CIRCULAR

PROMULGATING PRINCIPLES, STANDARDS “GOOD PHARMACY PRACTICE”

Pursuant to the Pharmacy Law No.34/2005-QH-11 dated June 14, 2005;

Pursuant to the Decree No.188/2007/ND-CP dated December 27, 2007 of the Government regulating functions, duties, powers and organizational structure of Ministry of Health;

Pursuant to the Decree No.79/2006/ND-CP dated August 09, 2006 of the Government detailing the implementation of some Articles of the Pharmacy Law,

The Ministry of Health issues principle and standard of "good pharmacy practice" as follows:

Article 1. Scope of governing

Principle and standard of "Good Pharmacy Practice" issued with this Circular are the drug trading conditions for the drug retail establishments according to the schedule stipulated in Circular No.43/2010/TT-BYT dated December 15, 2010 of the Ministry of Health defining the schedule to implement the principle and standard of "good pharmacy practice" GPP; location and scope of operation of the drug retail establishments.

Article 2. Dossier of registration for inspection of drug retailing conditions by the principles, standards of "good pharmacy practice"

1. An application for registration for inspection of drug retailing conditions by the principles, standards of "good pharmacy practice" (Form No.1/GPP);

2. A list of material facilities and equipment, list of personnel;

3. A GPP self-check list (Checklist) in Appendix II of this Circular.

Article 3. Dossier of registration for re-inspection of drug retailing conditions by the principles, standards of "good pharmacy practice"

An application for registration for re-inspection of drug retailing conditions by the principles, standards of "good pharmacy practice" (Form No.2/GPP).

 After the establishments filed dossiers for re-registration, they are still allowed to trade drug according to the extent specified in the issued certificates of "good pharmacy practice" and qualified certificates of trading drug (still valid).

Article 4. Competence to inspect, component of the inspection team

1. Competence to inspect and issue certificates

Health Departments of the provinces and centrally-run cities (referred to as the Health Departments) are responsible for receiving dossiers, appraising dossiers and establishing the inspection teams and granting certificates of the establishments achieved standard, "good pharmacy practice".

2. Standards of inspectors "good pharmacy practice"

a) The heads of inspection teams must have a degree of pharmaceutical university, have experienced in the management of drug for 2 years or more.

b) Members of the inspection teams must have a university degree or higher.

3. Component of the inspection teams shall be decided by the Directors of Health Departments.

Article 5. The order of inspecting drug retailing conditions by the principles, standards of "good pharmacy practice"

1. The Health Departments issuing the process and complying with process of granting certificates of "Good Pharmacy Practice" must ensure the principles:

a) Within 20 days after receipt of application for accreditation of the drug retail establishments meeting the principle and standard of "good pharmacy practice", the Departments of Health establish the inspection teams and carry out to inspect at the establishments.

b) The Health Departments issue the certificates of qualification of "good pharmacy practice" for the establishments within 05 working days from the date of ending the inspection; or within 10 working days from the date the Departments of Health receive the reports of overcoming the shortcomings mentioned in the inspection records.

c) In case of re-inspection, within 10 working days after receiving the report of remedy and application for inspection of the establishments, the Departments of Health must conduct the inspection.

2. Inspection records accompanying Checklist must be signed to certify by the professional manager and head of the inspection team and is made into 02 copies: 01 copy is stored at the establishment, 01 copy is stored at the Health Department of province, centrally-run city where the establishment operates. (Form No.3/GPP).

Article 6. The validity of qualified certificates of "good pharmacy practice"

Qualified certificates of "good pharmacy practice" have a valid term of 3 years from the signing date (Form No.4/GPP). The certificates which have been issued previously with a valid term of 02 years may continue to extend the operating time for 01 year from the expiry date. The Departments of Health shall issue the Decisions of extending together with the list of the establishments to be extended the certificates’ validity of "good pharmacy practice".

Article 7. Effect

This Circular takes effect from February 05, 2012 and replaces the Decision No.11/2007/QD-BYT dated 24/01/2007 on promulgating the principle and standard of "good pharmacy practice" and the contents related to "good pharmacy practice" in the Decision No.29/2007/QD-BYT dated 11/05/2007 on amending and supplementing some Articles of Decision No.11/2007/QD- BYT.

During the implementation process, if any difficulty arises, the units should promptly reflect to the Drug Administration of Vietnam - Ministry of Health for studying to amend and supplement properly./.

PRINCIPLES, STANDARDS

“GOOD PHARMACY PRACTICE”
(Issued together the Circular No.46/2011/TT-BYT dated December 21, 2011 of Minister of Health)

Chapter I

GENERAL PROVISIONS

I. PRINCIPLES OF "GOOD PHARMACY PRACTICE"

Assurance of use of drugs rationally, safely, and effectively is one of two basic objectives of the National Drug Policy of Vietnam. All imported, domestically produced drug sources distributed to the users are most directly through the activities of the drug retail establishments.

"Good pharmacy practice" (Good Pharmacy Practice, abbreviated as: GPP) is a document offering the principles and basic standards in occupational practice of pharmacists in the pharmacies and pharmaceutical personnel on a basis of voluntary, compliance with ethical and professional standards at higher level higher than the minimum legal requirements.

"Good pharmacy practice" must ensure to implement the following principles:

1. Putting the interests of patients and the public health first.

2. Providing drug required to ensure quality together with information of drugs; advise properly for users and supervision of the drug use.

3. Participating in self-treatment activities, including drug supply and consultancy of drugs use, self-treatment of symptoms of the simple diseases.

4. Contributing to promote appropriate, economical prescribing and safe, rational, and effective use of drugs.

II. Interpretation of terms

In this document, the following terms are construed as follows:

1. Retail establishments meeting the principles and standards of GPP mean the establishments meeting the principles, the standards specified in this Rules.

2. Retailers mean pharmacists graduated from university and those who are trained in drugs, operate in the drug retail establishments, including secondary pharmacists, prescription clerk, physician keeping drugs chests of the health stations and retailers of finished oriental drugs or finished drugs from medicinal herbs.

3. The pharmacy staffs mean pharmacist -pharmacy owner or professional manager and staffs with pharmaceutical qualifications operating in the pharmacy.

4. Drugs-selling means the professional activities of the pharmacy including the supply of drugs together with advice and guidance of using safe and effective drugs for users.

Chapter II

THE STANDARDS

I. PERSONNEL

1. Professional manager or owner of the retail establishment must have pharmaceutical practice certificate under current regulations.

2. Retail establishments have the appropriate human resources (number, qualifications, and professional experience) to meet the scale of operation.

3. Employees directly involved in selling drugs, delivery, preservation of drugs, drug quality control, preparation of drugs must meet the following conditions:

a) Having pharmaceutical qualifications and a period of professional practice in accordance with assigned works;

b) Having enough health, not being infected with contagious diseases;

c) Not being in the disciplined period from warning or more related to drug.

II. MATERIAL FACILITIES, TECHNIQUE OF DRUG RETAIL ESTABLISHMENTS

1. Construction and Design

a) Fixed, separate location; located in the safe, high and dry places and away from pollution sources;

b) Building firmly, with anti-dust ceiling, walls, and floors required to be easy to clean, enough light but not letting drugs directly affected by sunlight.

2. Area

a) The area must be in accordance with the business scale but at least must be 10m², required to have the areas for display and storage of drugs and area for drug users to contact and exchange information on the use of drugs with the retailers;

b) It must allocate more space for other activities such as:

- Preparation room according to prescription if there is organization to prepare according to prescription;

- The retailing room of drugs that have no longer packaging in directly contact with drugs for retailing directly to patients;

- Place where retailers and drugs buyers wash their hands;

- Private storage of drugs (if needed);

- Private consultancy room or area for patients and chairs for drug buyers in the waiting time.

c) In case of trading more cosmetics, functional foods, medical devices, there must be separate areas, not displaying along with drugs and not causing influence to drugs;

d) The pharmacy with drugs preparation by prescription or with retailing room of drugs that have no longer packaging in directly contact with drugs.

- Room of preparing prescription drugs or retailing drugs that have no longer packaging in directly contact with drugs must have anti-dust ceiling, floor and walls are made of materials easy to clean, when necessary, it may perform the cleaning;

- Having place for hand-washing, washing the preparation tools;

- Arranging seats for drug purchasers outside of preparation room.

3. Drugs storage devices at the drugs retail establishments

a) There are sufficient storage facilities for drugs to avoid the adverse effects of light, temperature, humidity, pollution, the entry of insects, including:

- Firm, smooth cabinets, counters, shelves, easy to clean, convenient for the sale, storage of drugs and aesthetic assurance;

- Thermometer, hygrometer to control temperature, humidity in the drug retail establishments. There is system of lighting, ventilation fan.

b) Equipment for preserving drugs must be consistent with preservation requirements on drug labels. Storage condition at room temperature is maintained at temperatures below 30 ° C, humidity not exceeding 75%.

c) There are tools for retailing and the packaging for retailing consistent with drug storage conditions, including:

- In case of retailing drugs that are no longer packaging in direct contact with drugs, it must use tight packaging, it is encouraged the use of hard packaging, closed for children not directly contacting with drugs. It is better to use manufacturer's original packaging. It can re-use the packaging after they have been treated according to the proper packaging handling process;

- Not using the drugs retailing packaging that contains content of advertising other drugs for use as drugs containing bag;

- Drugs used out of the prescription/narcotics, psychotropic drugs should be packed in distinctive packaging;

- Drugs prepared following prescription should be contained in pharmaceutical packaging for not affecting the drug quality and easy to compare with products which are not drugs - such as soft drink/food/ household products.

d) Record of drugs labels:

- In the case retailing drugs are not contained in their original packaging, it should clearly state: name of drugs: dosage forms; concentration, content of drugs; in case of having no prescription enclosed, it must be stated dose, number of use times and way to use;

- Drugs prepared following prescription: in addition to the complete record of the above provisions, it must write additionally date of preparation; expiration date, name of patient, name and address of the establishment preparing drugs; the safety warning for children (if any).

đ) The pharmacy preparing drugs by prescriptions must have chemicals, equipment for preparing, equipment for sterilizing tools (drier, autoclaves), table for preparation must be easy for preparation, cleaning.

4. Records, books and professional materials of the drugs retail establishments

a) Having documentation for drug use, the current pharmaceutical regulations for the retailers able to look up and use as needed.

b) The records and books related to drug-dealing activities, including:

- Books or computers are used to manage drugs to be stored (preserved), monitor number of lots, expiry of drugs, and other related issues. Encourage the retail establishments to have computer system and software to manage the activities and store data;

- Documents or records to store data related to patients (patients with prescriptions or other special cases) are put in the guaranteed places to look up timely when needed;

- Recording books, records and regularly recording activities of buying and selling drugs, storage of drugs for narcotic and psychotropic drugs and precursor substance in accordance with the provisions of the Regulations on management of narcotic drugs and Regulations on management of psychotropic drugs, book for preparing drugs in case of organizing the preparation of drugs following prescription;

- Records and books must be kept for at least a year since the expiration date of drug.

c) Development and implementation following the standard procedures, manipulation under form of text for all professional activities for all employees to apply, at least must have the following procedures:

- The process of buying drugs and quality control;

- The process of selling prescription drugs;

- The process of selling non-prescription drugs;

- The process of preservation and quality monitoring;

- The process for handling in case drugs to be complained or revoked;

- The process of preparing prescription drugs in case of organization to prepare prescription drugs;

- The other related processes.

III. MAJOR ACTIVITIES OF DRUG RETAIL ESTABLISHMENTS

1. Drugs purchase

a) Drugs are purchased at the lawful drug trading establishments.

b) Having records for monitoring, selecting suppliers who are prestigious and ensure drugs quality in the business process;

c) Only buying drugs permitted for circulation (drugs having registration number or drugs without registration number but permitted for import according to demand of treatment). Drugs must be intact and have full manufacturer's packaging, proper labels according to provisions under the current regulations. There are enough valid invoices, vouchers of the purchase of drugs;

d) When buying drugs, the retailers check its expiration date, check the label information following the labeling regulations, check quality (by sense organs, especially for drugs that are easy to change their quality) and control during storage;

đ) The pharmacy must have enough drugs of the list of essential drugs used for level C in the list of essential drugs in Vietnam defined by the local Health Department.

2. Drugs selling

a) The basic steps in the sale of drugs, including:

- The retailers ask the buyers the questions related to the disease, to drugs at request of the buyers;

- The retailers advise the buyers on drugs selection, drug usage, guide drug usage verbally. Where there is no accompanied prescription, retailers must guide additionally use of drugs by handwriting or typing, printing and attached to the packaging.

- Retailers provide appropriate drugs, inspect, cross-check sold drugs on the label of the drug, by sense organs on quality, quantity and type of drugs.

b) The provisions of advising buyers, including:

- The drug buyers should be got proper advice to ensure effective and appropriate treatment to the needs and aspirations;

- The retailers must clearly identify the circumstances required consultation of persons with expertise suitable to provided drugs to advise the buyers information on drugs, price and selection of non-prescription drugs;

- For patients required diagnosis by a physician before they can use drugs, retailers need to advise patients to see the appropriate specialized physicians or treatment doctors;

- For those who buy drugs without necessity for using drugs, drugs sellers should explain clearly for them to understand and self-care, self-monitor their diseases symptoms;

- For poor patients, who cannot afford to pay, the retailers should advise drug selection at reasonable prices, ensure treatment and decreased to the lowest cost;

- Not to conduct operations of information, advertising drugs at the place of selling drugs in contravention of the regulations on drugs advertising information, and encourage the buyers to consider drugs as ordinary goods and encourage buyers to buy drugs more than the necessity.

c) Sale of prescription drugs:

- Upon the sale of prescription drugs, it must be directly joined by retailers having appropriate professional qualifications and complied with current rules and regulations of the Ministry of Health on sale of prescription drugs.

- The retailers must sell drugs in compliance with the prescription. Where the description is found not being clear on drug name, concentration, content, quantity, or violation of legislation, expertise or affecting patient health, retailers must notify the prescribing persons for knowing.

- The retailers must explain clearly for the buyers and may refuse to sell prescription drugs in case of invalid prescriptions, prescription errors or doubt, invalid prescription not for treatment purpose.

- Retailers who are university pharmacists may substitute drugs with other drugs of the same active substance, dosage form, the same amount as being agreed by the buyers.

- The retailers guide the buyers on the method of drugs use, remind the buyers to use in compliance with prescriptions.

- After selling narcotic drugs, the pharmacy staff must record into the books, archive the original prescription.

3. Drugs preservation

a) The drugs must be preserved as required on drug labels;

b) The drugs should be arranged in groups of pharmacological effects;

c) The prescription drugs are displayed for sale and preserved in the private sector marked "Prescription drugs" or if it is in the same area, the prescription drugs must place separately. The arrangement must be ensured the convenience, avoid causing confusion.

4. Requirements for retailers in professional practice

a) For the people who work in the drugs retail establishments:

- Having polite, gracious attitude in contact with the drugs buyers, the patients;

- Providing for guidance and explanation, information and proper advice on the drugs usage to the buyers or the patients and the necessary consultation to ensure their safe and effective, rational use;

- Keeping confidential the information of the patients in the practice process as their illness, the information required by patients;

- Wearing white blouse, clean, neat, wearing a tag detailing the name and title;

- Strictly complying with pharmaceutical regulations, voluntarily complying with morality of pharmaceutical practice;

- Participating in the classes of training, updating professional knowledge and law on health;

b) Professional managers or owners of drug retail establishments shall:

- Always be present during the operation period and be responsible before law for all operations of the establishments; in case of absence, they must authorize for employees having equivalent professional qualifications or higher to administer under regulations;

- Directly participate in the sale of prescription drugs, advising the buyers.

- Contact with the doctor who has prescribed in the necessary cases to handle situation occurs.

- Control quality of purchased drugs, drugs preserved at the pharmacy.

- Regularly update professional knowledge, legal documents on pharmaceutical practice and continuously improve the quality of supply service.

- Train and guide staffs at the retail establishments on professional skill and morality of pharmaceutical practice as well as.

- Coordinate with the basis medical facilities and basis health staffs on the residential areas to supply essential drugs, participate in drug education and communication for the community and other activities.

- Monitor and inform the health authorities on the undesirable effects of the drugs.

c) The retail establishments’ activities required to do for drugs to be complained or recalled:

- It must have a system for information storage, notification of the complained drugs, drugs which are not allowed to circulate, the drug required to be withdrawn;

- It must have the recall notices to customers; inspection and direct recall, special reserves for drugs to be recalled;

- It must have records stating clearly on the complaints and remedies for the buyers on the complaints or drugs recall;

- If it is decided to destroy drugs, then must have records in accordance with the regulations on management of drug quality;

- It must send reports to the levels in accordance with provisions./.

APPENDIX I

INSTRUCTIONS OF MAIN CONTENTS OF THE STANDARD PROCESSES OF MANIPULATION

1. Purpose: Providing for the way of implementation of standard manipulations in the activities at the retail establishments

2. Scope of application: for a specific activity

3. Mission: objects required to implement

4. Content: the specific steps

5. Attached documents

6. Storage form

7. Amendment and supplement

Some basic requirements:

- Page 1: Introduction: Naming the retail establishments; the process name, number of pages; number and date of issuance, names of parts; full name of the editor/examiner/approver.

- Page 2 onwards is the main content of the process

- Required to write by imperative mood, short, easy to understand.

- The process must be inspected and approved by professional manager or owner of a retail establishment.

- The original of the process must be stored in the document. Several copies of each process are sent to the relevant departments and if necessary, it must put a copy in a convenient place for staff’s reference. After the issuance of a new process, it must recover the corresponding former process to store for a period, depending on the regulations of the establishment.

- Each process must be amended and supplemented periodically for updates. If it is not required for changes, the professional manager must state that it is not required for changes on the original and then sign and state date. When having amendments, supplements, it is required to re-print the entire process for issuance.

APENDIX II

CHECKLIST

I. GENERAL GUIDANCES

1. Purpose for developing the list

- For the business establishments to implement GPP; help the establishment to self-evaluate, self-inspect.

- For the pharmaceutical management agency to inspect, evaluate and recognize GPP.

- For unifying on the national implementation of GPP.

2. Principles for scoring

Total standard points if the establishments have enough activities in GPP (including preparation by prescription and having storage for drugs preservation) are 100.

Standard points are defined from about 0.5 to 2 depending on each criterion (principle of implementing step by step).

The criterion should be noted:

+ Scoring plus points (the incentive points) if the establishments perform higher than the minimum specifications. There are 10 contents applied plus points.

+ Scoring minus points if the establishments perform but there are also many existences. There are 9 contents applied plus points.

Scoring unacceptable points if the establishments fail to perform a number of criterions;

There are 9 unacceptable contents in the list.

The part in italics: additional inspection by interview form.

3. Method of counting points

3.1. Scoring maximum points, not giving intermediate points

3.2. The activities that the establishments have not got, for example: having no preparation by prescription, having no storage, the standard points shall be subtracted, namely:

- Having no preparation by prescription, standard point: 95

- Having no storage, standard point: 98

- Having no both preparation by prescription and storage, standard point: 93

3.3. For the establishments that are operating, the inspection, scoring is calculated on actual operations at the establishments.

3.4. For the establishments that have newly been established, not yet operated:

- The criterions that have been deployed in the preparation process: scoring is calculated on actual results.

- The criterions that shall be took place only when operating: points shall be calculated if the criterions were defined in the records, documentation, standard manipulation procedures, and forms... to deploy the activities and was signed for issuance by the competent persons, the employees of the establishments were trained, understand, and correctly practice.

4. The method of conclusion

- The establishments not getting any mistake of the unacceptable point.

- From 90% of points or more: The establishments shall be reviewed for recognition. If there is any existence, require for overcoming their existences in the implementation of GPP and used as a basis for further inspection, the next inspection.

- From 80% to 89% of points: The establishments should overcome and send a written report within 30 days for the inspection team to review the application for grant of certificate of qualification of GPP. If a period of 30 days is over but the establishments have not overcome and still want to practice, they should apply for re-inspection.

- Less than 80% of points: The establishments should overcome for re-inspection.

- The establishment getting the mistakes of the unacceptable point: The establishments should overcome for re-inspection.

II. CHECKLIST OF GOOD PHARMACY PRACTICE (CHECKLIST)