Regulations Regarding Operating of Pharmacies

Issued pursuant to Section 5, Clause 1
of the Pharmaceutical Law

I. General Provisions

1. These Regulations prescribe the procedures for the commencement of operating and operating of pharmacies (except veterinary pharmacies) and branches of pharmacies.

2. The special authorisation (licence) for pharmaceutical activities shall be within the premises of the pharmacy. A copy of the special authorisation (licence) for pharmaceutical activities shall be placed in the pharmacy and in the branch of the pharmacy in a location visible to customers.

3. The signboard of a pharmacy shall include an indication that it is a pharmacy. The signboard of the branch of a pharmacy shall include an indication that it is a branch of a pharmacy.

4. Information, in which the firm name, working hours, telephone number of the pharmacy, the address and telephone number of the nearest 24 hour pharmacy is indicated, shall be located in a clearly visible place ensuring that it can be seen without entering the pharmacy. Information regarding the branch of the pharmacy shall indicate the firm name of the branch, the working hours of the branch, the address and telephone number of the pharmacy of which this branch is a territorial unit, as well as the address and telephone number of the nearest 24 hour pharmacy.

5. A closed-type pharmacy shall be located within the territory of the inpatient medical treatment institution, which has opened the relevant pharmacy.

II. Requirements for Premises and Equipment of Pharmacies and Branches of Pharmacies

6. Pharmacies and branches of pharmacies shall operate in buildings which have been designed in accordance with the requirements specified in the regulatory enactments regarding the designing of public buildings and which have been put into service.

7. A general-type pharmacy shall have a separate entrance (exit) intended for customers to the customer servicing area and a separate entrance to the room for receipt of goods. The entrance (exit) intended for customers shall be equipped with an air curtain or an appropriate air exchange passage, it shall be without a threshold and shall be suitable for entering into the customer servicing area with wheelchairs and prams.

8. Structural and functional uniformity of rooms shall be ensured in the pharmacy and in the branch of a pharmacy. A pharmacy and the branch of a pharmacy shall have at least the following rooms:

8.1. a customer servicing area with a place arranged for customers' rest (in general-type pharmacies and in branches of pharmacies);

8.2. a room for receipt of requests from medical treatment institutions and issuance of orders (in a closed-type pharmacy);

8.3. a room for receipt of goods with a separate quarantine zone - an area which is provided for placement of incorrectly delivered goods or goods of questionable quality until they are returned to the supplier, for quality certification of goods or for receipt of the necessary accompanying documents;

8.4. an administrative room (in pharmacies operating in cities);

8.5. a goods storage room or goods storage zone in the customer servicing area;

8.6. a room or rooms for preparation of medicinal products (if medicinal products are prepared or packaged in the pharmacy);

8.7. separate rooms or partitioned areas in other rooms (except the customer servicing area, goods storage room or goods storage zone and rooms for preparation of medicinal products):

8.7.1. an employees changing room;

8.7.2. an area for keeping of cleaning materials; and

8.7.3. a defective goods zone for placement of poor quality goods; and

8.8. a lavatory for employees with a washbasin. Entry to the lavatory for employees from the customer servicing area or rooms for preparation of medicinal products shall not be permissible. Pharmacies and branches of pharmacies located in medical treatment institutions where medicinal products are not prepared need not have lavatories if the employees of the pharmacies or branches of pharmacies have access to the lavatory for employees of the relevant medical treatment institution.

9. The customer servicing area of general-type pharmacies shall normally be situated on the ground floor of the building. If the customer servicing area is situated higher or lower than the ground floor, customers with restricted movement capabilities shall be provided with the possibility to enter the customer servicing area and to move freely therein.

10. The premises of the pharmacy and the branch of a pharmacy shall only be used for the provision of pharmaceutical care in accordance with the conditions for the use of premises specified in the internal working procedure regulations of the pharmacy or the branch of the pharmacy.

11. The premises of a pharmacy and the branch of a pharmacy shall be organised and equipped in accordance with the activities to be performed therein, the sanitary requirements and the rights and duties of employees of the pharmacy or the branch of the pharmacy, ensuring accessibility to pharmaceutical care for customers, including persons with functional disorders (visual, hearing and movement disorders).

12. The area of the customer servicing area where customers may be present shall be at least 10 square metres.

13. Depending on the nature of the work, a pharmacy in which medicinal products are prepared shall have a room (rooms) for preparation of non-sterile forms of medicinal products, preparation of sterile forms of medicinal products, as well as auxiliary rooms necessary for the ensuring of the medicinal product preparation process.

14. In order to ensure the quality of the prepared products the rooms for preparation of medicinal products shall have an arrangement and equipment suitable for preparation of medicinal products . In order to ensure the quality of goods during the period of storage, the goods storage room shall have an arrangement and equipment suitable for the storage of goods. Materials which are easy to clean shall be used in decorating the relevant rooms.

15. Depending on the nature of the work, workstations for preparation of liquid, soft and solid forms of medicinal products, for the analysis of medicinal products and purified water, as well as for the packaging of medicinal products shall be arranged and equipped in the room for production of medicinal products.

16. The installations and room for the acquisition of purified water shall be used in order to ensure the acquisition of water required for the preparation of purified water or injection solutions accordingly.

17. Pharmacies, which service medical treatment institutions, shall have a workstation in the goods storage room for assembling orders of medical treatment institutions.

18. Pharmacies shall be provided telecommunications.

19. Pharmacies shall have a computer with appropriate software:

19.1. for entering the data of special prescriptions in accordance with the requirements of the Health Payment Centre, if the pharmacy has a contractual relationship with the Health Payment Centre; and

19.2. for electronic processing of prescription data.

III. Work Organisation at Pharmacies and Branches of Pharmacies

20. The manager of the pharmacy shall, observing the requirements specified in the Labour Law, the Labour Protection Law and the Epidemiological Safety Law, as well as the regulatory enactments regarding the Classification of Occupations, the basic tasks corresponding to the occupation and the basic requirements of qualification, ensure the development of employee position description and internal working procedure regulations. The internal working procedure regulations shall include the following:

20.1. working hours and work shift schedule of the pharmacy or the branch of a pharmacy;

20.2. conditions for the use of premises;

20.3. provisions for operation and checking of installations;

20.4. sanitary upkeep of rooms and installations; and

20.5. personal hygiene requirements for employees.

21. According to the activities to be performed by a pharmacy or the branch of a pharmacy, the manager of the pharmacy shall ensure the development of the following instructions:

21.1. procedures for the acceptance and issuance of medicinal products and other goods;

21.2. procedures for the storage of medicinal products and other goods, in which it is provided that medicinal products shall be stored separately from other goods, medicinal products shall not be placed in the customer servicing area where customers are present, and prescription medicinal products shall not be placed in a location visible to customers;

21.3. preparation, packaging and control of medicinal products (if medicinal products are prepared or packaged);

21.4. acquisition and control of purified water (if purified water is acquired);

21.5. recall procedures of poor quality medicinal products;

21.6. regulations for treatment of vessels received from the infection department, (if a medical treatment institution with an infection department is serviced by the pharmacy); and

21.7. procedures for the distribution of medicinal products on the Internet, if the pharmacy sells non-prescription medicinal products on the Internet in accordance with the regulatory enactments regarding the distribution of medicinal products.

22. The internal working procedure regulations, job descriptions and instructions referred to in Paragraph 21 of these Regulations approved by the manager of the pharmacy shall be binding on the employees of the pharmacy and the branch of the pharmacy.

23. Each employee shall be acquainted with the internal working procedure regulations and the description of the specific job, and the employee shall certify with his or her signature that he or she has become acquainted with the documents referred to and undertakes to observe them. The employees whose job description includes specific activities shall be acquainted with the instructions referred to in Paragraph 21 of these Regulations, and the employee shall certify with his or her signature that he or she has become acquainted with the instructions referred to and undertakes to observe them.

24. The manager of the pharmacy shall appoint a person responsible for the observance of the instructions referred to in Paragraph 21 of these Regulations.

25. The manager of the pharmacy shall be responsible for the fulfilment of the requirements of these Regulations in the pharmacy and the branch of the pharmacy, and for the following:

25.1. the conformity of the pharmaceutical activities with the requirements of the regulatory enactments regulating pharmaceutical activities;

25.2. the provision of the pharmacy with the necessary assortment of medicinal products in accordance with the requirements specified in the Pharmaceutical Law, in the regulatory enactments regarding the distribution of medicinal products and the reimbursement of expenses for the purchase of medicinal products intended for outpatient medical treatment and in these Regulations;

25.3. the implementation of the regulatory enactments regulating employment relationships, as well as the organisation of work in the pharmacy and in the branch of the pharmacy;

25.4. the provision of the pharmacy and the branch of the pharmacy with appropriately qualified employees observing the requirement that the relevant specialists shall perform the duties of employment provided for pharmacy specialists during the whole working time of the pharmacy (branch of pharmacy);

25.5. the development and implementation of a self-control system in the process of receipt, checking, storage, preparation, control and issuance of medicinal products, risk cause analysis, recording of self-control results and storage of such information for at least two years unless other regulatory enactments specify different procedures; and

25.6. the organisation of professional training of the employees of the pharmacy and the branch of the pharmacy, as well as the training of employees upon entering into employment legal relationships.

26. The employees of the pharmacy and the branch of the pharmacy shall observe work safety, fire safety and personal hygiene requirements, as well as sanitary requirements for premises and stock in the activity thereof in accordance with the requirements specified in the Labour Protection Law, the Fire Safety and Fire-fighting Law and the Epidemiological Safety Law.

IV. Pharmaceutical Care

27. The duty of a pharmacist is to ensure qualitative pharmaceutical care of customers.

28. When performing pharmaceutical care and ensuring the monitoring of side-effects caused by the use of medicinal products, the pharmacist shall inform customers regarding medicinal products and the use thereof, provide pharmacotherapeutic consultations, distribute medicinal products and other health care products, as well as propagate measures related to health promotion and illness prevention, on the basis of the latest scientific progress and taking into account consumer interests.

29. The pharmacist shall provide customers with the necessary consultations. Work in the pharmacy and the branch of the pharmacy shall be organised so that conversations with the customers shall proceed efficiently without disturbances, if necessary, ensuring the confidentiality of conversations.

30. The pharmacist shall provide information regarding the characteristics and storage provisions of the medicinal products and health care articles necessary for the customer, as well as advice regarding the correct and safe use thereof. When issuing medicinal products, the pharmacist shall ensure that:

30.1. the medicinal products to be issued are presented in accordance with the requirements specified in the regulatory enactments regarding the instructions for the labelling and use of medicinal products;

30.2. prescription medicinal products are issued together with written information, which is easy to read and contains at least the following information:

30.2.1. given name and surname of the patient (a person who is being treated or who is registered with a medical practitioner and, if necessary, is being treated);

30.2.2. dose of the medicinal product and frequency of use thereof; and

30.2.3. conditions for use of the medicinal product;

30.3. information regarding the correct and safe use of the medicinal product is appended to the medicinal product. The pharmacist shall also provide this information to the customer orally; and

30.4. the customer is informed regarding correct handling of the medicinal product if it is not used up and becomes unfit.

31. Advice and information provided by a pharmacist shall be correct, clear, unambiguous and the content and amount thereof shall conform with the requirements specified in the regulatory enactments regarding advertising of medicinal products. If the pharmacist establishes that a customer requires the assistance of a physician or another health care specialist, the customer shall be advised to see the relevant specialist.

32. In order to ensure a uniform monitoring system of the use of medicinal products and to promote co-operation of family doctors and pharmacists, a pharmacy may create a register of regular pharmacy customers (hereinafter - client). Data shall be entered in the register with the consent of the client, observing the requirements specified in the Personal Data Protection Law.

33. Personal and medical data regarding each client registered in the pharmacy shall be compiled in the register. Data regarding the use of medicinal products shall be kept for at least 12 months.

34. Monitoring of the use of medicinal products shall include the exchange of information between the pharmacist, client and doctor, informing the client's attending doctor in good time regarding the possible complications of the use of medicinal products in order to discover, assess and prevent the possible complications related to:

34.1. the first issuance of a medicinal product if the client has not used such medicinal product before or has not used it within the last 12 months;

34.2. the dose of the medicinal product if a dose is specified in the prescription that is smaller than the minimum standard dose of the medicinal product or larger than the maximum standard dose;

34.3. the interaction of medicinal products, which may be the cause for undesirable changes in the effect or side effects of two or more medicinal products used;

34.4. double medication if two or more medicinal products with similar composition and similar form of medicinal products are used at the same time;

34.5. pseudo-double medication if two or more medicinal products with different compositions or different form of medicinal products but with the same pharmacotherapeutic effect are used at the same time;

34.6. contraindications if the patient has diseases, syndromes or other indications which are incompatible with the use of specific medicinal products or are compatible only when observing certain conditions;

34.7. unforeseen and undesirable changes in the mode and course of use of the medicinal products determined by a doctor; and

34.8. side effects observed during the period of use of the medicinal product.

35. Within the framework of the monitoring of the use of medicinal products the pharmacist shall observe the following requirements in consultations and co-operation with clients, physicians and other pharmacists:

35.1. ascertain that the client is aware of his or her co-responsibility regarding the correctness and completeness of the data on the basis of which a decision regarding the use of medicinal products is taken. It shall particularly apply to non-prescription medicinal products, which are used for self-treatment purposes, as well as to medicinal products purchased in another pharmacy;

35.2. all monitoring data regarding the use of medicinal products by clients shall be available to their attending doctors; and

35.3. when a client registers in an inpatient medical treatment institution, the pharmacist shall provide, upon the request of the medical treatment institution, the information regarding the monitoring of the use of medicinal products as regards of the patient. When the patient is discharged from the inpatient medical treatment institution, the medical treatment institution shall forward information regarding the medicinal products used in the treatment of the patient to the pharmacy.

36. Information regarding the monitoring of the use of medicinal products shall be entered into the register referred to in Paragraph 32 of these Regulations. The pharmacist, according to his or her competence, shall ensure protection of individual data of clients in accordance with the Personal Data Protection Law.

37. The manager of a pharmacy shall be responsible for ensuring that medicinal products and other health care products conform with the quality requirements at the time of issuance thereof, and shall ensure that the requirements specified in the regulatory enactments regarding the distribution of medicinal products are observed in the pharmacy and the branch of the pharmacy and that the following measures are taken:

37.1. when accepting the ordered products, the accompanying documents are checked in order to verify their identity and quality certification;

37.2. if necessary, special treatment of products shall be carried out before placement for storage;

37.3. products, according to the belonging thereof to a specific group, are stored in accordance with the requirements specified in the regulatory enactments regarding the distribution of medicinal products, the distribution of medical devices or the circulation of food and manufacturer's instructions; and

37.4. stocks of medicinal products intended for distribution are not allowed to contain products the expiry date of which has passed.

38. When issuing medicinal products, a pharmacist shall ensure the observance of the following requirements:

38.1. when receiving a prescription, the pharmacist shall verify the conformity of the prescription with the requirements specified in the regulatory enactments regarding the writing out of prescriptions and the validity thereof;

38.2. when issuing medicinal products, it shall be verified whether the patient has been issued with medicinal products necessary for him or her with the relevant information; and

38.3. organise the issuance of prescription medicinal products so that it is possible to check whether the correct medicinal product has been issued.

39. When providing consultations regarding medicinal products, the pharmacist shall also inform regarding the price of the medicinal products, if equivalent medicinal products are available for a lower price and choice is possible. Prescribed medicinal products may be substituted with other medicinal products if they are pharmacologically equivalent.

40. Work in the pharmacy and in the branch of the pharmacy shall be organised so that patient is provided with any medicinal product prescribed to him or her within the shortest time possible. Non-registered medicinal products shall be ordered and delivered in accordance with the procedures specified in the regulatory enactments regarding the distribution of medicinal products. If the prescribed medicinal product is not available in a ready-made form of medicinal product, the pharmacist shall ensure the preparation thereof. If the pharmacy or the branch of the pharmacy does not prepare medicinal products, the pharmacist shall take the prescription from the patient and ensure the preparation of the medicinal product in another pharmacy or in the branch of the pharmacy and the delivery thereof to the pharmacy or to the branch of the pharmacy where the patient has handed in the prescription.

41. In order to ensure the conformity of medicinal products prepared in a pharmacy or in a branch of a pharmacy with the requirements specified in the regulatory enactments, when preparing medicinal products, the following conditions shall be observed:

41.1. the pharmacist shall assess the composition of the medicinal product prescribed in order to ensure the efficacy and safety of the medicinal product;

41.2. medicinal products shall be prepared in accordance with the instructions approved by the manager of the pharmacy, observing the technological principles of pharmaceutical forms and the compatibility and physico-chemical properties of substances;

41.3. only raw materials and packaging conforming with the requirements of the regulatory enactments regarding the manufacture of medicinal products shall be used;

41.4. during preparation and thereafter quality of the medicinal product shall be controlled in accordance with the instructions approved by the manager of the pharmacy and observing the requirements specified in the regulatory enactments regarding the control of medicinal products; and

41.5. medicinal products prepared shall be presented in accordance with the regulatory enactments regarding the labelling of medicinal products.

42. Medicinal products to be prepared in accordance with an individual prescription shall be available to the patient not later than within twenty-four hours from the moment the prescription was submitted to the pharmacy (in urgent cases - in accordance with the indication on the prescription "izsniegt nekavējoties" [to be issued without delay] or "ātri" [urgently]).

43. A pharmacy which does not prepare medicinal products shall enter into an agreement regarding preparation of medicinal products with a pharmacy which prepares medicinal products.

V. Closing Provisions

44. Cabinet Regulation No. 207 of 22 May 2001, Requirements for Opening and Operating of Pharmacies (Latvijas Vēstnesis, 2001, No. 80; 2003, No. 167, No. 183) is repealed.

45. A general-type pharmacy, which commences activities, shall ensure the following conditions of additional activities:

45.1. distribution of psychotropic medicinal products; and

45.2. distribution of narcotic medicinal products and psychotropic medicinal products equivalent thereto.

46. The requirements referred to in Paragraph 45 of these Regulations shall also apply to the pharmacies, which are moved within the territory of one populated area and, on the basis of the existing special authorisation (licence), commence activities in a new location of pharmaceutical activities.

47. The pharmacies, which have a special authorisation (licence) for pharmaceutical activities on the date of the coming into force of these Regulations, but activities of which or branch activities of which do not conform with the requirements specified in these Regulations, shall reorganise it in accordance with these Regulations by 1 July 2010.

48. The fulfilment of these Regulations shall be controlled by the Health Inspectorate.

49. These Regulations shall come into force on 1 April 2010.

Prime Minister V. Dombrovskis

Minister for the Interior
Acting for the Minister for Health L. Mūrniece

Translation © 2010 Valsts valodas centrs (State Language Centre)