Feasibility and cost of using mobile phones for capturing drug safety information in peri-urban settlement in Ghana: a prospective cohort study of patients with uncomplicated malaria

Information and communication technology has the propensity to improve a country’s health delivery system leading to positive implications for its health policy strategy [1]. An increasing number of countries in the world are using mobile communications to handle and address healthcare needs including behaviour change communication, training, education and awareness creation, data collection and monitoring in remote settings, disease and outbreak tracking, diagnosis and treatment [2]. The use of mobile phones to monitor health outcomes in low resourced settings, including Ghana will go a long way to reduce cost and maximize data collection within the health delivery system.

Malaria management in Africa is drastically hampered by poor, incomplete and untimely data on the incidence of disease and resource distribution and use, resulting in poor planning and implementation of interventions to ensure its control and elimination. To effectively deal with and sustain malaria control, Africa needs a quality health management system that can monitor malaria drug efficacy and safety. This requires timely and accurate data that is based on an effective and efficient communication network between health service providers and their clients [3]. Mobile health (mhealth) is the use of portable communication devices for creating, storing, retrieving and transmitting data between health service providers and their clients to improve the quality of care and patient safety [4, 5]. Decreasing cost and increasing network coverage has opened up more opportunities for many people in developing countries to access and use mobile phones and other communication gadgets. With the introduction of many and affordable wireless networks. Africa has indeed witnessed a significant improvement in communication in many of its rural communities and Ghana is no exception [6, 7]. Growing evidence suggests that mobile communication based health has the potential of radically improving healthcare in the most remote and less endowed communities in the world [8]. The use of mobile phone makes it easy for frontline health workers to use mobile technology rather than the traditional paper-based reporting system to gather and present health data with its inherent delays [9].

The growing need to capture data on health and health events using faster and efficient means to enable prompt evidence-based decision-making is making the use of mobile phones for health an alternative to traditional paper means of data capture [10, 11]. Growing mobile phone usage in Africa therefore offers the opportunity to explore its use in non-traditional modes of gathering data on health in resource-constrained settings, particularly on safety [12]. The use of medicines within the public and private health care system to treat large numbers of people presents the opportunity to generate real-life data on the safety and effectiveness of these medicines. Monitoring and documenting the safety of artemisinin-based combination therapy (ACT) is critical for public health programmes as any harm to a few patients, even if unrelated to the actual medicine administered, can impact negatively on the credibility, adherence to and success of any health programme [13, 14], as well as adherence to any recommended treatments.

Over the years, spontaneous reporting of adverse events has been the easiest way of monitoring drug safety. However, spontaneous reporting is associated with serious under-reporting and more active methodologies, including cohort event monitoring (CEM) are currently recommended by the World Health Organization (WHO) to complement spontaneous reporting [15‐17]. CEM is a prospective, observational cohort study of adverse events associated with one or more medicines [18]. It is an active form of safety surveillance and records all clinical events and not just suspected adverse reactions. In developing countries, CEM provides the possibility of obtaining more complete safety data on medicines. Although more expensive and intensive than spontaneous reporting, the CEM method offers numerous advantages, including the ability to obtain denominator values, calculate incidence rates, demonstrate the absence of harm, and provide indications of the risk factors for adverse reactions [19]. CEM studies in Africa usually involve follow-up of patients through home visits, a costly and time-consuming approach fraught with logistical challenges. Mobile phones, on the other hand could provide a convenient, safe and cost-effective alternative for collecting safety data in real-life settings [20].

Mobile phones in Africa are evolving from simple communication tools into service delivery platforms, as seen with mobile money (M-Pesa) in Kenya. This has shifted the development paradigm surrounding mobile phones from one that simply reduces communication and coordination costs to one that could transform lives through innovative applications and services. Over 60 % of Africans in cities and small villages own mobile phones [20, 21]. Africans are buying mobile phones at a world record rate, with uptake soaring by 55 % in 5 years. Mobile subscriptions in Africa rose from 54 million to almost 350 million between 2003 and 2008, the fastest growth in the world. On average there are now 60 mobile subscriptions for every 100 people in the world. In developing countries overall, the figure stands at 48 for every 100 people. In Africa, penetration rates range from 16 % in Central African Republic, 43 % in Cameroon, to 84 % in South Africa [21]. A previous study showed that toll-free mobile phones offer a practical means of reporting adverse reactions to anti-malarial drugs and may be a model of choice in Africa [21, 22], where mobile telephone penetration and coverage is already driving innovation in agriculture and commerce. [22, 23] In a study by Fraser and Blaya, they concluded that the cost of mobile technology especially phones keep diminishing, making them the best alternatives for overcoming traditional obstacles to deliver health services to less resourced communities [24].

In Ghana, the mobile phone penetration rate at the end of August 2011 stood at 80.5 % [25]. The high penetration rates make the mobile phone a relevant and appropriate tool for improving health care delivery. According to the Dodowa Health and Demographic Surveillance System (HDSS) data, approximately 62 % of households in the surveillance area own mobile phones [26]. In recognition of the challenges of post-registration safety monitoring and limitations of spontaneous reporting, the INDEPTH Network Effectiveness and Safety Studies (INESS) on anti-malarial was initiated in Ghana, Tanzania, Mozambique and Burkina Faso with funding from the Bill and Melinda Gates Foundation. In Ghana, these studies were conducted in three HDSS sites, including Dodowa. The platform has strengthened efforts to document and report adverse events (AEs) in resource-limited settings using CEM to follow-up patients treated with ACT for uncomplicated malaria. This study sought to examine the feasibility and cost of using mobile phones vis-à-vis the traditional home visits to monitor AEs associated with anti-malarial for uncomplicated malaria in peri-urban settings in Ghana.

The objective of this paper was to examine the feasibility and cost of using mobile telephone vis-à-vis home visit to monitor adverse events (AEs) related to ACT for treatment of uncomplicated malaria in peri-urban Ghana. Considering that 4124 out of 4270 patients were successfully followed upon telephone with majority responding on first attempt at call in the largely rural Dangme West District (now Ningo-Prampram and Shai-Osudoku), this was quite remarkable. Approximately 3586/4124 (86.9 %) of the patients provided mobile phone numbers at enrolment This large number of patients in such a less endowed community like the Dangme West District confirms other studies that Africa has indeed witnessed a significant improvement in communication in many of its rural communities and Ghana is no exception [6]. Again, the provision of mobile phone numbers by such a large number on enrolment indicates that many of the patients had access and were connected to mobile network; thus supporting the growing evidence that mobile communication has the potential of radically improving healthcare in the most remote and less endowed communities in the world [7].

Reporting rates of AEs proved slightly higher among telephone contacts than by home visit. This shows that mobile phones are a feasible option for collecting safety data, more especially as it was possible for majority of the patients to be interviewed within 7 days of medicine intake. This result confirms findings of previous studies where follow-up using mobile phones proved feasible for collecting data and monitoring desired health outcomes [27, 28].

On the basis of comparative cost analysis, the study revealed that for the follow up by telephone, the duration of calls ranged from 16 s to 53 min and cost between 0.26 Cedis (USD0.20) and 41.70 Cedis (USD27.0) respectively while for the follow-up by home visit, the distance per visit ranged from 0.65 to 62 kilometres and cost between 0.29 Cedis (USD0.20) to 279.00 Cedis (USD79.70). The cost per follow-up through home visit was much higher compared with that of the use of mobile phone. The average cost of obtaining AE feedback from patients who received anti-malarial through the mobile phone platform was far cheaper (USD2.00 per phone call) than through home visits (USD3.20 per visit). Telephone call cost was almost two times less than the cost of home visit. Aside the cost, time is also of essence; it took less time to get the needed feedback for prompt and other necessary action when using the mobile phone than the home visit This confirms a previous study that assessed the effectiveness, safety and cost of diabetes tele-management system, and found telephone call use to be safer and more cost-effective than the traditional health care of frequent physical visits for every drug [29]. The findings of this study is at variance with the study by Ryan et al., who concluded that telephone monitoring expenses was an additional cost in the mobile group compared with paper-based monitoring [30, 31]. It is worth noting that the average cost for home visits estimated in this study covers only the direct cost of motorbike usage. Indirect costs such as travelling time, associated risk of riding the bike and the effects of the weather, were not included in the cost. While wear and tear on the phones may be apparent over time that of the motorbike cannot be overlooked. One advantage of this study confirms the findings of Asiimwe et al. that the use of mobile phone makes it easy for frontline health workers to use mobile technology rather than the traditional home visit and paper-based reporting systems to gather and present health data with its inherent delays [7].

Other advantages related to the telephone interviews are that they are brief, specific and convenient for patients who may feel uncomfortable reporting in face-to-face interviews. This confirms a previous study that examined whether an allied health professional telephone visit could safely substitute for an in-person clinic visit and concluded that patients accepted telehealth as the exclusive means of follow-up and nearly all patients expressed great satisfaction with the telephone follow-up method [32, 33].

The types, frequencies, order and proportions of events reported by both methods of follow-up elicited similar AEs reporting for each ACT dispensed. Important symptoms such as rashes, dizziness and sore mouth were picked by telephone call as well as for home visits for participants prescribed ASAQ. The top four AEs reported on telephone and at home visit for both ALU and ASAQ were similar. This corroborates the submission by Abedeji and colleagues that availability of a toll-free telephone line may facilitate pharmacovigilance and follow-up of response to medicines in a poor resource setting [19]. This is the first report from Ghana that provides evidence of cost of safety monitoring of AEs using telephone and confirms a study by Dodoo et al. who recommended that future research around methods of collection of AE data is transferable to rural settings [34].

Majority of patients were successfully followed up by telephone and most AEs were on phone. The cost of telephone interview was almost two times less than the cost of home visit. Mobile phones thus represent an efficient, less costly and effective means of monitoring drug safety in resource-limited settings as demonstrated by this study in Ghana. Typical setbacks of spontaneous reporting, mainly under-reporting of AEs, is worse in low-resource settings such as Ghana and with the high mobile phone penetration, its use is the recommended method for collecting AEs as and when they occur, even in rural settings as propagated by Dodoo et al. [34].

Telephone calls and text messages may also reduce the problem of loss to follow-up which is unavoidable in the context of patients’ home visits [31]. Collecting AEs using the telephone can provide comprehensive real-life safety information on anti-malarials in resource-limited settings. The use of mobile phones to monitor health outcomes in Ghana and other developing countries in Africa will go a long way to reduce cost and maximize data collection within the health delivery systems of less resourced communities in the continent.