Most opioid analgesics are available in Romania, apart from buprenorphine. Injectable morphine, hydromorphone, pethidine, and methadone tablets are produced in the country. All others (including oral morphine and Fentanyl patches) are imported. However, prior to the introduction of a change in legislation in 2002, poor education and bias against opioids by health-care professionals had proved to be an underlying barrier to the use of opioid analgesics in Romania¹⁸. The country had a very complicated, restrictive and burdensome regulatory system for prescribing opioids that made it difficult and sometimes impossible for outpatients to receive pain medication. Under this system, specialists (including oncologists) did not have independent prescribing authority, and could not practice modern cancer pain management, involving titration, change of drug, dose or route. The result was unnecessary suffering, which was reflected in statistics that showed Romania's annual medical consumption of morphine - internationally recognized as an essential medicine – as being among the lowest in Eastern Europe:¹⁹

‘A lot of patients were, and are still in pain, great pain because of the delay of administer[ing] morphine. With the misunderstanding that morphine kills, the administering [of] the morphine is postponed very, very much until the last days - that is another aspect of using morphine.’²⁰

The reluctance to administer morphine is described further in this excerpt from an interview with Gabriela Baila:

‘When I started here nobody would give more than 3 ampoules of morphine a day, nobody will allow it because they were very afraid of morphine and they would not, some of them they won’t have from where to take the information in those early days, but there are still parts of Romania where doctors are very afraid to use opioids, and there are still parts of Romania where, because of the standard of life, patients are sent home to die without any help.’²¹

Since 2002, there have been several significant improvements in government legislation relating to the availability and prescribing of opioids in Romania. For example, the maximum daily dose of morphine has been increased from 60 mg, new opioid drugs and new routes of administration have been approved, and oral morphine has been introduced²². Progress in Romania has been due to several factors: the country has developed a strong foundation in palliative care so that unmet patient needs for medicine are apparent; there is strong leadership from experts in palliative care and related specialties who have represented patient needs to the government; in turn, the government has been willing to consider changing national policy and to appoint commissions and designated staff; external guidance and skills from WHO have helped to provide a strong public health and regulatory framework; the use of international criteria-based guidelines have helped with the assessment of national policy; grant resources have enabled dialogue between the partners, study of the issues and the regulatory environment, and the drafting of new policy.²³

In February 2002, The University of Wisconsin Pain and Policy Studies Group (University of Wisconsin Comprehensive Cancer Center/WHO Collaborating Center for Policy and Communications in Cancer Care), WHO European Regional Office, and the Open Society Institute sponsored a workshop on assuring the availability of opioid analgesics for palliative care. Romania was selected to be a pilot country for continued follow up work because regulatory barriers severely restricted access to pain relief, palliative care leaders were eager to address the problem, and the Ministry of Health of Romania had recognised the problem by appointing a palliative care commission to make recommendations²⁴. The commission was chaired by Professor Andre Achimas, whose interview with David Clark in 2004 can be accessed in the Life/oral histories section of this report.

In 2003, The University of Wisconsin Pain & Policy Studies Group (PPSG) worked with the Commission of Specialists in Pain Therapy and Palliative Care in Romania to recommend changes to the national narcotics control law. During this visit, PPSG worked with the delegation to draft a regulation that would implement the new law and the simplified prescription system²⁵. The Commission members were unanimous that opioid availability and the regulatory and administrative requirements were the main barriers to achieving pain relief. On July 16th 2003, the recommendations were personally presented to the Minister of Health by a Commission member and the Pain and Policy Studies Group²⁶. The draft law, regulations and implementation plan were presented at a palliative care conference in Bucharest in April 2005²⁷. According to the draft law and regulations, special authorisation is no longer necessary for opioids to be prescribed for outpatients. Specialists will have independent prescribing authority, the proposed prescription amount is for 30 days with no limit to dose, patient eligibility based on diagnosis has been removed, and non-specialists will be able to prescribe opioid analgesics after receiving certified training.²⁸

In 2005, the PPSG hosted a 5-person delegation from Romania to examine and recommend changes to the Romanian regulatory system. The delegation included regulatory experts from the Ministry of Health, as well as representatives of oncology, palliative care, pharmacology and pharmacy²⁹. These recommendations were partially incorporated in the new law that was adopted by the Romanian Parliament in December 2005. This law entered into force on the 5th of July 2006, one month following the release of the regulations accompanying the law³⁰. Training of health professionals and pharmacists is ongoing as the new law comes into use.³¹

For the years 2002-2004, the average defined daily dose consumption of morphine for statistical purposes (S-DDD)³² in Romania was 54. This compares with other Central and Eastern European countries as follows: Serbia and Montenegro 19; Republic of Moldova 26; Ukraine 46; Hungary 87; Bulgaria 111 (Table 2).

The International Narcotics Control Board³³ has published the following figures for the consumption of narcotic drugs in Romania (2004): codeine 913 kg (down from 1025 kg in 2003); morphine 65 kg (up from 15 kg in 2003); pethidine 78 kg (up from 75 kg in 2003); methodone 7 kg (up from 4kg in 2003); dihydrocodeine 74 kg (no data available from 2003).

In 2005³⁴, morphine was reported as the first opioid of choice for pain relief prescription at a cost of between 15 – 50 euros per month (51.83 – 172.81 Romania New Lei (RON). Fentanyl was the second most prescribed opioid derivative in spite of the greater cost of 67 euros per month (231.55 RON). Methadone was the third choice for pain relief, at a considerably cheaper cost of 7 euros per month (24.19 RON).³⁵

Table 2 Average daily consumption of defined daily doses (for statistical purposes) of morphine per million inhabitants, 2002-2004 Central and Eastern Europe/Commonwealth of Independent States (plus Mongolia)

Source: International Narcotics Control Board Narcotic Drugs: Estimated World Requirements for 2006. Statistics for 2002-2004. New York: United Nations, 2006.