Documentos de Académico
Documentos de Profesional
Documentos de Cultura
Johns Hopkins
Center for Drug Safety & Effectiveness
The Center will improve the safe and effective use of
medicines in the United States and around the world
through a four-part mission of training, research, clinical
care and public service
Outline
Background
Manufacturers
Food and Drug Administra:on
The Way Forward
A.Aripiprazole (Abilify)
B.Sildafenil (Viagra)
C.Hydrocodone/APAP (Vicodin)
D.Atorvastatin (Lipitor)
E.Esomeprazole (Nexium)
F.Etanercept (Enbrel)
6
hBps://www.youtube.com/watch?v=dnEERbXe5ZU
Complex Problem
Stakeholders
Diversion
Externalities
Addiction
Undertreatment
Of Pain
Complex Problem
Stakeholders
Diversion
Externalities
Addiction
Undertreatment
Of Pain
STOP
17
Stakeholders
Key issues
Health insurers
Prescribers
Pharmacies
Wholesalers
Consumer groups
Manufacturers
Regulatory authorities
Outline
Background
Manufacturers
Food and Drug Administra:on
The Way Forward
Manufacturers
Abuse vs. addiction
Abuse deterrent formulations
Marketing and promotion
19
21
22
Chemical Barrier
Deni3on
Example(s)
Ques:on: Do abuse-deterrent
formula:ons (ADFs) have a lower,
higher, or the same addic:ve
poten:al as their non-ADF
formula:on?
Percent of Respondents
60%
50%
40%
30%
20%
10%
0%
Lower
Same
Higher
24
GlaxoSmithKline (2007)
$64M class-action settlement on claims that GSK misled consumers about
safety of Paxil (antidepressant) in pediatric patients (no admission of fault)
Pfizer (2008)
$894M settlement on claims of unlawful marketing of painkillers Bextra and
Celebrex (no admission of fault)
31
32
Outline
Background
Manufacturers
Food and Drug Administra:on
The Way Forward
Regulatory Interventions
Up-scheduling hydrocodone
Labeling revisions
Prescriber and patient education
Risk Evaluation and Mitigation Strategies (REMS)
Abuse deterrent formulations
Treatments for opioid overdose and dependency
Improved packaging and storage strategies to prevent abuse
34
Opioid Labeling
Controlled Substance Act
36
37
38
4/13/1
6
39
Segal J. 2013.
Segal J. 2013.
43
Medication Guide
Communication Plan
Elements to Assure Safe Use (ETASU)
Implementation System
44
Segal J. 2013.
46
Outline
Background
Manufacturers
Food and Drug Administra:on
The Way Forward
Intervening Comprehensively
All along supply chain; clinic, community
and addiction treatment settings; primary,
secondary and tertiary prevention; creating
synergies across different interventions
49
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