Standards of good pharmacy practices for dispensaries in Vietnam

What are the regulations on the standards of good pharmacy practices for dispensaries in Vietnam? - Tuan Phong (HCMC, Vietnam)

Standards of good pharmacy practices for dispensaries in Vietnam (Internet image)

1. Standards on personnel in good pharmacy practices for dispensaries in Vietnam (Standards of GPP on personnel for dispensaries)

In Section I, Appendix I - Ib promulgated together with Circular 02/2018/TT-BYT stipulating standards on personnel in good pharmacy practices for dispensaries as follows:

- The chief pharmacist in charge of expertise in pharmacy of a dispensary must have an intermediate professional education diploma in pharmacy or higher and a valid pharmacy practice certificate as regulated by applicable laws.

- The dispensary must have reasonable and appropriate personnel (number of personnel, qualifications, and working experience) to meet its scope of business.

- A pharmacist who directly engages in drug retailing, delivery, and storage and quality management must have a professional qualification and practicing experience conformable with assigned duties. To be specific:

+ A pharmacist who directly sells drugs to buyers must have a basic-level education diploma in pharmacy or higher, except the case prescribed in Point b.

+ The employee who provides information for buyers of toxic drugs or prescription drugs must be the chief pharmacist of the dispensary or the one who has an intermediate professional education diploma in pharmacy or higher.

- All personnel in the dispensary as prescribed in Clause 3 of Section I, Appendix I - Ib promulgated together with Circular 02/2018/TT-BYT are not facing any penalties at warning level or higher for violations against regulations on medicine or pharmacy.

- All personnel must attend primary and continuous training courses in GPP standards.

2. Standards on material and technical facilities in good pharmacy practices for dispensaries in Vietnam (Standards on material and technical facilities)

Pursuant to Section II, Appendix I - Ib issued together with Circular 02/2018/TT-BYT stipulating standards on material and technical facilities in good pharmacy practices for dispensaries as follows:

2.1. Construction and design:

- The dispensary must have a fixed place of business, and be built at a safe, high and dry place, far away from sources of pollution;

- The dispensary’s activities must be separated from other activities;

- The dispensary must be firmly built, have an anti-dust ceiling, easy-to-clean walls and floor, and be well lighted to serve activities but drugs must be protected from direct sunlight.

2.2. Area:

- The area of dispensary premises must be suitable for its scope of business provided that it shall not be smaller than 10m²; the dispensary must have sufficient space for display and storage of drugs, and space for buyers to directly contact and exchange information concerning the use of drugs with pharmacists;

- The dispensary must have separate areas for other activities, including:

+ An area for retailing drugs without primary packages;

+ A separate area for storage of drugs (if necessary);

+ A room or an area for personal consultation for buyers/patients.

- Cosmetics, functional foods and medical equipment (if any) must be displayed in a separate area and not affect drugs; they must be identified by a notice “This product is not a medicine”.

- If a dispensary has the room for retailing drugs without primary packages:

+ This room must have anti-dust ceiling, floor and walls made of easy-to-clean materials; it must be easy to be decontaminated, where necessary;

+ It must have a hand washing area, and an area for washing and storing drug containers or packages;

2.3. Equipment for storage of drugs at the dispensary:

- The dispensary must have appropriate equipment for storing drugs and protecting them from adverse effects of sunlight, temperature, moisture, pollution and the infiltration of insects. To be specific:

+ Cabinets and shelves must be sturdy, easy to clean, convenient for display and preservation of drugs and beautiful look;

+ Lighting must be sufficient for performing activities, checking information on drug labels and preventing or avoiding confusion.

+ Thermometers and hygrometers must be available to control temperature and humidity in the retailing area. They must be calibrated periodically as regulated by law.

+ The dispensary that applies for issuance of a new Certificate of eligibility for pharmacy business or re-inspection of fulfillment of GPP requirements after the date of entry into force of Circular 02/2018/TT-BYT is required to equip a temperature data logger with a predetermined periodicity (temperature is commonly recorded for every 30 or 60 minutes depending on each season).

Dispensaries that have unexpired Certificates of eligibility for pharmacy business or GPP Certificates must equip temperature data loggers by January 01, 2020.

- Drug storage equipment must be suitable for storage conditions written on the labels. The ambient temperature and humidity must be maintained not exceeding 30°C and 75% respectively.

+ Refrigerator(s) or refrigerated storage facilities must be available for drugs requiring storage at cool temperature ((8-15°C) or cold temperature (2-8° C).

- Equipment and packages for dividing and retailing drugs must be suitable for storage conditions written on the labels. To be specific:

+ Drugs which are retailed without primary packages must be closely and firmly packaged by appropriate materials to protect drugs;

+ Packages or materials packaging retailed drugs must not contain advertising information for other drugs;

+ Topical drugs and controlled drugs must be packaged by appropriate materials and easily recognizable.

- Drug labeling:

+ If drugs to be retailed do not have intermediate packages, name of drug, dosage form, and concentrations or contents of active ingredients must be specified; if drugs are not accompanied by prescriptions, dose and directions must be also specified;

2.4. Documentation system, records and operational documents

- Documents or means for searching up-to-date documents concerning directions for use of drugs, applicable regulations on pharmacy and relevant notices by competent pharmacy agencies must be available for pharmacists’ use.

- Records or computers must be equipped to monitor the warehousing, distribution, inventory, batch number, expiry date and origin of drugs and other relevant information, including:

+ Drug-related information: Name of drug, number of Certificate of free sale or import license, batch number, expiry date, manufacturer, importer and storage conditions.

+ Drug origin: Distributor, date of purchase and quantity;

+ Transport facility and storage conditions during the transport of drugs;

+ Quantity of drugs of each type purchased, sold and stocked;

+ Buyers/patients, retailing date and quantity of drugs sold (with regard to narcotic drugs, precursors, psychotropic drugs, and combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors);

+ Name of prescribers must be specified if prescription drugs are sold;

- By January 01, 2020, all dispensaries are required to have appropriate IT equipment and apply information technology and networking so as to ensure their management of drug origin, prices, and sources of drugs purchased and sold. The dispensary must set up a mechanism for transmitting information concerning drug purchase and sale as well as drug quality from suppliers to buyers, and transmitting such information to competent authorities as requested.

- All records or documents must be kept for at least one year from the expiry date of drugs. Records or documents containing information of patients having prescriptions or special cases (patients suffering from chronic disease or requiring follow-up care, etc.) must be kept at a place convenient for use, where necessary;

- Dispensaries that trade in controlled drugs must comply with regulations in Article 43 of the Decree No. 54/2017/ND-CP dated May 08, 2017 and relevant documents.

- Documented standard operating procedures must be maintained for every professional operation and followed by all drugstore staff, and include the following primary contents:

+ Procedures for purchase of drugs and quality control;

+ Procedures for retailing of drugs, provision of information and instructions on use of prescription drugs;

+ Procedures for retailing of drugs, provision of information and instructions on use of OTC drugs;

+ Procedures for drug storage and control of drug quality;

+ Complaints or drug recall procedures;

+ Relevant procedures.

Vo Ngoc Nhi

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