Overview: Pharmacovigilance and Risk Management

Journal for Clinical Studies - Extracts - November, 2021

One of the most important responsibilities of pharmaceutical companies is assuring the protection of human subjects. The history of egregious failures in this regard means that all stakeholders must remain ever-vigilant. The human experimentation in World War II Germany and Japan, and the Tuskegee syphilis study of 1932 to 1972 in the United States, bear witness to these failings. And it was followed by societal and institutional responses: the Nuremberg Code of 1947, the Declaration of Helsinki of 1964, and the Belmont Report of 1979.

Pharmacovigilance is relevant for everyone whose life is touched in any way by medical interventions. The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems. The assessment of benefit versus risk begins during the preclinical evaluation of a medicinal product and extends throughout its full life cycle. As a result, there is added focus on safety and risk assessment after a product has received regulatory approval, when it is placed in the market and prescribed to large populations.

Risk management is a set of activities performed for identification of risk, risk assessment, risk minimisation or prevention, and risk communication. Good pharmacovigilance identifies the risks in the shortest possible time after the medicine has been marketed and will help to establish and/or identify risk factors. When communicated effectively, this information allows for intelligent, evidence-based prescribing with potential for preventing many adverse reactions and will ultimately help each patient to receive optimum therapy at a lower cost to the health system.

Operational Aspects of Pharmacovigilance and Risk Management Pharmacovigilance and risk management are essential part of pharmaceutical product development and commercialisation, the activities of which are highly regulated in many parts of the world. Rare adv erse events may not be identified until large number of patients receives the product, so benefit and risk must be continually assessed as more data becomes available about the product through its use. Building pharmacovigilance and risk management capacity requires a systematic approach to ensure that all safety aspects are monitored and addressed properly (see table below).
Activities currently included in the scope of pharmacovigilance:

Three core functions of pharmacovigilance are: individual case safety reporting, signal management, and benefitrisk management.
There are certain components and capabilities that are essential to have fully functioning pharmacovigilance system, regardless of how a company’s safety department is constructed.

These include:
• quality management plan (QMP) including standard operating
procedures (SOP) and work instructions (WI)
• safety case processing and review
• safety systems (database) support
• global safety reporting
• medical writing and aggregate reporting
• signal management and risk analysis
• product quality complaints analysis
• a qualified person for pharmacovigilance (QPPV) (Europe)

The global pharmacovigilance market is segmented based on phase of drug development, type of reporting methods, and type of service providers. On the basis of phase of drug development, the market has been segmented into preclinical studies, clinical studies (phase I, II, III), and postmarketing surveillance (or phase IV). On the basis of type of reporting methods, the market has been segmented into spontaneous reporting, intensified adverse drug reactions (ADR) reporting, targeted spontaneous reporting, cohort event monitoring
and electronic health records mining.

Pre-marketing actions include Post-marketing actions include
• Amending the protocol
• Temporarily suspending enrollment
• Discontinuing the study
• Discontinuing development of the
medicinal product
• Updating a development RMP/REMS
• Enhanced monitoring
• Mechanistic safety studies
• Variation of CCSI / SPC / product information leaflet
• Post-authorization safety studies (active/passive)
• Update of the RMP
• Presentation of the signal in the PSUR
• Provision of the safety information to HCP and/or
patients
• Suspension, withdrawal or revocation of the marketing
authorization (with recall of the medicinal product)
CCSI = company core safety information; HCP = healthcare professional; PSUR = periodic safety update report;
RMP = risk management plan; REMS = risk evaluation and mitigation strategy; SPC = summary of product characteristics
Following proactive measures could help to achieve effective operational alignment:
• Align operational activities across different functional groups
and reorganise it as needed for continuous improvement
• Implement well-defined decision-making models, escalation
processes, and communication channels
• Retain key pharmacovigilance personnel with cross-disciplinary
expertise and skill sets
• Establish corporate IT platform and have vision for a long term
strategy

Risk Management
Overall, risk management should ensure that the benefits of a particular medicinal product exceed the risks by the greatest achievable margin. The risk management plan (RMP; for European Union) and the risk evaluation and mitigation strategy (REMS; for theUnited States) are now a standard part of pharmacovigilance planning.
The guideline intended to aid in planning pharmacovigilance activities (ie, ICH E2E)10 was originally created to achieve consistency and harmonisation, particularly during the early postmarketing period of medicinal products. Within the past few years, the United States and European regulatory agencies have increased their guidance on benefitrisk assessment and risk minimisation. The intent of both the RMP and the REMS is to minimise risks related to a medicinal product through interventions and to communicate those risks to patients and healthcare providers. Recently, regulatory authorities are emphasising more on effectiveness check of risk minimisation activities.

Additional activities such as active surveillance, other clinical or epidemiological trials, specialised training, or restricted access may be included in the plan. The activities must be sufficient to minimise the likelihood of harm so that benefits still outweigh risks, and to ensure that the risk reduction procedures are communicated and implemented.

Following proactive measures could help to prepare an effective risk management strategy:
• Develop an objective, data-driven, team-oriented approach to
risk monitoring and evaluation
• Determine the pharmacovigilance workload and sufficiently
resource the required effort
• Implement workflow management technology to ensure
appropriate transparency and accessibility of safety information
• Select a vendor that best matches the pharmacovigilance
operating model, business process and vendor/system selection
criteria
• Develop risk management action plans based on pre-established
risk scoring mitigation processes

Market Overview

Pharmacovigilance has been fundamental to pharmaceuticals industry; however, it has been monitored and followed critically by regultory authorities and companies. The growing number of drug patient approval has made it tough for companies to monitor pre and post effect of each and every drug on the human. That is a prominent reason behind the splendid growth of the pharmacovigilance outsourcing market.

The pharmacovigilance market was valued at approximately USD 5.6 billion in 2020, and it is expected to reach 8.6 billion by 2026, registering a CAGR (ie, compound annual growth rate) of nearly 7.54% during the period of 2021–2026.12 The key factors propelling this market are increasing drug consumption and drug development rates, growing incidence rates of ADR and drug toxicity, and increasing trend of outsourcing pharmacovigilance services. The increasing incidence of lifestyle-related diseases, such as diabetes, hypertension, and cardiac disorders, as a result of sedentary lifestyles, lack of physical activities, changing lifestyle patterns, and poor diets, leads to increased consumption of drugs, which indicates the high demand for drug monitoring and fuels the growth of the market.
With the growing drug consumption, the need for regular monitoring of drugs has also augmented, eventually boosting the pharmacovigilance market.12 The emergence of COVID-19 has brought the world to a standstill. This health crisis has brought an unprecedented impact on businesses across industries. Rising support from governments and several companies can help in the fight against this highly contagious disease.

The rising demand for drugs has significantly increased the need for new drug development via extensive clinical trials. Manufacturers are now focusing on remodelling their drug development processes to cater to patient needs across the globe. Presence of a competitive milieu has led to improved manufacturing operations, pharmacovigilance system, clinical data management, streamlined research and development (R&D), and medical writing. Manufacturers are rapidly considering outsourcing as a viable cost curbing tool. Moreover, organisations are targeting Asia Pacific countries, such as India and China, to conduct clinical trials owing to a wide presence of skilled labour, lower infrastructure & manufacturing costs, and presence of a large patient pool.

Pharmaceutical companies are facing productivity crisis and their R&D investments have increased. Hence, the demand for postmarketing surveillance and safety services is increasing.

Read the entire article: 2021-JCS-5-October-Pharmacovigilance

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