Use of a Text Message-Based Pharmacovigilance Tool in Cambodia: Pilot Study

Abstract

BackgroundThere is no functional pharmacovigilance system in Cambodia to our knowledge. Mobile phone–based tools, such as short message service (SMS) text messages, are increasingly used for surveillance purposes.ObjectiveTo pilot-test the FrontlineSMS mobile phone–based tool for notification of adverse events, using Cambodia’s only International Vaccination Center at the Institut Pasteur du Cambodge as a field site.MethodsPeople receiving vaccinations, aged over 18 years, and who owned a cell phone were recruited in the study following informed consent. The names and mobile phone numbers of the participants interviewed were entered each day into the FrontlineSMS software. Two days after being vaccinated, participants received an automatically generated SMS text message asking whether any adverse events had occurred. Their SMS reply was number-coded and exported from the software daily to an Excel spreadsheet and examined before being saved. If the participant replied with a code for a severe adverse event (8 or 9), they were automatically advised to consult the nearest doctor.ResultsThe active surveillance study was conducted over 72 days in the spring of 2012. Patients agreed to be asked by SMS text message whether unwanted events had occurred after vaccination. Of 1331 persons aged over 18 years referred to the vaccination unit, 184 (13.8%) were asked and agreed to participate. When texted for clinical status 48 hours after vaccination, 52 (28.3%) participants did not reply, 101 (54.9%) sent an immediate SMS reply, and 31 (16.8%) sent an SMS reply after additional prompting. Of the initial 184 participants, 132 (71.7%) replied. These 132 participants received 135 vaccine doses and 109 (82.6%) reported no adverse events, whereas 23 (17.4%) reported adverse events, all benign.ConclusionsNotification using an SMS-based text message system is already used in Cambodia for syndromic surveillance in health centers and reporting by health care workers. Our results show that such tools can also be useful for notification by patients or health users in Cambodia, especially in an urban setting.

21st Century Patient Registries, Ebook Addendum to Registries for Evaluating Patient Outcomes: A User's Guide, 3rd Edition

“…26 Feelings of distrust were especially pronounced among the Spanish-speaking patients, who were afraid they would be treated like "guinea pigs." This was consistent with prior studies suggesting a general distrust towards research in minority populations [28][29][30] .…”

“…Chief amongst these areas is in recruitment and retention, often considered the "Achilles' heel" of clinical research. 30 In cases where a patient registry is required by a regulatory agency to evaluate the safety and effectiveness of a pharmaceutical product (drug, vaccine, device, biologic), registry sponsors have often had to request extensions and/or increase the number of countries or clinical sites to meet recruitment goals. In addition, many registries are designed to follow patients over many years in order to provide information on natural history and/or long-term outcomes.…”

“…Recently, in Cambodia, mobile phone-based, short message service (SMS) text messages were used to conduct pharmacovigilance on 17 different vaccines. 30 Their intention was to provide a timely and efficient pharmacovigilance platform to a developing country that would otherwise not have such a system. There is high unmet need for such a system because of the higher risk for patients in developing countries to be subjected to illegal and counterfeit drugs and vaccines.…”

Comparison of text-messaging to voice telephone interviews for active surveillance of adverse events following immunisation

“…Timely collection of vaccine safety data is necessary in 67 order to identify early warning signals and ensure vaccine quality. 68 69 Some vaccine safety surveillance programs incorporate short message service (SMS) 70 communication to monitor adverse events following immunisation (AEFI) details in near real-71 time [10][11][12][13]. While such methods offer rapid data collection and dissemination of results, to 72 date, no study has investigated the potential differences between SMS and telephone 73 interview data collection methods.…”

Mobile phone use among female entertainment workers in Cambodia: an observation study

“…In Cambodia, several successful mHealth health programs have been introduced in the areas of post-abortion contraceptive use (29), pharmacovigilance (30), diabetes self-management (31), case detection/notification (32), and HIV education (33). This current evidence base for using mobile phones to make health assessments and encourage uptake of services in hard-to-reach populations that face stigma and discrimination in developing countries is promising, but stronger impact evaluations are needed to understand the full benefits of such interventions.…”