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Pollution from drug manufacturing: review and perspectives

October 16, 2014 Comments off

Pollution from drug manufacturing: review and perspectives
Source: Philosophical Transactions of the Royal Society

As long ago as the sixteenth century, Paracelsus recognized that ‘the dose makes the poison’. Indeed, environmental concentrations of pharmaceuticals excreted by humans are limited, most importantly because a defined dose is given to just a fraction of the population. By contrast, recent studies have identified direct emission from drug manufacturing as a source of much higher environmental discharges that, in some cases, greatly exceed toxic threshold concentrations. Because production is concentrated in specific locations, the risks are not linked to usage patterns. Furthermore, as the drugs are not consumed, metabolism in the human body does not reduce concentrations. The environmental risks associated with manufacturing therefore comprise a different, wider set of pharmaceuticals compared with those associated with risks from excretion. Although pollution from manufacturing is less widespread, discharges that promote the development of drug-resistant microorganisms can still have global consequences. Risk management also differs between production and excretion in terms of accountability, incentive creation, legal opportunities, substitution possibilities and costs. Herein, I review studies about industrial emissions of pharmaceuticals and the effects associated with exposure to such effluents. I contrast environmental pollution due to manufacturing with that due to excretion in terms of their risks and management and highlight some recent initiatives.

See also:
+ Detection and drivers of exposure and effects of pharmaceuticals in higher vertebrates
+ Risks of hormonally active pharmaceuticals to amphibians: a growing concern regarding progestagens
+ Putting pharmaceuticals into the wider context of challenges to fish populations in rivers

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Antibiotic resistance threats in the United States, 2013

October 13, 2014 Comments off

Antibiotic resistance threats in the United States, 2013
Source: Centers for Disease Control and Prevention

This report, Antibiotic resistance threats in the United States, 2013 gives a first-ever snapshot of the burden and threats posed by the antibiotic-resistant germs having the most impact on human health.

Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections. Many more people die from other conditions that were complicated by an antibiotic-resistant infection.

Antibiotic-resistant infections can happen anywhere. Data show that most happen in the general community; however, most deaths related to antibiotic resistance happen in healthcare settings such as hospitals and nursing homes.

Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology

October 10, 2014 Comments off

Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology
Source: Neurology

The Patient Safety Subcommittee requested a review of the science and policy issues regarding the rapidly emerging public health epidemic of prescription opioid-related morbidity and mortality in the United States. Over 100,000 persons have died, directly or indirectly, from prescribed opioids in the United States since policies changed in the late 1990s. In the highest-risk group (age 35–54 years), these deaths have exceeded mortality from both firearms and motor vehicle accidents. Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction. The objectives of the article are to review the following: (1) the key initiating causes of the epidemic; (2) the evidence for safety and effectiveness of opioids for chronic pain; (3) federal and state policy responses; and (4) recommendations for neurologists in practice to increase use of best practices/universal precautions most likely to improve effective and safe use of opioids and to reduce the likelihood of severe adverse and overdose events.

Deaths Related to Drug Poisoning in England and Wales, 2013

October 7, 2014 Comments off

Deaths Related to Drug Poisoning in England and Wales, 2013
Source: Office for National Statistics

Key Findings

  • 2,955 drug poisoning deaths (involving both legal and illegal drugs) were registered in 2013 in England and Wales (2,032 male and 923 female deaths).
  • Male drug poisoning deaths increased by 19% compared with 2012. Female drug poisoning deaths have increased every year since 2009.
  • Male drug misuse deaths (involving illegal drugs) increased by 23%, from 1,177 in 2012 to 1,444 in 2013. Female drug misuse deaths increased by 12%, from 459 in 2012 to 513 in 2013.
  • Heroin/morphine remain the substances most commonly involved in drug poisoning deaths. 765 deaths involved heroin/morphine in 2013; a sharp rise of 32% from 579 deaths in 2012.
  • Deaths involving tramadol have continued to rise, with 220 deaths in 2013. This is almost 2.5 times the number seen in 2009 (87 deaths).
  • There was a sharp increase of 21% in the number of drug misuse deaths in England in 2013, with no change to the number of these deaths in Wales. However, mortality rates from drug misuse were still significantly higher in Wales than in England.
  • Male mortality rates significantly increased in three substance categories: heroin/morphine, benzodiazepines and paracetamol. Conversely female mortality rates remained relatively stable except for a sharp increase in the cocaine-related death rate.
  • In England, the North East had the highest mortality rate from drug misuse in 2013 (52.0 deaths per million population), and London had the lowest (23.0 deaths per million population).
  • All figures presented in this bulletin are based on deaths registered in a particular calendar year. Out of the 2,955 drug-related deaths registered in 2013, 1,488 (just over half) occurred in years before 2013.

New From the GAO

October 2, 2014 Comments off

New GAO Reports
Source: Government Accountability Office
1. 2020 Census: Census Bureau Can Improve Use of Leading Practices When Choosing Address and Mapping Sources. GAO-15-21, October 2.
http://www.gao.gov/products/GAO-15-21
Highlights – http://www.gao.gov/assets/670/666344.pdf

2. Compounded Drugs: TRICARE’s Payment Practices Should Be More Consistent with Regulations. GAO-15-64, October 2.
http://www.gao.gov/products/GAO-15-64
Highlights – http://www.gao.gov/assets/670/666338.pdf

Breaking Through the Noise: Pharmaceutical Multichannel Marketing in a Digital World

October 1, 2014 Comments off

Breaking Through the Noise: Pharmaceutical Multichannel Marketing in a Digital World
Source: Boston Consulting Group

It is a buzzword that has been thrown around in the pharmaceutical industry for years: multichannel marketing (MCM). MCM—the use of a variety of sales and marketing channels, from face-to-face meetings to digital marketing campaigns to smartphone and tablet apps—can produce large gains in company performance. How large? Effective MCM can boost top-line growth by more than 10 percent or reduce costs by 10 to 25 percent—or both.

To deliver on that promise, companies must see MCM for what it is: a transformation of the entire marketing and sales approach. This calls for a new way of thinking. Too many people still view MCM as an add-on to traditional marketing when in fact it must be fully integrated across the organization, serving as a mechanism for coordinating all interactions with customers. In addition, many companies spend too much time with small pilots instead of moving to implement MCM on a large scale. Only when MCM is viewed clearly as the future direction, rather than as just another experiment, can companies build the required support to deploy it aggressively—and be able to “move the needle” in a meaningful way.

Other industries, such as retail banking and telecommunications, have demonstrated how to make this transformation. In retail banking, for example, almost 70 percent of direct customer interactions went through remote channels such as phone calls, online banking, and mobile banking by 2013, up from only 30 percent in 1999. The pharmaceutical industry lags far behind. The Boston Consulting Group’s MCM benchmarking study found that no pharmaceutical companies are strongly satisfied with their MCM efforts and that a full 55 percent are either partially or strongly dissatisfied.

Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II

October 1, 2014 Comments off

Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II
Source: U.S. Drug Enforcement Administration (via Federal Register)

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration reschedules hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products.

See: DEA: Vicodin, Some Other Pain Meds Will Be Harder to Get (Kaiser Health News)

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