MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 31/2012/TT-BYT | Hanoi, December 20, 2012 |
CIRCULAR
PPROVIDING GUIDELINES ON CLINICAL PHARMACY ACTIVITIES IN HOSPITALS
Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 on defining functions, tasks, powers and organizational structures of the Ministry of Health;
At the request of the Minister of Agency of Health Examination and Treatment;
The Minster of Health promulgates the Circular on providing guidelines on clinical pharmacy activities in hospitals.
Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular provides guidelines on clinical pharmacy activities in hospitals having Departments of Pharmacy with full structures according to the regulations.
Article 2. Definitions
1. Clinical pharmacy is a practice in the field of health science, in which pharmacists play the roles of counselors who provide advices about drugs and optimize the treatment guidelines; they also provide information, counseling and instruction on a safe and reasonable use of drugs for medical employees and patients.
2. Clinical pharmacists are those who work in the field of clinical pharmacy at the health facilities; provide counseling about drugs for the doctors to provide treatment, write prescription and provide instruction on the use of drugs for the medical employees and patients.
Chapter II
REQUIREMENTS FOR CARRYING OUT CLINICAL PHARMACY ACTIVITIES
Article 3. Requirements for clinical pharmacists
A specialized clinical pharmacist must have a bachelor degree in pharmacy and must satisfy one out of the following three requirements:
1. Receive continuous trainings and have practicing certificate in clinical pharmacy.
2. Receive specialized university trainings in clinical pharmacy
3. Receive postgraduate specialized trainings in pharmacology – clinical pharmacy.
Article 4. Requirements for human resources and facilities
1. Human resources:
a. The clinical pharmacists must be trained and regularly updated with Vietnamese and international treatment guidelines, related documents on medicine and pharmacy, as well as documents on scientific and technological subjects which serve the clinical pharmacy activities.
b. The clinical pharmacists must be allowed to participate in scientific conferences and professional classes in order to get access to domestic, regional and international clinical pharmacy.
2. Facilities:
a. Equipment: there must be a computer system connected to the internet, printers, fax machines and telephones.
b. Office chairs and desks, bookshelves.
c. Documents, books, newspapers, magazines, scientific drugs research software: there must be a minimum number of documents, books, newspapers, magazines and scientific drugs research software which is specified in the list of must-have facilities, according to Appendix 1 hereto.
Chapter III
SPECIALIZED TASKS OF THE CLINICAL PHARMACISTS
Article 5. General tasks
The clinical pharmacists have the following general tasks:
1. Participate in the analysis and evaluation of the drug use process.
2. Participate in consultation during the process of developing the unit’s list of drugs and provide opinions or information based on the evidence on which drugs should be included or excluded from such list, in order to ensure a safe, reasonable and effective use of drugs.
3. Participate in developing the specialized processes related to the use of drugs: drug preparation process (for Pediatrics, Specialized Oncology, artificial feeding other than gastrostomy feeding), treatment guidelines and technical process of the hospital.
4. Participate in developing the process of supervising the use of listed drugs (including the drugs which have narrow therapeutic index, serious side effects, are antibiotics and drugs requiring special preparation methods (pediatrics, oncology) and drugs requiring special preservation conditions). Such list of drugs is promulgated by the Director of the hospital as guided by the Drugs and Treatment Council.
5. Provide guidelines and supervision for the use of drugs in the hospital.
6. Drug information for patients and medical employees: the clinical pharmacists must be updated with the information on drug use and new drugs, as well as warnings about drugs which are sent to the medical employees and patients in different forms, such as: in person, in writing, in the hospital news, via emails, through pictures and photos, in guidelines and on websites.
7. Trainings in clinical pharmacy: the clinical pharmacists shall make plans, prepare documents and update knowledge on the use of drugs for doctors, pharmacists, nurses, technicians and midwives. Such plans and contents must be approved by the Director of the hospital.
8. Provide monthly, quarterly, annual and surprise reports as required by the Board of Directors and the Drug and Treatment Council: the clinical pharmacists shall report about the drug use activities during the meeting with the Drug and Treatment Council or during the standard meeting of the unit, as well as providing opinions about the cases where drugs are not properly used.
9. Monitor the adverse reactions of drugs (ADR) and be the key pharmacist to report about the ADRs at the unit, according to the current regulations.
10. Participate in the scientific research activities and works, especially the trials which are related to the safe and reasonable use of drugs, to the quality improvement and effectiveness enhancement of clinical pharmacy activities and clinical drug trials.
11. Participate in specialized consultation about drugs, especially in cases where the diseases are severe or require special drugs, or the patients are infected with drug-resistant bacteria.
12. Participate in the periodic clinical case study in the hospital.
13. Strictly supervise the compliance with the drug use process which is adopted by the Drug and Treatment Council and approved by the Director of the hospital.
14. Participate in developing and carrying out the treatment supervision process by observing the drug concentration in the blood (Therapeutic Drug Monitoring – TDM) at the hospitals which have the capability to carry out TDM.
Article 6. Tasks in the clinical department
The clinical pharmacists shall visit the patients' rooms and analyze the drug use of such patients. Each hospital shall select the clinical department and the priority patients based on the hospital’s speciality, in order to carry out the clinical pharmacy activities. For each patient, the clinical pharmacist must perform the following four groups of tasks:
1. Exploit information from the patient (including even exploiting information specified in the clinical record and start interviewing the patient about:
a. Drug use history.
b. Summary of the clinical data and the existing paraclinical results.
2. Examine the drugs prescribed for the patients (during their visits to the patients' rooms with doctors, and examine the medical instructions specified in the medical records and prescriptions) about:
a. Indication
b. Contraindication.
c. Drug selection.
d. Drug instruction for the patient: dosage, frequency, route, if drugs are used for the special patient and time of use.
dd. Drug interaction which requires attention.
e. Adverse reactions of drugs.
After considering the drugs prescribed for patients, if any problem related to the use of drugs is detected, the clinical pharmacists shall exchange information with the medical doctors, in order to optimize the drug use and fill in the drug use analysis form for each patient (using the form in Appendix 2 (including Appendix 2A and Appendix 2B) hereto. In necessary cases, send a report to the Dean of the Pharmacy Department to receive directions.
3. Provide drug instructions for nurses.
4. Cooperate with the medical doctors to provide counseling for patients about the special attentions required while using drugs.
Chapter IV
RESPONSIBILITIES FOR CARRYING OUT CLINICAL PHARMACY ACTIVITIES
Article 7. Responsibilities of the Director of the hospital
1. Select and train clinical pharmacists.
2. Give directions to the Dean of the Pharmacy Department and carry out specific clinical pharmacy tasks in accordance with the conditions of the unit. Such tasks must be reported to the Director of the hospital for approval; and arrange human resources and equipment for clinical pharmacy activities.
3. Direct the clinical department, paraclinical department, infection control department and related departments to cooperate with the Pharmacy Department in carrying out clinical pharmacy activities.
Article 8. Responsibilities of the Dean of Pharmacy Department
1. Cooperate with the clinical department and paraclinical department in carrying out clinical pharmacy activities.
2. Develop tasks and monitor the clinical pharmacists’ process of carrying out clinical pharmacy activities.
3. Send the quarterly, annual or surprise report about the clinical pharmacy activities to the Director of the hospital.
Article 9. Responsibilities of the manager of the General Planning Department
Cooperate with the Pharmacy Department, clinical department and paraclinical department in developing the plan for carrying out clinical pharmacy activities.
Article 10. Responsibilities of the Dean of clinical department
1. Cooperate closely with the Pharmacy Department in carrying out clinical pharmacy activities. Direct the doctors to cooperate with the clinical pharmacists in carrying out clinical pharmacy activities.
2. Take charge to invite the clinical pharmacists to participate in the specialized consultation if necessary.
Article 11. Responsibilities of the clinical pharmacists
1. Carry out the tasks specified in Article 5 and 6 hereof and the clinical pharmacy plan approved by the Director of the hospital.
2. Carry out other tasks assigned by the Dean of the Pharmacy Department.
Chapter V
IMPLEMENTATION
Article 12. Entry into force
This Circular takes effect from February 04, 2013.
Article 13
The Dean of the Agency of Health Examination and Treatment shall implement this Circular.
During the implementation process, if any problem or difficulty arises, the units and localities shall provide timely feedbacks to the Ministry of Health (Agency of Health Examination and Treatment) in order to receive guidance and solutions.
| PP. MINISTER |
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