Wednesday, July 11, 2012

Pharmaceutical companies must provide pain drug education to docs

PMLIVE:  Pharmaceutical companies in the US will have to provide doctors with an education programme for any extended-release (ER) and long-acting (LA) opioid medications they market in an effort to prevent drug abuse and misuse in patients.

FDA opioid safety planThe requirement is part of wider measures from the US Food and Drug Administration (FDA) to reduce risks and improve safe use of the pain drugs that include Pfizer’s Avinza, Actavis’ Kadian, Janssen’s Nucynta ER and Duragesic and several products from Purdue Pharma, all of which can cause serious harm and even death if used improperly.

The extra training will be based on an FDA design and will inform healthcare professionals about the safe prescribing of ER/LA opioid medications so they can have a greater knowledge and awareness when having a conversation with a patient about the risks and appropriate use of a prescribed medicine.

Companies are expected to achieve goals established by the FDA for the percentage of prescribers of ER/ LA opioids who complete the training, and prescriber understanding will be audited and assessed. Courses will either be free or charged at a small fee. Despite pharma firms being made to provide such training, prescribers are not required to take it under current US law.

Instead, the FDA said it “continues to support this approach, but absent the needed legislation, intends to exercise its authority to require mandatory elements for companies and voluntary elements for prescribers”.
In addition, the full risk evaluation and mitigation strategy (REMS) also includes an updated medication guide for each drug, provided to patients via pharmacists that explains how to safely use ER/LA opioid medicines.
“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA commissioner Dr Margaret Hamburg.

“The FDA’s goal with this REMS approval is to ensure that healthcare professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.” The FDA is also encouraging the safe storage of such medicines to prevent them being taken by someone other than the person they are prescribed for.  "Just because it's safe for the patient, doesn't mean it's safe for someone else," said Dr Sharon Hertz, deputy director of the FDA's division of anaesthesia, analgaesia and addiction products.

According to IMS Health, it is estimated that 22.9m prescriptions of the painkillers were dispensed in 2011. There were 15,597 deaths involving these medications in 2009, said the US Centers for Disease Control and Prevention.

Published: 11/07/2012

Sunday, July 8, 2012

"Highless" cannabis developed for medicinal use in Israel

I just got an email from a friend of mine who has relatives in Israel with some impressive news regarding medical cannabis research there.  It seems that a new strain has been developed with negligible THC, but very large percentages of CBD.  What this does, is let those individuals who are sensitive to the "high" of cannabis utilize it for its potent anti-inflammatory properties.

We all know that cannabis has a number of medicinal properties, but everyone using it for medical reasons is always accused of  "just wanting to get high."  This should put an end to that argument.  However, THC has potent medicinal properties of its own, so not everyone will be happy with a strain without it.  But for those who cannot tolerate the effects of THC, this strain could be a blessing.  Thanks to the researchers in Israel for all the work they have done on it.

Below is an excerpt from the original article which you can find at:
Note:  This site requires a free registration to read the article.

Dr. Ruth Gallily of the Hebrew University, who works for the company and has been studying CBD for more than 12 years, said she has found that the substance has impressive anti-inflammatory qualities. She has been testing the effects of Tikun Olam's CBD-enhanced cannabis on mice and expects clinical trials to begin in a few months.

Avidekel is a new strain of a plant that is already permitted for medical use so there is nothing stopping patients who are already being treated with marijuana from trying Avidekel. About 10 patients began using it in the past six months, Klein said.

"The cannabis plant, enriched with CBD, can be used for treating diseases like rheumatoid arthritis, colitis, liver inflammation, heart disease and diabetes," she said, adding there are no side effects.

"It's a huge advantage," said one 35-year-old patient who asked not to be identified, "I can smoke during the day, function with a lot less pain and still be focused, work and drive. It is a great gift."