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Archive for the ‘prescription drugs’ Category

New From the GAO

November 24, 2014 Comments off

New GAO Reports
Source: Government Accountability Office
1. Group Purchasing Organizations: Funding Structure Has Potential Implications for Medicare Costs. GAO-15-13, October 24.
http://www.gao.gov/products/GAO-15-13
Highlights – http://www.gao.gov/assets/670/666643.pdf

2. Medicare Program Integrity: CMS Pursues Many Practices to Address Prescription Drug Fraud, Waste, and Abuse. GAO-15-66, October 24.
http://www.gao.gov/products/GAO-15-66
Highlights – http://www.gao.gov/assets/670/666648.pdf

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Pharma Pays $825 Million to Doctors and Hospitals, ACA’s Sunshine Act Reveals

November 24, 2014 Comments off

Pharma Pays $825 Million to Doctors and Hospitals, ACA’s Sunshine Act Reveals
Source: Brookings Institution

A not so well-known provision of the Affordable Care Act is the Sunshine Act. The purpose of this act is to increase the transparency in the health care market by requiring doctors, hospitals, pharmaceutical companies, and medical device manufacturers to disclose their financial relationships. Mandated by the Sunshine Act, on September 30th, Centers for Medicare and Medicaid Services (CMS) publicly released the first set of data, under the Open Payments title. This data includes $3.5 billion paid to over half a million doctors and teaching hospitals in the last five months of 2013.

A subset of Open Payments data that is individually identifiable includes two categories of payments. The first category are the payments that are made for other reasons such as travel reimbursement, royalties, speaking and consulting fees and the second are payments which are made as research grants. These datasets together include more than 2.3 million financial transactions which amount to a total of more than $825 million.

Harms of prescription opioid use in the United States

November 21, 2014 Comments off

Harms of prescription opioid use in the United States
Source: Substance Abuse Treatment, Prevention, and Policy

Background
Consumption levels of prescription opioids (POs) have increased substantially worldwide, particularly the United States. An emerging perspective implicates increasing consumption levels of POs as the primary system level driving factor behind the observed PO-related harms. As such, the present study aimed to assess the correlations between consumption levels of POs and PO-related harms, including non-medical prescription opioid use (NMPOU), PO-related morbidity and PO-related mortality.

Findings:
Pearson’s product-moment correlations were computed using published data from the United States (2001 – 2010). Consumption levels of POs were extracted from the technical reports published by the International Narcotics Control Board, while data for NMPOU was utilized from the National Survey on Drug Use and Health. Additionally, data for PO-related morbidity (substance abuse treatment admissions per 10,000 people) and PO-related mortality (PO overdose deaths per 100,000 people) were obtained from published studies. Consumption levels of POs were significantly correlated with prevalence of NMPOU in the past month (r =0.741, 95% CI =0.208-0.935), past year (r =0.638, 95% CI =0.014-0.904) and lifetime (r =0.753, 95% CI =0.235-0.938), as well as average number of days per person per year of NMPOU among the general population (r =0.900, 95% CI =0.625-0.976) and NMPOU users (r =0.720, 95% CI =0.165-0.929). Similar results were also obtained for PO-related morbidity and PO-related mortality measures.

Conclusion
These findings suggest that reducing consumption levels of POs at the population level may be an effective strategy to limit PO-related harms.

High-Cost Generic Drugs — Implications for Patients and Policymakers

November 18, 2014 Comments off

High-Cost Generic Drugs — Implications for Patients and Policymakers
Source: New England Journal of Medicine

It is well known that new brand-name drugs are often expensive, but U.S. health care is also witnessing a lesser-known but growing and seemingly paradoxical phenomenon: certain older drugs, many of which are generic and not protected by patents or market exclusivity, are now also extremely expensive. Take the case of albendazole, a broad-spectrum antiparasitic medication. Albendazole was first marketed by a corporate predecessor to GlaxoSmithKline (GSK) outside the United States in 1982 and was approved by the Food and Drug Administration (FDA) in 1996. Its patents have long since expired, but no manufacturer ever sought FDA approval for a generic version. One reason may be that the primary indications for the drug — intestinal parasites, neurocysticercosis, and hydatid disease — occur relatively rarely in the United States and usually only in disadvantaged populations such as immigrants and refugees. In late 2010, the listed average wholesale price (AWP) for albendazole was $5.92 per typical daily dose in the United States and less than $1 per typical daily dose overseas.

By 2013, the listed AWP for albendazole had increased to $119.58 per typical daily dose.1 We found that at some pharmacies in Minnesota, an uninsured patient requiring 6 months of treatment would have faced costs amounting to tens of thousands of dollars.1 Although the AWP may not reflect the actual cost of the product, Medicaid data show that spending on albendazole increased from less than $100,000 per year in 2008, when the average cost was $36.10 per prescription, to more than $7.5 million in 2013, when the average cost was $241.30 per prescription (see graph).

The albendazole story is not unique. According to the National Average Drug Acquisition Cost pricing file, the price of captopril (12.5 mg), which is used for hypertension and heart failure, increased by more than 2800% between November 2012 and November 2013, from 1.4 cents to 39.9 cents per pill. Similarly, the price of clomipramine (25 mg), a long-established tricyclic antidepressant also used for obsessive–compulsive disorder, increased from 22 cents to $8.32 per pill, and the price of doxycycline hyclate (100 mg), a broad-spectrum antibiotic that has been around since 1967, increased from 6.3 cents to $3.36 per pill.2

Yet many of these drugs remain key therapeutic tools. The number of prescriptions for albendazole has increased dramatically, in part because the drug has increasingly been used to treat parasitic infections in refugees. The Centers for Disease Control and Prevention recommends presumptive treatment of refugees arriving in the United States if they have not had prior treatment. Because the people who need albendazole are generally disadvantaged, the costs resulting from the enhanced demand and associated price increases are largely borne by the patients themselves through substantial out-of-pocket payments or by taxpayers through public insurers such as Medicaid and the Refugee Medical Assistance program.

Antimicrobial Resistance: A Problem Without Borders (2014)

November 13, 2014 Comments off

Antimicrobial Resistance: A Problem Without Borders (2014)
Source: Institute of Medicine

The Centers for Disease Control and Prevention identified antimicrobial resistance as one of five urgent health threats facing the United States this year. Antimicrobial resistance is a global health security threat that will demand collaboration from many stakeholders around the world. This report highlights the crosscutting character of antimicrobial resistance and the needs for many disciplines to be brought together to be able to deal with it more effectively.

New From the GAO

November 10, 2014 Comments off

New GAO Reports
Source: Government Accountability Office

1. Compounded Drugs: Payment Practices Vary across Public Programs and Private Insurers, and Medicare Part B Policy Should Be Clarified. GAO-15-85, October 10.
http://www.gao.gov/products/GAO-15-85
Highlights – http://www.gao.gov/assets/670/666463.pdf

2. Financial Audit: Bureau of the Fiscal Service’s Fiscal Years 2014 and 2013 Schedules of Federal Debt. GAO-15-157, November 10.
http://www.gao.gov/products/GAO-15-157

Potential Antidepressant Overtreatment Associated with Office Use of Brief Depression Symptom Measures

November 4, 2014 Comments off

Potential Antidepressant Overtreatment Associated with Office Use of Brief Depression Symptom Measures
Source: Journal of the American Board of Family Medicine

Background:
Use of brief depression symptom measures for identifying or screening cases may help to address depression undertreatment, but whether it also leads to diagnosis and treatment of patients with few or no symptoms—a group unlikely to have major depression or benefit from antidepressants—is unknown. We examined the associations of use of a brief depression symptom measure with depression diagnosis and antidepressant recommendation and prescription among patients with few or no depression symptoms.

Methods:
We conducted exploratory observational analyses of data from a randomized trial of depression engagement interventions conducted in primary care offices in California. Analyses focused on participants scoring <10 on a study-administered 9-item Patient Health Questionnaire (PHQ-9) (completed immediately before an office visit and not disclosed to the provider) with complete chart review data (n = 595). We reviewed visit notes for evidence of practice administration of a brief symptom measure (independent of the trial) and whether the provider (1) diagnosed depression or (2) recommended and/or prescribed an antidepressant.

Results:
Among the 545 patients without a practice-administered measure, 57 (10.5%) had a visit diagnosis of depression; 9 (1.6%) were recommended and another 21 (3.8%) prescribed an antidepressant. Among the 50 patients (8.4% of total sample) with a practice-administered measure, 10 (20%) had a visit diagnosis of depression; 6 (12%) were recommended and another 6 (12%) prescribed an antidepressant. Adjusting for nesting within providers, trial intervention, stratification variables, and sample weighting, use of a brief symptom measure was associated with depression diagnosis (adjusted odds ratio, 3.2; 95% confidence interval, 1.1–9.2) and antidepressant recommendation and/or prescription (adjusted odds ratio, 3.80; 95% confidence interval, 1.0–13.9). Analyses using progressively lower PHQ-9 thresholds (<9 to <5) and examining antidepressant prescription alone yielded consistent findings. Analyses by practice-administered measure (PHQ-9 vs PHQ-2) indicated the study findings were largely associated with PHQ-9 use.

Conclusions:
These exploratory findings suggest administration of brief depression symptom measures, particularly the PHQ-9, may be associated with depression diagnosis and antidepressant recommendation and prescription among patients unlikely to have major depression. If these findings are confirmed, researchers should investigate the balance of benefits and risks (eg, overdiagnosis of depression and overtreatment with antidepressants) associated with use of a brief symptom measure.

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