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Benzodiazepines

Guidelines
Reasons for Introduction
Prevalence and Patterns of Use
Safety and Efficacy Issues
Indications for Use
Benzodiazepine Misuse
Residential Aged Care Facilities
Drug Dependent Patients
References

Guidelines

1. Wherever possible avoid prescribing benzodiazepines especially to known polydrug users, including those with dependence.
2. When a programme of benzodiazepine reduction is undertaken it should be with the patient's consent and co-operation.
3. All patients prescribed benzodiazepines should be advised of the risk of dependence associated with long-term use.
4. Patients receiving prescriptions for benzodiazepines should be advised to obtain all such prescriptions from the same doctor, wherever possible, so that risk of dependence may be monitored.
5. Treatment review should include a review of the indication(s) for continued use of the benzodiazepine, medication dose and possible adverse effects. For all patients receiving long-term benzodiazepines review is particularly relevant.
6. Non-medication management for conditions such as anxiety and insomnia includes clarification of the problem, counselling and specific advice, with referral where the diagnosis is uncertain, or where assistance in management is required.
7. Detoxification from benzodiazepines may be facilitated by changing patients to long half-life medications eg diazepam, and then slowly reducing the dose. One-to-one counselling may be supplemented by self-help support programmes during withdrawal.
8. The management of anxiety and insomnia should rely largely on non-pharmacological interventions.
9. When benzodiazepines are prescribed, the lowest dose to achieve the desired outcome for the shortest duration necessary should be provided.
10. For residents of aged care facilities, discontinuation of benzodiazepines can often be achieved gradually, provided patient, family and nursing staff are cooperative. Medication may occasionally be required to control anxiety, agitation or other disturbed behaviours. Staff should be knowledgeable in appropriate management of challenging behaviours.

Reasons for the Introduction of RACGP Guidelines

These Guidelines were formulated to provide assistance to general practitioners in relation to appropriate prescribing of benzodiazepines in the context of general practice. The Guidelines are based on the evidence regarding the advantages and disadvantages, particularly the danger of dependence, associated with the use of benzodiazepines ^1,2. They have been updated with reference to a recent Australian systematic review ³. The updated version takes into account new evidence:

• that benzodiazepines are frequently found in fatal and non-fatal opioid overdose among heroin users ⁴
• the efficacy of non-pharmacological interventions for late-life insomnia ⁵ and
•  the efficacy of interventions to reduce benzodiazepine use in aged care facilities ^6,7.

New practice resources, published since the last update, are Therapeutic Guidelines: Psychotropic 4th edition ⁸ and the National Prescribing Service Newsletter and Prescribing Practice Review Number 4 (July 1999) which specifically covers benzodiazepine withdrawal and management of insomnia ⁹.

The prescribing of benzodiazepines for drug dependent patients is included with this update of the Guidelines in response to concerns over what is reasonable care for patients who use benzodiazepines in high doses on a regular basis.

Prevalence and Patterns of Use

Overall, prevalence of use declined each year between 1989 and 1992 and has now plateaued. According to the Australian Statistics on Medicines, a total of 8.89 million prescriptions were dispensed through Australian pharmacies in 1998 (including PBS/RPBS, private and under copayment prescriptions). The total was 10.68 million prescriptions in 1990 ⁹. In the 1995 National Health Survey 2% of Australians reported use of benzodiazepines in the two weeks prior to interview. Women use benzodiazepines more often than men. The use of night-time sedation increases markedly with age. While the prevalence of use has declined since the 1989/90 survey, 58% of current users reported daily use for six months or longer. Thus although overall usage has declined, long-term use remains common ⁹.

Safety and Efficacy Issues

The safety of benzodiazepines is very high, relative to the barbiturates or the tricyclic antidepressants. During the 1980s it became apparent that long-term use of benzodiazepines in therapeutic doses can be associated with a definite withdrawal syndrome ¹⁰. It is also recognised that a withdrawal syndrome can appear while the patient is still taking medication, possibly because the patient avoids increasing the dose to cover increased tolerance ¹¹. The benzodiazepine withdrawal syndrome is highly variable. Withdrawal symptoms can usually be minimised by gradual reduction ⁸.

Harmful effects of the benzodiazepines other than the risk of dependence with long-term use, are less clear. Short-term or long-term use can be associated with excess sedation, with obvious caution to be exercised in driving or operating machinery. Epidemiological studies have demonstrated an excess of consultations for accidents among persons taking benzodiazepines ¹². For the elderly benzodiazepine user, a higher risk of falls and fractures has been demonstrated in some studies ¹³.

Indications for Use

Benzodiazepines are effective for relief of anxiety symptoms and will induce sleep if given in sufficient doses ⁸. The appropriateness of prescribing benzodiazepines for symptom reduction in anxiety management has been questioned, and the equal effectiveness of simple counselling demonstrated ¹⁴. For insomnia, short-term effectiveness of benzodiazepines is clear, but effectiveness beyond two weeks has not been demonstrated ¹. Insomnia is a symptom to be evaluated, not a diagnosis. When a sleep-wake history is taken, the patient may be found to be functioning normally on the amount of sleep obtained, may have unrealistic expectations of the requirements for sleep, may have a disorder of the sleep-wake schedule (including problems associated with shift work) which is not improved with hypnotics, or may have a specific sleep disorder such as sleep apnea or narcolepsy in which case hypnotics are contraindicated. Finally many patients who have taken benzodiazepines for period in excess of 4-6 months have become, unwittingly, dependent and experience withdrawal insomnia ^8,9.

Benzodiazepine Misuse

Polydrug use among injecting drug users is increasing and is associated with high rate of HIV risk taking behaviour ¹⁵. Moreover among heroin users, the risk of overdose is increased by the use of other drugs, particularly alcohol and benzodiazepines ⁴ Guidelines approving short-term prescription take no account of the realities of easy access to multiple single prescriptions. This complicates the issue of rational prescribing for all long-term benzodiazepine-using patients, as well as for the minority of polydrug users ¹⁶.

Residential Aged Care Facilities

Prescribing for residents in aged care facilities (and other residential facilities) presents special difficulties. With accreditation of aged care facilities has come a heightened awareness of the responsibilities of the facility for quality use of medicines ¹⁷. This responsibility includes drug utilisation review by an accredited pharmacist. The use of benzodiazepines is less when staff receive education in geriatric care and where the organisational culture is supportive ⁶. Benefits for the elderly in aged care accommodation following successful reduction in rates of benzodiazepine use include increased mobility and alertness, reduced incontinence and improved well-being ⁷.

Drug Dependent Patients Using High Doses of Benzodiazepines on a Regular Basis

Preamble

The RACGP Guidelines for the rational use of benzodiazepines state general principles based on the best available evidence. Guiding principle no 1 advises general practitioners wherever possible to avoid prescribing for polydrug users, notably those with dependence. A recent review of evidence strongly supports this principle ³. However, the principle leaves unspecified the distinction between reasonable care for difficult patients, consistent with the principles of harm minimisation, and clearly unacceptable practice. In the National Drug Strategy Household Survey 1995, 3% of respondents reported 'ever use' of tranquillisers for non-medical purposes ¹⁸. Benzodiazepine overuse occurs both as polydrug use and as single drug use ³.

This addition to the Guidelines specifies peer views, in the absence of higher levels of evidence, which would indicate the standard of practice to be expected of general practitioners who prescribe benzodiazepines in high doses on a regular basis.

Definition of benzodiazepine use for the purposes of this protocol

For the purposes of definition, "high doses on a regular basis" could be more than three occasions per month for more than two months in any one year. As with other aspects of the management of polydrug users, the principle of harm minimisation applies. Benzodiazepines are implicated in a high proportion of fatal and non-fatal opioid overdoses4 as well as other problems for injecting drug users ^20,21.

Best practice recognises the high risk of the patient seeking large quantities of benzodiazepines (and other drugs of dependence) from the prescriber, as well as the high risk of the patient seeking drugs from multiple prescribers. Experienced prescribers have found that most high dose users cannot be managed with an ordinary script.

Distinct from high dose prescribing on a regular basis, which this addendum addressees, another "grey" area is prescribing regularly for the patient, usually on a monthly basis, where the general practitioner is unsure if the patient is a "doctor shopper". In this context the general practitioner is well advised to telephone the Health Insurance Commission's Doctor Shopping Service.

Aims of this protocol:

• To reduce deaths from drug overdose due to combinations of drugs, including benzodiazepines
• To reduce the indiscriminate prescribing of benzodiazepines to polydrug users
• To reduce the barriers to doctors seeing drug dependent patients
• To integrate and standardise quality medical practice
• To facilitate the work of the Medical Boards in identifying doctors practising unacceptable quality medicine
• To maintain the good reputation of medical practitioners

Protocol for prescribing of benzodiazepines in high doses on a regular basis

Where relevant and appropriate the following should be undertaken and adequately documented in the medical record:

1. A full history, including use of alcohol and other drugs and psychiatric co-morbidity
2. Adequate physical examination
3. Problem/diagnosis list
4. Management plan, which should include the following:
   • consultation with another medical practitioner with experience in management of drug dependence
   • communication with other prescribers, notably methadone prescriber
   • supply of specified small quantities (e.g. daily), whether at the surgery or, if applicable, at a community pharmacy.
   • communication with the Health Insurance Commission's Doctor Shopping Service to clarify whether the patient is seeing multiple doctors for prescriptions for benzodiazepines and/or narcotic analgesics
   • monitoring of consumption where applicable by the Health Insurance Commission's Doctor Shopping Service, with agreement by the patient to attend only one doctor and one pharmacy and signed consent to the doctor receiving feedback on actual consumption for the period of the contract.

References

1. NH&MRC. Guidelines for the prevention and management of benzodiazepine dependence. Canberra: AGPS 1991:14.
2. Tyrer P. Dependence as a limiting factor in the clinical use of minor tranquillisers. Pp. 173-188 in Balfour DJK, Psychotropic drugs of abuse. International Encyclopaedia of Pharmacology and Therapeutics, New York: Pergamon 1990.
3. Spinks A, Bulbeck K, Del Mar C, Glasziou P, Nikles J. Using benzodiazepines: the best evidence. Centre for General Practice, University of Queensland, Consultancy for the PHARM Benzodiazepine Working Group, 2000.
4. Zador D, Sunjic S, Darke S. Heroin-related deaths in New South Wales, 1992: toxicological findings and circumstances. Med J Aust 1996;164:204-7.
5. Morin CM, Colecchi C, Stone J, Sood R, Brink D. Behavioral and pharamcological therapies for late-life insomnia: a randomised controlled trial. J Am Med Assoc 1999; 281: 991-9.
6. Roberts MS et al. Medication prescribing and administration in nursing homes. Age and Ageing 27:385-392.
7. Gilbert A, Owen N, Innes JM, Sansom L. Trial of an intervention to reduce chronic benzodiazepine use among residents of aged-care accommodation. Aust NZ J Med 1993;23:343-7.
8. Therapeutic Guidelines Inc. Therapeutic Guidelines: Psychotropic Version 4 2000, Melbourne 2000.
9. NPS News. National Prescribing Service Newsletter and Prescribing Practice Review No 4 (July). National Prescribing Service Limited, Sydney 1999.
10. Busto U, Sellers EM, Naranjo CA, Cappell H, Sanchez-Craig M, Sykora K. Withdrawal reaction after long-term therapeutic use of benzodiazepines. N Engl J Med 1986; 315:854-859.
11. Ashton H. Protracted withdrawal syndromes from benzodiazepines. J Substance Abuse Treatment 1991; 8: 19-28.
12. Oster G, Huse DM, Adams SF, Imbimbo J, Russell MW. Benzodiazepine tranquilizers and the risk of accidental injury. Am J Public Health 1990;80:1467-70.
13. Leipzig RM, Cumming RG, Tinetti ME. Drugs and falls in older people: a systematic review and meta-analysis. 1. Psychotropic drugs. J Am Geriatr Soc. 1999;47:30-39.
14. Catalan J, Gath D, Edmonds G, Ennis J. The effects of non-prescribing of anxiolytics in general practice - 1: controlled evaluation of psychiatric and social outcome. Br J Psychiat 1984; 144: 593-602.
15. Darke S, Hall W, Ross M, Wodak A. Benzodiazepine use and HIV risk-taking behaviour among injecting drug users. Drug Alcohol Depend 1992; 31:31-36.
16. Woods JH, Katz JL, Winger G. Abuse liability of benzodiazepines. Pharmacol Rev 1987; 39:251-390.
17. Australian Pharmaceutical Advisory Committee. Integrated best practice for medication management in residential aged care facilities. AGPS, Canberra, 1997
18. National Drug Strategy Household Survey. Survey Report 1995. Commonwealth of Australia, 1995.
19. Zador D, Sunjic S, Darke S. Heroin-related deaths in New South Wales, 1992: toxicological findings and circumstances. Med J Aust 1996;164:204-7.
20. Darke S, Ross JE, Hall WD. Benzodiazepine use among injecting heroin users. Med J Aust 1995;162: 645-7.
21. Dobbin M. Prescription drug abuse. Victorian Department of Human Services, Melbourne, 1998.

Publication Date: 1 December 2000
Authorised By: Quality Care