Community Pharmacists Monitoring of Pulmonary Tuberculosis Outpatients (Preliminary Study)

Authors Usasiri Srisakul, M.Sc. in Pharm (Clinical Pharmacy) Phayom Sookaneknun, PharmD Sunantha Osiri, Ph.D Institution: Faculty of Pharmacy and Health Sciences, Mahasarakham University, Thailand, 44150 Study funded by: Human Systems Research Institute (HSRI), Thailand

ABSTRACT Problem Statement: DOTS (Directly Observed Treatment, Short Course) for pulmonary tuberculosis (PulTB) is a major strategy in the Thai National Tuberculosis Program (NTP) following the World Health Organization (WHO) global plan. Thailand was ranked 16th of 22 high-burden countries in 2002 in the WHO global tuberculosis control report. Community pharmacists are part of the health care team that should play a role in improving outcomes in pulmonary tuberculosis outpatients. Objectives: To compare clinical outcomes between community pharmacists monitoring patients and control patients receiving normal care. Design: Quasi experimental study design. Setting and Population: Eighty pulmonary tuberculosis outpatients without HIV co-infection were treated with DOTS category 1 (2HRZE+4HR) between December 2002 and January 2004 at Mahasarakham provincial hospital. Patients who were diagnosed with PulTB and had completed the intensive treatment phase (2rd month with sputum converted to negative) volunteered to be monitored and receive medications from pharmacists at a University pharmacy. This was the treatment group. Patients who wanted to be monitored only from the hospital were the control group. Intervention: Pharmaceutical care by pharmacists and refill of DOTS medications. The non-intervention group received care from the hospital. Outcome Measures: Clinical outcomes were assessed when the patients completed DOTS (6 months). Following the WHO tuberculosis treatment definition, outcomes were cure rate (sputum conversion at month 6); treatment success rate (summation of cure and completion rate); default rate (lost more than 2 months); and failure rate (positive sputum test at month 6). Results: Fifty-four PulTB patients who completed DOTS during the preliminary study period (December 2002 to October 2003) were male (61.80%), age 52.69 + 15.58 years. There were 27 eligible patients in both the pharmacist-monitored group and the control group.There were no significant differences between groups with respect to age and gender (p = 0.495, 0.573, respectively). Smear positive patients in the pharmacist- monitored group were 62.96% and 44.44% in the control group. Smear positive cases showed a cure rate of 94.12% for the treatment group and 66.67% for the control group. Treatment success rate in the treatment group was 96.23% and 74.10% in the control group (p = 0.022). Default rate in the control group was 22.22% (6 cases) and in treatment group was 3.7% (1 case, p = 0.043). The control group had one failure case but there were none in the treatment group. Conclusions: Community pharmacist monitoring can improve the treatment success rate to achieve the WHO goal (more than 85%) and decrease default and failure rates. The results show that community pharmacists involvement in a DOTS multidisciplinary team improved clinical outcomes in pulmonary tuberculosis outpatients.

Content Introduction Objectives Method Results Discussion and implementation Conclusion

Introduction DOTS (Directly Observed Treatment, Short Course) for pulmonary tuberculosis (PulTB) is a major strategy in the National Tuberculosis Programme (NTP) following WHO global plan. Thailand ranked the 16th in 22 high-burden countries.

Objectives To compare clinical outcome between Community pharmacists monitoring patients Control patients receiving normal care

Method Quasi experimental study design Patients: Preliminary study: Pulmonary Tuberculosis (PulTB) without HIV co-infection DOT category 1 (2HRZE + 4HR) December 2002 – January 2004 Mahasarakham provincial hospital Preliminary study: December 2004 – October 2003 N = 54

PulTB with DOT category1 N=54 Completed intensive treatment phase 2nd month Volunteered Community pharmacists monitoring group N=27 Control group N=27 3rd – 5th month Clinical outcomes 6th month Figure 1 Research procedure

Method (cont.) Community Pharmacists monitoring group Control group Refill of DOTS medication Pharmaceutical care Control group Self DOTS for 3rd – 5th month Clinical outcomes Cure rate Treatment success rate Default rate Failure rate

Results: Demagraphic data Treatment gr. Control gr. p-value N=27 Age (year) 54.15 + 15.31 51.22 + 16.00 0.495 Male (%) 16 (47.10%) 18 (52.90%) 0.573 Smear positive (%) 17 (63.00%) 12 (44.44%) 0.172 No significant differences in all demographic data betweent both groups.

Results: Clinical outcomes Treatment gr. Control gr. p-value N=27 Cure rate 94.12% (16) 66.67% (8 ) 0.054 Treatment Success rate 96.30% (26) 74.10% (20) 0.022* Default rate 3.7% (1) 22.22% (6) 0.043* Failure rate 0% (0) 0.313 * Significant differences

Results: Clinical outcomes 0.022* 0.054 0.043* 0.313 Figure 2 Clinical outcomes

Discussion Community pharmacist monitoring can improve treatment succes rate (WHO goal > 85%), decrease default and failure rate Show the community pharmacist involvement in DOTS multidisciplinary team In the future study should be expanded number of patients, community pharmacy setting and referral system

Conclusion Community pharmacist involvement in a DOTS multidisciplinary team improved clinical outcomes in pulmonary tuberculosis outpatients.

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