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PharSafar

By- Graeme Ladds

Current Industry Situation

Throughout the years, pharmaceutical companies, for their developmental and marketed products, have continuously worked towards ensuring their products comply with the varied, numerous, and extensive legal safety/medical obligations – established and put in place by various national and international governing authorities and agencies – to ensure the appropriate level of vigilance is upheld in accordance with the safety requirements of each region.

Since the 1960s, the number of adverse reaction reports received by pharmaceutical companies, Market Authorisation Holders (MAHs), and regulatory authorities has risen year after year – a trend which continues to rise to this day, with the emergence and exponential growth of markets such as the cosmetics and medical device industries and the additional legislative changes for all of these areas bring to the wider pharmaceutical industry, giving reason to believe this rise will show no sign of slowing any time soon.

In Europe alone, since the introduction of numerous pieces of revised and additional legislation in 2021, as a cumulative result of macro factors such as Brexit and the Covid-19 pandemic, adverse reaction reports have increased significantly – with the number of reports being submitted per year now at an all-time high.

As a result, this has placed an increased demand within the drug safety Departments of Companies for adverse event case processing and analysis duties and has inevitably led to the subsequent, ever-increasing demand being placed on employee output and labor; the need for new and additional staff; the associated cost of hiring and properly training said staff initially and long term, and the added pressures placed on ensuring processing timelines are met in accordance with regulatory requirements.

Moreover, this concern is one already shared by major industry stakeholders, with notable bodies such as the World Health Organisation (WHO) and European Medicines Agency (EMA) highlighting the implementation of automation as a key factor in addressing issues with increasing safety reporting demands and combating the increasingly inaccurate and poor quality of case reports respectively.

The Importance of Finding a Solution

In recent years, most notably as a result of the Covid-19 pandemic, the subject of patient safety has excelled to new heights, with many areas of regulation have been and still being extensively reviewed and updated, and greater levels of public interest and involvement leading to large proportions of both patients and consumers becoming more aware of the requirements placed on industry organizations and MAHs. This is paired with industry companies and MAHs being required to adapt, update and outright change their company processes to align with any amendments made to regulation and case volume increases, usually to scales and within timespans previously otherwise unseen during this period.

Furthermore, when looking beyond the realm of safety data capture, reporting, and obtaining follow-up information and towards the wider pharmacovigilance activities, due to the activity of case processing is instrumental to ensuring a company can best address potential new safety information relating to their product, issues with inaccurate and poor quality of data processing have a direct, negative impact on the reliability of safety data analysis duties such as signal detection, periodic report writing, and benefit-risk determinations.

Consequently, the ever-rising demand being placed on safety reporting activities – in line with the aforementioned factors – has ultimately resulted in an unsustainable strain being placed upon the wider industry, with the unavoidable outcome of serious regulatory findings originating from inaccurate data, incomplete data, and reduced quality of data reported together with failing compliance becoming more of an eventuality than a possibility.

The Solution

For these reasons, the need for greater levels of automation within the pharmaceutical industry and, more specifically, drug safety has never been greater.

In order for governing and guiding authorities such as the WHO, FDA, PDMA, and EMA to ensure their goals of greater levels of ensuring safe and effective products and patient well-being on a global scale are achieved, the wider industry will require companies and MAHs to innovate and streamline processes supported by seeking an automated leap into the future of data entry and safety reporting and, in doing so, industry stakeholders will not only see their issues resulting from the ever-rising demands placed upon the workforce addressed, but improved to levels not previously seen before.

Through a greater implementation of automation, companies will now expect to see the human element of data entry repositioned towards analysis duties – freeing up professionals and enabling them to better utilize their skill sets and apply their knowledge towards finding solutions to potential safety issues – with manual case data entry set to become something overseen and driven by automated processes.

The greater implementation of automation will allow safety professionals to better concentrate on their analysis duties, providing greater levels of job fulfillment by removing the growing pressures felt from increased manual case processing; removing any repetitious procedures associated with data entry; eliminating human errors that result directly from issues with reporting quantities and timescales, whilst also maximizing the efficiency and affordability of case processing through superior global coverage; unprecedented reporting capabilities for both quantity and timescales; enhanced disaster recovery and business continuity processes, and reduced costings typically associated with staffing recruitment and initial and on-going training.

Furthermore, by addressing issues associated with case processing and enhancing vigilance over the first phase of safety reporting processes, improving the efficiency, consistency, and accuracy of safety data capture and collection will undoubtedly result in a positive, knock-on effect on the quality and speed of analysis activities and promote greater levels of global patient safety for years to come.

About the Author

Graeme Ladds, CEO

With a first degree in Biochemistry and Pharmacology, and a Ph.D. focusing on drug metabolism and Pharmacokinetics, Graeme has worked in the areas of Drug Safety and Medical services for over 30 years.

Graeme has been working as Head of Global Pharmacovigilance for a multi-national innovator Company and EU QP PV for several of the top ten Pharma Companies, large generic and smaller innovative Pharma, and is also the CEO of PharSafer® – a position held for the last 19 years.

Furthermore, Graeme is also a member of the DIA; TOPRA; RQA, PIPA and MAPS and has helped small start-up Companies (Biotech; Advance Therapy; Medical Devices; Biologics; Generics; Herbal; OTC) in their planning and growth, and has been involved in Company and product acquisitions, due diligence activities for product in-licensing and marketing, and development strategies with partner and distributor Companies.

Additionally, Graeme has been involved in many drug-development programs, taking products from the bench to market in a wide range of therapeutic areas, and also has an additional role as Research & Development Director for products to be developed for global launches.