Transcript PHARMACOVIGILANCE Systems in NEPAL

PHARMACOVIGILANCE
Systems in NEPAL
PROF. N.R. BISWAS ,MD, DM, DNB, DSc
Prof. of Clinical Pharmacology & Therapeutics , BPKIHS,
Dharan, NEPAL
And
Govt. of India Advisor to BPKIHS, Dharan, NEPAL
Brief History
• In Nepal, Pharmacovigilance
( ADR reporting ) started in 2003.
• It was mainly due to initiation by
Prof. Kumud. K. Kafle of Institute
of Medicine , Kathmandu, Nepal
The Department of Drug
Administration (DDA), MoHP
( Ministry of Health and
Population ) is the focal point
of Pharmacovigilance in Nepal.
The (5) regional centers of
Pharmacovigilance in Nepal
- (1) BPKIHS, Dharan
- (2) Institute of Medicine (IOM), Kathmandu
- (3) Manipal College of Medical Sciences
(MCOMS), Phokhra
- (4) Nepal Medical College (NMC) ,
Kathmandu
- (5) KIST Medical College, Kathmandu
Total number of ADR cases reported to
Department of Drug Administration
Year
2003
2004
2005
2006
2007
2008
2009
2010
Total=
Number of Cases
1
8
23
9
70
209
44
28
392
Pharmacovigilance Centre,
Clinical Pharmacology Department,
Institute of Medicine , katmandu
80 cases of adverse drug reactions reported from OPDs and
wards of Tribhuban University Teaching Hospital, Katmandu
(Nov, 2006 – May, 2010)
Type of ADRs and Number of
Cases
Drug
Cases
Phenytoin
Stevens Johnsons Syndrome – 4
Erythroderma – 2
Exanthematous drug rash – 1
Nystagmus – 1
Diplopia , Vomiting – 1
Dizziness – 1
Isoniazid
Hepatitis – 5
Ciprofloxacin
Erythroderma – 3
Hypersensitivity – 2
Vasculitis – 2
Erythema multiforme – 1
Ibuprofen
Upper GI bleeding – 3
Toxic epidermal necrolysis – 1
Steven Johnson syndrome (SJS)– 1
Renal impairment – 1
Diclofenac
Upper GI bleeding - 4
Penicillin
Drug eruption – 3
Cotrimoxazole
Angioedema – 1
SJS – 2
Sodium Valproate
Pancytopenia – 1
Drug eruption – 1
Lamotrigine
Cutaneous drug eruption – 1
Skin rash – 1
Aspirin
Upper GI bleeding – 1
Paracetamol
Rash – 1
Naproxen
Upper GI bleeding – 1
Prednisolone
Addison’s crisis – 1
Cushingoid syndrome – 1
Warfarin
Upper GI bleeding – 1
Coagulopathy – 2
Chloramphenicol
Pancytopenia – 1
Arthralgia - 1
OTHER ACTIVITIES
The department of Clinical Pharmacology ,
Institute of Medicine , Katmandu also
provides following services
1. Drug information unit
• Question-answering services to the
prescribers of TUTH
• Publication of four issues IN A YEAR of Drug
and Therapeutics Letter
2. Drug Monitoring and Toxicology
Laboratory
• Service provided since 1987
• Total number of services utilized (July,
2009 – March, 2010) - 757
Future Plannig--1. The focal point should encourage
regional centers to report cases
2. Regional centers should
collect/encourage spontaneous reporting
of cases in their institutions
3. The focal point should identify more
regional centers
PHARMACOVIGILANCE at
BPKIHS, DHARAN
• Dept of Clinical Pharmacology and
Therapeutics is the in –charge of Regional
Pharmacovigilance Centre.
• It is registered as Regional
Pharmacovigilance Centre at International
Pharmacovigilance Centre, UPPSALA ,
Sweden , through Dept. of Drug Authority ,
Katmandu , Nepal.
ACTIVITIES of the Department
• Collection and monitoring ADR data from
various clinical departments
• Teaching Pharmacovigilance to
undergraduate ( MBBS and BDS) students
so that the students can be familiar with
ADRs.
• Conducting research on Rational Use of
Drugs at BPKIHS and providing feedback
to respective departments to prevent ADR
INCIDENCE of ADRs in different
Disciplines
DISCPLINES
percentages
Medicine
No. of
PATIENTS
12
Surgery
3
5.76
Dermatology
35
67.30
23.07
Ophthalmology 1
1.92
Pediatrics
1
1.92
Total
52
100
TYPES of ADRs encountered at
BPKIHS
Sl.No Name of
Drug
Types of reaction
1
Clonazepam
Disorientation, Ataxaia, Dizziness
2
Ciprofloxacin
Nausea
3
Amlodipine
Itching
4
Triphala
Vomiting
5
Vigoran
Tingling sensation
6
Ketoprofen
G.I.Bleeding
7
Ampicillin
Maculopapular rash
8
Phenytoin
Erythematous macules
9
Diclofenac
Erythematous rash, itching
10
Chlorpromazine
Erythematous rash
11
Metochlorpromide
Dystonia
12
Cotrimoxazole
Vomiting, rash , SJS
13
Pantoprazole
Vomiting,
14
Promethazine
Disorientation
TYPES of ADRs encountered at
BPKIHS ( contd.)
Sl.No Name of
Drug
Types of reaction
15
Prednisolone
Cataract
16
Dapsone
Fever, malaise, Fixed Drug Reaction ( reddish
raised lesion)
17
Chloramphenicol
Steven Johnson Syndrome
18
Sulphadoxime+
Pyrimethamine
Steven Johnson Syndrome
19
Fluconazole
Bullous Fixeddrug eruption
20
Steroid
Bullous pemphigoid
21
Paracetamol
Macular papular rash
22
Nimesulide
Erythema multiforme
23
Allopurinol
Erythema multiforme
24
Morphine
Thickening of skin
FUTURE PLAN at BPKIHS
• To do ADR reporting more effective , the
Residents and Clinical Faculties will be
trained by delivering lectures on ADR .
• To include zonal hospitals of Eastern
Nepal and to train them on how to report
ADRs.