Malaria prevention and treatment awareness and practice among patent medicine vendors (PMVs) in Gombe Metropolis, Nigeria

The ravaging consequences of Malaria in Sub-Saharan Africa (SSA) have been a subject of serious concern to every stakeholder. Literature and anecdotal evidence shows that around 60% of Nigerians seek fever treatment from Patent Medicine Vendors (PMVs) despite the limited formal dispensing knowledge most possess. This study attempts to establish a base line of knowledge, attitude and practices of Malaria control among PMVs in Gombe Metropolis, North Eastern Nigeria. The study was a descriptive cross sectional survey based on structured questionnaires used to collect relevant information from 109 PMVs selected by purposive sampling technique. The result show that 85.3% of the participants in this study correctly identified fever or high body temperature as the common sign of uncomplicated (UC) Malaria, while 70.6% recognized convulsion as one of the main symptoms of severe Malaria. Furthermore, 86.2% of the PMVs also knew that sleeping inside treated nets constitute one of the best ways to prevent Malaria. In the same vein, awareness of change in Malaria treatment policy from monotherapy to Artemisinin based combination therapy (ACT) was high (73.3%) among them. However, those PMVs that had ever undergone some degree of drug dispensing training exhibited a significantly higher level of awareness of change in malaria treatment policy (X2 =17.903, P = 0.000). Although 85.3% of PMVs frequently recommend Arthemeter Lumefantrine (AL) as treatment of uncomplicated Malaria, only 39.4% of the participants would refer severe malaria cases. Even though most Malaria control awareness and practice variables were found to be fairly good among the participants, it is clear from the study that there is the need for enhanced training, monitoring and supervision by the relevant authorities so as to fully harness the vast potential in PMVs.


Introduction
According to the WHO world Malaria report, an estimated 212 million cases of malaria occur worldwide and 90% malaria cases were in the WHO African Region, with 29% being contributed by Nigeria alone [1]. Global malaria mortality estimate was 429, 000 of which 92% occurred in the WHO African Region, with Nigeria accounting for 26% of the death [1,2]. Despite some modest achievement recorded in the fight against Malaria 303, 000 malaria deaths were estimated to have occurred in children aged under 5 years, equivalent to 70% of the global total deaths -malaria remains a major killer of children, and is estimated to take the life of a child every 2 minutes [1,2]. While the healthcare system in the country does present limitations around access to malaria and other communicable diseases, community access to PMVs and essential health-care products are core elements of patient-centred health-care systems which the community rely upon especially in places without access to formal health care [2,3]. The disturbing epidemiological pattern of communicable diseases has resulted in the conceptualization and deployment of so many control efforts including the Public Private Partnership (PPP) model, especially in the African region where communities are worst hit [4,5].
The involvement of Patent Medicine Vendors (PMVs) in the delivery of some form of primary health care and malaria control in developing countries has for some time now been a subject of robust debate and active research [3,6,7,8,9,10,11]. The growing body of evidence points more to the merits than demerits of PMVs involvement in the promotion of access to medicines especially in Low and Middle income countries [3,6,12]. The introduction of global initiatives such as the Affordable Medicines Facility for malaria (AMFm) was viewed as an avenue to explore ways in which PMVs can be utilized as vehicle to help expand coverage for essential health services delivery [3,6,13,14]. However, the apprehension on the use of this medium is around the lack of existing veritable machinery for effective monitoring and quality assurance, and lack of capacity for service delivery considering the fact that the licensing requirement for PMVs has no minimum academic benchmark [15]. This is against the back drop of preponderant cases of fake drugs dispensation by Patent Medicine Shops, lack of adherence to the Pharmaceutical Council of Nigeria stipulated rules of practice for PMVs, rampant cases of inappropriate dispensing and irrational use or dosing of drugs sold by PMVs [2,16,17,18]. The regulation of malaria drug in Nigeria is complex, with several key stakeholders involved. The National Malaria Control Program (NMCP), an organ under the Federal Ministry of Health (FMOH) regulates the scientific basis for recommending appropriate treatment [19]. The National Agency for Food and Drugs Administration and Control (NAFDAC) is charged with testing, approval, registration as well as inspection of drug manufacturing premises and regulations of advertisement of pharmaceutical in country [2,17,20].
Despite these concerns PMVs accounts for 39% source of malaria treatment in Nigeria [17]. Most people do not obtain appropriate treatment for malaria, and depend on informal private providers for anti-malarial drugs, mainly through patent medicine vendors (PMVs). The picture is similar across sub-Saharan Africa where PMVs are widely used source of drugs for malaria treatment across the continent [3,6,21]. The Nigeria Malaria Indicator Survey, 2010, reported higher estimate (57%) of people in Nigeria that would first call at a PMV store to seek treatment [22]. It has been widely reported that there are several brands of Artemisinin-based combination therapies (ACTs) first-and second-line drug for malaria treatment as recommended by the national treatment guideline in the Nigerian market that are now purchased over the counter [13,17,20].
In Nigerian context, PMVs are major providers of health care services and most PMVs in Nigeria belong to local affiliates of the National Association of Patent and Proprietary Medicine Dealers (NAPPMED) [23]. As frontline health workers, PMVs perform multiple tasks, including consultation, counseling, treatment and referral of sick clients in medically underserved communities. The operations of PMVs is licensed by the Pharmacy Council of Nigeria to sell patent medicine and in possession of patent and proprietary medicine vendors' license in the form B or C as contained in the Pharmacy Law of Nigeria [3,7]. Under this arrangement PMVs are permitted to sell pre-packaged, over-the-counter (OTC) medicines only, and in addition such licensees are required to be at least 21 years of age and required to complete an apprenticeship training with a more senior PMV [3,10,20,24]. To a certain degree, there is almost nonexistence of evidence of completion of apprenticeship documented within the system. Other PMVs are retired health workers such as pharmacy assistants, nurses, community health workers, and civil servants. To have further insight into the role played by PMVs in the delivery of healthcare in Gombe metropolis the study explores the knowledge, awareness and practice of malaria prevention and management among the PMVs within the area.

Study Setting
Participants were drawn from Gombe metropolis, the state capital of Gombe within the North eastern region of the country. The state borders with Borno, Yobe, Adamawa, Taraba, and Bauchi states, with a land area of 20, 265 SqKm and population of 3,256,962 and around 11.4% are resident within the state capital [25]. The climatic conditions are characterized by a dry season lasting from October to April, while the rainy season lasts between May and September. Climate change, flooding, deforestation, waste management, and mining are emerging health and environmental challenges in the region.

Study Design and Study Population
An exploratory cross sectional descriptive survey was adopted to measure the participants' knowledge, awareness and practice and any association of their characteristics with malaria drug dispensing. The study population comprises Patent Medicine Vendors (PMVs) registered with the state chapter of the National Association of Patent and Proprietary Medicine Dealers (NAPPMED) with physical stores or "chemists" within Gombe Metropolis.
As at the time of the data collection a total of 137 PMVs were officially listed on NAPPMED register. Though all (137) were targeted to take part in the study, only 109 of them eventually responded to the questionnaires. The rest either declined or were absent at the times of the data collection.

Data Collection Instrument and Data Collection
A structured questionnaire comprising 28 items was developed and validated prior to the data collection. The developed questionnaire was first tested among 15 participants outside the sampling area within the metropolis and based on the information generated further adjustments were done on the questionnaire to make it more comprehensible and adopted for the main study. The questionnaire was divided into sections that seek information around participants' socio-demographic data, knowledge of Malaria diagnosis and prevention, practice around Malaria treatment and training/awareness among the PMVs. The data for this work was collected between the months of June and September, 2014; during the monthly coordination meetings of the association (NAPPMED).

Ethical Considerations
The data collection was done in conjunction with the PMVs association (NAPPMED) officials who were made to understand the significance of the study. That notwithstanding, none of the participants was compelled to participate in the survey such that all was done in compliance with the Helsinki declaration.

Data Analysis
The data collected was analyzed using Statistical Package for Social Sciences (SPSS) Window Version 16.0 (Chicago, SPSS Inc.) Simple frequency tables, bar charts and cross tabulations were generated and relationships between variables were tested using chi square and Odd Ratio (OR). Associations were considered significant at P-values < 0.05. Table 1 presents socio-demographic characteristics of the participants. The data analyzed show that the participants mean age was 30.41±9.26 years and 88% of the participants age lie between 17 and 40 depicting an active population engaged in the vending trade within the study area. High proportion of the participants (83.2%) were males which shows an under representation of females working in the industry. In addition, 54.1% of the participants were educated only up to secondary school level, leaving 40.4% as having tertiary level education.   (2) also present the participants' knowledge of common signs and symptoms of malaria for uncomplicated and severe malaria. For uncomplicated malaria, 85.30% of the respondents identified fever or elevated body temperature as the main sign malaria. Bodily pain was the least symptom (0.9%) the participants identified as sign of uncomplicated malaria followed by vomiting (2.8%). When asked of the symptoms of severe malaria 70% participants indicated convulsion, followed by fever/elevated body temperature (21.1%). Other signs and symptoms asked were less likely to be considered when attending to clients.  Table 3 shows PMVs' exposure to training on malaria and awareness of the new national malaria treatment policy.

Results
Majority of the participants (89.5%) that demonstrated awareness of the new treatment policy also indicated having undergone training on malaria treatment based on the new policy. Hence, there were higher (about 8 times) odds (OR = 8.095, 95% CI = CI = 2.8490 -23.0024) of awareness of the new malaria treatment policy among those exposed to training than those who were not. This relationship between participants awareness of the new malaria treatment policy and having undergone training on malaria, was statistically significant (X 2 =17.903, df = 1, p = 0.000).   In addition, malaria preventative approach as part of service offered to patients prior to dispensing malaria drugs was assessed. Based on the question asked, 86.2% of participants identified sleeping inside long lasting insecticidal nets (LLINs) or insecticide treated nets (ITNs) as the best way of preventing Malaria. Use of insecticide and other means (i.e. traditional methods) were the least favoured malaria preventive measures considered among the participants.

Figure 1
Best ways to prevent Malaria (n=109)

Discussion
Participants socio-demographic characteristics is typical of an active sub-population with a mean age of 30.41±9.2585 years with male dominance of 83.2% and more than a half (54.1%) of the PMVs were educated only up to secondary school level. This outcome affirms the fears expressed by many, that the lack of a good benchmark for enrollment into the trade might compromise quality of drug vending and public health [15,24,26,27]. A vast majority of the respondents said their diagnosis of malaria is based on symptoms of which body ache, high temperature, loss of appetite, convulsion etc. are the most frequent symptoms they use to base their conclusion. Overwhelming majority (85.3%) of the PMVs said fever or high body temperature is the main sign of uncomplicated (UC) malaria and convulsion as the major sign (70.6%) of severe malaria. This findings corroborate the conclusion drawn by Goodman et al and Beyeler & Sieverding where high temperature (fever), convulsion, loss of appetite are among the most common symptoms identified PMVs [3,7].
The study revealed Artemisinin Lumefantrine as the most likely malaria treatment to be dispensed among the participants when treating either uncomplicated or severe malaria. Only 39.4% of the participants will consider referral of patients manifesting signs of severe malaria to health facilities (hospital/clinics) for further management. The study also highlighted on the need to enhance training and awareness around the national malaria treatment guidelines to help strengthen capacity among the PMVs considering the vital role they play towards the delivery of primary healthcare especially in areas with limited access to health facilities. While the present study did not assess the content and accuracy of information provided to customers at the point of dispensing malaria treatment, previous studies have demonstrated that PMVs vary widely in the amount, accuracy and quality of information they are likely to provide to their clients [3,24,26,28]. There is also the need to apply caution on the role played by PMVs in the delivery of basic health services as it relates to quality assurance. Previous studies conducted in LMICs including Nigeria has demonstrated poor capacity of PMVs in preventive care, diagnosis and proper dispensing of drugs as well as their engagement in unlicensed practices, trade in substandard and counterfeit antimalarial drugs which have contributed significantly to high burden of malaria and comorbidities in the country [2,20,26,29,30,31]. There is no doubt that addressing this gap will result in fewer hospitalizations and death due to malaria infection in the country.
In addition to dispensing antimalarial drugs, the participants said they provide other advise around malaria prevention of which 86.2% said they encourage sleeping inside insecticide treated nets (ITNs) to prevent malaria infection. This further demonstrates the potential in PMVs for the delivery of some form of Primary Health care interventions [3,7,8,21].  [11,35]. In these scenarios, drug promotion and clients' demand could have been a key factor on the frequency of each drug being sold to the public.
A good proportion (73.3%) of the PMVs were found to be aware of changes made in the malaria treatment policy from mono-therapy (such as Chloroquine, SP etc) to Artemisinin-based Combination Therapy (ACT) such as Arthemeter Lumefantrine (AL). This could be explained by the scores of capacity building and sensitization activities deployed by government in collaboration with other organizations among the PMVs in the study area. And this is further buttressed by another finding of this study which show that 89.5% of the participants who had undergone training on malaria demonstrated awareness of the new malaria treatment policy and preventive measures. This relationship was found to be very significant (X2 =17.9034, df = 1, P = 0. 000, OR=8.095, CI =2.8490 -23.0024). The odd ratio (OR) shows that those PMVs who had training on malaria were eight times more likely to be aware of new malaria treatment policy and preventive measures than those who didn't. This finding justifies the continued efforts in making a case for some form of capacity building training for PMVs [3,7,8,36]. This training should be made mandatory as a condition for the renewal of PMVs' license.

Conclusion
It is obvious from the foregoing, that high proportions of PMVs in Gombe metropolis know about presumptive malaria diagnosis, prevention and treatment. Notwithstanding, gaps were observed in referral practices and compliance with the new malaria treatment policy. However, since this study also established that trainings were more likely to influence awareness, more could still be done by all stakeholders in the area of training as well as behavior change communication (BCC) activities, and monitoring and supervision of the PMVs.
This study was not without limitations, the sample size of 109 was imposed by the choice of the study area and the limited number of registered PMVs. In addition, the design of the study being cross sectional would mean that generalizations from the findings of the study should be done with caution.