International Journal of Drug Policy 12 (2001) 91 – 101 www.elsevier.com/locate/drugpo
Survey of injectable methadone prescribing in general practice in England and Wales Berry Beaumont Primary Care Research Group, Health Promotion Research Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK
Abstract Little is known about the extent and conduct of general practice prescribing of injectable methadone to opiate users in England and Wales. A postal questionnaire survey of general practitioners (GPs) was conducted in 1999 to ascertain how many GPs were prescribing injectable methadone, to describe their prescribing practices and to explore their perceptions of the service they provided. Four hundred and seven GP practices in 77 out of 105 health authorities were apparently prescribing injectable methadone. The difficulties in identifying, and obtaining a response from, GPs prescribing injectable methadone are discussed. Analysis of 93 usable returned questionnaires showed a range of GP characteristics and experience. The GPs were treating 211 patients with injectable methadone and a further 2003 patients with oral methadone. Prescribing practice and monitoring arrangements did not always follow national guidelines. A minority of GPs had received training in the management of drug dependency. They were most likely to decide to prescribe injectable treatment on the recommendation of a specialist drug agency, and to discontinue prescribing if there was a suspicion of diversion of prescribed ampoules. Although significant numbers of GPs felt unsure about their skills and the support available to them, most appeared to be managing their patients thoughtfully and with appropriate outcomes in mind. Recent policy documents from the Department of Health and the Home Office have questioned the place of injectable methadone in the treatment of opiate misuse, particularly in a general practice setting. A Home Office licence will shortly be required to prescribe injectable methadone. This survey suggests a minority of GPs would apply for such a licence. More research into the effectiveness of injectable methadone treatment in a range of settings is needed before conclusions can be drawn about the appropriateness of providing this treatment in general practice. © 2001 Elsevier Science B.V. All rights reserved. Keywords: Injectable methadone; General practice; Prescribing policy; Licensing
Introduction The prescribing of methadone for the management of opiate misuse is a well-established and effective treatment (Farrell et al., 1994). Britain is unusual in allowing any registered
medical practitioner to prescribe methadone as an injectable or oral preparation for treatment of opiate misuse (Shaw et al., 1997). Because injectable methadone can be prescribed without the requirement of a Home Office licence (unlike heroin), General Practi-
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tioners (GPs) as well as specialists have been involved in this treatment modality for three decades. Methadone in injectable form became available for use in 1968, and by 1973 more patients on injectable treatment were being prescribed methadone than heroin. Methadone has remained the more commonly prescribed injectable opiate even though it is not licensed for this use (Mitcheson, 1996). Recent studies have shown benefits from injectable methadone treatment within specialist services (McCusker and Davis, 1996; Metrebian et al., 1998; Strang et al., 2000) but there is no nationally agreed treatment protocol for prescribing injectable methadone, no consensus over patient eligibility criteria and no legal or recommended dose limits (Ford and Metrebian, 1998; Sarfraz and Alcorn, 1999). The Department of Health’s 1996 Task Force review of treatment services acknowledged the lack of formal treatment outcome studies of injectable methadone and recommended that more research should be carried out. It also recommended that injectable opiate prescribing should be undertaken only by ‘doctors (including GPs) with appropriate training and expertise, working with adequate multidisciplinary input and by specialist drug misuse services’ (Department of Health, 1996a). More recent clinical management guidelines for treatment of substance misuse from the Department of Health suggested that probably only doctors who fulfil the criteria of ‘specialists’ (usually consultant psychiatrists) should prescribe injectable methadone (Department of Health, 1999). The Advisory Council on the Misuse of Drugs has also made known its views on this issue, although citing no evidence in support of its contention that restricting injectable methadone prescribing will reduce drug related deaths. ‘We advise against the prescrip-
tion of methadone ampoules to opioid users by GPs….If these ampoules are to be prescribed by clinics it should only be in exceptional circumstances and under stringent control’ (Home Office, 2000a). The Home Office has consulted on proposals to amend the regulations of the Misuse of Drugs Act 1971 (Home Office, 2000b). These proposals include restricting the prescribing of injectable methadone to doctors licensed to prescribe on the basis of having appropriate training and clinical competence, and working in a suitable clinical environment. The outcome of the consultation is not known at the time of writing but the Second National Plan of the United Kingdom AntiDrugs Co-ordinator clearly states that new licensing arrangements will be introduced during the next year (Cabinet Office, 2000). Government policy is to increase the involvement of GPs in the treatment of drug users (Department of Health, 1996a,b). The numbers of GPs currently providing any form of methadone treatment for opiate misusers is unknown. However, a 1 in 4 sample survey of community pharmacies in England and Wales in 1995 suggested that about 8% of methadone prescriptions from National Health Service (NHS) GPs were for the injectable form of methadone (Strang et al., 1996). There is clearly a need to explore current prescribing of injectable methadone in the general practice setting, in the light of recent policy developments. A preliminary study carried out in three inner London practices suggested that injectable methadone treatment was being provided in a considered way, consonant with patient need. Treatment outcomes appeared good and patients were satisfied with the service (Ford and Ryrie, 1999). A focus group interview with GPs described in this preliminary study identified relevant issues to include in the questionnaire for the national survey of GPs reported here.
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The aims of this survey were to assess the extent of injectable methadone prescribing to opiate users by GPs in England and Wales, to describe GPs’ current prescribing practice and to explore GPs’ perceptions of the service they provide. Methods General practices thought to be prescribing injectable methadone were identified through the PACT (prescribing analysis and cost) system, which provides information about all NHS prescriptions written by GPs. However, this information is confidential to the prescribing doctor, and to health authority pharmaceutical advisers. There are further limitations in that prescriptions can only be identified by GP practice, not at individual prescribing GP level, and the information available is the number of items prescribed over a given period, with no information about the number of patients for whom these items were prescribed, nor the indication for which it was prescribed. However, it was feasible to distribute questionnaires to GPs by an indirect approach to practices through health authority pharmaceutical advisers. Pharmaceutical advisers in the 105 health authorities in England and Wales were asked to supply figures for the numbers of GP practices in their health authority which had written prescriptions for injectable methadone within the most recent 6 month period for which data were available. Seventy five pharmaceutical advisers replied that one or more practices in their health authority were prescribing injectable methadone, in total 407 practices in these 75 health authorities. Twenty-five advisers ascertained that no practices were prescribing injectable methadone within the 6 month period in question, two advisers were unable to obtain this information accurately and three did not reply.
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The pharmaceutical advisers in the 75 health authorities with practices prescribing injectable methadone were then sent questionnaires to be forwarded to these practices. Confidentiality was thus maintained, as the identity of the practices involved was not revealed to the researcher. However, this meant that practices were only contacted once, and it was not possible to follow up non-responders. A response was received from practices in 41 health authorities. Pharmaceutical advisers in the 34 remaining authorities were contacted to confirm that questionnaires had in fact been sent out. Sixteen advisers confirmed this, 14 replied in the negative, and no response was obtained from the other four advisers. Thus the survey only definitely included 57 out of 75 eligible health authorities, and 324 practices out a possible 407. This is shown diagrammatically in Fig. 1. Questionnaires were returned from 107 practices that had been correctly identified as currently or recently prescribing injectable methadone. A further 42 practices returned blank questionnaires, claiming never to have written injectable methadone prescriptions. The overall response rate was 46% (149/324). Excluding the 42 incorrectly included practices from both numerator and denominator gives a response rate of 38% (107/282). In order to investigate these inaccuracies in the identification of practices, pharmaceutical advisers in the 20 health authorities which had identified unusually high numbers of practices, or had significant numbers of ineligible practices returning questionnaires were contacted and asked to run another search to check the original figure they had given for eligible practices. Their second search gave very similar numbers to the first. Table 1 describes the injectable methadone prescribing status of the practices from which the questionnaires were returned. Ninety-
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three questionnaires from 91 practices were considered appropriate to include in the analysis. A further six questionnaires from GPs who used to prescribe for patients in the practice but now only prescribed injectable methadone in a specialist clinic setting were excluded.
Results The GPs and their methadone prescribing
Fig. 1. Response from health authority (HA) pharmaceutical advisers.
Table 1 Returned questionnaires Injectable methadone prescribing status of responding practices
Number of practices
Currently prescribing — usable 84 questionnaire Recently prescribing — usable 7 questionnaire Now only prescribing in drug clinic 6 Currently prescribing — 2 incomplete questionnaire Recently prescribing — incomplete 6 questionnaire Prescribing to terminally ill patients 2 Never prescribed injectable 42 methadone Total returned questionnaires 149 Total sent questionnaires 324
The 93 responding GPs worked in 91 practices of all sizes from small single-handed to large group practices. Thirty-eight (41%) were working in the inner city, 41 (44%) in an urban environment and 14 (15%) in a rural location. Sixty-nine (74%) GPs qualified between 1970 and 1990, and 68 (73%) were male. Their years of injectable methadone prescribing experience ranged from 1 year to 23 years and they were between them prescribing injectable treatment for 211 patients. Fifty-two (60%) GPs were treating just one patient with injectable methadone, and only ten (12%) were prescribing for five or more patients, the maximum number being 21 patients. The GPs were also between them treating a further 2003 patients with methadone mixture in their practices. Thirteen (14%) GPs worked in a methadone treatment setting outside their own practice as well as treating patients in the practice. Almost all of these were community drug teams, with one police surgeon and one GP led specialist clinic. All but three of these 13 GPs treated patients with injectable methadone in this setting. Seven treated ten or fewer patients, and the others 20, 36 and 100 patients
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Table 2 Characteristics of GPs prepared to prescribe more than 120 mg injectable methadone daily Characteristic
Also work in other setting Trained in drug misuse Trained in oral methadone Trained in injectable methadone Have specialist support In shared care scheme Consider themselves specialists Would apply for licence
Chi2
GPs prepared to prescribe\120 mg methadone daily
All other respondents
Yes (%)
n
Yes (%)
n
6 14 13 7 12 10 11 14
22 22 22 22 22 22 22 22
7 21 20 6 49 37 19 22
71 69 69 69 61 57 68 67
(27) (64) (59) (32) (55) (45) (50) (64)
The GPs were asked about the range of doses within which they were currently prescribing in general practice. The lowest daily dose currently being prescribed was 20 mg, and the highest 300 mg. Sixteen GPs (19%) were currently prescribing more than 120 mg a day but only two of these were prescribing more than 200 mg. They were also asked about the maximum daily dose they would be prepared to prescribe. Only 73 GPs answered this question. The maximum dose ranged from 20 to 500 mg. Seventeen GPs (23%) named a dose between 40 and 70 mg a day; 30 (41%) named a dose between 80 and 120 mg; and 22 (30%) a daily dose over 120 mg. Three of this latter group named doses above 200 mg (250, 300 and 500 mg). Some characteristics of the 22 GPs who were prepared to prescribe more than 120 mg a day were analysed. Seventeen of them had been prescribing injectable methadone for at least 5 years, and seven of them were currently prescribing to five or more patients. Table 2 shows other characteristics of these GPs compared to all other respondents. There were significant differences (P B 0.01) in having received training (in management of drug misuse, prescribing oral methadone, and prescribing injectable methadone) and in
(10) (30) (29) (9) (80) (65) (28) (33)
PB0.05 PB0.01 PB0.01 PB0.01 PB0.05 P\0.05 P\0.05 PB0.01
intending to apply for a Home Office licence to continue prescribing injectable methadone. Rationale for prescribing injectable treatment Table 3 shows the likelihood of GPs deciding to offer patients injectable methadone treatment in different situations. They were most likely to agree to provide a prescription for an injectable drug if this had been recommended by a specialist drugs agency, and least likely to do so if the patient was already receiving this from a private doctor. Table 4 shows the importance they ascribed to various outcomes of injectable methadone treatment. The most important treatment outcomes were considered to be safer injecting and reducing use of illicit drugs. The least important outcome was an improvement in employment prospects. Prescribing and monitoring arrangements Forty-eight (58%) GPs always or usually required their patients to collect their methadone ampoules daily from the pharmacy, 18 (22%) sometimes did, and 17 (20%) rarely did. Fifty-five GPs (63%) requested urine
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drug screens at least every 6 months, and 36 (44%) always or usually required clean urines as a condition of the prescription. Eightythree GPs (91%) expected the patient to consult with the same GP in the practice at each visit and 59 (65%) always or usually required their patients also to be seeing a drugs worker. Table 5 shows the reasons why GPs might discontinue a prescription for injectable methadone. The most likely reasons were a suspicion that the patient was selling on the
ampoules prescribed, and failure of the patient to comply with the rules of behaviour expected in the surgery. The least likely reason for discontinuing the prescription was ‘dirty’ urine screens.
3.4. GPs’ 6iews about pro6iding an injectable methadone ser6ice in general practice Forty-eight (53%) GPs had concerns about the service they provided. Sixteen GPs felt that primary care was an inappropriate set-
Table 3 Likelihood of GPs deciding to prescribe injectable methadone Reason for prescribing injectable methadone
Already on injectable treatment from specialist drugs service (n =84) Injectable treatment requested after assessment by local drugs agency (n=82) Serious health and social problems and can’t stop injecting (n=83) Failure of oral methadone (n=83) Inadequate local service (n= 81) Already on injectable methadone from private doctor (n=84)
No. of GPs (%) 1 — most likely
2
3
4
5 — least likely
52 (62)
14 (17)
8 (19)
5 (6)
5 (6)
41 (50)
23 (28)
7 (8)
3 (4)
8 (10)
40 (48)
18 (22)
13(16)
6 (7)
6 (7)
24 (29) 13 (16) 9 (11)
16 (19) 20 (25) 12 (14)
18 (22) 22 (27) 16 (19)
14 (17) 11 (13) 16 (19)
11 (13) 15 (19) 31 (37)
Table 4 GPs’ views on the importance of different treatment outcomes Treatment outcome
Safer injecting (n =89) Reduced illicit use (n=89) Reduced crime (n=88) Social stability (n =89) Improved health (n= 89) Cease illicit use (n=87) Contact with services (n=87) Improve employment (n=88)
No. of GPs (%) 1 — very important
2
56 55 49 44 46 41 32 33
29 30 26 32 28 23 32 18
(63) (62) (56) (49) (52) (47) (37) (38)
3 (33) (34) (30) (36) (31) (26) (37) (20)
4 4 11 12 12 22 18 24
4 (4) (4) (12) (13) (13) (25) (20) (27)
0 0 2 1 3 1 5 9
5 — not important (0) (0) (2) (1) (3) (1) (6) (10)
0 0 0 0 0 0 0 4
(0) (0) (0) (0) (0) (0) (0) (5)
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Table 5 Likelihood of GPs discontinuing a prescription for injectable methadone Reason for discontinuing injectable prescription
No. of GPs (%) 1 — very likely
Suspicion of selling on ampoules (n= 91) 76 (84) Failure to comply with behaviour expected in the 46 (51) surgery (n=91) Patient moved out of practice area (n =91) 67 (74) Continuing injection of illicit drugs (n =90) 37 (41) ‘Dirty’ urines (n=82) 15 (18)
2
3
4
5 — least likely
10 (11) 29 (32)
3 (3) 8 (9)
0 (0) 4 (4)
2 (2) 4 (4)
6 (7) 22 (25) 23 (28)
11 (12) 20 (22) 21 (26)
5 (5) 8 (9) 17 (21)
2 (2) 3 (3) 6 (7)
Table 6 GPs’ training in drug misuse management Training in
Managing drug dependency Prescribing oral methadone Prescribing injectable methadone
Working in general practice only (n= 78)
GPs also working in another All GPs (n= 91) setting (n= 13)
Yes (%)
No (%)
Yes (%)
No (%)
Yes (%)
No (%)
24 (31) 23 (29) 8 (10)
54 (69) 55 (71) 70 (90)
11 (85) 10 (77) 8 (62)
2 (15) 3 (23) 5 (38)
35 (38) 33 (36) 13 (14)
56 (62) 58 (64) 78 (86)
ting, nine expressed fears of diversion of injectable methadone onto the market, 12 GPs thought they provided a poor service, six found the inadequate local specialist service was a problem, and others mentioned lack of training (four), time constraints (four) and the cost (not a ‘core’ service) (four). Forty-four respondents mentioned factors that would improve the service they offered. Twenty-five GPs wished for better specialist and shared care services, five wanted more time, four mentioned training and two wanted a supervised administration facility. Six GPs felt that general practice was not an appropriate setting for prescribing injectable methadone. Thirty-one (38%) GPs said there would be no alternative injectable methadone pre-
scribing service in their area if they were to cease prescribing. Training, support and skills The GPs were asked if they had ever received training in substance misuse management, if they felt supported in this work, and whether they considered themselves as specialists or would apply for an injectable prescribing licence. Their replies are shown in Tables 6–8. The 13 GPs who also worked in another drug treatment setting were significantly more likely to have received all types of training, to consider themselves to be specialists and to wish to apply for a licence than those only treating patients in the practice (PB0.01).
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Respondents who had not received any formal training were asked how they had acquired the skills necessary for injectable methadone prescribing. Twenty-eight (33%) mentioned the local specialist agency and a further 28 (33%) said ‘on the job’, 11 (13%) mentioned networking with GP colleagues, and nine (11%) said from reading about it. Two GPs did not feel they had the necessary skills.
Discussion The PACT prescribing information obtained in this survey suggests that GPs in 77 out of 105 health authorities may be prescribing injectable methadone, and that around 407 GP practices are involved. However, the actual number of practices involved may be smaller than this because 42 practices identified from PACT data as prescribing injectable methadone returned questionnaires stating they did not prescribe. Possible explanations for this might be that the question-
naire was only seen by a non-prescribing GP in the practice who was unaware that a partner was prescribing, that a locum had prescribed, or that GPs did not wish to admit that they prescribed injectable methadone. Inaccuracies in PACT data or in the searches carried out by the pharmaceutical advisers are other possible explanations. There are no comparable published data available from the PACT system that can confirm the extent of GP prescribing of injectable methadone. Low response rates are acknowledged to be a particular problem in postal surveys of GPs, and non-response rates tend to be higher amongst older GPs, those without postgraduate qualifications and those working in non-training practices (Templeton et al., 1997; Stocks and Gunnell, 2000). Two recent postal surveys of GPs asking about substance misuse issues reported response rates of 33% (Deehan et al., 1997) and 32% (Kaner et al., 1998) after two mailings. In light of this, the 38% response rate achieved in this survey after only one mailing appears reasonable, but there is likely to be bias
Table 7 Support available to GPs Support from:
Yes (%)
No (%)
Not sure (%)
n
Local specialist unit Shared care scheme
61 (73) 47 (60)
8 (10) 32 (40)
14 (17) –
83 79
Table 8 GPs’ views on applying for a Home Office licence
Consider themselves specialists Would apply for licence to prescribe injectable methadone
Working in general practice only
GPs also working in another setting
All GPs
Yes (%)
No (%)
Yes (%)
No (%) Yes (%)
No (%)
n
19 (25) 24 (31)
58 (75) 53 (69)
11 (85) 12 (100)
2 (15) 0 (0)
60 (67) 53 (60)
90 89
30 (33) 36 (40)
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introduced by the overall low response. The survey findings are also difficult to interpret because 83 practices identified as suitable for inclusion were not sent a questionnaire at all, and unforeseen inaccuracies in the identification of other practices resulted in the mistaken inclusion of at least 42 practices. However, there were sufficient questionnaire responses to merit this descriptive account of injectable methadone prescribing activity in general practice around the country, particularly in view of the fact that no similar survey has been attempted before. As discussed in the introduction, there are no evidence-based guidelines for good practice in injectable methadone prescribing, although it is logical to assume that the Department of Health guidelines for good practice in prescribing oral methadone might also apply to the injectable preparation. These guidelines suggest a daily maintenance dose of 60 – 120 mg methadone is usually appropriate. Doses higher than 120 mg oral methadone are only rarely required. Twentytwo GPs in the survey were prepared to prescribe injectable methadone at doses higher than 120 mg. Although these GPs were mostly both experienced and trained in drug misuse management, their high dose prescribing may be a matter for concern. However, it could be argued that patients receiving injectable methadone treatment are likely to have a long history of opiate use, including failed oral methadone treatment, and may therefore have developed more tolerance to opiates, justifying methadone doses higher than 120 mg a day. A recent feasibility study of prescribing injectable methadone supports this view. The study set an upper dose limit of 200 mg, and found that the mean daily dose of injectable methadone used over a twelve month period was 161 mg (range 90 – 200 mg) (Metrebian et al., 1998).
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The Department of Health guidelines suggest the need for more rigorous monitoring of treatment than the GPs in this survey were observing, particularly in respect of frequency of urine screens and frequency of pick-up of ampoules from the pharmacy. It may be relevant that the survey found that significant numbers of GPs were only prescribing to one patient, had not received appropriate training, and felt unsure of their skills and unsupported in their treatment of these patients. Nevertheless, most of the GPs surveyed demonstrated some awareness of a harm minimisation approach to treatment as shown by their views on important treatment outcomes where reduction in illicit drug use was rated as more important than ceasing illicit use. This awareness was also apparent in their reasons for discontinuing a prescription for injectable methadone. Continued injecting of illicit drugs was perceived as achieving less harm reduction than use of illicit drugs in general, and was more likely to lead to the discontinuation of the prescription than just evidence of illicit drug use from urine screens. The commonest reasons for providing a prescription for injectable methadone in the current survey were on the recommendation of, or continuing a prescription started by, a specialist agency. A number of respondents commented that they would not themselves initiate a prescription for injectable treatment in the absence of such advice. This suggests that despite a lack of formal training or strict adherence to guidelines, these GPs were cautious and thoughtful in their prescribing of injectable methadone treatment. This is consistent with the findings of the earlier small survey conducted in London (Ford and Ryrie, 1999) and an audit from one general practice in Bedfordshire which included 43 patients prescribed injectable methadone over a 10 year period (Martin et al., 1998).
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Less than half of the GPs in the survey would wish to apply for a Home Office licence if this were needed to allow them to continue to provide this treatment in their practices, and probably only a proportion of those who might apply for a licence would fulfil the criteria to be granted one. There were a number of unsolicited comments on the questionnaires, as well as those reported in the results, indicating that some GPs would not wish to take on any further patients, or would prefer not to provide this service in primary care at all. This has implications for the continuing availability of this treatment modality. There is still insufficient research into the place of injectable methadone as one of a range of options for substitute prescribing treatment of opiate misuse, in whatever setting treatment is delivered. Further work is needed to establish if and how injectable methadone treatment can be appropriately provided in a variety of settings, including primary care. The Department of Healthfunded UK pilot, currently underway, of a randomised controlled trial of injectable methadone treatment compared with oral methadone in specialist settings, is welcomed (Metrebian N, personal communication). This needs to be followed by a definitive trial. GPs in this survey gave support to the contention that drug users may find it difficult to gain access to a prescription for an injectable drug, hence the involvement of GPs, despite the reluctance of some, in providing this service. It seems premature to further limit the availability of injectable methadone treatment through licensing before it has been adequately evaluated. An alternative approach whilst awaiting research findings would be to direct resources to improving the training and support available to the GPs who are currently providing this service in response to an expressed need for
injectable methadone treatment from a small number of drug users.
Acknowledgements Funding: this research was supported by London Region Research and Development funds.
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