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Medicine Acquisition, Storage, Use And Accounting Procedures Of Treatment Institutions

Original Language Title: Zāļu iegādes, uzglabāšanas, izlietošanas un uzskaites kārtība ārstniecības iestādēs

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The Republic of Latvia Cabinet of Ministers of 28 September, Regulation No 333 (in Riga. Nr. 51, 6. §) medicine acquisition, storage, use and accounting treatment of institutions Issued the order in accordance with article 5 of the law on Pharmacy's point 7 and the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 37 i. General questions 1. These rules shall determine any treatment services purchased, stored, used and lists medications (including medicine, which is under the supervision of the Ministry of Welfare of existing drugs , psychotropic substances and precursors included in list II and III substances).
2. Treatment Services Manager is responsible for the purchase of medicinal products, storage, use and accounting procedures, as well as on the measures required to not go to the illegal movement and would not be used maliciously.
3. Treatment Services Manager according to the hospital's work profile and structure in the order in which the rules set out in detail the procedure for implementing the medical institution. The order specifies the officer responsible for medicinal products, also for the illicit manufacture of narcotic drugs and psychotropic medicines recognized (narcotic drugs) and psychotropic drugs, acquisition, storage, use and enforcement (hereinafter referred to as the responsible executive) medical institution, as well as the responsible medical authority departments.
4. Medical institutions, with more than 100 hospital beds, the hospital's head of order creates medicine Committee, composed of medical and pharmaceutical specialists. The Committee for medicinal products in accordance with the Statute, the hospital's Manager. Rules are set for the Committee's tasks, functions, rights and structure, as well as the analysis of results of operations.
5. Use the following basic functions: 5.1 develop medical institution to use the list of medicinal products;
5.2. promoting rational use of medicines in the medical institution, ensuring that the patient is given time obtain medications according to clinical needs with accurate information about the use of the product, as well as low cost as possible;
5.3. to give proposals to the treatment of medicinal products required for rational purchase;
5.4. to promote a rational distribution of medicinal products for patients;
5.5. to analyze the movement of medicinal products and to provide proposals for its development;
5.6. promoting the medicinal side effects.
5.7. to ensure that persons receive medical treatment independent information on medicines.
6. fixed type of treatment services manager for the responsible person to designate pharmaceutical training.
7. Medical institutions, with more than 100 hospital beds, the type of closed pharmacies.
II. the purchase of medicinal products medicinal products buy 8 are eligible for treatment services, which included the Ministry of welfare created the medical institutions. The medicines allowed to buy only from licensed pharmaceutical operations companies (companies).
9. Medical institution, which is a closed type pharmacy, hospital medicine required for the acquisition, storage, inventory and issue of the hospital's departments or clients provide pharmacies leader.
10. Medical institution that does not have a closed-type pharmacies, hospital medicine required for the acquisition, storage, inventory and issue of the hospital's departments or patients provide the officer.
11. The medical establishment, which is not a closed type pharmacies, drug products are eligible to purchase only when received by the Ministry of welfare issued a permit to the illicit manufacture of narcotic drugs and psychotropic medicines recognized purchases (hereinafter licence). Permit is issued after the State Pharmacy Inspectorate monitored the drug for medicinal use, storage and accounting of the medical institution. Permit is issued for a period of between one and three years.
12. the head of the hospital's national pharmaceutical inspection submitted the application for the permit and documents certifying the compliance of regulatory treatment requirements. If the documents submitted information is incomplete or inaccurate, the national pharmaceutical inspection is entitled to request additional information.
13. national pharmaceutical inspection within 30 days of the application and required documents are checked by the date of receipt of the narcotic drug storage, use and accounting procedures of the medical institution, the results of the inspection certificate and the record of its competence give orders identified or the prevention of abuse.
14. where the medical institution does not adhere to the narcotic drug acquisition, storage, use and accounting procedures, as well as if the previous investigation found deficiencies or irregularities are not corrected, the State Pharmacy Inspectorate proposes to refuse the authorisation or withdraw.
15. Treatment services officer provides slip-invoice and other documents accompanying the accounting and storage. Requests and invoices-invoices narcotic and psychotropic drugs separately. The volume of drug trafficking article numbers and words.
16. the Narcotic Drugs can be obtained only with the hospital's driving privileges. Mandate indicates that officials are entitled to narcotic drugs, drug name, form, active substance dosage unit and narcotic drug quantity (numbers and letters). Submit to the supplier of the medicinal powers. Authorization valid for seven days.
17. Medical institution that does not have a closed-type pharmacies, drug stocks may not exceed one month's consumption needs.
18. The medical establishment, which is not a closed type pharmacies, is entitled to receive only the finished product.
19. Medical authority allowed to purchase only the operation of the necessary medicine. Get benefits and prohibited material or non-material benefit for ordering, purchase, sale or transfer of other legal or natural persons.
20. Free medical samples and humanitarian shipments of medicines medical establishment receives, records and used according to the procedures laid down in the laws.
21. the competent authority shall ensure that the storage of the medicinal product does not lose quality and chain quality requirements of only medicine.
III. the storage of medicinal products 22. Medical institution, which is a closed type pharmacy, medicine to the treatment of the issue of units or patients kept in the pharmacy according to this provision the 24, 25 and 26 the requirements set out in paragraph. Pharmacy manager shall ensure that the storage of the medicinal product does not lose quality.
23. the medical institution that does not have a closed-type pharmacies, medicines to the issue of the hospital's departments or patients in a separate room, subject to this provision 24, 25 and 26 in. Space against unauthorised access.
24. Psychotropic drugs stored in cupboards, lockers, separate from other medications.
25. Narcotic Drugs stored in a safety deposit box or metal cabinet that (if necessary) is fastened to the wall or floor. Safe deposit box or metal wardrobe shall be fitted with sound or light alarm. Space secured against unauthorised entry and shall be equipped with an alarm.
26. in the absence of the safety of Personnel or the metal closet and room door locks and add alarm. Key storage procedure determines the rules referred to in paragraph 3 of the hospital's head of the order.
27. Hospital's organ Hall stored no more than five days of consumption. Medications stored in accordance with the provisions of 24, 25 and 26 in.
28. the responsible officer provides the fastest possible quality medicines for the identification and withdrawal.
IV. the use of the medicinal product 29. Hospital's departments or the patient receives medicine from the pharmacy closed type or officers in accordance with the provisions referred to in paragraph 3, the hospital's head of the order.
30. Medicines used, based on the referring physician or the duty doctor's medical history record, ordination or ambulatory patients in the medical card.
31. On drug use of medicines, the supervising nurse or procedure room nurse's medical history record, ordination or outpatient patient medical card, indicating the name of the medicinal product used, dose and time of use.
32. the person provides medical treatment to patients, their relatives or legal representatives shall transfer unused narcotic drugs medical institution. Medical institution returned unused narcotic drugs register quality and received back the illicit manufacture of narcotic drugs registration journal (annex 1), where the pages are numbered and cauršūt. A journal by the hospital's seal and signature of the driver.

33. the medicinal products authorised for use only in the process of treatment for medical institution. Necessary for the treatment of medicine outpatient patients acquire the General type of the pharmacy to the recipe that the laws set out in the order. If delaying treatment can cause irreversible consequences to the health of the patient, as well as threaten the patient's life, treatment the person authorized to issue a patient medicine outpatient treatment for in such quantities that ensure the process of treatment until the patient can buy medicine pharmacy.
34. The medical officer of the authority provide patient instructions for use of prescriptions after the service of the patient's request.
V. medicine acquisition, storage, use and control of accounting 35. Treatment services business unit provides monthly news on the official responsible utilisation of medicinal products in accordance with the provisions referred to in paragraph 3, the hospital's head of the order.
36. Medical institution and its departments narcotic drugs recorded drug drug mandatory log (hereinafter mandatory magazine) (annex 2), which pages are numbered and cauršūt. Mandatory log confirms the hospital's seal and signature of the driver.
37. the mandatory log also recorded the medicine in pure form or mixed with substances containing such indiferent psychotropic substances: 37.1. ephedrine;
37.2. pseudo;
37.3. St.Johns;
37.4. triheksifenidil.
38. Psychiatric treatment or profile hospital's psychiatric profile departments St.Johns and triheksifenidil is not mandatory in the journal.
39. the mandatory entries in the journal shall be leaving free space and not deleting. Corrections records certifies as "correct to believe", the responsible medical authority signature seal.
40. the Minister of Welfare to individual medicinal products containing narcotic drugs or psychotropic substances, may identify other control measures.
41. With the head of the hospital's order created a Commission that has at least three officers, not less frequently than quarterly checks to the illicit manufacture of narcotic drugs and psychotropic drug acquisition, storage, use and accounting procedures. The Commission shall draw up the results of the inspection acts, stored in three years.
42. Medical authority shall submit to the Ministry of welfare Pharmacy Department quarterly and annual reports on the illicit manufacture of narcotic drugs and psychotropic medicine movement. Reports to be submitted within 15 days of each quarter and the end of the year.
43. the circulation of Medicinal treatment facilities under the control of the pharmaceutical inspection.
Vi. Quality of medicines used in the illicit manufacture of narcotic drugs and drug ampoule destruction 44. Poor quality medicines until their destruction in a separate room or in a separate place, eliminating the chance to mess with quality products. Poor quality of narcotic drugs and psychotropic drugs and the patients returned unused narcotic drugs stored in accordance with the provisions of 24, 25 and 26 the requirements set out in paragraph.
45. Low quality products that is not transferred back to the supplier, as well as from the patients returned unused narcotic drugs destroyed with the hospital's head of order created in the presence of the Commission in accordance with legislative requirements on hazardous waste. The Commission is made up of: 45.1. treatment services manager or his authorized officer;
45.2. the responsible officer;
45.3. the national pharmaceutical inspection agent.
46. The provisions referred to in paragraph 45 of the Commission on the destruction of the medicinal product, which is signed by all the members of the Commission. The Act specifies the name of the medicinal product, the serial number, quantity, the destruction of reason, the members of the Commission of the name and job title. For the illicit manufacture of narcotic drugs and psychotropic drug destruction shall be drawn up in duplicate and one copy shall be sent, within three days of national pharmaceutical inspection. Act number qualitative and not put back the narcotic drug received log. The legislation is kept for a period of five years.
47. Treatment Services Manager determines the narcotic ampoules for medicinal products used for the destruction order and creates the appropriate Commission, as well as designate the officials responsible for the narcotic drug ampoule used. The designated officer once a day spent in the illicit manufacture of narcotic drugs recorded drug ampoules, special accounting journal.
VII. Illicit traffic in narcotic drugs and psychotropic drug shortage, theft, robbery or loss of the disaster will be 48. If found in the illicit manufacture of narcotic drugs and psychotropic drug shortage or surplus, theft or robbery took place or where the losses resulted from natural disasters, space and safety sealed and secured against unauthorised access. The underlying fact treatment services manager reports: 29.9. national pharmaceutical inspection;
48.2. local police department;
48.3. The national police anti-drug Office (if the medicine shortage or surplus, theft or robbery took place).
49. following this rule 48, paragraph fact finding by the hospital's head of the order is created, the Commission, which is made up of: 30.5. treatment services manager or his authorized officer;
30.6. the responsible officer;
30.6. the State inspection of pharmaceutical representative;
49. The national police anti-drug Office representative (if the medicine shortage or surplus, theft or robbery took place).
50. The rules referred to in paragraph 49 of the Commission shall draw up a document signed by all the members of the Commission. The Act specifies the name of the medicinal product, the serial number, quantity, the members of the Commission of the name and job title. The legislation is kept for a period of five years.
51. The narcotic drug shortage or surplus, theft or robbery, as well as damages due to natural disasters also tracks the mandatory log.
VIII. Closing questions 52. Be declared unenforceable on Cabinet 4 July 1995 No. 189 of the rules "rules for the procedure for the circulation of illicit drug treatment institutions" (Latvian journal, 1995, nr. 106; 1998, 212./213.nr.).
53. This provision (4) and (5) shall enter into force by 1 January 2000.
54. The provisions of paragraphs 6 and 7 shall enter into force by 1 January 2001.
 
Prime Minister a. slice Welfare Minister r. Jurdž in