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The “4pt-classification” of the state of evolution of national pharmacovigilance systems

This is the first in a three-part blog series on National Pharmacovigilance systems and the role of ‘e- enablement’ technology in bridging the gaps in pharmacovigilance of regulatory authorities across the world.

A typical framework for a pharmacovigilance system at the national level includes a primary national regulatory body and several regional centers/ national centers. As described by World Health Organization (WHO), “National Centres (NCs) are WHO-approved pharmacovigilance (PV) centres in countries participating in the WHO Programme for International Drug Monitoring. National Centres are usually a part of or closely linked to the national drug regulatory agency. Healthcare professionals and patients (in some countries) send individual case safety reports (ICSRs) to a regional PV centre or a NC. The latter forwards the reports to the central WHO Global ICSR database, VigiBase that is managed and maintained by the Uppsala Monitoring Centre (UMC).”[1]

In order to ensure a high-level of protection to public health from unsafe medicinal products, the pharmacovigilance system should be able to achieve optimal functioning capabilities.

Historically there have been several methods applied to understand the functioning of pharmacovigilance systems. These methods have used various factors as surrogate markers for evaluating the performance of national pharmacovigilance systems.

The World Health Organization measures the robustness of the national pharmacovigilance systems by assessing[2]:

  • Structural indicators such as pharmacovigilance centers, and the related infrastructure required for functioning
  • Process indicators concerning the adverse event reports received, their completeness, causality, etc.
  • Impact indicators such as signals detected, risk management activities and the number of regulatory actions taken

The Food and Drug Administration (FDA) funded program, the Systems for Improved Access to Pharmaceuticals and Services (SIAPS), evaluates the national pharmacovigilance systems using the Indicator-Based Pharmacovigilance Assessment (IPAT) tool[3] . The tool evaluates the national pharmacovigilance systems based on five key components:

  • Policy, Law, and Regulation
  • Systems, Structure, and Stakeholder Coordination
  • Signal Generation and Data Management
  • Risk Assessment and Evaluation
  • Risk Management and Communication

Pharmacovigilance is an important component of public health. A comprehensive framework for understanding the national PV capabilities should also include indirect health indicators such as the national healthcare expenditure (% GDP) and Human Development Index, in addition to the direct factors mentioned above.

The level of evolution of pharmacovigilance systems in a country has a direct correlation to the healthcare expenditure.

The countries with a median healthcare expenditure greater than 10.1% of their GDP generally have an advanced pharmacovigilance system, whereas the countries with a lower median healthcare expenditure of generally have a less developed pharmacovigilance system (Figure 1).

Figure 1: Health Expenditure as a Measure of National Pharmacovigilance System Maturity.
Reference: The World Bank, World Health Organization Global Health Expenditure database, Health expenditure expressed as a total percentage of GDP for the year 2014.; Where: Argentina (AR), Australia (AU), Brazil (BR), Canada (CA), China (CN), Egypt (EG), European Union (EU), India (IN), Japan (JP), Malaysia (MY), New Zealand (NZ), Nigeria (NG), Russia (RU), Singapore (SG), South Africa (SA), Thailand (TH), United Arab Emirates (AE), United Kingdom (GB), United States (US), and Vietnam (VN).

Another indirect indicator of a country’s pharmacovigilance maturity can be the Human Development Index (HDI).

The Human Development Index (HDI) is a composite statistic of life expectancy, education, and per capita income indicators. The HDI can be categorized as, very high (HDI between 0.9 and 1), high (HDI between 0.8 and 0.9), medium (HDI between 0.5 and 0.8) and low (HDI below 0.5). Generally, the countries with ‘very high’ and ‘high’ HDI had an advanced pharmacovigilance system, while the countries with lower HDI generally do not have well-developed pharmacovigilance systems (Table 1).

Table 1 is an attempt to demonstrate a possible correlation between the Human Development Index and the Pharmacovigilance system evolution of a country.

Table 1:  Correlation of Human Development Index (HDI) with National Pharmacovigilance System Maturity


Note: The European Union has been represented in the table above as the top five European Union countries comprising of France, Germany, Italy, Spain, and United Kingdom.
Source: United Nations Development Programme, Human Development Reports, 2015

There should be a comprehensive approach for evaluating a country’s pharmacovigilance system. Here we would like to broaden the scope of the existing evaluation systems and propose a new approach for assessment and coined the term “4pt-classification”. The classification takes into account five major areas:

  • Pharmacovigilance infrastructure (p)
  • Pharmacovigilance related policies, legislature and regulations (p)
  • Pharmacovigilance outcome such as signal assessment and risk management (p)
  • Public health indicators such as healthcare expenditure, HDI and (p)
  • Technologies for pharmacovigilance (t)

Taking these factors into account the countries can be classified as – Advanced (A), Emerging (E) and Rudimentary (R) pharmacovigilance systems. This classification would provide a holistic picture of national pharmacovigilance and would help prompt necessary initiatives to enhance the country’s pharmacovigilance systems from a lower to higher level by measuring against this benchmark.

Although, all the above mentioned factors are interdependent, one key factor that can have a significant influence on all the components is the IT infrastructure. Modern technological advancements have a potential to bridge the gaps among national pharmacovigilance systems. The advanced IT systems when incorporated into the healthcare systems, including the systems for education and awareness about drug related safety issues can have a major impact on public health. Specifically, the application of modern IT systems into pharmacovigilance structures and processes for data management, signal generation, risk assessment and communication, can make a substantial difference to the functioning of the pharmacovigilance systems.

Regulatory Authorities are increasingly moving up the value chain from being emerging to advanced regulatory authorities by opting for ArisGlobal’s LifeSphere Safety solutions. Eight regulatory authorities with seven of them in Europe and North America are using ArisGlobal’s safety solution as their national pharmacovigilance systems. This e-enablement of the pharmacovigilance systems will make a rudimentary regulatory authority system to an enhanced or advanced pharmacovigilance system.

Look for our second blog in this series, “Modern technologies in pharmacovigilance- the way forward for national pharmacovigilance systems,to be published shortly.




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