MaxPharm – Pharmacovigilance and CRM

Camsoft CRM Solutions, a local consultancy and provider of CRM Solutions in South Africa with over 25 years of experience in the industry, recently revealed the launch of a Pharmacovigilance CRM system called MaxPharm. According to the World Health Organization (WHO), Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The WHO initially established its Programme for International Drug Monitoring in response to the thalidomide disaster that was first detected in 1961, and the FDA Software and Equipment validation in the wake of the Therac-25 radiation treatment accident. Briefly, what happened in that particular case was that user input was not being controlled and checked and that the machine output was too far over the safe limits, resulting in a deadly effect in some cases. Had they followed a validation exercise then this was unlikely to have occurred.

According to Mark Annett, the head of Camsoft CRM Solutions, the main aims of Pharmacovigilance are to enhance patient care and safety in relation to the use of medicines in addition to supporting public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. Camsoft CRM Solutions, in partnership with major pharmaceutical companies, developed the MaxPharm CRM software application to manage and report on all aspects of patient advocacy and communication programmes. Software applications in the industry should all be validated as this is the best way to be assured of an accurate result or report and improve patient treatment efficacy.

MaxPharm also copes with and reports on adverse events during the treatment cycle. The success of the solution, commented Annett, is as a result of the built-in features which offer cloud and mobile access, one-click reports and dashboard delivery, among other things. And this is together with built-in adverse event reporting systems and outstanding local support. When an adverse event is logged in the system, MaxPharm ensures that all stakeholders are immediately notified via email or text message. Furthermore, the system expects a response and will ensure case escalation if the response time is not up to specification. Built-in intelligence will warn professionals when they engage further with patients and their history is available at the click of a button. All the information collected is collated and presented in the form of either dashboards or traditional reports. The result is an all-round industry focused application that is highly configurable and, most importantly, validated under the US FDA guidelines. Validation is a critical part of the software implementation process, especially in the pharmaceutical industry, as it assures all the parties involved that the data flow is accurate and free of any output anomalies. The validation also means that the system can be used worldwide and will be accepted by auditors and authorities in virtually all countries across the globe.