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Freifeld C.C.,Boston University | Freifeld C.C.,Childrens Hospital Informatics Program | Brownstein J.S.,Childrens Hospital Informatics Program | Brownstein J.S.,Harvard University | And 6 more authors.
Drug Safety | Year: 2014

Background: Traditional adverse event (AE) reporting systems have been slow in adapting to online AE reporting from patients, relying instead on gatekeepers, such as clinicians and drug safety groups, to verify each potential event. In the meantime, increasing numbers of patients have turned to social media to share their experiences with drugs, medical devices, and vaccines. Objective: The aim of the study was to evaluate the level of concordance between Twitter posts mentioning AE-like reactions and spontaneous reports received by a regulatory agency. Methods: We collected public English-language Twitter posts mentioning 23 medical products from 1 November 2012 through 31 May 2013. Data were filtered using a semi-automated process to identify posts with resemblance to AEs (Proto-AEs). A dictionary was developed to translate Internet vernacular to a standardized regulatory ontology for analysis (MedDRA®). Aggregated frequency of identified product-event pairs was then compared with data from the public FDA Adverse Event Reporting System (FAERS) by System Organ Class (SOC). Of the 6.9 million Twitter posts collected, 4,401 Proto-AEs were identified out of 60,000 examined. Automated, dictionary-based symptom classification had 72 % recall and 86 % precision. Similar overall distribution profiles were observed, with Spearman rank correlation rho of 0.75 (p < 0.0001) between Proto-AEs reported in Twitter and FAERS by SOC. Conclusion: Patients reporting AEs on Twitter showed a range of sophistication when describing their experience. Despite the public availability of these data, their appropriate role in pharmacovigilance has not been established. Additional work is needed to improve data acquisition and automation. © 2014 The Author(s).


PubMed | U.S. Food and Drug Administration, Uppsala Monitoring Center and Epidemico Inc.
Type: | Journal: Drug safety | Year: 2017

The rapid expansion of the Internet and computing power in recent years has opened up the possibility of using social media for pharmacovigilance. While this general concept has been proposed by many, central questions remain as to whether social media can provide earlier warnings for rare and serious events than traditional signal detection from spontaneous report data.Our objective was to examine whether specific product-adverse event pairs were reported via social media before being reported to the US FDA Adverse Event Reporting System (FAERS).A retrospective analysis of public Facebook and Twitter data was conducted for 10 recent FDA postmarketing safety signals at the drug-event pair level with six negative controls. Social media data corresponding to twoyears prior to signal detection of each product-event pair were compiled. Automated classifiers were used to identify each post with resemblance to an adverse event (Proto-AE), among English language posts. A custom dictionary was used to translate Internet vernacular into Medical Dictionary for Regulatory Activities (MedDRAA total of 935,246 posts were harvested from Facebook and Twitter, from March 2009 through October 2014. The automated classifier identified 98,252 Proto-AEs. Of these, 13 posts were selected for causality assessment of product-event pairs. Clinical assessment revealed that posts had sufficient information to warrant further investigation for two possible product-event associations: dronedarone-vasculitis and Banana Boat Sunscreen--skin burns. No product-event associations were found among the negative controls. In one of the positive cases, the first report occurred in social media prior to signal detection from FAERS, whereas the other case occurred first in FAERS.An efficient semi-automated approach to social media monitoring may provide earlier insights into certain adverse events. More work is needed to elaborate additional uses for social media data in pharmacovigilance and to determine how they can be applied by regulatory agencies.


PubMed | University of Colorado at Denver, Nova Southeastern University, Denver Health and Hospital Authority, Epidemico Inc. and 2 more.
Type: Journal Article | Journal: Pain medicine (Malden, Mass.) | Year: 2016

Prescription opioid analgesics are commonly prescribed for moderate to severe pain. An unintended consequence of prescribing opioid analgesics is the abuse and diversion of these medications. Tapentadol ER is a recently approved centrally acting analgesic with synergistic mechanisms of action: -opioid receptor agonism and inhibition of norepinephrine reuptake. We assessed the amount of diversion and related cost of obtaining tapentadol IR (Nucynta) and tapentadol ER (Nucynta ER) as well as other Schedule II opioid medications in street transactions in the United States using the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System.The Drug Diversion Program measures the number of cases opened by 260 drug diversion investigators in 49 states. StreetRx(TM) uses a crowd-sourcing Website to collect the prices paid for licit or illicit drugs.The population-based rates of diversion were 0.003 (tapentadol IR), 0.001 (tapentadol ER), and 1.495 (other Schedule II opioid tablets) reports per 100,000 population. The tapentadol ER rate was lower than the other Schedule II opioid tablets (P <0.001) and tapentadol IR (P=0.004). Diversion rates based on drug availability were 0.03 (tapentadol IR), 0.016 (tapentadol ER), and 0.172 (other Schedule II opioid tablets) per 1,000 prescriptions dispensed. The median street price per milligram was $0.18 (tapentadol IR), $0.10 (tapentadol ER), and $1.00 (other Schedule II opioid tablets).Our results indicate that tapentadol ER is rarely sold illicitly in the United States. When sold illicitly, tapentadol ER costs less than other Schedule II opioid products.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: SEC-2012.6.1-3 | Award Amount: 5.44M | Year: 2013

The ATHENA project brings together major user communities with world leading experts in crisis management and experts and technology developers of mobile and social media use and development. The goal of the ATHENA project is to deliver two major outputs that will enable and encourage users of new media to contribute to the security of citizens in crisis situations and for search and rescue actions: First, a set of best practice guidelines for LEAs, police, first responders and citizens for the use of new media, supporting tools and technologies in crisis situations Second, a suite of prototype software tools to enhance the ability of LEAs, police, first responders and citizens in their use of mobile and smart devices in crisis situations This project will explore how the huge popularity of new communication media, particularly web-based social media such as Twitter and Facebook, and the prolific use of high-tech mobile devices, can be harnessed to provide efficient and effective communication and enhanced situational awareness during a crisis. The ATHENA system is a crisis communication and management system that encourages and enables the public to participate, in an ethical way, in the process of emergency communication to contribute to the security of the citizen in crisis situations and for search and rescue actions. ATHENA makes use of new social media and high tech mobile devices to efficiently and effectively acquire, analyse and disseminate crisis information and intelligence that is appropriate and useful to LEAs/police/first responders and the public.


Severtson S.G.,Rocky Mountain Poison and Drug Center | Ellis M.S.,University of Washington | Kurtz S.P.,Nova Southeastern University | Rosenblum A.,American Association for the Treatment of Opioid Dependence | And 8 more authors.
Drug and Alcohol Dependence | Year: 2016

Background The development of abuse deterrent formulations is one strategy for reducing prescription opioid misuse and abuse. A putative abuse deterrent formulation of oxycodone extended release (OxyContin®) was introduced in 2010. Early reports demonstrated reduced abuse and diversion, however, an analysis of social media found 32 feasible methods to circumvent the abuse deterrent mechanism. We measured trends of diversion, abuse and street price of OxyContin to assess the durability of the initial reduction in abuse. Methods Data from the Poison Center Program, Drug Diversion Program, Opioid Treatment Program, Survey of Key Informant Patients Program and StreetRx program of the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS®) System were used. The average quarterly rates of abuse and diversion for OxyContin were compared from before reformulation to the rate in second quarter 2015. Rates were adjusted for population using US Census data and drug availability. Results OxyContin abuse and diversion declined significantly each quarter after reformulation and persisted for 5 years. The rate of abuse of other opioid analgesics increased initially and then decreased, but to lesser extent than OxyContin. Abuse through both oral and non-oral routes of self-administration declined following the reformulation. The geometric mean difference in the street price of reformulated OxyContin was 36% lower than the reformulated product in the year after reformulation. Discussion Despite methods to circumvent the abuse deterrent mechanism, abuse and diversion of OxyContin decreased promptly following the introduction of a crush- and solubility- resistant formulation and continued to decrease over the subsequent 5 years. © 2016


PubMed | Rocky Mountain Poison and Drug Center, Nova Southeastern University, University of Washington, Epidemico Inc. and American Association for the Treatment of Opioid Dependence
Type: | Journal: Drug and alcohol dependence | Year: 2016

The development of abuse deterrent formulations is one strategy for reducing prescription opioid misuse and abuse. A putative abuse deterrent formulation of oxycodone extended release (OxyContinData from the Poison Center Program, Drug Diversion Program, Opioid Treatment Program, Survey of Key Informant Patients Program and StreetRx program of the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARSOxyContin abuse and diversion declined significantly each quarter after reformulation and persisted for 5 years. The rate of abuse of other opioid analgesics increased initially and then decreased, but to lesser extent than OxyContin. Abuse through both oral and non-oral routes of self-administration declined following the reformulation. The geometric mean difference in the street price of reformulated OxyContin was 36% lower than the reformulated product in the year after reformulation.Despite methods to circumvent the abuse deterrent mechanism, abuse and diversion of OxyContin decreased promptly following the introduction of a crush- and solubility- resistant formulation and continued to decrease over the subsequent 5 years.


Powell G.E.,Glaxosmithkline | Seifert H.A.,Glaxosmithkline | Reblin T.,Glaxosmithkline | Burstein P.J.,Glaxosmithkline | And 10 more authors.
Drug Safety | Year: 2016

Introduction: Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media (‘social listening’) to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. Objectives: The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. Methods: A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. Results: In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Conclusion: Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source. © 2016, Springer International Publishing Switzerland.


Conover M.M.,University of North Carolina at Chapel Hill | Howell J.O.,University of North Carolina at Chapel Hill | Wu J.M.,University of North Carolina at Chapel Hill | Kinlaw A.C.,University of North Carolina at Chapel Hill | And 3 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2015

Objective: Compare incidence of opioid-managed pelvic pain within 12months after hysteroscopic and laparoscopic sterilization. Methods: Using administrative claims, we identified women aged 18-49years without recent history of childbirth who underwent hysteroscopic or laparoscopic sterilization between 2005 and 2012. We defined the outcome as ≥2 diagnoses for pelvic pain and ≥2 prescription fills for opioids. We calculated adjusted hazard ratios (HR) using Cox models and propensity score methods (matching and inverse-probability-of-treatment-weighting [IPTW]). Results: We identified 71875 eligible women (hysteroscopic n=26927 [37.5%], laparoscopic n=44948 [62.5%]). Of those, 236 (0.88%) hysteroscopic patients and 420 (0.93%) laparoscopic patients experienced the outcome (crude HR=0.97, 95%CI: [0.83, 1.14]). Adjusted analyses also yielded near-null results (matched HR=1.08, 95%CI [0.90, 1.31]; IPTW HR=0.97, 95%CI [0.80, 1.18]). While most sensitivity analyses generated results close to the null, hazard ratios estimated using propensity score matching ranged from 0.65 to 1.53. Conclusions: Among women without recent history of childbirth, we did not find compelling evidence of a clinically meaningful increase in the incidence of pelvic pain requiring opioids during the year after hysteroscopic sterilization. However, effects observed in sensitivity analyses may merit further investigation. © 2015 John Wiley & Sons, Ltd.


PubMed | Facebook, Rti International and Epidemico Inc.
Type: Journal Article | Journal: Pharmaceutical medicine | Year: 2015

Preparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40min. User-friendly Web and mobile reporting apps may increase efficiency. Further, coupled with strategies for direct patient involvement, patient engagement in AE reporting may be improved. In 2012, the FDA Center for Devices and Radiologic Health (CDRH) launched a free, public mobile AE reporting app, MedWatcher, for patients and clinicians. During the same year, a patient community on Facebook adopted the app to submit reports involving a hysteroscopic sterilization device, brand name EssurePatient community outreach was conducted to administrators of the group Essure Problems (approximately 18,000 members as of June 2015) to gather individual case safety reports (ICSRs). After agreeing on key reporting principles, group administrators encouraged members to report via the app. Semi-structured forms in the app mirrored fields of the MedWatch 3500 form. ICSRs were transmitted to CDRH via an electronic gateway, and anonymized versions were posted in the app. Data collected from May 11, 2013 to December 7, 2014 were analyzed. Narrative texts were coded by trained and certified MedDRA coders (version 17). Descriptive statistics and metrics, including VigiGrade completeness scores, were analyzed. Various incentives and motivations to report in the Facebook group were observed.The average Essure AE report took 11.4min (10) to complete. Submissions from 1349 women, average age 34years, were analyzed. Serious events, including hospitalization, disability, and permanent damage after implantation, were reported by 1047 women (77.6%). A total of 13,135 product-event pairs were reported, comprising 327 unique preferred terms, most frequently fatigue (Outreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed ICSRs to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further research is needed to understand how biases operate differently from those of traditional pharmacovigilance.


PubMed | Blue Zone Industries, Zero Chaos, Glaxosmithkline and Epidemico Inc.
Type: Journal Article | Journal: Drug safety | Year: 2016

Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media (social listening) to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources.The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance.A third-party vendor acquired 24months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information.In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA()) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26% of posts also contained benefit information.Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

Loading Epidemico Inc. collaborators
Loading Epidemico Inc. collaborators