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Each year, we celebrate the contributions of nurses as advocates for patient safety. The role of nurses in Pharmacovigilance (PV) and Drug Safety is often overlooked, since this unique role is out of the mainstream of traditional healthcare nursing. Close examination, however, demonstrates the strong patient safety and advocacy responsibility of nurses who work in the pharmaceutical industry.

Drug safety requires ongoing monitoring and surveillance to protect consumer safety. PV at C3i Solutions support companies in the pharmaceutical industry as they monitor the safety profiles of their products and report safety information to regulatory authorities both in the US and globally. Since we operate in a regulated environment, we understand that over time, the FDA and other regulatory authorities throughout the world have worked to decrease the “noise” in safety reporting and to focus on the serious adverse events that could ultimately affect the safety profiles of the drugs. Our PV Team consistently monitors the regulatory landscape to ensure that the drug safety reporting that we do is in compliance with the most up to date regulatory intelligence. For example, in March, 2011, the FDA issued guidance known as the Final Rule, which indicated that a pharmaceutical company should have evidence suggesting causality of the event to a drug or device before expediting a report to the FDA. While this guidance decreases the total number of individual events reported, it results in a higher percentage of reports actually being caused by the product under investigation, which decreases that “noise” in safety reporting. The non-expedited reports are presented in an aggregate format for review by the FDA. CROs and individuals involved in drug safety and pharmacovigilance can be considered the “watchdogs” for patients and consumers, since the ultimate goal is safety of the drugs, vaccines, and medical devices that are widely used.

The value of reporting data for quality and safety

The reality is that regulatory authorities want to make reporting of safety information as easy as possible and a mixed method of surveillance is most effective. In the US, the FDA uses both passive and active surveillance to overcome the obstacles of under-reporting of events. Passive surveillance is voluntary reporting of adverse events. These reports come into an electronic database from HCPs, manufacturers, and patients for review and assessment. At the same time, the FDA also does active surveillance called the Sentinel Initiative, which uses data from multiple sources to assess the safety of approved products. In this initiative, data mining and outreach through electronic health records and health claims is utilized to identify and assess adverse events while protecting the privacy and data security of patients. In addition, the FDA and other global regulatory authorities continuously monitor safety reporting processes to provide guidelines like the Final Rule that help to encourage and streamline reporting. As technology continues to change, the industry has also expanded surveillance into areas such as social media to ensure that events discussed in this arena are not missed. In conjunction with the regulatory authorities, the industry encourages the reporting of events through as many avenues as possible.

Nurses on the frontline of safety reporting

Formal training is essential in making safety reporting consistent and meaningful. Best practice also involves a certain amount of follow-up and due diligence to ensure that the reported information is complete, which speaks to quality of the data. The serious adverse event reporting function is the primary way that safety is monitored throughout the drug development process. Nurses use their knowledge and experience to identify and assess events for safety reporting, thereby increasing both the consistency and quality of the safety data that is reported to the FDA and globally.

The nursing education and background really puts nurses in a unique position to understand the importance of reporting adverse events. Experienced drug safety managers and nurses often mentor and teach nurses and other healthcare providers new to the drug safety industry, so that they understand the importance of pharmacovigilance for patient safety. The patient safety aspect is in the forefront of pharmacovigilance, which makes it a natural transition for nurses. Drug safety nurses are empowered to use this education and experience to continue the circle of safety by remaining vigilant to events that could be drug related and should be reported.

As nurses and patient advocates, we are obliged to report suspected adverse drug reactions noted when providing care. Healthcare institutions and the FDA provide guidance for nurses and any healthcare professional to make it easier for reporting of these adverse drug reactions. In the drug safety industry, the clinical trial and post marketing worlds are distinct and the FDA regulations have specific sections relating to each domain. Clinical trials constitute the gold standard to assess the efficacy and safety of new medicines or devices. However, because they are conducted in controlled conditions far from the real world of prescription and use of the product, practices in patient selection or treatment conditions may alter both the effectiveness and risks associated with new drugs. For example, clinical trials use strict inclusion and exclusion criteria when selecting patients to participate, data is collected in a more standardized way, all reports of adverse events are medically confirmed and the data is generally considered clean and reproducible. In contrast, post marketing surveillance is more observational to determine the long-term effectiveness of the drug and is generally conducted right after the commercialization of the drug to the “real world”. Post marketing includes looking at the long term effects in diverse groups and looking for drug-drug and/or drug-food interactions. In most cases of post-marketed surveillance, pharmaceutical companies and regulatory authorities are looking for any adverse events that are increased in severity and/or reported more frequently than were noted in clinical trials.

Conclusions and recognitions

If you are looking to use your nursing knowledge in a non-traditional setting, pharmacovigilance offers you that opportunity to be autonomous and continue to work on behalf of the patient and ultimately the consumer of marketed drugs. I would recommend that interested nurses look into opportunities within the pharmaceutical industry with pharmaceutical companies, CROs or clinical research sites within hospitals or physician practices. The opportunities are out there and the industry recognizes and values the contributions nurses make to drug safety. It is really a great way to utilize your nursing background in a completely different way from the traditional clinical practice. The US Food and Drug Administration website www.fda.gov has a wealth of information regarding the regulations and how they apply to the different phases of drug development. Anyone interested in a career in pharmacovigilance should visit the website to get a flavor of how drug safety is administered and monitored in the US from in-patient settings, clinical trials and the post-marketing arena.

C3i Solutions recognizes and thanks all the nurses, physicians, pharmacists and support personnel who work tirelessly to monitor and protect the safety of patients and consumers. We celebrate the success of pharmacovigilance and drug safety in making the medications, vaccines, devices and consumer products we use safe and effective for individuals everywhere.

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