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

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.