Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient Safety.

BACKGROUND: Over the past decade, the volume of adverse events (AEs) reported to marketing authorization holders and regulators has been rapidly increasing each year, which has led to significant challenges in patient safety assessment. Three data sources that have largely contributed to the expansion in adverse event reports are patient support programs (PSPs), market research programs (MRPs), and social media. In this study, we sought to further understand the contribution of these safety data sources to the characterization of a product's safety profile. METHODS: Three separate approaches were taken that, when combined, can be used to evaluate each data source. The first identified any core company data sheet changes or drug safety label changes. The second evaluated the similarity of information through proportions of AEs between each solicited data source and spontaneous sources. Lastly, the completeness of information reported was evaluated through vigiGrade and compared across each data source. RESULTS: One drug safety label change was identified from a patient support program, which involved regular contact with health care providers. No label changes were identified from market research programs or social media. Patient support programs, market research programs, and social media report similar proportions for HLGT as spontaneous sources. Market research programs and social media display very low vigiGrade scores. When broken down by subtype, traditional PSPs display high vigiGrade scores, while patient assistance programs display lower vigiGrade scores that were program dependent. CONCLUSIONS: This study did not demonstrate that certain data sources such as market research programs, social media, and patient assistance programs meaningfully contributed to the further understanding of the characterization of a product's safety profile.

Pooling Different Safety Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection In Pharmacovigilance.

INTRODUCTION: The volume of adverse events (AEs) collected, analysed, and reported has been increasing at a rapid rate for over the past 10 years, largely due to the growth of solicited programmes. The proportion of various forms of solicited case data has evolved over time, with the main relative volume increase coming from Patient Support Programmes. In this study, we sought to examine the impact of the pooling of AE report data from solicited sources with data from spontaneous sources to safety signal detection using disproportionality analysis methods. METHODS: Two conditions were explored in which disproportionality scores from hypothetical drugs were evaluated in a simulated safety database. The first condition held occurrence of events constant and varied solicited case volume, while the second condition varied both proportion of occurrence of events and solicited case volume. RESULTS: In the first setting, where all AE terms have the same probability to occur with any drug, increasing volumes of solicited cases while keeping occurrence of events constant leads to reduced variability in disproportionality scores, consequently reducing or eliminating identified signals of disproportionate reporting. In the second setting, varying both case volume and reporting rates can mask true safety signals and falsely identify signals where there are none. CONCLUSIONS: This analysis of simulated data suggests that pooling AE data from solicited sources with spontaneous case data may impact the results of disproportionality analyses, masking true safety signals and identifying false positives. Therefore, increased volumes of safety data do not necessarily correlate with improved safety signal detection.

Levetiracetam: the first SV2A ligand for the treatment of epilepsy.

Levetiracetam is a multiple action drug that primarily acts through an interaction with the synaptic vesicle protein 2A. Levetiracetam is the first drug of its kind to be approved for the treatment of epilepsy and is now the most prescribed among the newer antiepileptic drugs. The discovery process identifying levetiracetam's antiepileptic potential was unique because it challenged several dogmas of antiepileptic drug discovery, and thereby encountered skepticism from the epilepsy community. This was contrasted by a very successful development programme leading to rapid regulatory approval by the FDA. The history of levetiracetam proves that a small core group of committed scientists and physicians, who dare to challenge the conventional scientific doctrine, can be successful in bringing to market a truly novel therapy for epilepsy patients.

Identifying baseline characteristics of placebo responders versus nonresponders in randomized double-blind trials of refractory partial-onset seizures.

In add-on studies of partial-onset seizures, the placebo response, defined as a 50% decrease from baseline in seizure frequency, ranges from 0-19%. Reasons for this significant difference between placebo groups in different trials are not given in the literature. This exploratory analysis was undertaken to compare the baseline characteristics of placebo responders and nonresponders, in an attempt to identify common features. The pooled statistical analysis was performed on the database for three pivotal studies of levetiracetam (n = 904). Using the 50% response definition, we found that 45.6% of placebo nonresponders were on one antiepileptic drug at baseline, compared with 69% of placebo responders. The difference in number of baseline antiepileptic drugs was almost statistically significant (p = 0.056). Placebo nonresponders also tended to have epilepsy for longer than responders. The mean age at onset of epilepsy was consistently different between placebo nonresponders and responders (15.2 versus 20.8 years, respectively; p = 0.019). These findings suggest that the placebo response is higher in patients with partial-onset seizures who are taking only one antiepileptic drug at baseline and have later onset and shorter duration of epilepsy than in patients on more than one antiepileptic drug at baseline with earlier onset and longer duration of epilepsy.