All medicines have the potential to cause unwanted, uncomfortable or dangerous effects also known as adverse drug reactions (ADRs).
“To protect patients and to identify and characterise evidence-based causal relationships between ADRs and their suspected medicines, data must be communicated efficiently and effectively along all stages of the pharmacovigilance* system," says Dr Max Schurer who obtained his doctorate in industrial engineering at Stellenbosch University recently.
According to Schurer, the primary goal of any pharmacovigilance system is to improve and protect patient safety by enabling health care professionals to make more informed therapeutic decisions.
“Pharmacovigilance is based on the medical assessment of ADRs or drug-related problems collected within organised health programmes and is crucial in the pharmaceutical world to prevent illness and death that might result from ADRs.
“Achieving this goal is dependent on the successful communication of relevant ADR information from the patient to the relevant pharmacovigilance authority. One such method of communication is the spontaneous reporting of ADRs, which is widely regarded as the cornerstone of data generation in pharmacovigilance during post-marketing authorisation safety surveillance.
“Unfortunately, spontaneous reporting systems (SRSs) face problems such as under-reporting and the communication of incomplete, unrepresentative, and uncontrolled data. Data management is a key principle of pharmacovigilance and the vast majority of safety information is as a result of spontaneous reporting of ADRs."
In terms of pharmacovigilance, an interoperable SRS would be a system in which data on ADRs is reported once with high quality to facilitate the analysis of the causes of the adverse reaction. It should be a transparent system where data is accessible by all stakeholders, including those involved with public health programmes, regulatory authorities, marketing authorisation holders, healthcare professionals, etc.
Schurer says stakeholders in pharmacovigilance operate SRSs with different goals in mind such as maintaining regulatory compliance, mitigating financial risk, or protecting and promoting patient safety in public health programmes.
He points out that the lack of standardisation and interoperability among these systems results in a reduced capability to detect and characterise new ADRs. Within healthcare, interoperability refers to the ability of different information technology systems and software applications to communicate and exchange data. This information is used to ensure that when there is uniform movement of health data from one system to another, the clinical or operational purpose and meaning of the data is preserved and unaltered.
To help address some of these challenges, Schurer developed a model that pharmaceutical companies and regulatory authorities and even institutions like the World Health Organisation can use to improve the interoperability of their product safety information systems. This type of model, which considers technical, social, and organisational factors, can be used to drive improvement and control progress.
Schurer says the model will promote and improve interoperability by addressing the degree of integration of the systems involved, offer guidance on which system components need to be improved, as well as provide a means for measuring interoperability progress across SRSs in the global pharmacovigilance landscape.
“If the model leads to more interoperable SRSs, then acquiring the necessary data to facilitate statistical analysis of ADRs in determining their causality is made easier and more efficient. This will ultimately lead to better and safer medicines being on the market and help prevent medicine-related problems, including drug-related illnesses and deaths."
Schurer adds that the model was implemented in a case study by a prominent national regulatory authority in the SADC region and the results were promising.
He says pharmacovigilance teams of the future must include, among others, clinicians, engineers, statisticians, computer scientists, and IT developers, adding that we should not only view pharmacovigilance activities as a mechanism to achieve regulatory compliance, but also to gain a competitive advantage.
*A system in which important evidence-based data about medicines and their potential adverse reactions are gathered and communicated to relevant stakeholders".
FOR MEDIA ENQUIRIES ONLY
Dr Maximillian Schurer
Corporate Communication and Marketing