Godofreda V. Dalmacion,
Ma. Lourdes Amarillo
November 1, 2009-April 30, 2011
BACKGROUND: Paper-based Adverse Drug Reaction (ADR) reporting has been in place for more than six decades, a result of the unreliability of premarketing drug trials to completely identify all adverse drug reactions. Under-reporting continues to trouble the system for many reason among which "time to write a report" is one of them. With the widespread use of mobile phones and short messaging service (SMS) or texting, their use by health professionals and patients to report ADR becomes an important subject to be explored as an alternative or supplemental of reporting.
OBJECTIVES: to determine the use and efficiency of SMS-computer System for reporting ADR by health professionals and patients.
STUDY METHODOLOGY: Cross sectional before and after study measuring number of ADR reports from pre-registered physicians of tertiary hospital in Metro Manila during a 12-month observation period.
RESULTS: the rate of reporting in 12 months among 51 pre registrants was 2/51 or 3.9%. After several discussions, it was decided that legal, ethical and medical issues may arise from of patient thus participation was confined to physicians. The system was not efficient because of power interruption, competition with the existing paper-based reporting and unforeseen expiration of prepaid loads. However, SMS can be effective in releasing drug information especially about new safety profile of drug or recent withdrawals from EMA and the US FDA. The most common ADR in the study was vivid dreams, nightmares with montelukast for asthma which is a known adverse reaction to the drug. It appears that the most common cause of not reporting is the perception that there is no ADR Followed by the confining syntax required to report which can be addressed by allowing texting without a fixed format.
CONCLUSION: The rate of reporting ADR was 3.9% using SMS. At its present form, SMS reporting of ADR is not efficient at a cost of 4886 PhP per report excluding the capital outlay of 240,000 to set up the SMS-Computer Reporting system alone. However, SMS appears to be a good option to release drug information and advisories related to new drug profiles. The use of free form texting can encourage reporting compared to predefined syntax. However, the most important factor that will encourage reporting remains to be constant and consistent communication through reminders and educational campaigns of the benefits of ADR reporting emphasizing those clinical trials are conducted in a sample of patients computed based on the outcome of efficacy.