The Minister of Health signed a very important last-minute official order, together with the president of the National Health Insurance House, CNAS, and this is because Alexandru Rafila talks below about order number 1386, for the approval of therapeutic protocols regarding the prescription of medicines for Romanians.
The Minister of Health explains below what the doctors who are going to prescribe drugs of this kind for Romanian patients should know, and this is because Alexandru Rafila and CNAS establish a series of very clear rules regarding the way in which they must be carried out the trial.
"According to art. 7 para. (4) from Government Decision no. 144/2010 on the organization and operation of the Ministry of Health, with subsequent amendments and additions, and of art. 17 para. (5) from the Statute of the National Health Insurance House, approved by Government Decision no. 972/2006, with subsequent amendments and additions, the Minister of Health and the President of the National Health Insurance House issue the following order.
Order of the Minister of Health and the President of the National Health Insurance House no. 564/499/2021 for the approval of the therapeutic protocols regarding the prescription of medicines related to the international common names provided in the List containing the international common names corresponding to the medicines that the insured benefit from, with or without personal contribution.
On the basis of medical prescription, in the social health insurance system, as well as the international common names corresponding to the drugs that are granted within the national health programs, approved by Government Decision no. 720/2008, and the methodological norms regarding their implementation, published in the Official Gazette of Romania, Part I, no. 474 and 474 bis of May 6, 2021, with subsequent amendments and additions, are amended as follows.
Appendices no. 1 and 2 are modified according to the annex that is an integral part of this order. In annex no. 3, in article 4, paragraph (2) is amended and will have the following content: The therapeutic protocols provided for in paragraph. (1), as well as those amended/completed ex officio, assumed by the majority of the members of the specialized commission and approved by the president of the commission, are forwarded, through the specialized direction of the Ministry of Health, to ANMDMR for critical analysis and approval, according to the legal provisions in force. In annex no. 3, article 5 is amended and will have the following content.
The therapeutic protocol will consider the description of the following mandatory elements: I. Therapeutic indication. II. Criteria for including a patient in treatment. 1. Criteria for inclusion in the treatment. 2. Exclusion criteria. III. Treatment (will describe, but not be limited to: doses, route of administration, period of treatment, dose adjustment, special precautions for use, etc.). IV. Treatment monitoring/Criteria for evaluation of therapeutic efficacy. V. Criteria for discontinuation of treatment. VI. Prescribers.”
