Vigilance by Another Name

Do regulations and guidance documents sometimes stagnate your learning progress because of the terminology used? Regulation confusion is a common complaint heard from current and prospective new clients. To understand which rules apply in each situation, and to which parties, we have to first start at the beginning teasing apart the broad categories. Perhaps your knowledge in this area is extensive, in which case this will just be a fun refresher for you.

Vigilance is the state of being alert. In the healthcare and research industries, this is everyone's responsibility. The 'how' of being vigilant though depends on the type of vigilance involved, as each area has its own rules and timelines.

Pharmacovigilance

Pharmacovigilance is probably the most well-known area coming from the Greek word pharmakeia meaning druggist. As you've probably guessed, it means vigilance regarding medicines, specifically drugs and vaccines.

Health authorities typically have pharmacovigilance areas on their websites, which is where you will find what, when, and how of reporting to that health authority. Each one includes nuances so carefully reading those documents is critical, but there is also a shortcut. Contract Research Organizations (CROs) maintain their own repository of this information by country and health authority so that the company as a whole is working in sync. These repositories, of what is known as regulatory intelligence, also include the company's interpretations of the various guidances and regulations. These interpretations are worth gold in this industry because they can save resources, redundant reporting, and rejections from the health authority. A PV vendor may share theirs with you or sell it to you, and this offering should not be overlooked.

One last note: pharmacovigilance includes all phases of drug and vaccine development (pre-clinical, clinical, and post-marketing) however the synonyms may not. For example, Drug Safety or Safety Surveillance primarily includes the clinical development phase, when patient safety is almost a singular focus. The difference would be that pharmacovigilance also includes the benefit and risk assessment tasks critical to late-stage development and marketed products. To wrap this up, pharmacovigilance can refer to all areas of drug and vaccine vigilance while Drug Safety has a singular clinical focus.

Cosmetovigilance

Another area of vigilance stems from the Greek word kosmetikos meaning cosmetics. No surprise here then that Cosmetovigilance refers to vigilance surrounding cosmetic products. Not every country has developed a cosmetovigilance system so this is where regulatory intelligence can really save you from searching for the needle in the haystack that doesn't exist. The products included in this area range from skin moisturizers, perfumes, fingernail polishes, and makeup to shampoos, hair colors, toothpastes, and deodorants. The interesting distinction about cosmetovigilance is that manufacturers do not receive a formal marketing authorization but instead hold the responsibility for compliance with the cosmetic regulations through the full lifecycle of the product.

Materiovigilance

The next area of vigilance has a Latin origin with the word materio referring to the material that a product is made of. Did you guess? Materiovigilance is vigilance of medical devices and technically only refers to those once they have been released on the market. Oddly there is no fancy word for vigilance of medical devices in the clinical phase, so this is often referred to as Device Vigilance, Safety Vigilance, or just blended into materiovigilance. The requirements for materiovigilance compliance are quite different compared to pharmacovigilance including different terminology, scales of risk, and reporting timelines.

Additional Vigilance Areas

We can add to that list with a few more-- Veterinary pharmacovigilance of course relates to drugs and vaccines for animals. Clinical vigilance covers the donation and clinical application of blood, cells, tissues and organs. Haemovigilance is the vigilance of blood product safety monitoring. Phytovigilance covers herbal medicines, food supplements, plant-based cosmetics, and other plant-based products. And lastly only recently coined, there is Algorithmovigilance which is vigilant over the use of algorithms in health care such as with artificial intelligence.

Vigilance by any other name opens a diverse array of regulations, terminology, and timelines. Staying informed through use of regulatory intelligence is the best protection for successful compliance.

Author

Laura Hopper

President, Pharmacovigilance