Adverse Drug Reaction Reporting System in Nepal

1
Adverse Drug Reaction Reporting System in Nepal

• Bhupendra B. Thapa
• Director General
• Government of Nepal
• Ministry of Health and Population
• Department of Drug Administration
• Bijulibazar, Kathmandu

2
Country Situation

• Nepal situated in between India and China.
• Geographical regions mountain, hill and plain
  (Terai)
• Administrative divisions
• 5 Development regions, 14 zones, 75 districts,
• 58 municipalities and 3912 village Development
  Committees (VDC).
• District is the local administrative unit
• Large part of the country remains inaccessible by
  modern transport and communication.

3
Health facilities Government

• Primary level
• Primary healthcare centre (Doctor)
• Health post (Health assistant 3 year medical
  education after 10 year of school)
• Sub health post (Auxiliary Health Worker 1.5
  years medical education after 10 year of school)
• Every VDC has at least one health facility
• Secondary level Regional, Zonal and District
  hospitals.
• Tertiary level Central and specialized hospitals

4
Health facilities Other

• Teaching hospitals 2 government, 8 in private
  sector
• Medium and small hospitals in private sectors
  many are coming up
• Clinics and polyclinics are common

5
Pharmaceutical Service

• No hospital pharmacy in Govt hospitals
• One Non-govt teaching hospital has hospital
  pharmacy
• One Govt teaching hospital running hospital
  pharmacy inadequately
• Private hospitals do not have pharmacy
• Hospitals rent the space for private pharmacy

6
Essential Medicine Concept

• National List of Essential Drug First published
  in 1986, latest revision 2002
• The list is further classified for
• District hospital
• Primary Health Care Centre
• Health post
• Sub health post
• Primary treatment level

7
Availability of Medicine at Primary Level Health
Facilities

• 56 medicines from EDL supplied by the government
• Medicines supplied for free distribution, but not
  enough for whole year
• Cost sharing scheme for medicines applied in many
  districts to make medicines available throughout
  the year

8
Where patients get medicines from?

• About 14000 private pharmacies all over the
  country
• Almost ALL prescriptions are dispensed from the
  private pharmacies

9
Qualification of a Dispenser

• Pharmacist very few working in community or
  hospital pharmacy (Government has policy to have
  pharmacists in pharmacies at hospital premises)
• Pharmacy Assistants 3-year Pharmacy education
  after 10 year of school (Govt. policy to involve
  Pharmacy Assistants in all pharmacies)
• Trained retailer training course of short
  duration (About 15,000 trained about 10,000
  persons working)
• Trained drug retailers operate most of the
  pharmacies.

10
Drug Administration in Nepal

• Drug Act 1978
• Department of Drug Administration (DDA) 1979
• Main Objective of Drug Act To assure safety,
  efficacy and quality of medicine
• Rational Drug Use is addressed in the National
  Drug Policy 1995
• Pharmaceutical Unit of Ministry of Health and
  Population for monitoring and evaluation recently
  established

11
Assurance of safety

• Some Examples of Banned drugs
• Amidopyrin, Phenacetin, Clioquinol,
  Methaqualone, Chlorphentermine, Santonin,
  Amphetamine, Phenformin, Meprobamate, Analgin
• Registration of COX-2 inhibitors, Gatifloxacin
  was not done on the basis of adverse drug
  reaction reported elsewhere.
• Assessment was done on the data available from
  abroad (no reporting system within the country)

12
Initiation of ADR Reporting

• Activity related to ADR reporting was initiated
  in 2004
• Government decided to join WHO Programme for
  International Drug Monitoring on November 4,
  2004 
• DDA designated as the National Centre
• Meetings were convened for hospital
  administrators, pharmacists and physicians to
  initiate reporting system 
• Manipal Teaching Hospital pioneer in reporting
• Nepal became the member of UMC in July 2006 
• A form has been developed for reporting based on
  the requirements of UMC
• At present information is mainly collected from
  hospitalized patient.
• Reporting not mandatory

13

• Government of Nepal
• Ministry of Health and Population
• Department of Drug Administration
• Reporting Form for
• Suspected Adverse Drug Reactions
• Patient Patient initials (first name, last name)
  ____________ Sex Female
• Male
• Hospital record no. or chart no. or patient ID
  no.
• (for use in any future correspondence)
  _________________________________
• Date of birth (dd/mm/yyyy use English
  calendar) ________________________
• Age _______________ Body weight __________
  Body height __________
• (at time of reaction)
  (kg) (cm)
• Drug(s) Name of suspected drug (brand name)
  ____________________________
• generic name) ____________________________
• Batch number _________________
  Dosage/strength __________________
• Dosage form __________________ Frequency of
  intake ________________
• Date started __________________ Date
  stopped _____________________
• Prescribed for / indication ____________________
  _______________________

14
Constraints

• Too many patients no time for filling the forms
• Lack of trained manpower
• Lack of sense of responsibility regarding ADR
• Ignorant about the benefit (personal,
  institutional)
• Lack of institutional commitment
• Lack of pharmaceutical care service in hospital

15
Requirement for successful ADR reporting

• Institutional commitment
• Resource allocation
• Functioning DTC
• Hospital formulary and pharmacy
• Involvement of pharmacists

16
ADR Reporting Is it a priority?

• Are the people getting basic health service?
• Can the time involved for ADR reporting be better
  utilised for patient care?
• Is ADR Reporting priority area for resource
  allocation?

17
For Further Information.

• Tel [phone] and 4780432
• Fax [phone]
• E-mail dda_at_healthnet.org.np
• Web site www.dda.gov.np