Present: see attendance list
MUDr. Adam Hlôška CEO of the Pharmacy Section and Director of Pharmacy Department
Agenda of the meeting:
- falsified medical prescriptions
- Authorisation register
- professional representative in public pharmacy
- dispensation to the patient - non-contractor, patient debtor health insurance
- anabolics
- Reexport of medicines - unavailable
- cross-border healthcare
- Ethics committees
- Miscellaneous
Dr. Slaný informed about the request of the Bratislava self-governing region and Slovak Pharmacy Chamber to solve problem of counterfeits medical prescription by introducing protective features on medical forms Regulations. Representatives of BSK and SLEK briefed on the problem. SLEK expressed the need to introduce any economically viable protective measures the element of medical prescriptions with a view to checking the security features in practice no further technical equipment of the pharmacy was required, with priority The aim of legislative regulation should be to prevent the copying of medical the rules, as well as the introduction of a record-keeping check on the issue of forms.
Ing. Rastislav Beliansky, Director General of the Informatics Section, informed that The problem of falsified prescription forms will solve the introduction of information electronic system e-health from 1.1.2017.
Representatives of printers, ŠEVT and PROMPT printers have commented on technical options for introducing security features.
ŠEVT offered the possibility of water printing as a protective element, the price of the prescription would is increased to about 3 cents, leaving the current price 1.5 cents.
- The representative of ŠEVT further stated that it is necessary to require from the producers and distributors of the forms comply with the method of selling medical the rules laid down by Decree No 60 / 2012 Z.z, and in this decree suggest the method of control and penalties in case of breach of those provisions. In case of if consideration would be given to the introduction of protective features of watermark paper, special Colours, holograms suggested the use of such protective elements that are not bound only for printing in printing works certified for the printing of prizes, due to fact, that medical regulations are not included in the price list.
- The representative of ŠEVT stated that according to their previous experience of solving similar issues at the Ministry of Education of the Slovak Republic, use of watermark paper. This paper is available for any printer Þ not only for the printing works of cenins, but also unique in that the producers such the type of paper guarantees that one type of watermark is produced and sold only to one to the customer. This type of protection element is easily identifiable and v combined with registered numbering guarantees a high degree of protection. Provisional the increase in the cost of producing and distributing prescription forms is estimated ŠEVT
- More precisely, an increase in production and distribution costs would be have been estimated by the determination of other parameters - exact specification Watermark, weight of paper, duration of production of this kind of recipes and z the resulting production and distribution regime...
Estimated cost of manufacturing and distribution of medical equipment regulations using other protective will be able to estimate more accurately specification (colour type, area covered, number of medically produced regulations, production and distribution arrangements)..
PROMPT offered the solution of classical printing using a pricein color with by mechanical control using a coin. This is a priceless color from Switzerland, which can only be used by cenin printers, this color is strictly registered and is detectable even under the UV lamp.
MUDr. The depth pointed out that the increase in the price of the prescription could be maximum up to 20% optimal 0% to 10%. MZ SR will communicate with Slovak Ministry of Education, Ministry of Economy of the Slovak Republic and Ministry of Finance of the Slovak Republic the security features on their documents so that in the next procedure concerning the amendments to the relevant decree have not distorted the principles of competition; and the whole process has been clearly transparent.
Register of authorisations prepare individual NCZI VÚCs under the law. 578/2004 Coll., Law No. 362/2011 Coll. and Law No. 538/2005 Z. z. z. The authority issuing the authorisation shall indicate on the authorisation the identifier of which creation is not clearly defined and VÚC has difficulty creating it. Ing. Beliansky addressed the NCZI, which subsequently informed that on 24.4.2015 this the topic of the working meeting.
At last year's meeting of MZ SR, pharmacists VÚC and ŠÚKL, it was agreed that individual VÚCs will send the SWD an up-to-date register of permits upon request inspection activities in a format other than that laid down by law. Dr. Peterovich strongly pointed out that without the current authorisation register in the SPA the required format is carrying out the inspection activity complicated. Requested the transmission of the register authorisation in the SWD required format . as agreed on the last working meetings. Since Slovak legislation does not require VUC to inform ŠUKL on changes in authorisation registers and agreement with VUC on the transmission of these data to ŠUKL in other format than that imposed by the law, was not filled by several VUC, MZ SR is not authorised under the applicable legislation to require the VUC to this Agreement They were. Therefore, the requirement for VUC to do so is waived. MZ SR asks NCZ, to send these data, which VUC receives from law, to ŠUKLA.Professional representative under Law No 362/2011 Z.z. may operate an expert representative in only one place of activity. MZ SR records cases, where the professional representative was also a professional representative in the public pharmacy and in the a large distribution company. Individual representatives of VÚC and SleK agreed on that in many cases the function of a professional representative is only fictitious and professional In many cases, the representative is not present at the workplace at all. Present suggested that at the next amendment of Law No 362/2011 Z.z. have been modified the conditions for the appointment of an expert.
Medicinal product to the patient - non-contractor, patient debtor insurance premiums. The MZSR Section has already dealt with the issues legiaslatively and legally.
nabolic on the development of the issue of anabolic abuse and control informed Dr. Slaný, who regularly attends working meetings organised by Naka. A law is being prepared to address this issue.
Re-export of medicinal products MUDr informed about the situation. Table in the European Commission's comments.
Cross-border healthcare currently in force the order of MZ SR 42/2015 Z.z., supplementing the decree of the Ministry of Health of the Slovak Republic Republic No 60/2012 Forms intended for prescribing medicinal products and medical devices, on graphical elements and details of these forms and their points of sale and details of registration their expenditure.
Ethics commissions Dr. Slaný also informed about the current situation he made the proposals made on 15.04.2015 at the working meeting.
Miscellaneous
Conclusions of the working meeting:
The representatives of Shevt and Prompt will propose technical solutions to prevent forgery of prescription forms,
Department of Pharmacy and Drug Policy in conjunction with the Department of Informatics and NCZI ensure a methodology for the creation of an identifier.
Developed by Dr. Katarína Gelienová