1. IMPACT OF AN INTERVENTION PROGRAM FOR THE TREATMENT OF MALARIA IN CHILDREN IN PAPUA NEW GUINEA SUNDERLAND VB JOSHUA IB † PASSMORE PR School of Pharmacy, Curtin University of Technology Kent Street, Bentley, Western Australia 6102 † Currently, Discipline of Pharmacy, University of Papua New Guinea, Port Moresby, Papua New Guinea Abstract This study evaluated the impact of patient carer directed drug information on the understanding and treatment outcomes in uncomplicated malaria in children. A pre-post intervention study was carried out at an urban health clinic using an intervention of written and verbal reinforcement of directions and information about treatments, drug administration, compliance and understanding of the treatment with respect to the control group. Patient carer understanding of basic medication administration dosage and frequency was unchanged (P>0.05) however significant improvements were evident in patient carer understanding of medications (P<0.05), understanding of storage of medicines (P<0.001), reading labels and instructions (P<0.001), remembering to give medicines (P<0.001) and correct administration timing (P<0.001). The reported improvement in treatment cure rate (health outcome) increased from 57.9% to 92.3% (P=0.007). Other than understanding of administration all other parameters showed marked improvements as a result of the intervention including self-reported patient outcomes. Background and Setting Malaria is still significant today with in excess of 2 million deaths reported annually, and most are children (1). Few studies have been reported for malaria with an aim to improve patient compliance and understanding of their medications. One study in China initially with inferior quality medications showed that lack of understanding of administration instructions was improved by blister packaging and provision of written instructions (2). A study from Cambodia found that public education of patients by posters and videos was effective if patients visited health practitioners rather than drug vendors (3). A recently reported study found additional labelling and verbal instruction of carers significantly improved compliance with chloroquine in uncomplicated malaria in children(4). In other disease states patient education has been shown to result in significant and long lasting improvements in Type 1 diabetes (5). Study Aims The aims of this study were: (1)Evaluate the impact of an intervention program on patient carers on the understanding of antimalarial drugs in children for uncomplicated malaria. (2)Evaluate the level of rational use for uncomplicated malaria in children. Methods The trial was a pre-post intervention protocol with a control group (Control). The intervention arm (Clinic) was at an urban clinic in the National Capital District of PNG serving approximately 20,000 people. The control clinic was similar in size and services provided but located about 15km distant serving a different population. Inclusion criteria: children 0-10 years diagnosed with uncomplicated malaria and prescribed the standard treatment protocol. Consent was required from carers. Exclusions were children in the post-intervention phase who participated in the pre- intervention phase. In the pre-intervention current and previously prescribed drugs, doses and frequencies prescribed were recorded. Patients were asked to complete a standardised questionnaire on past and present medications and issues related to compliance (6). Patients were requested to return to the clinic after 7 days and report to the researcher if the child had recovered or not. In the post-intervention phase the following were introduced: A dispensing label providing directions for use and the importance of completing the course The carer was verbally counselled on the directions and importance of completing the treatment The same questionnaire was administered. Carers were advised to return to the clinic after 7 days and report if the child was well or not. The pre-intervention stage was maintained for the whole period of the study at the control clinic. Differences in pre-post elements of the study periods were evaluated using Chi- squared, Kruskal-Wallis, Fisher’s Exact or Student’s - t tests as appropriate. Diagnosis and treatment was from national standard treatment guidelines which require any child with fever to be treated for malaria. The first line treatment was amodiaquine with chloroquine or Fansidar ®(7). Results and Discussion The demographic data (Table 1) show that the mean age for each of the groups was approximately 2 years. There were no significant differences in any of the population characteristics. Table 1. Patient demographics at the clinic pre-post and control pre-post groups P-value 1 from oneway-anova TestP-value 2 from Pearson Chi-Square Test The appropriate drug prescribing (Table 2) according to the PNG guidelines for malaria (7) showed no change in either setting over the course of the study. No intervention occurred in relation to prescribing. Table 2: Levels of appropriate prescribing in accordance with the PNG prescribing guidelines CountSubgroupTotal Clin-preClin-post Not appropriate36 (36.0%)27 (27.8%)63 (32.0%) All aspects appropriate 64 (64.0%)70 (72.2%)134 (68.0%) P-value0.141 SubgroupTotal Con-preCon-post 14 (58.3%)37 (52.1%)51 (53.7%) 10 (41.7%)34 (47.9%)33 (46.3%) 0.387 P-value from Fisher’s Exact Test The “not appropriate” category usually occurred from prescribing additional drugs such as primaquine and antibiotics which were not according to the guidelines. It is evident that carers had a reasonable understanding of their medicines. (Table 3) Approximately 70% understood the dosing schedules for antimalarial medication. It is evident the intervention provided no improvement in patients ability to describe their understanding of these requirements. DrugUses count SubgroupsTotalP-value Con-preCon-postClin-preClin-post Amodiaquine 100mg tablet Incorrect10 (45.5%)25 (39.7%)25 (29.1%)22 (26.8%)82 (32.4%)0.184 Correct12 (54.5%)38 (60.3%)61 (70.9%)60 (73.2%)171 (67.6%) Chloroquine 150mg tablet Incorrect2 (28.6%)2 (100.0%)4 (30.8%)0.098 Correct1 (100.0%)3 (100.0%)5 (71.4%)9 (69.2%) Quinine 300 mg tablet Incorrect1 (100.0%)1 (50.0%)0.157 Correct1 (100.0%)1 (50.0%) SubgroupsTotal Con-preCon-postClin-preClin-post Sample Size N25 (8.3%)75 (24.8%)103 (34.0%) 100 (33.0%) 303 (100.0%) Age (years)Mean1.901.992.782.322.36 SD2.141.932.601.982.23 P-value 1 0.079 Weight (kg)Mean10.0410.1611.8711.01 SD3.973.605.515.254.92 P-value 1 0.094 GenderMale15 (60.0%)35 (46.7%)59 (57.3%)51 (51.0%)160 (52.8%) Female10 (40.0%)40 (53.3%)44 (42.7%)49 (49.0%)143 (47.2%) P-value 2 0.455 DrugDose count SubgroupsTotalP-value Con-preCon-postClin-preClin-post Amodiaquine 100mg tablet Incorrect4 (18.2%)14 (22.2%)25 (29.1%)30 (36.6%)73 (28.9%)0.175 Correct18 (81.8%) 49 (77.8%)61 (70.9%)52 (63.4%)180 (71.1%) Chloroquine 150mg tablet Incorrect2 (28.6%)1 (50.0%)3 (23.1%)0.545 Correct1 (100.0%) 3 (100.0%)5 (71.4%)1 (50.0%)10 (76.9%) Quinine 300 mg tablet Incorrect1 (100.0%) 2 (100.0%) Correct DrugDays count SubgroupsTotalP-value Con-preCon-postClin- pre Clin-post Amodiaquine 100mg tablet Incorrect4 (18.2%)13 (20.6%)24 (27.9% ) 24 (29.3%)65 (25.7%)0.519 Correct18 (81.8%)50 (79.4%)62 (72.1% ) 58 (70.7%)188 (74.3%) Chloroquine 150mg tablet Incorrect2 (28.6% ) 2 (100.0%)4 (30.8%)0.098 Correct1 (100.0%)3 (100.0%)5 (71.4% ) 9 (69.2%) Quinine 300 mg tablet Incorrect1 (100.0%) 2 (100.0%) Correct DrugFrequency count SubgroupsTotalP-value Con-preCon-postClin-preClin-post Amodiaquine 100mg tablet Incorrect4 (18.2%)15 (23.8%)24 (27.9%)24 (29.3%)67 (26.5%)0.699 Correct18 (81.8%)48 (76.2%)62 (72.1%)58 (70.7%)186 (73.5%) Chloroquine 150mg tablet Incorrect2 (28.6%)2 (100.0%)4 (30.8%)0.098 Correct1 (100.0%)3 (100.0%)5 (71.4%)9 (69.2%) Quinine 300 mg tablet Incorrect1 (100.0%) 2 (100.0%) Correct Table 3 Patient/Carer Understanding of (a)Use of the Medicine (b) Dosage of the Medicine (c) Frequency of Dosage (d) Duration of Treatment In contrast to the specific directions recall patient carers in the intervention (clinic) group showed much improved understanding about the storage and usage of their medicines as shown in Table 4 Table 4Patient Carers responses to aspects of knowledge about medicines GroupActivitySub-groupNMean rankP-value Control groups Store the medicines Con-pre2547.400.014 Con-post7551.50 Read label / understand instructions Con-pre2556.360.153 Con-post7548.55 Remember to give the medicines Con-pre2551.000.884 Con-post7550.33 To give the medicines on time Con-pre2549.780.836 Con-post7550.74 Clinic groups Store the medicines Clin-pre10277.480.000 Clin-post100126.00 Read label/understa nd instructions Clin-pre10269.640.000 Clin-post100134.00 Remember to give the medicines Clin-pre10260.370.000 Clin-post100143.45 To give the medicines on time Clin-pre10260.370.000 Clin-post100143.45 Follow-up data for patients carers returning after 7 days to provide information on the treatment outcome is provided in Table 5. Table 5Follow up data comparing control pre-post and clinic pre-post ActivityCountSubgroupTotalP-value Con-preCon-post Are they cured No3 (27.3%)9 (31.0%)12 (30.0%)0.570 Yes8 (72.7%)20 (69.0%)28 (70.0%) Clin-preClin-post Are they cured No16 (42.1%)3 (7.7%)19 (24.7%)0.000 Yes22 (57.9%)36 (92.3%)58 (75.3%) As expected the response rate was not high (approximately 40%) as it required the patient carer to report back. There does seem to be sufficient evidence in the clinic-post (post- intervention) group to indicate the overall simple intervention had a significant effect on the numbers cured. P-Value from Kruskal-Wallis Test It is evident from the above data that the education elements of the intervention were valued when compared with the control group Discussion The populations enrolled into this study were homogeneous. This study has shown that a simple intervention of providing detailed information on a label regarding exact dosage, storage and use of medicines together with verbal reinforcement provided no improvement in patient reported understanding the basics of medicine dosage administration. Correct response levels in all cases were approximately 70% in all pre and post categories. This may indicate a ceiling effect or other barriers (e.g. literacy) limiting improvement of this finding. Additional underlying information would need to be collected to provide an understanding of the basis of this lack of improvement. In both control and clinic groups the pre-intervention group had a history of greater numbers of previous prescribed medications from earlier consultations than the post intervention period for both groups. This would indicate both “post” groups would be less experienced in medication based upon previous prescribing. The intervention had a marked improved influence on patients knowledge relevant to compliance such as the understanding of instructions, remembering to give the medications and giving the medications on time. Overall the intervention seems to have had a significant improvement on reported cure rates and therefore patient outcomes which is a significant community benefit. Conclusions and Recommendations This study has demonstrated that a targetted intervention has shown significant improvements in aspects of patients understanding of medicines in relation to compliance. It has demonstrated no impact on the understanding of the basic issues of medicine administration. A significant improvement occurred in patient outcomes. The study found that less than 75% of patients received treatment in accordance with the guidelines. Improved packaging and labelling of medications and procedures to be followed when a dose was vomited should be incorporated into routine patient carer information. The provision of liquid medications rather than the crushing of tablets should be trialled in children who have difficulties with medication administration. References 1.www.emro.who.int/ accessed 5 th March 2004www.emro.who.int/ 2.QingjunL, Duan J, Tang L, Zhang X, Liang J, Hay A, Shires S, Navaratnam V, The effect of drug packaging on patients’ compliance with treatment for Plasmodium rival malaria in China. Bulletin of the World Health Organisation 1998; 79 (suppl 1): 21-27. 3.Denis MB. Improving compliance with quinine + tretracycline for treatment of malaria: Evaluation of health education interventions in Cambodian villages. Bulletin of the World Health Organisation 1998; 79 (suppl 1): 43-49. 4.Okonkwo PO, Akpala Co, Okafor HU, Mbah AU, Nwaiwo O. Compliance to correct dose of chloroquine in uncomplicated malaria correlates with improvement in the condition of rural Nigerian children, Transactions of the Royal Society of Tropical Medicine and Hygiene 2001; 95: 320-324. 5.Loveman E, Cave C, Green C, Royle P, Dunn N, Waugh N. The clinical and cost- effectiveness of patient education models for diabetes: a systematic review and economic evaluation. Health Technology Assessment 2003; 7: No 22. 6.Avarstad BL, Chewping BA, Steath BL, Claesson C. A brief medication questionnaire: A tool for screening patient adherence and barriers to adherence. Patient Education and Counselling 1999; 37:113-124. 7.Standard treatment for common illnesses of children in Papua New Guinea. A manual for nurses, health extension officers and doctors. 7 th Edn. Port Moresby: National Department of Health, 2000. P-value from Fisher’s Exact Test