Directive No. 01/2008/CT-BYT on Promoting the Implementation of Good Pharmacy Practice (GPP) Principles and Standards at Retail Drug Outlets

DIRECTIVE

Regarding the promotion of the implementation of principles and standards

Good Pharmacy Practices - GPP at retail pharmaceutical establishments

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On January 24, 2007, the Minister of Health issued Decision No. 11/2007/QĐ-BYT on the issuance of principles and standards for "Good Pharmacy Practices" (GPP). According to this Decision, from January 1, 2011, all pharmacies nationwide must meet the GPP standards, and from January 1, 2013, all pharmacy counters must meet the GPP standards. The time remaining until these deadlines is not long, but currently, most provinces and cities have yet to develop specific plans to implement the GPP standards (including some areas that have reached the mandatory application deadline); some areas have implemented the standards but progress has been very slow, failing to meet the timelines set out in Decision No. 11/2007/QĐ-BYT.

Delay in implementing the GPP standards will significantly impact achieving the goal of "improving the quality of pharmaceutical supply activities, ensuring rational, safe, and effective drug use," and fulfilling Vietnam's commitments during its process of international economic integration. To accelerate the implementation of the GPP standards in retail pharmaceutical establishments across the country according to the established timeline, thereby contributing to ensuring rational, safe, and effective drug use and improving the quality of pharmaceutical care services for the people, the Minister of Health requests leaders of Departments, Bureaus, Office, Inspectorate of the Ministry of Health, Directors of Provincial Health Services under central cities (hereinafter referred to collectively as Provincial Health Services), and related units to focus on performing the following tasks based on their functions and responsibilities:

1. The Director of the Provincial Health Service shall be responsible for:

a) Developing and implementing a plan to apply the GPP standards in accordance with the regulations and timeline stipulated in Decision No. 11/2007/QĐ-BYT dated January 24, 2007, of the Minister of Health for retail pharmaceutical establishments within their jurisdiction.

b) Directing provincial hospitals to immediately apply the GPP standards to all retail pharmaceutical establishments within public hospitals and encouraging their application to other types of healthcare facilities within their jurisdiction.

c) Coordinating with relevant provincial departments and agencies to develop and advise the Chairman of the People's Committee of the province or centrally-administered city to issue, within their authority, or submit to competent authorities for issuance mechanisms and policies providing tax, land, scale, and investment scope incentives to encourage retail pharmaceutical establishments to proactively and positively apply the GPP principles and standards.

d) Organizing basic and advanced training sessions on the GPP principles and standards for management agencies, businesses, pharmacy owners, managers, and pharmacy staff.

đ) Cooperating with local mass media to strengthen publicity and mobilization to raise public awareness about the benefits of applying the GPP standards, while promoting the brand of retail pharmaceutical establishments that meet the GPP standards within their jurisdiction.

e) Specifically, for the Health Services of Hanoi, Da Nang, Ho Chi Minh City, and Can Tho, it is required that:

- The Director of the Health Service strictly implement the application of the GPP standards for pharmacies supplementing business functions or newly established.

- For existing retail establishments, measures should be taken to encourage and motivate them to apply the GPP standards even before the mandatory application date to improve the quality of pharmaceutical care services for the people.

- Each city should strive to achieve a target of at least 30 retail pharmaceutical establishments meeting the GPP standards by the end of 2008.

2. The Director of hospitals shall be responsible for:

a) Implementing the GPP standards for hospital pharmacies or those located within hospital premises (hereinafter collectively referred to as hospital pharmacies) and only being allowed to operate after meeting the GPP principles and standards as prescribed by the Ministry of Health. This timeline will be implemented by the end of 2008.

b) Applying the self-management and self-responsibility mechanism of public health institutions as stipulated in Decree No. 43/2006/NĐ-CP dated April 25, 2006, of the Government or other joint venture or partnership forms in accordance with the law to implement the GPP standards for hospital pharmacies in compliance with the Ministry of Health's regulations.

c) Directing the Drug and Treatment Council to institutionalize and standardize the selection and rational, safe use of drugs; intensify inspections of prescription writing and drug dispensing practices, and the "Good Prescription Practice" regulations in hospitals to facilitate the effective implementation of the GPP standards.

3. The Director of pharmaceutical trading enterprises and the owner of retail pharmaceutical establishments shall be responsible for:

a) Studying and implementing the GPP principles and standards at retail pharmaceutical establishments or within their retail distribution networks in accordance with the timeline stipulated in Decision No. 11/2007/QĐ-BYT.

b) Applying incentive measures (such as pricing, services, information technology...) to supply drugs to retail establishments that meet the GPP standards.

c) By June 30, 2008, each enterprise with a retail pharmaceutical network must establish at least one retail pharmaceutical establishment meeting the GPP standards as prescribed by the Ministry of Health to serve as a model for replication throughout the system.

4. The Director of the Bureau, Department Head, Chief Inspector of the Ministry of Health shall be responsible for:

a) The Drug Administration Bureau:

- Developing and submitting to the leadership of the Ministry for issuance a Decision establishing a Task Force to implement the GPP principles and standards, comprising representatives from the Drug Administration Bureau, the Medical Examination and Treatment Management Bureau, the Vietnam Association of Pharmaceutical Manufacturers and Traders, the Vietnam Pharmacists' Association, the Hanoi University of Pharmacy, the Ho Chi Minh City University of Medicine and Pharmacy, the Hanoi Health Service, the Da Nang Health Service, the Ho Chi Minh City Health Service, and the Can Tho Health Service. The Decision should clearly outline the functions, duties, and operational rules of the Task Force to organize and guide the effective implementation of the GPP standards nationwide.

- Organize specific and detailed training sessions on GPP principles and standards, and guide the implementation steps for civil servants involved in pharmaceutical management, enterprises, and retail drug outlets.

- Guide units to implement preferential mechanisms and policies regarding tax, land, and other incentives, as well as regulations on importing and distributing drugs for retail drug outlets that meet GPP principles and standards after they are issued by competent authorities, with the aim of encouraging the nationwide application of GPP standards.

- Submit to the Ministry's leadership for issuance of the "Hospital Pharmacy Operation Regulation" (retail drug outlets within healthcare facilities) by January 2008.

- Serve as the coordinating unit to work with relevant units to build and submit to the Ministry's leadership for issuance of the Operation Regulation of the GPP-compliant pharmacy system (GPP Pharmacy Chain) by January 2008.

- Develop and submit to the Ministry's leadership for issuance of the List of Over-The-Counter (OTC) Drugs by March 2008.

b) Department of Medical Examination and Treatment:

- Promptly revise, supplement, and complete the Prescription Drug and Dispensing Regulation, and organize guidance on its implementation for all medical examination and treatment units across the country. - Submit to the Ministry's leadership for issuance of the Prescription Drug and Dispensing Regulation; organize guidance on its implementation for all medical examination and treatment units across the country.

- Serve as the coordinating unit to work with relevant units to develop and submit to the Ministry's leadership for issuance of the List of Prescription Drugs by March 2008.

- Develop and submit to the Ministry's leadership for issuance of the Good Prescribing Practices principles and standards; organize guidance on their implementation for all medical examination and treatment facilities across the country.

- Amend and supplement Circular No. 23/2005/TT-BYT dated August 25, 2005, of the Minister of Health on guidelines for classifying and ranking hospitals, including the addition of hospital pharmacies meeting GPP principles and standards as one of the criteria for evaluating and ranking hospitals.

c) Ministry Inspectorate:

- Strengthen the organization of inspections on prescription writing and dispensing according to prescriptions, and the application of Good Prescribing Practices principles and standards at medical treatment facilities, and Good Pharmacy Practice principles and standards at drug business establishments across the country.

- Strictly handle violations in accordance with the provisions of the law.

Upon receipt of this Directive, the leaders of the Departments, Bureaus, Ministry Office, Ministry Inspectorate, Heads of subordinate units under the Ministry, Provincial Health Department Directors, and Heads of health sector units are required to promptly implement it and report the results every three months to the Department of Medicine Management for consolidation and reporting to the Minister./.