Import Page 1249 - Table 1
| Questions: | Answer: |
|---|---|
| What to do from the point of view of the pharmacist if the doctor indicates on the prescription the name of the particular medicinal product whose active substance is listed in Annex 1 to the Act | The pharmacist will not issue the medicine if the doctor has given only the name of the medicine. |
| On page 9, last paragraph, the generic prediction manual states "The physician must not dispense the medicine with another medicinal product or other medicinal product, or in another strength or other pack size, or any other number of pack sizes than prescribed by the physician'. I would like to ask that, in terms of the number of packages and the size of the package, we can instead of two packages, for example, Predictal 60 tbl release one 120 tbl Predictal? | The prescriber is responsible for the correct choice of the active substance or human medicinal product, the route of administration, the pharmaceutical form, the size and number of doses in weight, volume or unit units when prescribing the human medicinal product in the context of healthcare provision. The pharmacist will only issue the pack size and the number of packages as indicated by the doctor on the prescription. |
| Doctors prescribe us IM and IV medicines with a generic prescription stating the name of the medicine in brackets. . Is such a prescription valid? | No. In these cases, it is not prescribed under § 119 (5) of Law No 362/2011. Z. z. z. Annex 1 does not list the active substances with route of administration IM and IV. |
| How should health care vouchers be issued? | The prescription of medical devices is not subject to a generic prescription. |
| § 119 (5) refers to Annex No 1, the name of the active substance, the route of administration and the ATC code. Is the ATC code important when prescribing the active substance? | It's not. It is only a device to determine more quickly whether the drug is present in Annex No. 1. The law provides a drug that is prescribed with a prescription. |
| Why is there a lack of certain active substances in Act No 362/2011 Coll. Annex No 1? | Mandatory generic prescription does not apply to all medicinal products that are categorised. Therefore, Annex 1, which specifies the extent of the medicinal products covered by the generic prescription, is listed in the Act. For example, antiarrhythmics, antiepileptics, antiparkinsonian agents, monoclonal antibodies and other highly specific active substances are active substances that are not covered by a generic prescription. |
| According to the new law, is it possible to dispense the cure within a generic substitution? | Generic substitution applies to all medicinal products the active substance of which is Annex 1. If, for medical reasons, the doctor does not prohibit the dispensing of any particular medicinal product containing the active substance from Annex 1, the pharmacist is obliged to dispense the cheapest medicine for the patient or the patient has the option to choose another. Therefore, generic substitution is applied to this extent. |
| If the active substance is not listed in Annex 1 and does not apply to drugs containing narcotic drugs and psychotropic substances, several active substances, antiarrhythmics, antiepileptics, antiparkinsonian drugs, monoclonal antibodies and other highly specific drugs and is the medicinal product still to be administered p.o., how should the doctor prescribe it? | If the active substance is not in Annex No. 1 doctor will prescribe the medicine by name of the medicine, in which case the code of the medicine will also indicate the medicine, so it will be prescribed as until 30.11.2011. |
| Can the prescription be handwritten? | Yes, it can. |
| How is the doctor supposed to write out applications, orders at the hospital facility for patients? To write the active substance? | No, generic prescription applies only to medicinal products prescribed by a medical prescription issued by a public pharmacy. |
| If the doctor prescribes the name of the medicinal product and other particulars to be included in the prescription but does not write down the route of administration. Should such a prescription be returned to the patient? | The route of administration shall be the mandatory requirement of a prescription in accordance with § 119 (5). Therefore, for the active substance listed in Annex I, 1, the route of administration must be indicated in the prescription. |
| Will new recipes be used? | No, the current medical regulations remain in force in the same format as before. |
| Can the product code for the recipe be used if the whole active substance does not fit? | No. When prescribing medicinal products pursuant to § 119 (5) only the medicinal product is prescribed on medical prescription. The SUKL code of the medicine is not prescribed. |
| What to do if the patient has a prescribed medicine that is covered by a generic prescription, i.e. the Rp is prescribed only an effective bar / without a company name/ the cheapest medicine is offered to the patient, but the patient does not want the cheapest medicine. | The pharmacist is obliged to offer the patient the medicine without extra charge with the lowest surcharge. If the patient opts for a different than the cheapest, he can choose for himself what extra charge he wants. The pharmacists will enter the SUKL code for the medicine actually given to the patient in the pharmacy when retoxing. |
| If it appears after 1.12.2011 Rp with the medicine to which the generic prescription applies, but it is written in the old form, so on Rp is the company name with the drug code. Should the issue of such a medicinal product be refused? | If the prescription is issued on 1.12.2011, it is necessary to comply with the current legislation and to proceed with the new Act No. 362/2011 Coll. - the active substance. |
| Can the doctor first recommend the name of the corporate medicine and then prescribe the active substance? | No, the doctor will first write the drug, the pharmaceutical form, the strength of the medicine, the size of the pack and the number of packs of the medicine, and then he may recommend a specific medicine. |
| Programmers - it could be put on the web. excel. a file with specific active substances separately outside the manual? | The Excel Table of Drugs is published on the following link: http://www.mzsr.sk/?generica-prescription&right=notation-of-generic-prescription |
| Is the prohibition to issue a generic medicinal product still valid? | No, it's not. If the doctor has medical reasons for refusing to dispense any of the available drugs, he will write it on the back of the recipe and the pharmacist must respect this prohibition. At the same time, the physician has the duty to indicate in the patient's medical documentation the reason why he prohibits the dispensing of a replacement generic medicinal product. |
| Prioritise the order on the Rp of the active substance and if the doctor also writes the name of the particular drug, what will be on the Rp first in order and what the second | The first will be the active substance, the pharmaceutical form, the strength of the medicine, the size of the medicine. If the doctor chooses to use the possibility to write the name of the medicine, he shall state this as the last indication. See manual published by the Ministry on its website. |
| Method of administration , strength , number of pcs or number of packages to write both for the active substance and for the specific drug, or will this be sufficient only for the active substance ? | The law imposes this obligation on the active substance. |
| How will the doctor receive feedback (from the pharmacy, ZP or directly over the net? | Under Paragraph 6 (4) (a). k) of Law 581/2004 Z.z. on health insurance companies, health care supervision and amending certain laws, as amended, to which Article Art. VIII of Law No 362/2011 Z. z. z. |
| Will it be necessary to record feedback in the patient's medical documentation from a forensic point of view what the patient actually had in the pharmacy? | The doctor does not have this obligation. The doctor shall record the prescription with all the particulars required by § 119 (5). After receiving information from the patient's health insurance company about the medicinal product released, this can also be recorded in the patient's medical file. |
| Medicinal products covered by Annex 1 to the new law must be prescribed by reference to the prescription. Non-Annex 1 medicinal products must be prescribed by name of the medicinal product. Does the number 1 fall into the Annex of all medicinal products with the medicinal product listed above, or only those which have the same route of administration as indicated for the medicinal product in the Annex? | Annex 1 shall apply to medicinal products depending on the route of administration as set out in Annex No. 1. It is practically a drug with a route of administration p.o. |
| Can a ZP contracted by a general practitioner prescribe to a patient a medicinal product recommended by a non-contracting physician in his report? | In such a case, the doctor shall proceed with the prescription according to § 119 (9). |
| Must the recipes print the product code when the active substance is prescribed? | If the medicine is prescribed as an active substance, the doctor will not indicate the SUKL code of the medicine on the prescription. This is indicated by the person who dispenses the medicinal product on the basis of the specific medicinal product that has been given to the patient. |
| For the medicinal product listed in Appendix 1 to the Product Act (generic prescription), the requirement to dispense to the patient is " a human medicinal product which is free of charge or with the lowest patient surcharge and which is available unless the patient chooses otherwise." Is the medicine available on the market or in the pharmacy? Is the lowest surcharge considered the lowest surcharge according to the categorisation list or may it be another medicine (e.g. in the case of a reduction in the producer's price or in the application of the loyalty system)? If this is not done when dispensing, is it the correct offence of the holder of the authorisation to provide medical care or what are the penalties for breaching this obligation? | Accessibility is thought in Slovakia. Medicines covered by public health insurance should also be legally available. However, there may be a situation of short-term drug failure caused by various factors and the pharmacy is unable to influence availability. |
| Is the person issuing the medicinal product obliged to indicate in a certain way that another medicinal product (not the lowest supplement) has been issued at the request of the patient? | No. |
| How does MZ SR intend to resolve the issue of medicinal products intended for generic prescription in order to comply with the SPC, since not all medicinal products have the same indications? | This issue is treated in a sufficiently and comprehensible manner by the provision of Article 119 (1). 6 |
| What to push on the recipe? Name of active substance, name supplement and dosage? Or also ATC and SD active substance? Or what combination of...? | Name of the active substance, route of administration, pharmaceutical form, strength and number of packages. ATC and JD need not be printed. |
| If the doctor decides to print a code and the name of the particular medicine along with the active substance, where do they place it all on the recipe? Will there be new recipe forms? | No new recipe forms. If you have a generic prescription, your doctor should not print the code for the medicine ♦ the code of the medicine you give will mark the pharmacist. |
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