Article of the Month
Carla Ripamonti, MD
(Italy)
REFORM OF DRUG CONTROL POLICY FOR PALLIATIVE CARE IN ROMANIA
Author(s): Mosoiu D, Ryan KM, Joranson DE, and Garthwaite JP
Journal: The Lancet 2006; 367 June 24: 2110-2117 www.thelancet.com
According to the World Health Organization (W.H.O.) about 22 million people in the world have cancer and these numbers are expected to double by 2020. More than 50% of new cases and deaths from cancer occur in developing countries. In Romania , more than two thirds of cancer patients are diagnosed in the terminal phase of the disease with the highest number diagnosed with HIV infection in the sub-region of central and south-eastern Europe . The need is paramount to have Palliative Care (PC) and opioid analgesic availability in this country.
Many countries still do not have access to opioid analgesics (codeine, morphine and others) that are classified as essential medicines* by the W.H.O. This represents a serious impediment to effective pain control. The causes of these obstacles are well recognized and described by the International Narcotic Boards ( http://www.painpolicy.wisc.edu/ ). Eastern Europe is particularly at risk of inadequate availability of essential drugs needed by patients with incurable diseases.
The government of each country has the responsibility to make opioids available for pain relief. The authors report about the reform of the drug control policy for Palliative Care (PC) in Romania .
In Romania , PC started in the 80’s especially for children afflicted with AIDS. In 1992, in Brasov , the first Hospice, Casa Sperantei, opened. In 1997, the Romanian Association for PC was created and in 2000, PC was recognized as a medical subspecialty and 146 doctors were graduated. In 2002, standards for PC were defined and at the end of 2004 many PC services (hospital-based, in patient, hospice home-care teams, day-care, outpatient clinic, educational and training) were active with the leading PC service located in Brasov .
Although many opioids (except buprenorphine) are available in Romania , the use of these drugs, in particular morphine, is scarce because of the presence of various barriers.
Barriers to the use of opioid analgesics in Romania are similar to those of other countries and can be summarized as:
1. Educational problems regarding pain management;
2. Fears of health caregivers and the general population toward morphine;
3. Restrictions posed by narcotic control policies (in Romania this policy started 35 years ago during Ceausescu’s regime. The most important barrier for the prescription of opioids for outpatients by all physicians is that only a maximum of a 3-day supply can be prescribed, and the prescription must be written in triplicate;
4 There must be an oncologist in outpatient departments of state hospitals who has a special authorisation to write for a longer-term prescription in 4 copies. There are only one, or two, oncologists for a population of 300,000 to 600.000 people;
5. There areonly one, or two, pharmacies in each district that have special authorisation from the Ministry of Health to provide strong opioids;
6 . Only patients with incurable cancer, advanced arthritis at the gangrene stage, cardiopathy and severe dyspnea have the right to be administered opioids;
7 . The family doctor is not able to change the dosage, or the type of opioid, prescribed by an oncologist even if the patient’s health deteriorates;
8 . The maximum daily dose of morphine has been set at 60 mg for a very long time;
9 . It is only possible to prescribe a single opioid administered by a single route, thus making it impossible to prescribe rescue doses of short release opioid medications.
In February 2002, during a workshop in Budapest on opioid availability for PC sponsored by the Pain and Policy Studies Group (PPSG) WHO European regional office (University of Wisconsin), Romania was selected as a country to be monitored for WHO guideline implementation regarding the access by patient’s to drugs for pain relief and to note the regulatoryand administrative barriers to obtain these drugs which are considered to be the principal causes of poor pain relief. In 2003, the Ministry of Health and the Commission of Specialists in Pain Therapy and PC invited the PPSG to work together with them to analyse the existing regulatory and administrative policies in Romania and to define the appropriate changes that are necessary and consistent with medical and scientific knowledge and with international guidelines for opioids control policy.
It was not an easy task, thankfully it was possible to achieve success because of the collaboration of the various political, scientific, educational and organizational committees. The final document was furthermore reviewed and appraised by the PPSG.
In November 2005, the proposed law was passed by both the Senate and Chamber of Deputies. Some of the proposed changes reduce barriers to the writing of prescriptions, they are:
- it is no longer necessary to have a special authorisation for opioid prescription for outpatients;
- more than one opioid can be prescribed on a single form;
- the type of opioid, the route of administration and the dose can be changed according to the patients’ need independently of the diagnosis and the stage of the disease;
- PC specialists will have the ability to prescribe the amount of the required drug for 30 days with no limit on the dose.
- Non-specialists must be trained and then their capacity certified before being authorized to prescribe these drugs
Why I chose this article
This article describes a task carried out with great effort and commitment by PC physicians with the help of experts and associations from other countries to improve national drug-control policy. Thanks to this collective effort and the strong leadership undertaken by experts in PC in cooperation with the Palliative Care commission of the Ministry of Health and the Romanian Parliament. The awareness of the problem by the latter entities, and their taking in hand their responsibilities with mutual respect, successfully brought about the reform of Romania ’s drug control policy for palliative care. This result is a breakthrough for elderly patients with various pathologies and at different stages of their illnesses.
My choice of this study as the article of the month demonstrates that achievements of this kind should be motivating and encouraging to the many people who live in various countries (and not only those defined as developing countries), and who work with great enthusiasm to create or intensify palliative care. It seems that perseverance, despite the great deal of effort, is finally rewarded when targets are reached. We also extend our gratitude and thanks for the support of groups and international associations that intervene when called upon to do so in these difficult situations, and together, with the local specialists in the various countries, are able to bring about change.
* Also see our website under the Treatment Guidelines in the Resources Section in http://www.hospicecare.com/resources/treatment.htm Look for IAHPC Essential List of Medicines in Palliative Care that has recently been developed in collaboration with others.
Regards,
Carla Ripamonti, MD
Member of the Board of Directors, IAHPC
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http://www.hospicecare.com/AOM/
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