MENTORED PRACTICUM: PROGRESS REPORT 1 (15% of practicum grade)NOTE: All information in all sections of this report obtained from outside sources must be appropriately cited in APA format. Student name: Uwamariya JoseeSupervisor name: Catherine KirkProject title: Assessment of anti-malaria and antibiotics drugs dispensing practice in retail pharmacies within Rubavu District.PART 1. INTRODUCTIONBackground (provide a short description of how the problem was discovered, the magnitude of the problem, the significance of the problem)This project was formulated in response to reports and observation of the over-dispensing of antimalarial and antibiotic drugs in retail pharmacies in Rwanda (Rwanda Ministry of Health, 2016). Irrational dispensing of medicines occurs “when patients receive medications that is not appropriate to their clinical needs, in doses that doesn’t meet their own individual requirements and for an inadequate period of time” (WHO, 2011) . One of the consequences of widespread irrational dispensing of medicines is the development of drug resistance (Bloland, 2001). Selling antimalarial and antibiotic drugs without prescription, wrong dosage, and use of both drugs to treat other infections such as viral common cold are contribute significantly to the over-dispensing of medications (USAID, 2015). Fairhurst et al. (2012) noted that repeated intake of antibiotics and artemesinin derivatives in small doses reduced sensitivity to both group of drugs and results in the development of resistant strains (Fairhurst, Nayyar, Breman, & Hallett, 2012). While containment efforts to stop spread of resistant parasites were underway, it was discovered that artemisinin resistance had emerged independently in multiple areas and that threatens the progress achieved in countries like Cambodia, Myanmar, Thailand and Vietnam (WHO, 2016).Following the resistance of the malaria parasites to chloroquine and amodiaquine in Rwanda, the Rwanda Ministry of Health introduced artemesinin combination therapy (coartem) as a response to the repeated resistance (“Rwanda Malaria Operational Plan,” 2007). In order to prevent future resistance of the parasite to this lifesaving drug, the current malaria treatment policy recommends that coartem be dispensed exclusively under medical prescription (Rwanda ministry of health, 2006). Despite that, irrational dispensing of antimalarial drugs continues to be reported in private pharmacies (Rwanda Ministry of Health, 2016) and may lead to coartem resistance. In addition to the resistance of chlroroquine and amodiaquine in the past, Rwanda had also experienced antimicrobial resistance. A study conducted at Kigali University Teaching Hospital (KUTH) about antimicrobial resistance among common bacterial found that, Rwanda had a high rates of antimicrobial resistance among gram negative and gram positive organisms (Ntirenganya et al, 2015). The magnitude of antimalarial and antibiotics that are dispensed without medical prescription in Rwanda is still unknown. However, in this study we have measured the magnitude of antimalarial and antibiotics that were dispensed without medical prescription in Rubavu district. The result from participant observation indicated that 66% of antimalarial treatment was dispensed without medical prescription, whereas 76% of antibiotics were dispensed without medical prescription. This magnitude is the ratio of antimalarial and antibiotic packages dispensed without medical prescription over the overall number of dispensed antimalarial and antibiotic packages. This study will help in understanding factors underlying the dispensing practices of non-prescribed antimalarial and antibiotic drugs.Problem Statement (provide a clear, brief and appropriate problem statement for your practicum)Factors underlying dispensation of antimalarial and antibiotics without medical prescription in Rubavu retail pharmacies is unknown.SMART Practicum Objective (State the SMART objective of your practicum project)Long-term objectiveDetermine the factors underlying dispensation of antimalarial and antibiotics without a prescription in Rubavu retail pharmacy by February 2018.Short-term objective- To measure the percentage of antimalarial drugs requested without medical prescription by December 2017.- To measure the percentage of antibiotic drugs requested without medical prescription by December 2017.- To identify the root cause of dispensers dispensing antimalarial and antibiotic drugs without prescription by December 2017.Setting and Beneficiaries.This project took place in retail pharmacies that are located in Gisenyi Sector, which is the urban area of Rubavu District. Rubavu is the most populated district in the western province of Rwanda with more than 400,000 residents (National Institute of Statistics of Rwanda (NISR), 2015). There are overall 15 registered retail pharmacies in Rubavu district and each retail pharmacy has at least three health workers (typically one registered pharmacist and two registered nurses). These pharmacies serve the urban town of Gisenyi, which is in Western Rwanda on the border with the Democratic Republic of Congo. The retail pharmacies dispense medicines to clients who use private health insurance and to clients who pay out of their own pocket. The main beneficiaries of this project are pharmacy health workers and policy makers, whom the results from the study will help to improve policy based on evidence, ultimately the improvement of dispensing practices for pharmacy health workers.PART 2. LITERATURE REVIEW(Provide a full review of what is currently known about the question or issue being addressed, as described in the literature, and what knowledge gap you will be addressing. Organize your literature review with headings from general to specific, and fully cite all evidence using APA style.)Malaria and infectious diseases remain the major cause of death in sub-Saharan Africa (Wafula, 2013). Each year, 154-289 million people contract malaria, causing up to 971,000 deaths (WHO, 2012), whereas in 2008, 3.4 million people have died from lower respiratory tract infections (Wafula, 2013). Timely and appropriate treatment of malaria and bacterial infections could prevent millions of deaths. Malaria is a disease caused by parasites that are transferred from one person to another through the bites of infected female Anopheles mosquitoes (WHO, 2016). In addition to high mortality rate associated with malaria, it causes financial burden in malaria endemic countries (Roll Back, 2010). It is estimated that “malaria costs Africa US$12 billion per year in direct costs and reduces GDP growth by 1.3 percent annually” (Nonvignon et al., 2016). Malaria cases are mostly concentrated in sub-Saharan Africa due to altitude, climate, population movement, and irrigation schemes (USAID, 2016). Malaria is an avoidable and curable disease (WHO, 2017). WHO recommends artemesinin based combination therapy (ACT) as the first line treatment for uncomplicated cases of malaria caused by Plasmodium falciparum (WHO, 2017). ACTs have been found to be more effective in treating the disease and decreasing the rate of transmission of plasmodium parasites (Bloland et al, 2000). However, ACT needs to be used properly in order to avoid future resistance of that lifesaving drug (Ajonina et al, 2015). While anti-malarial drugs can combat malaria, irrational dispensation and use of antimalarial drugs can create the opposite effect and increase the burden of malaria by increasing disease morbidity, mortality and risks of emergence of resistance (WHO, n.d.). Rational dispensing of medicines refers to “Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community” (WHO, 2011); any deviation from such practice is considered irrational dispensing of medicines. In addition to irrational dispensing of anti malaria drugs, irrational use of antibiotics is also a global health concern given the consequences associated with it (Shehadeh et al., 2012). Though antibiotics are supposed to be dispensed only under medical prescription (Hadi et al., 2016), they are the most commonly self medicated drug in developing countries (Núñez, Tresierra-Ayala, & Gil-Olivares, 2016). It is estimated that more than 50% of antibiotics are dispensed without medical prescription despite the fact it is illegal (Hadi et al., 2016).One of the major consequences of irrational dispensation and use of medicines is the development of drug resistance (Ajonina et al., 2015) .Drug resistance is defined as ” the ability of a parasite strain to remain alive regardless the administration and absorption of a drug given in doses equal or higher than those usually recommended”(Bloland, 2001). Irrational dispensing of antimalarial and antibiotic drugs constitute major risks of increasing parasite resistant to effective treatment by increasing disease recurrence, morbidity and mortality (Ezenduka et al., 2014). Irrational dispensing of antimalarial and antibiotic drugs has been reported in many developing countries including Sudan, Togo, Ethiopia, Kenya and Uganda (Kimoloi et al, 2013). Studies have found that the knowledge of the provider, financial incentives and competition were factors contributing to inappropriate dispensing of medicines in the retail sector (Ezenduka, 2014). Pharmacists may be driven by patient demand and profit, instead of guided by principles of professionalism (Uzochukwu et al., 2011). Lack of professional ethics and ignorance of treatment guidelines among healthcare workers in retail pharmacies may also contribute to the high rate of irrational dispensing and inappropriate use of antimalarial and antibiotic treatment, which further can induce parasite strains resistant to currently effective treatment (Aborah et al., 2013).Sustainable Development Goal number 3 focuses on health and within this aims to control malaria and other diseases (United Nations, 2015). Among the primary preventive measures is to ensure the availability of effective anti-malaria therapies and integrated vector control (Lutgen, 2016). Despite the multiple efforts, irrational dispensing and use of anti-malaria drugs continue to be reported in different country especially in developing countries (Ajonina et al., 2015).The malaria burden in Rwanda was 1,957,000 population in 2015 (Rwanda Ministry of Health, 2016b) and the development of resistance to antimalarial has contributed to that burden in the past (MSF, 2002). Since 2015, Rwanda have experienced a sudden increases of malaria cases from 2,473,387 in 2015 to 4,669,687 in 2016 (Rwanda Biomedical Center, 2017).?Though they were an increase of malaria cases in all Rwandan districts, 75% of malaria cases were located in Rubavu District (Rwanda Biomedical Center, 2017). Plasmodium strain’s resistance to chloroquine and sulfadoxine combined with pyrimethamine (Fansidar) were first identified in Rwanda in 1999, therefore the country switched its malaria treatment protocols to the combination of amodiaquine and fansidar (MSF, 2002). Later the parasite also developed resistance to this combination therapy of amodiaquine and fansidar (MSF, 2002). In response to repeated resistance, Rwanda has shifted its malaria treatment protocol and adopted the artemesinin based combination therapy Coartem (atemether plus lumefentrine,) as the first line treatment (Rwanda ministry of health, 2006). Despite the effectiveness of artemesinin derivatives in treating malaria, potential resistance of artemesinin cannot be ignored. In another study on artemesinin resistance found resistance mutation increased from 2.5% in 2014 to 4.5% in 2015 in Rwanda (Lutgen, 2016). Despite that, irrational dispensing of coartem has still been reported in retail pharmacies in Rwanda (Rwanda Ministry of Health, 2016).In addition to the resistance of antimalaria drug in the past, Rwanda had also experienced antimicrobial resistance. A study conducted at Kigali University Teaching Hospital (KUTH) about antimicrobial resistance among common bacterial found that, Rwanda had a high rates of antimicrobial resistance among gram negative and gram positive organisms (Ntirenganya et al, 2015).The prevention of further development of antimalarial and antibiotic drug resistance requires the assessment of dispensing practice in retail pharmacies due to the fact that the greater number of malaria treatment and antibiotics are provided through the private retail pharmacies (Kimoloi et al., 2013). Ezenduka et al,( 2014), recommended that malaria case management in developing country require appropriate attention to private retail pharmacies, given the fact that retail pharmacies are the main suppliers of antimalarial drugs in developing countries.In Rwanda, private retail pharmacy should operate under the supervision of a registered pharmacist who is responsible for overseeing day-to-day activities of the pharmacy (Ministry of Health (MOH), 2013). The law regarding dispensation of pharmaceutical products released by the Rwanda ministry of health in the official gazette of 17/01/2013 stated that prescription only medicine (POM) shall be dispensed on basis of a medical prescription under the control of a pharmacist (Ministry of Health (MOH), 2013). This implies that dispensing of POM without a medical prescription is illegal. Artemether-lumefantrin (Coartem) and oral antibiotics available in the reference book that we use here in Rwanda as a practical guidance for physicians, pharmacist and nurses are considered as POM (MSF, 2016).In the context of fighting against illegal practices in retail pharmacy, the ministry of health request each pharmacist appointed in retail pharmacy to sign an oath letter (Ministry of Health (MOH), n.d.). This oath letter states that a pharmacist will respect all rules and regulations governing pharmaceutical sector and pharmacy profession (Ministry of Health (MOH), n.d.). In addition to that, the code of ethics and conduct was developed by the National Pharmacy Council (NPC) and enumerates disciplinary measures that will endure a pharmacist who will not comply with it (Ministry of Health (MOH), 2013). Among the disciplinary measures that are currently in place, there are reprimand, temporary suspension or definitive removal from the list of registered pharmacists (Ministry of Health (MOH), 2013). For example, in 2016, the ministry of heath has suspended 7 pharmacists and nurses working in retail pharmacy due to malpractice (Rwanda Ministry of Health, 2016).PART 3. METHODSSetting (Describe the primary features of the organization/location where the practicum will take place and include all information relevant to your project (e.g. number of beds in the hospital department, number of program beneficiaries, mapping of the current supply chain of drugs, etc.). This project took place in retail pharmacies that are located in Gisenyi Sector, which is the urban area of Rubavu District. Rubavu is the most populated district in western province with more than 400,000 residents (National Institute of Statistics of Rwanda (NISR), 2015). There are overall 15 registered retail pharmacies in Rubavu district and each retail pharmacy host at least three health workers (typically one registered pharmacist and two registered nurses). These pharmacies serve the urban town of Gisenyi, which is in Western Rwanda on the border with the Democratic Republic of Congo. The retail pharmacies dispense medicines to clients who use private health insurance and to clients who pay out of their own pocket. Private retail pharmacy typically open from 7 AM to 10 PM and their staff work in shifts. Typically, the first shifts start from 7AM to 3 PM and the second one start from 3 PM to 10 PM.Design (the basic study design you have chosen for the project)This descriptive cross-sectional study is being conducted in Rubavu retail pharmacies from December 2017 to February 2018. The study is using both direct participant observation and a self-administered survey of dispensing practices for pharmacy staff. An observation form was used to measure the percentage of antimalarial and antibiotics that are requested without medical prescription by pharmacy clients. The self-administered questionnaire for pharmacy staff will be used to understand reasons for irrational dispensing. The data collector (principal investigator) sat in the pharmacy and observed the clients that requested antibiotics/antimalarial without medical prescription, while completing the observation checklist. She observed each pharmacy for 6 hours per day. In order to meet different staff that works in the same pharmacy, the observation period dedicated for each pharmacy was divided in two parts: Three hours in the first shift from 7AM to 10 AM and three hours in the second shift from 5 PM to 8 PM. These hours were selected because these tend to be the times when retail pharmacies are full of clients. The observation period took 15 working days and the schedule of observation was determined randomly using a random number generator. During the observation, the data collector used a structured observation checklist to record the number of clients requesting antimalarial/antibiotics without medical prescription. Administration of the knowledge assessment will be done after the observation period, to avoid biasing observations of other pharmacies in the area, and our sample will be the health workers that have participated in the observation period. The questionnaire will be completed by the pharmacy staff using a paper-based form; the participants will complete the survey in the presence of the data collector. Sample (what is your target population? how will you sample? what are the inclusion and exclusion criteria? Sample size, and justification (calculation for quantitative projects)? Where and will you find the sample? How will you approach subjects? )The populations of this study are private pharmacy health workers that are based in Gisenyi town of Rubavu district that were working during the period of data collection and were entrusted at the counter for dispensing medicines and whose managers and staff consent to participate. To maximize the number of study participants, all staff working at the time of observation was invited to participate in the study and it was expected that there would typically be at least two staff working in a single shift. As we have 15-target retail pharmacy, the minimum sample size was 30 workers and the maximum was approximately 60 workers in case we meet 2 pharmacist and 2 nurses in each retail pharmacy at the time of observation. Pharmacy health workers who did not hold a license for working provided by their council, and licensed health workers who did not want to participate in the study were excluded from the study.