The Czech Republic Annual Report 2010 Drug ... - Drogy-info.cz

Table 5-6: Number of outpatient healthcare facilities according to number of addictive substance users treated and
facility locations in 2010 (Nechanská, 2011c)
Number of clients
Region
1–10 11–50 51–100 101–
150
151–
200
201–
300
301–
400
Over
401
Total
number
of
facilities
Total
number
of
clients
Prague 19 26 9 6 1 5 6 5 77 9,175
Central Bohemia 6 14 3 7 0 2 1 0 33 2,485
South Bohemia 5 9 3 2 0 1 0 0 20 926
Pilsen 10 7 3 1 2 1 0 2 26 2,525
Karlovy Vary 2 6 2 0 1 1 0 0 12 702
Ústí nad Labem 9 8 5 4 1 1 1 0 29 1,864
Liberec 3 4 2 2 2 1 0 0 14 1,082
Hradec Králové 6 10 3 1 1 0 3 0 24 1,864
Pardubice 0 8 1 3 1 1 0 0 14 1,036
Vysočina 6 12 4 3 0 3 0 0 28 1,727
South Moravia 12 24 9 6 3 4 0 1 59 4,081
Olomouc 6 16 9 4 0 1 1 2 39 3,781
Zlín 2 4 10 6 0 2 1 0 25 2,427
Morava-Silesia 2 22 9 7 5 2 3 3 53 6,523
Total 88 170 72 52 17 25 16 13 453 40,198
5.2.2.2 Opiate Substitution Treatment
In 2010, three products for the substitution treatment of opiate addiction were available: (1) methadone prepared
from an imported generic substance, available in specialised substitution centres since 1997; (2) Subutex ® ,
containing buprenorphine as the active substance, available since 2000, and (3) Suboxone ® , a combined medicinal
product containing buprenorphine and naloxone as the active ingredients, available since February 2008. Subutex ®
and Suboxone ® , which are available in pharmacies as proprietary medicinal products, can be prescribed by any
medical doctor, regardless of their specialisation. Substitution drugs are administered only orally in treatment.
Additional proprietary medicinal products (PMPs) containing methadone or buprenorphine 67 for substitution
treatment were registered in the Czech Republic in 2009–2011, and several were released onto the market. It has
been possible for Suboxone ® 8 mg to be partially reimbursed from the resources of the health insurance system
since 2010 68 .
A total of 22.5 kilograms of pure methadone substance was imported into the Czech Republic and 3,308 grams of
buprenorphine in Subutex ® and Suboxone ® were distributed in 2010; see Table 5-7. Since 2008 there has been a
decline in the share of Subutex ® and an increase in the share of Suboxone ® in the total amount of buprenorphine
distributed (consumed) for substitution treatment, although Subutex ® retains a dominant share (Ministerstvo
zdravotnictví ČR, IOPL, 2011); see Figure 5-1.
67
On 18 March 2009, the State Institute for Drug Control (SUKL) registered Methadone-Zentiva ® 5mg/ml in the form of an oral solution
in packages of 10, 50, and 1000 ml; on 1 July 2011, the Institute's decision not to grant reimbursement for this medication from the
public health insurance system came into legal force. Whether (and when, if so) the proprietary medicinal product methadone will be
placed on the market despite the fact that reimbursement from the public health insurance system was not granted is not yet known.
The main reasons not to grant the reimbursement included the inferior safety profile of the medication (a higher risk of overdose in
comparison with buprenorphine) and the fact that the public health insurance system already provides reimbursement for Suboxone ® 8
mg. In addition, on 29 October 2009 the State Institute for Drug Control (SUKL) registered the medication Buprenorphine Alkaloid ® in
strengths of 0.4 mg, 2 mg, and 8 mg in the form of sublingual tablets and on 19 May 2010 the medicinal product Ravata ® in strengths of
2 mg and 8 mg, also in the form of sublingual tablets. Buprenorphine Alkaloid ® was placed on the Czech market on 28 January 2011, in
strengths of 2 mg and 8 mg, and Ravata ® on 15 June 2011 in the same strengths. The latest substitution product, authorised in the
Czech Republic on 15 September 2010, is Addnok ® , containing buprenorphine, also in strengths of 0.4 mg, 2 mg, and 8 mg; this product
has not yet been placed on the market.
68
On 1 February 2010, a decision by the State Institute for Drug Control (SUKL) came into effect on the basis of which Suboxone ® 8 mg
is partly reimbursed. Reimbursement is subject to medical expertise (it must be prescribed by a psychiatrist or physician with
specialisation in the field of addiction), and the treatment is not reimbursed without the patient’s compliance (for example, if they miss an
appointment); an additional condition for the reimbursement of Suboxone ® is that treatment must take place in (selected) specialised
medical facilities. This is the first time in the country’s history that a medicinal product for substitution treatment for opiate/opioid
addiction has been covered by the public health insurance system. However, the nature and scope of the conditions for reimbursement
are such that, in practice, the cost is never covered by the public health insurance system.
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