PHARMACOVIGILANCE Systems in NEPAL PROF. N.R. BISWAS,MD, DM, DNB, DSc Prof. of Clinical Pharmacology...
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Transcript of PHARMACOVIGILANCE Systems in NEPAL PROF. N.R. BISWAS,MD, DM, DNB, DSc Prof. of Clinical Pharmacology...
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 Number of Cases 2003 1 2004 8 2005 23 2006 9 2007 70 2008 209 2009 44 2010 28
Total= 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 – 4Erythroderma – 2Exanthematous drug rash – 1Nystagmus – 1Diplopia , Vomiting – 1Dizziness – 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 No. of PATIENTS
percentages
Medicine 12 23.07
Surgery 3 5.76
Dermatology 35 67.30
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