Drug Laws Restricting Pain Medicines Set To Be Relaxed In Romania

Main Category: Pain / Anesthetics
Also Included In: Cancer / Oncology;  Palliative Care / Hospice Care
Article Date: 25 Jun 2006 - 0:00 PDT

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Overly restrictive national drug policies that hinder access to pain relief by patients with cancer, AIDS and other diseases are set to be revised in Romania. The changes are the result of an innovative and broad reaching initiative led by Romania and supported by the World Health Organisation (WHO) and the University of Wisconsin.

The 3-year collaborative project to identify and remove regulatory barriers to pain relief was led by a commission of Romanian pain and palliative care experts and the Romanian Ministry of Health with assistance from the University of Wisconsin Comprehensive Cancer Center's Pain & Policy Studies Group (PPSG).

The project used WHO guidelines to evaluate the anti-narcotics law that had been adopted in 1969 during the Ceausescu regime. The Commission recommended changes to the law and Ministry of Health prescribing regulations. As a result, the Romanian Parliament has adopted a new law, and the Ministry of Health is finalising simplified new regulations for opioid prescribing.

In addition, a twinning called "Fighting against drugs trafficking and abuse" was organised by the European Union between Romania, Spain and France in 2004 and 2005. One component concerned the licit circuit of narcotics and psychotropic substances. During this component, experts from Spain and France also proposed a draft of the law and the regulation to the Romanian authorities.

Since 1969, drug policies in Romania prevented physicians in the country from prescribing opioid analgesics for chronic pain management. Too often patients died before all the paperwork necessary to obtain pain medicines could be completed. As a result, Romania has one of the worst records in Europe regarding patient access to drugs that the WHO deems essential for pain relief. Unrelieved severe chronic pain can destroy an individual's quality of life and the will to live. Morphine and other pain-relieving opioids can help restore what a patient has lost due to inadequate pain relief.

According to the WHO and the International Narcotics Control Board, barriers to pain relief worldwide are due in part to excessively strict national drug-control policies that limit the medical use of morphine and other opioids. These actions by the Romanian government are an important milestone towards ensuring that patients with severe pain can obtain the medications that are available in other European countries.

"There is a genuine sense of excitement amongst palliative care professionals," explained Dr Daniela Mosoiu, palliative care specialist and co-chair of the Romanian Palliative Care Commission. "Very soon, specialists and certified general practitioners will be able, for the first time, to practice modern pain medicine. When the final regulations are approved, the process we used to evaluate our national policies may be an example for other governments and palliative care organisations to consider."

Mr David Joranson, Director of the PPSG, said "This project was an exemplary effort of government working with palliative care experts to identify and remove unduly strict prescription regulations and improve access to opioids for pain relief"

The new regulations are expected to be approved later this year. In addition, a comprehensive educational program about pain management and opioid medication for general practitioners is under discussion.

-- The reform of drug control policy for palliative care in Romania project began in Budapest, 2002, during a World Health Organisation workshop focusing on improving availability of opioid analgesics for palliative care.

-- The workshop was attended by teams from 6 countries, including Bulgaria, Croatia, Hungary, Lithuania, Poland, and Romania.

-- Following the workshop, the Romanian Ministry of Health appointed a Palliative Care Commission to make recommendations for changing policy that controls prescribing of opioid analgesics. The PPSG, a WHO Collaborating Center for Policy and Communications in Cancer Care, was invited to assist the Commission.

What are Opioids?

For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)

http://www.medsch.wisc.edu/painpolicy

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