Use of Statins and the Risk of Incident Diabetes: A Retrospective Cohort Study.

INTRODUCTION: Even though several landmark statin trials have demonstrated the beneficial effects of statin therapy in both primary and secondary prevention of cardiovascular disease, several studies have suggested that statins are associated with a moderate increase in risk of new-onset diabetes. These observations prompted the US FDA to revise statin labels to include a warning of an increased risk of incident diabetes mellitus as a result of increases in glycosylated hemoglobin (HbA1c) and fasting plasma glucose. However, few studies have used US-based data to investigate this statin-associated increased risk of diabetes. OBJECTIVE: The primary objective of our study was to examine whether the use of statins increases the risk of incident diabetes mellitus using data from the Thomson Reuters MarketScan (®) Commercial Claims and Encounters Database. METHOD: This study was a retrospective cohort analysis utilizing data for the period 2003-2004. The study population included new statin users aged 20-63 years at index who did not have a history of diabetes. RESULTS: The proportion (3.4 %) of statin users (N = 53,212) who had incident diabetes was higher than the proportion (1.2 %) of non-statin users (N = 53,212) who had incident diabetes. Compared with no statin use and controlling for demographic and clinical covariates, statin use was significantly associated with increased risk of incident diabetes (hazard ratio 2.01; 99 % confidence interval 1.74-2.33; p < 0.0001). In addition, risk of diabetes was highest among users of lovastatin, atorvastatin, simvastatin, and fluvastatin. Diabetes risk was lowest among pravastatin and rosuvastatin users. DISCUSSION: Because the potential for diabetogenicity differs among different statin types, healthcare professionals should individualize statin therapy by identifying patients who would benefit more from less diabetogenic statin types.

Using the theory of planned behavior to examine pharmacists' intention to utilize a prescription drug monitoring program database.

BACKGROUND: Prescription drug monitoring programs (PDMPs) are state-operated electronic databases that contain patients' controlled drug histories. Most states provide these data to pharmacists via online web portals to combat prescription drug abuse and diversion. OBJECTIVES: The objectives of this study were to: 1) explore the theory of planned behavior's (TPB) utility in predicting Texas pharmacists' intention to utilize an online accessible PDMP; 2) to determine the contribution of each construct, attitude (A), subjective norm (SN) and perceived behavioral control (PBC) in predicting pharmacists' intention; and 3) test whether the addition of perceived obligation (PO) is significantly related to pharmacists' intention. METHODS: A cross-sectional, 36-item questionnaire was developed from focus groups and literature of pharmacists' views regarding prescription drug abuse. A total of 998 practicing Texas community pharmacists were surveyed to collect data on their intention to utilize a PDMP database. Descriptive statistics, multivariate and hierarchical logistic regression analyses were used to address the study objectives. RESULTS: The response rate was 26.2% (261/998). TPB constructs were significant predictors of pharmacists' high intention to utilize the PDMP. Pharmacists with positive attitudes were almost twice as likely to have high intention (odds ratio [OR] = 1.8, 95% confidence interval [CI] = 1.2-2.8). SN was the strongest predictor of pharmacists' high intention (OR = 2.2, 95% CI = 1.4-3.3). Pharmacists with high PBC were also twice as likely to have high intention (OR = 1.9, 95% CI = 1.2-3.0). Additionally, pharmacists' PO contributed to the prediction of high intention (OR = 1.8, 95% CI = 1.0-3.1) above that explained by the TPB model constructs (X(2) = 4.14, P < 0.05). CONCLUSIONS: TPB with the addition of PO was useful in predicting pharmacists' high intention to utilize a PDMP database. Interventions that address pharmacists' A, SN, PBC, and PO may be valuable to increase pharmacists' high intention. Pharmacists' utilization of PDMPs may lead to a decrease in the morbidity and mortality associated with prescription drug abuse. Future studies that assess whether intention to use PDMPs translates to actual usage are needed to strengthen these findings.

Examination of why some community pharmacists do not provide 72-hour emergency prescription drugs to Medicaid patients when prior authorization is not available.

BACKGROUND: Existing federal law requires that a 72-hour emergency supply of a prescription drug be dispensed to Medicaid patients when prior authorization (PA) is not available and the medication is needed without delay. The pharmacist's role is to contact prescribers and inform them that PA is needed. If the prescriber cannot be reached, the pharmacist can dispense a 72-hour emergency supply. OBJECTIVES: To determine (a) the reasons why some community pharmacy owners/managers, staff pharmacists, and technicians are not compliant with the law; (b) how often the decision is made; and (c) estimate how often pharmacies do not dispense the 72-hour emergency supply when PA is not available. METHODOLOGY: A questionnaire was mailed to selected Texas community pharmacies. The instrument was developed by the researcher and reviewed by the Texas Medicaid Vendor Drug Program staff. The University of Texas, Office of Survey Research collected the data in September and October of 2011 by mail and online. The data were forwarded to the researcher for analyses. A total of 788 identified community pharmacies were mailed a packet containing 3 questionnaires to be completed by the pharmacist-in-charge, a staff pharmacist, and a pharmacy technician. There were 2 mailings of the questionnaire packet and follow-up telephone calls to nonrespondents. RESULTS: A total of 653 questionnaires were completed and returned from 288 community pharmacies (36.7%) out of 788 pharmacies that were mailed the questionnaire packets. A total of 368 (57.5%) completed questionnaires came from chain store pharmacy respondents and 272 (42.5%) questionnaires from independent pharmacy respondents. A total of 21.3% (n = 134) of the respondents indicated that they were not aware of the federal and state requirement to dispense a 72-hour emergency supply of a prescription drug to Medicaid patients when prior authorization (PA) is not available. A greater proportion of the chain store respondents (26.6%) were unaware of the requirement compared with the independent pharmacy respondents (14.3%). A total of 77.7% of the respondents estimated that they make the decision of providing or not providing a 72-hour emergency supply of medication 6 or fewer times a month. A total of 14.6% indicated that they make the decision 6 to 11 times a month, and 7.7% make the decision more than 11 times a month. When asked how often respondents had seen a 72-hour emergency prescription not being dispensed for Texas Medicaid recipients when PA was not available, 49.1% answered "never"; however, 30.0% indicated once or twice a month, 16.5% indicated from 1 to 5 times a week, and another 4.5% indicated more than 5 times a week. The top 2 reasons for not dispensing a 72 hour-emergency drug supply were: "Reluctant to open a new 'unit-of-use' container (especially 30-day supply bottles)" and "The Rx will most likely be changed with the PA call, so why dispense a 72-hour supply of the originally prescribed drug?" The top categories of 72-hour emergency prescription drug products that respondents would "likely" dispense were antibiotics; inhaler canisters; products for nausea/vomiting, cough, and cold; antiseizure agents; and diabetic treatment products. CONCLUSIONS: The results show that there are many factors why pharmacists do not provide 72-hour emergency medications when PA is unavailable. The lack of awareness of the federal and state requirements was significantly related to the frequency of 72-hour medications not being dispensed. In addition, other factors inhibiting the process were the pharmacists' inability to reach physicians or the lack of cooperation with physicians, prescriptions for controlled substances, drug-packing limitations, and the financial risk involved with dispensing a 72-hour supply.

Comparison of the claim percent gross margin earned by Texas community independent pharmacies for dual-eligible beneficiary claims before and after Medicare Part D.

OBJECTIVES: To describe dual eligibles' claims before and after Medicare Part D and to evaluate the effect that Medicare Part D has had on the claim percent gross margin (CPGM) earned by Texas community independent pharmacies. DESIGN: Nonexperimental time series study. SETTING: Texas, October 2005 through September 2006. PARTICIPANTS: 313 community independent pharmacies. INTERVENTION: Review of more than 150,000 Medicaid and 300,000 Medicare Part D claims acquired from a drug claims processor. MAIN OUTCOME MEASURES: CPGM per prescription claim before and after the implementation of Medicare Part D, controlling for generic/brand drug status. RESULTS: The mean CPGM for prescriptions dispensed before Part D (Medicaid claims) was 26.7%. The mean CPGM for claims dispensed after Part D (Medicare claims) was 17.0% (using ingredient costs in 2006 dollars) or 20.4% (using ingredient costs adjusted to 2005 dollars), a reduction of 36.3% and 23.6%, respectively. Under both Medicaid and Part D, pharmacies earned higher margins for generic drugs (39.9% and 29.5%, respectively) than for brand-name drugs (8.7% and 8.3%, respectively). CONCLUSION: These results support community pharmacy assertions of lower reimbursements from Part D payers compared with Medicaid payers. Based on these results, pharmacies can respond to this evolving environment by carefully reviewing their Part D plans' impact on CPGM and taking available steps to increase the proportion of generic drugs dispensed to Medicare beneficiaries.

Extended-release, once-daily morphine (Avinza) for the treatment of chronic nonmalignant pain: effect on pain, depressive symptoms, and cognition.

OBJECTIVE: To evaluate the impact of an extended-release, once-daily morphine sulfate formulation on depressive symptoms and neurocognition in patients with chronic nonmalignant pain. DESIGN: Prospective, open-label, one-group trial with a pretest-posttest design. SETTING: Outpatient pain management clinic. PATIENTS AND INTERVENTION: Chronic nonmalignant pain patients inadequately controlled with short-acting opioid analgesics and eligible for treatment with once-daily morphine sulfate were initiated on a dose at or near the morphine-equivalent dose of the short-acting regimen. OUTCOMES: The following assessments were made at baseline and 4 weeks after initiating intervention: pain intensity, pain unpleasantness, pain suffering, pain behaviors, Beck Depression Inventory, and cognitive function. RESULTS: Eighty-four patients provided usable data. Pain intensity, unpleasantness, and suffering scores were significantly reduced at follow-up (P = 0.001). The mean Beck Depression Inventory scores were significantly lower at follow-up (P = 0.001). Significant improvements were seen in scores at follow-up on the three validated neurocognitive tests: the digit span test, the digit symbol substitution test, and the paced auditory serial addition test (P = 0.001). CONCLUSIONS: Achieving adequate pain control with once-daily morphine was associated with a reduction in pain and improvements in depressive symptoms and cognitive functioning in the short term.

Use of a diagnosis-based risk adjustment model to estimate costs of indigent care in a community at Medicaid reimbursement rates.

OBJECTIVES: This study used a diagnosis-based risk adjustment model to estimate the annual costs of uninsured patients in Austin, Texas, and describe the prevalence and costs of their chronic conditions. The data were supplied by the Indigent Care Collaboration, a partnership of local safety-net hospitals and clinics. METHODS: This study used the Diagnostic Cost Groups prospective Medicaid All-Encounters model, which uses diagnoses, age and gender to assign relative risk scores to patients. The relative risk scores were multiplied by the per capita Texas Medicaid expenditure to obtain estimated annual costs. Chronic diseases were described in terms of prevalence and total estimated annual cost. RESULTS: A total of 471,194 encounters were recorded for 163,729 patients meeting the study inclusion criteria between the 1st March 2004 and the 28th February 2005. The mean estimated patient yearly cost was US $1,307, and the total estimated yearly population cost was $228,909,529. The most common chronic conditions included hypertension, diabetes, depression, substance abuse, pregnancy, asthma, chronic obstructive pulmonary disease and congestive heart failure. CONCLUSIONS: This study demonstrates how the unknown costs associated with caring for indigent uninsured patients in a community can be estimated at Medicaid reimbursement rates using the Diagnostic Cost Group model on aggregated patient encounter data.

Comparison of mail-order with community pharmacy in plan sponsor cost and member cost in two large pharmacy benefit plans.

BACKGROUND: Pharmacy benefit managers (PBMs) play a major role in administering prescription drug benefit programs for health plans and employers. PBMs have often encouraged the use of self-owned mail-order pharmacy services with the promise to plan sponsors of lower prescription drug costs compared with those of the community pharmacy network. Some plan sponsors have requested a higher degree of disclosure of contract relationships and transparency in pricing. Unfortunately, little research exists based on empirical data to determine the net plan cost and member cost for mail-order drugs, as opposed to having these drugs dispensed by community pharmacies. OBJECTIVES: To determine the difference between mail-order and community pharmacy in the (1) payment (cost) per day of drug therapy for the plan sponsor and for the member for the highest expenditure therapeutic classes, (2) generic dispensing ratios for all drugs and for a comparative market basket of drugs, and (3) cost per unit for the top 20 generic drugs dispensed through the mail-order channel. METHODS: Pharmacy claim records were obtained from 2 publicly financed pharmacy benefit plans in Texas for fiscal year 2004 (September 1, 2003, through August 31, 2004). There were approximately 460,000 members in Plan A and 177,000 members in Plan B. Pharmacy cost per day (product costs plus dispensing fees, divided by days supply) was calculated for each drug in the 30 highest expenditure therapeutic categories and aggregated for mail-order and community pharmacy channels for each plan. Differences in the mail-order and community pharmacy cost per day were calculated for each drug (adjusted for dosage) in the therapeutic category and weighted by the product's share of mail-order therapy days within the therapeutic category. A weighted cost per day for each therapeutic category was calculated with a comparison of what the cost would have been for plan cost and member cost if all mail claims had been paid based on the community pharmacy cost per day. Comparison of the cost per day helped control for differences in quantity dispensed per day per product and for product mix within each therapeutic category. Descriptive analyses were conducted to compare generic dispensing ratios between (1) all mail-order and community pharmacy claims, and (2) a market basket of therapeutic categories most commonly found within the mail-order channel. Finally, the difference in price per unit was calculated between mail-order and community pharmacy channels for the top 20 generic drug products. RESULTS: Mail-order drugs accounted for 34.4% of overall pharmacy benefit spending, including plan cost and member cost, in Plan A and 43.4% for the market basket of drugs compared with 56.0% of overall spending and 63.1% for the market basket in Plan B. When comparing the cost per day for the top therapeutic categories, the authors found the plan sponsor cost was higher for mail-order than for the community pharmacy channel for approximately half of the top therapeutic categories. This result contributed to a 0.5% higher plan cost per day for mail-order ($1.24) than for community pharmacy ($1.23) for Plan A but a 0.4% lower plan cost per day for Plan B ($1.43 for mail-order vs. $1.44 for community pharmacy). The member cost was lower for mail-order than for community pharmacy for almost every therapeutic category, and overall was 29% lower in Plan A ($0.73 per day for mail-order vs. $1.03 for community pharmacy) and 37% lower in Plan B ($0.52 for mail-order vs. $0.82 for community pharmacy). For all claims, the generic dispensing ratios were lower in the mail-order channel than in the community pharmacy channel (37.7% vs. 49.0% for Plan A and 34.7% vs. 45.0% for Plan B). The cost per unit (tablet, capsule, etc.) for the top 20 generic drug products dispensed by mail order was 16.5% lower than community pharmacy for the plan sponsor in Plan A but 18.0% higher in Plan B; member cost was 29.9% lower in Plan A for mail order and 34.0% lower in Plan B. Comparing plan and member costs combined, 9 of 20 (45%) of the generic prices were higher through mail order in Plan A, and 10 of 20 (50%) were higher through mail order in Plan B. CONCLUSIONS: Overall, savings from lower unit pricing through the mail-order channel benefited the member and did not translate into significant cost reductions for the plan sponsor. In both pharmacy benefit plans, the plan sponsor either realized small savings or incurred slightly higher costs when paying for drugs in the top therapeutic categories through the mail-order channel. Some generic drug prices are higher through mail-order pharmacy than through community pharmacy, and 1 of the 2 plans in this study paid higher net costs after member cost share for generic drugs through mail order.

Product-line extensions and pricing strategies of brand-name drugs facing patent expiration.

OBJECTIVE: This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. METHODS: The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, and American Druggist, respectively. Market success was defined as whether an original drug brand was listed in the top 100 prescriptions most frequently dispensed before facing generic entry. Product-line extension was defined as the appearance of another product that a company introduces within the same market after its existing product. Drug prices were average wholesale prices from the Drug Topics Red Book. The relationship between product-line extension and market success was examined using a logistic regression analysis. The price rigidity to entry was tested using a panel regression analysis. RESULTS: A total of 27 drug brands lost their patents between 1987 and 1992. Drug brands that achieved market success were 16 times more likely to be extended than were those that did not (OR=16, 95% confidence interval, 2.12-120.65). The price rigidity to entry existed in drug brands with extensions (beta=2.65%, P <0.033), but not in those brands without extensions (beta=-2.40%, P <0.001). CONCLUSION: This study provided some support for the alternative explanation to brand loyalty that a new product-line extension introduced for an original brand helps the original price be rigid despite the entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act.

Family support and diet barriers among older Hispanic adults with type 2 diabetes.

BACKGROUND AND OBJECTIVES: Diet plays an important role in the management of diabetes, and a suboptimal diet is a commonly identified problem. Family support may be important in overcoming barriers to good diet. We conducted this study to examine the role of the family in overcoming barriers to diet self-care among older Hispanic patients with diabetes. METHODS: We performed a cross-sectional survey of 138 older Hispanic adults seeking care at an outpatient university clinic. Patients reported on their perception of family functioning, family support for diet, and barriers to diet self-care. RESULTS: Level of family functioning was related to family support for diet self-care, and family support for diet was related to perceived barriers to diet self-care. Scores for family support were higher for those who perceived their family as functional compared to those who perceived their family as mildly dysfunctional or dysfunctional. As family support for diet increased, perceived barriers to diet self-care decreased. CONCLUSIONS: To fully understand difficulties encountered by older Hispanic adults with adherence to a diabetic diet, primary care physicians should explore the role of family support and family functioning. For those with poorly functioning families or low levels of family support, family-level interventions may need to be considered.

Family support, diet, and exercise among older Mexican Americans with type 2 diabetes.

PURPOSE: The purpose of this study was to examine the relationship between diabetes-specific family support and other psychosocial factors with regard to diet and exercise self-care behavior among older Mexican Americans with type 2 diabetes. METHODS: Adults aged 55 years and older who presented for care in a primary care clinic for type 2 diabetes (N=138) completed a survey to assess family support specific to diabetes, barriers to self-management, self-efficacy, and diabetes self-care activities. Multivariate regression analyses were conducted to evaluate the relationship between family support and self-care activities for diet and exercise. RESULTS: Higher levels of perceived family support and greater self-efficacy were associated with higher reported levels of diet and exercise self-care. As the barriers to exercise increased, the levels of exercise self-care decreased. Living with family members (more than just a spouse or significant other) was associated with higher levels of diet self-care, as was older age. CONCLUSIONS: Family behavior is associated with diet and exercise self-care. Diabetes educators and healthcare providers should consider involving the entire family in the management of older patients with type 2 diabetes. Interventions designed to improve diabetes self-management should address family support specific to diabetes, self-efficacy, and barriers to self-care.

Provision of pharmacy services in community health centers and migrant health centers.

OBJECTIVES: To assess the frequency with which pharmacy services are provided in community health centers (CHCs) and migrant health centers (MHCs), the importance of these services in these settings, and pharmacists' preparedness to provide these services and to determine whether pharmacist- and site-specific characteristics are related to the provision of pharmacy services. DESIGN: A self-administered mail survey was used to collect information on the provision of traditional pharmacy services and on the provision of pharmaceutical care services in four domains: collecting, organizing, and evaluating information; formulating a course of action; providing medications and counseling patients; and monitoring and managing patient outcomes. Data were also gathered on pharmacist- and site-specific characteristics. Descriptive and inferential statistics were calculated. PARTICIPANTS AND SETTING: Surveys were mailed to a sample of 1,260 contact persons (medical/executive directors and pharmacists). MAIN OUTCOME MEASURES: Pharmacist-reported frequency of the provision of pharmacy services, respondents' perceptions regarding the importance of the provision of pharmacy services, and respondents' perceived level of preparedness to provide pharmacy services. RESULTS: Pharmacists in CHCs and MHCs provided traditional services very often, felt that the services were important, and felt very prepared to provide the services. Although frequency and perceived importance and preparedness varied across and within the four pharmaceutical care domains, pharmacists most often reported collecting, organizing, and evaluating information and providing medications and counseling patients. Least often reported was formulating a course of action, followed by monitoring and managing patient outcomes. Similarly, pharmacists felt least prepared to provide these services. Pharmacists who had received additional education and training reported that they provided pharmacy services significantly more often (P < .05) and felt significantly more prepared to provide the services. CONCLUSION: Additional pharmacy-related education and training may be helpful in preparing pharmacists in CHCs and MHCs to increase their provision of pharmaceutical care services.

Secretin treatment for autistic disorder: a critical analysis.

We assessed evidence of the effects of secretin on behavior in individuals with autistic disorder. Articles were obtained through a MEDLINE search of the English-language literature from January 1966-November 2001; all investigations and case reports on the topic were included. Press releases obtained from the World Wide Web also were included. Secretin, a gastrointestinal hormone, is suggested to improve autistic symptoms, particularly social function and communication. Two formulations, porcine and synthetic human secretin, were evaluated in humans. A small body of literature and popular belief in autistic disorder communities supported the agent's efficacy. A number of controlled clinical trials did not show improvement in autistic symptoms with secretin compared with placebo, possibly indicating no role for the drug in autistic disorder.

Relationship between direct-to-consumer advertising and physician diagnosing and prescribing.

The relationships between direct-to-consumer advertising expenditures and the monthly frequencies of diagnoses and prescriptions written associated with the products advertised are examined. The analyses utilized quasi-experimental time-series techniques. Data from the National Ambulatory Medical Care Survey and Competitive Media Reporting were used to calculate monthly levels of the dependent and independent variables. The dependent variables included monthly frequencies of diagnoses for the products' FDA-approved indications, medications prescribed within the advertised pharmaceutical class, and medications prescribed for the specific advertised agent. The independent variables included monthly expenditures for advertising each pharmaceutical class and each specific agent. Several significant monthly relationships were found. The diagnoses of hyperlipidemia (p = 0.008) and the number of prescriptions written for antilipemics (p = 0.003) were positively associated with the advertising expenditure for antilipemics. The number of prescriptions written for Claritin (p = 0.004) and Zocor (p < 0.001) was positively related to the advertising expenditure for their respective pharmaceutical classes; the amount of prescriptions written for Hismanal (p = 0.007), Seldane (p < 0.001), and Zantac (p = 0.004) was negatively related to the advertising expenditure for their respective pharmaceutical classes. The number of prescriptions written for Claritin (p = 0.005) and Zocor (p < 0.001) was positively related to the advertising expenditure for each specific product; the amount of prescriptions written for Hismanal (p = 0.049) was negatively associated with the amount of money spent specifically advertising the agent. No significant associations were found in antihypertensive drugs and drugs to treat benign prostatic hypertrophy. The results of the analyses suggest that the direct-to-consumer advertising expenditure is associated with physician diagnosing and physician prescribing for certain drugs and drug classes.

Analysis of the movement of prescription drugs to over-the-counter status.

BACKGROUND: The transition of prescription drugs (Rx) to over-the-counter (OTC) status is a very complex and multifaceted process involving many parties and many issues. This article examines the regulatory history and process and presents a review of the issues involved, using recent Rx-to-OTC conversions as examples. FINDINGS: Data are presented on the growth of the OTC market and the impact recently switched products have had on this market growth. Drug product characteristics that make drug products amenable to OTC conversion are described. Reasons are presented for why more and more prescription drug products are being reviewed as candidates for OTC conversion. A list of high-profile Rx-to-OTC products is provided, along with a discussion of new proposals for OTC conversions and those products that have not been approved for OTC conversion. CONCLUSION: Conversion of prescription products to over-the-counter availability can have an impact on prescription-drug-benefit costs and on total health care costs. There are opportunities and limitations for managed care organizations in the coverage and promotion of OTC products as therapeutic alternatives to prescription-only drugs.