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The Canadian Journal of Hospital Pharmacy- Volume 47, No. 5, October, 1994 197

A Drug Use Evaluation of Bedtime Sedation in Geriatric Patients

Janet W. Demsey

ABSTRACT RESUME A pilot study was designed to assess the feasibility of On a effectue un projet pilote pour voir si on pouvait a shared regional drug use evaluation (DUE) program implanter un programme regional d'evaluation de involving patients. A retrospective DUE on the use of ! 'utilisation des medicaments par !es patients ages. benzadiazepines, hydrate and neuroleptics On a procede pour cela a une analyse retrospective for bedtime sedation was performed on geriatric de !'utilisation des benzadiazepines, de !'hydrate de patient populations from two hospitals. Regional chloral et des neuroleptiques par des patients ages de program staff coordinated the DUE, including deux hopitaux, au coucher, en guise d'hypnotique. Le development of the criteria and chart review. The personnel du programme regional a coordonne participating Pharmacy departments performed the l'exercice, etabli les criteres d'evaluation et.revu Les internal administrative and Pharmacy and dossiers. Les departements de pharmacie participants Therapeutics committee communications. se sont occupes des communications entre Forty patient charts from two sites were reviewed. !'administration et le Comite de pharmacologie. The DUE results indicated different rates ofdrug use Les dossiers de 40 patients ant ete examines aux and discontinuation of therapy between the two deux endroits. Les resultats revelent des taux geriatric patient populations. The overall rates of differents d'utilisaton des medicaments et d' abandon inappropriate drug use were similar. One undesirable du traitement pour Les deux populations de patients clinical outcome occurred. Benzadiazepine use for ages. Le taux global d'utilisation inappropriee des more than 30 days was high in both groups. medicaments etait similaire dans Les deux hopitaux. Identification ofthe justification for drug use, dosage Un seul denouement clinique indesirable a ete re/eve. reduction and drug discontinuation did not occur in L'utilisation de benzadiazepine pendant plus de 30 the majority of patients. The pilot study identified jours etait relativement elevee pour les deux groupes. areas where use of bedtime sedation could be On n'a pas justifie ['indication du medicament, la improved, and allowed development of DUE criteria diminution de la posologie et ['abandon du traite­ for future evaluation. ment dans la majorite des cas. Le projet pilote a cerne Key Words: bedtime sedation, , dans quelles situations il conviendrait d'ameliorer drug use evaluation, geriatrics !'utilisation des hypnotiques au coucher et a permis l'etablissement de criteres en vue d'une evaluation ulterieure de !'utilisation des medicaments. Mots cles: benzodiazepines, evaluation de I 'utilisation Can J Hosp Pharm 1994;47:197-202 des medicaments, geriatrie, hypnotique

INTRODUCTION patient incidents in hospital. To from the literature concerning Quality assurance for pharmacy facilitate DUE in geriatric patients, adverse drug reactions and the departments includes drug use a pilot study was designed to assess prevalence of use evaluation (DUE). Since accredi­ the feasibility of a shared program in geriatric patients. These concerns tation reviews for hospitals examine between two hospitals. This was have led to national health care quality assurance activities, DUE is done as part of a larger regional regulations in the United States a significant responsibility of formulary review and DUE project (Omnibus Budget Reconciliation pharmacists, physicians, and in which members of the program Act, 1990) which attempt to limit hospital administrators. With the staff coordinated and assisted in the psychoactive drug use in geriatric growth of the geriatric population completion of DUE within the nursing home patients. The use of has come the recognition of adverse participating hospitals. benzodiazepines with long drug reactions as a reason for The reasons for selection of a elimination half-lives has been hospital admission. Adverse drug DUE on bedtime sedation in the associated with hip fractures. 1 The reactions are also associated with geriatric patient group stemmed literature also includes documen-

Janet W. Demsey, Pharm.D., was Formulary/DUE Coordinator, Ottawa Valley Regional Drug Information Service, Ottawa General Hospital, Ottawa, Ontario. She is currently working at the Stratford General Hospital. Acknowledgements: The author would like to acknowledge the contributions of Michael Tierney and Carol Repchinsky in the Department of Pharmacy at Ottawa General Hospital, and Shirley Mack for data collection. Funding was provided by a Hospital Incentive Grant, Ministry of Health, Ontario. 198 The Canadian Journal of Hospital Pharmacy - Volume 47, No. 5, October, 1994

tation of adverse drug reactions (e.g., number of measures to encourage Patient identification occurred early falls, , and bizarre appropriate drug use.6 First, in 1993. This was done by the behaviour) related to triazolam use treatment of underlying medical or Pharmacy contact in each hospital in geriatric patients. 2 Indeed, psychiatric disorders should occur (Director of Pharmacy). The criteria specific recommendations to limit since is a common were submitted by the Directors to the dosage and duration of use for symptom of many conditions. the hospitals' Pharmacy and triazolam were developed by the Second, insomnia should be Therapeutics (P & T) committees in Health Protection Branch (Health classified as transient, short-term or April - June, 1993. The forms used and Welfare Canada) in 1991 and in long-term. Transient or short-term for data collection were tested and 1992. 3.4 In the United Kingdom, insomnia may require drug use of revised by the program staff during the drug was withdrawn from the several days or three weeks duration, the summerof 1993. Data collection market. Avorn et al5 reported a respectively. Drug use for long-term for the DUE occurred between reduction in the use of benzodi­ insomnia is controversial since the August 23 and September 23, 1993. azepines of 20% in the study group drugs are not considered effective All data collection was performed compared to 9% in the control group for long-term use. Third, drug selec­ by one program staff member. A after implementation of an edu­ tion, when indicated, should report of each hospital's results was cational program targeted at consider the elimination half-life prepared by the program staff and physicians, nurses, and aides. They and presence of active metabolites discussed with the Director of noted reduced psychoactive drug of the chosen. Pharmacy in October, 1993. The use without adverse effects on Fourth, duration of use should be report was discussed with the behaviour or level of functioning. related to the degree to which the participating hospitals' medical staff Bedtime use of selected patient is troubled by the insomnia, and/or P & T committee by the psychoactive agents was chosen for and patient education and non-drug Directors of Pharmacy. the DUE. The prevalent agents in measures should accompany Patients eligible for inclusion in the participating hospitals were intermittent benzodiazepine use. the DUE were identified. Geriatric benzodiazepines, , Fifth, the risks of drug use are not patients were defined as over the and neuroleptics. insignificant (e.g., decreased day­ age of 60 years. Hospital A was a DUE criteria for appropriate use time performance, drug dependence, 202-bed long-term care facility with of any drug for bedtime sedation rebound exacerbation of sleep a pharmacy staff of 3.0 full-time have not been published. Benzo­ disturbance upon withdrawal). The equivalents (FTE). For Hospital A, diazepines are first line drugs for population at increased risk for patients admitted to the chronic or bedtime sedation. 6 However, adverse effects is geriatric patients. rehabilitation beds, for whom a neuroleptics and chloral hydrate Hence, benzodiazepine, neuro­ benzodiazepine, neuroleptic or remain in use in geriatrics. When a leptic, and chloral hydrate use for chloral hydrate for bedtime sedation neuroleptic is used for bedtime bedtime sedation was chosen as a was prescribed, were eligible. sedation, haloperidol has his­ regional DUE pilot study to describe Patient admissions, over a six-month torically been chosen. 7 The choice the characteristics of drug use in an period from October 1991 to March of drug may be considered attempt to improve geriatric patient 1992, were used to identify potential somewhat controversial. Dosing care. charts for review. Hospital B was a recommendations for geriatric 200-bed psychiatric facility with patients are also problematic. METHODS pharmacy staff of 5.0 FTE. For Typical geriatric drug dosing A retrospective DUE was carried Hospital B, patients admitted to the references suggest the reduction of out in two hospitals. Consent was acute psychogeriatric ward, for drug doses by 50%.7 Some required from Pharmacy, hospital whom one of the above drugs for recommend use of 25% to 50% of administration, and medical staff bedtime sedation was prescribed, the standard dose of and for participation in the program to were eligible. Patient admissions, for patients over 80 years ensure access to patient charts and over a six-month period from of age because of altered to address the issue of patient September 1992 to February 1993, and pharmaco­ confidentiality. The DUE criteria were used. Patients for whom the dynamics. 8 Despite these general were developed by the program staff reason for drug use was unclear recommendations, specific dosing and reviewed by a pharmacy ( e.g., twice daily and bedtime use of guidelines for many drugs do not advisory group, a psychogeriatric a neuroleptic) were excluded. A exist. A 1984 consensus conference physician, and the Pharmacy random sample of 20 patient charts on drugs and insomnia suggested a departments of both hospitals. from each hospital was selected with The Canadian Journal of Hospital Pharmacy- Volume 47, No. 5, October, 1994 199

the use of a random numbers table. diazepines, the appropriate dose for b) Ifthere was no side effect resulting The choice of sample size was patients started on the drug was less in dose reduction or drug discon­ arbitrary but was made in an attempt than or equal to 1 mg tinuation, then the outcome was to review at least 50% of the patient "qhs" equivalent. For patients considered appropriate; c) Dosage admissions. Description of the already on the drug, the appropriate outcome was considered appropriate results was limited to the number of dose was not to exceed the if drug use for bedtime sedation was patients with drug use for bedtime equivalent oflorazepam 2 mg "qhs". absent at the end of the review or if sedation, discontinuation of therapy The appropriate dose of neuroleptic still present, the dose was lower by the end of the review, inap­ was less than or equal to haloperidol than at the beginning of the review. propriate drug use and outcome of 1 mg "qhs" equivalent. For chloral Dosage outcome was considered drug use, and benzodiazepine use hydrate, the appropriate dose for inappropriate if the dose was for greater than 30 days. patients started on it was 500 mg unchanged or higher at the end of The DUE criteria were approved "qhs", and 1 g "qhs" for those the review. It could not be assessed by the participating hospitals' P & already receiving it; d) Dosage if the drug used at the end of the T committees. Appropriate drug use titration toward discontinuation of review was of a different category and outcome are outlined in brief as the drug (not due to side effects) than the initial drug (e.g., benzo­ follows. Justification for use of was considered appropriate if at least diazepine followed by neuroleptic bedtime sedation was appropriate if one attempt to titrate the dose down use) since the relative doses could transient or short-term drug use of was made during the period of chart not be compared; d) Clinical less than 21 days duration occurred, review. Titration of the dose implied outcome was desirable if drug use or iflong-term insomnia was noted that the physician changed the drug for bedtime sedation was discon­ by the physician in the patient order; e) Duration of therapy was tinued by the end of the review or if chart.6,9- 12 Poor documentation of related to the justification for use. still present, no complications were the justification for use was Transient or short-term drug use noted. Clinical outcome was anticipated, therefore, "cannot was up to 21 days duration. For undesirable if complications assess" was also present in the chloral hydrate, appropriate duration occurred or if inadequate sedation criteria for the purpose of describing was less than 14 days of continuous was noted at the end of the review. the findings. Patient data collected use. 11 When the justification for Overall, outcome of drug use was were age, sex, concurrent medica­ use could not be assessed, it was not classified as appropriate or tions, and past medical and psy­ possible to evaluate the duration of inappropriate based on the four chiatric history. In order to maintain therapy. More specifically, the first elements described above. confidentiality, patient names and drug used for bedtime sedation for treating physician names were not each patient was assessed for RESULTS included on the data collection selection and initial dose relative to Forty patient charts were reviewed forms. A coding form was main­ the criteria. For patients admitted to in this DUE on benzodiazepines, tained by the Director of Pharmacy Hospital A, only the first three neuroleptics, and chloral hydrate which identified the applicable months of each admission were for bedtime sedation. Twenty of the patients and physicians for future reviewed. For patients admitted to patients were geriatric admissions use within the hospital. Hospital B, the entire admission to Hospital A. The total number of was reviewed since admissions were admissions to this hospital during Assessment of Drug Use on average three months long. the applicable period was 83. Of Five elements were included in the Overall, drug use was classified as these, 30 patients (36%) were assessment of drug use: a) The drug appropriate or inappropriate based prescribed one of the drugs for for bedtime sedation was considered on the five elements described bedtime sedation and, therefore, appropriate if chloral hydrate, above. were eligible for inclusion in the haloperidol, lorazepam, DUE. A sample of20 of the eligible or was used;7-9 11 ,13 Assessment of Outcome of Drug charts (67%) were reviewed. The b) Contraindications to the drug used Use other 20 patients were admissions were noted if present; l l, l 4 c) For the Four elements were included for the to Hospital B. The usual number of purposes of defining the appropriate DUE: a) If there was no significant admissions per month to this ward dose, approximate equivalent doses with the benzo­ was 12 to 13. During a six-month ofbenzodiazepines and neuroleptics diazepine, neuroleptic or chloral period, a minimum of 72 admis­ were included as part of the DUE hydrate, then the outcome of drug sions would be anticipated. Thirty­ criteria;7•8•11 , 13•15- 17 For benzo- use was considered appropriate; 11 five patients were prescribed one of 200 The Canadian Journal of Hospital Pharmacy - Volume 47, No. 5, October, 1994

the drugs for bedtime sedation and lower dose at the end of the review lorazepam use, six cases of oxaze­ were eligible for inclusion in the in one case. The initial dose used pam use, and three cases of DUE. A sample of20 of the eligible was inappropriate in one case. This temazepam use. Chloral hydrate was charts (57%) were reviewed. Table patient received triazolam 0.375 mg used in three cases and haloperidol I summarizes the numbers of male "qhs". Duration of therapy was in one case. No inappropriate drug and female patients, and age inappropriate in one case. A patient was used. Dosage titration was distribution for the patients received chloral hydrate regularly inappropriate in 13 cases. Dosage reviewed. Table II presents the DUE for 81 days. No contraindications to titration led to discontinuation of results for the two patient groups. drug use were noted. Overall, the drug in two cases, lower dose at inappropriate drug use was noted in the end of the review in three cases, Drug Use 14 cases. Justification for use was and unchanged dose at the end of For the patient group from Hospital "cannot assess" in all 20 cases. There the review despite attempts at dose A, a benzodiazepine was used in 19 was no transient or short-term drug reduction in two cases. Initial dose of the cases and chloral hydrate in use, and no documentation of long­ was inappropriate in three cases. one case. The benzodiazepine used term insomnia in any patient chart. These included the use of was oxazepam in nine cases, This resulted in poor assessment of haloperidol 2 mg "qhs", temaze­ lorazepam in six cases, and duration of therapy. Fifteen of the pam 30 mg "qhs", and oxazepam 30 triazolam in four cases. The use of 16 patients in hospital for more than mg "qhs". Duration of therapy was triazolam accounted for the cases of 30 days who were treated with a inappropriate in two cases: chloral inappropriate drug used. Dosage benzodiazepine received the drug hydrate was given regularly to one titration was inappropriate in 14 for more than 30 days. patient for 18 days and lorazepam cases as no attempt to reduce the For the patient group from was given to another patient dose was evident on chart review. Hospital B, a benzodiazepine was continuously for 37 days for Dosage titration led to discontin­ used for bedtime sedation in 16 documented long-term insomnia. uation of the drug in five cases and cases. This included seven cases of One case of contraindicated drug use occurred: chloral hydrate was TABLE I: Patient gender and age characteristics for the DUE used for a patient with estimated Hospital A Hospital B creatinine clearance of less than 50 No. of Patients Studied 20 20 mL/min. Overall, inappropriate drug use was noted in 15 cases. Number of males/females 5/15 5/15 Justification for use was "cannot Age distribution assess" in 18 cases. Again the data 60 - 70 years 4 2 on duration of therapy were 71 - 80 years 7 12 > 80 years 9 6 incomplete. Benzodiazepine use for more than 30 days occurred in 10 of TABLE II: Results of the DUE 11 cases.

Hospital A Hospital B Outcome of Drug Use No. of Patients Studied 20 20 For the patient group from Hospital No. of patients not receiving A, no significant drug interactions, drug at end of review 9 2 side effects or undesirable clinical outcome were noted. Outcome was Inappropriate drug use 14 15 Drug used 4 0 not assessed in one case since the Contraindication 0 1 relative doses could not be evaluated Initial dose I 3 when a change from a benzodi­ Duration I 2 azepine to chloral hydrate was made. Dosage titration 14 13 Inappropriate dosage outcome Inappropriate outcome 9 14 occurred in nine cases. Drug use for Drug interaction 0 0 bedtime sedation was present at a Side effects 0 I lower dose in one case, and was Dosage outcome 9 13 Clinical outcome 0 I absent at the end of the review in another nine cases. Four of these Benzodiazepine use for patients had active "pm" drug orders more than 30 days 15 of 16 cases 10 of 11 cases at the end of the review, but were The Canadian Journal of Hospital Pharmacy - Volume 47, No. 5, October, 1994 201

not receiving any drug. On the inappropriate drug use was high in the dosage outcome was judgement of the nursing staff, the both groups with the main reason inappropriate. However, approx­ drug was not required. For the being the lack of dosage titration imately half of the appropriate remaining five cases, the drug was down toward discontinuation of the dosage outcome cases in the discontinued by physician order. drug. There was an apparent lack of Hospital A patients were due to For the patient group from definition of a treatment plan with nursing assessment with no drug Hospital B, outcome was attention to justification, dosage therapy for bedtime sedation in inappropriate in 14 cases. Outcome titration, and duration of therapy. patients with "prn" orders. was not assessed in one case where Specific recommendations on drug Upon discussion of the results a change from a benzodiazepine to use in long-term care facilities by with the Directors of Pharmacy, chloral hydrate occurred. Inappro­ the Coroner's Committee of the some areas of concern became priate dosage outcome accounted Ontario Medical Association apparent. The difficulties in the for 13 of the cases. In the last case, suggest documentation of the withdrawal of a drug for which the dose was reduced after the patient reasons for drug use. 18 physical and/or psychological sustained a fall in hospital. The initial There were also some differences dependence has evolved is much dose used was inappropriate as between the results of the two more complex than can be defined defined by the criteria and the patient groups. There appeared to be a in DUE criteria. Related to the DUE had a history of difficulty with difference in the rate of use of drug criteria, the areas of concern were mobility. Therefore, the patient may therapy for bedtime sedation, with the lack of identification of the have experienced side effects and Hospital A exhibiting use in 36% of justification for use (transient, short­ experienced a complication admissions while the rate of usage term or long-term insomnia), long resulting in an undesirable clinical in the Hospital B patients was duration of therapy, lack of dosage outcome. Drug use for bedtime estimated to be higher titration, triazolam use and chloral sedation was present at a lower dose (approximately 50% ). The DUE hydrate use. The definition of in three cases and was absent at the results also showed differences in justification for use, though difficult, end of the review in two cases. the rates of inappropriate initial dose would facilitate the involvement of used and inappropriate drug used. both nursing and pharmacy staff in DISCUSSION For the three patients from Hospital encouraging appropriate dosage All facets of this DUE should be B, initial drug doses were higher titration and duration of therapy. evaluated in light of its preliminary than defined in the criteria. It is The use of automatic stop orders nature. For simplicity, dimenhydri­ interesting to speculate on the (ASO) as a policy initiated by the P nate, , and other reasons for this. It may have been & T committee is one option to limit alternative agents for bedtime due to an increased comfort level by the duration ofuse, however, it may sedation were excluded. Their the physicians with higher sedative not lead to the development of a exclusion is not meant to comment dosing in the patient population or treatment plan for the patient. on their place in therapy. the presence of underlying Increased attention to drug use for Discussion of the reports of the psychiatric disorders more resistant bedtime sedation by all members of two participating hospitals' results to therapy. However, one of the the health care team may be more with the Directors of Pharmacy took patients treated with an effective in promoting patient care place in October, 1993. inappropriate dose experienced a objectives. Termination of long­ Several areas of similarity in the fall which may have been associated term drug use presents a difficult results of the DUE on the two patient with drug therapy. For the patient dilemma for physicians. The groups were noted. Lack of transient group from Hospital A, triazolam attending physician may not have or short-term drug use (up to 21 use resulted in the four cases of initiated the drug and may hesitate days), and lack of documentation of inappropriate drug used. Since the to change it. However, it is easy to long-term insomnia was common time of these patient admissions see how inappropriate use of drugs to both hospital groups. Subsequent triazolam use has declined, however for bedtime sedation may be to this, lack of dosage titration and the drug was present on the hospital perpetuated in this manner. The long duration of therapy would not formulary (Fall, 1993). The overall concerns over triazolam have been be unexpected due to an apparent rate of inappropriate outcome was widely publicized to physicians in lack of definition of the endpoint of quite high due to unchanged or newsletters.3.4 The patients in this therapy. Benzodiazepine use for higher doses at the end of the review. DUE who received triazolam were more than 30 days was common to For nine of the Hospital A patients treated before publication of the both hospital groups. The overall and 13 of the Hospital B patients, newsletters, however, these 202 The Canadian Journal of Hospital Pharmacy - Volume 47, No. 5, October, 1994

newsletters followed published sedation, dose used, duration of reduce the use of psychoactive drugs reports in the literature at least as benzodiazepine use, and duration in nursing homes. New Engl J Med 2 l992;327:168-73. early as 1987. Concerns about of chloral hydrate use would be 6. Consensus Conference: Drugs and chloral hydrate use have not been as useful. Within the Pharmacy insomnia - the use of medications to widely publicized, however, its use department, review of the results promote sleep. JAMA has apparently declined. It should could lead to improvement in the I 984;251:2410-4. not be included as an appropriate drug order review process (e.g., 7. Kane RL, Ouslander JG, Abrass IB. Drug Therapy. In: Essentials of drug if the criteria were revised. evaluation of doses ordered for clinical geriatrics. New York: Chloral hydrate is metabolized patients relative to their age and McGraw-Hill; 1989:341-71. primarily to trichloroethanol which medical history). Pharmacy 8. Lader M. 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