University of Ghana http://ugspace.ug.edu.gh UNIVERSITY OF GHANA SCHOOL OF PUBLIC HEALTH COLLEGE OF HEALTH SCIENCES PATTERN OF RATIONAL USE OF DRUGS IN THE TREATMENT OF MALARIA IN OUT PATIENTS AT THE PRINCESS MARIE LOUIS HOSPITAL IN THE GREATER ACCRA REGION OF GHANA. SALOMEY SAKYIBEA ADDO (10636503) THIS DISSERTATION IS SUBMITTED TO THE UNIVERSITYOF GHANA, LEGON IN PARTIAL FULFILMENT OF THE REQUIREMENT FOR THE AWARD OF MASTER OF PUBLIC HEALTH DEGREE. JULY, 2018 University of Ghana http://ugspace.ug.edu.gh DECLARATION I, Salomey Sakyibea Addo hereby declare that apart from references to other people’s works which have been duly acknowledged, this proposal is a result of my own independent work and has not been submitted for the award of any degree in any institution. …………………………… ………………………….... Salomey Sakyibea Addo Dr. Francis Anto Student Academic Supervisor Date………………. Date……………….. i University of Ghana http://ugspace.ug.edu.gh ACKNOWLEDGEMENT The successful completion of this work was made possible by the support, contributions and constructive criticisms of a number of persons. I am very grateful to Dr Francis Anto, my academic supervisor for his unreserved direction, time and judicious contributions throughout this study. I also appreciate the entire department of Epidemiology and Disease Control for their contributions that have helped in shaping my work. I am also thankful to Dr Isaac Kobina Abban, the Acting Medical Superintendent, Mr Gideon Akpele , the head of the records department and staff of the Princess Marie Louis Hospital for their permission and assistance during the period of this study. My heartfelt gratitude to my research assistants Thomas, Carl and Silas for your commitment and dedication during the period of data collection. I am indebted to my family for all the support and encouragement, especially my father Mr. G. A. Addo for being my number one cheerleader. Finally to the Weekend MPH class of 2018, thanks for the family love. ii University of Ghana http://ugspace.ug.edu.gh TABLE OF CONTENTS DECLARATION ........................................................................................................................... i ACKNOWLEDGEMENT ........................................................................................................... ii TABLE OF CONTENTS ............................................................................................................ iii LIST OF TABLES ....................................................................................................................... vi LIST OF FIGURES .................................................................................................................... vii LIST OF ABBREVIATIONS ................................................................................................... viii ABSTRACT .................................................................................................................................. ix CHAPTER ONE ............................................................................................................................1 INTRODUCTION .........................................................................................................................1 1.1 Background of the study ........................................................................................................1 1.2 Statement of the problem .......................................................................................................2 1.3 Justification ............................................................................................................................3 1.4 Narrative for the conceptual framework ................................................................................6 1.5 Objectives ...............................................................................................................................7 1.6 Research Questions ................................................................................................................7 CHAPTER TWO ...........................................................................................................................8 LITERATURE REVIEW .............................................................................................................8 2.1 Overview ................................................................................................................................8 2.2 WHO Rational Drug Use Indicators ....................................................................................10 2.3 Recommended approaches to Rational Use of Drugs ..........................................................15 2.4 Case Management of Malaria ..............................................................................................15 CHAPTER THREE .....................................................................................................................18 METHODOLOGY. .....................................................................................................................18 3.1 Study Design ........................................................................................................................18 3.2 Study Setting ........................................................................................................................18 3.3 Study Population ..................................................................................................................20 3.4 Variables ..............................................................................................................................20 3.5 Sampling ..............................................................................................................................22 3.6 Data Collection Techniques and Tools ................................................................................22 iii University of Ghana http://ugspace.ug.edu.gh 3.6.1 Data Collection .................................................................................................................23 3.7 Quality Control ....................................................................................................................24 3.8 Data Processing and Analysis ..............................................................................................24 3.9 Ethical Issues ........................................................................................................................25 CHAPTER FOUR .......................................................................................................................26 RESULTS .....................................................................................................................................26 4.1 Demographic Characteristics of participants .......................................................................26 4.2 Prescribing Indicators ..........................................................................................................27 4.3 Diagnostic test results and antimalarials prescribed ............................................................27 4.4 Patient Care Indicators .........................................................................................................29 4.5 Indices of WHO Drug Use Indicators ..................................................................................29 4.6 Socio-demographic characteristics of Prescribers ...............................................................30 4.7 Prescribers training and knowledge of RUD .......................................................................31 4.8 Factors influencing practice of RUD ...................................................................................32 4.9 Socio-demographic characteristics of caregivers. ................................................................33 CHAPTER FIVE .........................................................................................................................35 DISCUSSION ...............................................................................................................................35 CHAPTER SIX ............................................................................................................................41 CONCLUSION AND RECOMMENDATION .........................................................................41 6.1 Conclusion ...........................................................................................................................41 6.2 Limitation .............................................................................................................................41 6.3 Recommendation .................................................................................................................42 REFERENCE ...............................................................................................................................43 APPENDIX ...................................................................................................................................46 Appendix I ..................................................................................................................................46 Appendix II ................................................................................................................................48 STRUCTURED QUESTIONAIRE FOR PRESCRIBERS .......................................................48 Appendix III ...............................................................................................................................52 QUESTIONNAIRE FOR CAREGIVERS .................................................................................52 Appendix IV ...............................................................................................................................55 PRESCRIBING INDICATOR FORM ......................................................................................55 iv University of Ghana http://ugspace.ug.edu.gh Appendix V ................................................................................................................................56 v University of Ghana http://ugspace.ug.edu.gh LIST OF TABLES Table 3.1 Variables under study ................................................................................................... 20 Table 4.1 Demographic Characteristics of participants .............................................................. 26 Table 4.2 Prescribing Indicators ................................................................................................... 27 Table 4.3. Treatment of Malaria ................................................................................................... 28 Table 4.4 Patient Care Indicators ................................................................................................. 29 Table 4.5 Indices of WHO Drug Use Indicators (Akl et al., 2014) .............................................. 30 Table 4.6 Socio-demographic characteristics of Prescribers ........................................................ 31 Table 4.8 Bivariate analysis of independent variables.................................................................. 32 Table 4.9 Socio-demographic characteristics of patients’ parents/guardians ............................... 33 Table 4.9.1 Caregivers’ knowledge on drugs prescribed ............................................................. 34 vi University of Ghana http://ugspace.ug.edu.gh LIST OF FIGURES Figure 1.1 Conceptual Framework for rational use of drugs .......................................................... 5 Figure 3.1 Map of the Princess Marie Louis Hospital .................................................................. 19 Figure 4.3 Percentage distribution of prescribed antimalarial drugs at the out patients’ department..................................................................................................................................... 28 vii University of Ghana http://ugspace.ug.edu.gh LIST OF ABBREVIATIONS DTC Drug and Therapeutic Committee EDL Essential Drug List PML Princess Marie Louis RDT Rapid Diagnostic Test RUD Rational Use of Drugs STG Standard Treatment Guidelines WHO World Health Organization viii University of Ghana http://ugspace.ug.edu.gh ABSTRACT Many disease conditions have either lingered or resulted in death largely because drugs have been irrationally used in their management or treatment in developing countries. Malaria is one of such diseases which have featured in numerous mortality reviews especially in Ghana in the most vulnerable population, children. This study sought to assess how drugs are rationally used in the treatment of Malaria. It also sought to identify the types of anti-malarials used in the management of Malaria, the appropriateness of the prescription for the children (dose, frequency of dosing and the duration of therapy) and the adherence of the prescriptions to the WHO rational prescribing indicators. The study was conducted at the Princess Marie Louis Children’s Hospital in Accra a referral centre for children located in the heart of Accra. This study employed the WHO prescribing indicators to assess the trend of rational use of drugs in the management of malaria by reviewing records on children treated for malaria at the hospital between January 2017 and December 2017 as well as interviewing of prescribers and care givers who visited the facility during the study period. Data was entered, cleaned, coded and analyzed using STATA version 15 statistical software package. A total of 150 patient records were reviewed. The average number of drugs per prescription was 3.19 (95% CI 3.02-3.37). The percentage of drugs written in generics and from the essential drug list were 78.3% (CI 74.43-82.08) and 89.8% (CI 86.60-92.96) respectively. The percentage of encounters with antibiotics and injections were 48% (CI 40.66-56.67) and 4% (CI 0.86-7.13) respectively. The mean patient consulting time with prescriber was 13 minutes (CI 11.92-14.19) and dispensing time was 1.20 minutes (0.94-1.34). More than half of the patients’ parents and ix University of Ghana http://ugspace.ug.edu.gh guardians (83% (CI 77.30-89.37) could accurately recall the dosage regimen of drugs dispensed to them. The proportion of the drugs dispensed that were accurately labeled was 91.4% (88.77- 94.07). Training and profession of prescriber (whether the prescriber is a medical doctor or a physician assistant) had significant association with knowledge and practice of Rational Use of Drugs. The antimalarials prescribed in the facility were Artemether Lumefantrine 73% (CI 65-79), Artesunate Amodiaquine 24% (CI 18-32) and Dihydroartemisinin Piperaquine 3% (1.4-7.8). Eighty nine percent of the prescriptions were appropriate treatment (right dose per weight, for out-patients at the facility). Polypharmacy, indiscriminate prescribing of antibiotics and brand prescribing may be the practice in this facility. The other prescribing indicators were of tolerable levels compared to the WHO stipulated limits. Consulting time was appreciable, dispensing time was, however, inadequate which might have influenced the proportion of parents or guardians who could correctly recall the dosage regimen of the dispensed drugs. Continuous training on Rational Use of Drugs and the profession of the prescriber (whether the prescriber is a doctor or physician assistant) of the prescribers have significant impact on knowledge and practice of Rational Use of Drugs. x University of Ghana http://ugspace.ug.edu.gh CHAPTER ONE INTRODUCTION 1.1 Background of the study Drug therapy is a vital part of healthcare delivery, it can advance a patient’s quality of life and wellbeing status if only utilized properly (Hospital & Sciences, 2016). From a medical point of view, the unsuitable usage of medicines can commence at any of the four primary phases of the medicines use cycle. These four stages are diagnosis, prescribing, dispensing, and patient compliance. The diagnosis step entails recognizing and outlining the issue(s) requiring intervention. This underlying step can set up a cycle of improper medicine usage if the wrong disease condition is outlined for intervention. Once a conclusion on a diagnosis is arrived, an intervention will typically be recommended—this could be a pharmacological or a non-drug intervention. Subsequently, patients are given the indicated medicines, and are then anticipated to adhere to them (Ofori-Asenso & Agyeman, 2016). Reasonable use of drugs necessitates that patients get remedies suitable for their medical requirements, in doses that correspond to their individual requirements, for a sufficient period of time, and at the barest cost to them and their community. The idea of the rational use of medicines is an ancient one, since 300 B.C, when the Greek physician Herophilus said that “medicines are nothing in themselves, but are the very hands of god if employed with reason and prudence”(Ofori-Asenso & Agyeman, 2016). Rational drug prescription and use has been a matter of concern in healthcare settings, particularly in developing countries (Afriyie, et al 2015). Rational Use of Drugs (RUD) basically entails suitable prescribing, correct apportioning and proper use of medicines by patients for the diagnosis, inhibition, alleviation and management of diseases. RUD can also be depicted as safe, 1 University of Ghana http://ugspace.ug.edu.gh worthwhile and cost-effective use of drugs. RUD can be achieved if patients obtain medicines suitable for their health needs, at ideal dosages and ample time, as well as at a cost affordable to the patient and the public (Desalegn, 2013). This implies that irrational prescribing can be described as the therapeutically improper and cost ineffective usage of pharmaceuticals. It may occur in varying forms; ill use, abuse, polypharmacy, adverse drug events or drug-drug interactions (Agabna, 2014). It results in reduction in effectiveness of drug intervention, increased hospitalization, mortality, cost of therapy, risks of unwanted drug effects, ultimately promoting poor patient outcomes and wastage of limited resources (Afriyie, 2014). 1.2 Statement of the problem As indicated by World Health Organization (WHO), fifty percent of all medicines are recommended, dispensed or sold inappropriately while fifty percent of patients do not comply with the prescribed regimen (Michelo, 2015). This is also the pattern in healthcare systems in the third world countries. A systematic analysis (1995-2015) of the pattern of drug use within the WHO African region revealed trends that do not meet the WHO standards (Ofori-Asenso, Brhlikova, & Pollock, 2016). Similar studies done in Zambia (Michelo, 2015), Tanzania (Hospital & Sciences, 2016) and Ghana (Afriyie, 2014) also suggest a high prevalence of irrational drug use in Africa. All over the world, the commonest motives for improper usage of medicines include inadequate literature on prescribed drugs, poor correspondence between health care providers and patients, lack of diagnostic facilities, request from the patient (assuming that ‘every ill has a pill’), and flawed drug supply system (Michelo, 2015) . This has measurable untoward impact on health care costs, worth of drug therapy and upsurge of antimicrobial resistance. Other negative effects are the increased danger of adverse drug events, drug-drug interactions and non-compliance of patients to the intervention (Sisay et al, 2017) 2 University of Ghana http://ugspace.ug.edu.gh Most of the studies done in rational drug use targeted the general population whiles focus is taken off infants and children who are vulnerable to contract illnesses and to the harmful effects of drugs due to their under developed make-up. The recent incidences of morbidity and mortality attributed to irrational drug use in children in some facilities in the country (https://www.myjoyonline.com/.../boy-10-dies-over-alleged-medical-negligence7/11/17) are issues of concern. In order for such a study to be done efficiently, attention needs to be centered on the trend of drug usage in the management of a prevalent disease in a health facility. Malaria is one of such prevalent diseases amongst children. It represented 13% mortality in children under 5 years, 42% in children aged 5-9 years (the leading cause of death in children in this age bracket), and 27.6% in the adolescent age group at the Princess Marie Louis Hospital according to a cross sectional review of mortality data from 2003-2013 (Tette et al, 2016). These high mortality rates could be ascribed to various factors of which the pattern of rational treatment is inclusive hence the need for studies in this area. 1.3 Justification In developing countries, most of the studies done in rational drug use targeted the general population whiles focus is taken off infants and children who are vulnerable to contract illnesses and to the harmful effects of drugs because of their under developed make-up. Irrational drug use is one such practice which needs to be studied extensively because of the possible effects it can have on the pediatric population. Unfortunately most drug use studies done centered on the adult population and the results extrapolated to describe the possible pattern in children. Studies done on rational drug use locally by Ahiabu and colleagues (2017) on review of antibiotic prescriptions in primary health-care facilities, Afriyie et al. (2015) on the trend of antimalarial 3 University of Ghana http://ugspace.ug.edu.gh drugs prescription at the Ghana Police Hospital, and Afriyie (2014) also describing the trend of appropriate drug use at the Police Hospital, all paid attention to the general population. Promotion of appropriate drug use in children is the need of the hour globally. This could only be done when in-depth studies are directed to the pediatric population in this area. Results and findings from such studies will influence policies and protocols in child friendly health facilities, affect the relevance prescribers and all stakeholders will attach to drug use and ultimately affect the health outcome of children who access health from these facilities. 4 University of Ghana http://ugspace.ug.edu.gh SOCIODEMOGRAPHICS OF PRESCRIBERS/DRUG DISPENSERS AGE SEX WORK EXPERIENCE P ATIENT FACTORS AG E OF CHILD PRESCRIBER PATIENT’S PARENT’S FACTORS PREFERNCE AND BELIEFS WHO DRUG USE INDICATORS KNOWLEDGE OF RUD PATIENT’S PARENT’S EXPECTATIONS PRESCRIBING INDICATORS PHARMACEUTICAL COMPANIES SOCIO ECONOMIC PATIENT CARE PROMOTIONAL STATUS OF INDICATORS ACTIVITIES PARENTS/NHIS FACILITY EDUCATIONAL LEVEL OF PARENTS INDICATORS FACILITY FACTORS ENABLING FACTORS DIAGNOSTIC FACILITIES AVAILABILITY OF DRUG & TREATMENT THERAPEUTIC GUIDELINES COMMITTEE RATIONAL PRESCRIBER/D USE OF WORK LOAD ISPENSER DRUGS TRAINING ON RUD Figure 1.1 Conceptual Framework for rational use of drugs 5 University of Ghana http://ugspace.ug.edu.gh 1.4 Narrative for the conceptual framework Figure 1.1 is a conceptual framework which explains how various factors affect the order of rational drug use in a health facility. The practice of prescribing drugs rationally is directly or indirectly influenced by the socio-demographic factors of the prescriber and the dispensers. These factors being the age, sex, final academic level and work experience also has an influence on the clinical skills, knowledge of rational use of drugs and the extent to which a pharmaceutical company’s promotional activities can persuade his prescribing pattern. The presence of diagnostic facilities in the facility helps in proper diagnosis of a disease or condition which will invariably enable the prescriber settle on the right drug to prescribe for particular patients. A Drug and Therapeutic Committee which has a role of conducting effective interventions to improve medicine use by way of education of prescribers and dispensers , proper management of pharmaceutics stocks and regulation of prescribing pattern. Generally the high work load in health facilities due to high patient to prescriber/dispenser ratio also has an impact on rational drug use in most health facilities. Patient factors like patient’s parents preference for certain drugs, beliefs, expectations, socio-economic status and educational level also invariably determine the pattern of rational drug use in a facility. Lastly but most importantly the availability of enabling factors like drug policies guiding prescriptions, treatment guidelines and frequent training of prescribers and drug dispensers also have a huge influence on the degree at which prescribers and dispensers adhere to the WHO standards of prescribing and ultimately rational prescribing. 6 University of Ghana http://ugspace.ug.edu.gh 1.5 Objectives General Objective: To assess the pattern of Rational Drug Use in the treatment of Malaria in out-patients at the Princess Marie Louis Hospital Specific Objectives: 1. To identify the types of anti-malarial used in the treatment of malaria in the Hospital. 2. To assess the appropriateness of the prescription for the children (dosage regimen). 3. To assess the prescriptions for adherence to the WHO rational prescribing guidelines. 1.6 Research Questions 1. What are the types of anti-malarial used in the treatment of Malaria in out-patients at the Hospital? 2. Are the drugs prescribed appropriate for the patients (appropriate regimen)? 3. Do the prescriptions adhere to the WHO rational prescribing guidelines? 7 University of Ghana http://ugspace.ug.edu.gh CHAPTER TWO LITERATURE REVIEW 2.1 Overview The resolution to recommend medicine(s) is entirel in light of medical rationale (which may be as a result of classical signs and indications and a diagnostic test procedure) The choice of drug is founded on its viability, safety, suitability, accessibilty and cost. The patient who is the focal point is to be considered. Factors such as the age, sex, co-morbidity and contraindication also influence the remedy chosen. After a choice of drug is made, precise, relevant and clear information with respect to the patient’s conditions and medications recommended should be made available to the patient (Ofori-Asenso et al, 2016). This brings to for the issue of Rational Use of Drugs. Rational Use of Drugs (RUD) by and large involves proper prescribing, correct supply and suitable patient use of medications for the diagnosis, inhibition, alleviation and management of ailments. It is also termed as safe, worthwhile and cost effective use of drugs. To enhance RUD, the patient ought to get medicines which are apt for their health care conditions, at ideal doses and adequate period, and in addition at the cost that the individual and the community can bear (Desalegn, 2013). Inappropriate Drug Use, however, entails the therapeutically unsuitable and economically unproductive use of pharmaceuticals. It is a typical practice that occurs in both developed and developing countries, with great expense considering the constrained resources available and the medical implications involved. It may occur in various forms; abuse, overuse, polypharmacy, adverse drug occurences or drug-drug interactions (Agabna, 2014). Its effect includes decrease in value of drug, increased hospitalization, mortality, cost of therapy, risks of undesirable drug 8 University of Ghana http://ugspace.ug.edu.gh effects, eventually resulting in poor patient outcomes and wastage of limited resources (Afriyie, 2014). Studies have been done in this area by Hogerzeil, (1995) where the global situation of this problem was evaluated using the WHO indicators. The study also elaborated strategies to advance rational drug use. It made a claim that prescribing practice in teaching hospitals which serve as a training field for students is often improper and inconsistent. As high as 41-91% of all antibiotics prescriptions in teaching hospitals were considered inappropriate (Hogerzeil, 1995). In a cross-sectional study in Eastern Ethiopia, rational drug use was assessed based on WHO core drug use pointers in some selected public hospitals. This study uncovered a trend of polypharmacy, high exposures to antibiotics and injections, short consultation and dispensing periods. It also spelt out administrative, educational, regulatory and economic interventions as strategies to annul the trend of irrational drug use (Sisay et al., 2017). A retrospective appraisal of antibiotic prescriptions in essential health-care facilities in the Eastern Region of Ghana suggested a high level and inappropriate antibiotic use, limited use of analytical tools and non-compliance to standard treatment guidelines in these facilities (Ahiabu et al., 2017). A study on prescribing trends of anti-malarials at the Ghana Police Hospital however demonstrated an acceptable and rational prescribing pattern. The use of injectable anti- malarials was however high even though there were low numbers of complicated malaria cases for which that is indicated. The study recommends that further critical studies had to be done to establish the appropriateness of prescribed antimalarial drugs and dosage regimens (Afriyie et al., 2015). 9 University of Ghana http://ugspace.ug.edu.gh 2.2 WHO Rational Drug Use Indicators The World Health Organization/International Network of Rational Use of Drugs (WHO/INRUD) drug utilization pointers are designed to quantify the nature of prescribing in essential health care centres. These are highly reliable and offer evidence to healthcare administrators regarding drug utilization, prescribing procedures and vital features of patient care. This helps to compare or surveil facilities over time. In a number of countries, these pointers have been verified in the field comprehensively and have been observed to be applicable, not difficult to create, quantifiable, valid, unfailing, representative, amenable and comprehensible (Hospital & Sciences, 2016). The indicators center on performance of the health facility in prescribing convention by healthcare providers, areas of patient care covering both clinical consultation and pharmaceutical supply and the availability of facility-related factors which enhances rational drug use (WHO, 1993). The WHO indicators that measure the prescribing practices are: Prescribing Indicators: These measure the performance of health care providers in key areas related to the appropriate use of drugs. They include: 1. Average number of medications for every encounter. 2. Percentage of drugs prescribed by generic names. 3. Percentage of encounters in which an antibiotic is recommended. 4. Percentage of encounters with an injection prescribed. 5. Percentage of medications prescribed from essential list or formulary. 10 University of Ghana http://ugspace.ug.edu.gh Patient Care indicators: These measure the experience of patients at health facilities with reference to how well they have been informed about the pharmaceuticals recommended for them. They include: 1. Average Consultation time 2. Average dispensing time 3. Percentage of prescribed drugs actually dispensed 4. Percentage of drugs adequately labelled 5. Knowledge of patients on dosage Facility Indicators: These speak to the features of the work setting at the healthcare facility that affect the ability to prescribe drugs rationally. They include: 1. Availability of copy of essential drugs list or formulary 2. Availability of key drugs (Hogerzeil, 1995), (Akl, El Mahalli, Elkahky, & Salem, 2014). 2.2.1 Prescribing Indicators Average number of drugs per prescription evaluates the degree of polypharmacy. It is computed by the ratio of total number of different drug products prescribed to the number of prescriptions reviewed (World Health Organization, 1993). Ideally not more than two drugs are to be prescribed per encounter per WHO standards (Sisay et al., 2017). Rational drug use studies conducted in Uganda (Ministry of Health, 2008), Nigeria (Adebayo, 2010) and Yemen (Abdo- Rabbo, 2003) gave values like 3.0, 2.8 and 3.9 respectively. A comparative study at the Ghana Police Hospital also gave an average value of 3.7 which are all higher than the recommended value (Afriyie et al., 2015). This trend shows a pattern of polypharmacy which is linked with a 11 University of Ghana http://ugspace.ug.edu.gh high risk of unfavorable health outcomes. Polypharmacy involves the use of multiple medications or more than are medically necessary. It increases drug-drug interactions, adverse drug events and reduces patient compliance, Percentage of drugs prescribed by generic names measures the likelihood of prescribing in generics. This indicator is the result of the ratio of the number of prescribed drugs in generics to the total drugs prescribed multiplied by 100 (Desalegn, 2013). WHO highly recommends that all drugs recommended ought to be in generics (Sisay et al., 2017). It is considered as a safety measure for the patient as it gives a clear identification and guarantees better correspondence between health care providers (Akl et al., 2014). According to Ofori-Asenso et al(2016), the trend of generic prescribing may vary for government (68.9-84.5%) and private (47.7-75.7%) health facilities. This trend of generic prescribing could be attributed to the prevailing practice of procuring generic drugs in government health facilities (Sisay et al., 2017). Using generic names in prescribing is an effective way of reducing patient cost and also comes with ease of recollecting medication and accessibility (Wang et al., 2013 and Sisay et al., 2017). Factors that may influence generic prescribing include prescribers’ confidence and trust in branded products, limited documents to endorse claims on bioequivalence and bioavailability of generics and also influence of drug marketers (Joda & Aderemi-williams, 2013) . Percentage of encounters in which an antibiotic is prescribed evaluates the level of use of antimicrobials in the health facility. This is calculated by the result of the ratio of number of patient consultation with prescribers during which an antimicrobial is recommended to the total number of encount surveyed, multiplied by 100 (World Health Organization, 1993). Per WHO standards less than 30% of encounters are expected to have antibiotics prescribed. In a drug utilization pattern study in 12 third world countries, the percentage of prescriptions with antimicrobials were 56% in Uganda, 48% in Nigeria, 63% in Sudan and 29% in Zimbabwe 12 University of Ghana http://ugspace.ug.edu.gh which is impressively on the higher side. Irrational and over use of antibiotics results in antimicrobial resistance which will result in a post antimicrobial era sooner or later. This will occur as a result of imbalance between the upsurge of antimicrobial resistance and waning rate of antimicrobial drug development (Sisay et al., 2017). Percentage of encounters with an injection prescribed explains the level of use of injections in the health facility and is figured by the ratio of the number of patient prescriptions in an injection is prescribed by the total number of encounters surveyed multiplied by 100 (World Health Organization, 1993). Accepted limits of encounters with injections in a drug use study in a health facility is 13-21% (Sisay et al., 2017). Reasons for excessive use of injections may be beliefs and attitudes of patients about the efficacy of injections compared to oral medications. Indiscriminate use of injections may result in unnecessary injection cost, risk of transmitting infections through needle injuries, physiological and psychological pain during injection. Percentage of drugs prescribed from the essential list or formulary gives an idea the degree to which prescribing practices comply with the national drug policy. This is calculated by dividing the number of drugs prescribed from the essential drugs list by the total number of medications prescribed, multiplied by 100 (World Health Organization, 1993). In a study on the prescribing trends of anti-malarials at the Ghana Police Hospital, 89.6% of drugs were prescribed from the essential drug list compared to the standard of 100% (Afriyie et al., 2015). 2.2.2 Patient Care indicators Average Consultation time measures the time spent with patients in the consultation and prescribing process. It is the time between entering and exiting the consulting room. This is calculated by dividing the total time for a number of consultations by the number of consultations (World Health Organization, 1993). The average consultation time stipulated by 13 University of Ghana http://ugspace.ug.edu.gh WHO is 15 minutes. It is perceived that longer consultation time brings about improved patient satisfaction and more effective resource use. Average dispensing time measures the average time a personnel dispensing drugs spends with patients. It is the time between arriving at the dispensary counter and leaving. It is calculated by dividing the total time for dispensing drugs to a series of patients, by the number of encounters (World Health Organization, 1993). Percentage of drugs actually dispensed measures the extent to which health facilities are able to provide the drugs prescribed. It is calculated by dividing the number of drugs actually dispensed at the health facility by the total number of drugs prescribed multiplied by 100 (WHO, 1993). WHO requires that all drugs prescribed in a facility should be dispensed there at the facility’s pharmacy (Sisay et al., 2017). A description of the pattern of rational use in Ghana Police Hospital revealed that 64.8% of prescribed drugs were actually supplied from the hospital pharmacy of which 24.2% of the encounters received all their prescribed medications, whilst 31.7% and 14.2% received more than half and half of their drugs respectively (Afriyie, 2014). Percentage of drugs adequately labeled measures how well dispensers provide essential information on the drugs they dispense. This is calculated by dividing the number of drugs packages which has the drug name and dosage regimen by the number of drugs dispensed multiplied by 100 (WHO, 1993). Patient’s knowledge of correct dosage indicator measures well the patients understands the information given to them on the dosage schedule of the drugs they receive. It is calculated by dividing the number of patients who can adequately report the dosage regimen for all drugs given them by the total number of patients interviewed, multiplied by 100 (WHO, 1993). 14 University of Ghana http://ugspace.ug.edu.gh 2.3 Recommended approaches to Rational Use of Drugs Instituting and utilizing national or hospital-specific standard treatment guidelines (STG), clinical procedures, conventions and organized strategies to diagnosis and therapy helps to advance rational drug use. STGs most especially are to be developed and reviewed in consultation with prescribers periodically for each level of care taking into account the prevalent morbidities and the specialties of available prescribers. The STG is supposed to be consistent with treatment plan established by National Disease Program such as Malaria, diarrhea and tuberculosis (Laing & Hogerzeil, 2001). Another important component of rational drug use is the Essential Drug List which is formulated based on the familiar conditions and complaints pertaining in the health facility and the treatment recommendations in the Standard Treatment Guidelines. The presence of a functional Drug and Therapeutic Committee with defined responsibilities regarding monitoring and promoting quality use of medicines in a health facility also propels rational drug use. This committee has the fundamental assignment of developing and updating institutional STGs (usually formulated from the national guidelines); performing drug utilization audits using prescription surveys. It likewise sets up framework for review of patients records, peer-review and continuing education (Laing & Hogerzeil, 2001). 2.4 Case Management of Malaria Malaria is a major cause of morbidity and mortality in Ghana and responsible for many hospital admissions in children. Prevalence among children under 5 years in the Malaria Indicator Cluster Survey (2011) demonstrated levels between 4-51% per region. In the light of this the Strategic Plan for Malaria Control in Ghana 2014-2020 outlines blueprints both preventive and curative interventions to bring prevalence to minimum. It suggests that every suspected case of Malaria 15 University of Ghana http://ugspace.ug.edu.gh ought to be tested, positive cases treated with recommended quality-guaranteed antimalarial medicine and treated cases should be tracked to reduce the burden of the disease. This strategy is to prevent the numerous instances where every fever related condition is associated with malaria and treated indiscriminately (Akotsen-Mensah, 2014). Malaria based on clinical diagnosis is associated with unnecessary treatment and inappropriate use of drugs, toxicity and increased cost to both the patient and the health care system (Field et al., 2002). A suspected case of uncomplicated malaria which is normally seen on the out-patient basis shows symptoms and signs of fever within the preceding 2-3days, chills, headache, sweating, vomiting, abdominal pains, irritability and refusal to feed (especially in children), bitterness in the mouth. These signs and indications are similar to that of other febrile infectious diseases like pneumonia, meningitis, otitis media, tonsillitis and enteric fever hence the requirement for a definitive diagnosis. This could be made with microscopy or a Rapid Diagnostic Test (RDT) to determine the presence of malaria parasites in the blood. Parasitological diagnosis is currently the basis for treatment for malaria in conformity to global proposals and recommendations. Children of all ages are to be tested to confirm disease prior to giving anti-malarial treatment (Akotsen-Mensah, 2014). 2.4.1 Recommended Drug Therapy for Malaria Artemisinin-based Combination Therapy (ACT) products have been recommended for the treatment of uncomplicated malaria after it was established that the malaria parasite is resistant to Chloroquine and other monotherapies. Three ACTs available for use in Ghana are Artesunate- Amodiaquine (AS-AQ), Artemether-Lumefantrine (A-L), and Dihydroartemisinin –Piperaquine (DHAP) (National Drug Policy, Ghana, 2009). These oral ACTs must be taken for at least three days for optimum effect. 16 University of Ghana http://ugspace.ug.edu.gh The dosing of these drugs is done according to the body weight of the patient hence the need for health facilities to have weighing scales. The patient’s weight is also to be indicated in the folder or on the prescription form for drugs to be dispensed accordingly. The recommended dose of 4mg/kg/day Artesunate and 10mg/kg/day Amodiaquine is given once or twice daily for 3 days. Artemether-Lumefantrine is also a 6-dose regimen over a 3-day period. Its dosing is based on the number of tablets per dose according to predefined weight ranges. Children with weights which range from 5-14 kg will take 1tablet (20/120mg) at a dose, 15-24 kg=2 tablets (40/240), 25-34 kg=3 tablets (60/360 mg) and those above 34 kg will take 4 tablets (80/480 mg) for 3days.This indicates that Artemether-Lumefantrine is not recommended in babies below 5kg. Absorption of Lumefantrine is augmented by the ingestion of fat containing meal. Patients’ caregivers are to be notified of this when Artemether-Lumefantrine is being dispensed. The dosage regimen for Dihydroartemisinin Piperaquine on the other hand is 4 mg/kg/day Dihydroartemisinin and 18 mg/kg/day Piperaquine once daily for 3 days (Akotsen- Mensah, 2014). Management of fever with an antipyretic like paracetamol is a necessary supportive care in treatment of malaria. Treatment may also come with a multivitamin which can boost the immune system for speedy recovery ( Nwachukwu et al., 2016). 17 University of Ghana http://ugspace.ug.edu.gh CHAPTER THREE METHODOLOGY. 3.1 Study Design Outpatient folders were reviewed and data on prescribing pattern for malaria treatment were collected from folders at the Records Department of the Hospital. Antimalarial drug prescribing patterns for a period of one year (January, 2017 to December, 2017) was assessed using modified WHO prescribing indicators for rational drug use in a health facility (WHO, 1993) to obtain the mean number of drugs per encounter, proportion of antimalarial drugs prescribed by their generic name, proportion of encounters with antibiotics, proportion of encounters with injections and proportion of the drugs prescribed from the national essential drug list and recorded using a data collection form adapted from (WHO,1993). Folders were also checked for evidence of a diagnostic testing for malaria, either the rapid diagnostic or microscopic test and recorded. 3.2 Study Setting The study was conducted at the Princess Marie Louis Hospital in June, 2018. Princess Marie Louis Hospital is a Ghana Health Service Children’s Healthcare Institution located in Accra within the Ashiedu Keteke Sub Metro of the Greater Accra Region (figure 3.1). It is an 82 bed facility that provides medical and Child healthcare services to about 73,000 infants and children in the Accra Metropolis and beyond annually. It has the largest Nutritional Rehabilitation Unit in the country. Princess Marie Louise Children’s Hospital provides both primary and secondary care for pediatric patients under the age of 18 years, in accordance with the definition of a child in the Children’s ACT Ghana, 1998. Thus; parents can bring their children to the hospital with or 18 University of Ghana http://ugspace.ug.edu.gh without a referral at any time. Referrals are also received from health centres, private clinics, government polyclinics and hospitals located in and around Accra. The hospital has a total of 273 staff with 6 permanent doctors and 147 nurses .The medical services of PML consist of an Out-patient Department (OPD), Emergency ward, Laboratory unit/Blood Bank, Radiology Unit, Dietetics and Environment Health Unit, Disease Control Unit, Family Planning and Reproductive and Child Health (RCH) units among others. These services are complemented with a Pharmacy unit with a staff strength of 12 (includes 3 Pharmacists, 1 Dispensing Technologists, 1 Dispensing Assistants, 2 Supply officers and the rest auxiliary staff), which runs a 24 hour service for both In-patients and Out-patients in the hospital. Figure 3.1 Map of the Princess Marie Louis Hospital https://www.google.com.gh/maps/place/Princess+Marie+Louise+Children's+Hospital, 27/06/18 19 University of Ghana http://ugspace.ug.edu.gh 3.3 Study Population The study population included children who visited the out-patient department of the Princess Marie Louis Hospital between the period January, 2017 and December, 2017 and were managed for Malaria. Prescribers who were at post during the month, June 2018 when data was collected and parents or guardians of children who visited the facility during the study period were also included in the study. 3.3.1 Inclusion criteria Folders of all children who visited the out- patient Department of the Princess Marie Louis Hospital with Malaria during the period January, 2017 to December, 2017 with complete diagnosis were included in the assessment of the prescribing indicators; parents of patients who visited the hospital during the study period (June 2018) and their prescriptions were examined for the patient care indicators. 3.3.2 Exclusion criteria Folders of out-patients who were not treated for malaria or had incomplete records were excluded. 3.4 Variables The variables under study are Rational Use of Drugs ( Prescribing Indicators, Patient Care Indicators and Facility Indicators) being the Dependent variable. The Independent Variables are the Socio-demographics of the patients, caregivers and prescribers which are clearly spelt out in Table 3.4. 20 University of Ghana http://ugspace.ug.edu.gh Table 3.4 Variables under study Variable Type of Operational definition Measurement Variable scale (RUD) Average number of drugs per encounter. Discrete Prescribing Dependent Percentage of drugs prescribed by generic Indicators names. Percentage of encounters in which an antibiotic is prescribed. Percentage of encounters with an injection prescribed. Percentage of drugs prescribed from essential list or formulary. Patient Care Dependent Average Consultation time Continuous Indicators Average dispensing time Percentage of prescribed drugs actually dispensed Discrete Percentage of drugs adequately labelled Percentage of caregivers with knowledge of correct dosage regimen Facility Dependent Indicators Age Independent Age of Children, Prescribers and caregivers continuous measured in years Sex Independent Sex of Children, Prescribers and caregivers Binary being either male or female Profession Independent Defined by whether the prescriber is a Nominal medical, doctor, physician assistant Workload Independent Number of Patients seen by the prescriber in Discrete a day Years of Independent Years spent as a prescriber Continuous Prescribing Educational Independent Educational level of Caregivers being none, Ordinal Level primary, secondary and Tertiary 21 University of Ghana http://ugspace.ug.edu.gh 3.5 Sampling 3.5.1 Sample Size Determination WHO (1993) recommends the use of at least 100 patients records for Drug Utilization Studies in a single health facility. In order to get more reliable results (greater point estimate of the population) 150 out-patient folders were assessed for the prescribing indicators. All prescribers available during the period of data collection were included in the study. 3.5.2 Sampling Procedure An ordered list of out-patient encounters treated for malaria in the facility within the period of January, 2017 to December, 2017 was made according to the date of admission. This amounted to 452 encounters. This number of encounters during the period was divided by the sample size of 150 giving a sampling interval of 3. The sampling process was started on the first encounter represented in the chronological frame. The first encounter was selected and subsequent encounters were selected by skipping 3 encounters. The 4th encounter was selected as the 2nd sample, the 7th encounter as the 3rd sample and so forth till 150 encounters were selected. 3.6 Data Collection Techniques and Tools Training of Research assistants Three research assistants; Pharmacist interns who are familiar with pharmaceutical terms were trained on ethical issues, questionnaire administration and extraction of information on demographic data, diagnosis and treatment from patients’ medical records and engaged for the collection of data. 22 University of Ghana http://ugspace.ug.edu.gh Pretesting of data collection tools Pretesting was done at the children department at the Korle Bu Hospital because it had similar characteristics as the study population to validate my data collection tools and make them more reliable for use. 3.6.1 Data Collection 3.6.2 Prescribing Indicators Data were collected by reviewing Prescribing Indicator Forms from folders of patients, who were diagnosed and treated for malaria within the period January, 2017 and December, 2017; this included demographic characteristics such as age and sex, evidence of a diagnostic test, diagnosis, anti malarials used, drugs prescribed in generics, whether an injection or antibiotic was prescribed and appropriateness of treatment with regards to the weight of the patient, dose of antimalarial prescribed, frequency and duration of treatment. 3.6.2 Patient Care Indicators With the help of a stop watch, contact time of health care providers with patients (consultation and dispensing time) was determined. Consultation time was obtained by starting the stop clock when the patient enters the consulting room and stopping it when they exit. The time spent was noted and recorded. Dispensing time was also recorded as the time the patient spent at the counter when he/she is called to receive his/her drugs at the pharmacy. Other data regarding patient care, like prescribed drugs actually dispensed, drugs adequately labeled, Patient’s parent/guardian knowledge of correct dosage were assessed from their prescription and dispensed drugs at the OPD during the period of data collection using the patient care form. The 23 University of Ghana http://ugspace.ug.edu.gh availability of Essential Drug List and Standard Treatment Guidelines was assessed at the consulting room and recorded. Questionnaires were administered to prescribers in the consulting rooms at the out-patient department to assess their knowledge on rational prescribing and prescribing practices and also to parents and guardians of patients who visited the out-patient department of the hospital to assess the level of care they receive at the hospital with respect to drug use as they exit the pharmacy. 3.7 Quality Control The research assistants (pharmacist interns) were recruited based on their exposure to hospital practice, names of medicines, medical abbreviations and medical diagnosis. They were trained for two days on the use of the data collection tools, information to collect from folders, administering of questionnaires and how to handle ethical and security issues. The prescribing indicator forms were checked periodically for completeness and errors and where necessary corrections were made. As part of data validation, double entry was done. 3.8 Data Processing and Analysis The data collected with the Prescribing Indicator Forms were screened for errors and completeness. The data were entered into Stata 15 and descriptive statistical analysis was carried out to obtain summary tables and graphs containing age groups, sex, percentage of drugs prescribed from the EDL, by generic and percentage of prescriptions with antibiotics and injections that were prescribed. All statistical analyses were reported with 95% confidence intervals (C.I) with the level of statistical significance set at p<0.05 for all tests. Results were expressed as means, frequencies, and percentages and in graphs. A measure of association 24 University of Ghana http://ugspace.ug.edu.gh between the outcome variable and predictive variables was determined using Chi squared test and Fisher’s Exact. 3.9 Ethical Issues The proposal for this study was submitted to the Ethics Review Committee of the Ghana Health Service for review and approval (GHS-ERC078/02/18) before commencement of the study. Appropriate facility entry process was taken before starting data collection. Informed consent was sought from all participants before data was collected. The aims and objectives of the study were clearly spelt out to participants. Data collected from participants was kept confidential and was used only for the purposes of the study. Individuals who wished to opt out of the study were allowed to do so at any point of the study. The study participants were assured that all their information will be confidential and will not be disclosed to anyone without their permission. The study materials (questionnaires and inform consent forms) were labeled with unique identification numbers for each study participant. All information obtained was kept in locked files by the principal investigator. 25 University of Ghana http://ugspace.ug.edu.gh CHAPTER FOUR RESULTS 4.1 Demographic Characteristics of participants A total of 150 patient folders were reviewed for children between the ages of 3 months and 12 years with an average age of 3 years 4 months. Sixty-nine (46%) of these folders were for males and eighty-one (54%) for females as shown in in (Table 4.1) Table 4.1 Demographic Characteristics of participants Variables Frequency (N=150) (%) Age (months) 0-23 54 36.00 24-47 39 26.00 48-71 29 19.33 72-95 16 10.67 96-119 7 4.67 120-143 4 2.67 144-167 1 0.67 Sex Male 69 46.00 Female 81 54.00 26 University of Ghana http://ugspace.ug.edu.gh 4.2 Prescribing Indicators A total of 479 drugs were prescribed for treatment of malaria during the period under study. One to six drugs were prescribed per encounter with a mean of 3 (CI 3.02-3.37). Most (78.3%, CI 74.43-82.08) of the drugs were prescribed using their generic names with the majority of them (89.8%, CI 86.60-92.96) being drugs from the essential drug list. About half (49%, CI 40.66-56.67) of the encounters had antibiotics prescribed for their treatment and few (4% CI 0.86 -7.13) had injections as part of their treatment. Significant differences were observed between the prescription practice and that recommended by WHO (Table 4.2). Table 4.2 Prescribing Indicators Variables Value WHO Value p-value WHO RUD Indicators Average number of drugs per encounter 3.19 2 < 0.001 Percentage of drugs prescribed in generic names 78.26% 100% < 0.001 Percentage of encounters with antibiotics 48.70% < 30% < 0.001 Percentage of encounters with injection 4.00% < 10% < 0.001 Percentage of drugs from the essential drugs list 89.78% 100% < 0.001 4.3 Diagnostic test results and antimalarials prescribed Twenty-eight (19%) of the encounters were not taken through a diagnostic test before treatment while 40% had negative test results and 41% positive test results (Table 4.3). The types of antimalarials prescribed were Artemether Lumefantrine 73% CI (65-79), Artesunate Amodiaquine 24% CI (18-32), Dihydroartemisinin Piperaquine 3% CI (1.4-7.8) (Figure 4.3). 27 University of Ghana http://ugspace.ug.edu.gh Table 4.3. Treatment of Malaria Variables Frequency (N=150) (%) Types of Antimalarials prescribed Artemether Lumefantrine 109 73.0 Artesunate Amodiaquine 36 24.0 Dihydroartemisinin Piperaquine 5 3.0 Diagnostic test No diagnostic test 28 19 Negative results 60 40 Positive results 62 41 Appropriate treatment (dosage regimen) 134 89 Figure 4.3 Percentage distribution of prescribed antimalarial drugs at the out patients’ department. 28 University of Ghana http://ugspace.ug.edu.gh 4.4 Patient Care Indicators Patients spent between two to sixteen minutes (mean: 13 minutes, CI: 11.92-14.19) during consultation with the doctors. Dispensing time lasted between one to seven minutes and a mean period of 1.20 minutes CI (0.94-1.34) for each patient. Most (89.6%, CI: 86.83-92.28) of the drugs prescribed during consultation were obtained from the hospital pharmacy, with majority (91.4%, CI: 88.77-94.07) of the drugs dispensed at the pharmacy adequately labeled. Eighty three percent (CI: 77.3-89.37) of the out-patient relatives who took their medications from the hospital pharmacy could give accurate information on the dose, frequency and duration for the drugs dispensed to them, with statistically different differences between the practice at the pharmacy and that recommended by WHO (Table 4.4). Table 4.4 Patient Care Indicators Variables Value WHO Optimal Value p-value Average consultation time 13 mins 15 mins < 0.001 Average dispensing time 1.20 mins >3 mins < 0.001 Percentage of drugs actually dispensed 89.6% 100% < 0.001 Percentage of drugs adequately labeled 91% 100% < 0.001 Percentage of Patients’ relatives who know Correct dosage regimen 83% 100% < 0.001 4.5 Indices of WHO Drug Use Indicators The indices of the Drug Use Indicators from the study were all lower than the optimal index with the exception of Index of safe injection use and consultation time which were 2.5 and 1.3 respectively (Tables 4.5). 29 University of Ghana http://ugspace.ug.edu.gh Table 4.5 Indices of WHO Drug Use Indicators (Akl et al., 2014) Indices Index of study optimal index Index of non-polypharmacy 0.63 1 Index of drugs prescribed in generic name 0.78 1 Index of safe antibiotics use 0.61 1 Index of safe injection use 2.5 1 Index of drugs prescribed from the essential drugs list 0.90 1 Consultation time index 0.86 1 Dispensing time index 0.40 1 Index of drugs actually dispensed 0.89 1 Index of drugs adequately labeled 0.91 1 Index of Patients’ relatives who know Correct dosage regimen 0.83 1 Index of availability of EDL 1 1 Index of key drugs in stock 0.89 1 4.6 Socio-demographic characteristics of Prescribers Prescribers who were available for consultation at the Out-Patient Department consultation during the period of study numbered 15; 8 (53%) of them were males while 7 (47%) of them were females. Their mean age was 33 years (31.28-36.59) with the oldest being 45 years and the youngest 28 years. Three (20%) were physician assistants while 12 (80%) were medical doctors who had worked averagely for 6 years (2-15 years) (Table 4.6). Each prescriber saw on the average 42 patients daily. Sixty percent of them indicated that they had knowledge of RUD. 30 University of Ghana http://ugspace.ug.edu.gh Table 4.6 Socio-demographic characteristics of Prescribers Variables Frequency (N=15) (%) Age (years) ≤29 3 20.00 30-34 6 40.00 35-39 4 26.67 40-44 1 6.67 45-49 1 6.67 Sex Male 8 53.33 Female 7 46.67 Profession Physician Assistants 3 20.00 Doctors 12 80.00 Years of prescribing ≤4 6 40.00 5-9 6 40.00 10-14 2 13.33 15-19 1 6.67 4.7 Prescribers training and knowledge of RUD Only 9 out of the 15 prescribers representing 60% (CI: 31.8-82.9) of them indicated that they had knowledge of and practice RUD. Forty-seven percent of them (CI 21.7-73.4) said they acquired the knowledge through previous training. The prescribers gave reasons for non-adherence to RUD to be as a result of complexities of disease, 6 (40% CI 17.14-68.23%), late presentation of lab results, 4 (26.7% CI 9.04-57.06), desire to experiment drugs introduced by pharmaceutical 31 University of Ghana http://ugspace.ug.edu.gh representatives, 2 (13.3% CI 2.77-45.27) and hospital pharmacy stocks, 3 (20% CI 5.62-51.17). Two of the prescribers (13.33%) indicated that they do not always test for malaria before treatment whiles 13 of them (86.67%) said they always test for malaria before treatment. 4.8 Factors influencing practice of RUD Table 4.7 shows the result of a Fisher’s exact analysis of the independent variables. This shows whether there is a significant association between the independent variables and the knowledge and practice of RUD. The P values obtained showed that none of the variables have significant association with knowledge with the exception of profession and training on RUD which had P values of 0.044 and 0.007 respectively. Table 4.7 Bivariate analysis of independent variables Variables Fisher’s exact P value Age 0.597 Sex 0.608 Profession 0.044 Years of prescribing 0.849 Workload 0.197 Presence of DTC in the hospital 1.000 Source of Information on drugs 1.000 Training on RUD 0.007 Test for malaria 0.486 32 University of Ghana http://ugspace.ug.edu.gh 4.9 Socio-demographic characteristics of caregivers. Table 4.8 shows the characteristics of patients’ parents/guardians who brought their children to the hospital for treatment and were interviewed during the study, 15 (10%) of them were men and 135 (90%) women. Their ages were between 22 years and 45 years with a mean of 33.93 years. Those who had some level of education were 126 (84%) whiles 24 (16%) had no form of formal education. A Chi squared analysis of their Socio-demographic characteristics revealed that there was no significant association between any of these characteristics and their ability to adequately recall the dosage regimen. However, the time they spent at the counter of the pharmacy during dispensing was seen to have a significant association χ2 14.636 (pvalue 0.023) with their ability to recall the dosage regimen. Table 4.8 Socio-demographic characteristics of patients’ caregivers Variables Frequency (N=150) (%) x² (pvalue) Age (years) 4.438(0.350) 21-25 9 6 26-30 36 24 31-35 52 35 36-40 36 24 41-45 17 11 Sex 1.200(0.273) Male 15 10 Female 135 90 Educational level 3.569(0.312) None 24 16 Primary 49 33 Secondary 62 41 33 University of Ghana http://ugspace.ug.edu.gh Tertiary 15 10 4.9.1 Caregivers’ knowledge of the drugs dispensed Out of the 150 caregivers interviewed, 87 (58%) of them had knowledge of the name of drugs dispensed to them, 63 (42%) had no knowledge of that. Those who had knowledge of the dosage regimen were 125 (83%), only 99 (66%) had knowledge of how to store the drugs. None of them had knowledge of the side effects of the drugs they had received as spelt out in Table 4.9.. Table 4.9 Caregivers’ knowledge on drugs prescribed Variables Frequency (N=150) (%) Knowledge of name of drug Yes 87 58 No 63 42 Knowledge of regimen Yes 125 83 No 25 17 Knowledge of side effect Yes 0 0 No 150 100 Knowledge of storage Yes 99 66 No 51 34 34 University of Ghana http://ugspace.ug.edu.gh CHAPTER FIVE DISCUSSION Irrational use of drugs is a global issue which comes with its detrimental outcomes and antimalarials are no exception. The WHO/INRUD drug use indicators were used to: describe pattern of treatment in outpatients at the Princess Marie Louis Hospital. The study uncovered that the average number of drugs prescribed per encounter was 3 (CI 3.02-3.37). This was statistically different from the Optimal value of 2 drugs set by WHO. This value is, however, similar to that of studies done in general populations in Uganda, by the Ministry of Health, Uganda, (2008), Nigeria, Adebayo & Hussain, (2010) and Yemen, Abdo-Rabbo (2003) with values of 3.0, 2.8 and 3.9 respectively. A similar study at the Ghana Police Hospital also gave an average value of 3.7 (Afriyie et al., 2014) which are all higher than the WHO recommended value. This may have happened as a result of overuse of antibiotics, injections, analgesics, haematinics and multivitamins stemming from syndromic management of disease, inadequate knowledge on RUD and also to please patients who request for particular drugs to be prescribed. This trend shows a pattern of poly-pharmacy which is associated with a number of negative effects being unnecessary cost to the patient, drug-drug interactions which comes with adverse drug reactions and reduced adherence to the drugs because of the number (Viktil et al., 2007). The percentage of drugs prescribed in generics marker is considered as a safety measure for the patient as it gives a distinguishing identification and guarantees better communication between health care providers (Akl et al., 2014). It was identified that 78.30% of all drugs prescribed for the treatment of malarial in the hospital were written in generics. The value obtained in this study was significantly below the ideal of 100% as set out by WHO. It was however comparable to the 35 University of Ghana http://ugspace.ug.edu.gh values obtained in a study done in government (68.9-84.5%) and private (47.7-75.7%) health facilities ( Ofori-Asenso et al., 2016). This trend could be as a result of pressure from pharmaceutical agents who visit hospitals frequently to promote their brands (Toop & Mangin, 2015). Other causes may be prescribers’ lack of trust in generics and the perception that they are substandard ( Joda & Aderemi-williams, 2013). These, however, come with unnecessary cost to the patients as branded drugs are more expensive, inconvenience of running around to source branded drugs especially when they are not notable and readily available brands (Pulcini et al, 2007). Prescribing antimalarials by generic name may reduce duplicity, improve access to medicines and, consequently, increase patient compliance with drug therapy and disease control and also ensure less potential for confusion and error, especially when brand names are similar (Ojo, Igwilo, & Emedoh, 2014). Indiscriminate prescribing of antibiotics was a trend identified with prescriptions at the Princess Marie Louis Children’s Hospital. The value obtained for this indicator (48%) was significantly different from the WHO expected value of less than 30%. This shows that close to half of all prescriptions written in the facility have antibiotics. This value is similar to those revealed in a systematic analysis study done by Ofori-Asenso et al. (2016) but was lower than the value (65.4%) arrived at in a study in Zambia(Michelo, 2015). This inclination may have been as a result of unavailability of immediate diagnostic test and treating every febrile condition as one which needs an antibiotic(Hospital & Sciences, 2016). This trend could contribute to the current high prevalence of antibiotic resistance in developing countries(Ahiabu, Tersbøl, Biritwum, Bygbjerg, & Magnussen, 2018). The pattern of prescriptions for the treatment of malaria with injections 4% (0.86-7.13%) fell within the stipulated limits (less than 10%) for rational prescribing. This is a commendable 36 University of Ghana http://ugspace.ug.edu.gh practice since it saves the children the risk of complications in the form of abscesses at the site of injection, disabilities, unnecessary cost to the parents (generally injections are more expensive than oral medications) (Hospital & Sciences, 2016), unbearable pains from needle pricks and exposure to infections when unsterilized needles are used. It was revealed that only 89.8% of the drugs prescribed prescribed for malaria were from the essential drug list and it is significantly different from the optimal of 100%. It is comparable to the trend at the Ghana Police Hospital where the value obtained was 89.6% (Afriyie et al., 2015) and in health facilities in Eastern Region of Ghana (Ahiabu et al, 2016). It is, however, lower than the trend observed in healthcare centres in Egypt. This adds unnecessary cost to the therapy of patients. Drugs from the EDL issued by WHO are older drugs, already tested in practice, with established clinical use, and of lower cost than newer drugs (Akl et al., 2014). Results of the study indicated that averagely the patients spend about 13 minutes with prescribers during consultation which is significantly lower than that recommended by the WHO, 15 mins. Studies done in Southern India, Malawi and Egypt show shorter consulting periods of 8minutes (Aravamuthan et al, 2017), 2.1minutes (Sosola, 2007) and 7.1minutes (Akl et al., 2014) respectively. A Rational Drug Use study at the Cape Coast Teaching Hospital gave a comparable outcome of 13.2minutes (The Ghana Pharmaceutical Paracelsus, 2017). This result may have come about due to the patient overload during clinic hours. This means that the patients spend less time than expected with the prescriber which could affect the outcome of the consultation process. This will come about as patients’ parents will have less time to give total clinical complains and prescribers will not have ample time to physically examine patients for accurate diagnose for appropriate therapy to be prescribed (Akl et al., 2014). 37 University of Ghana http://ugspace.ug.edu.gh Another important indicator in the study of drug use is the dispensing time. From the study, the patients spend averagely 1.20 minutes at the counter during dispensing. This is significantly different and less than half of the time given by WHO, 3minutes but similar to a study done at the Ghana Police Hospital (Afriyie, 2014) however lower than the situation in India ( Binu et al, 2013). Inadequate time during dispensing means patient does not get enough information on their antimalaria drugs dispensed and this can affect adherence and thereby therapeutic success or failure (Akl et al., 2014). This is evident in the proportion of drugs appropriately labeled (91%) and proportion of parents (83%) who could accurately recall the dosage regimen of antimalarial drugs dispensed to them which are both below the stipulated value of 100%. It is essential that medicines are appropriately labeled and appropriate instructions given to suit the needs of patients ( Binu et al, 2013). According to Akotsen-Mensah, (2014), case management of malaria should start with a diagnostic test. This has been made easy with the availability of the Rapid Diagnostic Test (RDT) kit (Uzochukwu et al., 2010). It was surprising, however, to find out that 19% of the children were treated for malaria symptomatically without a diagnostic test while 40% of them were treated for malaria even with a negative test result. This was higher than the proportion (30%) treated for malaria even though a diagnostic test proved negative in a study in Zambia which looked at the quality of case management of malaria (Review, 2014). Looking at this trend it could be said that some of the children were given antimalarials even when they were not needed and that could be described as inappropriate drug use. Antimalarials prescribed were all from the Artemisinin based combination therapy which is in accordance with the National Antimalarial Drug Policy as the first line of treatment for uncomplicated malaria (Policy, 2009). These have been shown to be effective, less toxic and well tolerated (Nwachukwu et al, 2016). 38 University of Ghana http://ugspace.ug.edu.gh The drugs prescribed were Artemether Lumefantrine 73%, Artesunate Amodiaquine 24% and Dihydroartemisinin Piperaquine 3%. According to the policy these drugs are to be given with respect to the weight of the patient continually for three days (Akotsen-Mensah, 2014). A review of the patient prescriptions revealed that of 134 prescriptions, (89%) of them were appropriately written with regards to their dosage regimen. This implies that about 11% of the children treated within the period received either an under dose or overdose of their drugs for treatment. Children who find themselves in this group will not fully recover, may grow resistance to these antimalarials or may experience the severe form of the disease (Ofori-Asenso & Agyeman, 2016). The indices of the drug use indicators helps to conveniently compare the values of the rational drug use indicators revealed in the study to that set out by WHO (Akl et al., 2014). The values from Table 4.5 indicate that all the indicators were below the stipulated standards with the exception of the rational use of injections and availability of EDL in the facility. All prescribers who were interviewed during the study were between the ages of 28 and 45 years with a mean age of 33 years who had prescribed averagely for 6 years. Physician Assistants formed 20% of the prescribers whiles 80% were Medical Doctors who attended to averagely 42 patients in a day. Only 60% of these prescribers had knowledge on RUD and indicated that factors like complexities of disease, (40%) (CI 17.14-68.23%), late presentation of laboratory results, (26.7%), desire to experiment drugs introduced by pharmaceutical representatives, (13.3%) and pharmacy stock levels (20%) influenced their inclination to prescribing rationally or not. 39 University of Ghana http://ugspace.ug.edu.gh Interestingly, from the Fisher’s analysis, it was revealed that there was a significant association between the profession (whether the prescriber is a physician assistant or a medical doctor) and knowledge of RUD and between training on RUD and knowledge of RUD. Factors like age, years of prescribing, workload, presence of Drug and Therapeutic Committee, prescribers’ source of information on drugs, whether a prescriber tests for malaria before treatment or not, were, however, were not significantly associated with knowledge of RUD. A Chi square analysis of the socio-demographic characteristics of the patients’ parents/guardians to show association with their knowledge with their ability to recall their dosage regimen revealed that their age, sex and their educational background were all not significantly associated. This signifies that these characteristics had no significant influence on their ability to recall their dosage regimen. Further analysis to identify if the patient care indicators (consulting time and dispensing time) had some association with their ability to recall their dosage regimen showed that dispensing time had a significant association with their ability to recall the dosage regimen. This clearly shows that adequate and quality time spent with the patient during dispensing of their drugs informs how well they will know their drugs and invariably adhere to them. From Table 4.9, only 58% of the caregivers interviewed knew the name of the drugs dispensed to them, 83% of them had knowledge on the dosage regimen (dosage, frequency and duration), 34% of them knew how they were supposed to store their drugs but none had knowledge on the side effects. This trend may result in non adherence, drug overuse or abuse, reduced efficacy of drugs (most drugs after reconstitution become unstable hence has to be kept in the refrigerator, Al Zomor et al, (2013)) and ultimately the health outcome after drug treatment. Patient’s knowledge of correct dosage is highly beneficial to avoid irrational use of drugs(Akl et al, 2014). 40 University of Ghana http://ugspace.ug.edu.gh CHAPTER SIX CONCLUSION AND RECOMMENDATION 6.1 Conclusion The antimalarials prescribed in the facility were Artemether Lumefantrine, Artesunate Amodiaquine and Dihydroartemisinin Piperaquine which is in accordance with directions by The National Drug Policy and Guidelines to Case Management of Malaria. A greater proportion of prescriptions were appropriately written for out-patients at the facility. Polypharmacy, indiscriminate prescribing of antibiotics and brand prescribing may be a practice at the Princess Marie Louis Hospital, however, Injections were prescribed moderately in the facility and were within tolerable limits indicated by WHO. Consulting time was appreciable, dispensing time was, however, inadequate which might have influenced the proportion of parents or guardians who could correctly recall the dosage regimen of the dispensed drugs. Training on RUD and the profession (whether the prescriber is a doctor or physician assistant) of the prescribers have association with knowledge and practice of RUD. 6.2 Limitation It was assumed that the prescribers whose prescriptions for the period of January, 2017 to December 2017 were reviewed were the same prescribers who were interviewed during the study and that their prescribing practices had not changed significantly over time through training and increased knowledge. 41 University of Ghana http://ugspace.ug.edu.gh 6.3 Recommendation 1. Prescribers should be trained periodically on Rational Use of Drugs to ensure better patient care outcomes. 2. Dispensers should be entreated to spend quality time with patients during dispensing, give adequate information on dose, frequency, duration and storage of drugs dispensed to them. 3. Prescribers should be motivated to prolong consultation time that allows them to take thorough history, examine patients comprehensively, and establish good rapport with patients to improve patients care. 4. Further studies should be done on drug use by nurses in the children at the wards. 42 University of Ghana http://ugspace.ug.edu.gh REFERENCE Abdo-Rabbo, A. (2003) Prescribing rationality and availability of antimalarial drugs in Hajjah,Yemen. East Mediterranean Health Journal 9: 607-617. Adebayo E. T., Hussain N. A. (2010) Pattern of prescription drug use in Nigeria Army Hospitals. Ann Afri Med 9: 152-158. Afriyie, D. K. (2014). Full Length Research Paper A description of the pattern of rational drug use in Ghana Police Hospital. Int J Pharm & Pharmacol, 3(1), 143–148. Afriyie, D. K., Amponsah, S. K., Antwi, R., Nyoagbe, S. Y., & Bugyei, K. A. (2015). Prescribing trend of antimalarial drugs at the Ghana Police Hospital. Journal of Infection in Developing Countries, 9(4), 409–415. https://doi.org/10.3855/jidc.5578 Agabna, N. M. (2014). Irrational Prescribing. Sudan Journal of Rational Use of Medicine, 1(7), 4. Ahiabu, M. A., Tersbøl, B. P., Biritwum, R., Bygbjerg, I. C., & Magnussen, P. (2016). A retrospective audit of antibiotic prescriptions in primary health-care facilities in Eastern Region, Ghana. Health Policy and Planning, 31(2), 250–258. https://doi.org/10.1093/heapol/czv048 Ahiabu, M., Tersbøl, B. P., Biritwum, R., Bygbjerg, I. C., & Magnussen, P. (2017). A retrospective audit of antibiotic prescriptions in primary health-care facilities in Eastern, (June 2015), Journal 250–258. https://doi.org/10.1093/heapol/czv048 Akl, O. A., El Mahalli, A. A., Elkahky, A. A., & Salem, A. M. (2014). WHO/INRUD drug use indicators at primary healthcare centers in Alexandria, Egypt. Journal of Taibah University Medical Sciences, 9(1), 54–64. https://doi.org/10.1016/j.jtumed.2013.06.002 Akotsen-Mensah, C. (2014). Management of insects in Ghana. Journal of Ghana Science, 11(5), 201–242. Al Zomor, A. K., Alakhali, K. M. A., & Al Mekhlafi, A. G. (2013). Stability of Reconstituted Cefuroxime Axetil at Different Temperature Storage Conditions. Pharmacie Globale (IJCP), 4(1), 1–5. Aravamuthan, A., Arputhavanan, M., Subramaniam, K., & Udaya Chander J, S. J. (2017). Assessment of current prescribing practices using World Health Organization core drug use and complementary indicators in selected rural community pharmacies in Southern India. Journal of Pharmaceutical Policy and Practice, 10(1), 1. https://doi.org/10.1186/s40545-016-0074-6 43 University of Ghana http://ugspace.ug.edu.gh Binu, M., Sabbu, R., Surendra, K. and Hiremath, D. (2013). Assessment of Drug Prescribing Practices Using WHO Prescribing Indicators in a Private Tertiary Care Teaching Hospital. International Research Journal for Inventions in Pharmaceutical Sciences, 1(2), 26–31. Desalegn, A. A. (2013). Assessment of drug use pattern using WHO prescribing indicators at Hawassa University teaching and referral hospital, south Ethiopia: a cross-sectional study. BMC Health Services Research, 13(1), 170. https://doi.org/10.1186/1472-6963-13-170 Field, M. S. F., Philippe, J., Wen, L., Guerin, P. J., Olliaro, P., Nosten, F., … White, N. J. (2002). Treatment , and a Proposed Agenda for Research and Development. Hogerzeil, H. (1995). Promoting rational prescribing: an international perspective. British Journal of Clinical Pharmacology, 39(1), 1–6. https://doi.org/10.1111/j.1365- 2125.1995.tb04402.x Hospital, I. D., & Sciences, A. (2016). Quality of drug prescription in primary health care facilities in Mwanza , north-western Tanzania, 18(4), 1–11. https://doi.org/10.4314/thrb.v18i4.5 Joda, A. E., & Aderemi-williams, R. I. (2013). Full Length Research Paper A comparative study of prescribing patterns in two tertiary care teaching hospitals in Lagos , Nigeria. International Journal of Pharmacy and Pharmacology, 2(1), 41–46. Laing, R. O., & Hogerzeil, H. V. (2001). Ten recommendations to improve use of medicines, Journal 16(1), 13–20. Michelo, C. (2015). Factors Associated with Irrational Drug use at a District Hospital in Zambia : Patient Record-based Observations, Journal 42(1), 25–30. Ministry of Health Uganda (2008) Pharmaceutical Situation in Uganda, Kampala: Ministry of Health Uganda. Nwachukwu, N. F., Mishra, M., Marcelle, T., Owolabi, J. B., & Owolabi, J. B. (2016). Effects of Vitamins in Augmentation of Malaria Treatment : A review, Journal 3(4), 34–43. https://doi.org/10.21276/apjhs.2016.3.4.6 Ofori-Asenso, R., & Agyeman, A. (2016). Irrational Use of Medicines—A Summary of Key Concepts. Pharmacy, 4(4), 35. https://doi.org/10.3390/pharmacy4040035 Ofori-Asenso, R., Brhlikova, P., & Pollock, A. M. (2016). Prescribing indicators at primary health care centers within the WHO African region: a systematic analysis (1995–2015). BMC Public Health, 16(1), 724. https://doi.org/10.1186/s12889-016-3428-8 Ojo, M. A., Igwilo, C. I., & Emedoh, T. (2014). Prescribing patterns and perceptions of health care professionals about rational drug use in a specialist hospital clinic, Journal 5, 99–103. https://doi.org/10.4081/jphia.2014.242 44 University of Ghana http://ugspace.ug.edu.gh Policy, D. (n.d.). Drug policy for ghana. Pulcini C, Cua E, Lieutier F, Dellamonica P, R. P. (2007). Report December 2007. Eur J Clin Microbiol Infect Dis (Vol. 26). Review, P. (2014). retrospective evaluation of the quality of malaria case management at twelve health facilities in four districts in Zambia, Journal 4(6), 498–504. https://doi.org/10.12980/APJTB.4.2014C153 Sisay, M., Mengistu, G., Molla, B., Amare, F., & Gabriel, T. (2017). Evaluation of rational drug use based on World Health Organization core drug use indicators in selected public hospitals of eastern Ethiopia: a cross sectional study. BMC Health Services Research, 17(1), 161. https://doi.org/10.1186/s12913-017-2097-3 Sosola, A. G. (2007). College of Medicine An Assessment of Prescribing and Dispensing Practices in Public Health Facilities of Southern Malawi, (December). the Ghana Pharmaceutical Paracelsus. (2017) (Vol. 12). Toop, L., & Mangin, D. (2015). The art and science of marketing medications. The New Zealand Medical Journal, 128(1421), 11–12. https://doi.org/10.1371/journal.pmed.1000352 Uzochukwu, B. S. C., Chiegboka, L. O., Enwereuzo, C., Nwosu, U., Okorafor, D., Onwujekwe, O. E., Uguru N. P., Sibeudu F. T., Ezeoke, O. P. (2010). Examining appropriate diagnosis and treatment of malaria : availability and use of rapid diagnostic tests and artemisinin-based combination therapy in public and private health facilities in south east Nigeria, Journal1–9. Viktil, K. K., Blix, H. S., Moger, T. A., & Reikvam, A. (2007). Polypharmacy as commonly defined is an indicator of limited value in the assessment of drug-related problems. British Journal of Clinical Pharmacology, 63(2), 187–195. https://doi.org/10.1111/j.1365- 2125.2006.02744.x Wang, H., Li, N. N., Zhu, H., Xu, S., Lu, H., & Feng, Z. C. (2013). Prescription Pattern and Its Influencing Factors in Chinese County Hospitals: A Retrospective Cross-Sectional Study. PLoS ONE, 8(5). https://doi.org/10.1371/journal.pone.0063225 World Health Organization. (1993). How to investigate drug use in health facilities. Retrieved from http://apps.who.int/medicinedocs/pdf/s2289e/s2289e.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3255423/ 20th December 2017. https://www.google.com.gh/maps/place/Princess+Marie+Louise+Children's+Hospital/ 27th June 2018. 45 University of Ghana http://ugspace.ug.edu.gh APPENDIX Appendix I INFORMED CONSENT Purpose I am Salomey Sakyibea Addo from the School of Public health, University of Ghana, and Legon. I am conducting a study on the Pattern of Rational Use of Drugs in the treatment of Malaria at the Princess Marie Louis Hospital. Procedure I will be seeking information on the pharmaceutical services you receive for your children from this facility. This will involve responding to some questions. I believe that the information obtained from this study will help identify the prescribing pattern in the treatment of malaria in this Hospital and generally improve upon the rational use of drugs in children who are the most vulnerable in society. Risks and Discomfort. There are no foreseen major risks associated with participating in this study. The procedure for this study which involves responding to some questions may cause some form of discomfort to 46 University of Ghana http://ugspace.ug.edu.gh you. However you are free to opt out at any point of the study if you wish to. This is purely an academic exercise and forms part of a research work towards the award of a Master of Public Health. Benefits There are no direct benefits to you. However, the information that will be obtained from this study may help improve health care delivery in the hospital and the nation as a whole. Confidentiality Information gathered from the study would be used purposely for research. Study participants are assured of confidentiality, no personal identifying information concerning you or your child will be presented in the analysis or publications of this study. The information gathered from the study will not be disclosed to anyone without participant’s permission. Contacts for additional information Please call the Principal Researcher Salomey Sakyibea Addo on 0245345022 if you have questions about the study. If you have any questions about your rights as a research participant or feel you have been treated unfairly, you may contact any of the following for further clarification or redress. - GHS/ Ethical Review Committee Administrator, Hannah Frimpong (mobile: 0507041223) - School of Public health, University of Ghana, Legon. 47 University of Ghana http://ugspace.ug.edu.gh I have read and understood the purpose of this exercise and agreed to be a participant. SIGNATURE: ………………………………………….. DATE: ……………………………… NAME OF RESEARCHER: ……………………………………………………………………… SIGNATURE: …………………………………………... DATE: ……………………………… Appendix II STRUCTURED QUESTIONAIRE FOR PRESCRIBERS I am Salomey Sakyibea Addo from the School of Public Health, University of Ghana, Legon. I am conducting a study on the ‘Pattern of Ration al Use of Drugs for the treatment of Malaria at the Princess Marie Louis Hospital. The purpose of this study is to identify the various anti- malarials in the hospital and how they are rationally used. I hope that the information obtained from this study will help identify the pattern of prescribing which will contribute to improve the care given to the children who access the facility. SECTION A: Name of Health Facility………………………………………………………… Date of Interview…………………………………………………………. SECTION B: SOCIO DEMOGRAPHIC INFORMATION OF PRESCRIBER 1. Age …………… 2. Gender Male [ ] Female [ ] 48 University of Ghana http://ugspace.ug.edu.gh 3. Profession Doctor [ ] Physician Assistant [ ] other, specify………….. 4. Years of Practice as a Prescriber…………………….. 5. Average number of patients you see in this facility per day………………. 6. How long does it take you to see a patient on the average……………..mins 7. Do you always give drug prescription to each patient that to you see? Yes [ ] No [ ] 8. Do you always fill out the prescription form order (Name, sex, age, weight, date, dose, frequency, duration)? Yes [ ] No [ ] SECTION C: RATIONAL USE OF DRUGS (RUD) 9. Do you have knowledge on RUD? Yes [ ] No [ ] 10. How would you rate your satisfaction with the RUD set standard? a) Highly satisfied [ ] b) Satisfied [ ] c) Normal [ ] d) Dissatisfied [ ] e) Highly dissatisfied [ ] Any reasons for your answer above ………………………………………………………….. DRUG INFORMATION 11. Do you have a Drug Information Unit in this facility? Yes [ ] No [ ] 49 University of Ghana http://ugspace.ug.edu.gh 12. Do you have a Drug and Therapeutic Committee in the facility? Yes [ ] No [ ] 13. What are your sources of information on drugs? a) Standard Treatment Guidelines [ ] b) British National Formulary [ ] c) Internet [ ] 14. Do you prescribe from the Essential Medicine List? Yes [ ] No [ ] TRAINING ON RATIONAL USE OF DRUGS 15. Have you received any training on RUD? Yes [ ] No [ ] 16. Has the training been beneficial to you in your practice? Yes [ ] No [ ] SOCIO-CULTURAL FACTORS 17. Have you had an encounter with clients who demanded/ preferred the following even though they were not needed? Yes [ ] No [ ] 18. Are all your patients who are treated for malaria tested before the treatment? Yes [ ] No [ ] 19. What are the types of Anti-malarials you normally prescribe for treatment in your patients here? a) Sulfadoxine-Pyrimethamine (SP) [ ] 50 University of Ghana http://ugspace.ug.edu.gh b) Chloroquine [ ] c) Artemisinin Monotherapy [ ] d) Artemether-Lumefantrine (AL) [ ] e) Artesunate+Amodiaquine (AA) [ ] f) Dihydroartemisinin-Piperaquine (DP) [ ] 20. REASONS WHY PRESCRIBERS MAY NOT FULLY ADHERE TO RUD STANDARDS a) Complexities of Disease Yes [ ] No [ ] b) Late presentation of laboratory results Yes [ ] No [ ] c) Desire to experiment new drugs introduced by Medical Representatives Yes [ ] No [ ] h) Stock of pharmacy Yes [ ] No [ ] 51 University of Ghana http://ugspace.ug.edu.gh Appendix III QUESTIONNAIRE FOR CAREGIVERS I am Salomey Sakyibea Addo from the School of Public Health, University of Ghana, Legon. I am conducting a study on the ‘Pattern of Ration al Use of Drugs for the treatment of Malaria at the Princess Marie Louis Hospital. The purpose of this study is to identify the various anti- malarials in the hospital and how they are rationally used. I hope that the information obtained from this study will help identify the pattern of prescribing which will contribute to improve the care given to the children who access the facility. SOCIO DEMOGRAPHIC INFORMATION 1. Age …………………. 2. Gender Male [ ] Female [ ] 3. Educational level Basic [ ] Secondary [ ] Tertiary [ ] 4. Averagely how long does it take you to see a doctor during consultation? ……………….. 5. Do you expect a drug prescription every time you see a Prescriber? 52 University of Ghana http://ugspace.ug.edu.gh Yes [ ] No [ ] 6. Averagely how many drugs do you expect on a drug prescription? ....................... 7. Do you expect an injection every time you see a doctor? Yes [ ] No [ ] 8. Have you ever demanded/ preferred a drug to be prescribed for you. Yes [ ] No [ ] 10. Averagely how long did you spend with the pharmacist or dispenser when taking your drugs? at the pharmacy?......................................... 11. Knowledge on Drugs dispensed. a) Name of Drug Yes [ ] No [ ] b) Dose Regimen (Dose, Frequency, Duration) Yes [ ] No [ ] c) Side effects Yes [ ] No [ ] d) storage of drugs Yes [ ] No [ ] 12. Did you get all your prescribed drugs from the hospital pharmacy? Yes [ ] No [ ] 13. If No, what proportion of the prescribed drugs did you get? ………………………………… 53 University of Ghana http://ugspace.ug.edu.gh 54 University of Ghana http://ugspace.ug.edu.gh Appendix IV PRESCRIBING INDICATOR FORM Location: ………………………………………………………………….. Investigator: …………………………………... Date……………………. *0=NO 1=YES ID Date Age Sex # # Antibiotics Injections # on of (yrs) Drugs Generics (0/1)* (0/1)* EDL Diagnosis Rx 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Total Aver. % 55 University of Ghana http://ugspace.ug.edu.gh Appendix V PATIENT CARE FORM Location……………………………………………………………………………………………. Investigator……………………………………………….. Date………………*0=No 1=Yes Seq. Patient Consulting Dispensing # Drugs # Drugs # Drugs Knows # Identifier Time Time Prescribed Dispensed Adequately Dosage (min) (sec) labeled (0/1) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Total Aver. % 56