Model regulations on the formulary commission of a medical organization
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HEALTH DEPARTMENT OF THE ADMINISTRATION OF THE PERM REGION
ORDER
ON THE CREATION OF A FORMULAR COMMISSION
In order to further improve quality medical care, rational use of financial resources when planning the purchase of medicines medical institutions, maximum satisfaction of the population’s needs for medicines and in pursuance of the decision of the board of the Ministry of Health of the Russian Federation dated September 28, 1999 “On the concept of the program for the development of the drug supply system for healthcare and the population Russian Federation"I order:
1. Create a formulary commission under the health department of the regional administration. Approve the composition of the commission (Appendix No. 1).
2. Approve the Regulations on the regional formulary commission(Appendix No. 2).
3. Approve standard Regulations on the formulary commission of the medical institution (Appendix No. 3).
4. Chief doctors of medical and preventive institutions create and approve formulary commissions at medical institutions.
5. Entrust control over the execution of the order to the deputy head of the department, A.M. Alikin.
Head of Department
S.A. RYZHAKOV
Appendix No. 1
to the order
dated 19.09.2000 N 290
FORMULARY COMMISSION UNDER THE HEALTH ADMINISTRATION
REGIONAL ADMINISTRATION
Shagova T.V. - First Deputy Head of Department
Chairman of the Commission
Alikin A.M. - deputy head of department
Deputy Chairman of the Commission
Melentyeva I.A. - Deputy Head of the Department of State Supervision of Pharmaceutical Activities of the Department of Pharmaceutical Activities and Drug Production Secretary of the Commission (as agreed)
Members of the commission:
Melnikova T.P. - Deputy Head of the Regional Health Department
Nazarenko N.V. - chief therapist of the region
Ladeishchikov V.M. - chief surgeon of the region
Sitnichenko E.P. - chief pediatrician of the region
Kolobov A.Ya. - chief epidemiologist of the region
Kon E.M. - chief freelance anesthesiologist - resuscitator of the region
Goldyreva E.V. - chief obstetrician-gynecologist of the region
Kudlaev V.R. - chief physician OPB N 1 - chief freelance psychiatrist of the region
Svetlakov B.I. - chief physician of the OTD "Phthisiopulmonology" Chief freelance phthisiatrician of the region
Zhelnin A.V. - chief freelance neurologist of the region
Sominich S.B. - Deputy Chief Physician of OOD
Maerovich T.M. - head of the department for interaction with self-regulatory organizations and municipal organizations of POFOMS (as agreed)
Soloninina A.V. - Vice-Rector for Financial and Economic Affairs of the Perm State Pharmaceutical Academy (as agreed)
Reshetilov A.E. - Head of the Department of Pharmacy and Drug Production of the Regional Administration (as agreed)
Sukhikh V.A. - Director of State Unitary Enterprise "Permpharmacy" (as agreed)
Appendix No. 2
to the order
dated 19.09.2000 N 290
POSITION
ABOUT THE FORMULAR COMMISSION OF THE HEALTH ADMINISTRATION
REGIONAL ADMINISTRATION
I. GENERAL PROVISION
1. The formulary commission of the health department of the regional administration (hereinafter referred to as the commission) is created for the purpose of developing and constantly updating the formulary list of medicines in the Perm region (formulary list).
2. The commission is an expert body of the health department of the administration of the Perm region.
3. The commission in its work is guided by the legislation of the Russian Federation, regulatory legal acts Ministry of Health of the Russian Federation, the State Register of Medicines, approved by the List of Vital and Essential Medicines, and the legislation of the Perm Region.
II. TASKS OF THE FORMULAR MANAGEMENT COMMISSION
HEALTH CARE AREA
III. FUNCTIONS OF THE FORMULAR MANAGEMENT COMMISSION
HEALTH CARE AREA
The functions of the commission are:
1. Organize, at least once a year, the revision and re-issue of the formulary list.
2. Review and analysis of formulary lists of treatment and preventive health care institutions.
3. If necessary, organize additional examination of the formulary list or its sections.
4. Analysis of the pharmacoepidemiological situation in the Perm region in order to substantiate the need for specific drugs.
IV. PROCEDURE FOR FORMING A FORMULAR MANAGEMENT COMMISSION
HEALTH CARE AREA
1. The structure of the commission is approved by the head of the health department of the administration of the Perm region.
3. The composition of the commission is submitted for approval by the chairman of the commission in the prescribed manner
4. The composition of the commission is approved by order of the regional health department.
5. The chairman of the commission is the first deputy head of the regional health department
6. The functions of the chairman of the commission are:
Management of the commission;
7. The deputy chairman of the commission is the deputy head of the department or one of the main specialists of the health department of the administration of the Perm region.
8. Candidates for members of the commission are proposed by municipal health authorities, scientific, pedagogical and medical health care institutions, public medical and pharmaceutical organizations.
9. The functions of the commission members are:
10. Members of the commission carry out work in accordance with the plan approved by the chairman of the commission.
11. Members of the commission are responsible for the timeliness and objectivity of the information being considered.
12. The functions of the commission secretary are:
V. WORKING ORDER OF THE FORMULAR MANAGEMENT COMMISSION
HEALTH CARE AREA
3. Decisions at commission meetings are considered adopted if at least two-thirds of the commission members who participated in voting at the commission meeting voted positively for them.
5. The Commission corresponds with all interested departments, organizations and individuals, both in the Russian Federation and abroad.
Appendix No. 3
to the order
dated 19.09.2000 N 290
STANDARD PROVISIONS
ABOUT THE FORMULAR COMMISSION OF TREATMENT AND PREVENTION
HEALTH INSTITUTIONS
I. GENERAL PROVISIONS
1. A formulary commission for treatment (hereinafter referred to as the commission) is created for the purpose of developing and constantly updating a formulary list of medicines for a treatment and preventive hospital-type health care institution (hereinafter referred to as a formulary list).
2. The commission is an expert body of a treatment and preventive health care institution.
3. The commission in its work is guided by the legislation of the Russian Federation, regulatory legal acts of the Ministry of Health of the Russian Federation, the State Register of Medicines, the approved List of Vital and Essential Medicines, the legislation of the Perm Region, orders of higher health departments and the chief physician of a medical and preventive health care institution.
II. TASKS OF THE FORMULARY COMMISSION FOR TREATMENT -
PREVENTIVE HEALTH INSTITUTION
The main tasks of the commission are:
1. Consideration of proposals for the inclusion or exclusion of medicines, changes and additions to the formulary list.
2. Review and submission for approval in the prescribed manner of the draft formal list.
III. FUNCTIONS OF THE FORMULARY COMMISSION TREATMENT -
PREVENTIVE HEALTH INSTITUTION
The functions of the commission are:
1. Organize a revision of the formulary list at least once a year.
2. Review and analysis of statistical data on morbidity, analysis of pharmacoepidemiological data, the range of drugs purchased by the medical and preventive healthcare institution and other data within its competence.
3. Accounting and analysis of side effects from the use of drugs.
4. Analysis of the rationality of the use of medicines in treatment and preventive health care institutions.
5. Organization of additional examination of the formulary list or its sections if necessary.
IV. PROCEDURE FOR FORMING A FORMULAR COMMISSION FOR TREATMENT -
PREVENTIVE HEALTH INSTITUTION
1. The structure of the commission is approved by the head of the treatment and preventive health care institution.
2. The commission includes: chairman, deputy chairman, members of the commission, secretary of the commission.
3. The composition of the commission is submitted for approval by the chairman of the commission in the prescribed manner.
4. The composition of the commission is approved by order of the medical and preventive institution of the region.
5. The commission includes all deputy heads of medical and preventive health care institutions responsible for the provision of medical care, all heads of departments of medical institutions, the head of a pharmacy, representatives of educational and scientific medical organizations located on the basis of the health care institution, representatives of public professional organizations, representatives of all medical insurance organizations operating compulsory medical insurance in health care facilities.
6. The chairman of the commission is the deputy head of the health care facility for medical work.
7. The functions of the chairman of the commission are:
Conducting commission meetings;
Management of the commission;
Formation of proposals for the composition of the commission;
Representation of the commission in other organizations and departments.
8. The deputy chairman of the commission is one of the heads of the department of the health care facility.
9. Candidates for members of the commission are proposed by the municipal health care authority, departments of the PGMA Academy located on the basis of a health care institution, and insurance companies operating compulsory health insurance in health care facilities.
10. The functions of the commission members are:
Participation in the work of the commission with a voting right;
Review and scientific examination of materials submitted for inclusion in the formal list;
Presentation of expert opinions on the materials received to the commission meeting.
11. Members of the commission carry out work in accordance with the plan approved by the chairman of the commission.
12. Members of the commission are responsible for the timeliness and objectivity of the information being considered.
13. The functions of the commission secretary are:
Keeping minutes of commission meetings;
Conducting the commission's paperwork;
Preparation of statements and correspondence of the commission.
V. WORKING ORDER OF THE FORMULARY COMMISSION TREATMENT -
PREVENTIVE HEALTH INSTITUTION
1. Meetings of the commission are held at least once a quarter. If necessary, the chairman of the commission calls an extraordinary meeting.
2. The decisions of the commission are considered valid if more than two-thirds of the commission members took part in the meeting of the commission.
3. Decisions at commission meetings are considered adopted if at least two-thirds of the commission members who participated in voting at the commission meeting voted positively for them.
4. Meetings of the commission are recorded, the minutes are signed by the chairman and secretary of the commission.
5. The Commission corresponds with all interested departments, organizations and individuals both in the Russian Federation and abroad.
No. 1 2015
1. Chairman: – First Deputy Director of the Department of Health of the Yamal-Nenets Autonomous Okrug;
Members of the commission present:
2. - Deputy Chairman, Deputy Director of the Department of Health of the Yamal-Nenets Autonomous Okrug;
3. - Head of the Drug Supply Department of the Yamalo-Nenets Autonomous Okrug Department of Health;
4. – Chief Specialist Department of Organization of Medical Care and Health Development of the Department of Health of the Yamal-Nenets Autonomous Okrug;
5. – chief specialist of the drug supply department of the Yamalo-Nenets Autonomous Okrug Department of Health.
MEETING AGENDA:
1. Consideration of a new application form for inclusion medicinal product in the TPGG Yamalo-Nenets Autonomous Okrug to provide inpatient care and (or) to provide for certain categories of citizens
2. Consideration of applications for inclusion in the TPGG and RLO lists of medicinal products from manufacturing companies.
3. Introduction of changes and additions to the lists of vital and essential medicines and medical products necessary for the provision of inpatient medical care, medical care in day hospitals of all types, as well as emergency medical care and medicines, medical devices, diagnostic tools, specialized medical nutrition products used in outpatient treatment and prescribed by doctors free of charge.
According to the conclusions presented by the chief freelance specialist, clinical pharmacologist of the Department of Health of the Yamal-Nenets Autonomous Okrug, clinical pharmacologist of the Central City Hospital of Noyabrsk, we heard
1.Approve new uniform applications for inclusion of a medicinal product in the TPGG of the Yamal-Nenets Autonomous Okrug for the provision of inpatient care and (or) to provide for certain categories of citizens.
2. Include in Appendix No. 2 “List of medicines, medical devices, diagnostic tools, specialized medical nutrition products used in outpatient treatment and dispensed free of charge according to doctors’ prescriptions”, approved by the Decree of the Government of the Autonomous Okrug-P “On approval of the territorial program of state guarantees of free provision of medical care to citizens for 2015 and for the planning period of 2016 and 2017”, the following medications.
3.Refuse inclusion:
1.Insulin degludec (Tresiba).
Solution for subcutaneous administration. Vital and Essential Drugs drug, not included in treatment standards, registered in 2013. It is not possible to assess the benefit and pharmacoeconomics. In addition, there is no experience of use, no convincing data for a statistically significant reduction in hypoglycemia, especially in patients with type 2 diabetes, there is no point in increasing the cost of treatment by 70-80%, while receiving only some ease of use, the presence of analog insulin in the list of drugs circadian action. The wait-and-see approach concerns clarification of pharmacoeconomics and the possibility of allocating funds for a limited number of patients, for example, 25, subject to the availability of funds, with a cost of up to 5 million rubles per year. The decision on the advisability of inclusion in the state guarantee program must be made with the mandatory participation of the chief freelance endocrinologist. Refuse.
2. Dapagliflozin (Forxiga) tablet: Indications for the use of type 2 diabetes in addition to diet and exercise to improve glycemic control as: monotherapy; addition to metformin therapy in the absence of adequate glycemic control over this therapy; starting combination therapy with metformin, if this therapy is appropriate. The drug was registered in the Russian Federation on August 21, 2014. The mechanism of action is independent of B cell function and insulin action. The drug blocks the reabsorption of glucose in the kidneys, promotes its excretion, reducing glycemic levels. Absent from the list of vital and essential drugs and “Algorithms for specialized medical care for patients with diabetes”, 2013 edition. According to the information presented, it is effective in placebo comparison; in clinical studies, comparison drugs, the combination of metformin + glipizide and dapagliflozide + metformin, are equally effective, there are no studies with other combinations: dipeptidyl peptidase inhibitors 4. The advantage of this drug is that the risk of developing hypoglycemia is minimal, there are no analogues, but there is a dependence of the excretory function of the kidneys associated with the mechanism actions. Due to the absence in the list of vital and essential drugs for 2015, standards, registration in the Russian Federation only on 08.2014, lack of data on the safety profile. Refuse.
3. Tofacitinib (Yaquinus) tab. Indications for use: Rheumatoid arthritis. The drug was registered in the Russian Federation on March 16, 2013. It is original and has no analogues. Not on the list of vital and essential drugs. The cost of a package of 5 mg No. 56 is 52,390 rubles. Unlike the currently used genetically engineered biological drugs, the tablet form will allow treatment to be carried out entirely in an outpatient setting.
Due to the absence in the list of vital and essential drugs for 2015, standards, registration in the Russian Federation only on 03.2013, the cost of the drug. Refuse.
4. Fortelysin. The drug is a Russian-made drug and is not a vital and essential drug; studies have compared it with the fibrinolytic Actilyse; a study comparing the effectiveness with Metalyse has been opened. Taking into account the other fibrinolytics available in TPGG: Alteplase, Urokinase, the presence of several indications for use, and the declared Fortelysin has only one: acute myocardial infarction in the first 6 hours, this drug must be compared with the drug available in TPGG Tenecteplase, which has the same indications for use and high cost; upon completion of clinical trials, resubmit documents with the results for inclusion. Refuse.
5. Degludec+insulin aspart (Ryzodeg® FlexTouch®) Solution for subcutaneous administration, indications for use of the drug according to the instructions for use: Diabetes mellitus in adults, date of registration in the Russian Federation 2013. The safety and effectiveness of the drug was studied in 5 studies, in 26 centers of the Russian Federation, involving 193 patients with type 1 and 2 diabetes, prices were produced in rubles. per package. Not a vital and essential drug. Refuse.
Exclude drugs from the hospital list of TPGGs that are not VED.
Papaverine - solution for injection; pills; rectal suppositories;
Palonosetron – solution for intravenous administration;
milk thistle fruit extract - tablets; capsules; dragee
granisetron - film-coated tablets;
Lactobacillus acidophilus - lyophilisate for preparing a solution for oral and topical use;
Saccharomyces boulardii - powder for the preparation of suspension for oral administration;
bifidobacteria longum + enterococcus fecium - enteric capsules;
lactobacilli acidophilus + kefir fungi – capsules;
metformin + saxagliptin - modified-release film-coated tablets;
paricalcitol - solution for intravenous administration, capsules;
rosehip fruits – syrup;
magnesium lactate dihydrate + pyridoxine hydrochloride - film-coated tablets;
iron sulfate - film-coated tablets, dragees;
perfluorodecalin + p+ proxanol + water for injection;
strophanthin-K - solution for intravenous administration;
lily of the valley leaves glycoside - solution for intravenous administration;
levomenthol solution in menthyl isovalerate - sublingual tablets; sublingual capsules;
eplerenone - film-coated tablets;
hesperidin + diosmin - film-coated tablets;
troxerutin – capsules;
clindamycin - vaginal suppositories;
miconazole - vaginal suppositories;
metronidazole + miconazole - vaginal suppositories;
fenoterol - concentrate for the preparation of solution for infusion;
lidocaine + chlorhexidine - gel for topical use;
benzathine benzylpenicillin - lyophilisate for preparing a suspension for intramuscular administration;
doripenem - powder for the preparation of solution for infusion;
spiramycin - tablets;
erythromycin - enteric-coated tablets, ointment for external use, lyophilisate for preparing a solution for intravenous administration;
norfloxacin - film-coated tablets, eye and ear drops;
anidulafungin - lyophilisate for the preparation of a concentrate for the preparation of a solution for infusion;
aceclofenac - film-coated tablets;
clonazepam – tablets;
oxymetazoline - nasal drops, nasal spray;
Framycetin - nasal spray;
ambazon - lozenges;
theophylline - extended-release tablets, extended-release capsules.
Chairman of the FC
Secretary
Registered in the Office of the Republic of Belarus for organizing the activities of justices of the peace and maintaining registers of legal acts on February 10, 2012 N 1818
MINISTRY OF HEALTH OF THE REPUBLIC OF BASHKORTOSTAN
ORDER
REPUBLIC OF BASHKORTOSTAN
In order to organize work on the formation and updating of the republican list (formula) of vital and essential medicines necessary for the provision of inpatient medical care (hereinafter referred to as the republican list (formula) of vital and essential medicines), in accordance with the Program of State Guarantees for the Provision of Citizens of the Russian Federation of free medical care, annually approved by the Decree of the Government of the Russian Federation, Order of the Ministry of Health of the Russian Federation dated March 26, 2001 N 88 “On the introduction into force of the industry standard “State Information Standard for Medicines.” Basic provisions" and the Order of the Ministry of Health and social development Russian Federation dated February 12, 2007 N 110 “On the procedure for prescribing and prescribing medications, medical products and specialized medical nutrition products”, I order:
1. Create a Formal Commission of the Ministry of Health of the Republic of Bashkortostan.
2. Approve:
2.1. Regulations on the Formal Commission of the Ministry of Health of the Republic of Bashkortostan (Appendix No. 1).
2.2. Regulations on the Formal Commission medical organization(Appendix No. 2).
2.3. Form of proposal for inclusion (or exclusion) of a medicinal product in the republican list (formulary) of vital and essential drugs (Appendix No. 3).
2.4. Form of a card for recording cases of prescription of drugs to inpatients that are not included in the republican list (formulary) of vital and essential drugs (Appendix No. 4).
2.5. Form of a summary report on the structure and volumes of purchases of medicines not included in the republican list (formula) of vital and essential medicines (Appendix No. 5).
3. To the heads of medical organizations subordinate to the Ministry of Health of the Republic of Bashkortostan:
3.1. Approve the composition of formulary commissions of medical organizations and organize their work in accordance with the Regulations on the formulary commission of a medical organization.
3.2. Submit, if necessary, to the Formulary Commission of the Ministry of Health of the Republic of Bashkortostan proposals for the inclusion (or exclusion) of drugs in the republican list (formulary) of vital and essential drugs with the mandatory attachment of: an order on the composition of the Formulary Commission of a medical organization, minutes of the meeting of the Formulary Commission medical organization to discuss proposals signed by all members of the commission, records of at least fifty cases of prescription of drugs proposed for inclusion in the republican list (formula) of vital and essential drugs.
4. The order must be registered in the prescribed manner with the Office of the Republic of Bashkortostan for organizing the activities of justices of the peace and maintaining registers of legal acts.
5. Execution control of this Order entrusted to First Deputy Minister A.A. Bakirov.
Minister
G.A.SHEBAEV
Appendix No. 1
Republic of Bashkortostan
POSITION
ABOUT THE FORMULAR COMMISSION OF THE MINISTRY OF HEALTH
REPUBLIC OF BASHKORTOSTAN
I. GENERAL PROVISIONS
1.1. The Formulary Commission of the Ministry of Health of the Republic of Bashkortostan (hereinafter referred to as the Formulary Commission) is created for the purpose of developing and constantly updating the republican list (formula) of vital and essential drugs.
1.2. The formulary commission is an expert body of the Ministry of Health of the Republic of Bashkortostan.
1.3. The formulary commission in its work is guided by the legislation of the Russian Federation, regulatory legal acts of the Ministry of Health and Social Development of the Russian Federation, the Ministry of Health of the Republic of Bashkortostan and these Regulations.
II. TASKS AND FUNCTIONS OF THE FORMULAR COMMISSION
2.1. The main task of the Formulary Commission is to consider proposals from medical organizations for the inclusion or exclusion of medicines, making changes and additions to the republican list (formula) of vital and essential medicines.
2.2. The functions of the Formal Commission are:
organizing a revision of the republican list (formula) of vital and essential drugs at least once a year;
if necessary, organize additional examination of the republican list (formula) of vital and essential medicines or its sections.
III. PROCEDURE FOR FORMING A FORMULAR COMMISSION
3.1. The Formal Commission includes: Chairman, Deputy Chairman, members of the Formal Commission, Secretary of the Formal Commission.
3.2. The composition of the Formulary Commission is approved by order of the Ministry of Health of the Republic of Bashkortostan.
3.3. The members of the Formal Commission include heads or deputy heads of departments of the Ministry of Health of the Republic of Bashkortostan, chief specialists of the Ministry of Health of the Republic of Bashkortostan, a representative Government institution Territorial Fund of Compulsory Medical Insurance of the Republic of Bashkortostan.
The main freelance specialists of the Ministry of Health of the Republic of Bashkortostan are invited to participate in meetings of the Formulary Commission with the right to an advisory vote, as necessary.
3.4. The Chairman of the Formulary Commission is the Deputy Minister of Health of the Republic of Bashkortostan, who is in charge of drug supply issues.
3.5. The functions of the Chairman of the Formulary Commission are:
a) holding meetings of the Formal Commission;
b) management of the Formal Commission;
c) formation of proposals on the composition of the Formal Commission;
d) presentation of the collective opinion of the members of the Formulary Commission to the Minister of Health of the Republic of Bashkortostan, as well as in other organizations and departments.
3.6. In the absence of the Chairman of the Formal Commission, his functions are performed by the Deputy Chairman of the Formal Commission.
3.7. The functions of the members of the Formal Commission are:
a) participation in the work of the Formulary Commission with the right of a casting vote;
b) consideration and examination of proposals submitted for inclusion in the republican list (formula) of vital and essential medicines;
c) presentation of expert opinions on the materials received to the meeting of the Formal Commission.
3.8. Members of the Formal Commission are responsible for the timeliness and objectivity of the information being considered.
3.9. The functions of the Secretary of the Formal Commission are:
a) notifying members of the Formal Commission about the place and time of the meeting;
b) keeping minutes of meetings of the Formal Commission;
c) maintaining the records of the Formal Commission;
d) preparation of extracts from the protocols of the Formal Commission;
e) familiarization of the members of the Formal Commission with the agenda regular meetings Formal commission.
All materials on medicinal products prepared for consideration at the Formulary Commission are kept by the secretary for one year from the date of the meeting.
IV. WORKING ORDER OF THE FORMULAR COMMISSION
4.1. Meetings of the Formal Commission are held at least once a year. If necessary, the Chairman of the Formulary Commission appoints an extraordinary meeting.
4.2. Decisions of the Formulary Commission are considered valid if more than two-thirds of the members of the Formulary Commission took part in the meeting of the Formulary Commission.
4.3. Decisions at meetings of the Formulary Commission are considered adopted if they are voted positively by the majority of members of the Formulary Commission who participated in the voting at the meeting of the Formulary Commission.
4.4. Meetings of the Formal Commission are recorded, the minutes are signed by the Chairman, Secretary and members of the Formal Commission.
Appendix No. 2
to the Order of the Ministry of Health
Republic of Bashkortostan
POSITION
ABOUT THE FORMULAR COMMISSION OF A MEDICAL ORGANIZATION
I. GENERAL PROVISIONS
1.1. The formulary commission of a medical organization (hereinafter referred to as the Commission) is an expert body of a hospital-type medical organization, responsible for the implementation of a formulary system - restrictive lists of drugs for procurement and use in medical organizations, leading to a reduction in healthcare costs for drugs and optimization of drug therapy.
1.2. The Commission in its work is guided by the legislation of the Russian Federation, regulatory legal acts of the Ministry of Health and Social Development of the Russian Federation and the Ministry of Health of the Republic of Bashkortostan, the republican list (formula) of vital and essential drugs, orders of the chief physician of a medical organization, and these Regulations.
II. TASKS OF THE FORMULAR COMMISSION OF A MEDICAL ORGANIZATION
The main tasks of the Commission are:
2.1. Development and implementation of professional policies for the selection of drugs, their evaluation, procurement, safe use and information support in a medical organization.
2.2. Providing assistance in matters of advanced training of personnel on the use of medications.
III. FUNCTIONS OF THE FORMULAR COMMISSION OF A MEDICAL ORGANIZATION
The functions of the Commission are:
3.1. Organizing at least once a year a review of the formulary list of a medical organization based on the republican list (formula) of vital and essential drugs, taking into account the profile of the institution, its capacity, the amount of funding, and the range of diseases for which medical care is provided.
3.2. Consideration, preparation and submission for approval in the prescribed manner of proposals for the inclusion or exclusion of medicines in the republican list (formula) of vital and essential medicines.
3.3. Review and analysis of statistical data on morbidity, analysis of pharmacoepidemiological data, the range of drugs purchased by a medical organization and other data within its competence.
3.4. Analysis of the rationality of the use of drugs in a medical organization with an ABC/VEN analysis carried out once a year with the presentation of results, according to the form of Section IV of the reporting form N 71 “Report on the service “Clinical Pharmacology” to the department of organization of pharmaceutical activities and drug supply to the population of the Ministry of Health of the Republic of Belarus during the period of submission of annual reports.
3.5. Accounting for the use in a medical organization of medicinal products that are not included in the republican list (formulary) of vital and essential medicinal products, in the form in accordance with Appendix No. 4 to this Order.
3.6. Providing a summary report on the structure and volumes of purchases of medicines not included in the republican list (formula) of vital and essential medicines, once a year in the form according to Appendix No. 5 to this Order in electronic (in Excel format) and paper submission to the Department of Organization of Pharmaceutical Activities and Drug Supply to the Population of the Ministry of Health of the Republic of Belarus by the 10th day of the month following the reporting month.
IV. PROCEDURE FOR FORMING A FORMULAR COMMISSION
MEDICAL ORGANIZATION
4.1. The composition and structure of the Commission are approved by the head of the medical organization.
4.2. The Commission includes: Chairman, Deputy Chairman, members of the Commission, Secretary of the Commission.
4.3. The composition of the Commission is submitted for approval by the Chairman of the Commission in the prescribed manner.
4.4. The composition of the Commission is approved by order of the medical organization.
4.5. The Commission includes all deputy heads of a medical organization responsible for the provision of medical care, heads of departments, heads of pharmacies, and clinical pharmacologists.
4.6. The Chairman of the Commission is one of the deputy heads of the medical organization, who oversees the provision of medical care.
4.7. The functions of the Chairman of the Commission are:
a) holding meetings of the Commission;
b) management of the Commission;
c) formation of proposals for the composition of the Commission;
d) representation of the Commission in other organizations and departments.
4.8. The Deputy Chairman of the Commission is a clinical pharmacologist or one of the heads of the department of a medical organization.
4.9. The functions of the members of the Commission are:
a) participation in the work of the Commission;
b) review and scientific examination of materials submitted for inclusion in the republican list (formula) of vital and essential medicines;
c) presentation of expert opinions on the materials received to the Commission meeting.
4.10. Members of the Commission carry out work in accordance with the plan approved by the Chairman of the Commission.
4.11. Members of the Commission are responsible for the timeliness and objectivity of the information considered.
4.12. The functions of the Secretary of the Commission are:
a) notifying the members of the Commission about the time and place of the meeting of the Commission;
b) keeping minutes of Commission meetings;
c) maintaining the records of the Commission;
d) preparation of statements from the Commission;
e) collection of records of cases of prescription of drugs to inpatients that are not included in the republican list (formulary) of vital and essential drugs, in the form according to Appendix No. 4 to this Order.
V. WORKING ORDER OF THE FORMULAR COMMISSION
HEALTH INSTITUTIONS
5.1. Meetings of the Commission are held at least once a quarter. If necessary, the Chairman of the Commission appoints an extraordinary meeting.
5.2. Decisions of the Commission are considered valid if more than two thirds of the members of the Commission took part in the meeting of the Commission.
5.3. Decisions at meetings of the Commission are considered adopted if they are voted positively by the majority of members of the Commission who participated in the voting at the meeting of the Commission.
5.4. Meetings of the Commission are recorded, the minutes are signed by the Chairman, Secretary and members of the Commission.
Appendix No. 3
to the Order of the Ministry of Health
Republic of Bashkortostan
OFFER
ABOUT INCLUSION (OR EXCLUSION) INTO THE REPUBLICAN
LIST (FORMULAR) OF VITAL NEEDS AND
IMPORTANT DRUGS
(filled out by the formulary commission of the medical organization
and submitted to the Formal Commission of the Ministry of Health of the Republic of Belarus)
1. A proposal for inclusion (or exclusion) of a medicinal product in the republican list (formulary) of vital and essential drugs must be drawn up in Russian, signed and contain information about:
state registration of a medicinal product (copy of the registration certificate);
international nonproprietary name of the medicinal product in accordance with state register medicinal products, if the medicinal product does not have an international nonproprietary name, its replacement name (trade, original, scientific, chemical) is indicated;
dosage forms in accordance with the state register of medicines;
pharmacotherapeutic group of the drug;
clinical effectiveness of the drug (target population, dosage regimen, duration of use, the need for special skills or conditions when prescribing, links to clinical recommendations, information on the level of evidence of the data presented) indicating the source of publication (copies of the works are attached);
safety of the medicinal product, indicating the source of publication (copies of the works are attached);
the results of comparative clinical studies of medicinal products, if the medicinal products proposed for inclusion (or exclusion) in the republican list (formula) of vital and essential medicinal products belong to the same pharmacotherapeutic group and are intended for the diagnosis, prevention or treatment of certain diseases, clinical conditions or syndromes;
results of pharmacoeconomic studies, including economic assessment according to the criterion “cost-effectiveness” with the attachment of relevant materials indicating the source of publication.
2. The criteria for inclusion (or exclusion) of a medicinal product in the formation of the republican list (formula) of vital and essential medicinal products are:
scientifically based data on the effectiveness and safety of the drug in a specific disease, syndrome or clinical situation;
scientifically based data on the therapeutic equivalence of the drug to drugs with similar mechanisms of pharmacological action;
scientifically based data on the need and validity of the use of a specific drug for the diagnosis, prevention or treatment of certain pathologies, including those prevailing in the morbidity structure of citizens of the republic, characterized by high performance mortality, and requiring significant financial costs in the appropriate conditions of providing medical care to citizens in the Republic of Bashkortostan;
results of pharmacoeconomic studies of a medicinal product within one pharmacotherapeutic group, including an economic assessment of the effectiveness of the medicinal product using the cost-effectiveness criterion;
the demand (social significance) of a specific drug by practical healthcare and the population;
availability of the drug in duly approved standards of medical care, patient management protocols, clinical recommendations for doctors, including international ones.
SAMPLE REGULATIONS ON THE FORMULARY COMMISSION OF A HOSPITAL INSTITUTION
1. GENERAL PROVISIONS
The formulary commission of a hospital institution is an expert body created at a hospital institution.
The regulations on the Formular Commission of a hospital institution (hereinafter referred to as the Commission) are approved by order of the chief physician of the hospital institution.
Members of the Commission in their work are guided by the legislation of the Russian Federation, the legislation of the Moscow Region, regulatory legal acts of the Ministry of Health and Social Development of the Russian Federation, the Ministry of Health of the Moscow Region, as well as these Regulations.
The work of the Commission is carried out in accordance with these Regulations.
2. PURPOSE OF CREATING THE COMMISSION
The purpose of creating the Commission is to analyze the provision of a hospital institution medicines and preparation of expert opinions that can be used in making decisions aimed at improving the quality of medical care provided to patients.
3. OBJECTIVES OF THE COMMISSION
3.1. Conducting an analysis of the drug supply of patients undergoing treatment in a hospital institution.
3.2. Conducting a clinical and economic analysis of the effectiveness of the treatment regimens used and developing economically sound proposals for improving the drug supply of the treatment process carried out in patients undergoing treatment in a hospital institution.
4. OPERATING PROCEDURE OF THE COMMISSION
4.1. The Commission works in accordance with the work plan developed by the members of the Commission and approved by the chief physician of the hospital institution.
4.2. Meetings of the Commission are held at least once a quarter.
4.3. Meetings of the Commission are considered valid if more than half of the members of the Commission are present at them.
4.4. Decisions of the Commission are considered adopted if at least two-thirds of the members of the Commission present at the meeting vote for them.
4.5. Meetings of the Commission are documented in minutes. The minutes are signed by the chairman and secretary of the Commission.
5. COMPOSITION OF THE COMMISSION
5.1. The Commission includes:
Chairman of the Commission;
Secretary;
Members of the Commission.
5.2. The Chairman of the Commission is appointed by order of the chief physician of the hospital institution, and the secretary is elected from among the members of the Commission by open voting by a simple majority of votes of the members of the Commission.
5.3. Members of the Commission may include representatives of other organizations, including public organizations who voluntarily expressed a desire to participate in the work of the Commission.
5.4. Personal composition members of the Commission is approved by order of the chief physician of the hospital institution.
6. RIGHTS, DUTIES AND RESPONSIBILITIES OF COMMISSION MEMBERS
6.1. Members of the Commission have equal rights.
6.2. Members of the Commission have the right to:
Participation in the work of the Commission with the right of casting vote when voting on issues considered at meetings of the Commission;
Statement of your own opinion, which must be reflected in the minutes of the Commission meeting;
Conducting correspondence and obtaining information necessary for analysis from organizations involved in the provision of medicines to the population of the Moscow region, regardless of the form of ownership and legal form of these organizations;
Participation in conducting targeted and random inspections of the drug supply of patients undergoing treatment in departments of a hospital institution;
Inviting officials related to the provision of medicines to the population to meetings of the Commission (in agreement with the Chairman of the Commission);
Refusal to further participate in the work of the Commission.
6.3. The duties of the Chairman of the Commission are:
Development, coordination with members of the Commission and submission of a work plan of the Commission for approval to the chief physician of the hospital institution;
Distribution of responsibilities between members of the Commission;
Organization of meetings of the Commission;
Informing the chief physician of the hospital institution about the decisions made by the Commission.
6.4. The duties of the Secretary of the Commission are:
Keeping minutes of Commission meetings;
Conducting the Commission's records;
Familiarization of members of the Commission with the agenda of regular meetings of the Commission.
6.5. The duties of the members of the Commission are:
Participation in conducting targeted and random inspections of drug supply to patients in structural divisions hospital facility;
Presentation at meetings of the Commission of statistical and analytical data characterizing the organization of drug provision in a hospital institution;
Making proposals to improve the drug supply of the treatment process.
