The veterinary and human health industries have much in common. Both are highly regulated environments and have similar goals: To improve lives and provide the best possible outcomes for patients.
As in the human medical sciences field, the world of veterinary pharmacovigilance (PV) is constantly evolving. Within the animal health spectrum specifically, regulatory environments continue to change, and even in regions that have not yet formally adopted the Veterinary International Conference of Harmonization (VICH) guidelines, they are usually considered.
Yet there are considerations beyond the purely regulatory. As in human drug development, the animal health product life cycle is dependent on quality, safety, efficiency and compliance. It is critical for companies to be aware of the various factors at play within this realm when planning a pharmacovigilance program.
In fact, the term pharmacovigilance intrinsically calls us to be aware of these factors. The word is derived from the Greek word “pharmakon,” meaning drug, and the Latin word “vigilare,” which means to be alert, awake or to keep watch.
Let’s explore how companies, independent of size, can begin to develop and successfully implement their own PV programs, with attention to the four main components of an animal health PV program: compliance and stewardship, and advisory and tactical considerations.
The first key component of a successful animal health PV system is compliance. This includes accuracy in following global regulations, including having the policies and procedures in place to guide practices surrounding the PV lifecycle of all products. Within veterinary pharmacology, multiple agencies are usually involved in the regulatory process before a drug or device is approved for market use.
In the United States, for example, animal health PV is overseen by not only the FDA Center for Veterinary Medicine, but also the Environmental Protection Agency (or EPA, which may be involved in regulations for topical flea and tick products, for instance) and the Department of Agriculture (USDA; for animal vaccines). That additional overseeing agency also plays a role in monitoring PV.
Because veterinary pharmaceuticals are regulated by multiple agencies, it is an onerous yet important task to remain compliant in data keeping and collecting, while still keeping the pace to bring drugs that prevent or treat illness in animals to market.
2) Product Stewardship
Having invested colleagues who take accountability of product stewardship is key to a successful PV program. PV includes the receipt and processing of adverse events (AEs) and product quality complaints (PCQs) in a validated database, as well as the processing and reporting of that data. Due to the number of species and the wide variety of animal health products, there are incredibly massive amounts of data.
To start, the drug-event pair should be evaluated for seriousness, relatedness and expectedness. Aggregate PV data for a product can be compiled and analyzed to ensure that the expected AEs remain stable (such as the local reaction an animal may experience after receiving a vaccine), while ensuring there are minimal serious reactions (for example, anaphylaxis) and there are no changes to unexpected reactions.
Once a basic AE and PQC analysis has been established, advisory considerations must be acknowledged in a PV program.
What is the current profile of the product in the post-marketing setting? Actions from analysis may include label changes that reflect the reporting of AEs, audits or inspections of products, and a transparency in ensuring that the risks and benefits of products remain balanced. Competitor analysis comes into play within this segment of the program as well. For example, all products within a similar class should have the same labeling and AE profile across the market.
In a PV program, any spike in AEs or PQCs or a new type of either must be immediately addressed, verified and the root cause investigated. If there are changes in the AE profile that are verified through scientific rigor, those should be communicated to the overseeing regulatory agency. These changes may prompt labeling changes to the drug or promote new indications or changes in dosing. Any product quality complaints (PQCs) should be carefully evaluated to determine its relationship to AEs.
Finally, to ensure return on investment in a PV program, companies must find proactive and innovative uses for PV data.For example, AE reports may include animal owners or veterinarians using the product for a non-indicated use and reporting therapeutic success. This off-label use is captured as an AE, but may drive the business to act on valuable AE data to seek further expansions of indicated use.
Keeping all of this in mind, whether a company is creating a veterinary PV program or refining a current system, the following principles can provide that the correct steps are in place and the protocol is being followed. In the end, a system should:
- Ensure that the marketed product remains safe and effective for animals, and is also safe for any potential human exposure (i.e. risk/benefit profile remains favorable)
- Satisfy customers by providing prompt processing and follow-up of AEs
- Provide customers with a global view of product performance in the field
- Provide the company with results of data mining to use as one of many tools for guiding business decisions
- Proactively use AE data to discover trends, issues and opportunities utilizing a scientifically valid early-alert system
- Ensure compliance with both internal and external regulatory and legal requirements
In this way, a successful PV program has far-reaching benefits — for both the customer and the company.
In my next post, I will discuss the core components of the PV system: people, procedures and infrastructure.