Drug legislation in the Slovak Republic and monitoring of medicines

1. Drug legislation in the Slovak Republic and monitoring of medicines containing pseudoephedrine (PSE) PharmDr. Jozef NémetDepartment of Drug precursors SIDC Telephone: +421 2 5070 1220 E-mail: nemet@sukl.sk

2. Annual report 2012: The state of the drugs problem in Europe TheProblem ofamphetamines use • the Czech Republic (2010): 27 300–29 100 (3.7–3.9 cases per 1 000 aged 15–64) • increase compared with previous years • more than double the estimated number of problem opioid users • theSlovakRepublic (2007): 5 800–15 700 problem methamphetamine users (1.5–4.0 cases per 1 000 aged 15–64) • about 20 % fewer than the estimated number of problem opioid users

3. Annual report 2012: The state of the drugs problem in Europe Methamphetamine in Europe: Latvia, Sweden, Norway, Finland (to a lesserextent): • partially replaced amphetamine 2010 • at very low levels in: • Germany, Greece, Cyprus, Hungary and Turkey • drugseizuresincreased in: • Estonia, Austria illicit methamphetamine production concentrated in: • the Czech Republic (307 productionsites - small-scale ‘kitchen laboratories’ detected in 2010(down from 342 in 2009) • productionoccursalso in Slovakia, Germany, Lithuania, Netherlands and Poland

4. The Slovak Legislation - drug precursors • Act No. 268/2000 Coll. on the treatment of precursors of narcotic drugs and psychotropic substances and on the amendment of Act. 455/1991 Coll. on Trade Licensing (Trade Licensing Act), as amended - effective from 1.9.2000 (Article 12 of the UN Convention on trade in precursors) • Act No. 219/2003 Coll. on the treatment on chemicals that can be diverted to the illicit manufacture of narcotic drugs and psychotropic substances and amending Act no. 455/1991 Coll. on Trade Licensing (Trade Licensing Act), as amended - effective from 1.9.2003 (SR approximation of legislation with the EU legislation) • Act No. 331/2005 Coll. on the state administration in matters of drug precursors and on amendments to certain laws - effective from 18.8.2005 (Act on the basis of EU legislation1.,2.,3.) 1. REGULATION (EC) No 273/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof11 February2004 on drugprecursors; 2. COUNCIL REGULATION (EC) No 111/2005of22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drugprecursors; 3.COMMISSION REGULATION (EC) No 1277/2005of27 July2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament andof the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rulesfor the monitoring of trade between the Community and third countries in drug precursors

5. Extract from the report: 06.12.2007, Brussels The SecondMeeting of the Working Group ofthe EC on drug precursors • the question of abuse of pharmaceutical preparations containing ephedrine and pseudoephedrine for the illicit manufacture of drugsdiscussed • the Czech Republic and the United Kingdom facedthisproblem • theEC recommended to solvetheproblem by meansof a medical law • Transferrof products from OTC to be dispensed on medical prescription • the Slovak Republic: Act No.140/1998 on medicines

6. Situation in Slovakia: • repeated requests for resolving theabuse ofmedicines containing ephedrine and pseudoephedrine from the level of the EC - not successful • the Ministry of Health invitedforthecooperation • aim: to reducetheavailabilityofthe OTC medicinescontainingpseudoephedrine • negotiations startedatthe beginning of 2009 -theSlovak Chamber of Pharmacists, Association of distributors of medicines and main expert Ministry of Health SR for drug addiction medicineparticipated

7. Problem: The abuse of medicines containing pseudoephedrine (PSE) for the illicit manufacture of methamphetamine (pervitine) • There are data on medicines abuse • Is the classification for OTC medicines correct (= prescription medicines)? • May we limit the availability otherwise? • Dowe propose solutions to other departments? • Proposal to bind all products containing PSE to prescription.

8. Opinion of the Commission on the safety of medicines of the SIDC dated on 21.05.2008 Safety Commission recommended the following: maximum of 30 mgof PSE in the medicine unit andmaximum of 720 mg per medicinepackage for free sale

9. Opinion of the Commission for Medicinal Products dated on 19.08.2008 Taken the view of the Commission for the safety of medicinesand within this it recommended that the SIDCtakes appropriate measures.

10. The measures taken by the SIDC (the year 2008) • invited the holders of marketing authorizations for medicinal products (= pharmaceutical manufacturers) • containing more than 30 mg ofPSE in a solid unit dosage form and / or • more than 720 mg of PSE in one package • for Administration applicationto changethewayof dispensing to„only on medical prescription“

11. The minutes of the meeting of the Commission on safety of medicines which took place on 30.9.2009 Pseudoephedrine The Commission • sees no reason to change the original opinion of 21.5.2008 • appreciates that theirproposal to restrict the dispensingofmedicinal products in pharmacies per onetreatment cyclewillbeimplementedintothelaw • one treatment cycle = onepackageof OTC medicine • benefits of this groupofmedicines are very small • they canbe risky (e.g. unrecognized and untreated hypertension). • donotbelong to essential medicines for the treatment of influenza and cold • incorrect advertising = verydangerous • proposes to require fromholders of medicines • no misleading advertising promoting rational useofmedicine • compliance with theprinciplesof treatment of these diseases

12. 362 ACT of 13 September 2011 on medicines and medical devices and on amendments of certain laws § 129 The competence of the State Institute (1) The State Institute is the state administration body in the field of human pharmacy and drug precursors. The State Institute is a budgetary organization and is headed by the Director who is appointed and dismissed by the Minister of Health. (2) The State Institute a) performs state supervision in the field of human pharmacy and drug precursors, 88)

13. § 3 (3) For the treatment of medicinal products containing drug precursors, in addition to authorization stated in paragraph 1, a permission under special regulation is required.4)4) Act. 331/2005 Coll. on the state administration bodies in matters of drug precursors and amending some acts as amended by Act no. 425/2010 Coll. Regulation of the European Parliament and of the Council (EC) no. 273/2004 of 11 February 2004 on drug precursors (OJ Special Edition, Sec. 15/zv. 8; OJ L 47, 18.2.2004), as amended. § 22  Special conditions of the Internet dispensing (4) The holder of a license to provide pharmaceutical care in a public pharmacy or dispenser of medical devices providing the Internet dispensing is required a) to dispense human medicines containing drug precursors only in that number of packagesthat is necessary for one treatment cycle,

14. § 23 Obligations of the holder of a license to provide pharmaceutical care(1) The holder of a license to provide medical care is required aj) when dispensing the human medicinal product containing drug precursor the dispensing of which is not bound by medical prescription, to dispense this human medicine in maximum number of packages that is needed for one treatment cycle,

15. § 121 Dispensing human medicines, medical devices and dietary food (4) A person who dispenses human medicines the dispensing of which is not bound by medical prescription,is required to dispense the human medicine containing drug precrusor in maximum number of packages that is needed for one treatment cycle.

16. § 138 Other administrative offenses in the field of human pharmacy (5) The holder of a license to provide medical care committs another administrative offense ay) when dispensing human medicine containing drug precursors, the dispense of which is not bound by medical prescription, dispenses such human medicine in higher number of packages than necessary for one treatment cycle, (22) The health staff committs another administrative offensee)when dispensing human medicine containing drug precursors, the dispense of which is not bound by medical prescription, dispenses such human medicine in higher number of packages than necessary for one treatment cycle,

17. § 138 Other administrative offenses in the field of human pharmacy (29) The self-governing region shall impose a fine of 500 EUR to 25,000 EUR for other administrative offenses pursuant to paragraph 5 except letters bb) if it concerns a holder of the authorization for the provision of pharmaceutical care in a public pharmacy, the holder of the license to provide pharmaceutical care in a dispenser of medical devices, holder of provision of pharmaceutical care in the dispenser of audio-prothetic medical devices and holders of permission for the provision of pharmaceutical care in the dispenser of orthopedic and prothetic medical devices.

18. In this context, • the Ministry of Health of the Slovak Republic approved: • "Vocational Guidance No.: OF/1511/2010 of 30 November 2010 regulating the number of packages containing the drug of drug precursors needed for one treatment cycle" (valid from 01.12.2010 to 30.11.2011) and • "Vocational Guideline. OF/1111/2011 of 24 November 2011 regulating the • number of packages containing the drug of drug precursors needed for • one treatment cycle" (effective from 01.12.2011).

19. A part of these guidelines is a table which lists all OTC drugs containing pseudoephedrine (the "PSE") and the quantities of these drugs that can be given/sold in a pharmacy. Observance of the provisions of vocational guidance is ensured by: • control activity by inspectors of CorrectPharmacy Practiceofthe SIDC by targeted inspections in agreement with the joint police and customsunit; • jointpolice and customsunitcarriesoutanalyzesof supplyof OTC medicines containing PSE in public pharmacies. • Thedata of such deliveries are derived from monthly reporting ofwholesale distribution organizations that are presented basedon the direction of the Ministry of Health of the Slovak Republic (letter of the Minister of Health). • From the obtained data, pharmacies that buy prescription medicines containing PSE in amounts that far exceed the normal average quantity of such products required for the operation of public pharmacyare selected.

20. Monitoring of medicinal products with pseudoephedrine in the Slovak Republic Ephedrine and pseudoephedrine (PSE) are chemical substances used in medicinal products authorized for treatment ofsymptoms of respiratory infections and allergies. These substances are also main precursors for synthesis of methamphetamine/meth. From the European countries only the Czech Republic and Great Britain have problems with abuse of ephedrine and pseudoephedrine for manufacturing ofillegal drugs. European Commission recommended solving this problem on the national level, by changing the prescription status from over-the-counter (OTC) to prescription only medicines (POM). The Slovak Republic proceeded as follows: On 21st May, 2008 the Committee for Drug Safety at SIDC recommended OTC status only for medicinal products with maximum of 30 mg PSE in single dose of medicinal product and maximum of 720 mg in one packaging of medicinal products. This recommendation was supported by Committee for Medicinal Products at SIDC. Marketing Authorisation Holders of medicinal products with more than 30 mg PSE in single dose of medicinal product and more than 720 mg in one packaging of medicinal product were asked by SIDC to change from OTC to POM. In 2009, Committee for Drug Safety confirmed their previous statement from 2008. The Committee also agreed with the proposal to restrict dispensing of certain medicinal products to amounts needed for one treatment cycle. This proposal has been included into the Medicines Act No. 362/2011 coll.

21. Ministry of Health issued guidance specifying number of packagings of individual medicinal products needed for one treatment cycle (OF/1511/2010, OF/1111/2011; see below). Number of packaging of medicinal product containing drug precursors needed for one treatment cycle

23. Monitoring of consumption of products containing pseudoephedrine (PSE) • The monthly returns on marketing authorization holders of medicinal products (manufacturers) on supply of products containing PSE to wholesale distribution organizations (§ 128 paragraph. 1 point.) of Act no. 362/2011 Coll. on medicinal products and medical devices and Art. 14 point. f) of Regulation (EC) no. 273/2004 of the EP and of the Council on drug precursors) • Monthly reporting of organizations to supply wholesale distribution of medicinal products containing PSE to public pharmaciesand hospital pharmacies.

25. Analysis of sales of OTC medicines (over 600 packs / month)

26. SIDC targeted inspections are carried out since 2011 under the expert guidance of the Ministry of Health of the Slovak Republic No.: OF/1511/2010 of 30 November 2010 regulating the number of packages of medicines containing drug precursors needed for one treatment cycle, which took effect on December 1, 2010 (the professional guidance from November 24, 2011 was repealed and replaced by spec. Guideline OF/1111/2011). In 2011, 17 targeted inspectionswere carried out, in 2 cases administrative proceedings were initiated with a proposal to impose a fine. In 2012,there were 28 targeted inspections and in 2013 a total of 35 targeted inspections without imposing a fine. On the basis of targeted inspections carried out in public pharmacies in 2011/2012/2013 a decrease of supply of selected prescription medications containing PSE was noticed. The purpose of the adoption of these regulatory measures for supply / sale of such products was mainly to allow a pharmacist to reduce such expenditure / sale to persons suspected of abuse the medicines to illicit manufacture of methamphetamine (meth). In doing so, we are aware of the fact that such a restriction only hampers the availability of these drugs to those who want to abuse them. The effectiveness of these measures is documented in the following table on the evolution of supply (and subsequent dispensing / sale) of selected prescription medications containing PSE, which is most commonly misused for the illicit manufacture of methamphetamine:

31. = places where increased supply of products containing PSE was recorded

32. Thank you for your attention!