Importation of controlled release opioids first occurred in 1993 and these medications were registered the following year; but their usage remained highly restricted even in oncology centres, due to the high costs involved. Slow release morphine has been available in Bulgaria since 1992, but (in 1998) morphine was not available in immediate release tablets and liquid forms. Morphine consumption was 3.65 kg in 1992 and rose to 25 kg in 19945, but pethidine is 'the drug of choice for cancer pain relief provided by the majority of doctors.'6 Oxycodone, fentanyl, tramadol, dihydrocodeine and ketobemidone are also reported to be available. All prescriptions are made in triplicate. Sopharma Ltd is the sole producer of opioid analgesics in Bulgaria. The table shows patterns of opioid use in Bulgaria over the six years 1995-2000.
Opioid consumption in Bulgaria (1995-2000)
Dihydrocodeine
Fentanyl
Morphine
Pethidine
Tilidine
1995
638 g
58 g
8259 g
17547 g
32241 g
1996
0 g
42 g
5301 g
18498 g
14495 g
1997
480 g
74 g
10640 g
22240 g
22258 g
1998
1350 g
62 g
14492 g
17418 g
38040 g
1999
2948 g
71 g
16685 g
26383 g
31417 g
2000
4947 g
69 g
21705 g
26852 g
19545 g
Source: Country report for Bulgaria; Workshop on Assuring Availability of Opioid Analgesics for Palliative Care, Budapest, 25-7, 2002.
The average daily consumption of defined daily doses of these drugs per million inhabitants between 1994-98 was: codeine (5146); dihydrocodeine (2); ethyl morphine (229); morphine (103); methadone (30); pethidine (20).7
In February 2002, issues relating to the use of opioids in Bulgaria were summarised by an expert group8 as follows, and an action plan was formulated to address them:
Does national policy require the use of a special prescription form? Yes, triplicate form for opioids.
Does the physician or institution have to pay for the special prescription form? No
Does national policy establish a validity period for opioid prescriptions? If so, what amount? Yes, 7 days
Does national policy establish a maximum amount that can be prescribed at one time? If so, what amount? Yes, 15 days therapeutic dose
Does national policy limit the length of time that a patient may be treated with an opioid? No
Average defined daily doses of morphine, Central and Eastern Europe (1994-1998)
Source:Clark D, Wright M (2002)Transitions in End of Life Care: Hospice and Related Developments in Eastern Europe and Central Asia.Buckingham: Open University Press