Attached is a view on the importance of Automation & appropriate technology in the collection of Adverse Event data, and how this data can be used to the benefit of the patient population.

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 atthe 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 RMPcommitments 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
toPharma Co.
Economic impact
toHealthcare System
• AES TAKEN FOR GRANTED
• ASSUMEDLOW IMPACT
• UNINFORMEDPATIENT
• 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) arean increasingly
relevant issue for healthcare systems as they are
associated with poorer health outcomes and
avoidable misuse of resources
The EconomicBurden ofInappropriateDrug Prescribing,Lack ofAdherence andCompliance, AdverseDrug EventsinOlder
People;ASystematicReview;CarlosChiatti,1SilviaBustacchini,1GianlucaFurneri,1LorenzoMantovani,2Marco
Cristiani,3ClementinaMisuraca4andFabriziaLattanzio

8. H ea l th c a r e b u r d en o f ADR s
3.7% 39% 40%
ADRs accountfor 3.7%
of hospitaladmissions
inthe Developedworld.
~39% of ADRs in
pediatricpatientscanbe
life threateningor 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-adherenc e 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.
Pharmaceuticalpublicpolicy:Fulda,Lyles&Wertheimer; CRCPress2016

12. Targeted Follow u p Qu estion n aires
50% 20% 10%
Sent out as
required
Returned Contain Useful or
legible f/u
information

13. Throughthepatient’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. ……..
Knowledgeaboutmedication?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 relationto 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 IdentifyWell-DocumentedIndividual 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
Strengthof evidence:vigiRank
• ‘Informative Reports have
greatest impact’
Improved Statistical Signal Detection in Pharmacovigilanceby 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 toLearning
management systems
Active workflow with QC and auto-reconciliation delivers coded ICSRs
and PQCs

20. Reportum;thenext phase…

21. Pa ti en t i n c o n tr o l o f a vi r tu o u s c yc l e
Informed
patient
Compliance with
Label
Benefitsquantified
Risksidentified&
contextualized
AlertstoPhysicianor
Pharmateam
concerningSAE/AESI
Label & PILeaflet
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
unstructureddata
• Createslearning 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…
Makeit simple and standard to get therelevantdata first
time……

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