Part 1 Evidence based Pharmacy Practice in COVID-19 era

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 s.khan@griffith.edu.au

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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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 (1^st December 2019)

 Pneumonia of unknown origin (31^st December 2019)

 First case outside China (13^th January 2020)

 COVID-19 official term (11^th February 2020)

 Declared pandemic (11^th 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 of ACE2 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 hypoxia

Oxygen 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 of 2019 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 relevanttousers of research?

Appropriate research design, methods, and analysis?

Efficient research regulation and manag ement?

Fu lly accessible research i nform ation?

• Low priority questions addressed

• I mportantoutcomes not assessed

•More than 50% st udies designed without referencetosystematic 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 andinefficiency

•Disproport ionateto the risks ofresearch

•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?

•Morethan30%oftrial intervent ions not sufficient lydescribed

•More than 50%of planned study outcomes not reported

•Most new research not interpreted in the context ofsystematic assessmen t of other releva nt evidence

0 0

Research waste

Figure: Avoidable waste or inefficiency in biomedical research

Part 2

Pharmacists role and opportunities in global

health safety

GLOBALIZATIONO F

PHARMACY 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 not missing 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 up teddy bears in their windows for kids to spot 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…

Questions…

s.khan@griffith.edu.au