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National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain

January 26, 2015 Comments off

National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain
Source: Annals of Internal Medicine

The increase in the number of Americans with chronic pain and the concurrent increase in the use of opioids to treat this pain have created a situation in which large numbers of Americans are receiving suboptimal care. Patients who are in pain are often denied the most effective comprehensive treatments; conversely, many patients are inappropriately prescribed medications that may be ineffective or even harmful. At the root of the problem is the inadequate knowledge about the best approaches to treating various types of pain, which balance effectiveness with the potential for harm, as well as a dysfunctional health care delivery system that promotes prescription of the easiest rather than the best approach to addressing pain. The EPC report identified few studies that were able to answer key questions, which suggests a dire need for research on the effectiveness and safety of opioids as well as optimal management and risk mitigation strategies. Particularly striking to the panel was the realization that evidence is insufficient for every clinical decision that a provider needs to make about the use of opioids for chronic pain, leaving the provider to rely on his or her own clinical experience.

Because of the inherent difficulties of studying pain and the large number of patients already receiving opioids, new research designs and analytic methods are needed to adequately answer the important clinical and research questions. Until the needed research is conducted, health care delivery systems and clinicians must rely on the existing evidence as well as guidelines issued by professional societies. Systems of care must facilitate the implementation of these guidelines rather than relying solely on individual clinicians, who are often overburdened and have insufficient resources.

Opioids are clearly the best treatment for some patients with chronic pain, but there are probably more effective approaches for many others. The challenge is to identify the conditions in patients for which opioid use is most appropriate, the optimal regimens, the alternatives for those who are unlikely to benefit from opioids, and the best approach to ensuring that every patient’s needs are met by a patient-centered health care system. For the more than 100 million Americans living with chronic pain, meeting this challenge cannot wait.

See also: The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop

Measuring the return from pharmaceutical innovation 2014; Turning a corner?

January 26, 2015 Comments off

Measuring the return from pharmaceutical innovation 2014; Turning a corner?
Source: Deloitte

Key findings

  • 143 products launched globally since 2010 for the benefit of patients, with projected lifetime revenues of $995 billion.
  • 236 assets with forecast lifetime revenues of $1,171 billion progressed to late stage development, since 2010.
  • Rate of return has increased for the first time since 2010, to 5.5%.
  • Cost of bringing an asset to market rises for the fifth year, to $1,401 million.

Strategic factors impacting R&D returns

  • Company size – the larger the company, by revenue or R&D spend, the greater the cost to develop each asset and the lower the returns.
  • External innovation – for 75% of the companies, less than half of the projected revenue is from compounds discovered in their own laboratories.
  • Across all 12 companies, 58% of forecast revenues from innovation at the latest stage of development is sourced externally.
  • Portfolio focus – an emphasis on fewer therapy areas appears to deliver better returns.

Opioid Prescription Claims Among Women of Reproductive Age — United States, 2008–2012

January 23, 2015 Comments off

Opioid Prescription Claims Among Women of Reproductive Age — United States, 2008–2012
Source: Morbidity and Mortality Weekly Report (CDC)

Prescription opioid use in the United States has become widespread (1), and studies of opioid exposure in pregnancy suggest increased risk for adverse pregnancy outcomes, including neonatal abstinence syndrome and birth defects (e.g., neural tube defects, gastroschisis, and congenital heart defects) (2,3). The development of birth defects often results from exposures during the first few weeks of pregnancy, which is a critical period for organ formation. Given that many pregnancies are not recognized until well after the first few weeks and half of all U.S. pregnancies are unplanned (4), all women who might become pregnant are at risk. Therefore, it is important to assess opioid medication use among all women of reproductive age. CDC used Truven Health’s MarketScan Commercial Claims and Encounters and Medicaid data* to estimate the number of opioid prescriptions dispensed by outpatient pharmacies to women aged 15–44 years. During 2008–2012, opioid prescription claims were consistently higher among Medicaid-enrolled women when compared with privately insured women (39.4% compared with 27.7%, p<0.001). The most frequently prescribed opioids among women in both groups were hydrocodone, codeine, and oxycodone. Efforts are needed to promote interventions to reduce opioid prescriptions among this population when safer alternative treatments are available.

Tricyclic Antidepressants Found in Pilots Fatally Injured in Civil Aviation Accidents

January 21, 2015 Comments off

Tricyclic Antidepressants Found in Pilots Fatally Injured in Civil Aviation Accidents (PDF)
Source: Federal Aviation Administration

Since the 1950s, tricyclic antidepressants (TCAs) have been used for treating depression. The prevalence of this group of antidepressants in the pilot population has not been explored. Therefore, the National Transportati on Safety Board (NTSB) aviation accident and the Federal Aviation Administration’s (FAA’s) Civil Aerospace Medical Institute (CAMI) toxicology and medical certification databases were searched for the necessary information related to pilots fatally injured in aviation accidents.

During 1990 – 2012, CAMI received biological samples of fatally injured pilots from 7,037 aviation accidents for toxicological evaluation. Of these, 2,644 cases (pilot fatalities) were positive for drugs. TCAs were present in 31 pilo t fatalities. Only TCAs were found in nine cases; in addition to TCAs, other substances were also present in the remaining 22 cases. Blood samples were available for TCA analysis in only 17 cases. TCA blood concentrations ranged from therapeutic to toxic l evels.

The NTSB determined that the use of drugs and ethanol as the probable cause or contributing factor in 35% (11 of 31) of the accidents, and six pilots had taken TCAs, as documented in their personal medical records and histories obtained by the NTSB . None of the 31 pilots reported the use of TCAs during their aviation medical examination, though 45% of them did report other drugs.

The present study disclosed that the prevalence of TCAs in aviators was less than 0.5% (31 of 7,037 cases). This study s uggests that aviators should fully disclose the use of medications at the time of their aviation medical examination for the improvement of aviation safety.

Clinical Use of Extended-Release Injectable Naltrexone in the Treatment of Opioid Use Disorders: A Brief Guide

January 8, 2015 Comments off

Clinical Use of Extended-Release Injectable Naltrexone in the Treatment of Opioid Use Disorders: A Brief Guide
Source: Substance Abuse and Mental Health Services Administration

Offers guidance on the use of medication-assisted treatment (MAT) with extended-release injectable naltrexone for the treatment of an opioid use disorder. Covers patient assessment, initiating MAT, monitoring progress, and deciding when to end treatment.

2014 Access to Medicine Index – More being done, but progress is uneven

January 6, 2015 Comments off

2014 Access to Medicine Index – More being done, but progress is uneven
Source: Access to Medicine Foundation

The world’s leading pharmaceutical companies are doing more to improve access to medicine in developing countries, with a raft of new initiatives, scale-ups and innovations over the last two years. However, the industry struggles to perform well in some practices that matter, according to the 2014 Access to Medicine Index, published Monday.

GSK tops the Index for the fourth time. This is driven by robust performance across most areas, with several innovative practices. Novo Nordisk has made the most progress, improving in five of the seven areas the Index focuses on. This has resulted in a remarkable leap from 6th to 2nd place. Astellas, Daiichi Sankyo and Takeda remain at the bottom of the league.

The Access to Medicine Index is an independent initiative that ranks the world’s leading pharmaceutical companies according to what they are doing for the millions of people in developing countries who do not have reliable access to medicine.

The Challenge of Pricing Combination Therapies

January 5, 2015 Comments off

The Challenge of Pricing Combination Therapies
Source: Boston Consulting Group

The role of combination therapies in medicine continues to grow. For the treatment of HIV/AIDS, cancer, and hepatitis C, pharmaceutical companies are increasingly seeking approval for combination treatments—in many cases, entering crowded markets. That’s one reason why setting prices for these combinations is exceedingly complex. Pricing decisions require an analysis of multiple known factors, including time left under patent protection and potential market size, as well as an assessment of a host of unknown events, including the outcomes of pending clinical trials for products in the combination and for competing products, and the future pricing strategies of competitors.

Pricing combination treatments is a new challenge that requires a systematic approach to evaluating the numerous interconnected issues that come into play. The key is to understand how each development or pricing decision impacts current and future prospects for the therapies—and to set prices on the basis of that comprehensive view. In most cases, the goal will be to develop a strategy that keeps the company’s pricing options open, allowing for adjustment as events unfold.

An effective pricing strategy is key to securing reimbursement and maximizing the potential of therapies, particularly in developed markets such as Europe and the U.S., where gaining market access is increasingly difficult. And the risk of mismanaging all the trade-offs involved in price setting is significant. According to our estimates, suboptimal pricing may pare as much as 20 percent off the projected sales of a new drug over its life cycle.

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