British Columbia's central prescription database, PharmaNet, is often used for both clinical and research applications. However, PharmaNet details prescription transactions, not actual medication consumption, resulting in many potential sources of inaccuracy when the information is assumed to reflect population or individual drug utilization.
To assess the accuracy of PharmaNet for adherence assessment in patients with heart failure who are taking beta-blockers.
A 6-month prospective, longitudinal assessment of adherence to the prescribed beta-blocker regimen was carried out using both PharmaNet data and the Medication Event Monitoring System (MEMS) for each patient enrolled. The limit of agreement between the 2 adherence assessment methods was assessed using the Bland-Altman approach.
Fifteen of 58 patients initially enrolled in the study were excluded, most due to misuse of MEMS or failure to return the MEMS vial despite thorough follow-up. For the 43 patients included in the final analysis, mean +/- SD adherence was 97.8 +/- 11.8% when assessed by PharmaNet and 97.1 +/- 7.3% when MEMS was used. However, the limit of agreement, reported as the mean of the differences +/- 2SD, was 6.8 +/- 18.5%, indicating a moderate-to-high level of agreement between the 2 methods when the confidence interval is taken into consideration.
These results suggest that PharmaNet data accurately reflect medication adherence for most patients. The MEMS system proved unreliable in several cases, illustrating the difficulty of identifying a gold standard for adherence assessment.
ß-Adrenoblockers improve quality of life and in a number of cases life prognosis in patients with stable angina (SA). Dose of -adrenoblockers is considered optimal if at the background of treatment resting heart rate (rHR) is persistently decreased down to 55-60 bpm. But according to data of international registries rate of achievement of target rHR (trHR) in real clinical practice does not exceed 22%. Aim of this study was to determine what portion of patients with SA and arterial hypertension (AH) achieves trHR at the background of therapy with -adrenoblockers in routine practice in this country. Twenty centers in 6 towns in Russian Federation recruited 399 patients (mean age 64+/-10 years) with class I-III angina and concomitant primary AH. These patients for at least 2 months received any -adrenoblocker and did not change its dose during 4 weeks before inclusion into the program. Portion of patients with trHR was 15.5%. There were no significant differences between average daily doses of most frequently used -adrenoblockers (metoprolol, bisoprolol, carvediolol) in groups of patients who achieved and did not achieve trHR. Quality of life of patients who achieved was comparable with that of those who did not achieve trHR. Attainment of trHR was associated with significant decrease of short acting requirement nitrates. There was a significant direct correlation between attainment of trHR and target arterial pressure.
Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial.
Cancer and Leukemia Group B study CALGB 49907 was a randomly assigned trial comparing standard chemotherapy versus oral chemotherapy with capecitabine in patients age 65 years or older with early-stage breast cancer. We used microelectronic monitoring system (MEMS) caps on participants' capecitabine bottles to record pill bottle openings. Capecitabine was given in two divided daily doses for 14 consecutive days of a 21-day cycle for six cycles. Adherence was calculated as the number of doses taken divided by doses expected, taking into account toxicity-related dosing changes. A participant was defined as adherent if 80% or more of expected doses were recorded by MEMS.
Overall, 161 patients were enrolled. Median age was 71 years (range, 65 to 89 years); 124 patients (83%) persisted with capecitabine to completion of planned protocol therapy. Adherence was 78% across all cycles, and adherence did not vary by cycle (P = .32). Twenty-five percent of participants took fewer than 80% of expected doses and were nonadherent. In a logistic regression model, participants with node-negative disease (P = .01) and mastectomy (P = .01) were more likely to be nonadherent. Adherence was not related to age, tumor stage, or hormone receptor status. Adherence was not significantly associated with relapse-free survival or grade 3 or 4 toxicity.
Most older women with early-stage breast cancer were adherent to short-term oral chemotherapy in a randomized clinical trial. Age was not associated with adherence.
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The adherence of patients with stable angina to antianginal therapy is the key factor of controlling the disease. The purpose of the study was to evaluate the relationship of adherence of patients with stable angina to treatment with trimetazidine modified release (MR) with frequency (risk) of emergency medical care. We consistently included in the study patients with stable angina in primary health care. The results of treatment for 16 weeks were monitored at patients with angina attacks three times per week or more, use of short nitrate and treatment with generic trimetazidine. To strengthen the antianginal therapy generic was replaced with original trimetazidine MR. Adherence is considered relatively high while taking 80-120% of the recommended dose of the drug (70 mg/day). The effectiveness of treatment evaluated by the frequency of emergency hospitalizations and/or ambulance calls because of the pain, discomfort, tightness in the chest or ischemic changes on the electrocardiogram. 870 patients were included in the study, the results of treatment in 185 were assessed. Patients with a relatively high adherence to trimetazidine MR (n=151) were used (median) 99% (98, 104), with low (<80%, n=34) adherence - 67% (49, 76) of the recommended dose of the drug. During the study period, the primary end point is fixed in 7 (21%) patients with low and in 18 (12%) - with relatively high adherence (p=0.182). The number of angina attacks, having necessitated taking short-nitrate, decreased in the groups, respectively, with 5 (3; 10) and 6 (4; 10) to 2 (1; 3) per week (p=0.791). Thus, replacing generic trimetazidine with original trimetazidine MR in patients with a high frequency of angina attacks can achieve significant antianginal effect. Adherence of patients to the reception of the drug by an average 1/3 below the recommended amount does not affect the risk of emergency hospitalizations and/or ambulance calls for 16 weeks.
Efficient prevention of adverse drug reactions (ADRs) requires knowledge about their severity and pharmacological mechanisms and is dependent on reliable data on their frequencies and possible risk factors. The study was conducted to investigate the prescribers' experience and understanding of the ADRs of psychotropic drugs, and their attitude towards reporting these. In a questionnaire, physicians treating adult psychiatric patients were asked which ADRs that they regarded bothersome for some of the most widely used antidepressants and antipsychotics. Questions about the relationship between blockade of drug receptors and ADRs, and about the physicians' personal experience of and attitudes towards reporting of ADRs were also included. In total, 70 of 91 questionnaires (78%) were returned. The mean number of ADRs regarded bothersome ranged from 2.4 to 9.3 for the various drugs/drug classes. Qualified psychiatrists stated a significantly higher number of bothersome ADRs than did the residents. The percentage of physicians associating blockade of a receptor with a specific ADR varied from 76% (histamine receptor blockade and sedation) to 37% (alpha(1)-adrenergic blockade and tachycardia). Thirty-nine per cent of the physicians had never reported an ADR to the Norwegian Medicines Agency. The number of ADRs considered bothersome was relatively high. The pattern of these ADRs generally mirrored the typical ADR profiles of the drugs. The knowledge of the underlying mechanisms of ADRs was more or less incomplete. The reporting rate of ADRs to the national regulatory authorities was low.
Prescription drug monitoring programs (PDMPs) have begun to demonstrate themselves as useful tools in enhancing safe and responsible prescription of controlled substances. The purpose of this project was to describe current practice, beliefs, and barriers of Alaska nurse practitioners (NPs) regarding the Alaska PDMP.
A questionnaire was sent to 635 Alaskan NPs with a 33% return rate. The data depicted prescribing habits, barriers to use, barriers to registering, and opinions on how to make the PDMP more clinically useful.
More attention is needed to maximize PDMP exposure and incorporation into daily workflow if it is to achieve full potential. Registered users should be able to delegate PDMP authority to select staff members to reduce time commitments and increase usage. Many providers felt that assigning unique patient identifiers could prevent consumers from filling prescriptions under aliases. Finally, an overwhelming majority of users wanted faster data entry and proactive reports.
This project explored the differences between PDMP users and nonusers and outlined NP suggestions for process improvement. A better understanding of PDMP use will aid providers in safe prescribing while curbing the prescription drug epidemic and ultimately reducing abuse, misuse, and death from overdose.
The Alpha-Tocopherol, Beta-Carotene (ATBC) Lung Cancer Prevention Study was a randomized, double-blind, placebo-controlled, 2 x 2 factorial design, primary prevention trial testing the hypothesis that alpha-tocopherol (50 mg/day) and beta-carotene (20 mg/day) supplements reduce the incidence of lung cancer and possibly other cancers. Total and disease-specific mortality and incidence of various diseases and symptoms were monitored for safety. Between 1985 and 1993, 29,133 eligible male smokers aged 50 to 69 years at entry were randomized to receive daily active supplements or placebo capsules for 5 to 8 years (median 6.1 years), accumulating 169,751 follow-up years. This report describes the study design, methods, and protocol as well as the baseline characteristics and capsule compliance of the participants. The ATBC Study is the largest lung cancer chemoprevention trial conducted to date.
Comment In: Ann Epidemiol. 1994 Jan;4(1):758205274
Critically ill newborns in neonatal intensive care units (NICUs) are at greater risk of developing adverse drug reactions (ADRs). Differentiation of ADRs from reactions associated with organ dysfunction/immaturity is difficult. Current ADR algorithm scoring was established arbitrarily without validation in infants. The study objective was to develop a valid and reliable algorithm to identify ADRs in the NICU. Algorithm development began with a 24-item questionnaire for data collection on 100 previously suspected ADRs. Five pediatric pharmacologists independently rated cases as definite, probable, possible, and unlikely ADRs. Consensus "gold standard" was reached via teleconference. Logistic regression and iterative C programs were used to derive the scoring system. For validation, 50 prospectively collected ADR cases were assessed by 3 clinicians using the new algorithm and the Naranjo algorithm. Weighted kappa and intraclass correlation coefficient (ICC) were used to compare validity and reliability of algorithms. The new algorithm consists of 13 items. Kappa and ICC of the new algorithm were 0.76 and 0.62 versus 0.31 and 0.43 for the Naranjo algorithm. The new algorithm developed using actual patient data is more valid and reliable than the Naranjo algorithm for identifying ADRs in the NICU population. Because of the relatively small and nonrandom samples, further refinement and additional testing are needed.
Since all dental materials pose a potential risk to patients and members of the dental team, the post-market monitoring of adverse reactions caused by dental materials should be considered essential. This article reviews the current status of post-market monitoring of adverse reactions to dental materials and highlights some of the issues that arise in trying to establish an evidence base on the characteristics of adverse reactions to dental materials.
Norway, Sweden and more recently the UK have sought to monitor adverse reactions to dental materials systematically and proactively in an effort to add to the evidence base on the safety of dental materials. Their experiences in undertaking post-market surveillance have been combined in preparing this article.
To date the Norwegian, Swedish and the UK projects has received 1268 reports over 11 years, 848 reports over 5.5 years and 1117 reports over 3 years, respectively, relating to adverse reactions seen or experienced by dental personnel and patients. Presently, there are no harmonized criteria for what can be classified as an adverse reaction related to dental materials. Under reporting is a recognised problem and lack of awareness and lack of clarity as to what constitutes an adverse reaction may be contributory factors. A pro-active reporting system takes a considerable time to become established, but can generate a lot of potentially useful information.
There is a need to raise the awareness among dental professionals of the potential for adverse reactions due to dental materials and to develop an internationally accepted system of data gathering that can produce the evidence that reflect the extent, severity and incidence of adverse reactions to dental materials.