this power point presentation was presented during pharmacovigilance training at Kathmandu

1. Shyam K Adhikari
Pharmacist
Department of Drug Administration

2.  The DTC has a role to ensure that all
medicines prescribed and dispensed to
patients are safe and of good quality.
 This involves:
 monitoring and addressing
medication errors
 monitoring and ensuring drug
quality
 monitoring and managing ADRs

3.  Medication error is a failure in the
treatment process that leads to, or has
the potential to lead to, harm to the
patient
 Medication error is any preventable
event where a dose of medication that
is received by a patient differs from
what the prescriber has prescribed, or
from hospital policy and procedures
(AHSP 1999).

4.  During Treatment Process
 Diagnosis
 Prescription written
 Prescription received and processed
 Drug dispensed
 Drug administered
 Patient receives drug
 Patient response

5.  Prescribing the wrong drug
 Writing illegibly
 Confusing the name of one drug
 Prescribing the wrong dose
 Calculating or Writing wrong dose
 Wrong route of administration
 Prescribing the wrong formulation (slow
release drugs)
 Prescribing the duration of treatment
incorrectly

6.  Prescribing wrongly for a given individual
 Error in identity
 Failing to account pre-existing
disease
 Failing to account concurrent
therapy
 Prescribing with inadequate or incorrect
instructions
 Prescribing without informed consent of the
patient

7.  medicine given to the wrong patient
 Confusing Names
 wrong dose or strength given
 medicine given for the wrong duration
 medicine given to a patient with a known
allergy.
 prescribed medication not given
 Confusing in Abbreviation, e.g.
 QD vs QID
 IU vs IV

8.  AZT (Azithromycin) Vs AGT (Tinidazole)
 Alspan (Hyoscine Butylbromide) Vs Alpan (Loratidine)
 Metriz (Metronidazole) Vs Metrix (Glucosamide)
 Metlong (Metforming) Vs Metlog (Metoprolol)
 Itop (Itopride HCl) Vs Metop (Metoprolol)
 Aceclo (Aceclofen) Vs Seclo (Omeprazole)
 T-zine (Cetrizine HCl) Vs Tizan (Tizanidine)

9.  Errors in drawing up and giving medicines
 Wrong drug
 Correct drug, wrong dose
 Correct drug, wrong dilution
 Correct drug, wrong formulation
 Entraining air, particles or other contaminants with the
drug
 Errors in administration
 giving a drug outside or against currently accepted
practice
 Wrong route, wrong site, wrong rate, wrong patient
 Wrong drug by mistake
 IV drug incompatibility

10.  Establishing a consensus group of physicians,
nurses and pharmacists to select best practices
 Introducing a punishment-free system to collect
and record information about medication errors
 Developing written procedures with guidelines
and checklists for the administration of IV fluids
and high-risk drugs such as insulin, heparin
and narcotics
 Developing standardized times to administer
medicines and a policy to do so only when
patients are on the wards
 Requiring that a patient’s identity be confirmed
before administering a drug
 Allowing verbal or telephone orders only in an
emergency

11.  Requiring legible handwriting and complete
spelling of a drug name
 Requiring the use of standardized notation
 Dose units written in one way only, for example
‘mcg’ not ‘µg’ or ‘g’ not ‘gm’
 Use of leading zeros for values less than 1 (0.2
instead of.2) and avoidance of trailing zeros for
values more than 1 (2 instead of 2.0)
 Requiring that the route of administration and
the complete directions (for example ‘daily’ not
‘OD’) be written on all drug orders
(prescriptions)
 Requiring that prescribers write generic and
brand names for medicines with ‘look-alike’ or
‘sound-alike’ names.

12.  Dispensing and rechecking prescription
 In cases of suspected suicidal intent by
a patient, to counsel and report to
authorities is recommended.
 Automatic stop orders for critical drugs
that are not renewed by the physician in
the therapeutic order sheets like
mannitol, potassium and antibiotics are
sometimes made part of a hospital
policy.
 The pharmacists, through collaboration
with the hospital or district therapeutics
committee, issue a drug watch list for
all hospital staff to be aware of.

13.  An appreciably harmful or unpleasant
reaction, resulting from an intervention
related to the use of a medicinal product
 A serious adverse reaction is any medical
occurrence that at any dose normally used in
humans:
 results in death
 requires inpatient hospitalization or
prolongation of existing hospitalization
 results in persistent or significant
disability or incapacity
 is life-threatening.

14. Type A reactions
 These are an exaggerated but otherwise normal
pharmacological response to the effects of the
medicine given in therapeutic dose.
 These reactions cause significant morbidity but are
rarely severe. Examples include:
 pharmacodynamic, for example bronchospasm
with beta-blocker administration
 toxic, for example absolute or relative overdosing
of aminoglycosides causing deafness
 withdrawal syndrome or rebound effect, for
example spontaneous rise in blood pressure with
clonidine discontinuation

15. Type B reactions
 These are bizarre and unpredictable with
no relation to dose and are often allergic
in nature.
 They are often severe and cause high
mortality. Examples include:
 idiosyncratic reactions, for example
irreversible aplastic anaemia caused by
chloramphenicol
 anaphylactic reactions, for example
anaphylactic shock with penicillin
 drug-induced diseases, for example
antibiotic-associated colitis.

16.  The main ADR monitoring system is
Pharmacovigilance Program
 Any ADR monitoring system should include, as
a minimum:
 reporting of an ADR to the DTC on standard
forms
 investigation and analysis of reports by a
selected DTC member
 discussion and evaluation of reports by the
DTC on a regular schedule (quarterly) and
report to medical staff
 reporting to manufacturers and national
regulatory authorities of all events thought to
be ADRs (and not known side-effects).

17. WHO Definition:
“The science and activities relating to
the detection, assessment,
understanding and prevention of
adverse effects or any other drug
related problem”

18.  In 2002: National Drug Regulatory Authority of Nepal
(DDA) took initiatives to set up a pharmacovigilance
program in Nepal.
 In October 2004: Government of Nepal designated
DDA as National Center to liaison with the UMC,
Sweden, the WHO Collaborating Centre for
International Drug Monitoring.
 In July 2006: Nepal became a WHO UMC Programme
full member country.
 The revised National Drug Policy 2009 (Draft)
recognizes the need for a pharmacovigilance program
in Nepal.
 The DDA acts as a focal point for ADR monitoring and
regional centers operate under it.
 Establishing system of regular reporting of the
Adverse Drug Reaction and keeping it operational.

19.  Manipal Teaching Hospital,
Pokhara
 Tribhuwan University Teaching
Hospital (TUTH), Kathmandu
 Nepal Medical College, Kathmandu
 KIST Medical College, Lalitpur
 BP Koirala Institute of Health
Sciences, Dharan (BPKIHS)

20. ADR report
forwarded
via vigiflow
ADR reports
through
vigiflow
HOSPITALS
(Regional
Centers)
DDA UMC

22.  Anyone in the
treatment chain
should be responsible
to recheck orders.
 If unsure, ask and
validate.
 Detect, report,
analyze and feedback.