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Journal of Applied Pharmaceutical Science 01 (08); 2011: 235-238 Over prescribing and resistance to chloroquine
Gandhi AM, Patel PP, Desai CK, Desai MK and Dikshit RK
ABSTRACT
Malaria is a major health concern in the developing world including India. Overdiagnosis and overprescribing of malaria may lead to increase morbidity, mortality and o antimalarial drugs and hence increase the economical burden to Gandhi AM, Desai CK, Desai MK
health care system. The pres ent study was carried out to determine the actual cases of malaria and extent of chloroquine resistance at Civil Hospital Ahmedabad, a tertiary care teaching hospital in Gujarat, India. After Institutional Ethics Committee approval, adult patients of either gender, presenting with a his tory of fever at the Out Patient Department (OPD), diagnosed to nd prescribed chloroquine were included in the study. Peripheral thick blood smear test and OptiMAL-rapid diagnostic test (RDT) were carried out. RDT was Patel PP
performed in these patients on day 0 before the start of chloroquine treatment and after completion of the 3 day chloroquine treatment. They were again subjected to RDT on day 4. The positive cases on RDTo n day 4 were considered as resistant to chloroquine. During the study period of 12 months, out of the 250 clinically suspected cases of malaria who were prescribed chloroquine, 80 (31%) cases (35 cases of P. vivax and the 45 of P. falciparum ) were positive for malaria (by the peripheral smear and the Rapid Diagnostic Test (RDT) OptiMAL test). Thirty out of the 35 ca ses of P. vivax malaria, responded to the three- day chloroquine Dikshit RK
treatment. Out of the 45 case s of P. falciparum malaria, 30 responded to chloroquine while 15 patients (35%) continued to be OptiMAL positive on 4th day and required change of treatment. B.J. Medical college, Ahmedabad , It suggests that an early diagnosis, definitive treatment and avoiding overprescribing could delay drug resistance and reduce the morbidity and mortality due the disease. Keywords: Malaria, chloroquine, overprescribing, resistance.
INTRODUCTION
ment in malaria depends on the right diagnosis, selection of the right drug and its efficacy, correctne ss of the advice given to the patient and compliance of the patient Chloroquine (CQ) is the first drug of choice for among the available antimalarial drugs 2(National dr ug policy on malaria, 2008) and widely used as self-medication for ria despite the existence of parasite resistance to the drug (Picot et al, 1997). Resistance to antimal arial drugs is on the rise and has become a major factor in deciding gs. For instance, as per estimates in the past decade, 50% of the strains of P.falciparum are resi stant to chloroquine (Garg, 1999) and resistant strains of P. vivax are also increasing in different parts of India (Kochar, 2007). A presumptive approach alone may result in overdiagnosis of mala ria. Empirical treatment based on this approach may also result in For Correspondence
Dr Anuradha M Gandhi
g use with a consequent increased risk of morbidity, mortality, resistance to antimalarial drug s and increased cost of therapy (Plowe, 2003). It thus becomes imperative to detect the extent of presumptive diagnosis of malaria study was therefore conducted at Civil Hospital, Ahmedabad, a tertiary care teaching hospital in Gujarat, India, with an objective Journal of Applied Pharmaceutical Science 01 (08); 2011: 235-238 to determine the actual cases of malaria out of such clinically
diagnosed cases and to determine the extent of chloroquine
resistance in this population.
METHODS

The study protocol was approved by the Institutional Ethics Committee (IEC) of Civil Hospital, Ahmedabad (CHA). Adult patients of either gender, above the age of 18 years and presenting with a history of fever at the Out Patient Department (OPD) were screened for the study. All those patients who are clinically diagnosed to be suffering from malaria and prescribed chloroquine were included in the study. Patients who had taken prior treatment for malaria and those with a history of vomiting Table 1: Chloroquine sensitivity in patients suffering from malaria.
were excluded from the study. Pregnant and lactating women, Type of malaria ►
P. vivax malaria
P. falciparum malaria
patients with a history of hypersensitivity to antimalarial drugs and those suffering from major illnesses like hypertension or severe diabetes mellitus were also excluded from the study (OptiMAL –IT kit was supplied by Doctor & Company, Ahmedabad : Morepan Laboratories, New Delhi, Manufractured by DiaMed AG Diagnostics and Medical Products, Switzerland). DISCUSSION
Patients were informed about the aims and methods of the Outcome of treatment of malaria depends on the efficacy study and a written consent was obtained. Detailed history, clinical of the drug, right diagnosis, the treatment given and compliance of examination and treatment given were recorded in a case record patient while presumptive use of antimalarial drugs may increase form (CRF). Peripheral thick blood smear test and OptiMAL-rapid parasite resistance. Confirming the clinical diagnosis with diagnostic test (RDT) were carried out for malaria in all patients microscopy or Rapid Diagnostic Tests (RDTs) may prevent that were included in the study. RDT was performed in these overuse of antimalarial drugs and decrease the risk of drug- patients on day 0 before the start of chloroquine treatment. The cases that showed positive microscopic examination In the present study, 250 patients of fever were prescribed and +ve RDT for malaria on day 0 were considered as true/actual chloroquine on the basis of a presumptive clinical diagnosis. cases of malaria either P. vivax or P. falciparum. These patients However, only 80 cases were positive either for P. vivax or were advised to return on day 4 after the completion of the 3 day P.falciparum malaria on microscopy and RDT (OptiMAL) while chloroquine treatment. They were again subjected to RDT on day 170 cases (67.86%) showed a negative peripheral smear and 4. The positive cases on RDT on day 4 were considered as resistant We further observed that out of 80 cases detected to be positive for malaria by peripheral smear and RDT (OptiMAL) tests, 35 (44 %) were of P.vivax and 45 (56% ) were of P. During the study period, 250 cases of fever and clinically falciparum malaria. Chloroquine was effective in 30 cases (86%) suspected cases of malaria, who were prescribed chloroquine were of P. vivax & 30 cases (67%) of P. falciparum origin. Resistance studied. Out of these, 80 (31%) patients showed a positive was therefore observed in 5 patients (14%) and 15 cases of (33%) peripheral smear as well as positive RDT (OptiMAL test) for either P.vivax and P.falciparum of malaria respectively. There is P. vivax or P. falciparum malaria. Two false positive and one false therefore an evidence based of treatment on presumptive diagnosis negative cases were reported (cases where peripheral smear was alone, which may contribute to antimalarial drug resistance. positive for malaria parasites and RDT was negative were Treatment based on presumptive clinical diagnosis alone considered as false negative and vice versa). Therefore it was is an accepted approach for management of most cases of malaria observed that 170 (68%) cases of fever presumptively diagnosed in areas with high rates of transmission e.g. in rural and remote with malaria, were not actually suffering from this infection yet areas of the healthcare system where laboratory facilities for they were prescribed chloroquine. (Figure 1). Out of the 80 definitive diagnosis may not be available. Patients in endemic areas positive malaria cases, 35 cases were suffering from P. vivax are familiar with the symptoms and they frequently self-diagnose malaria (44%) and the remaining 45 patients were suffering from malaria and practice self medication with chloroquine and other P. falciparum (56%) (Table 1) Out of 35 cases of P. vivax malaria, antimalarial drugs. These drugs are easily available from 30 patients responded to chloroquine treatment while 5 patients pharmacies in India. Treatment based on presumptive clinical (14%) were still positive on RDT after three days chloroquine diagnosis alone may result in unnecessary and irrational drug use. treatment. They required alternate antimalarial drugs and were In addition, overdiagnosis and overprescribing of malaria may lead referred to the medicine consultant. Thirty out of 45 confirmed to increase morbidity, mortality and increases risk of resistance to Journal of Applied Pharmaceutical Science 01 (08); 2011: 235-238 antimalarial drugs and an increased economical burden to health investigated by microscopy or RDT and presumptive treatment care system of the country. Thus, the clinical diagnosis would benefit from laboratory confirmation by microscopy/Rapid Hence, We conclude that early diagnosis, treatment and reduction in overprescribing based on presumptive symptoms Therapeutic efficacy and / or parasitological resistance alone may delay the progress of drug resistance and reduce in may be measured by in vivo test. (Plowe, 2003) However, standard overall morbidity and mortality due to malaria. Rapid diagnostic in vivo tests are expensive and time-consuming while in vitro tests can be useful in monitoring and management of malaria. This methods for measuring drug resistance are not practical and have a may reduce the unnecessary use of antimalarial drugs and also limited scope. All available tests either do not give quick results to reduce risk of complications of P. falciparum malaria particularly influence the therapeutic decisions or nor do they give results that are not interpretable in terms of individual patient treatment (ICMR, 2002) . Alternatively, non-microscopic methods, rapid ACKNOWLEDGEMENT
We are thankful to Department of Medicine and Department of Microbiology for helping us in diagnosis and dehydrogenase (pLDH) have the capacity to detect and distinguish enrolling patients. We are also thankful to Government of Gujarat infections caused by P. falciparum and P. vivax species (Ferro et (India) for giving us funds for our study. OptiMAL is the first RDT, approved on June 13, 2007 by REFERENCES
the U.S. Food and Drug Administration (FDA) for use by hospital Chansuda Wongsrichanalai, Mazie J. Barcus, Sinuon Muth, and commercial laboratories. This RDT utilizes a dipstick coated Awalludin Sutamihardja, Walther H. Wernsdorfer.A Review of Malaria Diagnostic Tools: Microscopy and Rapid Diagnostic Test (RDT). with monoclonal antibodies against the intracellular metabolic Available from: http://www.ncbi.nlm.nih.gov/books/NBK1695/ (Accessed enzyme parasite lactate dehydrogenase (pLDH) and detects pLDH produced by viable parasites only. Its ability to follow its decline in Clinical and public health implications of antimalarial drug resistance, ICMR Workshop in Clinical Pharmacology (2002). sequential samples from that patients during treatment may be Ferro BE, Gonz·lez IJ, Carvajal FD et al. Performance of useful in evaluating clinical cases. (Palmer CJ e al, 1998, WHO, OptiMAL in the diagnosis of Plasmodium vivax and Plasmodium 2000) Thus, we have used this RDT as a tool for monitoring of falciparum Infections in a Malaria Referral Center in Colombia. Rio de antimalarial treatment. This diagnostic tests may provide rapid Janeiro. Mem. Inst. Oswaldo Cruz. 2002; 97(5): 731-735. Garg, MR, Gogtay NJ, Kshirsagar NA. Resurgence of malaria in confirmatory diagnosis of malaria even at the peripheral levels of mumbai is escalating chloroquine resistance a cause. J Assoc Physicians the health care system and can be performed by health workers with minimal training. This method can detect vivax and Guidelines for diagnosis and treatment of malaria in India. 2011. National Institute of Malaria Research and National Vector Borne Disease Control Programme. New Delhi. http://www.mrcindia.org/ Guidelines% dehydrogenase (pLDH) of viable parasites, decline of viable 20for%20Diagnosis2011.pdf (Accessed on 04/10/2011). parasites can be reflected in sequential samples from the patients Khan P, Noor I, Khan J. Treatment of P Falciparum malaria. J during treatment. Thus, this method can also be used for www.jpmi.org.pk/cms/PDF/5%20Perviaz%20Khan.pdf monitoring of chloroquine therapy. (Palmer et al, 1998, WHO, Kochar DK, Sirohi P, Kochar.SK. Malaria in India. Available Antimalarial drugs are used empirically and prescribing http://www.apiindia.org/medicine_update_2007/109.pdf chloroquine to any case of fever is a common practice (Khan, McCombie SC (2002) Self-treatment for malaria: the evidence 1993). This causes unnecessary expense to the patient and risks and methodological issues. Health Policy and Planning 17, 333–344. avoidable adverse effects as well as selection of resistant strains. In addition to that, their is a widespread use of chloroquine as Directorate of National Vector Borne Disease Control Programme, Directorate General of Health Services, Ministry of Health and Family selfmedication and inadequate dose or dosage schedule are Welfare.http://www.whoindia.org/LinkFiles/Malaria_Malaria_drug- prescribed at the health centres (Pfeiffer et al, 2008, McCombie, 2002). The cost of an RDT in developing countries is more than microscopic peripheral smear examination.However, prompt and Directorate of National Vector Borne Disease Control Programme, Directorate General of Health Services, Ministry of Health and Family accurate diagnosis will not only improve malaria treatment, but Welfare. http://nvbdcp.gov.in/Doc/drug-policy-2010.pdf (Accessed on possibly reduce morbidity due to other febrile illnesses. The cost effectiveness of RDTs may depend upon many factors e.g. New perspectives in malaria diagnosis: Report of joint prevalence of malaria, cost of RDT, cost of anti-malarial treatment, WHO/USAID informal consultation. 25-27 October, 1999 WHO 2000 Document No WHO/CDS/RBM/2000. 14; WHO/MAL/2000. 1091. and the cost of treatment of other febrile illnesses when malaria has Palmer CJ, Lindo JF, Klaskala WI, et al. Evaluation of the been ruled out. RDTs may become more cost effective as the price OptiMAL test for rapid diagnosis of Plasmodium vivax and Plasmodium of anti-malarials increase (Chansuda et al, 2007; WHO, 2006).
Pfeiffer K, Some F, ller OM, et al. Clinical diagnosis of malaria As per recommendation by National treatment guidelines and the risk of chloroquine self-medication in rural health centres in on malaria (2010), all fever cases suspected to be malaria should be Burkina Faso. Trop Med Int Health. 2008 : 13 (3); 418–426. Journal of Applied Pharmaceutical Science 01 (08); 2011: 235-238 Picot S, Akede NA, Chaulet JF, et al. Chloroquine self-treatment WHO REPORT Cost-Effectiveness of Malaria Diagnosis in and clinical outcome of cerebral malaria in children. Clin Exp Immunol; Sub-Saharan Africa: The Role of Rapid Diagnostic Tests in Rural Settings with High Plasmodium falciparum transmission Availabl from: Plowe CV. Monitoring antimalarial drug resistance: making the http://www.wpro.who.int/NR/rdonlyres/6A5EC04701F1-485E- most of the tools at hand. J Exp Biol. 2003; 206:3745-3752. 963C59D23C396E29/0/RDTinruralsettingswithhighPfalciparumtransmissionWHO2

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