Introducing 

Prezi AI.

Your new presentation assistant.

Refine, enhance, and tailor your content, source relevant images, and edit visuals quicker than ever before.

Loading content…
Loading…
Transcript

Vanessa's Law vs. Other countries

  • Clinical reviews in Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER)
  • Voluntary reports from health care professionals and consumers
  • Mandatory reporting from Industry and User facilities
  • Conduction studies on large databases
  • Can also request studies from manufacturers which is then mandatory to send to FDA
  • Deeper research if trend seen with a drug on adverse reactions
  • PDF and online forms

Vanessa's Law vs. Other countries

  • Lack of expected efficacy events (LEE)
  • When in doubt, report
  • EudraVigilance
  • Human
  • Veterinary
  • Reports are available online
  • Voluntary reporting for health care professionals
  • Mandatory for sponsors of clinical trials and marketing authorization stakeholders
  • Policy 0043 in 2010
  • Released all drug information to the public with "no strings attached"

What you can do on your spare time...

Vanessa's Law vs. Other countries

  • Relatively shorter history of drug surveillance system
  • 1998- joined WHO program for International Drug Monitoring
  • Countries collaborate and work at a national level to monitor and identify harm caused my medications
  • SFDA: organizes drug monitoring at a national level
  • Mandatory reporting from companies, hospitals, pharmacies, drug distributors

Regional Centers

National Centers

Report within 3 days

THE END

What is Covenant Health doing?

  • Educating HCP at Covenant Health via presentations
  • Providing education documents like FAQs, updating RLS pages to include Vanessa's Law on CompassionNet
  • New page will be set up dedicated to Vanessa's Law under Quality on CompassionNet
  • Implement policy changes to incorporate Vanessa's Law

Thanks for listening!

References

What do you think are some challenges to using RLS for reporting adverse events?

  • Systems- do they know how to use it
  • Not enough time
  • Access to a computer
  • However, they may choose to phone in an adverse reaction 1-877-338-3854
  • Distractions
  • Recall Bias
  • Doubts on whether this should be reported or not
  • When in doubt, REPORT

What is else is Covenant Health doing?

Health Canada. Government of Canada. Protecting Canadians from Unsafe Drug Act (Vanessa’s Law) Questions/Answers. Retrieved from https://www.canada.ca/en/health-canada/services/drugs-health-products/legislation-guidelines/questions-answers-regarding-law-protecting-canadians-unsafe-drugs-act-vanessa-law.html

CPSI. What the public needs to know about Vanessa’s Law. Retrieved from: https://www.patientsafetyinstitute.ca/en/toolsResources/Vanessas-Law/Pages/Public-Vanessas-Law.aspx

BMJ. 2019; 365:1825.

Canada finally opens up data on new drugs and devices. Retrieve from: https://www-bmj-com.login.ezproxy.library.ualberta.ca/content/365/bmj.l1825.long

Doshi, P., Herder, M., Jefferson, T., Honouring Vanessa’s Law? Retrieve from https://blogs-bmj-com.login.ezproxy.library.ualberta.ca/bmj/2016/03/08/honouring-vanessa/

Gribbons, B. Guest blog: High incidence of over-infusion supports need for Vanessa’s Law. Retrieve from http://bcpslscentral.ca/guest-blog-high-incidence-of-over-infusions-supports-need-for-vanessas-law/

Health Canada. Government of Canada. Advisories and Recalls. MedEffect Canada. Retrieved from: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html

HealthCareCAN. Leading practices in patient safety. Retrieved from https://www.healthcarecan.ca/our-work/champion/patient-safety/

Shamim, S., Sharib, S. M., Malhi, S. M., Muntaha, S.-U., Raza, H., Ata, S., … Hussain, M. (2016, October 12). Adverse drug reactions (ADRS) reporting: awareness and reasons of under-reporting among health care professionals, a challenge for pharmacists. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5061681/.

Al Dweik, R., Stacey, D., Kohen, D., & Yaya, S. (2017, April). Factors affecting patient reporting of adverse drug reactions: a systematic review. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/27868226.

Center for Drug Evaluation and Research. (n.d.). Questions and Answers on FDA's Adverse Event Reporting System (FAERS). Retrieved from https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers.

Sudden Cardiac Death: Vanessa's Story. Retrieved from https://rxisk.org/sudden-cardiac-death-vanessas-story/

Canadian Institute for Health Information. Drug Use Among Seniors in Canada, 2016. Ottawa, ON: CIHI; 2018.

What can MMST do?

  • SADR taskforce (MMST is a part of this)
  • Reviews RLS reports every 2 weeks
  • Validates and ensure RLS report information is correct
  • Submits monthly reports to Health Canada

CONS?

PROS?

QUESTIONS?

For Health Care Professionals:

Shirley.Zhang@albertahealthservices.ca

  • Education sessions (health care practitioners)
  • Encourage HCP to educate other patients on medication safety
  • Clear messaging to staff from SADR
  • Highlighting purpose and motivation

A Success Story as a result of Vanessa's Law

IV INFUSION PUMP

A medical device error

What about MDIPs?

  • Managed and reported to Health Canada via AHS
  • New forms coming soon...
  • BUT, can report MDIP through RLS

What can MMST do?

Patient Safety

How does this affect patients and Canadians?

For patients:

  • Increases patient safety- quicker action
  • Canadians can be more aware of recalls
  • Disclosure and transparency of drug company information
  • Patients can become more proactive about healthcare
  • Continuous research
  • Old and new medication= more information
  • Patient friendly posters
  • 5 Questions
  • Connect with patient with real life stories
  • Educate the public on where to find recalls and safety alerts on medications and devices

So many challenges... what to do... what to do...

Challenges to the Vanessa's Law

For Health Care Professionals:

  • 2008-2014 data, MEDLINE, EMBASE, PsychINFO, CINAHL, PubMed, Cochrane
  • Each relevant study was reviewed by 2 independent reviewers
  • AMSTAR used to assess the methodological quality of reviews
  • most of the studies were rated as medium to high quality
  • poor awareness (44 to 94%)
  • ADR reporting difficulties (16 to 80%)
  • do not see a benefit with reporting
  • lack of feedback on ADRs that was submitted
  • negative experiences - fear of disapproval by their HCP
  • Time limitations (30 days)
  • Uncertainty
  • Fear of consequences
  • Just culture
  • Lack of follow up and feedback
  • Complacency

For Patients:

  • Patient involvement and education
  • Patient awareness

This is where MMST has a HUGE role!

Cabrini building

Importance of post-market monitoring

  • Captures adverse events not seen during pre market
  • Captures responses in patients with other conditions, lab values that was not studied
  • Captures long term side effects, efficacy and response
  • Without mandatory reporting, it is hard for data to be collected= information can be missed

Vanessa's Law

Unsafe Drug Act

Creating Vanessa's Law

November 2014

Learning from Errors

VANESSA'S LAW

Purpose:

improve Health Canada's ability to collect post market safety information and take action as appropriate

accountability by Health Canada

Standardized method of sharing updated information to health care professionals, patients and other stakeholders

More rigorous post marketing reviews of medications

PROS

OTC, prescription medications (including radiopharmaceuticals) , vaccines, gene therapies, cells, tissues, organs, medical devices (e.g., infusion pump)

Quicker and more responsive- Health Canada

What it entails:

VS.

What about natural health products?

CONS

Community pharmacy? Medical clinics?

Non-hospital settings?

  • Mandatory health institution reporting
  • Penalties for unsafe products and medical devices
  • revising labels and updating health warnings for children
  • recalling unsafe products
  • further testing for at risk populations

Patient awareness?

Causation vs. Correlation?

-when in doubt, report

Law enforcement

-OBJECTIVES-

  • jail time
  • fines up to $5 million/day
  • larger fines if it was an intentional violation

What happened to Prepulsid after the incident with Vanessa?

December 16, 2019

What is considered a serious adverse drug reaction (SADR)?

Health Canada

1. Story behind Vanessa's Law

2. What is Vanessa's Law

3. Why was it created?

5. Vanessa's Law in other countries

4. Challenges

5. Role of MMST

  • Mandatory requirements for hospitals to report serious adverse drug reactions (ADR) and medical device incidents or problems (MDI)
  • What is Health Canada's definition of "hospital?"
  • "Licensed, approved or designated as a hospital by a province or territory to provide care or treatment"
  • "Operated by the Government of Canada to provide services to in-patients"
  • must be submitted within 30 days of first documentation of event
  • Require an in patient hospitalization or prolongs an existing hospitalization
  • Congenital malformation
  • Resulting in persistent or significant disability or incapacity
  • Life threatening or results in death

What is considered a medical device incident (MDI)?

The drug itself

  • Failure of a medical device or deterioration of its effectiveness
  • Inadequacy of labelling or direction for use leading to death or serious deterioration in state of health of a patient, user or other person or could do so were it recur

May 2000- withdrawn

Doctors

Some questions to start...

raise your hands if...

...Heard about what Vanessa's Law is?

...Seen stories on the news about medication side effects?

...Medication withdrawn from the market despite pre-marketing approval?

...Thalidomide incident?

How come this medication is still in the market after all these warnings???

Would the doctors not know about these risks?

Prior to Vanessa's Law...

Lack of post marketing regulations

Reporting of adverse events are not mandatory

2016

ISMP reports that only 6% of adverse events are reported internationally

1 in 143 Canadian seniors are hospitalized due to harmful effects of the medication (CIHI, 2016)

Newsletters may not have been distributed to all doctors... not everyone may have read it either

Not all adverse events, safety information would have been captured during pre-marketing studies

WHAT is Vanessa's Law

Why did this drug get approved in the first place?

based on a story of a 15 year old girl

Vanessa Young

Law was passed to provide better and more strict regulations on post market reporting and monitoring of medications.

Digging a little deeper...

1992

WHO

-Cardiac arrythmia concerns about medication

Canadian Adverse Drug Reaction Newsletter

-Serious ventricular arrhythmia in those with pre-existing for risk factors for arrhythmia

July 1996

Vancouver General Hospital Drug and Therapeutic Newsletter

-Cautioned in patient with history of arrhythmias, cardiac disease or electrolyte balance

1996

Vanessa's Story

FDA

1998

-Warned about irregular heartbeat

-ECG pre screening recommended

  • Suffered from bulimia and bloating
  • Doctor prescribed Prepulsid (cisapride)
  • Cisapride was marketed for 7 years before showing any trend in side effects

(Covenant Health, Compassionnet)

Note: No previous history of any HEART conditions

Oakville, Ontario

Learn more about creating dynamic, engaging presentations with Prezi