Nicole T. Ansani

Selection of a validated scale for measuring medication adherence

OBJECTIVE To evaluate literature describing medication adherence surveys/scales to gauge patient behaviors at the point of care. DATA SOURCES Literature was identified via PubMed and Ovid (1950 to June 2009) using the search terms medication adherence, medication compliance, and medication persistence and combined with the terms questionnaire, survey, scale, or self-report. STUDY SELECTION All articles in English with adherence scales validated in two or more diseases and containing 30 or fewer questions were selected. DATA SYNTHESIS Five adherence scales were identified and reviewed by evaluating positive characteristics (short length, internal consistency, reliability, barriers to adherence, literacy appropriate, and self-efficacy), sensitivity, specificity, and diseases in which they have been validated. The Medication Adherence Questionnaire (MAQ) is the shortest scale and easiest to score. MAQ identifies barriers to nonadherence but not self-efficacy. The Self-efficacy for Appropriate Medication Use Scale (SEAMS) is a 13-question scale, and the Brief Medication Questionnaire (BMQ) has three main question headings and multiple subquestions. Both assess barriers and self-efficacy; however, scoring is difficult. The Hill-Bone Compliance Scale and Medication Adherence Rating Scale (MARS) address barriers and self-efficacy but are limited in their generalizability. The Hill-Bone Compliance Scale focuses on hypertensive patients, while MARS is specific to psychiatric populations. CONCLUSION No gold-standard medication adherence scale exists. MAQ is most adaptable at the point of care and across populations. MAQ is the quickest to administer and score and has been validated in the broadest range of diseases. SEAMS, BMQ, and the Hill-Bone Compliance Scale allow self-efficacy to be assessed and therefore may be useful in medication management clinics. MARS is specific to psychiatric populations.

Adverse Drug Events Involving COX-2 Inhibitors

OBJECTIVE: To describe the types and severity of adverse drug-related events (ADEs) observed in patients receiving cyclooxygenase-2 (COX-2) inhibitors and to increase the awareness of risk factors that predispose patients to ADEs associated with COX-2 inhibitors. METHODS: A review of ADEs reported at the University of Pittsburgh Medical Center Presbyterian Hospital (UPMC-P) revealed significant events related to use of celecoxib or rofecoxib. A query of the internal ADE database was performed to identify ADEs involving COX-2 inhibitors from January 1999 to June 2002. A similar query was performed to identify ADEs involving nonselective nonsteroidal antiinflammatory drugs (NSAIDs) reported during this same time period. Utilization data were also collected. RESULTS: Forty-eight ADEs involving 24 patients receiving COX-2 inhibitors were reported and validated via the UPMC-P ADE review process compared with 38 events in 33 patients receiving nonselective NSAIDs. The types of ADEs reported as related to COX-2 inhibitors were similar to those reported in association with nonselective NSAIDs. Forty-two percent of ADEs (n = 20) involving COX-2 inhibitors and 45% of events (n = 17) involving nonselective NSAIDs were classified as severe. All patients receiving COX-2 inhibitors and 91% of patients receiving nonselective NSAIDs exhibited risk factors that increased their risk to experience an ADE; all but 1 of these patients were receiving outpatient COX-2 inhibitor therapy. CONCLUSIONS: The observed ADEs involving COX-2 inhibitors were similar to those associated with nonselective NSAIDs. Most events may have been preventable, highlighting the need for education regarding the appropriate use of COX-2 inhibitors.

Designing a Strategy to Promote Safe, Innovative Off-Label Use of Medications:

Innovative off-label medication use (defined as prescribing with reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns, yet is not clinical research) is common practice and provides challenges to ensuring high-quality health care and patient safety. This article describes a strategy to promote policy and standardization of innovative off-label medication use, ensure oversight of patient safety, and prospectively assess efficacy. A multidisciplinary group developed a policy and process to regulate innovative off-label medication use that standardizes formulary review, maximizes peer expertise input, and minimizes institution liability by evaluating the effectiveness of use, promoting evidence-based practices, and ensuring ethical obligations to patients and society. This strategy has been implemented through institutional staff structure. The review process balances benefits/risks for biologically plausible therapy that lacks rigorous data support. The authors’ strategy illustrates collaboration that enables a priori consideration for innovative off-label medication use while providing safety surveillance and outcomes monitoring.

United States medical practice summary: innovative off-label medication use.

Data are limited regarding how academic medical centers (AMCs) deal with medication use that represents a departure from product labeling; has reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns; yet is not clinical research (defined as innovative off-label medication use). This report describes national trends in management of innovative off-label medication use. A cross-sectional survey of US AMCs was conducted. Survey questionnaires were directed to drug information centers or pharmacy directors. Of 469 AMCs contacted, 104 responded (22%). Fifty-nine AMCs identified innovative off-label use as a challenge. Only 18 AMCs developed strategies to address this issue: 12 requiring initial reviews and 8 requiring clinical monitoring. Sixty-five AMCs indicated interest in data sharing of clinical outcomes for innovative off-label protocol(s). Innovative off-label medication use is a widely recognized challenge; however, few prospectively active AMC responses exist. The authors suggest development of systematic structured approaches within and across AMCs.

Role of Inhaled Nitric Oxide in Adult Heart or Lung Transplant Recipients

OBJECTIVE: To evaluate the role of inhaled nitric oxide (iNO) in adult heart or lung transplant recipients. DATA SOURCES: Pertinent literature was identified via a MEDLINE search (1966–July 2004). DATA SYNTHESIS: Pulmonary hypertension leading to right ventricular failure and ischemic reperfusion injury are complications following heart or lung transplant, respectively. A study of 16 heart transplant patients showed improvement in hemodynamic parameters and preservation of right ventricular function, but no improvement in mortality using iNO. Studies of lung transplant patients showed no benefit of iNO on mechanical ventilation duration, hospital length of stay, or mortality, but some studies indicate an improvement in hemodynamic parameters. CONCLUSIONS: iNO shows hemodynamic benefits in early postoperative heart transplant patients with preexisting pulmonary hypertension, and variable hemodynamic benefits in lung transplant recipients. Currently, morbidity and mortality data are not favorable for either indication; use of iNO is supportive and requires further study.

Impact of Nonsteroidal Antiinflammatory Drugs on the Cardioprotective Effects of Aspirin

OBJECTIVE: To examine the evidence of a pharmacodynamic interaction between aspirin and nonsteroidal antiinflammatory drugs (NSAIDs); specifically, to determine whether a deleterious relationship exists with respect to the cardioprotective effects of aspirin. DATA SOURCES: Primary articles were identified by a MEDLINE search (1966—May 2004). Search terms included aspirin, nonsteroidal antiinflammatory drug, drug interaction, mortality, myocardial infarction, and stroke. STUDY SELECTION AND DATA EXTRACTION: All prospective and retrospective studies conducted in human subjects and investigating the potential interaction between aspirin and NSAIDs were included. DATA SYNTHESIS: Several controlled pharmacodynamic studies indicate that the sustained inhibition of cyclooxygenase activity by aspirin is blunted in the presence of some NSAIDs. While these data are fairly consistent, they are limited in that they rely on surrogate markers and not clinical outcomes. Observational studies have shown conflicting results regarding the effect of combination NSAID and aspirin therapy on mortality risk and incidence of myocardial infarction. CONCLUSIONS: Pharmacodynamic data indicating an interaction between aspirin and NSAIDs have not translated to a consistent clinical effect in observational studies. In the absence of a randomized, controlled, clinical outcomes study, there is insufficient evidence to dictate a change in therapy.

Seizure potential of concomitant medications and radiographic contrast media agents

Objective To review seizure risk of concomitant medication administration and nonionic, water-soluble radiographic contrast media agents for myelography. Data Sources Clinical literature was identified through MEDLINE (1966–May 2003). Key search terms included metrizamide, iohexol, myelogram, myelography, seizure, and contraindications. Data Synthesis Administration of myelography contrast media can produce rare serious adverse events, including meningeal irritation, seizures, or psychological disturbances. An evaluation of case reports and clinical trials concerning seizure risks of nonionic, water-soluble radiographic myelography contrast media and concomitant medications with potential to lower the seizure threshold was performed. Conclusions Available data supporting the incidence of increased seizure risk with nonionic, water-soluble contrast media agents and concomitant medication administration that lowers the seizure threshold are anecdotal. However, because of product labeling and additive potential to decrease the seizure threshold, discontinuation of such medications should be considered to avoid the presumed increased risk of seizures.

Low-Dose Granisetron for Postoperative Nausea and Vomiting Prophylaxis

OBJECTIVE To evaluate the use of low-dose granisetron in postoperative nausea and vomiting prophylaxis. DATA SOURCES Clinical trials available through PubMed and OVID (1966—July 2003), as well as information supplied by the drug manufacturer, were accessed. DATA SYNTHESIS Safety concerns associated with droperidol and limited availability of other agents have created a need to restructure prophylaxis guidelines for postoperative nausea and vomiting. It has recently been proposed that granisetron may be effective at a dose that is one-tenth of the Food and Drug Administration—approved dose. Conflicting evidence for this regimen is evaluated. CONCLUSIONS Based on the scarcity of supporting data, this regimen is not recommended for prophylaxis in patients at risk for postoperative nausea and vomiting.

The Drug Information Center Arthritis Project: Providing Patients with Interactive and Reliable Arthritis Internet Education

The objective of the Drug Information Center Arthritis Project was to create and assess the value of a patient-focused interactive arthritis education program. A multidisciplinary team developed three content areas: an interactive ask-a-pharmacist component with a satisfaction survey; health assessment tools (SF-8™, osteoarthritis [OA] Impact Survey™, and rheumatoid arthritis [RA] Impact Survey™); and disease and drug information. Results: There were 1,800 patients with OA, RA, or both from a collaborating rheumatology practice who were invited to use a personalized, interactive, secured Internet arthritis Web site. During a 6-week pilot, 56 patients accessed the site for a total of 128 visits. Patient satisfaction scores showed that 83% of patients rated the site as useful to very useful; 83 % would both use the site again and recommend the site to a friend. Overall health-related quality of life as measured by the SF-8 physical and mental component scores and the OA and RA Impact Surveys for patients accessing the Web site was slightly higher than the US population norms for patients with arthritis. Conclusions: To our knowledge, there are no other Web sites that provide confidential, patient-specific arthritis Internet information as an extension of a rheumatology practice. Our Web site provided novel access to personalized, evidence-based, and up-to-date information for patients.