Background

Accuracy and transportability of the recorded outpatient medication list are important in the continuum of patient care. Classifying discrepancies between the electronic medical record (EMR) and actual drug use by the root cause of discrepancy (either system generated or patient generated) would guide quality improvement initiatives.

Objectives

To quantify and categorize the number and type of medication discrepancies that exist between the medication lists recorded in EMRs and the comprehensive medication histories obtained through telephone interviews conducted by a team of nurses providing advice to health plan members at the Palo Alto Medical Foundation in Palo Alto, California.

Methods

The study was conducted as a retrospective comparison of EMR medication lists with information obtained by patient interview. Interview data were obtained by a review of telephone calls made to a nurse advice line by health plan members seeking information about sinusitis, urinary tract infection, acute conjunctivitis, pharyngitis, emergency contraception, or mastitis. As part of the advice protocol, a medication reconciliation process was conducted between July 1 and December 31, 2006. Changes to the medication list made during the telephone visit were extracted, categorized, and evaluated by the study's principal investigator. Data extraction included the number and type of identified medication discrepancies, patient age, gender, and condition that prompted the telephone contact. A modified version of the Medication Discrepancy Tool (MDT) was used to categorize medication discrepancies as either system generated (e.g., failure of the provider to update a medication list) or patient generated (e.g., failure of the patient to report use of an over-the-counter product).

Results

A total of 233 discrepancies were identified from 85 medication reconciliation phone visits, averaging 2.7 per medication list. The most common type of discrepancy was a medication recorded in the EMR but no longer being used by the patient (n=164, 70.4%), followed by omission from the EMR of a medication being taken by the patient (n=36, 15.5%). 79.8% (n=186) of the discrepancies were attributed to system-generated factors, whereas 20.2% (n=47) were patient generated. Approximately half (n=118, 50.6%) of the discrepancies fell into 4 broad American Hospital Formulary System therapeutic classifications: anti-infective agents (14.2%), anti-inflammatory agents (14.2%), analgesics (12.4%), and vitamins (9.9%). The most common patient-generated discrepancy was omission of a multivitamin (n=13, 27.7%), and the most common system-generated prescription drug discrepancy was expired entry for the intranasal corticosteroid mometasone furoate (n=12, 6.5%).

Conclusion

Discrepancies in the outpatient setting were common and predominantly system generated. The most common discrepancy was the presence in the EMR of a medication no longer being taken by the patient. Adding foreseeable end dates to prescription drug orders at computerized order entry might be considered in an effort to improve the accuracy of the outpatient medication list. Reliable systems to involve patients in routinely reconciling EMRs with actual medication use may also warrant examination. The MDT methodology served as a useful qualitative guide for evaluating discrepancies and developing targeted means for resolution.

Objective

To raise pharmacist awareness about the needs and concerns of our patients with visual impairment and to review useful strategies to foster medication adherence.

Summary

As patient-centered pharmacists, we need to understand the challenges faced by our patients with low vision and tailor pharmaceutical care to best fit their needs. Evidence-based best practices in labeling and written communication have been developed by the American Foundation for the Blind in partnership with the American Society of Consultant Pharmacists. These recommendations include the use of specific font styles, minimum font size, and other standards known to enhance usability for those with limited vision. Recent advances in assistive technologies such as audio output and object recognition software can be used to ease the medication-taking process and effectively communicate important drug and safety information in a manner that can be understood by those with low vision. In July 2012, the Prescription Accessible Drug Labeling Promotion Act of 2012 (HR 4087) was signed into law. This new legislation is an addition to the Food and Drug Administration Safety and Innovation Act, which required the development and ultimate implementation by pharmacies of national best practices intended to improve the accessibility of prescription drug labeling for the visually impaired.

Conclusion

As a patient-centered profession, we need to advocate for our patients with special needs by partnering with government and patient groups to support and enact legislation intended to enhance people's ability to adhere to drug therapy.

The intent of this review is to present basic genetic concepts key to understanding oncogenesis and the role receptor tyrosine kinase (RTK) inhibition plays in the targeted treatment of many cancer types. Oncogenic signaling by RTKs can result from genetic events such as point mutations, chromosomal rearrangements, structural variation, and gene amplification in the cancer genome. The cancer pharmacogenes discussed encode RTKs that exemplify the link between gene variation, the oncogenic process, and the basis of targeted approaches to treatment. Biochemical pathways often involved in oncogenesis and affected by RTK variation are reviewed. Molecular diagnostic testing for the presence of specific gene variants, alterations, and amplifications direct therapy to indicated tyrosine kinase inhibitors and monoclonal antibody drugs. As pharmacists are integral to the selection, preparation, and monitoring of chemotherapy, it is important that they understand the genetic basis for targeted therapies as well as the underlying disease process.

This basic review of genetic principles will aid pharmacists in preparing for their eventual role of translating gene-drug associations into clinical practice. Genes, which are stretches of deoxyribonucleic acid (DNA) contained on the 23 pairs of human chromosomes, determine the size and shape of every protein a living organism builds. Variation in pharmacogenes which encode for proteins central to drug action and toxicity serves as the basis of pharmacogenomics (PGx). Important online resources such as PharmGKB.org, cpicpgx.org, and PharmVar.org provide the clinician with curated and summarized PGx associations and clinical guidelines. As genetic testing becomes increasingly affordable and accessible, the time is now for pharmacists to embrace PGx-guided medication selection and dosing to personalize and improve the safety and efficacy of drug therapy.

Background

Recent quality initiatives require that the routine annual therapeutic drug-monitoring (TDM) parameters for the high-risk medication digoxin include a measure of renal function and a serum potassium level but not a serum digoxin concentration (SDC) measurement. Several studies have shown that the majority of the SDCs obtained in hospital settings provide little clinically actionable information.

Objective

To evaluate the appropriateness and utility of SDCs ordered in a medical group practice setting by categorizing the reason the SDC was ordered and identifying action taken in response to the result.

Methods

The descriptive study was conducted as a retrospective, electronic medical record (EMR) review of 90 primary care patients with continuous prescriptions for digoxin current on their medication profile with no gaps in therapy for at least 2 years prior to an SDC result entered into the EMR between January 1, 2009, and September 30, 2009. The reason the SDC was ordered was abstracted independently by 2 reviewers, who then assigned it to 1 of 8 predefined indication categories based on previously published criteria and practice guidelines. A third reviewer resolved inter-reviewer discrepancy (n = 1).

Results

A total of 90 patients with at least 1 SDC met inclusion criteria. Routine monitoring was the most frequent SDC order indication category with 35 patients (38.9%), 17 (48.6%) of whom did not have the recommended monitoring measures of potassium or renal function drawn concurrently. Patients were included in other categories as follows: confirmation of signs/symptoms of toxicity 30 (33.3%); assessment of factors altering pharmacokinetics 5 (5.6%); assessment of dosage change 5 (5.6%); assessment of drug interaction 3 (3.3%); assessment of clinical response 3 (3.3%); assessment of adherence 1 (1.1%); and other 2 (2.2%). Across all categories, a total of 19 (21.1%) of SDC results were outside the therapeutic range of 0.5 nanograms (ng) per mL and 2.0 ng per mL, 18 of which were below 0.5 ng per mL, with none of the subtherapeutic levels leading to a change in digoxin therapy. Only 1 patient (1.1%) had therapy changed in response to an elevated abnormal SDC result of 2.1 ng per mL and was in the routine monitoring category.

Conclusions

The majority of SDC results obtained in our medical group setting did not lead to clinical action, such as dose adjustment or drug discontinuation. SDCs were commonly measured as part of routine monitoring, which is considered an inappropriate indication, and often without being accompanied by better markers for digoxin toxicity such as serum potassium levels and measures of renal function as recommended by drug-monitoring quality initiatives. Provider education is needed regarding the most indicative digoxin TDM parameters to obtain in order to satisfy quality initiatives.

Background

An analysis of the US Food and Drug Administration's Adverse Event Reporting System database found evidence suggesting that the combination of the cholesterol-lowering drug pravastatin and the antidepressant paroxetine, produced a significant increase in average blood glucose measures.

Objective

Our intent was to investigate the reproducibility of these findings by conducting a similar analysis of administrative and prescription claims data from patients receiving primary care at the Palo Alto Medical Foundation.

Method

We conducted an observational, retrospective review of 2149 adult patient records to compare mean measures of blood glucose between groups receiving concomitant paroxetine and pravastatin with the pooled means of those receiving 19 different combinations of a statin and a selective serotonin reuptake inhibitor (SSRI) antidepressant. Analysis of covariance (ANCOVA) was used to compare random glucose, fasting glucose, and glycosylated hemoglobin mean values, while adjusting for the covariates of age, gender, body mass index, and weight in patients with and without a diagnosis of diabetes mellitus.

Result

A total of 65 observations were analyzed from patients receiving concomitant paroxetine and pravastatin and 2084 from those receiving 19 other statin-SSRI pairs. The ANCOVA showed that significant covariate relationships included the diagnosis of diabetes mellitus, male gender, and body weight. After adjusting for covariates, no significant difference was found between the 3 mean glucose measures of the pravastatin-paroxetine pair groups and the corresponding means of the pooled statin-SSRI pair groups (P > 0.05).

Conclusion

Outpatients receiving concomitant pravastatin and paroxetine did not have significantly different mean glucose measures as compared with those receiving other statin-SSRI drug combinations.

Background

On May 21, 2007, a safety alert was widely disseminated through the media and US Food and Drug Administration (FDA) MedWatch concerning a possible increased risk of ischemic myocardial infarction and cardiovascular death in people receiving the antidiabetic drug rosiglitazone.

Objective

To determine whether notification of patients and providers about an FDA safety warning influenced the decision to discontinue rosiglitazone therapy and the resulting effect on glycemic control.

Study design

Retrospective electronic medical record (EMR) review.

Methods

EMR documentation review of 552 primary care patients with a prescription for rosiglitazone current on May 21, 2007, was conducted to determine the percentage that had rosiglitazone discontinued as a result of written notification about the FDA alert. We ascertained whether discontinuation was initiated by the physician or patient. We compared the change in glycosylated hemoglobin (A1C) values from baseline to follow-up between the group continuing on rosiglitazone and the group discontinuing therapy.

Results

Of 552 patients, 344 (62%) had rosiglitazone discontinued as a result of the warning. Discontinuation was initiated by the physician in 150 cases (43.6%), by the patient in 155 cases (45.1%), and was undetermined in 39 cases (11.3%). No significant difference was found in the mean change in A1C values from baseline to follow-up between the 2 groups.

Conclusions

Notifying patients and providers about FDA safety alerts does influence clinical decision making. The lay media should partner with the FDA to responsibly communicate drug safety information in evidence-based, understandable terms that quantify real risk.

Background

Trial data for the benefits and risks of dabigatran versus warfarin in the treatment of nonvalvular atrial fibrillation are lacking. We sought to review real-world observational evidence for the comparative effectiveness and safety of these agents.

Methods and results

A systematic search of multiple databases was conducted from first available date to March 10, 2015 for longitudinal, observational studies comparing dabigatran with warfarin. Two reviewers evaluated studies for eligibility and extracted hazard ratios for ischemic stroke and gastrointestinal and intracranial bleeding. hazard ratios were pooled using random-effects meta-analysis. Metaregression was performed to assess treatment-effect heterogeneity. We identified 232 unique citations. Seven retrospective cohort studies met study eligibility criteria, with 348 750 patients and a mean follow-up of 2.2 years. In pooled analyses, dabigatran-150 mg was not superior to warfarin in preventing stroke (hazard ratio, 0.92; 95% confidence interval, 0.84-1.01; P=0.066), but had a significantly lower hazard of intracranial bleeding (0.44; 0.34-0.59; P<0.001). Dabigatran-150 mg had a significantly greater hazard of gastrointestinal bleeding than warfarin (1.23; 1.01-1.50; P=0.041), which was potentiated in studies of older (elderly) versus younger populations (median/mean age, ≥75 versus <75 years; β=1.53; 95% confidence interval, 1.10-2.14; P=0.020).

Conclusions

In real-world clinical practice, dabigatran is comparable with warfarin in preventing ischemic stroke among patients with nonvalvular atrial fibrillation. However, dabigatran is associated with a lower risk for intracranial bleeding relative to warfarin, but-particularly among the elderly-a greater risk for gastrointestinal bleeding. Bleeding outcomes from observational studies are consistent with those from the pivotal Randomized Evaluation of Long-Term Anticoagulation Therapy trial.