project thisis

Department of Clinical Pharmacy, H.S.K. COP, Bagalkot

Chapter 1

Evaluation of antimalarial drugs use in

tertiary care teaching hospital


1.1 Introduction

Malaria is a tropical disease transmitted by the female Anopheles mosquito of

which Anopheles gambiae is the most efficient vector1. It is caused by infection by the

protozoan parasite of the genus plasmodium, is a disease of global importance2.

Malaria is a major cause of morbidity and mortality in the developing world3. It is a

public health problem in more than 90 countries. Each year, between 300 and 500

million new cases are reported worldwide4.

WHO now recommends that treatment policies for falciparum malaria in all

countries experiencing resistance to monotherapies such as chloroquine,

sulphadoxine-pyrimethamine and amodiaquine, should be combination therapies

preferably those containing an artemisinin derivative5.

Artemisinin also known as Qinghaosu and its derivatives are a group

of drugs that possess the most rapid action of all current drugs against Plasmodium

falciparum malaria, Treatments containing an artemisinin derivative (artemisinin-

combination therapies, ACTs) are now standard treatment worldwide for Plasmodium

falciparum malaria, artemisinin is a sesquiterpene lactone6.

India has the largest population in the world at risk of malaria, with 85%

living in malarious zones7. Around 1.5 million confirmed cases are reported annually

by the National Vector Borne Disease Control Programme (NVBDCP), of which

about 50% are due to Plasmodium falciparum8.

In recent studies, chloroquine-

resistant Plasmodium falciparum malaria has been observed with increasing

frequency across the country9. A revised National Drug Policy on Malaria has been

adopted by the Ministry of Health and Family Welfare, Govt. of India in 2010 and the

National guidelines have been prepared for healthcare personnel including clinicians

http://en.wikipedia.org/wiki/Medication

http://en.wikipedia.org/wiki/Plasmodium_falciparum

http://en.wikipedia.org/wiki/Plasmodium_falciparum

http://en.wikipedia.org/wiki/Malaria

http://en.wikipedia.org/wiki/Artemisinin-combination_therapy

http://en.wikipedia.org/wiki/Artemisinin-combination_therapy

http://en.wikipedia.org/wiki/Sesquiterpene_lactone


involved in the treatment of malaria10

. In 2010 artesunate plus sulphadoxine

pyrimethamine treatment became the first-line treatment throughout India7.

Malaria in pregnancy is a serious public health problem in endemic regions9.

This pathology is among the main causes of the low birth weight (LBW), resulting

from 3% to 8% neonatal and infant deaths10, 11

. This led the World Health

Organization (WHO) to recommend a package of affordable interventions including

the use of the insecticide-treated nets (ITNs), the intermittent presumptive treatment

(IPT) with sulphadoxine-pyrimethamine (SP), and the effective case management of

clinical malaria with recommended antimalarials. At least two doses of IPT-SP are

recommended during the second and third trimesters of pregnancy12

.

The occurring of clinical malaria should be treated with quinine or

artemisinin-based combinations. Quinine is considered to be a safe drug along all the

period of the pregnancy, but safety data of artemisinin derivatives during the first

trimester of pregnancy are limited, thus it should not be prescribed in this period12

.

The National Vector Borne Disease Control Program of India reported 1.6 million

cases and 1100 malaria deaths in 200914

.


Year Total cases PV cases Pf cases PF/PV ratio Population Deaths

1995 2.9 1.8 1.1 0.6 888,143 1151

1996 3.0 1.9 1.2 0.6 872,906 1010

1997 2.7 1.7 1.0 0.6 884,719 879

1998 2.2 1.2 1.0 0.9 910,884 664

1999 2.3 1.1 1.1 1.0 948,656 1048

2000 2.0 1.0 1.1 1.1 970,275 932

2001 2.1 1.1 1.0 0.9 984,579 1005

2002 1.8 0.9 0.9 1.0 1,013,942 973

2003 1.9 1.0 0.9 0.9 1,027,157 1006

2004 1.9 1.0 0.9 0.9 1,040,939 949

2005 1.8 1.0 0.8 0.8 1,082,882 963

2006 1.8 1.0 0.8 0.9 1,072,713 1707

2007 1.5 0.8 0.7 1.0 1,087,582 1311

2008 1.5 0.8 0.8 1.0 1,119,624 1055

2009 1.6 0.7 0.8 1.2 1,150,113 1144

2010 1.5 0.7 0.8 1.1 1,151,788 767

The two major human malaria species in India are Plasmodium falciparum and

Plasmodium vivex; Plasmodium malariae has been reported in the eastern India state

of Odisha, while Plasmodium ovale appears to be extremely rare if not absent.

Intriguingly, the two major infecting species vary in proportion across India. For

example, the southern state of Tamil Nadu suffers from Plasmodium vivex,

Plasmodium falciparum is the dominant parasite in Odisha, and mixed-species

infections are prevalent in the west (e.g. Gujarat state). Although Plasmodium

falciparum and Plasmodium vivax are unevenly distributed across India, this is not

due to Anopheles vector restriction (even though the vector species also differ in

geographical distribution) since both species are transmitted by the same vectors.

Historically, Plasmodium vivax has been the major infecting species; however, over

the past several years Plasmodium vivax cases have decreased: the ratio of

Plasmodium falciparum versus Plasmodium vivax malaria was 0.41 in 1985,

gradually increasing to 0.60 by 1995, and shifting to 1.01 by 2010. In states where

Plasmodium falciparum and Plasmodium vivax co-circulate, fluctuating proportions


of the two species complicate diagnosis and treatment. Treatment is based upon the

primary species identified in an infection by standard microscopy diagnosis,

subjecting all species in a single host to the same drug treatment14

.

Approximately 65% of those at risk for becoming infected with malaria in

Southeast Asia are individuals residing in India (WHO, 2007). The central and eastern

regions of India report the most malaria. Particularly the eastern states of Odisha,

West Bengal, and Jharkhand, the central states of Chhattisgarh and Madhya Pradesh,

and the western states of Gujarat, Karnataka and Rajasthan, with the largest number

of deaths reported in Odisha. Malaria cases in India are reported throughout the year,

since a perfect combination of average temperature (15–30 ℃), rainfall and

precipitation-inducing conditions persist across the different parts of the country over

all the seasons. With increasing ecological and man-made environmental change (e.g.

urbanization, construction of dams, agricultural intensification, deforestation) malaria

in India is exhibiting general trends from rural to urban malaria, from forest to plain

malaria, and from industrial to travel malaria16

. Karnataka is located in western side

of India, in the southern peninsular region. Since many years, the highest incidence in

Karnataka were recorded in regions of Bijapur, Bagalkot, Raichur, Kolar, Bellary,

Dakshina kannada and Mandya district which together accounted for more than 60%

of malaria cases.


1.2 A review of literature on evaluation of antimalarial drugs in tertiary care

teaching hospital

The brief review of literature on the earlier studies on drug use evolution of

antimalarial agent in patients were discussed as follows

Faheem et al. (2012) conducted study on drug utilization pattern of anti-

malarial drugs at a tertiary care hospital: a retrospective study. They analyzed the use

of anti-malarial agents in treatment of patients admitted to KMC Hospital, Attavar

(Mangalore) with a diagnosis of Malaria and compared it with the guidelines on

Diagnosis and Treatment of Malaria in India which were revised in 2007 by the

Ministry of Health of India. A total sample size was 478 and pattern of

Uncomplicated and complicated Malaria Parasite Infection was evaluated. In this

study it was observed that 26% of the admitted patients receive a combination of 3

anti-malarial agents, 58% received a combination of 2 antimalarial agents, while only

16% of the patients were managed with monotherapy as part of treatment.

Lumefantrine was the most commonly prescribed agent in 86.5% of the patients,

followed by Mefloquine 41.1%. Finally they concluded that there is an increased use

of Artemisinin as first line drugs in Mangalore, irrespective of the causative agent for

malaria, which is an unhealthy practice. The use of primaquine for all types of malaria

is also on the increase and this practice must be curbed too15

.

Dhara et al. (2012) evaluated drug utilization study of anti-malarial drugs in a

tertiary care hospital which was a retrospective, Single-centric study with cases of

anti-malarial drugs prescribed in duration of 1 year from Jan-2011 to Dec-2011 at

Lions General hospital, Mehsana, Gujarat, India. Data were analyzed with different

evaluations. A total of 474 cases were collected including 282 (59.49%) male and 192

(40.51%) female. Out of these 283 (59.70%) were uncomplicated, 115(24.26%) were


complicated and 76 (16.04%) were seen of non-malaria prescribed with anti-malarial

drugs. Artemisinin Combination Therapy (ACT) was prescribed in 44(7.96%)

patients. Artesunate monotherapy were prescribed in 230 (41.59%) patients.

Adherence to National Guideline in cases with Plasmodium vivax malaria is 71.53%

and for pregnant women and with mixed infection is 100%, while non adherence is

more than 80% seen in plasmodium falciparum malaria (87.39%) and clinical malaria

(84%) cases. Artesunate and Chloroquine were also prescribed in non-malarial

patients. Among all the cases IV injection of anti-malarial drugs prescribed were

48.82%. Average drug cost/prescription is INR 123.28 Rs and percentage drug cost

on injection is 87.50%. This study shows the prescribing pattern of anti-malarial drug

adherence to National Guideline therapy is low. They concluded that inappropriate

use of anti-malarial drugs among the patients is very high. So possibility of

development of resistance with anti-malarial drugs in the population will rapidly

spread and cost of the prescription will burden on the patients16

.

Dahal et al, (2012) evaluated drug use pattern in Primary Health Care (PHC)

facilities of Kaski district, Western Nepal. A total of 301 prescriptions were analyzed.

The average age of patients visiting PHC was 33.11 years (female 35.79; male 30.40).

The average number of drugs prescribed was 2.29. Percentage of encounters with at

least one antibiotic prescribed was 57% whereas encounters with at least one injection

prescribed was low 3%. The total percentage of drugs prescribed using generic names

was found to be 59.02% and percentage of drugs prescribed from EDL was 85.19%

respectively. The average consultation and dispensing time of 109 patients was 2.02

minutes and 42.52 seconds. Only 30% of patients had adequate knowledge of drug

whereas none of the drugs were adequately labeled. Percentage of drugs actually


dispensed was 89.63%. All health facilities had availability of Essential Drug List

(EDL). The total percentage of availability of key drugs in study PHCs was 89.69%17

.

Igbiks et al,(2012) evaluated the prescribing pattern of clinicians in the

general outpatient unit of the Aminu Kano Teaching Hospital, Kano (AKTH) This

was a descriptive retrospective study conducted using 500 prescriptions made at the

general outpatient unit of AKTH between April and July 2009. A total of 497

prescriptions were successfully analyzed. The average number of drugs per encounter

in the facility was 3.04. Generic prescribing was low at 42.7 % while antibiotic

prescription was high at 34.4 %. Injections were prescribed in 4 % of encounters

while 36.2, 19.1, 25.8 and 1 % of encounters had analgesics, antimalarials,

antihypertensive and anxiolytics prescribed, respectively. Vitamins were prescribed in

9.7 % of encounters18

.

Santoshkumar et al,(2010) studied prescribing pattern of anti malarial drugs

in a tertiary care hospital. It was prospective cross-sectional study was conducted for

6 months of patients visiting in Basaveshwar Teaching and General Hospital,

Gulbarga. Data were analyzed for various drug use indicators. A total of 212

prescriptions were collected, with 136 (64.15%) male and 76 (35.85%) female. There

were 128 (60.37%) Plasmodium vivax cases and 84 (39.63%) Plasmodium falciparum

cases. All Plasmodium vivax cases were treated with chloroquine alone and among

these 16 (12.5%) received radical treatment with primaquine along with chloroquine.

Among 84 patients with Plasmodium falciparum, 40 patients received single drug

such as quinine/ mefloquinine/artesunate/artemether. Another 44 patients received

multidrug regime like, quinine+artesunate (54.54%), quinine+mefloquine (27.27%)

and quinine+artemether (18.18%). Chloroquine was not administered to any of the

patients with Plasmodium falciparum malaria. The most common adverse effects with


chloroquine were anorexia, nausea, vomiting and tinnitus in 9.37% of the cases. With

quinine it was nausea and vomiting in 17.64%, tinnitus in 11.76% and hypoglycemia

in 2.1% of cases19

.

Anthony et al,(2013) evaluated prescription patterns and drug use among

pregnant women with febrile illnesses in Uganda. A total of 998 pregnant women

with a history of fever were interviewed and blood samples taken for diagnosis of

malaria and HIV infections. Data were captured on the drugs prescribed for the

current febrile episode and previous use of drugs especially SP, anti-retroviral drugs

(ARVs) and cotrimoxazole. Few pregnant women, 128 (12.8%) were parasitaemic for

P.falciparum; and of these, 72 (56.3%) received first-line treatment with Artemether-

lumefantrine (Coartem®) 14 (10.9%) SP and 33 (25.8%) quinine. Of the parasite

negative patients (non-malarial fevers), 186 (21.4%) received Coartem, 423 (48.6%)

SP and 19 (2.1%) cotrimoxazole. Overall, malaria was appropriately treated in 35.5%

of cases. Almost all febrile pregnant women, 91.1%, were sleeping under a mosquito

net. The majority of them, 911 (91.3%), accepted to have an HIV test done and 92

(9.2%) were HIV positive. Of the HIV positive women, 23 (25.0%) were on ARVs,

10 (10.9%) on cotrimoxazole and 30 (32.6%) on SP. A significant proportion of

women, 40 (43.5%), were on both SP and cotrimoxazole. Age and occupation were

associated with diagnosis and treatment of malaria and HIV infections20

.

Oshikoya et al,(2007) evaluated antimalarial prescriptions for children

presenting with uncomplicated Malaria to a teaching hospital in Nigeria. This was a

prospective study. A total of 3500 case files were used. In which 1855 (53.0%)

prescriptions were written for males, 1446 (41.3%) for females and 199 (5.7%)

patients with their gender not indicated. The mean age of the patients is 55.8±37.4

months. Those with ages between 12 to 72 months constituted the highest percentage


(47.6%) while those with ages 0 to 1 month constituted the lowest (1.3%). The mean

weight and the body temperature of the children were 10.3±5.5 kg and 37.2°C,

respectively. Antimalarials constituted the highest group of SP =

Sulphadoxine+pyrimethamine drugs prescribed as indicated in 2824 (80.1%) of the

case files. Antipyretic-paracetamol 2793 (79.8%) and vitamin B complex 2689

(76.8%) were the two commonly prescribed drugs with the antimalarial. While

Sulphadoxine+pyrimethamine only 564 (20.0%) was the highest antimalarial

prescribed, Artemether+lumefentine was the least 40 (1.4%). Only 23 (0.8%) of the

patients were investigated and confirmed to have malaria before prescribed

antimalarial drugs. Artemisinin-based combined drugs were the antimalarial

prescribed after the confirmation of malaria in the blood film of the investigated

patients. Artemisinin based combination drugs constitute 26.2% of all the antimalarial

prescribed, majority of which were prescribed, like other antimalarial, empirically

based on the symptoms and signs of malaria. Majority of the antimalarial drugs 2785

(98.6%) had their duration of use adequately prescribed. Of the artemisinin based

combined drugs, only Artemether+lumefentine was prescribed as a fixed combined

drug. The rest were prescribed as loose combined drugs. Sulphadoxine+

pyrimethamine and amodiaquine prescribed together were in loose forms. The

dosages of the antimalarial were adequately written for 1164 (41.2%) patients. Under

dosage and over dosage prescriptions of the antimalarial were associated with 711

(25.2%) and 302 (10.7%) patients respectively. Dosages of the antimalarial were not

stated in the case files of 647 (22.9%) patients. The dosage errors were most common

with Sulphadoxine+pyrimethamine prescriptions and least common with artemisinin,

its derivatives, combined forms and amodiaquine21

.


Martin et al,(2007) evaluated prescribing for uncomplicated malaria in

government and private health facilities in Cross River State. A665 patient records at

six private and seven government health facilities in 2003. Clinicians in the private

sector were less likely to record history or physical examination than those in public

facilities, but otherwise practice and prescribing were similar. Overall, 45% of

patients had a diagnostic blood slides; 77% were prescribed monotherapy, either

chloroquine (30.2%), sulphadoxine pyrimethamine (22.7%) or artemisinin derivatives

alone (15.8%). Some 20.8% were prescribed combination therapy; the commonest

was chloroquine with Sulphadoxine+pyrimethamine. A few patients (3.5%) were

prescribed sulphadoxine-pyrimethamine-mefloquine in the private sector, and only

3.0% patients were prescribed artemisinin combination treatments22

.

Alexander et al,(2011) evaluated pattern of the antimalarials prescription

during pregnancy in Bangui, Central African Republic. Study was conducted from

June to September 2009, A total of 565 women were enrolled for this study. Their

mean (±SD) age was 24.7 (±6.0) years (range: 15 to 45 years). A proportion of 21.8%

(n=123) has been given at least one dose of IPT-SP. Only a proportion of 8.5% of

them was given more than one dose of IPT-SP, as is recommended by the malaria

control programmed. Overall, 163 pregnant women (28.8%) were prescribed at least

once an antimalarial for a possible clinical malaria episode. The number of

antimalarials prescription ranged from 1 to 3 times per ANC cards. Eight ANC cards

contained 3 prescriptions (4.9%), and 29 ANC cards contained 2 prescriptions

(17.8%). Overall, four different groups of antimalarials were prescribed to the 163

women during the pregnancy, and the total number of those prescriptions was 208

(the mean number of antimalarials prescription per women was 1.28): quinine

(56.7%), artemisinin-based combinations (26.8%), artemisinin monotherapies


(14.4%), and other antimalarials monotherapies (chloroquine, halofantrine, and

amodiaquine). The malaria laboratory microscopy diagnosis was available in the

ANC cards for only 18.9% antimalarials prescriptions (39/208). All those results were

positive and the quinine was the only antimalarial prescribed accordingly.

Antimalarials prescription began in the second month of gestation, reaching a peak at

the sixth month of gestation. The global proportion of those prescriptions significantly

increased from the first trimester (16.8%) to the second trimester (56.3%) (value <

10−6). There were a total of 85 artemisinin components prescriptions during the

current pregnancies (30 artemisinin monotherapies and 55 artemisinin-based

combinations). Among those prescriptions, four (13.3%) prescriptions of artemisinin

monotherapies and six (10.9%) artemisinin-based combinations prescriptions

occurred in the first trimester of pregnancy. Otherwise, we recorded a total number of

118 quinine prescriptions. The number of quinine prescription in the first trimester is

24/35 (68.6%) and in the second trimester 65/117 (55.5%), while artemisinin-based

combinations Pattern of the Antimalarials Prescription during Pregnancy in Bangui,

Central African Republic are 6/35 (17.1%) for the first trimester and 40/117 for the

second, and artemisinin monotherapy is 4/35 (11.4%) for the first trimester and

22/117 (18.8%) for the second. Within each category of antimalarials, the distribution

trend increased from the first trimester to the second trimester: 24/118 (20.3%) to

65/118 (55.1%) for quinine, 6/55 (10.9%) to 30/55 (54.5%) for artemisinin-based

combinations and 4/30 (13.3%) to 22/30 (73.3%) for artemisinin monotherapies23

.

Gawde et al,(2013) evaluated drug prescription pattern in pregnant women

attending antenatal outpatient department of a tertiary care hospital. This was cross-

sectional study. Out of 760 women, one third (33.18%) women were anemic. Majority

drugs were prescribed for the treatment of upper respiratory tract infection, vaginal


discharge, and fever with chills, nausea and vomiting. The average number of drugs

per prescription was 2.27. Only 4% drugs were prescribed by their brand name and 96

% by generic name. Iron, folic acid and calcium were prescribed to all pregnant

women. Majority of the patients were prescribed Category A and B drugs. No patient

was given Category X drugs24

.

Modupe et al,(2014) evaluated prescription pattern of antimalarial drugs in a

teaching hospital in Nigeria. This was retrospective quantitative study, case record

files of 130 patients were selected, and 80.7% of the patients were prescribed

antimalarial drugs. 55.2% of patients admitted for malaria were males, 44.8% were

between 21-50 years of age. Fever (35.2%) was the most common presenting

symptom, 71.4% of the patients had diagnostic blood slides. Antimalarial drugs were

prescribed for malaria and malaria associated with other disease conditions,

artemisinin and lumefantrine was the most prescribed antimalarial agent. 44.0% of

these drugs were prescribed by trade names, 29.0% were administered orally. The

most antimalarial drug prescribed for prevention of malaria in pregnant women was

sulphadoxine-pyrimethamine, all the practitioners followed current WHO guidelines ,

half of the clinicians would prescribe parenteral antimalarial drugs for severe and

cerebral malaria, laboratory and clinical assessment were used for malaria diagnosis,

71.4% of the physicians adhered to hospital guidelines25

.


1.3 Guidelines of Diagnosis and Treatment of Malaria

The main thrust of the National Vector Borne Diseases Control Programme

(NVBDCP) is on early diagnosis and prompt, complete and effective treatment.

Malaria diagnosis is carried out by microscopic examination of blood films collected

by active and passive agencies. Health agencies and volunteers treating fever cases in

inaccessible areas are being provided with Rapid Diagnostic Test (RDT) kits (Pf

specific so far and now Bivalent RDT) for diagnosis of Malaria cases so as to provide

full radical treatment to the confirmed cases. It is stressed that all fever cases should be

suspected of malaria after ruling out other common causes and should be investigated

for confirmation of malaria by Microscopy or Rapid Diagnostic Kit (RDK) so as to

ensure treatment with full therapeutic dose with appropriate drug to all confirmed

cases. Presumptive treatment of malaria with a single dose of chloroquine has been

stopped. In all cases of suspected malaria which cannot be immediately confirmed by

tests, full treatment with chloroquine for 3 days should be given. The malaria case

management is very important for preventive serious cases and death due to malaria.

So, the private healthcare providers should also follow the common National

Guidelines for treatment of malaria as per the Drug Policy 2013. Where microscopy

result is not available within 24 hours and Bivalent RDT is used.


Note: 1) If malaria is strongly suspected, prepare & send slide for

microscopy

2) If a patient has several symptoms at any stage, then immediately refer to

nearest PHC or other healthy facility with indoor patient management or a

registered medical doctor.

3) PQ is contra-indicated in pregnancy and in children under 1 year(Infant).

Suspected malaria case

Do blood test with RDT

Positive for

P.vivex

Discard slide

Treat with:

CQ 3 days

+ PQ 14

days

Positive for

P.falciparum

Discard slide

In Northeastern

states: Age-

specific ACT-AL

for 3 days + PQ

single dose on

second day

In other states:

Treat with ACT-

SP for 3 days +

PQ Single dose on

second day

Positive for

Mixed infection

Discard slide

In Northeastern

states: Age-

specific ACT-AL

for 3 days +

Primaquine 0.25

mg per kg body

weight daily for 14

days

In other states:

SP-AST 3 days +

Primaquine 0.25

mg per kg body

weight daily for 14

days

Negative

No anti-malarial

treatment


ACT-AL:- Artemisinin-based combination therapy-Artemether-Lumefantrine

ACT-SP:- Artemisinin-based combination therapy (Artesunate+sulphadoxine-

Pyrimethamine)

CQ :- Chloroquine PQ :- Primaquine

In the view of above background the study entitled “Drug use evaluation of

anti malarial drugs in a tertiary care teaching hospital”, have undertaken by author to

study the prescribing pattern of anti-malarial drugs with following objectives

General Objective

To evaluate the use of anti-malarial drugs in the treatment of patients

diagnosed with malaria.

Specific Objectives

• To assess rationality of anti-malarial drugs use.

• To assess potential interaction of anti-malarial drugs with other prescribed drugs.

• To evaluate cost of anti-malarial drugs prescribed.


References

1. Oshikoya K. Anti-malarial prescriptions for children presenting with

uncomplicated malaria to a teaching hospital in Nigeria after the change of

national guidelines for malaria treatment, World J Med Sci. 2007;2(1):49-53.

2. Dass R, Barman H, Duwarah SG, Deka NM, Jain P, Choudhury V. Unusual

presentations of malaria in children: an experience from a tertiary care centre in

North East India, Ind J Ped. 2010;77(6):655-60.

3. Krungkrai J, Imprasittichai W, Otjungreed S, Pongsabut S, Krungkrai SR.

Artemisinin resistance or tolerance in human malaria patients, Asian Pacific J of

Tropical Med, 2010;3(9):748-753.

4. Buabeng KO, Duwiejua M, Dodoo AO, Matowe LK , Enlund H. Self-reported

use of anti-malarial drugs and health facility management of malaria in Ghana,

Malar J, 2007;2(6):85.

5. Medicines Sans Frontiers ACTNOW to get malaria treatment that works to

Africa. MSF Access to Essential Medicines Campaign, Geneva, 2003;2(3):390-

393.

6. White NJ. "Assessment of the pharmacodynamic properties of antimalarial drugs

invitro". Antimicrob. Agents Chemother. 1997; 41(7):1413–22.

7. Shah NK, Dhillon GP, Dash AP, Arora U, Meshnick SR, Valecha N; Anti-

malarial drug resistance of Plasmodium falciparum in India: changes over time

and space, Lancet Infect Dis. 2011;11(1):57-64.

8. Government of India, Guidelines for diagnosis and treatment of malaria, 2nd

edition, June 2011.

9. Dellicour S, Tatem AJ, Guerra CA, Snow RW, and Ter Kuile FO, Quantifying

the number of pregnancies at risk of malaria in 2007: a demographic

study,2010;7(1);108-114.

10. Menendez C, Todd J, Alonso PL, Lulat S, Francis N, and Greenwood BM

,Malaria chemoprophylaxis, infection of the placenta and birth weight in

Gambian primigravidae,1994;97(4);244–248.

11. Steketee RW ,Wirima JJ , Hightower AW, Slutsker L, Heymann DL, and Breman

JG, The effect of malaria and malaria prevention in pregnancy on offspring birth

weight, prematurity, and intrauterine growth retardation in Rural

Malawi,1996;55(1);33-41.

12. WHO A strategic framework for Malaria prevention and control during

pregnancy in the African Region, 2004.

13. White NJ, Intermittent presumptive treatment for malaria, 2005; 2(1):e3.

14. Aparap D ,Anupkumar R. Malaria in India: The centre for the study of complex

malaria in India, 2012; 121(3):267-273.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC163932

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC163932


15. Mubeen F. and Hardeep, Drug utilization pattern of antimalarial drugs at a

tertiary care hospital: retrospective study, 2013; 3(5):1-5.

16. Dhara L, Rina D and C.N.Patel, Drug utilization study of antimalarial drugs in a

tertiary care hospital, 2012; 2(4):761-770.

17. Dahal P. and Adhikari D, Drug use pattern in primary health care facilities of

Kaski district, western Nepal, 2012;1(1):2091-2102.

18. Igbks tamuno and Joseph, Drug use pattern in primary health care facilities of

Kaski district, western Nepal, 2012; 11(1):146-152.

19. Santosh R. and Manjunath S, Prescription pattern of anti-malarial drugs in

tertiary care hospital, 2010; 3(5):379-381.

20. Anthony K. and Josephine B, Prescription patterns and drug use among pregnant

women with febrile Illnesses in Uganda: a survey in out-patient clinics,

2013;1(13):237

21. Oshikoya K.A., Antimalarial prescriptions for children presenting with

uncomplicated malaria to a teaching hospital in Nigeria after the change of

national guidelines for malaria treatment, 2007; 2(1):49-53.

22. Martin M, Uduak and Angela O, Antimalarial drug prescribing practice in private

and public health facilities in south-east Nigeria: a descriptive study, 2007;6:55

23. Alexander Manirakiza, Pattern of the Antimalarials prescription during

pregnancy in Bangui, central African republic, 2011; 7(1):1-4.

24. Gawde SR, Bhide SS, Patel TC. Drug prescription pattern in pregnant women

attending antenatal outpatient department of a tertiary care hospital, 2013;

3(10):1-12.

25. Builders M, Degge H. Prescription pattern of Antimalarial drugs in a teaching

hospital in Nigeria, 2014; 2(1):267-276.


Chapter 2

Methodology of evaluation of antimalarial drugs use in tertiary care teaching hospital and research centre


2.1 Study Methodology

2.1.1 Study site

This study was conducted in inpatients in general medicine and Pediatrics

Departments of S.N Medical College and HSK hospital and research centre Bagalkot.

It is a 1000 bedded general hospital run by the BVV Sangh’s and it is one of the

premier institutes in Karnataka with different specialties, serving to the health care

needs of a huge population.

2.1.2. Study design

Prospective hospital based observational study.

2.1.3. Study period

The study was carried out for a period of 6 months from Nov 2013 to April

2014.

2.1.4. Study criteria

Inclusion criteria

Patients diagnosed with malaria.

Patients of all age group of either sex.

Patients receiving anti-malarial drugs.

Exclusion criteria

Patients attending outpatient department

2.1.5. Source of data

Data collected from

Case sheets of inpatients diagnosed with malaria

Treatment chart of patients, laboratory investigations of patients.


2.1.6. Data Collection

Data was collected from patient demographic details, Clinical data, Treatment

chart, Investigational reports, ADR notification form, Drug interaction and

intervention form. Data have to be collected by making personal visit to wards and all

the data are to be entered in patient data collection form.

2.1.7. Methodology

Personal visit made on daily basis to general medicine ward and pediatric

wards to identify the patients who were diagnosed with malaria. Patient demographic

details like name, age, sex, IPD No., weight was noted in specially designed patient

data collection form. Clinical history, diagnosis, laboratory investigations and

treatment regimen of the patients and discharge medications were recorded daily in

patient data collection form. Treatment chart of the patients were reviewed daily to

evaluate type of treatment regimen. Name of drug, dose, frequency, duration and cost

of treatment noted in patient data collection form. Further data were analyzed for the

anti-malarial drugs usage according to guidelines for the diagnosis and treatment of

malaria (2011). Potential drug -drug interactions in the treatment regimen have to be

assessed using Micromedex-2.0. The inpatient data collected and created separately in

computer based format, stored and retrieved when they required in MS office format.


2.2 Results

2.2.1. Demographic detail of patients characteristics

In the present prospective study the number of patient admitted in medicine

and pediatric department during study period at HSK tertiary care hospital total 98

cases, out of all cases 5 patients were of 2 years in that 2 males & 3 female patients

admitted and treated by 6(3.16%) antimalarial drugs , 3 children were of 2-6 years and

treated with 5(2.63%) antimalarial drugs. From 6-12 years age group 7 male children

were treated with 20(10.53%) antimalarial drugs and 8 patients were of 12-18 years

age group in that 4 male & 4 females, males prescribed with 6(3.16%) antimalarial

drugs females were treated 5(2.63%) antimalarial drugs. From age group 18-30 years,

22 patients were admitted out of that 12 were male prescribed with 20(10.53%)

antimalarial drugs and 10 female prescribed with 19(10.00%) antimalarial drugs. 24

patients over 30-45 age group out of that 10 were male treated with 14(7.37%)

antimalarial drugs and 14 were females treated with 27(14.21%) antimalarial drugs.

From age 45-60 years 15 patients were admitted, in that 11 were male treated with

27(14.21%) antimalarial drugs and 4 were female treated with 6(3.16%) antimalarial

drugs and in 60 years above age group 14 patients were admitted out of that 9 were

male treated with 17(8.95%) antimalarial drugs and 5 were female treated with

12(6.30%) antimalarial drugs. Results were summarized in Table no 2.2.1.

2.2.2. Cost of antimalarial drugs used in patients

During the hospital stay of the 98 cases with antimalarial drugs we find out the

cost of antimalarial drugs in each patient and results were summarized in Table 2.2.2a

to 2.2.2h.


2.2.3. Assessment of drug-drug interactions of antimalarial drug with other drugs

During the hospital stay of the 98 cases we found 36 drug-drug interactions in

prescription out of this 16(43.24%) major drug-drug interactions, 12(32.43%) moderate

drug-drug interactions, 6(18.92%) minor drug-drug interactions and 3(5.41%)

contraindicated drug-drug interactions. Results were summarized in Table 2.2.3a to

2.2.3r and figure 1.

2.2.4. Antimalarial drug prescribed for the patients

In present study the antimalarial drugs prescribed at our tertiary care hospital

was summarized in table 2.2.4a and 2.2.4b & figure 2. In briefly, 19(14.40%)

prescription of Artesunate were prescribed for patient admitted in our hospital,

Artesunate+Pyrimethamine+Sulphadoxine were prescribed in 26(19.70%)

prescription, Artemether/Lumefantrine prescribed in 23(17.42%) prescriptions,

chloroquine phosphate prescribed in 16(12.12%) prescriptions, Doxycycline

prescribed in 31(23.49%) prescriptions, Primaquine, Hydroxy chloroquine sulphate

and Quinine were prescribed in 11(8.33%), 3(2.28%) and 3(2.28%) prescriptions

respectively. Out of 98 cases artesunate were prescribed for 25(54.34%) malarial

patients from 46 malarial patients and 17(32.69%) prescriptions were of nonmalarial

patients from total 52 nonmalarial patients.

2.2.5. Pattern of malaria parasite infection in patient visiting tertiary care

hospital.

In present study 46 malarial patients were found & they were infected with

two different malarial parasites out of that Plasmodium falciparum parasite was

identified in 27(58.69%) prescriptions, Plasmodium vivax parasite was identified in

4(8.69%) prescriptions and mixed (Plasmodium falciparum + plasmodium vivex)


parasites were found in 3(6.52%) prescription, clinical malaria were identified in

3(6.52%), complicated malaria were identified in 9(19.58%). Results were

summarized in table 2.2.5.

2.2.6. Class of antimalarial drugs prescribed

During this study different class of antimalarial drugs were prescribed for

patients, in that 4-aminoquinoline were prescribed in 19(19.38%) prescriptions, 8-

aminoquinolines was prescribed in 11(11.22%) prescriptions, Cinchona Alkaloid

were prescribed in 3(3.06%) prescriptions, Sesquiterpine Lactones/sulphonamides

and sulfone/diaminopyrimidine were prescribed in 26(26.53%) prescriptions,

Sesquiterpine Lactones was prescribed in 19(19.38%) prescriptions, Sesquiterpine

Lactones/ amino alcohols were prescribed in 23(23.47%) prescriptions, Tetracycline

were prescribed in 31(31.63%) prescription. Results were summarized in table 2.2.6.

2.2.7. Pattern of drugs regimen prescribed for patients

In our study the 5 drug regimens were prescribed for patients via, 1 drug

therapy, 2 drugs therapy, 3 drugs therapy, 4 drugs therapy and 5 drugs therapy out of

this 1 drug regimen were prescribed in 34(34.69%) prescription, 2 drugs regimen

were prescribed in 24(24.48%) prescription, 30(30.61) prescription were prescribed

with 3 drugs combination, 9(9.18%) were of 4 drugs regimen & finally 1(1.02%)

prescription was found on 5 drugs regimen. Results were summarized in table 2.2.7a

to 2.2.7c.


2.2.8. Number of complicated malaria cases with treatment

In present study the antimalarial drugs prescribed for complicated malaria

cases at tertiary care hospital was summarized in table 2.2.8a and 2.2.8b. In briefly

out of 9 complicated malaria cases, Artesunate given in 2 cases one diagnosed with

ARF with complicated malaria and other Seizure disorder with malaria with LRTI

respectively, Artesunate + sulphadoxine + Pyrimethamine were given in 2 cases one

diagnosed with cirrhosis with malaria with lower limb cellulitis and other with dengue

fever with malaria, doxycycline given in 3 cases diagnosed with dengue fever with

malaria, ALD with malaria with gastritis and ALD with pancytopenia with malaria

with gastritis respectively, chloroquine given in 2 cases diagnosed with essential

hypertension with malaria, artemether & lumefantrine given in 2 cases diagnosed with

essential hypertension with malaria, primaquine given in 2 cases diagnosed with

cirrhosis with malaria with lower limb cellulitis and ARF with complicated malaria.

2.2.9. Uncomplicated malaria cases

In our present study 37 cases were uncomplicated out of that 26(70.27%)

cases were identified with Plasmodium falciparum infection, 3(8.11%) cases of

Plasmodium vivex, 1(2.70%) case of pregnant women with Plasmodium falciparum ,

4(10.81%) cases of mixed infection and 3(8.11%) cases were diagnosed with clinical

malaria. Results were summarized in table 2.2.9 and figure 3.

2.2.10. Assessment of rationality of antimalarial drugs prescription

In present prospective study, totally 46 malarial cases were prescribed with

antimalarial drugs. These patients were accesses for rationality according to

NVBDCP out of these 25 patients were rational and 21 were irrational. Here 3(12%)


were rational prescriptions and 1(4.76%) irrational prescription diagnosed with

Plasmodium vivax malaria, 13(52%) rational and 14(66.67%) irrational diagnosed

with Plasmodium falciparum malaria, 3(12%) rational and no irrational were found in

mixed malaria and 3(12%) rational and 6(28.57%) irrational were found in

complicated malaria. Finally out of 52 nonmalarial patients 9(17.3%) were prescribed

Doxycycline as prophylaxis which was rational and remaining 43(82.69%) patients

were prescribed irrationally. Result were summarized in 2.2.10, 2.2.13a to 2.2.13c and

fig.4

2.2.11. Antimalarial drugs prescribed for infectious diseases other than malaria

cases

In present study the antimalarial drugs prescribed for infectious disease other

than malaria cases at our tertiary care hospital was summarized in table 2.2.11a to

2.2.11c and figure 5. In briefly total 52 patients were found as non malarial patients,

out of this artesunate were prescribed in 13(20%) cases, artemether were prescribed in

11(19.92%) cases, hydroxychloroquine were prescribed in 3(4.62%) cases,

chloroquine were prescribed in 11(19.92%) cases, doxycycline in 19(29.23%) cases

and artesunate+sulphadoxine+pyrimithamine prescribed in 8(12.30%) cases.

2.2.12. Clinical outcome

In this study total 46 malarial patients were found out of them 22(47.83%)

patients were improved, 24(52.17%) patients were cured after treatment & finally

there are no worsened and expired cases. Results were summarized in table 2.2.12.


2.2.13. Drug use evaluation of antimalarial drugs prescribed for patients with

help of prescribing indicator.

In our study average number of drugs prescribed for patients were 1.42 and for

these patients 44.897% I.V injection were prescribed. Results were summarized in

table 2.2.14.

2.2.14. Cost benefit analysis of antimalarial drug prescribed.

In our present study average drug cost prescribed for patients were found 1085.22

rupees and percentage drug cost on injection were found 86.51% which was a core

region for increased cost on patient the data were summarized in table 2.2.15.


Table 2.2.1.Demographic detail of patients characteristics

Age Gender

Number of

cases

Number of antimalarial

drug prescribed

Antimalarial drug prescribed

(%)

0 - 02 years M 02 06 03.16%

F 03 06 03.16%

02 -06 years M 03 05 02.63%

F 00 00 00.00%

06 - 12 years M 07 20 10.53%

F 00 00 00.00%

12 - 18 years M 04 06 03.16%

F 04 05 02.63%

18 - 30 years M 12 20 10.53%

F 10 19 10.00%

30 - 45 years M 10 14 07.37%

F 14 27 14.21%

45 -60 years M 11 27 14.21%

F 04 06 03.16%

60 ≥ above M 09 17 08.95%

F 05 12 06.30%

Total M 58 115 60.52%

F 40 75 39.48%

(F=Female and M=Male)


Table 2.2.2a. Cost of antimalarial drugs used in patients.

I.P No. Gender Name of antimalarial drugs Cost of therapy

(Rs)

32597 F Tab Lariago (chloroquine) 8.40

5468 F Inj Larinate (Artesunate pyrimethamine

sulphadoxine)120 mg

1272.00

14-5694 F Inj Falcigo (Artesunate) 120 mg 2544.00

3261 F Tab lumerex 80 mg (Artesunate/artemethar) &

Tab Lariago (chloroquine)

126.80

2498 F Inj Falcigo (Artesunate) 120 mg

Tab Malirid DS (Primaquine)

Tab lumerex 80 mg (Artesunate/artemethar)

1011.94

9538 F Inj Falcigo (Artesunate) 120 mg 2975.00

3242 F Inj Falcigo (Artesunate)120 mg 5950.00

14-5810 F Cap Doxy (Doxycycline) 100 mg 6.35

6083 F Inj Larinate (Artesunate pyrimethamine sulphadoxine)

60 mg

1392.00

6088 F Inj Larinate (Artesunate pyrimethamine

sulphadoxine)60 mg

2320.00

10470 M Tab Doxy (Doxycycline) 100 mg 5092.00

5139 M Tab hydroxyl chloroquine sulfate 200 mg 212.40


Table 2.2.2b. Cost of antimalarial drugs used in patients.


(Rs)

13-30635 M Inj Larinate (Artesunate pyrimethamine

sulphadoxine)60 mg

1856.00

13-30478 M Inj Larinate (Artesunate pyrimethamine

sulphadoxine)60 mg

Tab Doxy (Doxycycline) 100 mg

3256.88

14-5664 M Tab Doxy (Doxycycline) 100 mg 9.42




9536 M Inj Falcigo (Artesunate) 120 mg 2550.00

29529 M Inj Larinate (Artesunate pyrimethamine

sulphadoxine)120 mg

Tab Larinate (Artesunate pyrimethamine sulphadoxine)

200 mg

1069.32


3240 M Inj Falcigo (Artesunate) 120 mg 5100.00


2812 M Inj Larinate (Artesunate pyrimethamine

sulphadoxine)120 mg

Tab Lariago (chloroquine)500 mg

1706.48


Table 2.2.2c. Cost of antimalarial drugs used in patients.


(Rs)

14-4113 M Tab Lariago (chloroquine) 11.20

31305 M Tab Malirid DS (Primaquine) 15 mg

Inj Larinate (Artesunate pyrimethamine

sulphadoxine)120 mg

3395.88

27408 M Tab Doxy (Doxycycline) 100 mg

Inj Falcigo (Artesunate) 120 mg

5111.68

32609 M Tab Doxy (Doxycycline) 100 mg

Inj Falcigo (Artesunate) 120 mg

Tab lumerex (Artesunate/artemethar) 80 mg

1731.00

2533 M Tab Malirid DS (Primaquine) 15 mg

Inj Larinate (Artesunate pyrimethamine sulphadoxine)

120 mg

1885.16

29908 M Inj Larinate (Artesunate pyrimethamine sulphadoxine)

60 mg

1856.00

5689 M T.Lariago (chloroquine)

16.80

5259 M T. Larinate (Artesunate pyrimethamine sulphadoxine)

kit

1272.00

3268 F T.lumerax (artemether/lumefantrine)80mg 242.40

29238 M I. Larinate (Artesunate pyrimethamine sulphadoxine)

60mg

I. Quinine

3327.60

576 M I.falcigo (Artesunate) 120mg

T.doxy 100mg

1710.80


Table 2.2.2d. Cost of antimalarial drugs used in patients.


(Rs)

2372/14 M T.lumerax (artemether/lumefantrine) 80mg 170.48

T.doxy (doxycycline)100mg

28670 F T.lumerax (artemether/lumefantrine) 80mg 176.40

T.doxy (doxycycline) 100mg

13-32510 M T.Lariago (chloroquine) 13.76

29700 F I.falcigo(Artesunate)120mg 1696.00

29321 M I.falcigo (Artesunate) 120mg 1705.72

T.malirid (Primaquine) 15mg

598 M I.falcigo (Artesunate) 120mg 3469.76

T.malirid (Primaquine) 15mg


T.Lariago (chloroquine)

3132 M T.falcigo (Artesunate) 50mg 194.84


329 M T.lumerax (artemether/lumefantrine) 80mg 202.00


740 M I.rezQ (quinine sulfate) 400mg 159.20


Table 2.2.2e. Cost of antimalarial drugs used in patients.


(Rs)

5156 F T.zyQ (hydroxychloroquine sulphate) 200mg 138.55



9536/14 M I.falcigo (Artesunate) 120mg 4240.00

9121 M T.doxy (doxycycline) 100mg 23.68


8856 F I.falcigo (Artesunate) 120mg 4240.00

9031 M T.doxy (doxycycline) 100mg 14.80

14/9643 F I.falcigo (Artesunate) 120mg 4240.00



4144 M T.zyQ (hydroxychloroquine sulphate) 200mg 73.35

8727 F Inj.larinate (Artesunate pyrimethamine sulphadoxine)

120mg

1856.00

29905 F Inj.Larinate (Artesunate pyrimethamine sulphadoxine)

15mg

Tab primaquine 2.5mg

581.00

31087 M Inj larinate (Artesunate pyrimethamine sulphadoxine)

20mg

232.00


Table 2.2.2f. Cost of antimalarial drugs used in patients.


(Rs)

594 F Syp lumerax (artemether/lumefantrine) 74.52

2905 M Inj.Larinate (Artesunate pyrimethamine sulphadoxine)

30mg

348.00


40mg

77.00


40mg


1087.45

30635 M Inj Larinate (Artesunate pyrimethamine sulphadoxine)

55mg

Tab Larinate kit (Artesunate pyrimethamine

sulphadoxine)

444.00

8428 F I.falcigo (Artesunate) 120mg

T lumerax (artemether/lumefantrine) 80mg

1056.00

31470 F T lumerax (artemether/lumefantrine) 80mg 226.00

11355 M T lumerax (artemether/lumefantrine) 40mg

T Lariago (chloroquine)

152.20

4859 M T.doxy (doxycycline) 100 mg 6.30

3973 M T.lumerax (artemether/lumefantrine) 80mg

T.malirid DS (Primaquine)

171.45

11032 F Inj.Larinate (Artesunate pyrimethamine sulphadoxine)

120mg

2320.00

5542 M Tab.lariago DS (chloroquine) 4.20


Table 2.2.2g. Cost of antimalarial drugs used in patients.


(Rs)

29067 F T.malarid DS (Primaquine)


Tab.rez Q (quinine) 300mg

1561.50

9170 F T.falcigo (Artesunate) 120mg


1830.00

10317 F Tab.Larinate kit(Artesunate pyrimethamine

sulphadoxine)

212.00

4880 M T.falcigo (Artesunate) 120mg

T.lumerax (artemether/lumefantrine) 80mg

2412.00


120mg

T.Lariago (chloroquine) 600mg

854.26

11681 F T.doxy (doxycycline) 100mg 6.30

2788 M T.lumerax (artemether/lumefantrine) 80mg


186.00

4113 M T.Lariago (chloroquine) 3.40


29760 F T.lumerax (artemether/lumefantrine) 80mg


T.malarid DS (Primaquine) 15mg

232.00

7018 F T.Lariago DS (chloroquine) 500mg 7.00

11499 M T.Lariago (chloroquine) 250mg 7.00


Table 2.2.2h. Cost of antimalarial drugs used in patients.


(Rs)


120mg

1856.00


120mg

1160.00

8974 F T.doxy (doxycycline) 100mg

T.Lariago DS (chloroquine)

30.00

7170 F I.falcigo (Artesunate) 120mg


3593.40

31751 M Inj.larinate (Artesunate pyrimethamine sulphadoxine)

120mg

1856.00

6247 F T.doxy (doxycycline) 100mg


31.00


5691 M T.doxy (doxycycline) 100mg


31.00

32606 M Inj.falcigo (Artesunate) 120mg

Tab.malarid DS (primaquine) 15mg

4989.00

5143 M Inj.larinate (Artesunate pyrimethamine sulphadoxine)

80mg

Tab.malarid DS (primaquine)

323.00


3152 F T.lumerax (artemether/lumefantrine) 80mg

Tab.malarid DS (primaquine)

288.00

11390 M T.doxy 100mg (doxycycline) 15.75

( F=Female and M=Male)


Table 2.2.3a. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE

&

SEX

DIAGNOSIS ANTIMALARIAL

DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

2812

3/2/14

37

Y/M

Fever /

meningitis

Artesunate and

chloroquine phosphate

Sesquiterpine lactones

&

4-aminoquinolines

2 drugs

therapy

Chloroquine

phosphate

with

Ondansetron

Concurrent use of

chloroquine and

Ondansetron may result in

an increased risk of QT

interval

prolongation

2498

31/1/14

40

Y/F

Complicated

malaria

Artesunate and

Artemethar/lumefantrine

& primaquine


& 8-aminoquinolines &

4 drugs

therapy

Artemethar/

lumefantrine

with

Ondansetron

Concurrent use of

artemether/lumefantrine

and Ondansetron may

result in an increased risk

of QT

Interval prolongation.

27408

14/11/13

55

Y/M

Meningo

encephalitis

Doxycycline and

Artesunate

Tetracycline &


2 drugs

therapy

1)Midazolam

HCl-

Thiophylline

Concurrent use of both

may result in decrease the

benzodiazepine

effectiveness

2)amikacine

sulphate-

pipracillin

sodium


may result in amino

glycoside efficacy


Table 2.2.3b. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE

&

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

5664

3/3/14

12

Y/M

Fever /

Hodgkin’s

lymphoma

Doxycycline Tetracycline 1 drug

therapy

Doxycycline-

rifampin


may result in an reduced

doxycycline serum

concentration and potential

loss of doxycycline

efficacy

3261

7/2/14

38

Y/F

Essential HTN

with malaria


and chloroquine

phosphate


&

4-aminoquinolines

3 drugs

therapy

−

30635

12/12/13

9 Y/M Malaria /

dengue fever

Artesunate

Pyrimithamine

sulphadoxine

Sesquiterpine lactones 3 drugs

therapy

_

30478

12/12/13

8 Y/M Malaria /

dengue fever

Artesunate and

Doxycycline


& tetracycline

2 drugs

therapy

_

32597

4/1/13

25

Y/F

UTI chloroquine phosphate 4-aminoquinolines 1 drug

therapy

_

4113

19/2/14

32

Y/M

Cervical

lymphatic

disorder

chloroquine phosphate 4-aminoquinolines 1 drug

therapy

_

32609

4/1/14

50

Y/M

Malaria chloroquine phosphate

and Doxycycline and


4-aminoquinolines &

tetracycline&


4 drugs

therapy

_


Table 2.2.3c. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE

&

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

5810

4/3/14

70

Y/F

Fever ↓

evaluation /

LRTI


therapy

_

31305

31/12/13

46

Y/M

Complicated

malaria

Artesunate

Pyrimithamine

sulphadoxine and

primaquine


&

8-aminoquinolines

4 drugs

therapy

_

2533

31/1/14

60

Y/M

Complicated

malaria

Artesunate

Pyrimithamine

sulphadoxine and

primaquine


&

8-aminoquinolines

4 drugs

therapy

_

5468

27/2/14

40

Y/F

Pyogenic

meningitis

Artesunate Sesquiterpine lactones 1 drug

therapy

_

29908

1/1/14

62

Y/M

Malaria Artesunate

Pyrimithamine

sulphadoxine


therapy

_

5694

3/2/14

32

Y/F

Anemia with

liver disease

Chloroquine 4-aminoquinolines 1 drug

therapy

_

29529

30/11/13

21

Y/M

Malaria Artesunate

Pyrimithamine

sulphadoxine


therapy

_

10470

17/4/14

2 Y/M Ricketsial

fever


therapy

_


Table 2.2.3d. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE

&

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

5139

10/3/14

6 Y/M SLE

& gangrenous

4th

toe

Hydroxyl chloroquine

sulphate

Aminoquinoline 1 drug

therapy

_

28160

17/12/13

28

Y/M

ALD with

malaria with

gastritis


therapy

Ciprofloxacin&

ondensetron

Concurrent use of

ciprofloxacin and

Ondansetron may result in

an increased risk of QT

interval

Prolongation.

Aluminium

hydroxide/magn

esium hydroxide

& ciprofloxacin

Concurrent use of

ciprofloxacin and antacids

may result in decreased

ciprofloxacin

effectiveness.

Aluminium

hydroxide/magn

esium hydroxide

& doxycycline

concurrent use of

aluminum, calcium or

magnesium containing

products and tetracycline

May result in decreased

effectiveness of

tetracycline.


Table 2.2.3e. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE

&

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

10218

17/4/14

29

Y/M

Malaria Doxycycline Tetracycline 1 drug

therapy

_

28617

16/11/13

24

Y/M

ALD with

pancytopenia

with gastritis


therapy

_

9536

10/4/14

30

Y/M

Viral fever Artesunate Sesquiterpine lactones 1 drug

therapy

_

11718

30/4/14

45

Y/M

Retroviral

disease with

AGE


therapy

_

3240

11/3/14

35

Y/M

Malaria Artesunate Sesquiterpine lactones 1 drug

therapy

_

12315

27/3/14

35

Y/M

Malaria Doxycycline Tetracycline 1 drugs

therapy

_

6083

3/3/14

70

Y/F

Clinical

malaria

Artesunate

Pyrimithamine

sulphadoxine


therapy

_

9538

7/4/14

32

Y/F

Malaria Artesunate Sesquiterpine lactones 1 drugs

therapy

_

3242

11/2/14

35

Y/F

Malaria Artesunate Sesquiterpine lactones 1 drug

therapy

_


Table 2.2.3f. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

6088

5/2/14

68 Y/F Clinical

malaria

Artesunate

Pyrimithamine

sulphadoxine


therapy

_

2788

5/2/14

28 Y/M Viral fever Lumefantrine

Artemether

Doxycycline

Amino alcohols


tetracycline’s

3 drugs

therapy

Artemether

+azithromycin


may result in increase the

risk of QT interval

prolongatation

32606

8/1/13

56 Y/M ARF with

complicated

malaria

Artesunate

Primaquine


8-aminoquinolines

2 drugs

therapy

_ _

3152

7/2/14

70 Y/F Malaria with

bronchitis

Primaquine

Lumefantrine

Artemether

8-aminoquinolines

Amino alcohols


3 drugs

therapy

_

_

29067

25/11/13

19 Y/F Malaria Doxycycline

Quinine

Primaquine

Tetracycline

Cinchona alkaloids

8-aminoquinolines

3 drugs

therapy

_

_

5542

26/2/14

19 Y/M Viral fever Chloroquine 4-aminoquinolines

1 drug

therapy

_ _

3972

12/2/14

18 Y/M Uncomplicat

ed malaria

Lumefantrine

Artemether

Primaquine

Amino alcohols


8-aminoquinolines

3 drugs

therapy

_

_


Table 2.2.3g. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

30478

17/12/13

8 Y/M Dengue fever Doxycycline

Artesunate

Sulphadoxine

pyrimethamine

Tetracycline


4 drugs

therapy

Ceftriaxone+

lactated ringer

solution

Ofloxacin+zinc

gluconate

Chloramphenicol

+ acetaminophen


may result in formation

of Ceftriaxone calcium

precipitate


may result in decrease in

efficacy of ofloxacine


may result in

chloramphenicol toxicity

29905

19/12/13

8M/F Malaria Artesunate

Sulphadoxine

pyrimethamine

Primaquine


8-aminoquinolines

4 drugs

therapy

Ceftriaxone+

lactated ringer

solution/


may result in formation

of Ceftriaxone calcium

precipitate

31470

22/12/13

15Y/F Severe

anemia

Lumefantrine

Artemether

Amino alcohols


2 drugs

therapy

_

_


Table 2.2.3h. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

2905

6/2/14

5Y/M Iron def.

nutritional

anemia

Artesunate

Sulphadoxine

pyrimethamine


3 drugs

therapy

_

_

30635

13/12/13

9Y/M Dengue fever Artesunate

Sulphadoxine

pyrimethamine


3 drugs

therapy

_

_

4709

21/2/14

27Y/F Malaria Artesunate

Sulphadoxine

pyrimethamine

Chloroquine


4-aminoquinolines

4 drugs

therapy

Ceftriaxone+

lactated ringer

solution

Chloroquine

+Ondansetron


may result in formation of

ceftriaxone calcium

precipitate

Concurrent use of

CHLOROQUINE and

ONDANSETRON may


of QT interval

prolongation

31087

20/12/13

10M/M Seizure with

LRTI

Artesunate

Sulphadoxine

pyrimethamine


3 drugs

therapy

Lorazepam+

phenobarbiton


may result in additive

respiratory depression

594

9/1/14

2Y/F Malaria Lumefantrine

Artemether

Amino alcohols


2 drugs

therapy

_ _

29760

3/12/13

35Y/F Malaria Lumefantrine

Artemether

Primaquine

Doxycycline

Amino alcohols


8-aminoquinolines

Tetracycline

4 drugs

therapy

Doxycycline+

iron


may result in decrease

tetracycline and iron

effectiveness


Table 2.2.3i. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

31751

31/12/13

55Y/M Tuberculosis Artesunate

Sulphadoxine

pyrimethamine


3 drugs

therapy

Levofloxacin+

Moxifloxacin

Moxifloxacin+

Rifampin

Amino

glycosides+

Penicillin


may result in increase the

risk of QT interval

Prolongation


may result in decrease

moxifloxacin exposure and

plasma concentration


may result in loss of amino

glycoside efficacy

8974

7/3/14

45 Y/f malaria Chloroquine

doxycycline

4-aminoquinolines

tetracycline’s

2 drugs

therapy

Budesonide+

dihydroergotami

ne

budesonide will decrease

the level or effect of

dihydroergotamine by

affecting hepatic/intestinal

enzyme CYP3A4

metabolism. Monitor

closely.


Table 2.2.3j. Patient demographic details with drug interaction and its details.

IP.NO

& DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

8727

7/4/14

6 M/F malaria Artesunate

Sulphadoxine

pyrimethamine


3 drugs

therapy

Mefenamic acid

+furosemide

Mefenamic acid increases

and furosemide decreases

serum potassium. Effect of

interaction is not clear,

use caution. Potential for

interaction, monitor.

7170

29/3/14

50 Y/F Acute GE Artesunate

Doxycycline


Tetracycline

2 drugs

therapy

Artemether+

Ondansetron

Artemether/lumefantrine

and Ondansetron both

increase QTc interval.

6247

10/3/14

55 Y/F Dengue fever Chloroquine

doxycycline

4-aminoquinolines

tetracycline

2 drugs

therapy

Doxycycline+

Ceftriaxone

Doxycycline decreases

effects of Ceftriaxone by

pharmacodynamic

antagonism. Significant

interaction

Possible, monitor closely.

bacteriostatic agents may

inhibit the effects of

bactericidal agents


Table 2.2.3k. Patient demographic details with drug interaction and its details.

IP.NO

& DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

7018

14/3/14

36 Y/F Viral fever Chloroquine 4-aminoquinolines

1 drug

therapy

Chloroquine

+tramadol

Chloroquine will increase

the level or effect of

tramadol by affecting

hepatic enzyme CYP2D6

metabolism.

Minor or non-significant

interaction.

10743

22/4/14

55 Y/F Brucellosis Doxycycline Tetracycline 1 drug

therapy

Doxycycline

+Ceftriaxone

Doxycycline decreases

effects of Ceftriaxone by

pharmacodynamic

antagonism. Significant

interaction

Possible, monitor closely.

Bacteriostatic agents may

inhibit the effects of

bactericidal agents.

10774

24/4/14

35 Y/F Viral fever Artesunate


1 drug

therapy

Azithromycin+

Lumefantrine

Artemether

Azithromycin and


both increase QT interval.


Table 2.2.3l. Patient demographic details with drug interaction and its details.

IP.NO

& DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

4880

29/4/14

22 Y/M Pancytopenia Artesunate

Artemether

lumefantrine


Amino alcohols

2 drugs

therapy

Levofloxacin

+Lumefantrine

Artemether

Levofloxacin and


both increase QT interval

4113

32 Y/M Cervical

lymph nodes

Chloroquine 4-aminoquinoline 1 drug

therapy

Furosemide

+Torsemide

Furosemide and

Torsemide both decrease

serum potassium.

8428

8/4/14

15 Y/F Massive

Splenomegaly

with

thalasemia

Artesunate

Artemether

lumefantrine


Amino alcohols

3 drugs

therapy

Artemether

+Ondansetron



increase QT interval.

5143

3/3/14

65 Y/M Cirrhosis of

liver+malaria+

cellulitis

Artesunate

Sulphadoxine

pyrimethamine

Primaquine


8-aminoquinolines

4 drugs

therapy

Metronidazole+

artemether



increase QT interval.

6527

10/3/14

38 Y/F Enteric fever Artesunate

Sulphadoxine

pyrimethamine


3 drugs

therapy

10317

15/4/14

20 Y/F Viral fever Artesunate

Sulphadoxine

pyrimethamine


3 drugs

therapy


Table 2.2.3m. Patient demographic details with drug interaction and its details.

IP.NO

& DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

9410

10/4/14

6 Y/F Viral

hemorrhagic

fever

Artesunate

Sulphadoxine

pyrimethamine


3 drugs

therapy

11390

8/4/14

52 Y/M Viral fever Doxycycline Tetracycline 1 drug

therapy

576

11/1/14

50 Y/M Acute febrile

Illness &

viral fever

Artesunate &

doxycycline

Sesquiterpine lactones &

tetracycline

2 drugs

therapy

Aluminium

hydroxide &

Doxycycline

Concurrent use of

Aluminum, Calcium or

Magnesium containing

products and Tetracycline

may result in decreased

effectiveness of

Tetracycline

2372

31/1/14

20 Y/M Fever of

unknown

origin &dog

bite

Artemether/

Lumefantrine &

doxycycline


Tetracycline

3 drugs

therapy

Artemether/

Lumefantrine &

Azithromycin

Concurrent use of

Artemether/ lumefantrine

and Azithromycin may


of QT interval

prolongation.

3268

20/2/14

70 Y/F Malaria Artemether/

Lumefantrine


therapy

Iron &

pantoprazole

Concurrent use of Iron and

Pantoprazole may result in

reduced iron

bioavailability.


Table 2.2.3n. Patient demographic details with drug interaction and its details.

IP.NO

& DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

11032

23/4/14

17 Y/M Viral fever Artesunate

Sulphadoxine

Pyrimethamine


3 drugs

therapy

10967

24/4/14

40 Y/F Splenomegaly Artesunate

Sulphadoxine

Pyrimethamine


3 drugs

therapy

11355

26/4/14

17 Y/M Malaria Chloroquine

Artemether

lumefantrine

4 Aminoquinoline


Amino alcohols

3 drugs

therapy

5691

30/2/14

55 Y/F Viral fever Chloroquine

Doxycycline

4-aminoquinolines

Tetracycline

2 drugs

therapy

11681

28/4/14

28 Y/F Appendicitis Doxycycline Tetracycline 1 drug

therapy

11280

22/4/14

70 Y/F Viral fever Doxycycline Tetracycline 1 drug

therapy

11032

23/4/14

17 Y/M Viral fever Artesunate Sesquiterpine lactones

1 drug

therapy

9170

28/4/14

20 Y/F Septicemia Artesunate

Doxycycline


Tetracycline

2 drugs

therapy

11499

28/4/14

23 Y/M Amoebic liver

abscess

Artesunate


1 drug

therapy


Table 2.2.3o. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

28670

23/11/13

20 Y/F Dengue fever Artemether/

Lumefantrine &

Doxycycline


Tetracycline

3 drugs

therapy

Artemether/

Lumefantrine &

Levofloxacin

Concurrent use of

Artemether/ Lumefantrine

and Levofloxacin may


of QT interval

prolongation.

29238

30/11/13

11 Y/M PF malaria Quinine &

Primaquine

Artesunate

Sulphadoxine

pyrimethamine


cinchona

Alkaloid & 8-

aminoquinoline

5 drugs

therapy

Quinine &

Ondansetron

Concurrent use of

Ondansetron and Quinine

may result in an increased

risk of QT interval

prolongation.

29700

1/12/13

24 Y/F PF malaria &

Enteric fever


therapy

_ _

740

22/1/14

7 Y/F Malaria fever Quinine sulfate Cinchona alkaloid 1 drug

therapy

_ _

329

13/1/14

32 Y/M Malaria Artemether/

Lumefantrine


therapy

_ _

598

14/1/14

40 Y/M PF malaria Artesunate &

Primaquine


8-aminoglycoside

2 drugs

therapy

_

_


Table 2.2.3p. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

13-

32510

2/12/14

16 Y/M Acute febrile

illness with

LRTI

Chloroquine 4-aminoglycosides 1 drug

therapy

_ _

29321

29/11/13

25 Y/M Jaundice↓

evaluation

with

malaria

Doxycycline &

Artesunate &

Primaquine


Tetracycline &8-

aminoglycosides

3 drugs

therapy

_ _

3132

6/2/14

50 Y/M Malaria Doxycycline &

Artesunate


Tetracycline

2 drugs

therapy

_ _

5259

3/3/14

55 Y/M Anemia with

Thrombocyto

penia

Artesunate

Sulphadoxine

pyrimethamine


therapy

_ _

31470

20/12/13

15 Y/F Severe

anemia

Artemether/

Lumefantrine


therapy

_ _

3261

10/2/14

38 Y/F HTN &

malaria

Artemether/

Lumefantrine &

Chloroquine


4-aminoquinolones

3 drugs

therapy

_ _

5689

3/3/14

35 Y/M Pain abd.↓

Evaluation


therapy

_ _

5156

7/3/14

20 Y/F Rheumatoid

arthritis

Hydroxychloroquine

sulphate

1 drug

therapy

Methotrexate-

Rabeprazole

Concurrent use of

Methotrexate and

Rabeprazole may result in

increased risk of

Methotrexate toxicity.


Table 2.2.3q. Patient demographic details with drug interaction and its details.

IP.NO &

DOD

AGE &

SEX


DRUG

CLASS OF

ANTIMALARIAL

THERAPY DRUG

INTERACTION

DRUG INTERACTION

DETAIL

10557

17/4/14

70 Y/M ARF with

LRTI

Artemether/

Lumefantrine

Sesquiterpine lactones 1 drug

therapy

_ _

9121

8/4/14

68 Y/M AGE with

dehydration


therapy

_ _

20658

22/4/14

66 Y/M LRTI Artemether/

Lumefantrine


therapy

_ _

9386

7/4/14

60 Y/M Viral fever Artemether/

Lumefantrine


therapy

_ _

9031

11/3/14

60 Y/M AGE Doxycycline Tetracycline 1 drug

therapy

_ _

10554

12/4/14

64 Y/M Malaria fever Artemether/

Lumefantrine


therapy

_ _

8856

14/3/14

32 Y/F Malaria Artesunate Sesquiterpine lactones 1 drug

therapy

_ _

8486

8/4/14

43 Y/F Malaria Artemether/

Lumefantrine


therapy

_ _

9536/14

9/4/14

30 Y/M Malaria Artesunate Sesquiterpine lactones 1 drug

therapy

_ _

14/9643

28/3/14

15 Y/F Viral fever Artesunate Sesquiterpine lactones 1 drug

therapy

_ _

4144

27/2/14

22 Y/M Arthritis Hydroxychloroquine

sulphate

1 drug

therapy

_ _

(M=male , F=female , Y=years)


Table 2.2.3r. Patient demographic details with drug interaction and its details.

Drug interaction Number of drug interaction Percentage

Major 16 43.24%

Moderate 12 32.43%

Minor 6 18.92%

Contraindication 3 05.41%

Total 37 100%

Major: - The interaction may be life threatening and/or require medical intervention to minimize or prevent sever adverse effect

Moderate: - The interaction may result in exacerbation of the patient condition and/or require an alteration in therapy

Minor: - The interaction would have limited clinical event. Manifestation may include an increase in the frequency or severity of

the side effect but generally would not require a major alteration in therapy

Contraindicated: - The drugs are contraindicated for concurrent use


Table 2.2.3s. Drug-drug interaction of artemisinin derivatives with other drugs in malaria and nonmalarial cases.

Infection Drug-drug interactions Percentage

Malarial cases(n=46) 1 2.17%

Nonmalarial cases(n=52) 7 13.46%

Figure 1. Table of drug interactions

43%

33%

19%

5%

Percantage

Major

Moderate

Minor

Contraindicated


Table 2.2.4a. Antimalarial drugs prescribed for patient visiting tertiary care hospital

Name of drugs

Numbers of prescription

percentage of prescription

Artesunate

19

14.40%

Aretsunate+Pyrimethamine+Sulphadoxine

26

19.70%

Artemether/Lumefantrine

23

17.42%

Chloroquine phosphate

16

12.12%

Doxycycline

31

23.49%

Primaquine

11

8.33%

Hydroxy chloroquine sulphate

03

2.28%

Quinine

03

2.28%


Figure 2. Percentage of prescription of antimalarial drugs

14%

20%

18% 12%

24%

8% 2% 2%

Percentage of prescription of antimalarial drugs

Artesunate

Aretsunate+Pyrimethamine+Sulphadoxine

Artemether/Lumefantrine

Chloroquine phosphate

Doxycycline

Primaquine

Hydroxy chloroquine sulfate

Quinine


Table 2.2.4b. Artesunate prescribed for patient visiting tertiary care hospital

Antimalarial

drug

Malaria cases(n=46) Non malarial cases(n=52)

Number of

prescription

Percentage

(%)

Number of

prescription

Percentage

(%)

Artesunate 25 54.34 17 32.69

Table 2.2.5. Pattern of malaria parasite infection in patient visiting tertiary care hospital.

Malaria parasite Number of prescription Percentage of prescription

Plasmodium falciparum 27 58.69%

Plasmodium vivax 4 08.69%

Mixed 3 6.52%

Clinical malaria 3 6.52%

Complicated malaria 9 19.5%

Total(n) 46 100%


Table 2.2.6. Class of antimalarial drugs used in treatment of patients.

Serial

number

Class Total no of prescriptions

(n= 132)

Percentage

1 4 Aminoquinoline 19 19.38%

2 8 Aminoquinoline 11 11.22%

3 Cinchona alkaloid 03 03.06%

5 Sesquiterpine lactones 19 19.38%

6 Sesquiterpine lactones/sulphonamides and

sulfone/diaminopyrimidine

26 26.53%

7 Sesquiterpine lactones/amino alcohols 23 23.47%

8 Tetracycline 31 31.63%


Table 2.2.7a. Pattern of drugs regimen prescribed for patients.

Drug regimen Name of drugs Number of prescriptions Percentage

1 drug therapy Artesunate 08 8.17%

Chloroquine 08 8.17%

Doxycycline 14 14.29%

Hydroxychloroquine sulphate 03 3.06%

Quinine sulfate 01 1.02%

Total 34 34.69%

2 drugs therapy Artesunate+doxycycline 06 6.12%

Artesunate+primaquine 03 3.06%

Artemether+lumefentine 11 11.22%

Artesunate+quinine 01 1.02%

Doxycycline+chloroquine 03 3.06%

Total 24 24.48%


Table 2.2.7b. Pattern of drugs regimen prescribed for patients.


3 drugs therapy Artesunate + Artemether + Chloroquine 01 1.02%

Artesunate + Pyrimethamine + Sulphadoxine 17 17.35%

Artesunate + Artemether + primaquine 01 1.02%

Artesunate + Artemether + doxycycline 01 1.02%

Artemether + lumefantrine + Chloroquine 02 2.04%

Artesunate + Artemether + lumefantrine 02 2.04%

Primaquine + Doxycycline + quinine 01 1.02%

Artemether + lumefantrine + Doxycycline 03 3.06%

Artemether + lumefantrine + primaquine 02 2.04%

Total 30 30.61%

4 drugs therapy Artemether + lumefantrine + Doxycycline + primaquine 01 1.02%

Artesunate + pyrimithamine + sulphadoxine + Chloroquine 02 2.04%


Table 2.2.7c. Pattern of drugs prescribed for malaria in combination


4 drugs therapy Artesunate + pyrimithamine + sulphadoxine + Doxycycline 02 2.04%

Artesunate + pyrimithamine + sulphadoxine + Primaquine 04 4.08%

Total 09 9.18%

5 drugs therapy Artesunate + Pyrimethamine + Sulphadoxine + Primaquine +

quinine

01 1.02%


Table 2.2.8a. Number of complicated malaria cases with treatment

Clinical

features

No.

of

cases

Antimalarial treatment

Artesunate Artesunate+sulphadoxine+

Pyrimithamine

Doxycycline Chloroquine Artemether & lumefantrine Primaquine

Essential

hypertension

with malaria

2 2 2

dengue fever

with malaria

1 1 1

ALD with

malaria with

gastritis

1 1

ALD with

pancytopenia

with malaria

with gastritis

1 1

ARF with

complicated

malaria

1 1 1

Acute

bronchitis

with malaria

1 1


Table 2.2.8b. Number of complicated malaria cases with treatment

Clinical

features

No.

of

cases

Antimalarial treatment


Pyrimithamine

Doxycycline Chloroquine Artemether & lumefantrine Primaquine

Cirrhosis

with malaria

with lower

limb

cellulitis

1 1 1

Seizure

disorder with

malaria with

LRTI

1 1

Total 9 2 2 3 2 3 2


Table 2.2.9. Number of uncomplicated malaria cases

Condition Numbers of cases Percentage

Plasmodium vivax 3 8.11 %

Plasmodium falciparum 26 70.27%

Pregnant women with plasmodium

falciparum

1 2.70%

Mixed 4 10.81%

Clinical malaria 3 8.11%

Total 37 100%


Figure 3. Number of uncomplicated malaria cases

8%

70%

3%

11%

8%

Plasmodium vivax

Plasmodium falciperum

Pregnant women withplasmodium falciperum

Mixed

clinical malaria


Table 2.2.10. Assessment of rationality of antimalarial drugs prescribed for patient according to guidelines.

Condition Treatment

Rational Irrational

Total Percentage Total Percentage

Plasmodium vivax 03 12% 01 04.76%

Plasmodium falciparum 13 52% 14 66.67%

Mixed 03 12% 00 00.00%

Clinical malaria 03 12% 00 00.00%

Complicated malaria 03 12% 06 28.57%

Total 25 100% 21 100%


Figure 4. Assessment of rationality of antimalarial drugs prescribed for patient according to guidelines.

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00%

plasmodium vivax

plasmodium falciperum

mixed

clinical malaria

complicated malaria

Percentage

Con

dit

ion

of

dis

ease

irrational

rational


Table 2.2.11a. Antimalarial drugs prescribed for infectious diseases other than malaria cases.

Condition number

of

patient

Antimalarial drug prescribed (n=65)


pyrimithamine

Doxycycline Chloroquine Hydroxy

chloroquine

Artemether

lumefantrine

Acute gastroenteritis with

Retroviral disease

1 1

Acute gastroenteritis with

dehydration

2 1 2

Acute gastroenteritis 1 1

Alcoholic liver disease 1 1

Anemia with liver disease 1 1

Acute renal failure with

LRTI

1 1

Amoebic liver abscess 1 1

Appendicitis 1 1

Anemia 2 2 1

Brucellocesis 1 1

Cervical lymphatic disease 2 2

Dengue fever 1 1 1

Enteric fever 1 1

Fever with chills 2 2


Table 2.2.11b. Antimalarial drugs prescribed for infectious diseases other than malaria cases.

Condition Number

of

patient



pyrimithamine


chloroquine

Artemether

lumefantrine

Fever ↓ evaluation 3 2 1 1

GERD 1 1

Hodgkin’s lymphoma 1 1

LRTI 4 2 1 1

Meningo encephalitis 1 1 1

Pyogenic meningitis 1 1

Pain abdomen ↓evaluation 1 1

Pancytopenia 1 1 1

PTB 1 1


Table 2.2.11c. Antimalarial drugs prescribed for infectious diseases other than malaria cases.

Condition Number

of

patient



pyrimithamine


chloroquine

Artemether

lumefantrine

Rheumatoid arthritis 2 2

Ricketsial fever 1 1

SLE 1 1

Splenomegaly with

thalasemia

1 1 1

Splenomegaly 1 1

Septicemia 1 1 1

Severe anemia 1 1 1

Viral fever 12 5 3 3 3 1

UTI 1 1

Total 52 13(20%) 8(12.30%) 19(29.23%) 11(19.92%) 3(4.62%) 11(19.92%)


Figure 5. Antimalarial drugs prescribed in infectious diseases other than malaria cases

13

8

19

11

3

11

0 2 4 6 8 10 12 14 16 18 20

Artesunate

Artesunate+Sulphadoxine+Pyrimithamine

Doxycycline

Chloroquine

Hydroxy chloroquine

Artemether/lumefentrine

Number of patients

An

tim

ala

rial

dru

gs

Numbers of patients


Table 2.2.12. Clinical outcome

Outcome Number of patients Percentage

Improved 22 47.83%

Cured 24 52.17%

Worsened 00 00.00%

Expired 00 00.00%

Total 46 100%


Table 2.2.13a. Assessment of rationality of antimalarial drugs for uncomplicated malaria as per national vector borne disease control

programme.

I.p. no. Disease Treatment given Comments

11355 Malaria(PF) Chloroquine


According to guidelines primaquine is recommended on day 2.

594 Malaria(PF) artemether/lumefantrine According to guidelines primaquine is recommended on day 2.

8727 Malaria(PF) Artesunate

Pyrimethamine

Sulphadoxine



Pyrimethamine

Sulphadoxine


329 Malaria(PF) Artemether/lumefantrine According to guidelines primaquine is recommended on day 2.


According to guidelines ACT-AL or ACT-SP is recommended and primaquine is recommended on

day 2.



day 2.


Table 2.2.13b. Assessment of rationality of antimalarial drugs for uncomplicated malaria as per national vector borne disease control

programme.



Pyrimethamine

Sulphadoxine




day 2.


Pyrimethamine

Sulphadoxine





day 2.




day 2.



day 2.


Table 2.2.13c. Assessment of rationality of antimalarial drugs for complicated malaria as per national vector borne disease control programme.


5259 Anemia with

thrombocytopenia

with malaria(PV)

Artesunate

Pyrimethamine

Sulphadoxine

According to guidelines primaquine is given for 14 days.

29700 Malaria(PF) with

enteric fever

Artesunate


day 2.

30478 Dengue with

malaria

Artesunate

Pyrimethamine

Sulphadoxine

Doxycycline

According to guidelines primaquine is recommended on 2nd day.

28160 ALD with malaria

with gastritis

Doxycycline According to guideline quinine is recommended for 3 days.

28617 ALD with

pancytopenia

with malaria with

gastritis

Artesunate


day 2.

32606 ARF with malaria Artesunate


day 2.


Table 2.2.14. Drug use evaluation of antimalarial drugs prescribed for patients

with help of prescribing indicator.

Indicator Data

Average no of drug 1.42

I.V. injection(percentage) 44.897%

Formula 1 (n=98)

Average number of drugs =

=

= 1.42

Formula 2 (n=43)

I.V. injection (percentage) =

=

= 44.897 %


Table 2.2.15. Cost of antimalarial drug prescribed for patient visiting tertiary

care hospital.

Indicator Data

Average drug cost 1085.22 Rs

Percentage drug cost on injection 86.51 %

Formula 3 (n=98)

Average drug cost/ prescription =

=

= 1085.22 Rs.

Formula 4

Percentage of drug cost spent on injection =

=

= 86.51 %


2.3 Discussion and conclusion

Drug use indicator as defined by WHO has provided easy & convenient

measures to assess optimal drug used in health facilities. Malaria is one of the major

public health problems of the country. Prompt & effective treatment is important for

preventing the transmission of malaria. In view of this we studied drug use of

antimalarial in malaria patients.

In present study, during 6 months 98 patients were admitted in hospital. The

demographic details of patients admitting in hospital shows male patients were more

number (60.52%) & female were less (39.48%) which was also seen in previous

studies conducted in various areas1,2

and this reflecting that the prevalence of the

disease was higher among adult patients in this region during the study.

During six months of study, out of 98 patients prescribed with antimalarial

drugs, only 46 patients showed malarial infection and 52 patients diagnosed with

nonmalarial infection. Out of 46 malarial cases 78.78% of patients were serum

positive for Plasmodium falciparum and 21.22% were with Plasmodium vivax and

mixed type of infection. This indicates Plasmodium falciparum is more common in

this area of Karnataka for malarial infection. This report was similar to the previous

study3.

During the study period, major prescription of antimalarial agents were

Artesunate (14.4%), Artesunate Sulfadoxine and Pyrimethamine (19.70%),

Artemether/Lumefantrine (17.42%), Chloroquine (12.12%) and others 2 to 8% were

observed. The Artesunate were prescribed alone, which leads to development of

resistance according to national vector borne disease control programme (NVBDCP).


NVBDCP recommended Artesunate should be given in combination with

Sulfadoxine/Pyrimethamine or lumefantrine.

In our study 3 drug combination therapy prescribed more (30.61%) for

inpatients of our hospital followed by two drugs combinations. In this combination

therapy almost all combination contain artemisinin derivatives which was in accord

with guidelines for diagnosis and treatment of malaria and similar study were done

previously4.

Rationality of antimalarial drug prescription was accessed by NVBDCP.

During the study we observed antimalarial drug given for 46 malarial infection

patients in these 45.65% irrational prescriptions found and out of 52 nonmalarial

patients 82.69% irrational prescriptions were found. This indicates antimalarials

prescribed irrationally more especially in nonmalarial patients. Thus, there is a need to

educate health care workers. 2.17 % of prescriptions were showed potential drug-

drug interaction of artemisinin derivatives in malarial patients but in non-malarial

patients 13.46% of potential drug-drug interactions were found which indicate DDIs

were more in nonmalarial cases.

After evaluation of this study by prescribing indicators it shows 44.879 % of

I.V. injections were prescribed, this will increase cost of the prescriptions as injections

are costlier then oral therapy. Not only quality but also cost of the antimalarial drugs

was important component of drug utilization study. As in our study drug cost on

injection is 86.51% out of total cost which indicated artemisinin derivatives were used

more because these are available as I.V preparations only and are much more

expensive than conventional antimalarial drugs this result were comparable with study

done in Gujarat3.


In conclusion this study shows that inappropriate use of antimalarial drugs was

high among patient with plasmodium falciparum and nonmalarial patients. Irrational

prescriptions are high which indicate non adherence to guidelines. Cost of therapy is

very high thus it contribute economic burden on patients. Bagalkot is endemic for

plasmodium falciparum & plasmodium vivax malaria and there is requirement of

rational prescriptions for betterment of therapy for malaria. This result should inform

education of health professional and rational drug use policy and to reduce the cost of

prescription.


Reference

1. Costa AD, Bhartiya S, Eltayb A, Nandeswar S and Diwan VK. Patterns of

Drug Use in the Public Sector Primary Health Centers of Bhopal District.

Pharm World Sci 2008; 30: 584-9.

2. Lamichhane D, Giri BR, Pathak OK, Panta OB and Sankar PR. Morbidity

Profile and Prescribing Patterns among Outpatients in a Teaching Hospital in

Western Nepal. McGill J Med. 2006; 9(2): 126-33.

3. Dhara L, Rina D and C.N.Patel, Drug utilization study of antimalarial drugs in

a tertiary care hospital, 2012;2(4):761-77

4. Alexander ND, Carole.F, Alex. A. Pattern of drug utilization for treatment of

uncomplicated malaria in urban. Ghana following national treatment policy

change to artemisinin combinational therapy malaria journal 2009; 8(2):1-8.


Annexure


Annexure 1

[Antimalarial drug cost documentation from]

Name of the Staff Incharge :

Signature of staff Incharge :

Remarks of the staff Incharge :

Name of

drug

Cost of

drug

1 2 3 4 5 6 7 8 9 10 Cost per

day

Total

[Total Day × cost per day]

Total

project thisis

Documents