Example 3: Regulatory Reform in Romania
Project Type: Regulatory Reform
University of Wisconsin, Pain and Policies Study Group
Madison, Wisconsin, USA
A team of health care workers in Romania worked with the Pain & Policy Studies Group at the University of Wisconsin to convince Romania’s regulators that a change in that country’s opioid control policy was necessary.
Romania’s drug-control policies were more than 35 years old and imposed an antiquated regulatory system on pain medication based on inpatient, post-surgical management of acute pain. This restricted prescription authority of opioids to only in-hospital patients who had just undergone surgery, making access to opioid treatment difficult for patients with severe chronic pain due to cancer or AIDS.
In 2002, a Romanian team composed of health care professionals, representatives from narcotic authorities and the ministries of health, social welfare, and insurance industry — all working on cancer, HIV/AIDS, pain, and palliative care issues — attended an International Palliative Care Initiative (IPCI) workshop on ensuring the availability of opioid analgesics for palliative care.
The Romanian team returned home and advocated for the creation of a national commission to reform Romania’s opioid control policies. To convince regulators that a change in opioid law was needed, the team cited to Romania’s patient rights law, which stated, “The patient has the right to palliative care in order to die in dignity.” (24/2003, Cap VI, art. 31). The Ministry of Health agreed to form a Palliative Care Commission (PCC) to study the matter. Finding that Romania’s opioid control policies fell short of WHO guidelines, the PCC invited the Pain & Policy Studies Group from the University of Wisconsin to collaborate in the preparation of recommendations.
Results and Lessons Learned
Altered legislation and regulation
Based on the resulting report, the Ministry of Health drafted legislation to replace the old narcotics law. Parliament passed this into law in 2005. The Pain and Policy Studies Group then worked with the Ministry of Health on implementing regulations. In 2006, the Ministry of Health approved the regulations.
Greater authority to prescribe opioid medication The new law grants greater authority to professionals to prescribe opioids and fewer restrictions on dosages and disease requirements. Special authorization is no longer necessary to prescribe opioid medications for outpatients (patients not admitted to a hospital). As well, non-specialists can prescribe opioids after receiving certified training. The law eliminated both dosage limitations and restrictions to approved diseases, freeing health care professionals to prescribe opioids for any condition and in any dosage. Every doctor has the authority to prescribe strong opioid medications, according to his/her medical judgment.
With this radically expanded authority to prescribe opioid medications, it was important for doctors to receive education on pain management. Article 54 of the regulations provided that: “Universities of medicine and pharmacy, the Ministry of Public Health, the College of Physicians from Romania, the College of Pharmacists from Romania and professional or scientific societies, as well as other suppliers of professional training shall take measures for the regular organization of training, courses for adequate therapy of pain and prescribing, use and legal status of narcotic and psychotropic plants, substances and preparations.”
Romania is currently conducting a country-wide effort to education health care professionals in the use of opioid analgesics. With a 15-month grant from the Open Society Institute, Hospice Casa Sperantei took the lead in training physicians in palliative care. The curriculum includes 20 hours of classroom teaching on two consecutive weekends, and six hours of clinical practice in each physician’s practice setting. After completing the course, physicians receive a certificate from the Ministry of Health.
The new law and regulations were a result of a four-year project between local professionals, international experts and national authorities. The new legislation and regulations meet the WHO guidelines and increase access to palliative care medicines.
WHO, Achieving Balance in National Opioids Control Policy: Guidelines for Assessment (2000).
This document served as a basis for the legislation. It outlines the need to balance modern pain management with obligation to control non-medicinal or recreational use of opioids.
Law no. 339/29.11.2005 on the legal status of narcotic and psychotropic plants, substances and preparations. Official Journal no. 1095, December 5, 2005.