FREQUENCY, TYPES, SEVERITY, PREVENTABILITY AND COSTS OF ADVERSE
DRUG REACTIONS AT A TERTIARY CARE HOSPITAL OVER A NINE MONTH
PERIOD
M.I. Geer - Dept. of Pharmaceutical Sciences, University of Kashmir,
Srinagar, J&K, India,
P.A. Koul - Dept. of Internal Medicine, Sher-i-Kashmir Institute of
Medical Sciences, Srinagar, J&K, India,
S.A. Tanki - Dept. of Pharmacology, MM Institute of Medical Sciences
and Research, Mullana, Ambala, India, and
M.Y. Shah - Dept. of Pharmaceutical Sciences, University of Kashmir,
Srinagar, J&K, India
Background:
Prior to this study, there were no pharmacovigilance centres or any other ADR
monitoring framework available in any of the leading hospitals of the Indian state of
Jammu and Kashmir including SKIMS.
Objective/Aim:
To assess the frequency, preventability, types, severity, causality and costs of drugrelated adverse effects in Kashmiri patients at a tertiary care hospital namely, SKIMS.
Methods:
A prospective, observational, cohort, ADR monitoring study was conducted on adult
patients admitted in Internal Medicine IPD, presenting to the Internal Medicine OPD and
those visiting the Accident and Emergency Department of a tertiary care hospital
namely, SKIMS, during a 270 day period. A total of 5482 patients belonging to both the
sexes were screened and monitored on a daily basis for the occurrence of any ADRs.
WHO definition1 of ADRs was used and causality of suspected ADRs was determined
using Naranjo’s algorithm2 whereas severity was assessed using modified Hartwig’s
Scale3 and preventability was determined using Hallas methodology4. Cost of ADRs was
calculated as per the protocols suggested by Lagnaoui et al5 and Nicholas et al6
(extension in hospital stay).
Results:
ADRs accounted for 6.23% of adult Kashmiri patients visiting a tertiary care hospital,
SKIMS, either for referral or hospitalization, with the majority (81.57%) of these ADRs
being preventable; 23.68% of patients had mild ADRs, 69.29% had ADRs of moderate
severity, and 7.01% had severe ADRs. The 4 classes of drugs most frequently
suspected in admissions due to ADRs were anti-infective agents (40.92%) including
anti-tubercular drugs (13.15%), steroids (14.03%), anti-coagulants (8.77%), and
NSAIDs (7.89%). Increasing age and female gender were identified as risk factors. The
total cost to the hospital due to hospitalization of patients presenting with ADRs over
the 9-month period in the internal medicine IPD was USD 22469.
Conclusion/Discussion:
The present work is the maiden pharmacovigilance study conducted on Kashmiri
patients, especially at a tertiary care teaching hospital like SKIMS that has provided
baseline information about the prevalence of ADRs and their distribution among
different age groups, genders, organ systems affected, and therapeutic classes of
medicines. The data collected will be useful in future for more extensive ADR
monitoring on Kashmiri patients and will also be useful in framing policies toward the
rational use of drugs. This study led to the establishment of a full-fledged
pharmacovigilance centre and initiation of pharmaceutical care services at the study
hospital.
Table - Demographic characteristics of the study patients
Characteristics
No, of patients with
ADR/No. of patients
visiting the hospital
No. (%) (n=121) of ADRs occurring
ADR related
during hospital
admissions
stay
Male
132/3283 (4.02%)*
21 (0.63%)*
111 (3.38%)*
Female
210/2199 (9.54%)*
47 (2.13%)*
163 (7.41%)*
Adult
187/3985 (4.69%)*
38 (0.95%)*
149 (3.73%)*
Elderly(>65yrs) 155/1497 (10.35%)*
30 (2.00%)*
125 (8.35%)*
Total
68 (1.24%)
274 (5.07%)
342/5482 (6.23%)
*P<0.0001 on student’s t-test/chi-square (ᵡ2) test (level=statistically highly
significant)
References:
1. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis
and management. Lancet 2000; 356:1255-9
2. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberst EA, et al. A
method for estimating the probability of adverse drug reactions. Clin
Pharmacol Ther 1981;30:239-45
3. Hartwig SC, Seigel J, Schneider PJ. Preventability and severity
assessment in reporting adverse drug reactions. Am J Health Syst Pharm
1992;49(9):2229-32
4. Hallas J, Harvald B, Gram LF, Grodum E, Prosen K, Haghfelt T, et al. Drug
related hospital admissions: the role of definitions and intensity of data
collection, and the possibility of prevention. J Intern Med 1990;228:83-90
5. Lagnaoui R., Moore N., Fach J., Longy-Boursier M., Begaud B. Adverse
drug reactions in a department of systemic diseases-oriented internal
medicine: Prevalence, incidence, direct costs and avoidability. Eur J Clin
Pharmacol 2000;55:181-86
6. Nicholas M, Dominique L, Catherine N, Michel M. Frequency and cost of
serious adverse drug reactions in a department of general medicine. Br J
Clin Pharmacol 1998;45:301-8
Improvements in drug policy of Indian state of J&K through persistent
advocacy and logical interventions by Civil Society Forum
M.I. Geer - Dept. of Pharmaceutical Sciences, University of Kashmir,
Srinagar, J&K, India
Background:
Draft drug policy of the Indian state of Jammu and Kashmir was made available on its
official website in the year 2009 by the Ministry of Health and Family Welfare. On
studying the draft it was found to be deficient in many important aspects. Hence a
sustained campaign was launched by Civil Society Forum, a group of activists drawn
from diverse sectors like health, education, media, trade, industry, politics etc in order
to incorporate necessary changes in the draft policy.
Objective/Aim:
To emphasize upon the importance of civil society interventions and involvement in
policy making process and decisions, with a view to bring changes in government drug
policies, necessary to ensure quality, safety, efficacy, availability and affordability of
medicines.
Methods:
Through sustained lobbying, persistent advocacy, persuasive pressure, wide
consultations and logical interventions, Civil Society Forum Kashmir got some
significant changes incorporated in the draft drug policy of J&K state, introducing some
fresh policy initiatives and novel approaches to tackle common problems of drug use in
the society like spurious drugs, drug abuse, misuse of drugs belonging to Indian
Systems of Medicines, over-the-counter sale of prescription drugs, recall and disposal of
unwanted drugs etc.
Results:
Draft drug policy formulated by the J&K govt. in 2009 was mainly focussed on selection,
procurement, storage and rational use of drugs particularly in govt health facilities.
However it was totally deficient in vital policy provisions related to spurious drugs
control, AYUSH drugs control, control of prescription drug abuse, recall and disposal of
uwanted drugs, drug licensing regulation, control of unethical promotion of drugs, drug
prosecution, hospital and clinical pharmacy services, pharmacy education regulation,
drug price control, medical financing/health insurance, blood banking and transfusion
etc. Through civil society interventions some of these provisions were accepted by the
J&K govt. for incorporation in the modified draft whereas few others were rejected. Net
outcome of interventions was that qualitatively a better draft could be evolved.
Conclusion/Discussion:
Taking cue from the Indian state of Jammu and Kashmir, this paper demonstrates the
need and importance of inclusion of civil society in policy making process and decisions
for achieving the overall goal of making drugs of standard quality, good efficacy and
reasonable safety available to common masses, particularly at govt. health centres.
Experiences gained from J&K emphasize upon the need to replicate such activism in
other Indian states too.
FRESH POLICY INITIATIVES INCORPORATED IN MAIDEN DRUG POLICY OF J&K
STATE THROUGH CIVIL SOCIETY INTERVENTIONS
Rational Medicine Promotion Policy
Control of AYUSH Medicines
Drug Licensing Policy
Disposal of Unwanted Medicines
Rational Blood Banking/Transfusion Policy Hospital Drug Management Policy
Drug Prosecution Policy
Cosmetics Control Policy
Drug Recall Policy
Drug Safety Monitoring Policy
Spurious Medicines Control Policy
Clinical Pharmacy Services Policy
Drug Abuse Control Policy
Pharmacy Education Policy
Drug Price Control Policy
Pharmacy Regulation Policy
References:
1. Geer M. I., Shah M. Y. Guiding Principles for the formulation of a Drug
Policy in the state of J&K. Journal of Pharmacovigilance and Drug Safety
2009;6(1):22-26.
2. Geer, M. I. Mushrooming of medical stores in J&K state – reasons and
solutions. Physicians Academy 2010; 4(7); 75-76.
3. Geer, M. I. Deficiencies in the draft Drug Policy of J&K government.
Physicians Academy 2011; 5(2): 16-19.
4. Geer M.I. Magnitude of spurious drug trade in J&K – Mountain or a
molehill? Physicians Academy 2012; 6(1):2-9.
5. Geer M.I. Approved drug policy of J&K government – A Review. Physicians
Academy 2012;6(2): 27-37.
6. Geer M.I. Generic Drug Prescribing in J&K - Boone or bane?. Physicians
Academy 2012; 6(5): 82-87.