On The Organization Of Public Access To Analogs Of Human Insulin And Vasopressin

Original Language Title: cu privire la organizarea accesului populației la analogi de insulină umană și vasopresină

Read the untranslated law here: http://lex.justice.md/index.php?action=view&view=doc&lang=1&id=363798

Repealed by OMS594 / 400 of 18/07/16, MO256-264 /
12.08.16 art.1286

In order to ensure patient access to analogs of human insulin to treat diabetes and diabetes insipidus vasopressin treatment to reduce morbidity, disability and mortality from diabetes and its complications insipidus and, pursuant to Section 9 of the Regulation on the organization and operation of the Ministry of Health, structure and personnel of the central apparatus thereof, approved by Government Decision no. 397 of 05/31/11, and under paragraph 29 e) of the Statute of the National Health Insurance Company, approved by Government Decision No. 156 of 11 February 2002
M Ordonez
:

1. To approve:
1) Regulation on the organization of public access to analogs of human insulin and vasopressin according to appendix. 1.
2) The list of public medical institutions responsible for the management of human insulin analogs and vasopressin, according to Annex No. 2.
2. Head of the Department of Health Chisinau Municipal Council, Head of Health Hall mun. Balti, the Director of Health Gagauzia, heads of medical institutions of public health centers (CS) / Centre of Family Doctors (CMF), directors Territorial Medical associations (AMT), University Clinic of MMA Medical University "N.Testemiţanu" district hospitals / Municipal Hospital Balti:
1) to take the necessary measures to organize access of patients, especially children, to analogues human insulin and vasopressin, according to the Regulation approved by this order;
2) to establish territorial Joint Commission, by joint orders of public medical institutions included in the list approved by district hospitals / Balti Municipal Hospital;
3) to ensure that all stakeholders, including placing information on the informational board of the institution on how to organize access to analogs of human insulin and vasopressin.
March. Directors Republican Clinical Hospital and the Institute of Mother and Child by Commissions selecting patients for expensive treatment within them, within 15 days from the date of entry into force of this order, will present the Ministry of Health for transmitting medical institutions public included in the approved list and the National Health Insurance Company of the following information:
1) the nominal lists of patients undergoing treatment with human insulin analogues for each district / municipality separately (including IDNP, indicating the period of stay of the patient in treatment, the amount of human insulin analogues, issued monthly / annually);
2) proposals to limit the quantities of insulin analogues and vasopressin, based on the number of people in treatment and quantities of human insulin analogues / vasopressin, which benefited patients annually in the administrative area;
3) Reserve for possible proposals on training in the treatment of patients framing us.
4. Leaders in public medical institutions AMT, AMP University Clinic of Medical University "N.Testemiţanu" Health Centers / Family Medical Center Balti Hospitals rational / Balti Municipal Hospital in common SMPhU "N.Testemiţanu" will provide training organization continuous family doctors and endocrinologists conduct to ensure adequate treatment of patients with diabetes and the insipid.
May. Department primary care, urgent and Community Assistance Division Hospital and Public Health Directorate of the Ministry of Health will provide consultative and methodological support on the implementation of this order.
June. National Company for Health Insurance will conclude additional agreements to contracts for medical assistance under compulsory health with each medical institution in the approved list for the year of management, quantitative limits analogs of human insulin and vasopressin estimated by commissions selecting patients for expensive treatment, approved by the Ministry of Health.
July. This order shall come into force after publication in the Official Gazette of the Republic of Moldova.

August. Control over execution of this order is awarded Ms Aliona Serbulenco, Ms Valentina Rotaru, Ms Liliana Iaşanu, deputy ministers of health, and Iurie Osoianu, deputy director of the National Health Insurance.

MINISTER OF HEALTH Deputy Director General Vasile PASCAL GLAVAN CNAM Ruxandra


N. 97/85-A. Chisinau, February 22, 2016.



Annex 1 to the Order Ministry of Health and Health
No. 97/85-A of February 22, 2016



REGULAMENTprivind organizing public access to analogs of human insulin and general IDispoziţii vasopresinăCapitolul

1. The regulation on the public access to analogs of human insulin and vasopressin (hereinafter - Regulation) is developed in accordance with Law No. healthcare. 411-XIII of March 28, 1995, Law 1585-XIII of 27 February 1998 concerning the compulsory health insurance, Law no. 263-XVI of 27 October 2005 on patient rights and responsibilities, Law no. 96-XVI of 13 April 2007 on public procurement.
2. The provisions of this Regulation are based on the principles: transparency, accessibility, fairness and equality, territorial principle of registration of the beneficiary family doctor.
March. The purpose of the Regulation is to regulate the organization's access to analogs of human insulin and vasopressin ensuring physical access of patients to drugs needed to treat diabetes insipidus and place of residence.

Chapter IIModul organization's access to analogs of human insulin and vasopresinăSecţiunea 1.Asigurarea
public medical institutions analogs of human insulin and vasopressin


4. Analogs of human insulin and vasopressin are procured centrally by means mandatory health insurance funds in the amount approved by the Ministry of Health in the auctions organized by the Agency for Medicines and Medical Devices, the limits of available funds for this purpose.
May. Commissions selecting patients for expensive treatment (hereinafter - the Committee of selectarе patients) of the Republican Clinical Hospital (SCR) and the Institute of Mother and Child (IMC), established under Order no. 91 of 09.04.2009 "On the selection of patients for expensive treatment," estimated quantitative limits for each administrative area analogs of human insulin and vasopressin for the year, based on the data of statistical evidence on the number of people in each district / municipality included in treatment and quantities of human insulin analogues and vasopressin, which benefited patients in that territory annually.
June. Quantitative distribution and amounts calculated for analogs of human insulin and vasopressin, for each medical institution in the approved list, approved by the Ministry of Health and presented the National Health Insurance Company for contracting health care institutions.

Section 2.Managementul cases of diabetes with insulin analogues
of human cases of diabetes insipidus

July. Inclusion of patients mayors lists of beneficiaries for prescription treatment with analogs of human insulin is made based on the Commission's decision selecting patients transmitted the joint commissions territorial by the extract from medical records (F 027e) and contains the following: the analogue of human insulin recommended individual scheme prescribed dosage and duration of treatment.
August. The Commission's decision selecting patients for prescription served basis analogs of human insulin, the doctor from the patient's place of residence, after registration and confirmation by the Joint Committee of the territory. The Commission's decision selecting patients will keep documentation of evidence of territorial Joint Commission.
September. Decision on extension of prescribing analogs of human insulin for patients already enrolled in treatment in question is registered and confirmed by the Joint Committee on the basis of territorial nominal lists for each administrative area presented by the committee selecting patients.

10. Prescription vazopresinei for patients with diabetes insipidus is performed by the doctor as recommended primary endocrinologist, recorded sheet ambulatory patient (F 025 s) or extract from medical records ambulatory patient (F 027's) within quantities distributed for each administrative area, submitted by the committee for selection of patients and approved by the Ministry of Health.

Section 3.The Commission for selecting patients for expensive treatment

11. Committee for selecting patients for expensive treatment consists of at least 5 members: the vice director of medical institution, the members of the specialized endocrinology Ministry of Health and head of the profile of the SCR (for adults), and BMI (for children). Commission meetings are convened monthly or as needed.
12. Responsible for convening, chairing the meeting and fairness patient selection is deputy director of the medical institution, who is also chairman of the selection of patients.
13. Commission decisions selecting patients are taken in a transparent manner based on medical and social data, evaluating indications and contraindications by most members of the Commission present and signed by the President and Secretary of the Commission.
14. Committee for selecting patients reasoned decisions registering the register of the Commission's work, according to appendix. 1 to this Regulation and minutes of meetings.
15. The Secretary is appointed by the President of the Commission and is a member of the Special Commission of the Ministry of Health endocrinology. Commission Secretary is responsible for maintaining medical records, registers and minutes of meetings. Minutes of Committee meetings shall be signed by all members of the Commission President.
16. Control of the Commission's work is carried out by the Ministry of Health.
17. The eligibility criteria for inclusion in the priority list of beneficiaries of human insulin analogues are patients enrolled, from which it appears:
1) type 1 diabetes in children;
2) frequent hypoglycemia regardless of the type of diabetes treated with insulin in compliance with current recommendations (diet, exercise and insulin)
3) onset type 1 diabetes in childhood and adolescence, already undergoing treatment with insulin analogues,
4) type 1 diabetes enrolled in education (pupils, students from 18) and into work
5) type 2 diabetes with insulin without compensation in compliance with the recommendations of rigor (diet, exercise and insulin).
18. Insured persons diagnosed with diabetes insipidus are beneficiaries of specific drugs.
19. Examination of the Commission for selecting patients analogs of human insulin applicant shall submit the following documents:
1) written application with personal signature in case of children - by the legal representative;
2) reference - extracted from the medical records of outpatient patient (Form 027-e), issued by the endocrinologist, explaining the need to release human insulin analogues;
3) outpatient medical record (025 F e), indicating the dynamics of glycated hemoglobin and glycemic profile on a minimum of 6 months;
4) zilnicul self-control of the diabetic patient;
5) copy of the identity card of the citizen of Moldova with residence visa;
6) copy of the insurance policy mandatory healthcare, that number will be checked by the Commission for selection of patients according to the database of the National Health Insurance Company for confirmation of the validity status of the insured person in the compulsory health insurance system medical.
20. Outpatient medical records of the patient (F 025's) Agreement is attached notice in accordance with Annex. 3 to this Regulation, signed by the beneficiary and the doctor, after full information regarding the proposed method of treatment, rights and responsibilities of the beneficiary, and permission to use personal data.
21. Committee for selecting the right patients to suspend treatment with human insulin analogues:
1) if the control repeatedly, in due time, confirming inefficiency treatment with insulin analogues (glycosylated hemoglobin level is increasing or decreases less than 1%);

2) if examining reports submitted by the Joint Commission semester territorial indicates inefficiency treatment with insulin analogues (glycosylated hemoglobin level does not correspond to objective individual glycemic control).
22. The Commission will inform the selection of patients Territorial Joint Committee on individuals who received treatment with insulin analogues suspended by reference statement (Form 027-e), the argumentation as to why the suspension.
23. Commission for selection of patients, the decision will take into account both the medical indications, as well as the quantity available in that territory under the approved limit and need to keep treatment of people already assigned to treatment with analogs of human insulin.
24. The Commission is responsible for the correctness of decisions and the criteria set out herein in accordance with law.
Section 4. The Commission
treatment monitoring territorial mixed analogue of human insulin and vasopressin

25. The Joint Commission territorial monitoring treatment with analogs of human insulin and vasopressin (hereinafter - Joint Committee Territorial) is established at the local level by order of the Director AMT mun. Chişinău, joint order of the Health Centre / Centre of Family Physicians and the Hospital district / municipal Hospital Balti.
26. The composition of the Joint Commission territorial enter at least 5 people - leader AMT, Health Center of district / Family Doctors Center, who is also Chairman of the Committee, GP and / or head of family medicine, pharmacist, head of advisory endocrinologist. Secretary of the Commission appointed by the president.
27. Territorial Joint Committee meets monthly or as required. Joint Commission regional powers are:
1) record, confirm and keep record of the territory ascribed patients, who are treated to analogs of human insulin under nominal lists submitted by the Commission for selection of patients;
2) records primary patients and confirms the Commission's recommendations for selecting patients for the prescription analogs of human insulin by the family doctor;
3) evaluates the effectiveness of treatment;
4) The selection committee headed by patients for patients, for medical indications;
5) assesses needs and vasopressin analogue of human insulin and monitor stocks;
6) submit the reports to the Commission for selection of patients in the form and deadlines;
7) argues and presents information on the real needs of patients in the territory ascribed to ensure full with insulin analogues and vasopressin.
28. Registration and / or confirmation that the Joint Commission authorities regarding prescription analogs of human insulin by the family doctor shall be based on nominal lists of patients received in administrative territory and / or the Commission's decision of selecting patients for patients mayors who registers / snaps into outpatient medical record (025 F e), and failing that, in the extract from medical records (F 027's) recommendation dosage conduct treatment etc. Joint Commission territorial examination data is recorded in the register of the Commission's work and in the minutes signed by all the members of the Commission and President.
29. Registration and / or confirmation that the Joint Commission territorial referring to the inclusion in the list of beneficiaries and informed consent, are presented to the patient and family doctor of the place of residence of the patient and kept in medical documentation ambulatory patient (F 025 e).
30. Patients with the status of insured persons entered on the lists of family doctors in institutions departmental or private, will benefit analogs of human insulin or vasopressin in accordance with the decisions of the Joint Commission territorial institutions of public healthcare, the approved list, which They are distributed (corresponding Annex no. 2 to this Order).
31. The Joint Commission will cease to issue territorial human insulin analogue according to the Commission's decision selecting patients and inform both the family doctor, the place of residence of the patient and the patient. The patient, who was suspended from analogue of human insulin will be provided further with human insulin.

Section 5.Prescrierea analogs of human insulin and vasopressin


32. Analogs of human insulin and vasopressin patients are prescribed by the family doctor, according to the territorial principle.
33. Consult your family doctor endocrinologist additional disease development in cases where treatment requires correction. If no endocrinologist in the territory, correction treatment is carried out by endocrinologist in the Division of Hospital Advisory Republicn Institute for Mother and Child adults and children.
34. Analogs of human insulin release and vasopressin is made based on free recipe (Form no. 3, approved by Order no. 960 of 01.10.2012 "On how prescribing and drug delivery"), prescribed for a range of 1 month, the Department of insurance with medicines and medical devices of Health Centres / Centers of Family Physicians of district / municipal branches of JSC "Sanfarmprim" in MTAs, which provides receiving, issuing and recording in accordance with the legal provisions in force.

Section 6.Evidenţa and reporting analogs of human insulin and vasopressin


35. Quantities of human insulin analogues and received vasopressin is taken on record, including accounting by the institution managing, monitoring their use in accordance with the regulations in force (Order no. 310 of 09.09.2009 "On ensuring patients outpatient drugs and supplies purchased centrally from state budget sources ").
36. The approved list of medical institutions will present the National Health Insurance Company The report personified on insured persons who have received treatment with the drug "___________" (Form no. 1-27 / d, approved by Order Ministry of Health jointly with National Health Insurance company no. 198/86 of 03.17.2014 "on approval of forms of primary medical records and the reports in the CHI").
37. The Joint Commission territorial submit once per semester (up to July 10 and December 20 respectively) Commission selecting patients report on the number of patients beneficiaries treatment with insulin analogues indicating full name, type of drug adminstrator , dosage, quantity released, glycosylated hemoglobin and the number of patients beneficiaries of vasopressin according to appendix. 2 to these Regulations, Model A.
38. Commission for selection of patients will present once per semester (up to July 10 and December 20 respectively) Ministry of Health and the National Company for Health Insurance, the summary totalizing on the amount distributed and stocks analogs of human insulin and vasopressin accordance with Annex. 2 to these Regulations, Model B.


Final Chapter IIIDispoziţii
39. Leaders AMT, Centers Health / Centers of Family Physicians of district / municipal:
1) bears personal responsibility for the organization of access to adults and children and vasopressin analogs of human insulin;
2) take the necessary steps to ensure transparency and fair distribution of analogs of human insulin and vasopressin.
Annex 1

Annex 2


Annex 3



Annex 2 to the Order Ministry of Health and Health
No. 97/85-A of February 22, 2016



The list of medical institutions responsible for the management of human insulin analogs and vasopressin


1. Territorial Association of Medical-Center, including Cricova CS, CS Ciorescu CM SinBioDan Polyclinic Secret Information Advisory Service
2. Medico-Territorial Association Buiucani, including CS Durlesti Truşeni CS, CS Vatra, Ghidighici CS, CS PROSAN
March. Territorial Association Medico-Botanical including Sîngera CS, CS Băcioi, Civil Aviation CM, CS OnClinic
4. Medico-Territorial Association Rīşcani including Grătieşti CS, CS Stăuceni, CME SANCOS SRL, SC "Galaxia"
May. Medico-Territorial Association Ciocana, including CS Bubuieci Budeşti CS, CS Colonita CM "St. Panteleimon "
June. AMP University Clinic of Medical University "Nicolae Testemitanu" including clean PMSI Association Clinic Sanatorium and Rehabilitation of the State Chancellery, Polyclinic Interior Ministry Consultative Diagnostic Center of Defense Ministry
July. Family Medical Center Balti
August.
Noi Health Center in September. Health Center Basarabeasca
10. Health Center Briceni

11. Health Center Cahul
12. Health Center Calarasi
13. Health Center Cantemir
14. Health Center Causeni
15. Health Center Ceadîr-Lunga
16. Health Center Cimişlia
17. Health Center Comrat
18. Health Center Criuleni
19. Health Center Dubosari
20. Health Center Donduşeni
21.
22 Drochia Health Center. Health Center Edineţ
23. Health Center Făleşti
24. Family Medical Center Floreşti
25. Health Center Glodeni
26. Health Center Hânceşti
27. Health Center Ialoveni
28. Health Center Leova
29. Health Center Nisporeni
30. Health Center Ocniţa
31. Health Centre Orhei No. 1
32. Health Center Rezina
33. Health Center Rīşcani
34. Health Center Sîngerei
35. Health Center Şoldăneşti
36. Health Center Soroca
37. Health Center Stefan Voda
38.
39 Străşeni Health Center.
40 Taraclia Health Center. Health Center Teleneşti
41. Health Center Ungheni
42. Health Center Vulcăneşti