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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.