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What Americans believe about opioid prescription painkiller use

April 28, 2015 Comments off

What Americans believe about opioid prescription painkiller use (PDF)
Source: National Safety Council

Key Takeaways:
1. Americans don’t know their painkillers contain opioids, or that it is a felony to share them.
2. Opioid users are unconcerned about addiction, but most have reason to worry.
3. Opioid users overestimate the benefits of opioids and underestimate the risks of addiction or death.

Borrowing for the Cure: Debt Financing of Breakthrough Treatments

April 24, 2015 Comments off

Borrowing for the Cure: Debt Financing of Breakthrough Treatments
Source: RAND Corporation

Recent market entries of breakthrough pharmaceutical products have reignited the debate about the affordability of high-priced drugs for public and private payers worldwide. Payers had voiced concerns about such drugs before but, faced with a possible outcry of patients and advocates, grudgingly accepted them. But as more high-cost drugs reach the market and treat more-prevalent conditions, medical professionals and government ministers have complained that this “blank check” might not be sustainable. Concerns about short-term budget impact have led countries to restrict access to expensive drugs, even when they met cost-effectiveness criteria and could lead to long-term savings. This paper offers a research-grounded perspective on innovative financing mechanisms to facilitate access to expensive yet highly effective breakthrough medical treatments. The authors outline the scope of the problem; describe several policy and market options, including bond financing and linking repayment to real-world value generation; and describe real-world applications.

Emergency Department Visits for Drug Poisoning: United States, 2008–2011

April 14, 2015 Comments off

Emergency Department Visits for Drug Poisoning: United States, 2008–2011
Source: Centers for Disease Control and Prevention

Key findings
Data from the National Hospital Ambulatory Medical Care Survey, 2008–2011

  • During 2008–2011, an average of 1.1 million emergency department (ED) visits were made each year for drug poisoning, with a visit rate of 35.4 per 10,000 persons.
  • The ED visit rate for drug poisoning was highest among persons aged 20–34. The rate declined with age after 20–34, and rates for those aged 0–19 were similar to those aged 50 and over.
  • Drug-poisoning ED visit rates did not differ by sex and age, with the exception of persons aged 35–49, where females had a higher visit rate than males. The ED visit rate for unintentional drug poisoning was higher than self-inflicted drug poisoning overall and for males, but did not differ for females.
  • About one-quarter (24.5%) of drug-poisoning ED visits resulted in hospital admission.

CDC publishes first national study on use of behavioral therapy, medication and dietary supplements for ADHD in children

April 6, 2015 Comments off

CDC publishes first national study on use of behavioral therapy, medication and dietary supplements for ADHD in children
Source: Centers for Disease Control and Prevention

The first national study to look at behavioral therapy, medication, and dietary supplements to treat attention-deficit/hyperactivity disorder (ADHD) among children ages 4-17 shows that less than one half of children with ADHD were receiving behavioral therapy in 2009-2010. The Centers for Disease Control and Prevention (CDC) study, “Treatment of Attention-Deficit/Hyperactivity Disorder among Children with Special Health Care Needs,” published today in The Journal of Pediatrics provides a snapshot into how ADHD was treated just before the release of the 2011 clinical guidelines for treatment of ADHD from the American Academy of Pediatrics (AAP).

According to the study, among children 4-17 years of age, about 4 in 10 children with ADHD were treated with medication alone, 1 in 10 received behavioral therapy alone, 3 in 10 were treated with both medication and behavioral therapy, and 1 in 10 received neither medication nor behavioral therapy. Overall, about 1 in 10 children took dietary supplements for ADHD.

The data show that 1 in 2 preschoolers ages 4-5 with ADHD received behavioral therapy and about 1 in 2 were taking medication for ADHD. Almost 1 in 4 preschoolers were treated with medication alone. Among children ages 6-17 with ADHD, fewer than 1 in 3 received both medication and behavioral therapy.

Medicinal products in the European Union: The legal framework for medicines for human use

April 6, 2015 Comments off

Medicinal products in the European Union: The legal framework for medicines for human use
Source: European Parliament Think Tank

EU legislation on human medicines goes back 50 years. Its twofold aim is to safeguard public health without hindering development of the European pharmaceutical industry or trade in medicinal products. The regulatory framework is complex and covers the entire lifecycle of a medicine, from manufacture, to clinical trials, to marketing authorisation, to pharmacovigilance and patient information. Added to that, the principles of good manufacturing, distribution and pharmacovigilance practice contribute to increasing medicines’ safety. An emerging approach to granting early access to medicines – adaptive pathways – could prove its future merits for patients with a medical condition not adequately addressed by an existing therapy.

FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids

April 3, 2015 Comments off

FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.

Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.

New Hepatitis C Treatments: Considerations and Potential Strategies for States

March 24, 2015 Comments off

New Hepatitis C Treatments: Considerations and Potential Strategies for States
Source: National Governors Association

The National Governors Association Center for Best Practices (NGA Center) convened an expert roundtable to discuss the opportunities and challenges presented by new hepatitis C virus (HCV) treatments and other pharmaceutical therapies known as high-impact drugs. Such drug treatments share the common characteristics of being more effective than prevailing drug therapies, often resulting in a change in clinical practice that includes treating many more people and being much more expensive. Experts participating in the roundtable included state health care leaders, scientists, national health care experts, subject-matter experts from insurance and pharmaceutical companies, Medicaid and corrections legal experts, and senior staff from the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Veterans Affairs (VA). This paper summarizes the expert roundtable discussion supplemented by NGA Center research to flesh out the background information and strategies discussed.

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