[e-drug] Independent Drug & Healthcare Newsletter for February 2016

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E-DRUG: Independent Drug & Healthcare Newsletter for February 2016
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N° 168 January 2016

View the table of contents for the current issue

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In Prescrire's Spotlight this month

Drugs to avoid in the name of better patient care: 2016 update
In conjunction with its annual Prescrire Awards, the independent French medical journal Prescrire has updated its list of drugs to avoid.

The goal is to help healthcare professionals and patients choose high-quality treatments that minimize the risk of adverse effects.

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Prescrire's Drug Awards for 2015 honour new indications for three older drugs

Independent French medical journal Prescrire held its annual Drug Awards in Paris on 28 January 2016. One drug was added to the "Honours List" and two others deemed "Noteworthy", but there was no "Pilule d'Or" ("Golden Pill") awarded this year.

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Prescrire's Drug Packaging Awards for 2015: still too many dangerous flaws
The annual Packaging Awards by independent French medical journal Prescrire demonstrate that, while solutions do exist, there are still far too many examples of dangerous drug packaging and incomplete patient leaflets.

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Prescrire's Information Awards for 2015: a handful of drug companies are honoured, amidst a general lack of transparency

A company's transparency, part and parcel of its credibility, is an essential component of drug safety. The 2015 Information Awards by non-profit French medical journal Prescrire reveal another year marked by a lack of transparency on the part of drug companies.

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"Adaptive licensing": the European Medicines Agency's unwise proposals. A discussion-debate at the annual Prescrire Awards

Speeding up patients' access to new drugs only makes sense if those drugs have an acceptable, and adequately studied, harm-benefit balance.

On 28 January 2016 the non-profit French medical journal Prescrire held its annual awards ceremony, with a discussion-debate on "adaptive pathways" for marketing authorisations, as proposed by the European Medicines Agency.

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"Weak" opioid analgesics: codeine, dihydrocodeine and tramadol are no less risky than morphine

FEATURED REVIEW When opioid therapy is needed, there is no evidence that codeine, dihydrocodeine or tramadol is less risky than morphine at its lowest effective dose. The efficacy of these drugs varies more from one patient to another, and their multiple pharmacokinetic interactions can be difficult to manage.

Weak opioids require at least as much vigilance as morphine, despite the major differences in their reputation and regulation.
Full review (7 pages) available for download by subscribers.

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In the February issue of Prescrire International:
Oseltamivir (Tamiflu°): over 15 years of data retention and systematic stonewalling

FREE DOWNLOAD Oseltamivir was authorised in the EU in 2002 for the prevention and treatment of influenza. Despite widespread belief in its efficacy, cleverly orchestrated by the drug's manufacturer and other organisations, a number of independent teams were not convinced and went on a hunt for missing data. They discovered that the available trial results were neither complete nor clinically relevant and provided only weak evidence. Full text available for free download.

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Prescrire International <international@prescrire.org>

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E-DRUG: Independent Drug & Healthcare Newsletter for February 2016 (2)
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  "Weak" opioid analgesics: codeine, dihydrocodeine and tramadol are no
   less risky than morphine?

   One of the issues in Prescrire International is the safety of "weak
   opioids" as compared to morphine. Apparently, the authors consider the
   risks of opioids to be respiratory depression and "addiction" (a term
   considered pejorative by WHO, and therefore, below I refer to this as
   "dependence".) The side effect drowsiness is not mentioned, although
   this is in addition to respiratory depression a sign of intoxication.

   In the abstract, the authors refer to dependence with the following
   paragraph:

   o All "weak" opioids can have the same dose-dependent adverse effects
   as morphine. There is no evidence that, at equivalent analgesic
   efficacy, weak opioids carry a lower risk of addiction than low-dose
   morphine.

   This quotation shows that unfortunately, they started from the
   erroneous assumption that morphine in pain patients carries a
   substantial risk that these patients become dependent on the opioid
   analgesic.

   In 2013, Minozzi, Amato and Davoli published a Cochrane systematic
   review on this aspect which was commissioned by WHO. The Cochrane
   review which was initially intended to be a meta-analysis, however,
   they did not find one study that met the inclusion criteria, and
   therefore, they limited their study to a literature review.

  Outcomes of the reviewed studies were incoherent with incidence of opioid
   dependence among patients following treatment with opioid analgesics
   for pain relief ranged from zero to 24% (median 0.5%) and prevalence
   ranged from zero to 31% (median 4.5%). The authors concluded that the
   available evidence suggests that opioid analgesics for chronic pain
   conditions are not associated with a major risk for developing
   dependence.

  The most impressive finding of their review is the
   deficiency of good-quality studies in contrast to the widespread
   concern of doctors and authorities relating to the prescription of
   opioids for pain management.

   The authors also continue to speak of one opioid being "less risky"
   than another. With their wording, they incriminate a group of important
   and essential medicines that is intrinsically safe, provided that it is
   used by skilled hands.

  For instance, one needs to know how to assess
   pain and how to titrate to the right dose. In particular, it is
   important not to increase the dose more than 50% in 24 hours, or the
   patient should be under constant monitoring with immediate availability
   of the antagonist naloxone.

   For more information, I refer to the WHO Guidelines for the
   pharmacological treatment of persisting pain in children with medical
   illnesses (unfortunately WHO has not yet modern guidelines on pain for
   adults or for acute pain). For references please see below.

    Minozzi S, Amato L, Davoli M. Development of dependence following
   treatment with opioid analgesics for pain relief: a systematic review.
   Addiction. 2013;108(4):688-698. doi: 10.1111/j.1360-0443.2012.04005.x

   World Health Organization, WHO Guidelines for the Pharmacological
   Treatment of Persisting Pain in Children with Medical Illness World
   Health Organization, Geneva 2012, ISBN 978 92 4 154812 0.
   [2]http://whqlibdoc.who.int/publications/2012/9789241548120_Guidelines.
   pdf Also available in several other languages than English.

Willem Scholten
Willem Scholten Consultancy
Willem Scholten PharmD MPA
Consultant - Medicines and Controlled Substances
Wielsekade 64
3411 AD Lopik, the Netherlands
Willem Scholten <wk.scholten@xs4all.nl>