essure problems: utilizing facebook and mobile apps in pharmacovigilance
TRANSCRIPT
Essure Problems: Utilizing Facebook and Mobile Apps in Pharmacovigilance
Chi Bahk, MS
Aug 25 2015 ICPE
Chi Y Bahk1, Melanie Goshgarian2, Krystal Donahue2, Clark C Freifeld1, Christopher Menone1, Carrie Pierce1, Harold Rodriguez1, John S Brownstein1, Robert Furberg3, Nabarun Dasgupta1 1 Epidemico, Boston, MA, USA 2 “Essure Problems” Facebook Group 3 RTI International, NC, USA
Disclosures • This research was funded in part by the Center for Devices and
Radiologic Health of the US Food and Drug Administration.
• Presenter is an employee of Epidemico, developer of MedWatcher App. Epidemico does not commercially benefit from the public’s downloading or use of the App. We do commercialize the information technology aspects of this research.
• This presentation contains adverse event information for a product manufactured by Bayer HealthCare Pharmaceuticals. Epidemico has no relationship with Bayer, and the manufacturer was not notified ahead of time about this presentation.
• This presentation contains patient-related information, which has been approved for presentation purposes by patient group.
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5. Participation 6. Outcome1. Motivation
2. Incentives
3. Incentive support
4. Activation
5. Report tomanufactureror clinician
6. Data sharedwith regulator1. Altruism
2. Prevent harm
4. Activation
Theoretical Model
Traditional Pharmacovigilance
5. Report viamobile app
6. Data sharedwith regulatorand community
1. Altruism
4. Activation
2. Prevent harm
3. Process endorsementby community
3. Empathyfrom community
2. Validation ofexperience
Intrinsic
Extrinsic
2. Recognition
Crowdsourcing with Community Outreach
Bahk C. et al, Pharmaceu1cal Medicine
MIAB Model for successful crowdsourcing
5
MedWatcher App
01
02
03
04
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Free, user-friendly Web & mobile app
Allows for rapid reporting of suspected adverse events
Increase public access to drug, device, and vaccine information
Supported by US FDA Center for Devices and Radiologic Health
US launch in 2010; EU expansion in in progress
Essure
Conduct Nullam eu tempor purus. Nunc a leo magna, sit amet consequat risus. Etiam faucibus tortor a ipsum vehicula sed hendrerit.
• Implantable, permanent birth control for women
• Coils made of polyester fibers, nickel-titanium and stainless steel,
implanted into fallopian tubes
• US FDA approved 2002
• 5-year fail rate: 0.27%
• Common and notable AEs: abdominal pain, pelvic pain, abdominal distension,
vaginal haemorrhage, alopecia, allergy to metals, device dislocation, pregnancy with
contraceptive device, salpingectomy, hysterectomy
01
02
03
04
05
Launched in March 2011 by patient, Angie Firmalino
As of August 2015, more than 19,000 members
Environment where patients can share information and experiences
Managed by 11 volunteer administrators; 2 elected as co-authors
Engaged by MedWatcher team starting October 2013
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“Essure Problems” Facebook Group
Methods
Outreach to Facebook
group “Essure Problems”
Work with administrators to promote AE reporting via mobile app
1,349 AE reports (May 2013 –
Dec 2014) coded & analyzed
WHO-UMC VigiGrade completeness scores
calculated & MIAB model for successful
crowdsourcing applied
Findings: Essure Reports per Month
7 per monthFDA MAUDE
132 months marketing authorization
103 per monthMedWatcher Mobile App
19 months collaboration with patient community
Findings: Crowdsourcing vs. Traditional Pharmacovigilance Comparison of Essure mobile app submissions with WHO-UMC database
Average Time for Submission App users submitted in 11.4 minutes
compared to 40 minutes via traditional forms
Average VigiGrade Score App submissions were more complete
than global avg in VigiBase.
“Well-documented” Reports App reports were considered “well-
documented” 4x more often than global avg in VigiBase
40 min 0.45
Bergvall T 2013 Drug Safety
11.4 min 0.80 56%
24% HCP
13% overall
5. Participation 6. Outcome1. Motivation
2. Incentives
3. Incentive support
4. Activation
5. Report tomanufactureror clinician
6. Data sharedwith regulator1. Altruism
2. Prevent harm
4. Activation
Theoretical Model
Traditional Pharmacovigilance
5. Report viamobile app
6. Data sharedwith regulatorand community
1. Altruism
4. Activation
2. Prevent harm
3. Process endorsementby community
3. Empathyfrom community
2. Validation ofexperience
Intrinsic
Extrinsic
1. Recognition
Crowdsourcing with Community Outreach
Bahk C. et al, Pharmaceu1cal Medicine
• June 24, 2015: FDA announces Advisory Committee meeting on Essure
• “The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants”
• 5093 reports on MAUDE through May 31, 2015; 2087 through MedWatcher app
• To date, 3592 reports received through MedWatcher app
To Date
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LIMITATIONS OF SOCIAL MEDIA & MOBILE APPS
CAUSALITY Patients may not correctly assess causality. Define methods to measure probability of real world significance.
VOLUME Volume of reports likely to be large. Reduce false positives and create automated tools to triage information.
SIGNAL DETECTION Very limited statistical methods to detect problems. Collaborate with academia, industry and regulators to refine methods.
PRIVACY Patient privacy expectations and fear of government oversight. Use publicly available data only.
REGULATION UNCLEAR When is there an obligation to monitor or report? Work with regulators and industry to clarify guidance.
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02
03
04
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All Adverse EventsSerious Adverse Events
*
Num
ber o
f Rep
orts
0
50
100
150
200
250
300
350
Year of Event2005 2010 2015
Serious EventsNon-serious Events
Num
ber o
f Rep
orts
0
10
20
30
40
50
60
70
Patient Age in Years20 25 30 35 40 45 50 55 60
Most frequently reported AEs Most frequently reported important medical events
252
271
278
316
318
357
368
397
411
411
418
430
459
468
491N
Alopecia
Dyspareunia
Migraine
Vaginal haemorrhage
Arthralgia
Abnormal weight gain
Pain
Headache
Uterine spasm
Menorrhagia
Abdominal distension
Abdominal pain
Pelvic pain
Back pain
Fatigue
Patient Age in Years30 32 34 36 38
5
5
7
7
11
13
14
16
18
26
27
43
62
108
142N
Salpingitis
Appendicetomy
Urinary retention
Systemic lupus erythematosus
Kidney infection
Pelvic inflammatory disease
Suicidal ideation
Autoimmune disorder
Spontaneous abortion
Endometrial ablation
Uterine perforation
Post-procedural haemorrhage
Salpingectomy
Device dislocation
Mental impairment
Patient Age in Years25 30 35 40 45
