Abstract ID: MA026 Author Name: Jackson A.K. Lauwo Email: lauwojak@daltron.com.pg Presenter Name: Jackson A.K. Lauwo Authors: Lauwo JAK, Hombhanje FW, Tulo SP, Maibani G, Bjorge S Institution: School of Medicine and Health Sciences, University of Papua New Guinea; National Department of Health, PNG Title: Impact of Pre-Packaging Antimalarial Drugs and counseling on Compliance with Treatment at Port Moresby General Hospital Adult Outpatient Department Problem Statement: Malaria medications are commonly dispensed to patients in loose packaging after being repacked from a bulk container. Patients frequently fail to adhere to the correct 3-day dosage regimen recommended by Papua New Guinea’s adult Standard Treatment Guidelines (STGs). Objectives: To contribute to the improvement of malaria treatment at Port Moresby General Hospital’s Outpatient Department through pre-packaging of the prescribed antimalarial drugs into an organized regimen with clearly delineated daily doses, and special counseling instructions in order to promote patient compliance. In addition, the study examines the acceptability of the pre-packaging by the hospital prescribing and dispensing health workers involved in patient health care. Intervention: An appropriately labeled pre-packaging was designed featuring three clearly partitioned sectors, each containing medication quantities required for each of the three days, as specified in the adult STGs for uncomplicated malaria. The impact of the pre-packaging and accompanying special instructions on patient compliance were investigated and compared to the standard practice of loose packaging over a 15-week period from March 2003. Results: This study demonstrated an 18% increase in compliance, when an intervention pre-packaging coupled with special instructions were applied compared to a Control Group that was neither given a pre-packaging nor additional special instructions. The increase in compliance was comparable to compliance rates obtained from similar studies elsewhere in the world. Conclusion: The pre-packaging linked with clear printed and verbal instructions improved patient compliance in taking antimalarial drugs. In addition, it was felt that pre-packaging will eliminate contamination of the products inherent in the common practice of uncontrolled extemporaneous repacking of patient regimens from bulk products. Product stability will also be enhanced by the pre-packaging system. Blister packaging should be employed in its final design. We strongly recommend to key health administrators and policy makers in Papua New Guinea to seriously consider the benefits of the new antimalarials pre-packaging system and implement it in the entire country. Study Funding: By the University of Papua New Guinea and the World Health Organization, Western Pacific.

Background & Settings Malaria is a major health problem in the world, and it is the second cause of morbidity and mortality in Papua New Guinea (PNG) . [The PNG Health Plan 2001- 2010] Resistance of P. falciparum to chloroquine & amodiaquine, led to new Standard Treatments Guidelines (STGs) for malaria in PNG [PNG DOH New STGs, 2000] Patients frequently fail to adhere to the correct 3-day dosage regimen recommended by PNG Adult STGs

Study Objectives To contribute to the improvement of malaria treatment at Port Moresby General Hospital (PMGH) Outpatient Department (OPD) through intervention by pre-packaged regimens with clearly delineated daily doses and special counselling instructions. To examine acceptability of the pre-package by prescribing and dispensing health workers.

Methods Setting: Port Moresby General Hospital (PMGH), PNG’s referral hospital. Study patients: Consenting Adult outpatients with uncomplicated malaria. Intervention: An appropriately labelled pre-package with partitioned, coloured sectors, each containing medications for each of the 3-days specified in the STGs. Design of pre-package & packaging A transparent polyethylene bag was partitioned into three sectors and names of the drugs, and instructions for use were clearly printed on a card under each sector of the bag, which was also differently colour coded. The three major languages; English, Pidgin and Motu were separately employed in the instructions. The Figure below shows a pre-package with English instructions.

Figure 1. Design of the Pre-package and Packaging P/N_____ Patient’s Name:___________ Address:__________________ Sex: F [ ] M [ ] Age: Adult [ ] years [ ] / Child [ ] Wt. [ ] Date ______ Day 1 Day 2 Day 3 CHLOROQUINE TABLETS FANSIDAR TABLETS Directions Take the above tablets in the first day Take the above tablets in the second day Take the above tablets in the third day CHLOROQUINE TABLETS Figure 1. Design of the Pre-package and Packaging

Methods (Continued) Documentation from Interviews & Patient cards Each patient was interviewed &a questionnaire was completed including the following: Patient characteristics: Gender, language spoken, diagnosis and drug treatment given. Other medicines prescribed Whether the patient was informed (instructed) about malaria. The patient’s understanding of instructions about antimalarial drug use. Data Analysis: Tabulations of specific characteristics and responses of intervention and control groups were made with the help of Excel spreadsheets. Chi-square analysis was performed, and the level of significance was set at p < 0.05

Special counseling Instructions Special instructions explained to the patient: the need for early treatment of uncomplicated malaria, Possible side effects of antimalarials The need to report serious side effects of the antimalarial drugs The Intervention group was compared with two Control Groups A and B. Control Group A: Standard package with special instructions. Control Group B: Standard package without special instructions

Methods (Continued) Patient Review on the Fourth Day Follow-up reviews on the fourth day were to elicit whether the patient: was cured took all drugs as prescribed could recall information about the disease and instructions on malaria drug usage as given in the first visit. A separate questionnaire sought the views of Prescribing and Dispensing Health Workers on their acceptability of the prepackage and whether they thought it would : improve patient compliance improve Patient drug management improve Clarity of directions to patients reduce waiting time and treatment costs be suitable to present other standard treatments.

Results ( Tables 1 – 4) Table 1. Number of patients enrolled in intervention and control groups and their basic characteristics. Intervention (N=129) Contr Gr A (N=151) Contr Gr B (N=156) p – value Males 73 (56.6) 78 (51.7) 91 (58.7) Females 56 (43.4) 73 (48.3) 65 (41.7) p > 0.05 English 57 (44.2) 57 (37.7) 77 (49.4) Pidgin Lang. 129 (100) 143 (94.7) 153 (98.1) Motu Lang. 38 (29.5) 10 (6.6) 52 (33.3) p < 0.001 Clinical 35 (27.1) 43 (28.5) 35 (22.5) MPS +ve 29 (22.5) 45 (29.8) 42 (26.9) Clin+MPS-ve 65 (50.4) 63 (41.7) 79 (50.6) Pts.reviewed (n = 91) (n=112) (n=119) 51 (56.0) 59 (52.7) 69 (58.0) 40 (44.0) 53 (47.3) 50 (42.0) p > 0.05 Figures in parenthesis are percentages

Table 2. Patients’ understanding about malaria and instructions on drug usage as compared among Intervention and Control Groups A and B. Understood: Intervention (N=129) Contr Gr A (N=151) Contr Gr B (N=156) - about malaria 1. Yes 85 (65.9) 116 (76.8) 9 (5.8) No 44 (34.1) 36 (23.8) 147 (94.2) - instructions on drug usage 2. 122 (94.6) 142 (94.0) 113 (72.4) 7 (5.4) 9 (6.0) 43 (26.6) Figures in parenthesis are percentages 1. Intervention vs. Control Group A: p > 0.05 Intervention vs. Control Group B: p < 0.001 2. Intervention vs. Control Group A: p > 0.05

Table 3. Number of patients reviewed, and their compliance ratings (%) among all groups. Intervention (n=91) Control Gr A (n=112) Control Gr B (n=119) Good 86 (94.5) 104 (92.9) 91 (76.5) Poor 5 (5.5) 8 (7.1) 28 (23.5) Intervention vs. Control Group A : p > 0.05; Intervention vs. Control Group B : p < 0.001 Control Group A vs. Control Group B : p < 0.001 Good: Patient’s ability to remember instructions, and to complete regimen as directed Poor: Inability to recall instructions, and non adherence to prescriber’s directions. Table 4. Views Of Prescribing & Dispensing Health Workers on the New Pre-package. Approvals of Pre-package (Yes) None approvals Of pre-package (No) p - value Yes / No 38 (95) 2 (5) Free comments 28 (70) 12 (30) p < 0.01 Figures in parenthesis represent percentages of (N = 40)

Discussion This study demonstrated an 18% increase in compliance when an intervention prepackage linked with special instructions were applied, compared to control group B that was neither given a prepackage nor additional special instructions. Increase in compliance was comparable to findings of similar studies elsewhere. In Ghana, pre-packaging of antimalarial tablets and syrups increased compliance by 21.5% & 22.1% resp. (Yeboah-Antwi. K et al., 2001) In China, organized blister prepackaging improved patient compliance by 20% (Quinjun L et al., 1998) verbal information about the disease, and instructions pertinent to the effects of drug(s) used showed impact on compliance. Majority (70%) of health workers interviewed supported the introduction of the new pre-package, while 30% were doubtful or undecided.

Conclusion and Recommendations The pre-package linked with clear printed and verbal instructions significantly improved patient compliance in taking antimalarial drugs. Pre-packaging could eliminate contaminations of the products inherent in the existing extempo- raneous repacking of patient regimens from bulk products. Product stability may also be enhanced by the pre- package system. Blister packaging should be employed in its final design. We recommend to the appropriate health authorities in Papua New Guinea to consider the implementation of the new antimalarials pre- packaging system. References Papua New Guinea National Health Plan 2001 – 2010, Vol III 1999. Department of Health, Papua New Guinea. Department of Health. Announcement of new combination treatments for all malaria in Papua New Guinea. August 2000. K Yeboah-Antwi, J O Jyapon, I K Asare, G. Barnish, D B Evans& S. Adjei. Impact of pre-packaging antimalarial drugs on cost to patients and compliance with treatment. Bulletin of the World Health Organization, 2001, 79 (5) 394 – 39 Li Quingjun, Duan Jihui, Tang Laiyi, Zhang Xiangjun, Liang Jun, A. Hay, S. Shires, & V. Navaratham. The effect of drug packaging on patient’s compliance with treatment for plasmodium vivax malaria in China. Bulletin of the World Health Organization, 1998, 76 (Suppl. 1): 21 – 27