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Objective: The rise in use of antipsychotics among U.S. children is well documented. Compliance rates with current safety-monitoring guidelines are low. In response, the North Carolina Division of Medical Assistance established the Antipsychotics-Keeping It Documented for Safety (A+KIDS) registry. The initial objectives of the project were to successfully establish a Web-based safety registry and to obtain and evaluate clinical information derived from the registry., Methods: In April 2011, A+KIDS began asking prescribers of antipsychotics for children age 12 and under to respond to a set of questions regarding dose, indication, and usage history. Antipsychotic registrations were examined by linking North Carolina Medicaid prescription claims to registry entries. Prescribers were classified into different types, and the number of patients and registrations per prescriber were examined., Results: In the initial six months, 730 prescribers registered 5,532 patients, 19% below age seven. By month 6 of the registry, 72% of all fills were registered with the program. Top diagnosis groups for registry patients were unspecified mood disorders, autism spectrum disorders, and disruptive behavior disorders. Top target symptoms were aggression (48%), irritability (19%), and impulsivity (11%). Psychosis accounted for 5% of the target symptoms. Twenty-eight percent of children were receiving no form of psychotherapy. Twenty-five percent of all A+KIDS prescribers were responsible for 81% of the registrations., Conclusions: The A+KIDS registry initiative has been successful, as measured by rapid uptake, and is providing clinical information not available from claims data alone. Future efforts will allow for detailed examinations of antipsychotic utilization and further safety improvement.

Background: Proton pump inhibitors (PPIs) are among the highest expenditure drugs covered by health care plans. During fiscal year 2001-2002, Medicaid programs nationwide spent nearly $2 billion on PPIs. Although the costs of individual PPIs vary widely, there is little variation in therapeutic effectiveness. On June 1, 2007, the North Carolina Medicaid program implemented an "instant approval" option simultaneously with a prior authorization (PA) program for PPIs with the goal of managing costs and maintaining high-quality care. Preferred PPIs included generic omeprazole and Prilosec OTC. This instant approval process (IAP) was expected to impose less administrative burden than is typically associated with PA programs by permitting physician and nonphysician prescribers to either write the PA criteria directly on a prescription form or use "MD Easy," a preprinted form that could be faxed by the prescriber to the dispensing pharmacy. A previous study found that from the prescriber's perspective the IAP reduced practice-related administrative burden and was associated with a reduced gap in PPI therapy when compared with traditional PA., Objective: To evaluate the acceptability and effectiveness of this IAP for PPIs as assessed by the outcome measures of (a) pharmacist satisfaction with the IAP; (b) physician and pharmacist satisfaction with the MD Easy form; and (c) utilization rates for preferred PPIs, comparing medical practices that used the MD Easy form with practices that did not., Methods: A cross-sectional design was used to assess pharmacist and physician satisfaction. A stratified random sample of 240 pharmacies was selected from 1,561 North Carolina pharmacies with claims in the Medicaid claims data file during state fiscal year 2006. Additionally, a stratified random sample of 240 medical practices was selected from 1,045 primary care practices serving Medicaid beneficiaries during 2006. Surveys were administered to pharmacists using either in-person interviews or self-administered questionnaires and to physicians using a mailed questionnaire with follow-up to nonrespondents. An interrupted time series analysis was used to evaluate the effect of the MD Easy form on switching to preferred PPIs using paid Medicaid claims of surveyed practices from calendar year 2007. Practices that reported both using the IAP and receiving the MD Easy form were defined as MD Easy users. Monthly market share data were analyzed using log negative binomial regression models to account for autocorrelation in the time series data., Results: The pharmacy survey was completed by 202 (84.2%) pharmacies selected for participation. Of 198 permanently employed pharmacists, 140 (70.7%) reported experience with the IAP for PPIs. More than two-thirds (68.6%) of the pharmacist respondents with IAP experience indicated that the IAP is better (34.3%) or much better (34.3%) than traditional PA with RESEARCH respect to overall administrative burden of phone calls, faxes, patient interactions, and doctor contacts. Surveys were completed by 171 (71.3%) of selected physician practices, of which 56 (32.7%) reported experience with the MD Easy forms. Of practices that recalled receiving the MD Easy forms, 52 of 56 (92.9%) reported that the forms "very much" or "somewhat" helped prevent gaps in PPI therapy; 54 of 55 (98.2%) reported that they helped identify patients affected by Medicaid PPI PA; and 100% reported that they helped physicians to follow PA requirements. Immediately after implementation of the IAP and MD Easy form, the observed market share of preferred PPIs increased by 4.1 times (95% CI = 3.57-4.62). From May to June 2007, the preferred PPI market share increased by 64.0 percentage points, from 19.3% to 83.3% (P < 0.001), for practices that reported using the IAP and receiving the MD Easy form (n = 56) and by 55.4 percentage points, from 21.8% to 77.2% (P < 0.001), for practices that either (a) reported not receiving the MD Easy form (n = 25) or (b) reported not using the IAP (n = 84) or (c) did not respond to the survey item asking about the MD Easy form (n = 4). The overall increase in preferred PPI market share after implementation of the IAP was 1.29 times higher for practices that used the MD Easy form than for those that did not based on negative binomial regression modeling; this difference approached statistical significance (95% CI = 1.00-1.68; P = 0.053)., Conclusion: This study suggests that an IAP for PPIs using either handwritten prescriptions or a preprinted form is an effective alternative to traditional PA. The IAP was associated with an increase in market share for preferred PPIs and was perceived by pharmacists as less administratively burdensome than traditional PA. Additional studies are needed to determine sustainability and the applicability to other prescription drugs.

Objective: To determine if the instant approval (IA) process differs from the traditional prior authorization (PA) process in preferred drug channeling, resultant gaps in therapy, and provider dissatisfaction., Study Design: An interrupted time series analysis using pharmacy claims and a retrospective cohort study., Methods: The study assessed changes in preferred drug use and subsequent cost reductions. A retrospective cohort study determined if the IA process produced fewer gaps in therapy than the PA process. Provider acceptance of the IA process was assessed using a brief survey of 240 randomly selected primary care practices., Results: Market share for preferred proton pump inhibitors quadrupled from a range of 17.6% to 19.3% at baseline to 76% in the first month after implementation of the new IA policy. Most practices (81.1%) reported reduced administrative burden with the IA process. The median gaps between medication fills for patients using IA were approximately one-half those of patients using PA (P <.001) and were one-fourth in a subset of highly adherent, regularly filling patients (P <.001)., Conclusions: Instant approval may be more patient friendly and prescriber friendly than PA as assessed by a proxy measure for access (gap in therapy) and physician-reported acceptance. Despite its ease of use, IA does not seem to reduce switching to preferred drugs.

Background: The high cost and undesirable consequences of polypharmacy are well-recognized problems among elderly long-term care (LTC) residents. Despite the implementation of the 1987 Omnibus Budget Reconciliation Act, which requires pharmacist review of drug regimens in this setting, medical and drug costs for LTC residents have continued to increase., Objective: This study evaluates the North Carolina Long-Term Care Polypharmacy Initiative, a large-scale medication therapy management program (MTMP) that combined drug utilization review activities with drug regimen review techniques., Methods: This was a prospective records-based study that used a difference-in-difference model with both historical and nonintervention group controls. To ensure equivalence among subjects, propensity scoring was used to match study subjects from participating LTC facilities with comparison subjects from nonparticipating facilities. Residents with interventions were grouped for analysis by intervention type-retrospective only, prospective only, or dual type (residents with both prospective and retrospective interventions)-and by intervention stage-review, recommendation, and drug change-plus an all-inclusive "all types" grouping that aggregated groups by intervention type, for a total of 10 total cohorts., Results: In the overall population of 5255 study subjects identified, a US $21.63 per member per month drug-cost savings was observed. Although only 1 of 10 cohorts had a change in the number of drug fills, substantial reductions in 2 of 5 types of drug alerts were observed in all 10 cohorts. A reduction in the relative risk for hospitalization (0.84 [95% CI, 0.71-1.00]) was observed in the cohort of residents receiving a retrospective review., Conclusions: This Initiative suggests that an MTMP can be quickly launched in a large number of LTC facility residents to produce monetary drug-cost savings and improved health outcomes. Additionally, the evaluation of this program illustrates the utility of using propensity scoring techniques to target future intervention groups in a cost-effective manner.

Objectives: Pediatric subspecialists are not routinely reimbursed by Medicaid or insurance payers for telephone consultations. Generally, access to pediatric subspecialists is limited because of the small number of providers, their concentration in academic medical centers, and increasing demand for their services. Little is known about the nature of such consults, the time required to provide them, or whether there is a positive economic impact for payers., Methods: Between March and October of 2007, pediatric subspecialists from 6 academic medical centers in North Carolina completed consultation reimbursement-request forms to prospectively track their telephone consultations with primary care physicians for the care of Medicaid patients<22 years of age. Data collected included the amount of time required per consult and consult outcomes in terms of service use and quality of care. Medicaid claims records and primary care physician surveys were used to validate the pediatric subspecialist consultation outcomes., Results: A total of 47 pediatric subspecialists provided 306 consults regarding the care of 292 Medicaid-insured children over the 8 study months. Telephone consults were generally <15 minutes in length and exceeded 30 minutes in <7% of calls. Pediatric subspecialists reported that telephone consults led to avoidance of specialist visits (n=98), hospital transfers (n=35), hospital admissions (n=14), and emergency department visits (n=14). Medicaid claims data supported these reports; matched primary care physician surveys suggested even higher levels of service avoidance. After adjusting for the reimbursed costs of providing telephone consults, an estimated $477274 was saved ($39 per dollar spent)., Conclusions: Telephone consultations with pediatric subspecialists provide a valuable service to primary care physicians providing medical homes to Medicaid patients. Rewarding physicians for telephone consults seems to be cost-effective because of reduced use of costly services and reported improvements in quality of care.

Objective: To assess whether equipping resident pediatricians and community pediatricians with both training and practical tools improves their perceived confidence, ease, and frequency of obesity-related counseling to patients., Methods: In 2005-2006, resident pediatricians (n = 49) and community pediatricians (n = 18) received training regarding three evidence-based obesity prevention/treatment tools and responded to pre- and post-intervention questionnaires. We analyzed changes in reported mean confidence, ease, and frequency of dietary, physical activity, and weight status counseling., Results: Baseline scores of confidence, ease, and frequency of counseling were higher in community pediatricians than residents. Mean scores increased significantly in the combined group, among residents only, and trended towards improvement in the community pediatricians following the intervention. Means for "control" questions were unchanged., Conclusion: Training and tools for residents and community pediatricians improved their confidence, ease, and frequency of obesity-related counseling., Practice Implications: This study demonstrates that when feasible and appropriate tools and training were provided through a simple intervention, physicians gained confidence and ease and increased their counseling frequency. The results here suggest that widespread implementation of such educational interventions for community practitioners and practitioners in training could change the way physicians counsel patients to prevent the often frustrating problem of childhood obesity.

Objective: The purpose of this work was to examine pediatricians' and endocrinologists' views about management for routine preventive and acute care, diabetes-specific care, and family education and care coordination for children with insulin-dependent diabetes., Methods: We conducted a mixed-mode survey of all of the pediatricians in 1 medicaid managed care network and all of the pediatric and adult endocrinologists who treat children with diabetes in North Carolina., Results: Of the 201 pediatricians surveyed, 132 responded (65%). Among the 61 endocrinologists who treat children, 59% replied. Nearly all of the respondents agreed that primary care physicians should have responsibility for routine primary care (eg, well-child checkups, treating minor illnesses or injuries, and immunizations). Likewise, large majorities favored endocrinologists as leads for diabetes-specific care (eg, 94% for training in use of an insulin pump and 82% for training in use of a glucometer). Many generalists and subspecialists reported that specific aspects of diabetes care should be comanaged (eg, 31% for tracking of hemoglobin A1c). However, large proportions of pediatricians and endocrinologists expressed differing opinions about the primary responsibility for family education and care coordination and for specific diabetes services. For example, 80% of endocrinologists saw subspecialists as leads for monitoring blood sugar levels, whereas 52% of pediatricians favored comanagement., Conclusions: An effective medical home model of care depends on establishing clear lines of responsibility between the primary care physician and subspecialist. Our findings suggest that primary care physicians and subspecialists agree on who should lead most aspects of care for patients with insulin-dependent diabetes and that some aspects of care should be comanaged. However, primary care physicians and subspecialists did not agree either between or within disciplines on who should be more responsible for the basic aspect of monitoring of blood sugar levels. Approaches that recognize the appropriate division of care between primary care physicians and subspecialists, facilitate comanagement when it is needed, and reward the collaboration required to provide medical homes for patients should be investigated as models of care.

Objective: The conversion of loratadine from prescription (Rx)-only to over-the-counter (OTC) status on November 27, 2002, brought about the question of how OTC products may influence utilization of both OTC and Rx-only low-sedating antihistamines (LSAs) simultaneously. North Carolina (NC) Medicaid initially did not cover loratadine OTC but subsequently changed the policy 1 year after OTC conversion, on November 23, 2003. The objective of this study was to determine patterns of LSA utilization in relation to changes in OTC availability and Medicaid coverage policy and to assess the rate of product switching associated with these policies., Methods: Administrative pharmacy claims from the NC Medicaid population of approximately 1.1 million eligible recipients were used to study the 3 years of LSA use between July 1, 2001, and June 30, 2004. Two general methods were employed to evaluate the extent of product switching. First, monthly rates of incident use, new starts (i.e., no LSA use in the prior 12-month period) and product switching in time series were determined. These series were constructed to include a baseline period of no OTC availability, a period of OTC availability without coverage, and a period of OTC availability with coverage. Second, product switching was assessed through the use of rate-ratio calculations. Three equal 12-month periods were compared using rate ratios: (1) a baseline referent period (July 1, 2001, to June 30, 2002) during which loratadine OTC was not yet available, (2) a noncoverage period (July 1, 2002, to June 30, 2003) during which loratadine OTC was introduced to the market but not covered by NC Medicaid, and (3) a coverage period (July 1, 2003, to June 30, 2004). The primary comparison periods for the 3 years were the 5-month periods from February to June of each year., Results: The use of individual drugs within the LSA class responded to coverage changes as expected, with alternative LSAs replacing loratadine use in the loratadine noncoverage period. Switching behavior for individual drugs within the LSA class was strongly associated with coverage changes. Recipients using loratadine were 2.16 times more likely to switch to an alternative Rx-only antihistamine in the noncoverage period (95% confidence interval [CI], 2.10-2.22) as compared with the baseline period. Yet they were only 1.11 times as likely not to use an Rx LSA during the last 5 months of the noncoverage period (95% CI, 1.09-1.13), as compared with the baseline period, suggesting minimal OTC uptake. The largest 12-month percentage increase in market share was observed for cetirizine (13.4%) although desloratadine accounted for the largest switch rate from loratadine at 3.10 (95% CI, 2.91-3.30), as compared with the baseline period, with a total market share increase of 7.8%. This suggests that new users of LSAs were most likely to initiate therapy with cetirizine, while existing loratadine users were most likely to switch to desloratadine. Compared with baseline switch rates, LSA users were only 0.34 (95% CI; 0.32-0.37) times as likely to switch to loratadine OTC from another (Rx-only) LSA during the subsequent OTC coverage period. LSA expenditure per member per month (PMPM) was essentially constant over time, at dollar 3.03 in the 5-month pre-OTC period, dollar 2.96 in the 5-month loratadine noncoverage period, and dollar 2.93 in the 5-month coverage period for loratadine OTC. Total LSA utilization increased slightly, from 1.37 days PMPM in the 5-month pre-OTC period to 1.41 in the 5-month loratadine noncoverage period and 1.45 in the 5-month coverage period for loratadine OTC. Loratadine OTC accounted for only 4.1% of the total LSA days of therapy and 4.2% of the LSA patients in the 5-month OTC coverage period from February to June 2004., Conclusion: Medicaid recipients switched to another covered (Rx) LSA when loratadine became available as an OTC and was not covered. After the subsequent policy change 1 year later to cover loratadine OTC, there was little switching to loratadine OTC. Though the average cost per LSA claim dropped dollar 4.15 (6.6%), from dollar 62.79 in the baseline period to dollar 58.64 in the OTC coverage period, time-series and rate-ratio results suggest that an additional dollar 6.01 (10.2%) could have been saved per LSA claim had OTC coverage been in effect at the time of the conversion of loratadine to OTC status. Although coverage of loratadine OTC offers a substantial cost-savings opportunity for the Medicaid program compared with Rx-only LSAs, not covering the OTC product immediately at the time of OTC availability contributed to (a) increased switching to Rx-only LSA products and (b) little use of loratadine OTC in the subsequent OTC coverage period.