Frequency of nonaspirin NSAID-relevant coexisting medical conditions in the primary-care setting: a retrospective database review.

BACKGROUND: Coexisting medical conditions and concomitant medications contribute to treatment challenges primary-care professionals (PCPs) face daily. The current study assessed the extent and distribution of nonaspirin NSAID-relevant coexisting medical conditions of interest (CMCOI) in patients visiting PCPs. METHODS: This retrospective database review analyzed data from three large health-care claim databases to identify the frequency of nonaspirin NSAID-relevant CMCOI among adults aged ≥18 years with a PCP visit in 2013. Claim databases employed were the Truven Health MarketScan® Commercial Claims and Encounters database, representative of the privately insured (PI) population; Truven Health MarketScan Multi-State Medicaid, representative of the Medicaid population (Medicaid); and Truven MarketScan Medicare Supplemental, representative of the Medicare population with employer-based supplemental Medicare insurance (Medicare-Supplement). Nonaspirin NSAID-relevant CMCOI, asthma, cardiovascular risk factors, gastrointestinal bleeding risk factors, and renal insufficiency were chosen based on US NSAID over-the-counter Drug Facts label warnings. Frequency of CMCOI was determined for those without and with a musculoskeletal diagnosis. RESULTS: In each database, ≥19% (19.0% PI, 29.9% Medicaid, 33.6% Medicare-Supplement) had a musculoskeletal diagnosis. A greater proportion of individuals with a musculoskeletal diagnosis had one or more CMCOI compared with those without a musculoskeletal diagnosis (61.3% vs 50.4% PI, 78.1% vs 66.8% Medicaid, 87.1% vs 82.3% Medicare-Supplement). The frequency of one or more CMCOI increased with age in each database. Across databases among CMCOI, cardiovascular risk factors were most common, followed by gastrointestinal bleeding risk factors, and proportions were higher among those with a musculoskeletal diagnosis. CONCLUSION: These data confirm the high frequency of nonaspirin NSAID-relevant CMCOI among patients presenting to PCPs for musculoskeletal diagnosis, as well as among older patients. These analyses reinforce the critical role health-care professionals can play in identifying patients with nonaspirin NSAID-relevant CMCOI, providing those patients with ongoing guidance on appropriate choice and use of over-the-counter analgesics, and educating patients about the impact aging, health status, concomitant conditions, and medicines have on selection of all medicines, including analgesics.

New insights into root causes of pediatric accidental unsupervised ingestions of over-the-counter medications.

CONTEXT: Changes to regulations, packaging, and labeling and ongoing educational efforts are intended to support appropriate use of medicines. Yet annually poison centers receive > 500 000 reports of accidental or unsupervised exposure to medicines for children under 6 years of age. OBJECTIVE: To identify root (i.e., fundamental and preventable) causes of accidental unsupervised ingestions (AUIs), we designed a questionnaire and conducted a follow-up survey of caregivers who contacted McNeil Consumer Healthcare (McNeil) following an AUI by a child under 12 years of age. METHODS: Reports received between 1 October 2008 and 22 January 2009 were screened retrospectively for specific Medical Dictionary of Regulatory Activities (MedDRA) Preferred Terms relating to AUIs. Using the questionnaire, we collected information about the child, caregiver, medicines involved in AUI, management of AUI, and storage location of medicines. RESULTS: Two hundred twenty reports met inclusion criteria and attempts to contact these caregivers were made throughout a 2-week period in March 2009; caregivers completed the questionnaire for 45 reports. All AUIs occurred in children under 7 years and 56% were boys. In 56% of AUI cases, the child involved was the intended recipient of the medicine; in 71%, a pediatric medicine was involved. Most AUIs occurred in the child's home; most caregivers reported not observing the AUI. Sixty percent of caregivers reported that the medicine involved in AUI was not in the normal storage location when AUI occurred. Among children involved in AUIs, 84% did not experience any symptoms. Seven children experienced mild, self-limiting symptoms which resolved. AUIs often occurred < 24 h after last therapeutic use when the medicine was removed from its normal storage location. CONCLUSIONS: These new insights may help guide-targeted interventions and educational efforts to focus caregivers' attention to reengaging childproofing mechanisms and returning medicines to a secure location, high and out of sight, immediately after use.

Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder.

BACKGROUND: Despite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group. OBJECTIVE: To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate. DESIGN: Adolescents (N = 220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n = 177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD. RESULTS: A significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52% of subjects in the OROS methylphenidate group improved compared with 31% receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups. CONCLUSION: In adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d.