Archive for the ‘prescription drugs’ Category

ACPA Resource Guide To Chronic Pain Medication & Treatment — 2014 Edition

June 24, 2015 Comments off

ACPA Resource Guide To Chronic Pain Medication & Treatment — 2014 Edition (PDF)
Source: American Chronic Pain Association

The American Chronic Pain Association (ACPA) advocates a multi-modal strategy for dealing with chronic pain. The ACPA focuses on pain management skills and self-help strategies that individuals can use with the approval of their healthcare providers.

The ACPA considers the use of medication and other treatments to be a matter for individuals to determine in conjunction with their healthcare provider. The ACPA takes no position on medical treatment choices. Thus, information the ACPA provides about medical care is educational and informative only.

The ACPA Resource Guide to Chronic Pain Medication & Treatment is an unbiased consensus document that combines practical clinical ex perience and the most recent scientific information.

Federal Guidelines for Opioid Treatment Programs

May 29, 2015 Comments off

Federal Guidelines for Opioid Treatment Programs
Source: Substance Abuse and Mental Health Services Administration

Provides updated guidelines for the operation of opioid treatment programs (OTPs). Covers patient assessment, treatment planning, medication-assisted treatment (methadone and buprenorphine), overdose and relapse prevention, and recovery care.

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

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.

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.

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.

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