d e v e l o p m e n t of n e w methods. If pharmaceutical companies do not profit from bulk sales of newly developed methods to the NHS, and have no prospect of long-term gains from developing novel contraceptives, future UK in-

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vestment in the research and development of c o n t r a c e p t i v e t e c h n o l o g y will b e cut. H o w e v e r it d e v e l o p s , t h i s s c e n a r i o still r e q u i r e s G P s to p r o v i d e c o n t r a c e p t i v e s e r v i c e s t o t h e m a j o r i t y of w o m e n , w i t h clinics p r o v i d i n g a s e r v i c e w h i c h is c o m p l e m e n t a r y to, r a t h e r t h a n d u p l i c a t i n g , t h e r o l e of t h e GP. C o n t r a c e p t i v e choice may be limited for some women, for e x a m p l e m a n y G P s m a y c o n t i n u e n o t to c o m p l e t e t h e t r a i n i n g n e c e s s a r y f o r t h e p r o v i s i o n o f IUDs or i m p l a n t s , a n d f i n a n c i a l c o n s t r a i n t s m a y m a k e them unwilling to provide more expensive m e t h o d s o f c o n t r a c e p t i o n . In t h e m o s t e x t r e m e eventuality, this m a y e x c l u d e G P p r e s c r i p t i o n o f newer, low-dose oral contraceptive formulations as well as i m p l a n t s . F o r t h e f u t u r e , it s e e m s likely t h a t c o m m u n i t y family p l a n n i n g clinics will b e c o m e m o r e specialist in n a t u r e . T h e i r clients will p r i m a r i l y b e w o m e n w h o a r e n o t a b l e to u s e oral c o n t r a c e p t i o n o r w h o p r e f e r to u s e o t h e r m e t h o d s . Specialist s e r v i c e s for y o u n g w o m e n a n d m e n will also b e p r i o r i t i s e d , in o r d e r t o a c h i e v e significant r e d u c t i o n s in t h e t e e n a g e p r e g n a n c y r a t e a n d t h e i n c i d e n c e o f sexually t r a n s m i t t e d infection a m o n g y o u n g p e o p l e . It will b e i n t e r e s t i n g to see if s t r a t e g i e s to r e d u c e u n p l a n n e d t e e n a g e p r e g n a n c y i n c l u d e m a k i n g i m p l a n t s a v a i l a b l e to young women who wish to use them. C o n t r a c e p t i v e i m p l a n t s a r e n o m o r e "perfect" than any other method of contraception, and the risks a n d b e n e f i t s o f t h e i r u s e m u s t b e e v a l u a t e d i m p a r t i a l l y a n d in t h e c o n t e x t o f r e p r o d u c t i v e

h e a l t h policy a n d p r a c t i c e , w h i c h affect t h e i r use. All c o n t r a c e p t i v e m e t h o d s , i n c l u d i n g i m p l a n t s , h a v e t h e p o t e n t i a l to b e u s e d in a n a b u s i v e a n d discriminatory manner, and abuses of implants h a v e b e e n well p u b l i c i s e d . It is n o t n e c e s s a r i l y c o n s t r u c t i v e , h o w e v e r , f o r t h e critical d i s c u s s i o n o f p h a r m a c e u t i c a l a n d m e d i c a l p r a c t i c e in o n e c o u n t r y , o r in o n e social c o n t e x t , to b e e m p l o y e d in o t h e r s in o r d e r to i n f l u e n c e w o m e n ' s p e r c e p t i o n s of n e w c o n t r a c e p t i v e m e t h o d s a d v e r s e ly. It is i m p o r t a n t to s e p a r a t e i s s u e s r e l a t e d to t h e m e t h o d s f r o m i s s u e s r e l a t e d to h e a l t h c a r e policy, p r i n c i p l e s a n d p r a c t i c e . T h e u s e o f i m p l a n t s to d e n y t h e h u m a n r i g h t s o f d i s a d v a n t a g e d w o m e n is n o t t h e p r i n c i p a l i s s u e in t h e UK. T h e i s s u e is t h a t t h o u s a n d s o f w o m e n w h o m a y w i s h to u s e c o n t r a c e p t i v e implants cannot get information about the m e t h o d , let a l o n e a c c e s s to it, e v e n t h o u g h in t h e o r y it is freely available. O f c o u r s e t h e experiences of women abused by unscrupulous policymakers and birth controllers deserve to be publicised - and so do the experiences of women w h o s e a c c e s s to i n f o r m a t i o n a n d c o n t r a c e p t i v e choice are restricted.

RI~SUMI~ Les i m p l a n t s N o r p l a n t s o n t d i s p o n i b l e s a u R o y a u m e - U n i d e p u i s 1993. L e u r i n t r o d u c t i o n a entrain6 une demande largement sup6rieure l'offre d e c e t t e m 6 t h o d e . C e t article p a s s e e n rev u e les p r o b l b m e s a s s o c i 6 s ~ l ' i n t r o d u c t i o n d ' u n e n o u v e l l e m 6 t h o d e c o n t r a c e p t i v e c o 0 t e u s e qui exige u n e f o r m a t i o n sp6cialis6e. I1 fait r e s s o r t i r les q u e s t i o n s p o r t a n t s u r la f o u r n i t u r e d e p l a n n i n g familial au R.-U. : le c o o t d e s m 6 t h o d e s et des s e r v i c e s , les s e r v i c e s s p 6 c i a l i s 6 s p a r r a p p o r t aux s e r v i c e s d e g 6 n @ a l i s t e s , le b e s o i n d e c o n sultation, la l i m i t a t i o n p a r r a p p o r t & l'61argissem e n t d u c h o i x c o n t r a c e p t i f et l ' 6 v a l u a t i o n d e s m 6 t h o d e s d a n s le c a d r e d e l e u r utilisation.

EXTRACTO Los i m p l a n t e s d e N o r p l a n t s o n o b t e n i b l e s e n el R e i n o U n i d o d e s d e 1993. Su i n t r o d u c c i 6 n h a resultado en un nivel de demanda que supera en g r a n m e d i d a al d e s u m i n i s t r o s . E s t e a r t i c u l o e x a m i n a los p r o b l e m a s v i n c u l a d o s a la i n t r o d u c ci6n de un nuevo y costoso m6todo anticonceptivo q u e r e q u i e r e d e c a p a c i t a c i 6 n e s p e c i a l i z a d a . H a c e h i n c a p i 6 s o b r e t e m a s r e t a c i o n a d o s c o n los s e r v i c i o s d e p l a n i f i c a c i 6 n f a m i l i a r e n el R e i n o U n i d o , v i n c u l a d o s a los c o s t o s d e m 6 t o d o s y servicios, los s e r v i c i o s d e e s p e c i a l i s t a s e n c o n t r a p o s i c i 6 n a los s e r v i c i o s g e n e r a l e s , la n e c e s i d a d d e o r i e n t a c i 6 n , la r e s t r i c c i 6 n o la a m p l i a c i 6 n d e la c a p a c i d a d d e e l e c c i 6 n d e m 6 t o d o s a n t i c o n c e p t i v o s y la e v a l u a c i 6 n d e los m 6 t o d o s d e n t r o del c o n t e x t o e n q u e s o n utilizados.

References 1. Taylor Nelson Research, 1992. (Unpublished, property of Roussel Laboratories) 2. MORI Market Research, 1993. (Unpublished, property of Roussel Laboratories)

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