opportunites and challenges in evidence based …
TRANSCRIPT
OPPORTUNITES AND CHALLENGES IN EVIDENCE BASED PHARMACY PRACTICE IN CONTEXT TO COVID-19
PANDEMIC AN INTERNATIONAL PERSPECTIVE
DR. SOHIL KHAN
GRIFFITH UNIVERSITY, GOLD COAST, AUSTRALIA
Presentation overview
Part 1 Evidence based Pharmacy Practice in COVID-19 era
Part 2 Pharmacists role and opportunities in global health safety
Part 3 The new world
A bird, camel or bat
SARS CoV 1 (2002-04)
H5N1 Bird flu (2002)
H1N1 Swine flu (2009)
MERS (2012)
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01' THE
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All public 1a1he,_n11 con1i11in1 of ten or'more areprohibited.
D. W.Sl[THERLAND,' Mayor,Kelowna, B.C.,
19th ,October, I918
Stages of transmission
STAGE 1 – first appearance of infection (people with travel history); no local spread; very few cases
1 2
STAGE 2 – local transmission; those who were infected spread the virus to close friends or family (every person in contact could be traced and isolated)
3
STAGE 3 – community transmission; infection in public, source of virus cannot be traced; large geographical lockdown
4
STAGE 4 – disease actually becomes an epidemic in a country with widespread infection
Epidemiology and global burden of COVID-19
First case reported in Wuhan, China (1st December 2019)
Pneumonia of unknown origin (31st December 2019)
First case outside China (13th January 2020)
COVID-19 official term (11th February 2020)
Declared pandemic (11th March 2020)
Confirmed cases – over 12M
Deaths
COVID-19 local impact
Infection control
• Hand hygiene, social distancing,
wearing masks, stay at home
Work differently
• Zoom, zoom, zoooom!
Live differently
• No restaurants, cafes, pubs or bars;
take away only; limits on numbers of
people in a room; no playgrounds; no
shopping; stockpile toilet paper?!
COVID-19 global impact
Economic policy
Unemployment
Poverty
Food security
Education
Part 1
EVIDENCE-BASED PHARMACY PRACTICE COVID-19 era
COVID-19 management approach (Prevention)
Social distancing
Hand washing and hygiene
Mask
Cough/sneeze etiquette
Lock down?
Vaccine?
COVID-19 management approach (treatment strategies)
Repurposed drugs
Adjunct therapies
Experimental therapies
Supportive care
• Ventilation
• Anticoagulation
Antivirals – primary treatment ?
Hydroxychloroquine (HCQ) /chloroquine (CQ)
Lopinavir/ritonavir
Remdesivir
Favipiravir
Specific treatment –HCQ Evidence?
Interferes with glycosylation ofACE2
and reduced binding efficiency
Increases pH of lysosomes, makes
cells resistant to viral replications
Reduces transcription of
proinflammatory genes thus reducing
cytokine storm
Specific treatment –HCQ Evidence?
BMJ (Tang et al 2020)
1200 mg loading dose for 3 days f/b 800 mg OD for 2-3 weeks
Outcome – Negative conversion of SARS CoV 2 by 28 days.
JAMA (Rosenberg et al 2020)
High cardiovascular abnormality in HCQ group (baseline
characteristics unequal? Already severe cases, hypoxia)
NEJM (Geleris et al 2020)
Patients on HCQ already with mild/moderate ARDS; several
patients not intubated due to lack of supportive care!
HCQ - the blame game?
Can’t be clearly blamed
Efficacy is still questionable
Cost?
Evidence?
Final nail
HCQ – to be or not to be?
Dose difference – impact on outcome?
ICMR, India recommendation
400 mg BD (day 1) followed by 200 mg BD X 4 days
Total dose 2400 mg
WHO halted study arm
(SOLIDARITY trial)800 mg BD (day 1) followed by 400 mg BD X 4 days
Total dose 9600 mg
Specific treatment– Remdesivir Evidence?
Adenosine analogue; incorporates
into nascent RNA leading to
premature chain termination
200 mg IV (day 1) f/b 100 mg daily
for 5 days
Not recommended in abnormal
liver function test (> 5 times upper
limit of normal)
Remdesivir – to be or not
to be?
“Clearly effective!”
– Fauci
Money – the third axis of choice for remdesivir?
Specific treatment– Corticosteroids Evidence?
Dexamethasone
Efficacy
Severity of COVID-19
• Remdesivir
• Dexamethasone
• Hydroxychloroquine
• Famotidine (H2 receptor antagonist)
Pharmacotherapy in COVID-19 key updates
Supportive care – crucial
Happy hypoxiaOxygen saturation is low
Patient not breathless
Sudden deterioration Respiratory care Anticoagulation
RESEARCH IN TIMES OF PANDEMIC
• Lockdown
• Access to research facilities
• Survey
• Follow-up
MEDICAL INFORMATION EXPLOSION IN
COVID-19 ERA
• More than 30,000 medical papers in the last 4 months
• Doubling every 20 days
• Biggest explosion of scientific literature ever!
• The National Library of Medicine registry ClinicalTrials.gov lists 2800 COVID-19 studies
• Predatory journals/publications!
PRE-PRINTS SERVERS
Postings in MedRxiv have increased over 400% (from 586 for the last 4 months of2019 to 2572 for the first four of 2020),while views and downloads have increased 100-fold
• Preprints may be widely shared and direct practice, but the speed of production may not be matched by critical analysis and the need for replication.
COVID-19
information
explosion
COVID-19 medical literature
“Healthcare practitioners tend to be satisfied with the
information they can readily summon, while often
sacrificing quality for convenience when providing
drug information”
Satisficing
Scott, 2012; Duggan, 2006
Is keeping up to date
Mission Impossible?
Bluegreenblog2006
There is an understandable urgency for evidence-based data synthesis and dissemination during the current crisis and the work being conducted by
practitioners and researchers across the globe is commendable.
The pressure to provide promising data and the race to achieve
recognition, however, should not compromise on quality of
evidence through publication bias and poor study methods.
The ethos of Evidence Based Medicine
• Core principles
• Feasibility, appropriateness,
meaningful, effective
• Core domains
A. Global health and collaboration
B. Evidence generation
C. Evidence synthesis
D. Evidence transfer
E. Evidence implementation
Globalisation in healthcare research
PRINCIPLE (platform randomised trial of interventions against COVID-19 in older people),
RECOVERY (randomised evaluation
of cOViD-19 Therapy) and,
REMap-CAP (a randomised,
embedded, Multi-factorial,
adaptive platform Trial for
community-acquired pneumonia)
Adaptive, agile and based on rigorous scientific principles
Search Smart
Clinical studies: PubMed, EMBASE, CINAHL
Synthesis: Cochrane Database of Systematic
Review, DARE, Joanna Briggs, Clinical Evidence, TRIP
Synopsis: Evidence Based Abstraction Journals
(Medicine, Dentistry, Nursing)
Summaries: Clinical Guidelines, DynaMed,
UptoDate, EvidenceUpdates
Computerised Decision Support: Essential Evidence
Plus, UptoDate
A re research decisions
based on que stions
relevant to users
of research?
Appropriate research
design, methods,
and analysis?
Efficient research
regulation
and manag emen t?
Fu lly accessible research
i nform at ion?
•Low priority questions
addressed
• I mportantoutcomes
not assessed
•More than 50% studies
designedwithout
referenceto systematic
reviewsof existing
evidence
• Adequate steps to
reduce bias not takenin
more than 50% ofstudies
• I nadequat e statistical
power
• I nadequat e replication
of i n it ial fin di ngs
•Compli cit withother
sources of waste
and inefficiency
• Disproport ionateto the
risks of research
•Regu latory and
management processes
are burdensome and
inconsistent
• More than 50% of studies
never fu llyreported
•Biased und er- reporti ng
of stud ies with
disappointing results
•Biased reporti ng of data
wit h i nstudies
Un biased and
usable research reports?
•Morethan 30%of trial
intervent ions not
sufficient lydescribed
• More than 50%of
plannedstudy outcomes
not reported
•Most new research not
interpreted in th e
contextof systematic
assessmen t of other
releva nt evidence
0 0Researchwaste
Figure: Avoidable waste or inefficiency in biomedical research
Part 2
Pharmacists role and opportunities in global health safety
GLOBALIZATIONOFPHARMACY SERVICES
Disease prevention and infection control
Adequate storage and drug supply
Patient care and support for multidisciplinary health team
THE GLOBAL PHARMACIST
• Video-telecon
– Residential Medication Management
Review (RMMR)
– Home medication reviews
• Aged care safety and quality
• Meds Check
• Special care for vulnerable and isolated cohort
• E script
• Vaccination
Part 3
THE NEW WORLD
• We must ensure that we continue to interrogate the uncertainties of COViD-19, review the totality of research to ensure we are notmissing important data, register and report trials, and press for better, not necessarily more, research.
• Pandemics may feel frightening, but even more frightening is
annexing the scientific method in dealing with it.
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Spanish flamenco guitarist Joselito Acedo plays the guitar on his balcony during COVID-19 lockdown in Seville, Spain
Woman wearing a mask sits by a bridge in New York
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Chinatown in Singapore shuts down in the wake of the pandemic
A man wearing a mask goes for a morning jog near the London Eye
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An MTA subway car lies empty during rush hour in New York
People line up outside a convenience store in suburban Mumbai while maintaining the social distance
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People of Auckland have propped upteddy bears in their windows for kids tospot when they are out walking
The deserted shopping hub of Regent Street in the West End, London
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Striking graffiti messages urge locals to stay home, in Fremantle, the port city in Western Australia
The fruit and vegetable delivery with rowing boats in Venice, Italy
The way ahead…
