Decree No. 131/2020/NĐ-CP on the organization and operation of clinical pharmacy activities in medical examination and treatment facilities.

 DECREE

Regulations on the organization and operation of clinical pharmacy at medical examination and treatment facilities

||| Pursuant to the Law on Organization of the Government dated June 19, 2015;

BASED ON THE PHARMACEUTICAL LAW dated April 6, 2016;

At the proposal of the Minister of Health;

The Government promulgates this Decree to regulate the organization and operation of clinical pharmacy at medical examination and treatment facilities.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree regulates the organization of clinical pharmacy; the operation of clinical pharmacy and the responsibility for implementing clinical pharmacy activities at medical examination and treatment facilities that engage in drug use as prescribed by laws on medical examination and treatment.

Article 2. Applicability

This Decree applies to medical examination and treatment facilities that engage in drug use as prescribed by laws on medical examination and treatment, including medical examination and treatment facilities of the People's Armed Forces; domestic and foreign organizations and individuals related to the organization and operation of clinical pharmacy in Vietnam.

Chapter II
ORGANIZATION OF CLINICAL PHARMACY

Article 3. Clinical Pharmacy Department and number of personnel engaged in clinical pharmacy work

1. Clinical Pharmacy Department:

a) The clinical pharmacy department under the pharmacy department of the medical examination and treatment facility organizes and implements clinical pharmacy activities at the facility to serve outpatients with health insurance cards and inpatients;

b) Medical examination and treatment facilities that do not organize a pharmacy department as prescribed by laws on medical examination and treatment must still establish a clinical pharmacy department to implement clinical pharmacy activities to serve outpatients with health insurance cards and inpatients;

c) Pharmacies within the premises of medical examination and treatment facilities carry out clinical pharmacy activities at the pharmacies to serve customers purchasing medicine when the medical examination and treatment facility has organized a pharmacy.

2. Number of personnel responsible for clinical pharmacy work and personnel engaged in clinical pharmacy work:

a) Medical examination and treatment facilities with 200 beds or more must allocate 01 person responsible for clinical pharmacy work and must have a number of personnel engaged in clinical pharmacy work with a ratio of at least 01 person for every 200 inpatient beds and at least 01 person for every 1,000 prescriptions issued to outpatients with health insurance cards in one day;

b) Medical examination and treatment facilities with fewer than 200 beds or medical examination and treatment facilities that do not organize a pharmacy department as prescribed by laws on medical examination and treatment must have at least 01 person responsible for clinical pharmacy work who also engages in clinical pharmacy work to serve inpatients (if any) and must have a number of personnel engaged in clinical pharmacy work with a ratio of at least 01 person for every 1,000 prescriptions issued to outpatients with health insurance cards in one day;

c) Pharmacies within the premises of medical examination and treatment facilities must have at least 01 person engaged in clinical pharmacy work for each business location of the pharmacy. The person responsible for the professional aspect of pharmacy may concurrently be the person engaged in clinical pharmacy work at the pharmacy.

3. Increase the number of personnel engaged in clinical pharmacy work at medical examination and treatment facilities according to the following schedule:

a) By January 1, 2026, hospitals from Class II and above must ensure a number of personnel engaged in clinical pharmacy work with a ratio of at least 01 person for every 150 inpatient beds and at least 1.5 persons for every 1,000 prescriptions issued to outpatients with health insurance cards in one day;

b) By January 1, 2031, all medical examination and treatment facilities must ensure a number of personnel engaged in clinical pharmacy work with a ratio of at least 01 person for every 100 inpatient beds and at least 02 persons for every 1,000 prescriptions issued to outpatients with health insurance cards in one day.

Article 4. Conditions for personnel engaged in clinical pharmacy work

1. Personnel engaged in clinical pharmacy work at medical examination and treatment facilities, except as provided for in Clause 2 of this Article, must have a bachelor's degree or higher in pharmacy (awarded or recognized in Vietnam).

2. Personnel engaged in clinical pharmacy work at medical examination and treatment facilities using traditional medicine must hold one of the following certificates (awarded or recognized in Vietnam):

a) A certificate meeting the conditions stipulated in Clause 1 of this Article and one of the certificates or qualifications in traditional medicine prescribed in Points i and l of Clause 1, Article 13 of the Medicine Law;

b) A bachelor's degree or higher in traditional pharmacy;

c) A bachelor's degree or higher in traditional medicine.

3. Personnel engaged in clinical pharmacy work at pharmacies within the premises of medical examination and treatment facilities must meet the conditions stipulated in Clause 1 of this Article. In cases where such personnel also bear responsibility for pharmaceutical matters, they must meet the conditions stipulated in Article 18 of the Medicine Law.

Article 5. Personnel responsible for clinical pharmacy work

1. Personnel responsible for clinical pharmacy work at medical examination and treatment facilities must meet the conditions stipulated in Article 21 of the Medicine Law and possess a Pharmaceutical Practice Certificate as prescribed in Clause 3, Article 11 of the Medicine Law.

2. Professional practice content for personnel responsible for clinical pharmacy work:

a) Personnel responsible for clinical pharmacy work at medical examination and treatment facilities must engage in one of the following professional practice areas: Bioequivalence testing of medicines; clinical drug trials; pharmacological and clinical pharmacology research; adverse drug reaction monitoring at drug information centers and adverse event tracking;

b) Personnel responsible for clinical pharmacy work at medical examination and treatment facilities using traditional medicine must engage in one of the following professional practice areas: Clinical drug trials; pharmacological and clinical pharmacology research; adverse drug reaction monitoring at drug information centers and adverse event tracking of traditional medicine.

3. The period of professional practice for personnel responsible for clinical pharmacy work is at least two years. For those holding a doctoral degree or a second-level specialty in fields related to the professional practice content, the required period of professional practice is at least six months. For those holding a master's degree or a first-level specialty in fields related to the professional practice content, the required period of professional practice is at least twelve months.

4. Personnel responsible for clinical pharmacy work at medical examination and treatment facilities, except as provided for in Clause 5 of this Article, shall engage in professional practice at one of the following facilities:

a) Facilities conducting clinical drug trials or bioequivalence testing of medicines for non-commercial purposes; facilities conducting clinical drug trials or bioequivalence testing of medicines not for commercial purposes;

b) Research centers or departments of pharmacology and clinical pharmacology at universities of medicine and pharmacy;

c) National or regional centers for drug information and adverse event tracking;

d) Medical examination and treatment facilities that organize and operate clinical pharmacy activities according to this Decree or have organized and operated clinical pharmacy activities according to the law prior to the effective date of this Decree.

5. Personnel responsible for clinical pharmacy work at medical examination and treatment facilities using traditional medicine shall engage in professional practice at hospitals or institutes with beds that conduct traditional medicine activities and organize and operate clinical pharmacy activities according to this Decree or have organized and operated clinical pharmacy activities according to the law prior to the effective date of this Decree.

Chapter III
CLINICAL PHARMACY ACTIVITIES

Article 6. Clinical pharmacy activities in the pharmacy department

The pharmacy department of medical examination and treatment facilities shall implement clinical pharmacy activities in accordance with Article 80 of the Medicine Law and shall be specifically defined as follows:

1. Advising on the development of drug lists at medical examination and treatment facilities with the aim of rational, safe, and effective drug use:

a) Establishing criteria for selecting drugs to advise the Medicine and Treatment Council of medical examination and treatment facilities;

b) Receiving and processing information related to the safety and efficacy of drug use within the drug list at medical examination and treatment facilities to propose supplements and adjustments to the drug list to ensure rational, safe, and effective drug use;

c) Analyzing and evaluating safety and efficacy based on cost-effectiveness, cost-benefit, risk-benefit evidence in drug use at medical examination and treatment facilities to provide advice and information for the development of drug lists at these facilities to ensure rationality, safety, and effectiveness.

2. Advising and monitoring drug prescription and use:

a) Advising on drug use for prescribers when selecting drugs for treatment. Checking and controlling the drug prescription process, reviewing medical orders to detect and prevent possible errors and mistakes. Summarizing and analyzing error causes to propose solutions for improvement and enhancement of prescription quality;

b) Participating in drug usage analysis (clinical audit) in cases where patients are infected with antibiotic-resistant microorganisms, require complex drug use, or as requested by the head of the medical examination and treatment facility;

c) Participating in consultations or specialized diagnosis councils related to drug selection for treatment.

3. Providing information and guidance on drug use for medical practitioners, drug users, and the community:

a) Updating new drug information for medical practitioners regarding the drug name, composition, pharmacological effects, indications, contraindications, drug interactions, dosage, administration methods, special patient group usage instructions, drug warning and safety information, and other necessary information;

b) Updating drug information for drug users and the community regarding the drug name, composition, concentration, dosage form, indications, contraindications, dosage, administration methods, and issues to note during drug use;

c) Organizing updates on drug information specified in points a and b of this clause through direct communication, written information, or posting on bulletin boards or electronic information pages of medical examination and treatment facilities.

4. Participating in the development of procedures and professional guidelines related to drug use and supervising the implementation of these procedures, including:

a) Developing professional procedures related to drug use and guiding the use of drug lists at medical examination and treatment facilities;

b) Cooperating with the Medicine and Treatment Council of medical examination and treatment facilities to develop monitoring procedures for drugs with narrow therapeutic windows, severe side effects, drugs requiring preparation for intravenous administration, or drugs used for special patient groups requiring close monitoring or drugs with special storage conditions according to treatment requirements;

c) Directly participating in treatment processes and supervising adherence to drug use procedures approved by the Medicine and Treatment Council of medical examination and treatment facilities or by the head of the medical examination and treatment facility.

5. Analyzing and evaluating drug use effectiveness at medical examination and treatment facilities:

a) Developing plans to analyze and evaluate drug use effectiveness every six months and annually, trends, and next year's drug use plans for medical examination and treatment facilities;

b) Evaluating drug use effectiveness through assessing the appropriateness of treatment guidelines and drug lists at medical examination and treatment facilities with the drug supply to clinical departments;

6. Participating in monitoring adverse drug reactions:

a) Updating information on adverse drug reactions, other drug safety information, and handling instructions for medical practitioners, nursing staff, nurses, technicians, and midwives to identify and handle adverse drug reactions;

b) Monitoring adverse drug reactions and receiving information to compile and report adverse drug reactions at the facility according to Ministry of Health guidelines;

c) Reporting immediately about health risks to patients related to drug use or inappropriate drug use cases at medical examination and treatment facilities to the head of the medical examination and treatment facility.

7. Participating in clinical trials and bioequivalence studies of drugs at medical examination and treatment facilities and other scientific research on rational, safe, and effective drug use.

Article 7. Clinical pharmacy activities at clinical departments, departments, outpatient clinics

Personnel engaged in clinical pharmacy work participate in analyzing and monitoring the use of medications for patients being examined and treated at healthcare facilities. For each patient, clinical pharmacy personnel must carry out the following activities:

1. Collecting patient information, including extracting information from medical records, conducting direct interviews with patients, including:

a) Medication history;

b) Summary of clinical data and existing ancillary test results.

2. Reviewing medications prescribed to patients during hospital rounds or reviewing medical orders in medical records, prescriptions, including:

a) Indications;

b) Contraindications;

c) Medication selection;

d) Administering medication to patients: dosage, interval, timing, route, administration to special populations, duration of treatment;

đ) Medication interactions requiring attention;

e) Adverse drug reactions.

3. Guiding medication use for nursing staff and midwives.

4. Collaborating with healthcare practitioners to provide advisory information to patients regarding precautions during medication use.

Article 8. Clinical pharmacy activities at clinical pharmacy units in healthcare facilities without a pharmacy department

Clinical pharmacy units in healthcare facilities without a pharmacy department must implement clinical pharmacy activities as stipulated in point a clause 2, Clause 3, point a clause 4, and Clause 6 Article 6 and Article 7 of this Decree.

Article 9. Clinical pharmacy activities at pharmacies within healthcare facility premises

The person responsible for professional matters or personnel engaged in clinical pharmacy work at pharmacies within healthcare facility premises must implement clinical pharmacy activities according to the content specified in Clause 2, 3, and 6 Article 80 of the Medicine Law and is specifically defined as follows:

1. Providing advice and information about medications to buyers and users of medications:

a) Advising, guiding, explaining, providing information, and giving recommendations on how to use medications to buyers or patients; guiding buyers on how to use medications and comply with prescriptions;

b) Advising patients to see appropriate specialist doctors for conditions that require diagnosis before medication can be used;

c) Replacing a medication listed in a prescription with another medication containing the same active ingredient, route of administration, and dosage with the buyer's consent and bearing responsibility for the change.

2. Advising and exchanging information with prescribers when detecting unreasonable prescribing practices:

a) In cases where prescriptions are unclear regarding the name of the medication, concentration, quantity, or contain legal or professional errors that may affect patient health, they must inform the prescriber;

b) Advising and explaining to buyers and having the right to refuse to sell medications based on invalid prescriptions, those with errors, or those raising suspicion; prescriptions not aimed at treating diseases and informing the prescriber.

3. Participating in monitoring and supervising adverse drug reactions:

a) Providing complete and accurate information related to side effects and known adverse reactions of medications to buyers and users of medications;

b) Guiding buyers and users of medications on how to handle over-dosage or side effects and adverse reactions during medication use;

c) Monitoring and receiving information about side effects and adverse reactions of medications to compile and report to the pharmacy department.

Chapter IV
RESPONSIBILITY FOR IMPLEMENTING CLINICAL PHARMACY ACTIVITIES

Article 10. Responsibilities of the Head of Medical Examination and Treatment Facility

The head of a medical examination and treatment facility must organize and be responsible for the results of clinical pharmacy activities at the facility in accordance with the following provisions:

1. Ensure sufficient number of personnel engaged in clinical pharmacy work as stipulated in Clause 2 or Clause 3, Article 3 of this Decree and organize clinical pharmacy activities at the medical examination and treatment facility.

2. Ensure continuous training and updating of specialized knowledge in clinical pharmacy for those responsible for clinical pharmacy work and those engaged in clinical pharmacy work.

3. Ensure adequate material and technical facilities to carry out clinical pharmacy activities as prescribed in Articles 6, 7, 8, and 9 of this Decree.

Article 11. Responsibilities of the Head of Pharmacy Department and Head of Clinical Pharmacy Unit at Medical Examination and Treatment Facilities without a Pharmacy Department

1. The head of the pharmacy department of a medical examination and treatment facility shall have the following responsibilities:

a) Directly organize clinical pharmacy activities at the medical examination and treatment facility in accordance with this Decree;

b) Be responsible for clinical pharmacy expertise at the medical examination and treatment facility;

c) Develop and submit to the head of the medical examination and treatment facility for issuance procedures for implementing clinical pharmacy activities at the facility;

d) Coordinate with clinical departments, paraclinical departments, and related departments to implement clinical pharmacy activities.

2. The head of the clinical pharmacy unit at a medical examination and treatment facility without a pharmacy department shall perform the responsibilities specified in Clause 1 of this Article.

Article 12. Responsibilities of the Head of Clinical Department, Head of Department, or Outpatient Clinic

1. Direct physicians, nurses, technicians, and midwives in the department or clinic to cooperate with those engaged in clinical pharmacy work to implement clinical pharmacy activities as prescribed in Articles 6, 7, 8, and 9 of this Decree.

2. The head of the clinical department shall be responsible for notifying in writing the plan to organize specialty consultations or diagnostic boards related to drug selection for participation by those responsible for specialty expertise and those engaged in clinical pharmacy work in accordance with point c, Clause 2, Article 6 of this Decree.

3. Coordinate with the head of the pharmacy department or the person responsible for clinical pharmacy work at the medical examination and treatment facility to review comprehensive reports on advisory opinions of those engaged in clinical pharmacy work regarding prescription and drug usage guidance. In cases where the advisory opinions are appropriate, the head of the clinical department, head of the department, or outpatient clinic shall be responsible for notifying in writing the prescriber and reporting to the Drug and Treatment Council of the medical examination and treatment facility for a final conclusion.

Article 13. Responsibilities of the Person Responsible for Clinical Pharmacy Work

The person responsible for clinical pharmacy work shall have rights and obligations as stipulated in Clause 1, Article 82 of the Medicine Law and shall have the following responsibilities:

1. Advise and propose to the head of the pharmacy department and the head of the medical examination and treatment facility models of operation and working regulations of the clinical pharmacy unit.

2. Assign specific tasks, direct professionally, instruct, and train those engaged in clinical pharmacy work.

3. Organize the implementation and supervision of the tasks of the clinical pharmacy unit.

4. Report the results of the clinical pharmacy unit's activities to the head of the pharmacy department and the head of the medical examination and treatment facility. Review and check to report during morning meetings with clinical departments and outpatient clinics about drug usage advisory content with prescribers, including cases where the prescriber agrees or disagrees with the advisory content of those engaged in clinical pharmacy work.

Article 14. Responsibilities of Clinical Pharmacy Personnel

Clinical pharmacy personnel shall have rights and obligations as prescribed in Clause 1 of Article 82 of the Medicine Law and shall bear the following responsibilities:

1. Implement clinical pharmacy activities as stipulated in Articles 6, 7, 8, and 9 of this Decree.

2. Work full-time or part-time in certain clinical departments according to assigned tasks; directly participate in treatment teams for patients; perform monitoring and reporting functions on drug usage situations at the facility for clinical pharmacy personnel working in the clinical pharmacy department of medical examination and treatment facilities.

3. Participate in scientific research and continuous training courses on clinical pharmacy as prescribed by the Minister of Health.

4. Compile reports on drug usage consultation activities for prescribers at least once every week for the person responsible for clinical pharmacy work or the head of the pharmacy department or the head of the medical examination and treatment facility, including cases where the prescriber agrees and disagrees with the consultation contents.

Article 15. Collaboration in Clinical Pharmacy Activities between Clinical Departments, Outpatient Departments, and Pharmacy Departments, Clinical Pharmacy Units

1. Clinical pharmacy personnel shall fulfill advisory functions related to prescription and drug use at medical examination and treatment facilities in accordance with this Decree and shall be responsible for the content of their advice.

2. In case of discovering issues regarding safety, efficacy, or rationality in drug use, clinical pharmacy personnel shall provide advice to the prescriber to optimize drug use, while recording the advice on the Drug Usage Analysis Form for Patients as prescribed by the Minister of Health for the prescriber to replace or adjust the prescription. If the advice is not accepted, the decision and responsibility for prescribing and using drugs remain with the prescriber.

3. The heads of pharmacy departments, outpatient departments, planning and integration units, outpatient departments, clinical departments, and doctors, technicians, nurses, and midwives at medical examination and treatment facilities shall be responsible for coordinating and creating conditions for clinical pharmacy personnel to fulfill their assigned duties and tasks.

4. Clinical pharmacy personnel shall be responsible for complying with assignments and professional guidance from the person responsible for clinical pharmacy work and the head of the pharmacy department.

Chapter V
IMPLEMENTING PROVISIONS

Article 16. Effective Date

Article 16. Effective Date

1. This Decree shall take effect from January 1, 2021.

2. The Circular No. 31/2012/TT-BYT dated December 20, 2012, issued by the Minister of Health guiding clinical pharmacy activities in hospitals is hereby abolished.

Article 17. Implementation Timeline

1. From January 1, 2021, the following medical examination and treatment facilities must organize clinical pharmacy activities:

a) Hospitals and Institutes with hospital beds (referred to as hospitals), including general and specialized hospitals from Class I upwards under the Ministry of Health, provincial health departments, centrally-administered municipalities, or under the Ministry of National Defense, Ministry of Public Security, and other ministries and sectors assigned by the Ministry of Health as the final level in terms of professional technical expertise.

b) Private medical examination and treatment facilities ranked equivalent to Class I hospitals.

2. By January 1, 2024, medical examination and treatment facilities that are Class II hospitals under the Ministry of Health, provincial health departments, private entities, or under the Ministry of National Defense, Ministry of Public Security, and other ministries and sectors must organize clinical pharmacy activities.

3. By January 1, 2027, medical examination and treatment facilities that are Class III and Class IV hospitals, unranked hospitals under district, county, town, and centrally-administered municipal levels, private entities, or under the Ministry of National Defense, Ministry of Public Security, and other ministries and sectors must organize clinical pharmacy activities.

Article 18. Responsibility for Implementation

4. By January 1, 2030, other medical examination and treatment facilities engaged in drug use activities as prescribed by laws on medical examination and treatment must organize clinical pharmacy activities.

Article 18. Responsibilities of Ministries and Agencies

1. The Minister of Health shall be responsible for providing professional guidance and technical support to implement clinical pharmacy activities as prescribed in this Decree.

2. The Ministers of National Defense, Public Security, and other ministers and sector heads shall be responsible for providing professional guidance and technical support to implement clinical pharmacy activities for medical examination and treatment facilities under their management authority.