Nguyen Thi Lien Huong

Outline- Real Situations of Medication Safety in VN

- Plan to improve Medication Safety in VN

Sources: Hanoi University of  PharmacyNational DI & ADR CentreDrug Administration  of  VietnamBach mai  Hospital

Medication safety concerns include:Adverse Drug Reactions (ADRs) and side effects

Interactions

Poor quality and counterfeit products

Medication use errors

…

Real Situations of Medication Safety in VN

Real Situations of Medication Safety in VN

Medication Safety

ADR Centers

ADR Reports

ADR Centers

1994: Establishment ofHanoi ADR Center

1998: Establishment ofHCMC ADR Center

ADR CenterFrom 1994 to 2006, the operation of ADR Centers was funded by SIDA (Sweden)- Collecting, evaluating and classifying ADR reports.

- Finding signals of serious ADR and informing to DAV.

- Organizing ADR training course for healthcare professional.

- Publishing books involved ADR.

- Releasing ADR posters

- Sending ADR reports to Uppsala monitoring Center

From 2006 to November 2008, lack of funding- ADR report verification is temporarily stopped- No reports were sent to UMC- The center continued to collect and receive reports

From November 2008 until present Reactivate ADR report verification

6/ 2009, National DI & ADR Center was established,

located in Hanoi University of Pharmacy

ADR ReportsADR Reports received from 2006 to 2008

- UMC: > 200 Reports/ a million people

Operation of ADR Reporting is effective

- Viet nam: only 25 Reports/ a million people

Reasons of Ineffective ADR reporting operation

Manifestations of ADR (Reports from 2006 to 2008)

47,3% Skin and appendages disorders 

General disorders of body 

Central nervous system disorders

Gastrointestinal disorders

Urticaria, eruption, pruritus…

Fatigue, fever, chill…

Vertigo, headache…

Nausea, vomiting, pain, epigastric discomfort…

ATC code J: Anti-infective

for systemic use

ATC code S: Sensory Organs

ATC code A:

Alimentary Tract and

Metabolism

ATC code N:Nervous System

ATC code of Drugs suspected causing ADR (Reports from 2006 to 2008)

10 Drugs commonly suspected causing ADR (Reports from 2006 to 2008)

ATC code Drug Number of cases Rate (%)

J01DD04 Ceftriaxon 912 5,9

A07AA04 Streptomycin 891 5,8

J01DD01 Cefotaxime 819 5,3

J04AB02 Rifampicin 567 3,7

J04AK01 Pyrazinamid 505 3,3

N02BE01 Paracetamol 496 3,2

J04AC01 Isoniazid 384 2,5

J01CA04 Amoxicillin 280 1,8

J01DB01 Cefalexin 199 1,3

M01AB05 Diclofenac 192 1,2

Total 15380 100,0

Comments on Received ADR Reports

All reports are spontaneous reports

Report quality:Inadequate information in many reports, example:- Name of medicine: Unclear, incorrect- Dose and Method of Administration: not mentioned completely-Description of disease process and signs of ADR was not detailed-There were mistakes between diagnosis and treatment in several

reports….

Real Situations of Medication Safety in VN

Medication Safety

ADR Centers

ADR Reports

National Policy on Drug(The Government Decree No. 37/CP dated 20 June 1996)

Drug and Therapeutic Committee (DTC)

Rational Use of Drug in Hospital

Clinical Pharmacy Practice

Drug Information

Unit

(1145 public hospital)

DTC – Functions 

‐ Building medicine list in Hospital

- Monitoring prescription

- Monitoring ADR

- Enhancing DI activities (with human resources and funds)

- Implementing research and training on medicine.

According to “The circular No8/BYT-TT dated 4 July 1997”

DI & CP – Functions 

Drug Information Unit

Providing DICollecting, monitoring and processing ADR reportsMonitoring drug quality problemsBesides, some hospitals have implemented training on using medicines for their own staffs and for the lower line hospitals. 

Role and responsibility of clinical pharmacist has not been clearly defined Guiding document related to clinical pharmacy practice in hospital has not been issued

(The circular No1076/YT-DT dated 13 November 2003)

Clinical Pharmacy Practice

In about 400 questions were collected in 1 year:- 44% question on dose (especially dose in patients with renal /hepatic impairment)- 13,6% questions on Method of Administration- 7,5% questions on ADR

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Classification of DI Questions

Doctors in Bachmai hospital interested in Medication Safety

DI & CP – Difficulties 

Lack of human resources:

- In VN hospital: 1.3 pharmacists per 100 beds and 1.4

pharmacists per 100 other healthcare professionals (physicians

and nurses). Only 10-15% pharmacist were responsible on DI &

CP.

- General pharmacists are not sufficiently trained for DI &CP

→ Lack of well-trained and specialized staff for DI & CP

activities

DI & CP – Difficulties 

Lack of material facilities; lack of update and reliable databases

Lack of standard operational procedures/activity regulations

Lack of financial budget

DI & CP activities supported ineffectively for Medication

Safety Practice in Hospitals in VN

Outline- Real Situations of Medication Safety in VN

- Plan to improve Medication Safety in VN

Plan in Future

Establishment of PV System in Viet Nam

Plan in Future

Establishment of PV System in Viet Nam

Plan in Future

Strengthening the DI&CP Practice for Hospital Pharmacist in Viet Nam

• Establishing new regulation in hospital operation. Defining

the roles and responsibilities of hospital clinical pharmacists

• Revising and completing graduate and undergraduate

training program specialized in clinical pharmacy. Establish

continuous training program for hospital pharmacist.

Implementing Projects focused on Medication Safety Practice

Plan in Future