Capturing relevant, essential and complete data at the first interaction  Why surfacing targeted questions and FAQs in-stream maximises the value of the initial contact and reduces low-value follow up. Digital solutions ensure your REMS and RMP commitments are met with appropriate evidence

1. USING DIGITAL INNOVATION
TO ESTABLISH AN AUTHENTIC REPORTER DIALOGUE
& TRANSFORM PROCESS EFFICIENCY
DR. ANDREW RUT,
CHIEF EXECUTIVE OFFICER,
MyMeds&Me
Capture Purer Data, Faster

2. “Consider the impact on American services if other industries
routinely operated in the same manner as many aspects of health
care:
• If airline travel were like health care, each pilot would be free
to design his or her own preflight safety check, or not to
perform one at all. ”
Pharmaceutical Public Policy – Thomas R. Fulda, Alan Lyles, Albert I Wertheimer

3. Digital solutions put the patient at the
forefront of the Safety processes
Capturing relevant, essential and complete data at the
first interaction
Why surfacing targeted questions and FAQs in-stream
maximises the value of the initial contact and reduces
low-value follow up.
Digital solutions ensure your REMS and RMP
commitments are met with appropriate evidence

4. AERs across product portfolio or lifecycle
New products
Need fast feedback as complete as
possible to fuel analytics for informed
decisions in a timely & consistent manner.
Established products
High data volumes that need to be processed
in a compliant, automated manner with an
emphasis on product quality. 4

5. • MISSING KEY INFO
• RMP GAPS
• INADEQUATE DATA
• INCOMPLETE B/R PROFILE
N E W P R O D U C T S E S T A B L I S H E D P R O D U C T S
• WARNINGS
• WITHDRAWALS
Economic impact
to Pharma Co.
Economic impact
to Healthcare System
• AES TAKEN FOR GRANTED
• ASSUMED LOW IMPACT
• UNINFORMED PATIENT
• LACK OF PATIENT ADHERENCE
• DISEASE POORLY TREATED
• HOSPITAL ADMISSIONS
The
Convention
Inadequate or
ignored data
LOW VALUE AERS
STABLE RISK/BENEFIT
HIGH VALUE AERS
EVOLVING RISK/BENEFIT

6. Missed Opportunity: Data has to be obtained first
time at source
Current systems are not working to capture data on
AERs; Targeted follow-up is failing
The impact is profound on the product, patients and
the healthcare system
No amount of post-processing by PV Professionals or
AI tools can rectify deficiencies of data quality

7. “
”
Adverse drug events (ADEs) are an
increasingly relevant issue for healthcare
systems as they are associated with poorer
health outcomes and avoidable misuse of
resources
The Economic Burden of Inappropriate Drug Prescribing,Lack of Adherence andCompliance,Adverse Drug
Events in OlderPeople;A Systematic Review;Carlos Chiatti,1 Silvia Bustacchini,1 Gianluca Furneri,1 Lorenzo
Mantovani,2 Marco Cristiani,3Clementina Misuraca4andFabrizia Lattanzio

8. H e a l t h c a r e b u r d e n o f A D R s
3.7% 39% 40%
ADRs account for
3.7% of hospital
admissions in the
Developed world.
~39% of ADRs in
pediatric patients
can be life
threatening or fatal.
Non-adherence
Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, et al. Which drugs cause preventable
admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007;63:136–47.

9. Non-adherence and AERs: ART for HIV
Patients with specific AEs were significantly less likely
to adhere to ART compared to patients without these
Adverse events:
Confusion OR = 0.349;
Taste disturbances OR = 0.485;
Nausea OR = 0.574;
The impact of specific HIV treatment-related adverse events on adherence to antiretroviral therapy:
A systematic review and meta-analysis Imad Al-Dakkak, Seema Patel, Eilish McCann, Abhijit
Gadkari, Girish Prajapati, and Eric M. Maiese

10. So how do Regulatory agencies try to
address these challenges?
FDA - REMS
EMA - RMPs
PMDA - PMS

11. The FDA most often determined that REMS were
not meeting their goals because of deficiencies in
patient and prescriber awareness of drug risks.
Pharmaceutical public policy: Fulda, Lyles & Wertheimer; CRC Press 2016

12. Targ e t e d F o llo w u p Qu e s t io nnaire s
50% 20% 10%
Sent out as
required
Returned Contain Useful
or legible f/u
information

13. Through the patient’s
eyes……..

14. “
”Factors related to high and low levels of drug adherence according to patients with type 2
diabetes Sander D. Borgsteede, Marjan J. Westerman,3 Irene L. Kok,1 Joke C. Meeuse,1 Theo P.
G. M. de Vries,1 andJacqueline G. Hugtenburg1
Medicines are prescribed, I use them. That’s it. I
never read the package leaflet. When you read it,
you lose courage to use them any longer, and in
my opinion you have to use them… the colours
tell me how: blue is for the prostate, and I have
orange and white, and for my sugar I use a tablet
somewhat larger. ……..
Knowledge about medication? I have no idea

15. “
”
Almost impossible. Cannot be statins. Not
possible. Denied possibility. CPK didn’t
indicate statin-related adverse effect.
Doctor said there were no side effects.
Can’t be the statins, thinks it is a miracle
drug
Dismissed relation to drug
Source: Beatrice A. Golomb et al, Physician Response to Patient Reports of
Adverse Drug Effects Implications For Patient-Targeted Adverse Effect
Surveillance, Drug Safety 2007

16. For Signal Detection
Data Quality is key

17. Data Quality: vigiGrade….Focus on the Intake
ICSR value is directly proportional to the amount of
clinically relevant information they include.
Overall, only 12% reports provide the desired
level of information
Physicians consumers using e-reporting tools also
generate greater proportions of well-documented
reports overall
vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues
Tomas Bergvall • G. Niklas Nore´n • Marie Lindquist

18. B e t t e r c a s e i n f o r m a t i o n
> b e t t e r s i g n a l d e t e c t i o n
Strength of evidence:
vigiRank
• ‘Informative Reports have
greatest impact’
Improved Statistical Signal Detection in Pharmacovigilance by
Combining Multiple Strength-of-Evidence Aspects in vigiRank -
Retrospective Evaluation against Emerging Safety Signals
Ola Caster, Kristina Juhlin, Sarah Watson & G. Niklas Norén

19. Reportum: Industry Standard SaaS capture solution for
Adverse Events & Product Complaints
Configurable web/mobile platform for dynamic data capture
in real time including targeted Qs
Multi-language, includes f/u processing and linked to
Learning management systems
Active workflow with QC and auto-reconciliation delivers
coded ICSRs and PQCs

20. Reportum; the next
phase…

21. P a t i e n t i n c o n t r o l o f a v i r t u o u s c y c l e
Informed
patient
Compliance with
Label
Benefits quantified
Risks identified &
contextualized
Alerts to Physician or
Pharma team
concerning SAE/AESI
Label & PI Leaflet
updated Ongoing
assessment
and comms. of
benefit-risk
Rapid
identification
of issues with
automated
triage

22. Patient
centred
digital
solutions

24. AI combined with
Reportum
• Manages any remaining
unstructured data
• Creates learning system
• Leverages the benefits of
Reportum business processes
Enables additional process
automation:

25. • ROBUST B/R ASSESSMENT
N E W P R O D U C T S E S T A B L I S H E D P R O D U C T S
Accurate product
label
Optimised Healthcare
• COMPLIANT
• AUTOMATED / STREAMLINED
• DRUG ADHERENCE
• FAST
• RELEVANT / COMPLETE
Purer data
I N F O R M E D P A T I E N T
D I G I T A L P R O D U C T S• ENRICHED SIGNAL DETECTION • EMPHASIS ON QUALITY
• DRUG INTERACTIONS

26. Summing up…
Make it simple and standard to get the relevant data
first time……

27. Discover more at:
www.mymedsandme.com/Reportum