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 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

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 DrugCases PhenytoinStevens Johnsons Syndrome – 4 Erythroderma – 2 Exanthematous drug rash – 1 Nystagmus – 1 Diplopia, Vomiting – 1 Dizziness – 1 IsoniazidHepatitis – 5 CiprofloxacinErythroderma – 3 Hypersensitivity – 2 Vasculitis – 2 Erythema multiforme – 1 IbuprofenUpper GI bleeding – 3 Toxic epidermal necrolysis – 1 Steven Johnson syndrome (SJS)– 1 Renal impairment – 1

DiclofenacUpper GI bleeding - 4 PenicillinDrug eruption – 3 CotrimoxazoleAngioedema – 1 SJS – 2 Sodium ValproatePancytopenia – 1 Drug eruption – 1 LamotrigineCutaneous drug eruption – 1 Skin rash – 1 AspirinUpper GI bleeding – 1 ParacetamolRash – 1 NaproxenUpper GI bleeding – 1 PrednisoloneAddison’s crisis – 1 Cushingoid syndrome – 1 WarfarinUpper GI bleeding – 1 Coagulopathy – 2 ChloramphenicolPancytopenia – 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 DISCPLINESNo. of PATIENTS percentages Medicine Surgery35.76 Dermatology Ophthalmology11.92 Pediatrics11.92 Total52100

TYPES of ADRs encountered at BPKIHS Sl.NoName of Drug Types of reaction 1ClonazepamDisorientation, Ataxaia, Dizziness 2CiprofloxacinNausea 3AmlodipineItching 4TriphalaVomiting 5VigoranTingling sensation 6KetoprofenG.I.Bleeding 7AmpicillinMaculopapular rash 8PhenytoinErythematous macules 9DiclofenacErythematous rash, itching 10ChlorpromazineErythematous rash 11MetochlorpromideDystonia 12CotrimoxazoleVomiting, rash, SJS 13PantoprazoleVomiting, 14Promethazine Disorientation

TYPES of ADRs encountered at BPKIHS ( contd.) Sl.NoName of Drug Types of reaction 15PrednisoloneCataract 16DapsoneFever, malaise, Fixed Drug Reaction ( reddish raised lesion) 17ChloramphenicolSteven Johnson Syndrome 18Sulphadoxime+ Pyrimethamine Steven Johnson Syndrome 19FluconazoleBullous Fixeddrug eruption 20SteroidBullous pemphigoid 21ParacetamolMacular papular rash 22NimesulideErythema multiforme 23AllopurinolErythema multiforme 24MorphineThickening 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.