Nghị định 131/2020/NĐ-CP hoạt động dược lâm sàng của cơ sở khám bệnh, chữa bệnh

DECREE

Providing regulations on clinical pharmacy organization and activities of medical examination and treatment establishments

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

Pursuant to the Law on Pharmacy dated April 06, 2016;

At the proposal of the Minister of Health,

The Government hereby promulgates the Decree on providing regulations on clinical pharmacy organization and activities of medical examination and treatment establishments.

Chapter I
GENERAL PROVISIONS

Article 1. Scope of regulation

This Decree provides regulations on clinical pharmacy organization; clinical pharmacy activities and responsibilities for carrying out clinical pharmacy activities of medical examination and treatment establishments engaged in drug use activities in accordance with the law on medical examination and treatment.

Article 2. Subjects of application

This Decree applies to medical examination and treatment establishments engaged in drug use activities in accordance with the law on medical examination and treatment, including medical examination and treatment establishments of the people’s armed forces; domestic and foreign organizations and individuals involved in clinical pharmacy organization and activities in Vietnam.

Chapter II

CLINICAL PHARMACY ORGANIZATION

Article 3. Clinical pharmacy division and the number of persons in charge of clinical pharmacy activities

1. Clinical pharmacy division:

a) A clinical pharmacy division of a medical examination and treatment establishment’s pharmacy department shall carry out clinical pharmacy activities at its establishment to serve out-patients holding health insurance cards and in-patients;

b) A medical examination and treatment establishment failing to organize pharmacy department in accordance with the law on medical examination and treatment still have to organize a clinical pharmacy division to serve out-patients holding health insurance cards and in-patients;

c) A drugstore within a medical examination and treatment establishment shall carry out clinical pharmacy activities at such drugstore to serve the drug buyers in case where the medical examination and treatment establishment organizes a drugstore.

2. The number of persons responsible for clinical pharmacy activities:

a) A medical examination and treatment establishment with a capacity of 200 patient beds or more must arrange 01 person responsible for clinical pharmacy activities and employs at least 01 person in charge of clinical pharmacy activities for every 200 in-patient beds, and at least 01 person in charge of clinical pharmacy activities for every 1,000 prescriptions granted for out-patients holding health insurance cards within a day;

b) A medical examination and treatment establishment with a capacity of less than 200 patient beds, or a medical examination and treatment establishment without a pharmacy department as prescribed must employs at least 01 person responsible for clinical pharmacy activities to serve in-patients (if any) and employs persons in charge of clinical pharmacy activities with the rate of at least 01 person for every 1,000 prescriptions granted for out-patients who have health insurance cards within a day;

c) The drugstore within a medical examination and treatment establishment must employs at least 01 person in charge of clinical pharmacy activities for every business location of such drugstore. A person responsible for professional pharmacy activities of a drugstore may acts as a person in charge of clinical pharmacy activities at that drugstore at the same time.

3. The roadmap for increasing the number of persons in charge of clinical pharmacy activities at a medical examination and treatment establishment is prescribed as follows:

a) By January 01, 2026 at the latest, level II hospitals or higher must ensure at least 01 person in charge of clinical pharmacy activities for every 150 in-patient beds, and at least 1.5 persons in charge of clinical pharmacy activities for every 1,000 prescriptions granted for out-patients holding health insurance cards within a day;

b) By January 01, 2031 at the latest, medical examination and treatment establishments must ensure at least 01 person in charge of clinical pharmacy activities for every 100 in-patient beds, and at least 02 persons in charge of clinical pharmacy activities for every 1,000 prescriptions granted for out-patients holding health insurance cards within a day.

Article 4. Conditions for persons in charge of clinical pharmacy activities

1. A person in charge of clinical pharmacy activities at a medical examination and treatment establishment other than those specified in Clause 2 of this Article must possess a university degree in pharmacy or higher (which is granted or recognized in Vietnam).

2. A person in charge of clinical pharmacy activities at a medical examination and treatment establishment applying traditional medicine must possess one of the following degrees (which are granted or recognized in Vietnam):

a) Degrees satisfying conditions specified in Clause 1 of this Article and one of degrees and certificates in traditional medicine and pharmacy as prescribed at Points i and l, Clause 1, Article 13 of the Law on Pharmacy;

b) University degrees in traditional pharmacy or higher;

c) University degrees in traditional medicine or higher.

3. A person in charge of clinical pharmacy activities at a drugstore within a medical examination and treatment establishment must satisfy the conditions specified in Clause 1 of this Article. In case where the person in charge of clinical pharmacy activities currently is a person responsible for professional pharmacy activities, he/she must satisfy conditions specified in Clause 1, Article 18 of the Law on Pharmacy.

Article 5. Persons responsible for clinical pharmacy activities

1. A person responsible for clinical pharmacy activities at a medical examination and treatment establishment must satisfy conditions specified in Article 21 of the Law on Pharmacy and possess a pharmacy practice certificate in accordance with Clause 3, Article 11 of the Law on Pharmacy.

2. Professional practice contents of persons responsible for clinical pharmacy activities:

a) A person responsible for clinical pharmacy activities at a medical examination and treatment establishment must practice one of the following professional practice contents: Bioequivalence trial of drugs; clinical trial of drugs; pharmacological and clinical pharmacy research; pharmacovigilance at a drug information center and monitoring adverse reactions of a drug;

b) A person responsible for clinical pharmacy activities at a medical examination and treatment establishment applying traditional medicine must practice one of the following professional practice contents: Clinical trial of drugs; pharmacological and clinical pharmacy research; pharmacovigilance at a drug information center and monitoring adverse reactions of a traditional drug.

3. The period of practice of a person responsible for clinical pharmacy activities is 02 years or more. For a person possessing a doctor s degree or second specialist degree related to the professional practice contents, the period of practice is at least 06 months. For a person possessing a master s degree or first specialist degree related to the professional practice contents, the period of practice is at least 12 months.

4. A person responsible for clinical pharmacy activities at a medical examination and treatment establishment other than those specified in Clause 5 of this Article shall practice at one of the following establishments:

a) Establishments providing the service of clinical trial or bioequivalence trial of drugs; establishments conducting clinical trial or bioequivalence trial of drugs for non-commercial purposes;

c) Pharmacological and clinical pharmacy research centers or departments, divisions of medical and pharmaceutical training schools at university level;

c) National or regional centers of drug information and monitoring of adverse reactions of drugs;

d) Medical examination and treatment establishments organizing and conducting clinical pharmacy activities in accordance with this Decree, or already organized and conducted clinical pharmacy activities as prescribed by law before the effective date of this Decree.

5. Persons responsible for clinical pharmacy activities at medical examination and treatment establishments applying traditional medicine shall practice at hospitals and institutes with patient beds served with clinical pharmacy activities that organize and conduct clinical pharmacy activities in accordance with this Decree, or already organized and conducted clinical pharmacy activities as prescribed by law before the effective date of this Decree.

Chapter III

CLINICAL PHARMACY ACTIVITIES

Article 6. Clinical pharmacy activities at pharmacy departments

A pharmacy department of a medical examination and treatment establishment shall conduct clinical pharmacy activities in accordance with Article 80 of the Law on Pharmacy and such activities are prescribed as follows:

1. Giving advice during the development of drug lists at medical examination and treatment establishments for the rational, safety and efficient use of drugs.

a) To develop criteria for drug selection and provide such criteria for the Medicine and Treatment Council of a medical examination and treatment establishment;

b) To receive and process information about the safety and efficiency related to the use of drugs on the drug list of a medical examination and treatment establishment to propose for supplement and adjust the drug list for the rational, safety and efficient use of drugs;

c) To analyze and evaluate the safety and efficiency on the basis of evidence of costs - effectiveness, costs - benefits, risks - benefits in the use of drugs by medical examination and treatment establishments for providing consultation and information in developing the medical examination and treatment’s drug list, ensuring rational, safe and efficient use of drugs.

2. Giving advice and monitoring of the prescription and use of drugs:

a) To give advice on the use of drugs for a prescriber during the treatment. To inspect and control the prescription, appraisal of physician’s instructions in order to detect and prevent errors and mistakes from occurring.  To summarize and analyze the error reasons and propose solutions to remedy and improve the prescription quality;

b) To participate in the analysis of drug use (assessment of clinical cases) in case the patient is infected with drug-resistant bacteria, or the patient have to treated with many complex drugs or upon request of the head of a medical examination and treatment establishment;

c) To participate in the consultation or professional diagnosis council related to the drug selection for treatment.

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

a) To update new drug information in term of drug name, components, pharmacological effects, indications, contraindications, drug interactions, dosage, route of administration, use on special patients, information related to warnings and safety, and other necessary information for medical practitioners;

b) To update the drug information in term of drug name, components, concentration, content, formulation, indications, contraindications, drug interactions, dosage, route of administration and precautions in the course of use for medical practitioners;

c) To organize and update drug information as prescribed at Points a and b of this Clause by directly providing information or sending written document or posting on the medical examination and treatment establishment’s bulletin board or website.

4. Participating in developing procedures and providing professional guidance relayed to the use of drugs and monitoring the implementation of such procedures, including:

a) To develop professional procedures related to the use of drugs, instruction for use of the drug list at a medical examination and treatment establishment;

b) To coordinate with the Medicine and Treatment Council of the medical examination and treatment establishment in developing the procedure for monitoring the use of drugs with narrow therapeutic rate, serious side effects, drugs requiring reconstitution for infusion or patients subject to monitoring or drugs requiring special preservation conditions as required by the treatment;

c) To directly participate in the treatment and monitoring the observance of drug use procedures passed by the Medicine and Treatment Council of the medical examination and treatment establishment or approved by the head of a medical examination and treatment establishment.

5. Analysis and evaluation of the effectiveness of drug use at a medical examination and treatment establishment:

a) To make a plan on a analysis and evaluation of the effectiveness of drug use every 06 months and every year, drug use trends and plans for the next year at the medical examination and treatment establishment;

b) To analyze and evaluate the effectiveness of drug use by evaluating the conformity of treatment instruction and drug lists at a medical examination and treatment establishment with indications of drugs provided to clinical department of that establishment.

6. Participating in the supervision and monitoring of adverse reactions of drugs:

a) To update information about adverse reactions of a drug, other information related to the drug safety and handling, guiding medical practitioners, nurses, technicians, midwives to detect and handle adverse reactions of a drug;

b) To monitor and supervise adverse reactions of a drug and receive information to summarize, report adverse reactions of a drug at the establishment according to the Ministry of Health’s instructions;

c) To make ad-hoc report on the patient s health risks related to drug use or inappropriate use of drugs at the medical examination and treatment establishment to the head of such medical examination and treatment establishment.

7. Participating in studying clinical trial and bioequivalence trial of drugs at the medical examination and treatment establishment and other scientific studies on the rational, safety and efficient use of drugs.

Article 7. Clinical pharmacy activities at clinical departments and medical departments or consulting rooms

A person in charge of clinical pharmacy activities shall participate in the analysis and supervision of the drug use of a patient who is examined and treated at the medical examination and treatment establishment. For each patient, the person in charge of clinical pharmacy activities must carrying out the following activities:

1. Gathering patient s information, including information on medical records, carrying out person-to-person interview with the patient, including:

a) Drug use history;

b) Summarization of clinical data and para-clinical results.

2. Checking drugs prescribed to patients when visiting patient rooms or checking physician’s instructions in medical records and prescriptions, including:

a) Indications;

b) Contraindications;

c) Drug selection;

d) Drug instruction for the patient: Dosage, frequency, route, use of drugs for special patients and time of use;

dd) Drug interactions which requires attention;

e) Adverse reactions of drugs.

3. Drug instruction for nurses and midwives.

4. Coordinating with medical practitioners in providing advice for patients about the special attentions required while using drugs.

Article 8. Clinical pharmacy activities at clinical pharmacy divisions of medical examination and treatment establishment without pharmacy departments

A clinical pharmacy division of a medical examination and treatment establishment that does not have a pharmacy department must carry out clinical pharmacy activities in accordance with Point a, Clause 2, Clause 3, Point a, Clause 4, Clause 6, Article 6 and Article 7 of this Decree.

Article 9. Clinical pharmacy activities at drugstores within medical examination and treatment establishments

A person responsible for professional activities or a person in charge of clinical pharmacy activities of a drugstore within a medical examination and treatment establishment must carry out clinical pharmacy activities in accordance with Clauses 2, 3 and 6, Article 80 of the Law on Pharmacy, and such activities are prescribed as follows:

1. Giving advice and providing information on drugs for the drug buyers and users:

a) To give advice and provide guidance, explanation, information and advice about drug instruction for the buyers or patients; to guide the buyers how to use drugs and follow the prescription;

b) To advise patients to the appropriate departments in case such diseases require physicians’ diagnosis before using drugs;

c) To replace the drug indicated in a prescription with another drug with the same active ingredient, route of administration and dosage if agreed by the buyer, and shall take responsibility for the replacement.

2. Giving advice to and talk with prescribers when detecting unreasonable prescriptions:

a) In case of detecting unreasonable prescriptions in term of drug name, concentration, content, quantity or there are legal or professional mistakes or likely affecting the patients’ health, it is required to notify the prescribers;

b) To give advice and explain to the drug buyers and may refuse to sell drugs requiring prescriptions in case where the prescriptions are unreasonable, containing mistakes or confusion; the prescriptions are not for treatment purposes and notify the prescribers.

3. Participating in the supervision and monitoring of adverse reactions of drugs:

a) To provide sufficient and accurate information related to side effects, predicted adverse reactions of a drug for the drug buyers and users;

b) To provide treatment instructions for drug buyers and users when using drugs overdose or when there are side effects or adverse reactions when using drugs;

c) To monitor and receive information related to side effects and adverse reactions of a drug to summarize and report to the pharmacy department.

Chapter IV

RESPONSIBILITIES FOR CARRYING OUT CLINICAL PHARMACY ACTIVITIES

Article 10. Responsibilities of heads of medical examination and treatment establishments

The head of a medical examination and treatment establishment shall organize, and take responsibilities for the results of, its implementation of clinical pharmacy activities in accordance with the following regulations:

1. Ensuring the quantity of persons in charge of clinical pharmacy activities as prescribed in Clause 2 or Clause 3, Article 3 of this Decree and organizing the implementation of clinical pharmacy activities at the medical examination and treatment establishment.

2. Ensuring the participation of continued training, clinical pharmacy knowledge update for the person responsible for clinical pharmacy activities and persons in charge of clinical pharmacy activities.

3. Ensuring infrastructure and equipment for clinical pharmacy activities as prescribed in Articles 6, 7, 8 and 9 of this Decree.

Article 11. Responsibilities of heads of pharmacy departments or clinical pharmacy divisions at medical examination and treatment establishments not having pharmacy departments

1. The head of a pharmacy department of a medical examination and treatment establishment shall:

a) Directly organize clinical pharmacy activities at the medical examination and treatment establishment according to this Decree;

b) Take responsibility for clinical pharmacy expertise at the medical examination and treatment establishment;

c) Formulate procedures for clinical pharmacy activities at the medical examination and treatment establishment and submit it to its head for promulgation.

d) Coordinate with clinical and para-clinical departments and relevant departments and divisions for clinical pharmacy activities.

2. The head of clinical pharmacy division at a medical examination and treatment establishment not having a pharmacy department shall comply with Clause 1 of this Article.

Article 12. Responsibilities of heads of clinical departments, of medical departments or consulting rooms

1. To direct treating doctors, nurses, technicians, midwives at departments or rooms to coordinate with persons in charge of clinical pharmacy activities in carrying out clinical pharmacy activities as prescribed in Articles 6, 7, 8 and 9 of this Decree.

2. Heads of clinical departments shall notify in writing plans of professional consultations or professional diagnosis councils related to drug selection in order that persons in charge of clinical pharmacy activities participate in them in accordance with Point c, Clause 2, Article 6 of this Decree.

3. To coordinate with heads of pharmacy departments or persons responsible for clinical pharmacy activities of medical examination and treatment establishments in considering reports synthesizing counseling opinions of prescription and drug using guidance of persons in charge of clinical pharmacy activities. If those consultation opinions are appropriate, heads of clinical departments, of medical departments or consulting rooms shall notify prescribers in writing and report the Medicine and Treatment Councils of medical examination and treatment establishments for final conclusions.

Article 13. Responsibilities of persons responsible for clinical pharmacy activities

Persons responsible for clinical pharmacy activities have rights and obligations specified in Clause 1, Article 82 of the Law on Pharmacy and shall:

1. Give counseling and proposal related to operating model and working regulations of clinical pharmacy divisions to heads of pharmacy departments, heads of medical examination and treatment establishments.

2. Carry out assignment of specific tasks, expert direction, professional guidance and training for persons in charge of clinical pharmacy activities.

3. Carry out and monitor the implementation of the clinical pharmacy divisions’ tasks.

4. Report on results of the clinical pharmacy divisions’ activities to heads of pharmacy departments, heads of medical examination and treatment establishments. Check and examine to report in briefings on contents of counseling of drug use provided to prescribers (in cases where prescribers agree or not with contents of advice on use of drugs of persons in charge of clinical pharmacy activities) to clinical departments, medical examination departments or divisions.

Article 14. Responsibilities of persons in charge of clinical pharmacy activities

Persons in charge of clinical pharmacy activities have rights and obligations specified in Clause 1, Article 82 of the Law on Pharmacy and shall:

1. Carry out clinical pharmacy activities as prescribed in Articles 6, 7, 8 and 9 of this Decree.

2. Work full-time or part-time at a number of clinical departments according to their tasks as assigned; directly participate groups treating to patients; monitor and report on use of drugs at establishments, for persons in charge of clinical pharmacy activities at clinical pharmacy divisions of the medical examination and treatment establishments.

3. Participate scientific research and continued training courses related to clinical pharmacy in accordance with regulations of the Minister of Health.

4. Summarize and report on counseling of drug use for prescribers at least once a week to persons responsible for clinical pharmacy activities or heads of pharmacy departments or heads of medical examination and treatment establishments, in cases where prescribers agree or not with contents of counseling.

Article 15. Coordination in clinical pharmacy activities between clinical departments, medical departments or consulting rooms and pharmacy departments or clinical pharmacy divisions

1. Persons in charge of clinical pharmacy activities shall provide counseling related to prescription, drug use at medical examination and treatment establishments according to this Decree and be responsible for counseling contents.

2. In case problems related on the safe, effective and rational use of a drug arise, persons in charge of clinical pharmacy activities shall provide advice to prescribers to optimize its use, simultaneously record counseling opinions in analysis form of patients’ drug use according to the form prescribed by the Minister of Health in order that the prescribers replace or adjust prescriptions. If a counseling opinion is not accepted, the prescriber shall decide and be responsible for the prescription and use of the drugs.

3. Heads of pharmacy departments, general planning divisions, medical departments, clinical departments and doctors, technicians, nurses, midwives at medical examination and treatment establishments shall coordinate with and facilitate persons in charge of clinical pharmacy activities for completion of tasks as assigned.

4. Persons in charge of clinical pharmacy activities shall comply the assignments and professional directions of persons responsible for clinical pharmacy activities and heads of pharmacy departments.

Chapter V
IMPLEMENTATION PROVISIONS

Article 16. Effect

1. This Decree takes effect on January 01, 2021.

2. To annul the Circular No. 31/2012/TT-BYT dated December 20, 2012 of the Minister of Health on guiding clinical pharmacy activities in hospitals.

Article 17. Implementation roadmap

1. From January 01, 2021, the following medical examination and treatment establishments must organize clinical pharmacy activities:

a) Hospitals or medical institutes having patient beds (hereinafter referred to as hospitals), including general hospitals, specialized hospitals of level I or higher under the Ministry of Health, Departments of Health of provinces and central affiliated cities or under the Ministry of National Defence, Ministry of Public Security and other ministries, branches assigned as the final level of profession and technique;

b) Private medical examination and treatment establishments classified as level I hospitals.

2. No later than January 01, 2024, level II hospitals under the Ministry of Health, provincial-level Departments of Health or private level II hospitals or level II hospitals under the Ministry of National Defence, Ministry of Public Security and other ministries, branches shall organize clinical pharmacy activities.

3. No later than January 01, 2027, level III and IV hospitals and unclassified hospitals at the level of districts, towns and provincial cities or in private ownership or under the management of the Ministry of National Defence, Ministry of Public Security and other ministries, branches shall organize clinical pharmacy activities.

4. No later than January 01, 2030, other medical examination and treatment establishments using drugs according to regulations on medical examination and treatment shall organize clinical pharmacy activities.

Article 18. Responsibility of implementation organization

1. The Minister of Health shall give the expert and technical guidance for clinical pharmacy activities prescribed in this Decree.

2. The Minister of National Defence, the Minister of Public Security and ministers of ministries and branches shall give expert and technical guidance for clinical pharmacy activities for medical examination and treatment establishments under their management.

3. The Minister of Education and Training shall coordinate with the Minister of Health in training human resources in charge of clinical pharmacy activities.

4. Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of People’s Committees of provinces, central-affiliated cities shall implement this Decree./.