www.ijpsonline.com
3.
4.
5.
6.
7.
8.
9.
Lam. a herbal medicine for hyperlipidemia: A pre–clinical report. Asian
Pac J Trop Dis 2012;2:S790‑5.
Vongsak B, Sithisarn P, Mangmool S, Thongpraditchote S, Wongkrajang Y,
Gritsanapan W. Maximizing total phenolics, total flavonoids contents and
antioxidant activity of Moringa oleifera leaf extract by the appropriate
extraction method. Indian Crop Prod 2013;44:566‑71.
Jaiswal D, Kumar Rai P, Kumar A, Mehta S, Watal G. Effect of
Moringa oleifera Lam. leaves aqueous extract therapy on hyperglycemic
rats. J Ethnopharmacol 2009;123:392‑6.
Chumark P, Khunawat P, Sanvarinda Y, Phornchirasilp S, Morales NP,
Phivthong‑Ngam L, et al. The in vitro and ex vivo antioxidant
properties, hypolipidaemic and antiatherosclerotic activities of
water extract of Moringa oleifera Lam. leaves. J Ethnopharmacol
2008;116:439‑46.
Cáceres A, Saravia A, Rizzo S, Zabala L, De Leon E, Nave F.
Pharmacologic properties of Moringa oleifera 2: Screening for
antispasmodic, antiinflammatory and diuretic activity. J Ethnopharmacol
1992;36:233‑7.
Usman M, Barhate S. Phytochemical investigation and study of
antiinflammatory activity of Moringa oleifera Lam. Int J Pharm Res
Dev 2011;3:114‑9.
Hamza AA. Ameliorative effects of Moringa oleifera Lam seed extract
on liver fibrosis in rats. Food Chem Toxicol 2010;48:345‑55.
Moyo B, Masika P, Hugo A, Muchenje V. Nutritional characterization
10.
11.
12.
13.
14.
15.
16.
of Moringa (Moringa oleifera Lam.) leaves. Afr J Biotechnol
2011;10:12925‑33.
Obi E, Akunyili DN, Ekpo B, Orisakwe OE. Heavy metal hazards of
Nigerian herbal remedies. Sci Total Environ 2006;369:35‑41.
Limmatvapirat C, Limmatvapirat S, Charoenteeraboon J, Phaechamud T.
Inductively coupled plasma mass spectrometric determination of heavy
metals in Moringa oleifera Lam. leaves. Res J Pharm Biol Chem Sci
2013;4:161‑8.
Limmatvapirat C, Limmatvapirat S, Charoenteeraboon J, Phaechamud T.
Simultaneous analysis of eleven heavy metals in Moringa oleifera
Lam. leaf capsules by ICP‑MS, in: Proceedings of the International
Conference on Life Science and Biological Engineering (LSBE), Tokyo,
Japan; October, 2013.
Commission Decision 2002/657/EC, Council Directive 96/23/EC, The
Performance of Analytical Methods and the Interpretation of Results;
August, 2002.
Commission Regulation (EC) No. 333/2007, The Methods of Sampling
and Analysis for the Official Control of the levels of Lead, Cadmium,
Mercury, Inorganic tin, 3‑MCPD and Benzo (a) Pyrene in Foodstuffs;
March, 2007.
Sauveur A, Broin M. Growing and Processing Moringa leaves. Moringa
news, Moringa Association of Ghana, France; 2010. p. 55‑63.
Agyarko K, Darteh E, Berlinger B. Metal levels in some refuse dump
soils and plants in Ghana. Plant Soil Environ 2010;56:244‑51.
Assessment of Adverse Drug Reactions Based on
Spontaneous Signals at Secondary Care Public Hospital
S. PONNUSANKAR*, M. TEJASWINI AND M. CHAITANYA
Department of Pharmacy Practice, JSS College of Pharmacy, Udhagamandalam–643 001, India
Ponnusankar, et al.: ADR Assessment Based on Spontaneous Signaling
Adverse drug reactions are considered to be among the leading causes of morbidity and mortality. Approximately
5‑25% of hospital admissions are due to adverse drug reactions and 6‑15% of hospitalized patients experience
serious adverse drug reactions, causing significant prolongation of hospital stay. Thus this study was aimed
at determining adverse drug reactions by conducting spontaneous reporting in secondary care Govt. District
Head Quarters Hospital at Ooty. A prospective Spontaneous Adverse Drug Reaction reporting study was
conducted over a period of 12 months from July 2012 to June 2013. The assessment, categorization, causality,
severity and preventability were assessed using standard criteria. A total of 47 suspected adverse drug reactions were
reported during the study period. Over all incidences was 1.29% among the study population. Antibiotics (31.91%)
were the class of drug most commonly involved, while ciprofloxacin (14.89%) was the most frequently reported.
Type H (Hypersensitivity) reactions (51.06%) accounted for majority of the reports and a greater share of the
adverse drug reactions are probable (89.36%) based on causality assessment. Mild reactions accounted 82.97%
based on modified Hartwig and Siegel severity scale. In 76.59% of the reports, the reaction was considered to be
preventable based on Schumock and Thornton preventability scale. The implementation of monitoring based
on spontaneous reporting will be useful for the detection and evaluation is associated with increase in morbidity
and duration of hospitalization. This study also has
established the vital role of clinical pharmacist in the
This is an open access article distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
adverse drug reaction monitoring program.
Key words: Adverse drug reactions, inpatient,
spontaneous reporting, secondary care hospital,
Naranjo’s scale, Wills and Brown classification
others to remix, tweak, and build upon the work non‑commercially, as long as the
author is credited and the new creations are licensed under the identical terms.
For reprints contact: [email protected]
*Address for correspondence
E‑mail: [email protected]
490
Indian Journal of Pharmaceutical Sciences
Accepted 07 August 2015
Revised 21 January 2015
Received 12 June 2014
Indian J Pharm Sci 2015;77(4):490-493
July - August 2015
www.ijpsonline.com
Clinical pharmacy is defined as that area of
pharmacy concerned with the signs and practice of
rational medical use[1]. Clinical pharmacy services
are those provided by pharmacists in an attempt
to promote rational drug therapy that is safe and
appropriate, one of the services provided by them
is pharmacovigilance[2]. Presently pharmacovigilance
has emerged as a part of clinical pharmacy by
ensuring the best pharmaceutical care. Adverse drug
reactions (ADRs) are considered to be among the
leading causes of morbidity and mortality[3].
intentional or accidental poisoning, medication
errors and patients with drug abuse were not
included. Patient case sheets, patient medical records
were used as main sources of data collection.
Adverse drug reaction documentation form, Wills
and Brown classification, Causality assessment
scale (Naranjo’s scale) [9], Modified Hartwig and
Siegel severity scale [10], Schumock and Thornton
preventability scale[11], ADR alert card and thank you
note were the various tools utilized for the conduct
of study.
According to WHO, an adverse drug reaction was
originally defined in 1972 as a response to a drug
that is noxious and unintended and occur at doses
normally used in humans for the prophylaxis,
diagnosis, or therapy of disease, or for modification
of any physiological function[4]. ADR reporting can
alert the health care providers against the chances
of occurrence of unexpected risks associated with
the drugs. In India, pharmacovigilance program is in
evolving stage and hence, pharmacists’ involvement in
such activities has been low[5].
The clinical pharmacist who was posted in a
particular ward, used to take part in the ward rounds
along with the health care professionals and actively
monitor for any ADRs. Patients who developed
ADR were interviewed throughout their hospital
stay, from the day ADR was reported. The case
details were documented in ADR documentation
form. ADR alert card was given to the patients who
exhibited hypersensitivity type of reactions or near
fatal reactions with any component of the drug. Thank
you cards were issued to the healthcare professionals
who reported ADR, so as to encourage further
reporting. ADRs were analyzed for incidence, type of
ADRs, drug classes, and individual drug. ADRs were
also assessed for causality, severity and preventability
using different scales.
The World Health Organization[6], The United States
Food and Drug Administration[7] (USFDA) and the
European Medicines Agency[8] (EMA) have recognized
the need to evaluate the beneficial and harmful effects
of drugs and to continually improve their use in order
to provide appropriate, safe and effective drug therapies.
The purpose of this study was reporting, assessing,
monitoring and observing the outcome of management
of ADRs. The main objective was to create awareness
among the health care professionals and patients
on adverse drug reaction and its reporting. The
implementation of ADR monitoring based on
spontaneous reporting will be useful for the detection
and evaluation of ADRs associated with increase in
morbidity and duration of hospitalization.
A prospective study was conducted for a period
of 12 months from July 2012 to June 2013 in
Government Head Quarters Hospital (GHQH),
Ooty, India. It is a 420‑bedded hospital providing
secondary healthcare to people of The Nilgiris
district. Institutional ethical committee approved the
study (JSSCP/DPP/IRB/01/2012‑13 Date 21.10.2012).
Patients admitted in medical ward, surgical ward
and pediatric ward were included. Patient with
July - August 2015
A total number of 6,729 patients visited the
particular wards during the study period. Among
these, 1.29% (n=45) patients either visited the
hospital with already developed ADRs or developed
ADR during their stay in the hospital. This
showed a similar pattern of results as reported
by Arulmani et al.[12] (fig. 1).
Out of total ADRs reported, 68.88% (n=31) involved
adults, 26.66% (n=12) involved geriatric patients and
4.44% (n=2) involved pediatric patients which was
similar to the results reported by Jose and Rao[13].
It was observed that 84.44% (n=38) of ADRs
in medical ward were reported followed by
11.11% (n=5) in surgical ward and 4.44% (n=2) in
pediatric ward. This may be due to more number
of patients who turned out with comorbid and
chronic disease conditions. Majority of the ADRs
through spontaneous reporting were due to antibiotics
31.91% (n=15) followed by H2 blockers 14.89% (n=7)
which was similar to the study report of Chan et al.[14]
Indian Journal of Pharmaceutical Sciences
491
www.ijpsonline.com
TABLE 1: SUSPECTED DRUG AND DESCRIPTION OF
ADVERSE DRUG REACTION THROUGH SPONTANEOUS
REPORTING
Drugs
Fig. 1: Percentages of spontaneous adverse drug reactions in different
gender.
Spontaneous adverse drug reactions reported gender wise. male
percentage female percentage.
The individual drugs that produced ADRs involved
ranitidine 14.89% (n=7) and ciprofloxacin
14.89% (n=7) which produced highest number of
reactions such as rashes and itching (Table 1).
According to the Wills and Brown classification,
the majority of the ADRs 51.06% (n=24) were of
Type H followed by 40.42% (n=19) of Type A
reactions. The results were very much similar to
Arulmani et al. [12] . This indicated that most of
the ADRs were predictable and not potentially
preventable. According to the Naranjo’s algorithm,
majority of the ADRs probable were 89.36% (n=42)
followed by possible 6.38% (n=3) and definite
4.25% (n=2) and the results showed similarity with
a study conducted by Patel et al. [15]. Majority of
the ADRs were mild 82.97% (n=39) in severity,
that is, total of 6 ADRs came under level 1 and
33 ADRs under level 2. Under moderate severity
number of cases were 14.89% (n=7) and severe
ADRs it was 1. On evaluation of preventability of
the ADRs it was evident that most of them were not
preventable 76.59% (n=36) which was similar to the
results of Jose and Rao[13] (Table 2).
ADR reporting and monitoring program targets to
identify and quantify the risks associated with the
drug use and thus promoting rational use of drugs.
Involvement of a pharmacist in patient care can help
in prevention and early detection of ADRs. Hence
the study has established the vital role of clinical
pharmacist in the ADR monitoring programs.
492
Ceftriaxone
Amoxicillin
Ranitidine
Spontaneous
ADRs (%)
1 (2.12)
1 (2.12)
7 (14.89)
Cefotaxime
Salbutamol
Aspirin
6 (12.76)
2 (4.25)
2 (4.25)
Heparin
Diclofenac
2 (4.25)
4 (8.51)
Ciprofloxacin
Enalapril
Amlodipine
ISDN
Glimepiride
Insulin
Metronidazole
Antisnake
venom
7 (14.89)
3 (6.38)
2 (4.25)
2 (4.25)
1 (2.12)
1 (2.12)
4 (8.51)
2 (4.25)
Description of reaction
Rashes (1)
Vomiting (1)
Rashes and itching (6) Drowsiness
and rash (1)
Rashes (4) vomiting (1) swelling (1)
Tremors (1) oral candidiasis (1)
Gastric irritation (1) abdominal
pain (1)
Haemoptysis (1) hematemesis (1)
Rashes (1) pedal edema (1) heart
burn (1) gastric irritation and
abdominal pain (1)
Rashes (6) vomiting (1)
Dry cough (3)
Headache (1) pedal edema (1)
Headache (2)
Rashes (1)
Hypoglycemia (1)
Vomiting (2) rashes (2)
Rashes (1) pruritis (1)
ISDN: Isosorbide dinitrate, ADRs: adverse drug reactions
TABLE 2: CLASSIFICATION OF CAUSALITY, SEVERITY,
PREVENTABILITY AND TYPE OF REACTIONS
Parameters
Causality
Definite
Probable
Possible
Severity
Mild
Moderate
Severe
Preventability
Definite preventable
Probably preventable
Not preventable
Type of reactions
Type A
Type B
Type C
Type D
Type E
Type F
Type G
Type H
Type U
Numbers (%)
2 (4.25)
42 (89.36)
3 (6.38)
39 (82.97)
7 (14.89)
1 (2.12)
5 (10.63)
6 (12.76)
36 (76.59)
19 (40.42)
‑
‑
‑
‑
‑
‑
24 (51.06)
4 (8.51)
Acknowledgements:
The authors wish to thank Dr. Mohd. Haneefa,
superintendent and other senior doctors of
Indian Journal of Pharmaceutical Sciences
July - August 2015
www.ijpsonline.com
Government District Head Quarters Hospital, Ooty
for their constant support and help during this study.
Financial support and sponsorship:
Nil.
7.
8.
Conflicts of interest:
There are no conflicts of interest.
9.
REFERENCES
10.
1.
11.
2.
3.
4.
5.
6.
American College of Clinical Pharmacy. The definition of clinical
pharmacy. Pharmacotherapy 2008;28:816‑7.
Parthasarathi G, Nyfort‑Hansen K, Nahata M, editors. A Text Book of
Clinical Pharmacy Practice‑essential Concept and Skills. Hyderabad:
Orient Blackswan; 2008. p. 09.
Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug
reactions (ADR): A meta‑analysis of observational studies. Pharm World
Sci 2002;24:46‑54.
Edwards IR, Aronson JK. Adverse drug reactions: Definitions,
diagnosis, and management. Lancet 2000;356:1255‑9.
van Grootheest K, Olsson S, Couper M, de Jong‑van den Berg L.
Pharmacists’ role in reporting adverse drug reactions in an international
perspective. Pharmacoepidemiol Drug Saf 2004;13:457‑64.
World Health Organization. The Safety of Medicines in Public
Health Programmes: Pharmacovigilance an Essential Tool. Geneva,
Switzerland: WHO Press; 2006. Available from: http://www.who.int/
12.
13.
14.
15.
medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.
pdf. [Last accessed on 2012 Feb 10].
Pearson KC, Kennedy DL. Adverse drug reactions and the food and
drug administration. J Pharm Pract 1989;2:209‑13.
Directive 2001/83/EC of the European Parliament and of the Council
of November, 2001 on the Community Code Relating to Medicinal
Products for Human Use. Official Journal L–311, 28 November, 2004.
p. 67–128. Available from: http://www.ec.europa.eu/health/files/eudralex/
vol‑1/dir_2001_83/2001_83_ec_en.pdf. [Last accessed on 2012 Feb 10].
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al.
A method for estimating the probability of adverse drug reactions. Clin
Pharmacol Ther 1981;30:239‑45.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity
assessment in reporting adverse drug reactions. Am J Hosp Pharm
1992;49:2229‑32.
Schumock GT, Thornton JP. Focusing on the preventability of adverse
drug reactions. Hosp Pharm 1992;27:538.
Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring
in a secondary care hospital in South India. Br J Clin Pharmacol
2008;65:210‑6.
Jose J, Rao PG. Pattern of adverse drug reactions notified by
spontaneous reporting in an Indian tertiary care teaching hospital.
Pharmacol Res 2006;54:226‑33.
Chan AL, Lee HY, Ho CH, Cham TM, Lin SJ. Cost evaluation
of adverse drug reactions in hospitalized patients in Taiwan:
A prospective, descriptive, observational study. Curr Ther Res Clin
Exp 2008;69:118‑29.
Patel KJ, Kedia MS, Bajpai D, Mehta SS, Kshirsagar NA, Gogtay NJ.
Evaluation of the prevalence and economic burden of adverse drug
reactions presenting to the medical emergency department of a tertiary
referral centre: A prospective study. BMC Clin Pharmacol 2007;7:8.
Pharmacodynamic Study of Interaction of Aqueous
Leaf Extract of Psidium Guajava Linn. (Myrtaceae) with
Receptor Systems Using Isolated Tissue Preparations
R. K. MAHASETH, S. KUMAR, SHAGUN DUTTA, RATIKA SEHGAL, PREETY RAJORA AND RAJANI MATHUR*
Department of Pharmacology, Delhi Institute of Pharmaceutical Sciences and Research, Pushp Vihar,
New Delhi‑110 017, India
Mahaseth, et al.: Interaction of Psidium Guajava with Receptor System
The present study investigates the interaction of aqueous leaf extract of Psidium guajava with muscarinic,
serotonergic and adrenergic receptor system using isolated rat ileum, gastric fundus and trachea, respectively. The
concentration‑dependent contractile response of aqueous leaf extract of Psidium guajava was parallel and rightward
of standard agonists, ACh and 5‑HT indicating agonistic activity on muscarinic and serotonergic receptor systems.
The inhibition of aqueous leaf extract of Psidium guajava mediated contractions in presence of atropine (10‑7 M) and
ketanserin (10‑6 M) confirmed the activity. Relaxant effect
of PG (0.2 mg/ml) on carbachol induced pre‑contracted
This is an open access article distributed under the terms of the Creative
rat tracheal chain indicated its agonistic action on
Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
adrenergic receptor system. Inhibition (P<0.05) of
others to remix, tweak, and build upon the work non‑commercially, as long as the
author is credited and the new creations are licensed under the identical terms.
the action in the presence of propranolol (1 ng/ml)
confirmed the activity. It may be concluded that PG
For reprints contact: [email protected]
possesses agonistic action on muscarinic, serotonergic
and adrenergic receptor systems.
Accepted 07 August 2015
Revised 21 January 2015
Received 17 July 2014
Indian J Pharm Sci 2015;77(4):493-499
*Address for correspondence
E‑mail: [email protected]
July - August 2015
Indian Journal of Pharmaceutical Sciences
493