Circular No. 31/2012/TT-BYT guiding clinical pharmacy activities in hospitals

CIRCULAR

Guidelines for Clinical Pharmacy Activities in Hospitals

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This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

Considering the proposal of the Director of the Department of Medical Examination and Treatment;

The Minister of Health issues this Circular to guide clinical pharmacy activities in hospitals.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

These guidelines apply to hospitals with a fully structured Pharmacy Department as prescribed.

Article 2. Interpretation of Terms

Article 1. Clinical pharmacy is a practice activity within the field of health sciences, wherein pharmacists perform advisory roles on medication for physicians, aiming to optimize treatment regimens; concurrently, they provide information, advice, and guidance on safe, rational, and effective medication use for healthcare staff and patients.

Article 2. Clinical pharmacists are pharmacists working in the field of clinical pharmacy at medical facilities; they advise on medications for physicians during prescription and treatment, and guide healthcare staff and patients on the use of medications.

Chapter II

CONDITIONS FOR IMPLEMENTING CLINICAL PHARMACY ACTIVITIES

Article 3. Conditions for clinical pharmacists

Pharmacists specializing in clinical pharmacy must be university graduates and meet one of the following three conditions:

Point 1. They have undergone continuous training and hold a certificate in clinical pharmacy practice.

Point 2. They have been trained in a bachelor's program oriented towards clinical pharmacy.

Point 3. They have completed postgraduate studies in pharmacology-clinical pharmacy.

Article 4. Conditions for ensuring human resources and infrastructure

Clause 1. Human Resources:

a) Clinical pharmacists must be trained and regularly updated on Vietnamese and international treatment guidelines, relevant pharmaceutical and medical literature, and scientific and technological issues supporting clinical pharmacy practice;

b) Clinical pharmacists must participate in scientific conferences and specialized courses to stay informed about clinical pharmacy practices domestically, regionally, and globally.

Clause 2. Infrastructure:

a) Equipment: Must include computer systems connected to the internet, printers, fax machines, telephones;

b) Work desks, chairs, bookshelves;

c) Literature, books, newspapers, journals, software for drug information retrieval: Must include a minimum set of literature, books, newspapers, journals, and drug information retrieval software from the priority list specified in Appendix 1 accompanying this Circular.

Chapter III

SPECIALIZED TASKS OF CLINICAL PHARMACISTS

Article 5. General tasks

Clinical pharmacists have the following general responsibilities:

Point 1. Participate in analyzing and evaluating the situation of drug usage;

Point 2. Participate in advising on the development of the drug list of the unit, providing opinions or information based on evidence regarding which drugs should be included or removed from the drug list to ensure safe, rational, and effective drug use;

Point 3. Participate in developing professional procedures related to drug use: drug compounding processes (for pediatric specialties, oncology, parenteral nutrition), treatment guidelines, hospital technical procedures;

Point 4. Participate in developing monitoring procedures for drugs in the list (including drugs with narrow therapeutic windows, serious side effects, antibiotics, special intravenous infusions (pediatric, oncology), drugs requiring special storage conditions) as issued by the Hospital Director based on advice from the Medicines and Treatment Council;

Point 5. Guide and monitor drug use in the hospital;

Point 6. Provide drug information to patients and healthcare staff: Clinical pharmacists update drug usage information, new drug information, drug alert information, and disseminate them to healthcare staff and patients through various means such as direct communication, written materials, hospital bulletin boards, emails, posters, electronic information pages;

Point 7. Training and education on clinical pharmacy: Clinical pharmacists develop plans, prepare materials, and update knowledge on drug use for doctors, pharmacists, nurses, technicians, and midwives in their units. Plans and contents must be approved by the Hospital Director;

Point 8. Regular monthly, quarterly, and annual reports, and ad hoc reports as required by the Management Board, the Medicines and Treatment Council: Clinical pharmacists report on drug usage activities in meetings of the Medicines and Treatment Council or departmental briefings, providing opinions in cases of inappropriate drug use;

Point 9. Monitor and report adverse drug reactions (ADR) at the unit according to current regulations;

Point 10. Participate in scientific research activities, particularly those related to safe and rational drug use, quality improvement, and enhanced effectiveness of clinical pharmacy work, clinical drug use research;

Point 11. Participate in specialized consultations on drugs, especially in severe cases, cases requiring special drugs, and patients infected with antibiotic-resistant microorganisms;

Point 12. Participate in regular clinical rounds at clinical departments and hospitals;

Point 13. Closely monitor adherence to drug usage procedures approved by the Medicines and Treatment Council and the Hospital Director;

Point 14. Participate in establishing and implementing therapeutic drug monitoring (TDM) procedures in hospitals capable of implementing TDM.

Article 6. Tasks at the clinical department

The clinical pharmacist participates in ward rounds and analyzes the use of medications for patients. Depending on the characteristics of each hospital, each hospital will select the clinical departments and patient groups that need priority to implement clinical pharmacy activities. For each patient, the clinical pharmacist must perform the following four groups of tasks:

1. Collecting information about the patient (including collecting information from medical records and conducting direct interviews with the patient) regarding:

a) Medication history;

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

2. Reviewing medications prescribed for the patient (during ward rounds together with doctors and reviewing medical orders in medical records, prescriptions).

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.

After completing the review of medications prescribed for the patient, if any issues related to medication use are identified, the clinical pharmacist discusses with the treating physician to optimize medication use while filling out the medication use analysis form for the patient (according to the form specified in Appendix 2 (including Appendices 2A and 2B) issued along with this Circular). In necessary cases, report to the Head of the Pharmacy Department for guidance.

3. Guiding the use of medications for nursing staff.

4. Collaborating with the treating physician to provide counseling information to patients about precautions during medication use.

Chapter IV

RESPONSIBILITIES IN CLINICAL PHARMACY ACTIVITIES

Article 7. Responsibilities of the Hospital Director

1. Recruiting and training clinical pharmacists.

2. Directing the Head of the Pharmacy Department to develop and implement specific tasks of clinical pharmacy suitable for the unit's conditions, to be approved by the Hospital Director; allocating human resources and equipment for clinical pharmacy activities.

3. Directing clinical departments, ancillary departments, infection control departments, and related departments to collaborate with the Pharmacy Department to implement clinical pharmacy activities.

Article 8. Responsibilities of the Head of the Pharmacy Department

1. Being responsible and closely coordinating with clinical and ancillary departments to implement clinical pharmacy activities.

2. Developing tasks and supervising clinical pharmacists in implementing clinical pharmacy activities.

3. Reporting quarterly, annually, or ad hoc on clinical pharmacy activities to the Hospital Director.

Article 9. Responsibilities of the Head of the Planning and Integration Department

Taking the lead and coordinating with the Pharmacy Department, clinical departments, and ancillary departments to develop plans to implement clinical pharmacy activities.

Article 10. Responsibilities of the Head of the Clinical Department

1. Closely collaborating with the Pharmacy Department to implement clinical pharmacy activities. Directing treating physicians to cooperate with clinical pharmacists to carry out clinical pharmacy activities.

2. Proactively inviting clinical pharmacists to participate in specialized consultations when necessary.

Article 11. Responsibilities of the Clinical Pharmacist

1. Implementing the tasks stipulated in Articles 5 and 6 of this Circular and the clinical pharmacy work plan approved by the Hospital Director.

2. Performing other tasks assigned by the Head of the Pharmacy Department.

Chapter V

IMPLEMENTING PROVISIONS

Article 12. Effective date

This Circular takes effect from February 4, 2013.

Article 13Responsibility for Implementation

The Director of the Department of Medical Examination and Treatment shall be responsible for organizing the implementation of this Circular.

During the implementation process, if there are difficulties or obstacles, units and localities need to promptly reflect them to the Ministry of Health (Department of Medical Examination and Treatment) for guidance, consideration, and resolution./.