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Objective: To examine the level of awareness of the findings of the Women's Health Initiative (WHI) study among recent users of hormone therapy (HT)., Methods: A survey was conducted on Canadian women older than 45 years of age who had used either an oral, topical, or vaginal HT within the preceding 3 years. Questionnaires were mailed to a random sample of 210 eligible women within an academic subspecialty rheumatology/osteoporosis practice between April and June 2003. Questionnaires were also provided upon request to women attending tertiary care multidisciplinary clinics and 6 community pharmacies in Hamilton, Ontario. The 98 questions in the survey were either categorical in nature (yes or no response) or followed by a Likert scale. Using chi-square and Student t tests, the responses of women who used combination estrogen/progestin were compared to those who used estrogen alone., Results: Of the 161 women who responded to the survey (128 from the osteoporosis practice, 33 from other clinics and pharmacies), 102 (63%) had used HT for more than 5 years. Ninety-one of 159 respondents (57%) discontinued HT, and 63% (57/91) of those stopped using HT after publication of the WHI principal findings. Sixty-four percent (33/52) of women on combination estrogen/progestin discontinued HT, compared to 50% (46/93) who were on estrogen only, and 5 other women who also discontinued HT but did not know what type of preparation they had been taking (P = .04 for the difference in rates between the 3 groups). Knowledge of the findings of the estrogen/progestin arm of the WHI study did not significantly differ among users of different types of hormone preparations. Of the women who indicated that they did not know if HT affected the risk of WHI-studied medical conditions, 44% (69/156) indicated being unaware of HT risks for stroke, 28% (44/157) for hip fracture, 39% (60/155) for myocardial infarction, 25% (39/155) for breast cancer, and 48% (73/152) for blood clots. Women who had recently taken HT generally did not regret their use of HT., Conclusion: Although many women discontinued HT following the publication of the principal findings of the estrogen/progestin arm of the WHI study, the majority of these women lacked a clear understanding of those findings.

Objective: To estimate the prevalence and predictors of medications deemed potentially inappropriate for the elderly among family physicians' patients aged 65 and older (seniors) taking multiple prescribed medications., Methods: Forty-eight randomly selected family practices in 16 towns and cities in Southern Ontario, Canada and 889 of their senior patients were recruited into a randomized trial. We conducted a cross-sectional analysis of prescription insurance data from the provincial universal prescription insurance database over 12 months, from the 777 seniors who completed the trial and agreed to have their data released. The prevalence and patient and physician predictors of use of a potentially inappropriate medication (PIM), as defined by published widely accepted criteria, were examined., Results: The median number of prescriptions filled was 24. Nearly one-fifth (16.3%) of the seniors received at least one prescription for a PIM, with short-acting benzodiazepine prescriptions for longer than 30 days (6.4%) and oxybutynin (3.7%) being the types prescribed most frequently. In univariate and multiple variable analyses, women were found to be statistically significantly more likely to be prescribed a PIM (adjusted OR = 1.6; 95% confidence interval = 1.0-2.4). Age, education, self-rated health, number of health conditions, and number of prescriptions were not associated with PIM use. Physician gender, family medicine certification status, and time since graduation were not significantly associated with PIM prescribing., Conclusions: Prescribing of PIMs, especially of short-acting benzodiazepines was common in seniors taking multiple medications. Interventions to reduce use of PIM, especially long-term benzodiazepines, are important in primary care.

Background: A common and often integral method of delivering patient information is the use of patient guides. However, the acceptability, utility and impact of evidence-based therapeutic guides on physicians, pharmacists and patients have not been well evaluated., Methods: This study was a prospective evaluation of 53 general practitioners' offices and 30 community pharmacies from three locations in Canada. Evidence-based guides were provided to 1176 patients who presented to either a general practitioner or a community pharmacist and were interested in receiving information about sore throat, heartburn, or osteoporosis (http://www.ti.ubc.ca/canadadrugguide). The acceptability, utility and impact of the guides were assessed via structured patient telephone interviews, structured health professional interviews, and patient chart audits., Results: Eighty to 90% of patients reported that the guides were 'very easy' to understand. Fifty six per cent/47%/38% (sore throat/heartburn/osteoporosis) of patients rated the guides as 'very' or 'extremely' useful. Seventy-two per cent/67%/58% of respondents reported that the information helped them make decisions about their treatment. Ninety eight per cent of physicians and 92% of pharmacists reported that the guides helped their patients understand the issues involved in their treatment. None of the analyses showed any significant differences in prescribing of medications between the intervention and control groups., Interpretations: Patients found these evidence-based guides to be useful, easy to understand, and that they helped them in their understanding of treatment options and the decision-making process. Physicians and pharmacists reported that the guides helped their patients understand the issues involved in their treatment. Further research is required to determine the degree to which providing evidence-based guides to patients can impact on prescribing and patient outcomes.

Objectives: To learn about the experiences of specially trained expanded role pharmacists (ERPs) and family physicians in a program in which they worked together to optimize drug therapy for elderly patients (aged 65 and older) and to identify shortcomings of the program, obstacles to its implementation, and strategies to overcome these obstacles., Design: Qualitative opinion analysis., Participants: Six family physicians and six community-based ERPs who had participated in a randomized controlled trial (Seniors Medication Assessment Research Trial [SMART])., Intervention: In-depth interviews., Main Outcome Measures: Themes that emerged from the interviews regarding the strengths and weaknesses of and ways to improve the program., Results: ERPs and physicians differed in their perceptions of appropriate roles for ERPs. ERPs saw the program as an opportunity to take on new professional roles. Physicians appreciated the information they received from ERPs about their patients' adherence and use of nonprescription medications, but they did not want ERPs to directly counsel their patients. Some physicians questioned the value of the program for some patients, since the inclusion criteria for patients were broad and not all patients meeting the criteria needed intense interventions by ERPs. Both ERPs and physicians identified the need to refine the referral process and to work out professional role relationships and ongoing collaboration more fully. If the program were to be implemented as a routine service, physicians were concerned about the demands on their staff and office space and the need for an external compensation mechanism., Conclusion: Issues to be addressed for future programs include clarification of the roles of pharmacist and physician when the professionals work together, targeting of appropriate patients for the program, identification of a more efficient way to deliver recommendations, and development of an appropriate compensation mechanism.

Objective: To describe what patients want to know about their medications and how they currently access information. To describe how physicians and pharmacists respond to patients' information needs. To use patients', physicians', and pharmacists' feedback to develop evidence-based treatment information sheets., Design: Qualitative study using focus groups and a grounded-theory approach., Setting: Three regions of Canada (British Columbia, Nova Scotia, and Ontario)., Participants: Eighty-eight patients, 27 physicians, and 35 pharmacists each took part in one of 19 focus groups., Method: Purposeful and convenience sampling was used. A trained facilitator used a semistructured interview guide to conduct the focus groups. Analysis was completed by at least two research-team members., Main Findings: Patients wanted both general and specific information when considering medication treatments. They wanted basic information about the medical condition being treated and specific information about side effects, duration of treatment, and range of available treatment options. Physicians and pharmacists questioned the amount of side-effect and safety information patients wanted and thought that too much information might deter patients from taking their medications. Patients, physicians, and pharmacists supported the use of evidence-based treatment information sheets., Conclusion: Patients and clinicians each appear to have a different understanding of what and how much information patients should receive about medications. Feedback from patients can be used to develop patient-oriented treatment information.

Objective: To compare the benefits and risks of bupropion and selective serotonin-reuptake inhibitors (SSRIs) in adults with depression., Data Sources: MEDLINE (1966-September 1999), Embase (1980-August 1999), PsyclNFO (1887-August 1999), International Pharmaceutical Abstracts (1970-August 1999), and CIANHL databases were searched. References from the selected citations, review articles, and the manufacturer were also screened., Study Selection: Included studies were randomized, double-blind, controlled trials evaluating bupropion versus SSRIs for depression in adults. Studies were assessed independently in duplicate. Discrepancies were resolved by consensus., Data Analysis: Data are reported as absolute weighted mean differences or relative risks and 95% confidence intervals comparing bupropion relative to SSRIs. Data not combined are presented qualitatively., Data Synthesis: Six full-length studies were included of 257 citations identified. SSRI comparators were fluoxetine, sertraline, and paroxetine. No differences in Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impressions Scale for Improvement of illness (CGI-I) were found, but data were not able to be quantitatively combined. The absolute weighted mean differences were 0.10 (95% CI -0.2 to 0.4) for the CGI for Severity of Illness and 0.37 (95% CI -0.85 to 1.6) for the Hamilton Rating Scale for Anxiety measurements. Relative risks of bupropion compared with SSRIs were 0.6 (95% CI 0.41 to 0.89), 0.31 (95% CI 0.16 to 0.57), and 0.27 (95% CI 0.15 to 0.48) for nausea, diarrhea, and somnolence, respectively. Sexual arousal disorder, orgasmic dysfunction, and sexual desire disorder occurred less with bupropion than with SSRIs, with relative risks of 0.46 (95% CI 0.26 to 0.83), 0.22 (95% CI 0.12 to 0.40), and 0.65 (95% CI 0.51 to 0.84), respectively., Conclusions: Bupropion and SSRIs have similar effectiveness; however, bupropion was associated with less nausea, diarrhea, somnolence, and sexual dysfunction.

Background: Reference-based pricing limits reimbursement for a group of drugs that are deemed therapeutically equivalent to the cost of the lowest-priced product within that group. We estimated the effect of reference-based pricing of nitrate drugs used for long-term prophylaxis on prescribing of and expenditures on nitrates and other anti-anginal drugs dispensed to senior citizens in British Columbia., Methods: We assessed trends in the monthly volume of prescriptions of anti-anginal drugs and the associated drug ingredient cost paid by the province's publicly funded drug subsidy program, Pharmacare, and by the patients themselves for the period April 1994 to May 1999. Trends in monthly rates of nitrate expenditures per 100,000 senior citizens before the introduction of reference-based pricing were extrapolated to infer what expenditures would have been without the policy., Results: During the 3 1/2 years after reference-based pricing was introduced, Pharmacare expenditures on nitrates prescribed to senior citizens declined by $14.9 million (95% confidence interval $10.7 to $19.1 million). Most of these savings were due to the lower prices that Pharmacare paid for sustained-release nitroglycerin tablets and the nitroglycerin patch, which were the 2 most frequently prescribed nitrates before the introduction of reference-based pricing; $1.2 million (8%) of the savings represented expenditures by senior citizens who purchased drugs that were only partially reimbursed. There were no compensatory increases in expenditures for other anti-anginal drugs. Use of sublingual nitroglycerin--a marker for deteriorating health in patients with angina--did not increase after the introduction of reference-based pricing. The nitroglycerin patch is now the most frequently prescribed nitrate, owing to the fact that Pharmacare resumed the provision of full subsidies for the drug after its manufacturers voluntarily reduced retail prices., Interpretation: Evidence to date suggests that reference-based pricing of nitrates has achieved its primary goal of reducing drug expenditures. The effects of this policy on patient health, associated health care costs and administrative costs remain to be investigated.

QUESTIONOne of my patients suffers from anxiety and was using lorazepam to treat it. When she became pregnant, she stopped the medication immediately, but now she is worried about the potential effect on the baby because she was using the drug just after conception. Is this class of drugs safe during pregnancy? What should she do if she needs antianxiety treatment during the rest of her pregnancy?ANSWEREvidence to date from cohort studies did not identify a notable association between use of benzodiazepines and increased risk of major malformations, including oral cleft. In contrast, data from case-control studies show a slightly increased risk of oral cleft. Hence, level 2 ultrasonography is recommended to rule out visible forms of cleft lip. Using benzodiazepines late in pregnancy could cause withdrawal syndrome in newborns.

Objectives: To compare the efficacy and safety of unfractionated heparin (UFH) and low-molecular-weight heparins (LMWHs) and to examine current controversies in the treatment of venous thromboembolism (VTE) (ie, setting, product type, and frequency of administration)., Methods: Data were abstracted from MEDLINE, HEALTH, previous reviews, personal files, clinical experts, and conference abstracts. Randomized controlled trials of patients diagnosed with acute VTE that compared LMWHs with UFH were included. Independent duplicate assessment was done for methodological quality and data extraction. Data are reported as pooled relative risks (RRs) and 95% confidence intervals (CIs) comparing LMWHs with UFH as determined by the random effects model., Results: Thirteen studies were included. There was no statistically significant difference in risk between UFH and LMWHs for recurrent VTE (RR, 0.85 [95% CI, 0.65-1.12]), pulmonary embolism (RR, 1.02 [95% CI, 0.64-1.62]), major bleeding (RR, 0.63 [95% CI, 0.37-1.05]), minor bleeding (RR, 1.18 [95% CI, 0.87-1.61]), and thrombocytopenia (RR, 0.85 [95% CI, 0.45-1.62]). There was a statistically significant difference for risk of total mortality (RR, 0.76 [95% CI, 0.59-0.98]) in favor of LMWHs. Inpatient treatment may reduce the risk of major bleeding vs outpatient therapy. Once-daily therapy is as safe and effective as twice-daily therapy when compared indirectly. Different products could not be statistically compared, but qualitative analysis shows that there are no apparent differences in efficacy and safety., Conclusions: Low-molecular-weight heparins are at least as effective as UFH in preventing recurrent VTE. It is unlikely that LMWHs are superior in the treatment of VTE, but they do show a statistically significant decrease in total mortality. No differences were seen in the development of recurrent VTE dependent on treatment setting. There were no apparent differences between once-daily and twice-daily therapy or among products. Inpatient therapy may be associated with less major bleeding; therefore, if LMWHs are given in the outpatient setting, patients should be rigorously monitored.

Objective: To determine if exposure to benzodiazepines during the first trimester of pregnancy increases risk of major malformations or cleft lip or palate., Design: Meta-analysis., Setting: Studies from 1966 to present., Subjects: Studies were located with Medline, Embase, Reprotox, and from references of textbooks, reviews, and included articles. Included studies were original, concurrently controlled studies in any language., Interventions: Data extraction and quality assessment were done independently and in duplicate., Main Outcome Measures: Maternal exposure to benzodiazepines in at least the first trimester; incidence of major malformations or oral cleft alone, measured as odds ratios and 95% confidence intervals with a random effects model., Results: Of over 1400 studies reviewed, 74 were retrieved and 23 included. In the analysis of cohort studies fetal exposure to benzodiazepine was not associated with major malformations (odds ratio 0.90; 95% confidence interval 0.61 to 1. 35) or oral cleft (1.19; 0.34 to 4.15). Analysis of case-control studies showed an association between exposure to benzodiazepines and development of major malformations (3.01; 1.32 to 6.84) or oral cleft alone (1.79; 1.13 to 2.82)., Conclusions: Pooled data from cohort studies showed no association between fetal exposure to benzodiazepines and the risk of major malformations or oral cleft. On the basis of pooled data from case-control studies, however, there was a significant increased risk for major malformations or oral cleft alone. Until more research is reported, level 2 ultrasonography should be used to rule out visible forms of cleft lip.