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Medications for the Treatment of Alcohol Use Disorder: A Brief Guide

May 22, 2015 Comments off

Medications for the Treatment of Alcohol Use Disorder: A Brief Guide
Source: Substance Abuse and Mental Health Services Administration

Provides guidance for the use of medication-assisted treatment for alcoholism and alcohol abuse in clinical practice. Summarizes approved medications and discusses screening and patient assessment, treatment planning, and patient monitoring.

HHS OIG — FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs

May 11, 2015 Comments off

FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs
Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY
OIG received a Congressional request expressing concerns about the safety and quality of generic drugs produced by foreign manufacturers and requesting that OIG evaluate whether FDA is achieving parity in inspections of foreign and domestic manufacturers. In 2012, nearly 80 percent of prescriptions filled in the United States were for generic drugs. But in recent years, several recalls of generic drugs have raised concerns about FDA’s oversight of manufacturers.

HOW WE DID THIS STUDY
We analyzed FDA data for inspections and registered manufacturers of generic drugs for 2011-2013 to determine the number and types of inspections. We also analyzed FDA data to determine whether manufacturers listed on approved applications had registered with FDA as required. We also analyzed FDA records and interviewed FDA staff to determine the extent to which it is progressing toward achieving parity in domestic and foreign inspections and more efficient processes for inspections.

WHAT WE FOUND
FDA increased its preapproval inspections of manufacturers of generic drugs by 60 percent between 2011 and 2013. However, it did not conduct all of the preapproval inspections requested by its own generic drug application reviewers during this time period. The graphic below illustrates the distribution of generic manufacturers and surveillance inspections worldwide (for more information, see Table 4 in the report).
In 2013, FDA conducted surveillance inspections of all generic manufacturers that it had identified as high risk. FDA also reported progress towards achieving parity in inspections of foreign and domestic manufacturers of generic drugs and ensuring compliance with generic manufacturer registration. Finally, FDA has created some policies and procedures to request manufacturer records in lieu or in advance of an inspection, but has not yet used these procedures to request records.

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.

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