Association of pharmacist intervention counseling with medication adherence and quality of life: A systematic review and meta-analysis of randomized trials.

OBJECTIVE(S): To assess the association between pharmacist intervention counseling with medication adherence and quality of life. Also, to assess if these associations vary by the focus, structure, training, or robustness of the counseling. METHODS: The initial search identified 1805 references, of which 62 randomized trials (RCTs) met inclusion criteria for the systematic review. Of the 62 RCTs, 60 (with 62 results) had extractable data for the meta-analysis. Data were pooled using a random-effects model. RESULTS: Most study patients were older and taking multiple prescription drugs. The pooled results showed a statistically significant increase in the odds of medication adherence with the pharmacist counseling intervention versus no counseling (pooled odds ratio [OR] = 4.41; 95% confidence interval [CI] 2.46-7.91; P < 0.01). The results of a subgroup analysis suggest the primary disease, counseling focus, location, and robustness may modify the effect of pharmacist counseling on medication adherence. There was a statistically significant improvement in the quality of life with pharmacist counseling versus no pharmacist counseling (pooled standardized mean difference [SMD] = 0.69; 95% CI 0.41-0.96; P < 0.01). The results of a subgroup analysis suggest that counseling focus, location, training, robustness, and the measurement method, but not the disease category, may modify the effect of pharmacist counseling on quality of life. CONCLUSION: The evidence supports pharmacist intervention counseling to increase mediation adherence and quality of life. The counseling location and structure may be significant factors in improving medication adherence. The overall methodological quality of evidence was very low.

Association of pharmacist counseling with adherence, 30-day readmission, and mortality: A systematic review and meta-analysis of randomized trials.

OBJECTIVE(S): To determine the association of pharmacist medication counseling with medication adherence, 30-day hospital readmission, and mortality. METHODS: The initial search identified 21,590 citations. After applying the inclusion and exclusion criteria, 62 randomized controlled trials (RCTs) (49 for the meta-analysis) were included in the final analysis. Data were pooled using a random-effects model. RESULTS: The participants in most of the studies were older patients with chronic diseases who, therefore, were taking many drugs. The overall methodologic quality of evidence ranged from low to very low. Pharmacist medication counseling versus no such counseling was associated with a statistically significant 30% increase in relative risk (RR) for medication adherence, a 24% RR reduction in 30-day hospital readmission (number needed to treat = 4.2), and a 30% RR reduction in emergency department visits. RR reductions for primary care visits and mortality were not statistically significant. CONCLUSION: The evidence supports pharmacist medication counseling to increase medication adherence and to reduce 30-day hospital readmissions and emergency department visits. However, higher-quality RCT studies are needed to confirm or refute these findings.

An Artistic Active-Learning Approach to Teaching a Substance Use Disorder Elective Course.

Objective. To incorporate an artistic, multimedia approach to teaching within a substance use disorder (SUD) elective course to intellectually, visually, physically, and emotionally engage Doctor of Pharmacy (PharmD) students in learning and applying clinical and legal SUD topics. Methods. Faculty members created a two credit-hour SUD elective course that required students to engage in visual, linguistic, and performing art forms, including acting, screenwriting, choreography, dancing, artwork, writing movie reviews, writing book reports, writing journal reflections, create-your-own-adventure storytelling, speech writing, examination writing, policy writing, and creative thinking in an escape room gaming environment to learn about SUD and related topics. Results. Student learning and perception of the activities was evaluated using faculty-created analytic rubrics, pre- and post-intervention tests, student feedback, and student responses on standard course evaluations. Students performed well on the graded assignments. Pre- and post-intervention tests administered for the escape room activity demonstrated an increase in scores from 56.7% to 94.9%. Student feedback and course evaluations revealed student engagement with subject material and enthusiasm for creative applications, critical thinking, and collaborative aspects of the activities. Conclusion. The PharmD students consistently rated the interactive class format highly on course evaluations and reported having the perception of simultaneously learning and having fun. Pharmacy instructors are encouraged to incorporate creative projects and activities in courses to enhance student learning experiences and increase student motivation to engage with the material, their classmates, and other professionals.

Pharmacists interventions using Bluetooth technology and telehealth to improve blood pressure-A pilot study.

OBJECTIVES: To assess patients' knowledge of blood pressure (BP) and their comfort level with using technology, including a Bluetooth-enabled BP device and pharmacist telemonitoring. The secondary objective was to discover if pharmacist interventions improved BP readings. SETTING: The study took place in Pharmacy Plus and the Family Medicine Department at the University of South Florida in Tampa, FL. PRACTICE DESCRIPTION: The pharmacists within Pharmacy Plus and the Family Medicine Department are part of the interdisciplinary team providing care to patients and seeking to achieve optimal patient outcomes. Pharmacy Plus breaks away from the traditional behind-the-counter model using innovative technology to create a personalized experience for patients. PRACTICE INNOVATION: During this pilot study, the patients received a Bluetooth-enabled BP monitor and were asked to obtain their BP readings at least once daily for 6 weeks. The patients' electronic health records automatically captured the BP readings, which were reviewed by the study pharmacists. The patients had an appointment with the pharmacists once weekly via a telehealth platform through which they were counseled on their weekly average BP, BP goals, lifestyle modifications, and proper use of the devices. EVALUATION: The patients completed a prestudy survey assessing their baseline knowledge of BP, comfort level when using technology, and ease in working with pharmacists. Reliability and satisfaction in using the BP device and telehealth communication with pharmacists were also assessed poststudy. RESULTS: Twelve patients enrolled, with 9 completing the study. There was a statistically significant increase in patients' knowledge of BP and an improvement in the recommended lifestyle modifications. In addition, comfort level regarding communication with the pharmacist was statistically significantly improved. The patients responded positively to using the Bluetooth-enabled BP monitor and telehealth for receiving health care services. CONCLUSION: Using Bluetooth-enabled BP monitors that report results in real time into electronic health records, along with pharmacist interventions within a team-based care model, may result in improved BP control and patient outcomes.

The changing cost to prevent diabetes: A retrospective analysis of the Diabetes Prevention Program.

OBJECTIVES: Diabetes prevention interventions are poorly implemented. While health care costs generally increase, 2 factors affect the relative cost of diabetes prevention interventions: the declining cost of metformin (even without insurance) and the new recommendation for vitamin B12 monitoring during metformin treatment. The study's objective was to update the relative health system cost estimate of metformin for diabetes prevention by incorporating the current health system cost of metformin and the cost of addressing potential metformin-associated vitamin B12 deficiency. The study was designed to assess whether metformin with vitamin B12 supplementation is a cost-saving measure for diabetes prevention and for the updated cost estimate to be useful in assessing future implementation studies. METHODS: In 2012, the Diabetes Prevention Program Research Group published detailed per capita total direct health system costs for the Diabetes Prevention Program (DPP) and the Diabetes Prevention Program Outcomes Study (DPPOS). The present analysis incorporated the declining cost of metformin and the increasing cost of metformin monitoring into the detailed per capita health system costs found in the DPP and DPPOS. The updated costs were used to assess the total cost of metformin use for diabetes prevention relative to placebo and lifestyle intervention. RESULTS: The current health system cost to acquire metformin ranges from $0 to $72 per year. The estimated health system cost to address potential metformin-associated vitamin B12 deficiency is $28 per metformin-treated patient per year. The 10-year total health system cost for metformin in diabetes prevention can decrease by $329 or increase by $21 depending on the cost to acquire metformin. Compared with placebo, the unadjusted cost savings of metformin is generally maintained, although it may double or quadruple depending on how metformin is acquired by patients. Metformin with vitamin B12 supplementation remained less costly and less effective than lifestyle intervention. CONCLUSION: Metformin is generally more cost-saving for diabetes prevention than previously reported because of decreasing costs for patients to acquire metformin. The cost savings was increased despite increased management cost associated with addressing metformin-associated vitamin B12 deficiency.

Active-learning Strategies for Legal Topics and Substance Abuse in a Pharmacy Curriculum.

Objective. To implement active-learning strategies to engage students in learning, applying, and teaching legal and substance abuse topics. Design. Medication Safety course student groups created films on a National Patient Safety Goal (NPSG) using a movie genre and presented them in film festival format. Pharmacogenomics course student groups taught ethical, legal, and social implications (ELSI) topics through presentation of short stories about comic book characters with genetic mutations. Students in the Drugs of Abuse course composed and performed dances depicting the mechanism of action of a drug in an in-class rave dance format. Assessment. Course evaluations revealed student engagement with subject material and enjoyment of the creative applications, critical thinking, and collaborative aspects of the activities. Students performed well on examination questions and graded assignments. Conclusion. These active-learning strategies facilitated students' abilities to learn, apply, and teach material in medication safety, pharmacogenomics, and substance abuse courses.

Guidelines for submitting adverse event reports for publication.

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

Guidelines for submitting adverse event reports for publication.

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

Epidemiology, comparative methods of detection, and preventability of adverse drug events.

BACKGROUND: Adverse drug events (ADEs) continue to be of concern to all health professionals. Even serious ADEs are underreported in all patient-care environments. OBJECTIVE: To discover the incidence and the best detection methods and preventability for ADEs at Al Qassimi Hospital, a 360-bed facility in the United Arab Emirates. METHODS: During the first and fourth quarters of 2003, data collection for ADEs was limited to spontaneous reporting. During the second and third quarters, active monitoring for ADEs took place in the adult, pediatric medical, and intensive care wards. ADEs were assessed for causality using the Naranjo algorithm and for severity and preventability. The incidence of ADEs was calculated and the detection methods were compared. RESULTS: The incidence of ADEs detected through surveillance was significantly higher (p < 0.001) than for ADEs reported spontaneously for both inpatients (3.592 vs 0.068/100 patient days) and outpatients (0.299 vs 0.022/100 patient visits). Most ADEs were judged to be of mild to moderate severity. About 56% of ADEs were judged definite or probable and, of these, 13.8% were consistently judged preventable. The most prevalent drugs implicated were central nervous system (23.6%), antiinfective (17.1%), and cardiovascular (16.5%) agents. The best ADE detection method was using physicians' notes. CONCLUSIONS: Active surveillance for ADEs, with the aid of ADE trigger alerts, yields a significantly higher number of reports than spontaneous reporting. Such surveillance is useful in identifying areas where improvements in the safe use of drugs can be made.

The quality of published adverse drug event reports.

BACKGROUND: Case reports of adverse drug events (ADEs) are an important source of information. OBJECTIVE: To determine what variables are reported in ADE case reports, how causality was assessed for each report, and what criteria are specified for publishing ADE case reports. METHODS: A descriptive analysis of highly significant ADE case reports published in English over a 20-year period was performed. Main outcome measures included frequency distributions for the types of variables reported. The presence of causality assessment and the criteria for submitting an ADE report to practitioner journals were also examined. RESULTS: A highly significant ADE was described in 1520 published case reports during the study period. Three patient variables were reported >90% of the time, while 12 others were reported <25% of the time. Only 1 drug variable was reported >90% of the time; 6 others were reported 14-74% of the time. Most of the relevant ADE variables were reported most often. Added information for drug interactions, medication errors, and allergic drug reactions were reported 61-99% of the time. Less than 1% of ADE reporters objectively assessed the probability of the ADE. All but one journal publishing the most ADE reports did not require such assessment. CONCLUSIONS: Professional journals might consider stricter requirements for publishing ADE reports. As a minimum, requirements should include an objective assessment of ADE causality, with explicit recognition in the published text and abstract of the report.

Risk of myocardial infarction with combination antihypertensive regimens including a dihydropyridine calcium channel blocker in hypertensive diabetics.

OBJECTIVE: The primary objective of this study was to determine if there was an increased risk of myocardial infarction (MI) in a high-risk hypertensive diabetic managed care population receiving combination antihypertensive therapy including a dihydropyridine (DHP) calcium channel blocker (CCB). METHODS: A retrospective, population-based, case-control study design was used to determine the risk of MI versus the prescribed antihypertensive drug regimen. During 1997-1999, 6,096 diabetics with hypertension were identified. After exclusions, there were 131.high-risk. study patients who suffered an MI during the study period. These were compared to an equally matched sample. High-risk patients were defined as those with a medical history of previous MI, angina pectoris or ischemic heart disease, or those who had undergone a coronary artery bypass graft and/or angioplasty procedure. Patients were then assigned to Group I cases and controls (DHP use) and Group II cases and controls (no DHP use). Odds ratios (OR) and 95% confidence intervals (CI) were determined for the independent variables and antihypertensive drug regimens. Logistical regression analysis was used to model age, ethnicity, and potential risk factors to identify any differences among calcium channel blockers. RESULTS: After adjusting for age and gender, the OR for an MI in patients on a combination DHP regimen was 0.75 (95% CI, 0.44, 1.29). The OR for other regimens ranged from 0.52 to 1.16, with no significant difference between antihypertensive drug classes. In comparison to nondihydropyridines (NDHPs), the OR for DHPs was 1.38 (95% CI, 0.54, 3.54), but it was determined to not be statistically different ( P=0.5065). CONCLUSION: No increase in risk of MI could be determined with the use of a combination antihypertensive regimen including a DHP CCB when compared to other antihypertensive drugs in a matched high-risk population of patients with hypertension and diabetes. Choice of antihypertensive drug regimen may be less important than strategies that focus on achieving optimal disease outcomes to reduce the incidence of MI and hospitalization and lower health care costs in this high-risk population in managed care.