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Developments and Future Directions of Prescription-Based Observational Cohort Pharmacovigilance

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Evidence-Based Pharmacovigilance

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

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Abstract

Lessons learnt from recent examples of drug safety hazards include the acknowledgment of discordance in learning about safety of new medicines during development as compared to during use within routine clinical practice, post marketing. Changes in pharmacovigilance regulations and legislation have given greater weight to the importance of post-marketing observational research and understanding more regarding natural variation in patients and their responses to treatment. In this chapter the origin and evolution of prescription-based event monitoring is described, with examples of real-life studies presented to offer some insight into the contributions and challenges of these post marketing systems in relation to monitoring the safety and use of new medicines.

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Notes

  1. 1.

    Formally known as the Prescription Pricing Division (PPD).

  2. 2.

    Identified risks (known from clinical trials), potential risks (effects not observed in trials but expected e.g. class effects) and missing risks (identified and potential effects that may occur in populations not studied).

  3. 3.

    Preferential prescribing to subsets of patients defined by a specific characteristic, such as having a condition resistant to previous therapy or pre-existing risk factor that may be a precaution for use or contraindication to certain treatments [31].

  4. 4.

    Past experience with an alternative drug that modifies the risk of adverse events associated with current use of the study drug [32].

  5. 5.

    For example, there may be a “depletion of susceptibles” if GPs selectively respond for those patients who tolerate and continue to use the drug. The reverse is also possible whereby GPs may be more likely to respond if patients have experienced adverse events with a new medicine [33].

  6. 6.

    “Off-label” refers to the use of a drug “in situations where a medicinal product is intentionally used for a medicinal purpose not in accordance with the authorized product information.” [40].

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  1. Deborah Layton

    Present address: IQVIA, London, UK

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  1. Drug Safety Research Unit, Southampton, UK

    Deborah Layton

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  1. Deborah Layton
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  1. Epidemiology Group Lead, Analytics, Worldwide Safety and Regulatory, Tadworth, Surrey, UK

    Andrew Bate

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Layton, D. (2018). Developments and Future Directions of Prescription-Based Observational Cohort Pharmacovigilance. In: Bate, A. (eds) Evidence-Based Pharmacovigilance. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8818-1_6

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  • DOI: https://doi.org/10.1007/978-1-4939-8818-1_6

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