Lukas Radbruch, Coordinator of the ATOME project (Access to Opioid Medication in Europe) reports on the ATOME National Symposium held in Belgrade on 3 October 2013.
Where would we like to go? This was the question put forward by Milica Prostran, President of the Government Commission for Psychoactive Controlled Drugs in Serbia. She reported that in Serbia the per capita consumption of opioids was only 40 mg morphine equivalent, much less than, for example, in the neighbouring country of Slovenia, which has scored a three times higher consumption of 112 mg per capita. All in all, 293 kg were used in 2010 in Serbia, whereas if all patients with severe pain were treated appropriately estimates of the actual need would be more than 2,088 kg! This points to a severe under treatment, which leaves many patients suffering from severe untreated pain.
The low morphine consumption is related to a range of legal, regulatory and attitudinal barriers. Snezana Bosniak, research professor in the Institute of Oncology and Radiology of Serbia, reported on a survey on opioidphobia: 88% of physicians were reluctant to prescribe opioids, with the major concern that it could cause respiratory depression (which is a very rare complication when opioids are titrated correctly against the pain severity). Patients were also reluctant to accept morphine, only 7% of patients did not object when morphine was suggested for pain relief. This was related to fear of tolerance, of addiction and of adverse effects; morphine also symbolised the terminal stage and imminent death for patients and so the prescription of morphine was seen as a death sentence. In addition, some patients did not want to appear as a weakling, and stated that they would not need morphine, but rather bear the pain.
Aukje Mantel from the University of Utrecht reported on the legal and regulatory barriers in practice in Serbia. Results from a quick scan of Serbian legislation on opioid regulation and prescription showed that the number of barriers in Serbia is lower than in other countries in the ATOME project. A number of barriers were identified in the prescription regulations. She also pointed out the use of negative language used in legal texts. For example: “in the event of a death caused by the use of psychoactive controlled substances…” might alert physicians, who would be afraid that death would be attributed to the opioid therapy, even in a cancer patient dying from his progressive disease.
The well-known author, actor and TV film director, Timothy Byford, suffering from multiple myeloma, reports his experience of suffering from severe pain caused by multiple myeloma which had been diagnosed eight years ago. He reported on the effect of the transdermal fentanyl patch. “Initially I could not function, and stopped taking it. But the pain got too strong, and so I slowly got used to the fentanyl.”
Byford is using 150 µg/h now. “You can say that I am a drug addict, as I cannot function without the analgesic” (though it is clear that he is not an addict, but a pain patient). He also reported that when he did not get the fentanyl patch because it was out of stock, he put up a message on Facebook asking if anybody had any fentanyl patches left, and got some offers almost immediately.
For harm reduction with opioid maintenance therapy, four regional centres and 26 centres were established in 2007 with support from the Global Fund. Three thousand patients now receive methadone substitution therapy according to Mirjana Jovanovic, President of the Republic Expert Commission for the Prevention and Control of Substance Abuse. However, there is still no underlying systematic approach and funding from the Global Fund will run out next year, leaving the centres with an unclear future.
Taking this information as the starting point, Milica Prostran emphasised the need for change. The Serbian rules on prescribing and dispensing medicines date back to 1994 (amended in 1997 and 2002), so it is outdated. However, Milica Prostran was able to provide some exciting news: a revision to the law is currently being drafted, using the impact from discussions at a previous ATOME workshop held in Utrecht earlier this year. Nine amendments are being discussed:
- No restriction on the total amount: currently 200 mg morphine per prescription. Considering that the Defined Daily Dose is 100 mg morphine per day, this would provide a supply for two days only.
- Extend the duration of treatment from 14 to 39 days.
- Extend the validity of prescription from seven to 30 days
- Allow more than one opioid at the same time, for example SR (sustained release) for continuous pain and IR (immediate release) for breakthrough pain, provided two separate prescriptions are filled.
- A clear statement that patients should be able to receive the medicines they need.
- Allow off-label use under strict circumstances for other indications, provided that this is based on evidence-based guidelines.
- Prescribe and reimburse without statement of the diagnostic code (ie when cancer diagnosis is not yet confirmed).
- Report adverse effects, but use the term ‘narcotic drug’ only when referring to substances listed in the Single Convention.
- Remove article that controlled substances can only be prescribed when necessary (any medicine should only be prescribed when necessary).
We do hope that these changes can be implemented, making morphine more accessible in Serbia for the patients who need it.
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