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Archive for the ‘prescription drugs’ Category

Ethical pharmaceutical promotion and communications worldwide: codes and regulations

April 15, 2014 Comments off

Ethical pharmaceutical promotion and communications worldwide: codes and regulations
Source: Philosophy, Ethics, and Humanities in Medicine

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.

Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.

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FDA approves new hand-held auto-injector to reverse opioid overdose

April 4, 2014 Comments off

FDA approves new hand-held auto-injector to reverse opioid overdose
Source: U.S Food and Drug Administration

The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.

It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

Brand-Name and Generic Prescription Drug Use After Adoption of a Full-Replacement, Consumer-Directed Health Plan With a Health Savings Account

April 2, 2014 Comments off

Brand-Name and Generic Prescription Drug Use After Adoption of a Full-Replacement, Consumer-Directed Health Plan With a Health Savings Account (PDF)
Source: Employee Benefit Research institute

+ A full-replacement HSA plan was associated with a 4.7 percentage-point rise in the generic-drug dispensing rate (GDR) after one year, and settled 3.4 percentage points higher after four years. The GDR for maintenance medications experienced a similar effect, while for nonmaintenance conditions the GDR rose by 4.1 percentage points after one year, but was just 1.7 percentage points higher after four years.

+ At the end of the four-year follow-up period, GDR was greater by 4.5 percentage points for hypertension, 15.4 per-centage points for dyslipidemia, and 7.8 percentage points for asthma/COPD. No significant effects were detected for diabetes GDR, but the measure for depression was lower by 8.4 percentage points after 2010.

+ GDR increases were due to individuals discontinuing use of brand-name drugs without substituting generic therapy. After one year under the full-replacement HSA plan, 0.43 fewer generic and 0.95 fewer brand-name prescriptions were filled, on average.

Bupropion XL use in comorbidity of depression and restless leg syndrome: a case report

April 2, 2014 Comments off

Bupropion XL use in comorbidity of depression and restless leg syndrome: a case report (PDF)
Source: Bulletin of Clinical Psychopharmacology

Restless leg syndrome (RLS) is a sensorimotor disorder with symptoms including uncomfortable subjective sensations in the legs and the urge to move them. This common disorder affects 10% of the population and may reduce quality of life. The pathophysiology of RLS is not well understood but dysfunction of dopaminergic pathways is the most prominent theory. Antidepressants, especially SSRIs, can aggravate the symptoms of RLS. Here we present a 42 year old woman diagnosed with major depressive disorder and comorbid RLS and who had been treated with paroxetine 20 mg/day for 2 months who benefited from switching to bupropion treatment. In this case the RLS symptoms had existed for approximately 3 years but were milder before paroxetine treatment. The patient met the diagnostic criteria for RLS. We used the International Restless Legs Scale (IRLS) and Montgomery-Asperg Depression Rating Scale (MADRS) to measure the patient’s symptom severity. The severity of her depressive symptoms was similar to baseline despite the two month paroxetine treatment. Due to symptoms of RLS and her ongoing depressive complaints, we decided to switch from paroxetine to bupropion. With 150 mg/day bupropion XL treatment, her RLS symptoms improved substantially at a one month follow-up while her depression severity was not changed significantly. Due to inadequate response for depression, bupropion XL was titrated to 300 mg/day. Her depressive symptoms improved significantly at a further one month follow-up. Comorbidity of RLS and depression was found to be as a frequent occurence reported in the literature. We concluded that bupropion, as a selective noradrenergic-dopaminergic reuptake inhibitor can be a good alternative to the SSRIs for patients, who suffer from both depression and RLS.

The Structural Genomics Consortium: A knowledge platform for drug discovery

March 27, 2014 Comments off

The Structural Genomics Consortium: A knowledge platform for drug discovery
Source: RAND Corporation

The Structural Genomics Consortium (SGC) supports drug discovery efforts through a unique, open access model of public-private collaboration. This report presents the results of an independent evaluation of the Structural Genomics Consortium, conducted by RAND Europe with the Institute on Governance. The evaluation aimed to establish the role of the SGC within the wider drug discovery and public-private partnership (PPP) landscape, assessing the merits of the SGC open access model relative to alternative models of funding R&D in this space, as well as the key trends and opportunities in the external environment that may impact on the future of the SGC. It also established the incentives and disincentives for investment, strengths and weaknesses of the SGC’s model, and the opportunities and threats the SGC will face in the future. This enabled us to assess the most convincing arguments for funding the SGC at present; important trade-offs or limitations that should be addressed in moving towards the next funding phase; and whether funders are anticipating changes either to the SGC or the wider PPP landscape. Finally, we undertook a quantitative analysis to ascertain what judgements can be made about the SGC’s past and current performance track record, before unpacking the role of the external environment and particular actors within the SGC in developing scenarios for the future.

Top 100 Selling Drugs of 2013

March 25, 2014 Comments off

Top 100 Selling Drugs of 2013
Source: Medscape

Hypothyroid medication levothyroxine (Synthroid, AbbVie) was the nation’s most prescribed drug in 2013, whereas the antipsychotic aripiprazole (Abilify, Otsuka Pharmaceutical) had the highest sales, at nearly $6.5 billion, according to a new report from research firm IMS Health on the top 100 selling drugs in the United States.

Following levothyroxine as most prescribed were the cholesterol-lowering drug rosuvastatin (Crestor, AstraZeneca), the proton-pump inhibitor esomeprazole (Nexium, AstraZeneca), and the antidepressant duloxetine (Cymbalta, Eli Lilly).

Rounding out the top 10 most prescribed drugs in 2013 (in order) were the asthma drugs albuterol (Ventolin, HFA) and fluticasone propionate/salmeterol (Advair Diskus, GlaxoSmithKline), the antihypertensive valsartan (Diovan, Novartis), the attention deficit drug lisdexamfetamine dimesylate (Vyvanse, Shire), the antiepileptic pregabalin (Lyrica, Pfizer), and the chronic obstructive pulmonary disease drug tiotropium bromide (Spiriva, Boehringer Ingelheim).

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The Miracle Drugs: Hormone Replacement Therapy and Labor Market Behavior of Middle-Aged Women

March 20, 2014 Comments off

The Miracle Drugs: Hormone Replacement Therapy and Labor Market Behavior of Middle-Aged Women (PDF)
Source: Institute for the Study of Labor

In an aging society, determining which factors contribute to the employment of older individuals is increasingly important. We examine the impact of medical innovations on the employment of middle-aged women focusing on the specific case of Hormone Replacement Therapy (HRT), a common treatment for the alleviation of negative menopausal symptoms. HRT medications were among the most popular prescriptions in the United States until 2002 when the Women’s Health Initiative Study – the largest randomized control trial on women ever undertaken – documented the health risks associated with their long term use. We exploit the release of these findings within a Fixed Effect Instrumental Variable framework to address the endogeneity in HRT use. Our results indicate substantial benefits of HRT use to the short-term employment of middle-aged women.

Potential Therapeutic Competition in Community-Living Older Adults in the U.S.: Use of Medications That May Adversely Affect a Coexisting Condition

March 18, 2014 Comments off

Potential Therapeutic Competition in Community-Living Older Adults in the U.S.: Use of Medications That May Adversely Affect a Coexisting Condition
Source: PLoS ONE

Objective
The 75% of older adults with multiple chronic conditions are at risk of therapeutic competition (i.e. treatment for one condition may adversely affect a coexisting condition). The objective was to determine the prevalence of potential therapeutic competition in community-living older adults.

Methods
Cross-sectional descriptive study of a representative sample of 5,815 community-living adults 65 and older in the U.S, enrolled 2007–2009. The 14 most common chronic conditions treated with at least one medication were ascertained from Medicare claims. Medication classes recommended in national disease guidelines for these conditions and used by ≥2% of participants were identified from in-person interviews conducted 2008–2010. Criteria for potential therapeutic competition included: 1), well-acknowledged adverse medication effect; 2) mention in disease guidelines; or 3) report in a systematic review or two studies published since 2000. Outcomes included prevalence of situations of potential therapeutic competition and frequency of use of the medication in individuals with and without the competing condition.

Results
Of 27 medication classes, 15 (55.5%) recommended for one study condition may adversely affect other study conditions. Among 91 possible pairs of study chronic conditions, 25 (27.5%) have at least one potential therapeutic competition. Among participants, 1,313 (22.6%) received at least one medication that may worsen a coexisting condition; 753 (13%) had multiple pairs of such competing conditions. For example, among 846 participants with hypertension and COPD, 16.2% used a nonselective beta-blocker. In only 6 of 37 cases (16.2%) of potential therapeutic competition were those with the competing condition less likely to receive the medication than those without the competing condition.

Conclusions
One fifth of older Americans receive medications that may adversely affect coexisting conditions. Determining clinical outcomes in these situations is a research and clinical priority. Effects on coexisting conditions should be considered when prescribing medications.

See: One in 5 older Americans take medications that work against each other (EurekAlert!)

Vital Signs: Improving Antibiotic Use Among Hospitalized Patients

March 6, 2014 Comments off

Vital Signs: Improving Antibiotic Use Among Hospitalized Patients
Source: Morbidity and Mortality Weekly Report (CDC)

Background:
Antibiotics are essential to effectively treat many hospitalized patients. However, when antibiotics are prescribed incorrectly, they offer little benefit to patients and potentially expose them to risks for complications, including Clostridium difficile infection (CDI) and antibiotic-resistant infections. Information is needed on the frequency of incorrect prescribing in hospitals and how improved prescribing will benefit patients.

Methods:
A national administrative database (MarketScan Hospital Drug Database) and CDC’s Emerging Infections Program (EIP) data were analyzed to assess the potential for improvement of inpatient antibiotic prescribing. Variability in days of therapy for selected antibiotics reported to the National Healthcare Safety Network (NHSN) antimicrobial use option was computed. The impact of reducing inpatient antibiotic exposure on incidence of CDI was modeled using data from two U.S. hospitals.

Results:
In 2010, 55.7% of patients discharged from 323 hospitals received antibiotics during their hospitalization. EIP reviewed patients’ records from 183 hospitals to describe inpatient antibiotic use; antibiotic prescribing potentially could be improved in 37.2% of the most common prescription scenarios reviewed. There were threefold differences in usage rates among 26 medical/surgical wards reporting to NHSN. Models estimate that the total direct and indirect effects from a 30% reduction in use of broad-spectrum antibiotics will result in a 26% reduction in CDI.

Conclusions:
Antibiotic prescribing for inpatients is common, and there is ample opportunity to improve use and patient safety by reducing incorrect antibiotic prescribing.

Implications for Public Health:
Hospital administrators and health-care providers can reduce potential harm and risk for antibiotic resistance by implementing formal programs to improve antibiotic prescribing in hospitals.

Less Than Half of Part D Sponsors Voluntarily Reported Data on Potential Fraud and Abuse

March 5, 2014 Comments off

Less Than Half of Part D Sponsors Voluntarily Reported Data on Potential Fraud and Abuse
Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY
In 2011, total expenditures for the Medicare Part D prescription drug program were $67.1 billion. CMS contracts with plan sponsors to provide Part D coverage to beneficiaries. The Office of Inspector General has recommended that CMS require sponsors to report data on potential fraud and abuse related to Part D to CMS. Rather than requiring these data, CMS encouraged sponsors to voluntarily report them beginning in 2010. This study provides information on the fraud and abuse data reported by sponsors and on whether CMS used these data to monitor or oversee the Part D program.

HOW WE DID THIS STUDY
We accessed CMS’s Healthcare Plan Management System to download data on potential fraud and abuse reported by Part D plan sponsors from 2010 through 2012. We also accessed CMS’s public files of Part D enrollment to determine the number of beneficiaries enrolled in Part D plans from 2010 through 2012. We reviewed the sponsors’ aggregate data to determine the number and percentage of sponsors that reported data on potential fraud and abuse each year. In addition, we surveyed CMS about its review and use of these reported data.

WHAT WE FOUND
More than half of Part D plan sponsors did not report data on potential fraud and abuse between 2010 and 2012. Of those sponsors that did report data, more than one-third did not identify any incidents for at least one of their reporting years. In total, sponsors reported identifying 64,135 incidents of potential fraud and abuse between 2010 and 2012. Sponsors’ identification of such incidents varied significantly, from 0 to almost 14,000 incidents a year. CMS requires sponsors to conduct inquiries and implement corrective actions in response to incidents of potential fraud and abuse; however, 28 percent of Part D plan sponsors reported performing none of these actions between 2010 and 2012. Although CMS reported that it conducted basic summary analyses of the data on potential fraud and abuse, it did not perform quality assurance checks on the data or use them to monitor or oversee the Part D program.

WHAT WE RECOMMEND
We recommend that CMS (1) amend regulations to require sponsors to report to CMS their identification of and response to potential fraud and abuse; (2) provide sponsors with specific guidelines on how to define and count incidents, related inquiries, and corrective actions; (3) review data to determine why certain sponsors reported especially high or low numbers of incidents, related inquiries, and corrective actions; and (4) share sponsors’ data on potential fraud and abuse with all sponsors and law enforcement. CMS did not concur with the first recommendation, partially concurred with the second and fourth recommendations, and concurred with the third recommendation.

Trends in Antidepressant Utilization and Expenditures in the U.S. Civilian Noninstitutionalized Population by Age, 2000 and 2010

March 5, 2014 Comments off

Trends in Antidepressant Utilization and Expenditures in the U.S. Civilian Noninstitutionalized Population by Age, 2000 and 2010
Source: Agency for Healthcare Research and Quality

Highlights

  • From 2000 to 2010, the number of people in the U.S. civilian noninstitutionalized population purchasing at least one outpatient prescription antidepressant increased for those ages 18-44, 45-64, and 65 and older. For those persons under age 18, there was no significant increase or decrease.
  • Comparing 2000 and 2010, the total number of outpatient prescription antidepressants purchased increased for those ages 18-44, 45-64, and 65 and older.
  • Comparing 2000 with 2010, for persons ages 18-44, 45-64, and 65 and older in the U.S. civilian noninstitutionalized population, the inflation adjusted total expense for antidepressants increased.
  • From 2000 to 2010, for people ages 45-64 the total number of people purchasing one or more prescribed antidepressant increased by 91.3 percent, the total number of antidepressants purchased increased by 107.4 percent, and total expense for antidepressants increased by 103.3 percent.
  • From 2000 to 2010, for persons age 65 and older, inflation adjusted total expense on antidepressants increased 125.6 percent and the number of antidepressants purchased increased 122.0 percent.

DoD OIG — Assessment of DoD Wounded Warrior Matters: Managing Risks of Multiple Medications

March 2, 2014 Comments off

Assessment of DoD Wounded Warrior Matters: Managing Risks of Multiple Medications
Source: U.S. Department of Defense, Office of Inspector General

We found that the Department of Defense did not have overarching policies and procedures to ensure consistent medication management and reconciliation practices in the Wounded Warrior population. The Services have adopted policies at various command levels; however, there is wide variance across the Services in the policies and standards for medication reconciliation.

Additionally, Wounded Warriors did not have a reliable, safe, accessible, and accountable method to dispose of medications that were no longer needed for treatment. As a result, Wounded Warriors may be at risk for overdose or misuse of unneeded medications that could result in unnecessary hospitalization and death.

New From the GAO

February 28, 2014 Comments off

New From the GAO
Source: Government Accountability Office

Reports

1. School Lunch: Implementing Nutrition Changes Was Challenging and Clarification of Oversight Requirements Is Needed. GAO-14-104, January 28.
http://www.gao.gov/products/GAO-14-104
Highlights - http://www.gao.gov/assets/670/660426.pdf

2. Defense Transportation: DOD Can Better Ensure That Federal Agencies Fully Reimburse for Using Military Aircraft. GAO-14-189, February 27.
http://www.gao.gov/products/GAO-14-189
Highlights - http://www.gao.gov/assets/670/661196.pdf

3. Electronic Health Records: VA and DOD Need to Support Cost and Schedule Claims, Develop Interoperability Plans, and Improve Collaboration. GAO-14-302, February 27.
http://www.gao.gov/products/GAO-14-302
Highlights - http://www.gao.gov/assets/670/661207.pdf

4. Financial Audit: U.S. Government’s Fiscal Years 2013 and 2012 Consolidated Financial Statements. GAO-14-319R, February 27.
http://www.gao.gov/products/GAO-14-319R

Testimonies

1. VA Vocational Rehabilitation and Employment: Further Program Management Improvements Are Needed, by Daniel Bertoni, director, education, workforce and income security, before the Subcommittee on Economic Opportunity, House Committee on Veterans’ Affairs. GAO-14-363T, February 27.
http://www.gao.gov/products/GAO-14-363T

2. Critical Infrastructure Protection: Observations on DHS Efforts to Identify, Prioritize, Assess, and Inspect Chemical Facilities, by Stephen L. Caldwell, director, homeland security and justice, before the Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies, House Committee on Homeland Security. GAO-14-365T, February 27.
http://www.gao.gov/products/GAO-14-365T
Highlights - http://www.gao.gov/assets/670/661180.pdf

3. Internet Pharmacies: Most Rogue Sites Operate from Abroad, and Many Sell Counterfeit Drugs, by Marcia Crosse, director, health care, before the Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce. GAO-14-386T, February 27.
http://www.gao.gov/products/GAO-14-386T
Highlights - http://www.gao.gov/assets/670/661178.pdf

4. Oil And Gas Management: Continued Attention to Interior’s Human Capital Challenges Is Needed, by Frank Rusco, director, natural resources and environment, before the Subcommittee on Energy and Mineral Resources, House Committee on Natural Resources. GAO-14-394T, February 27.
http://www.gao.gov/products/GAO-14-394T
Highlights - http://www.gao.gov/assets/670/661173.pdf

Press Release

1. U.S. Government’s 2013 Financial Report Reflects Continuing Financial Management and Fiscal Challenges. February 27.
http://www.gao.gov/press/challenges_governments2013financial_report.htm

FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs

February 21, 2014 Comments off

FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs
Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.

Factors Associated with Successful Discontinuation of Hormone Therapy

February 18, 2014 Comments off

Factors Associated with Successful Discontinuation of Hormone Therapy
Source: Journal of Women’s Health

Background:
Careful management of symptoms, particularly sleep and mood disturbances, may assist women in discontinuing hormone therapy (HT). We sought to describe characteristics associated with successful HT cessation in women who attempted to discontinue estrogen pills/patches with or without progestin.

Methods:
We invited 2,328 women, aged 45–70, enrolled January 1, 2005, to May 31, 2006, at Group Health in Washington State and Harvard Vanguard Medical Associates in Massachusetts, to participate in a telephone survey about HT practices. For the sample, we selected 2,090 women with estrogen dispensings (pharmacy data) during the study period, 200 women without HT dispensing after January 2005, and 240 women with no estrogen dispensings; 1,358 (58.3%) completed the survey. These analyses are based on survey responses.

Results:
Among 802 women who attempted HT discontinuation, the mean age was 50 years, 93% were postmenopausal, 90% were white, 30% had had a hysterectomy, and 75% experienced hot flashes after discontinuation. Those who did not succeed had greater trouble sleeping (74% vs. 57%) and mood disturbances (51% vs. 34%) than those who succeeded. In multivariable analyses, factors associated with successful discontinuation included doctor advice (odds ratio [OR] 2.62, 95% confidence interval [CI] 1.68–4.08), lack of symptom improvement (OR 4.21, CI 1.50–12.17), vaginal bleeding (OR 5.96, CI 1.44–24.6), and learning to cope with symptoms (OR 3.36, CI 2.21–5.11). Factors associated with unsuccessful HT discontinuation included trouble sleeping (OR 0.40, CI 0.26–0.61) and mood swings or depression (OR 0.63, CI 0.42–0.92).

Conclusions:
Doctor advice is strongly associated with successful HT discontinuation. Symptom management, particularly sleep and mood disturbances, may help women discontinue HT.

Technological Challenges in Antibiotic Discovery and Development: A Workshop Summary (2014)

February 12, 2014 Comments off

Technological Challenges in Antibiotic Discovery and Development: A Workshop Summary (2014)
Source: National Research Council

Technological Challenges in Antibiotic Discovery and Development is the summary of a workshop convened by the Chemical Sciences Roundtable in September 2013 to explore the current state of antibiotic discovery and examine the technology available to facilitate development. Through formal presentations and panel discussions, participants from academia, industry, federal research agencies discussed the technical challenges present and the incentives and disincentives industry faces in antibiotic development, and identified novel approaches to antibiotic discovery.

Antibiotic resistance is a serious and growing problem in modern medicine and it is emerging as a pre-eminent public health threat. Each year in the United States alone, at least two million acquire serious infections with bacteria that are resistant to one or more antibiotics, and at least 23,000 people die annually as a direct result of these antibiotic-resistant infections. In addition to the toll on human life, antibiotic-resistant infections add considerable and avoidable costs to the already overburdened U.S. health care system. This report explores the challenges in overcoming antibiotic resistance, screening for new antibiotics, and delivering them to the sites of infection in the body. The report also discusses a path forward to develop the next generation of potent antimicrobial compounds capable of once again tilting the battle against microbial pathogens in favor of humans. Technological Challenges in Antibiotic Discovery and Development gives a broad view of the landscape of antibiotic development and the technological challenges and barriers to be overcome.

New From the GAO

February 10, 2014 Comments off

New GAO Reports and Testimonies
Source: Government Accountability Office

Reports

1. Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability. GAO-14-194, February 10.
http://www.gao.gov/products/GAO-14-194
Highlights - http://www.gao.gov/assets/670/660787.pdf
Podcast - http://www.gao.gov/multimedia/podcasts/660638

2. Drinking Water: EPA Has Improved Its Unregulated Contaminant Monitoring Program, but Additional Action Is Needed. GAO-14-103, January 9.
http://www.gao.gov/products/GAO-14-103
Highlights - http://www.gao.gov/assets/670/660068.pdf

Testimony

1. Drug Shortages: Threat to Public Health Persists, Despite Actions to Help Maintain Product Availability, by Marcia Crosse, director, health care, before the Subcommittee on Health, House Committee on Energy and Commerce. GAO-14-339T, February 10.
http://www.gao.gov/products/GAO-14-339T
Highlights - http://www.gao.gov/assets/670/660770.pdf

Medicare Improperly Paid Millions of Dollars for Prescription Drugs Provided to Incarcerated Beneficiaries During 2006 Through 2010

February 10, 2014 Comments off

Medicare Improperly Paid Millions of Dollars for Prescription Drugs Provided to Incarcerated Beneficiaries During 2006 Through 2010
Source: U.S. Department of Health and Human Services, Office of Inspector General

An individual is eligible for Medicare Part D benefits if he or she is entitled to Medicare benefits under Part A or enrolled in Part B and lives in the service area of a Part D plan. Federal regulations specify that facilities in which individuals are incarcerated are not to be regarded as being within service areas for purposes of Part D coverage.

The Centers for Medicare & Medicaid Services (CMS) inappropriately accepted prescription drug event (PDE) records submitted by Part D sponsors for prescription drugs provided to incarcerated beneficiaries and used those records to make its final payment determinations. Specifically, for 49 of the 100 beneficiaries that we sampled, CMS accepted 1,298 PDE records submitted by sponsors for prescription drugs provided to incarcerated beneficiaries. The gross drug costs associated with these 1,298 accepted PDE records totaled $326,000. On the basis of our sample results, we estimated that CMS accepted PDE records with gross drug costs totaling an additional $11.7 million for incarcerated beneficiaries.

CMS inappropriately accepted PDE records submitted by sponsors for prescription drugs provided to incarcerated beneficiaries because it had inadequate internal controls during our review. Additionally, CMS did not provide sufficient and timely information to sponsors that would have allowed them to readily and accurately verify a beneficiary’s incarceration status and dates of incarceration.

We recommended that CMS (1) resolve improper Part D payments made for prescription drugs provided to incarcerated beneficiaries; (2) strengthen internal controls to ensure that Medicare does not pay for prescription drugs for incarcerated beneficiaries; and (3) identify and resolve improper payments made for prescription drugs provided to incarcerated beneficiaries, which would include the estimated additional gross drug costs identified in this report, by reopening and revising final payment determinations for all periods before implementation of the enhanced policies and procedures that would contribute to the strengthened internal controls. CMS concurred with our first two recommendations but did not concur with our third recommendation.

New From the GAO

February 10, 2014 Comments off

New From the GAO
Source: Government Accountability Office

Reports

1. Troubled Asset Relief Program: More Efforts Needed on Fair Lending Controls and Access for Non-English Speakers in Housing Programs. GAO-14-117, February 6.
http://www.gao.gov/products/GAO-14-117
Highlights - http://www.gao.gov/assets/670/660711.pdf

2. Economic Development Administration: Documentation of Award Selection Decisions Could Be Improved. GAO-14-131, February 6.
http://www.gao.gov/products/GAO-14-131
Highlights - http://www.gao.gov/assets/670/660724.pdf

3. U.S. Postal Service: Actions Needed to Strengthen the Capital Investment Process. GAO-14-155, January 7.
http://www.gao.gov/products/GAO-14-155
Highlights - http://www.gao.gov/assets/670/660032.pdf

Testimonies

1. Border Security: DHS Needs to Strengthen Its Efforts to Modernize Key Enforcement Systems, by David A. Powner, director, information technology management issues, before the Subcommittee on Oversight and Management Efficiency, House Committee on Homeland Security. GAO-14-342T, February 6.
http://www.gao.gov/products/GAO-14-342T
Highlights - http://www.gao.gov/assets/670/660705.pdf

2. Entrepreneurial Assistance: Opportunities Exist to Improve Collaboration and Performance Management for Financial Assistance Programs, by William B. Shear, director, financial markets and community investment, before the Subcommittee on Agriculture, Energy, and Trade, House Committee on Small Business. GAO-14-335T, February 6.
http://www.gao.gov/products/GAO-14-335T
Highlights - http://www.gao.gov/assets/670/660707.pdf

Reissued Report

1. Medicaid Prescription Drugs: CMS Should Implement Revised Federal Upper Limits and Monitor Their Relationship to Retail Pharmacy Acquisition Costs. GAO-14-68, December 19.
http://www.gao.gov/products/GAO-14-68
Highlights – http://www.gao.gov/assets/660/659834.pdf

This report was revised on February 6, 2014 to correct the omission of reprinting written comments from the Department of Health and Human Services (HHS) on a draft report. A copy of the HHS’s written comments was inserted in appendix V.

Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men

February 5, 2014 Comments off

Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men
Source: PLoS ONE

Background
An association between testosterone therapy (TT) and cardiovascular disease has been reported and TT use is increasing rapidly.

Methods
We conducted a cohort study of the risk of acute non-fatal myocardial infarction (MI) following an initial TT prescription (N = 55,593) in a large health-care database. We compared the incidence rate of MI in the 90 days following the initial prescription (post-prescription interval) with the rate in the one year prior to the initial prescription (pre-prescription interval) (post/pre). We also compared post/pre rates in a cohort of men prescribed phosphodiesterase type 5 inhibitors (PDE5I; sildenafil or tadalafil, N = 167,279), and compared TT prescription post/pre rates with the PDE5I post/pre rates, adjusting for potential confounders using doubly robust estimation.

Results
In all subjects, the post/pre-prescription rate ratio (RR) for TT prescription was 1.36 (1.03, 1.81). In men aged 65 years and older, the RR was 2.19 (1.27, 3.77) for TT prescription and 1.15 (0.83, 1.59) for PDE5I, and the ratio of the rate ratios (RRR) for TT prescription relative to PDE5I was 1.90 (1.04, 3.49). The RR for TT prescription increased with age from 0.95 (0.54, 1.67) for men under age 55 years to 3.43 (1.54, 7.56) for those aged ≥75 years (ptrend = 0.03), while no trend was seen for PDE5I (ptrend = 0.18). In men under age 65 years, excess risk was confined to those with a prior history of heart disease, with RRs of 2.90 (1.49, 5.62) for TT prescription and 1.40 (0.91, 2.14) for PDE5I, and a RRR of 2.07 (1.05, 4.11).

Discussion
In older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.

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