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Nguyen Thi Lien Huong · 2010. 12. 25. · Nguyen Thi Lien Huong. Outline - Real Situations of...
Transcript of Nguyen Thi Lien Huong · 2010. 12. 25. · Nguyen Thi Lien Huong. Outline - Real Situations of...
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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20
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60
80
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140
loại câu hỏi
số c
âu hỏi
1 BD, HC2 Bchế3 Dlý4 DĐH5 Đgiá sd6 LD7 Hchỉnh liều8 CD9 TDP10 CĐ11 CCĐ12 Tg kị13 TTT14 PNMT15 Khác
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