Yellow Card Spontaneous Monitoring

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Spontaneous reporting is done. Spontaneous or voluntary reporting involves a

doctor or patient describing his or her ownclinical observation of a suspected ADR with amarketed drug.


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The collection of spontaneous reports hasbecome the foundation of post-marketingsurveillance programs largely because of the high volume of information they supply,

their low maintenance costs

their demonstrated usefulness when supervised byexperienced evaluators.


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A large body of post-thalidomide safetyexperience suggests that spontaneousreporting programs can contribute to a betterunderstanding of the risk-benefit ratio of a

product as it is actually used in medicalpractice.


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Spontaneous reporting can be made to The regulatory authorities

To the pharmaceutical company that markets theproduct

To medical or scientific journals


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The pattern of reporting varies considerablybetween countries In UK

Doctor report to the Committee on Safety of Medicines

(CSM)/ Medicines Control Agency (MCA) using yellowcards

In USA and Germany

About 90% of reports to the regulatory authority arefrom companies.


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Disadvantages Under-Prescription

Inmansuggested this was due to seven deadly sins

Complacency (self-satisfaction or false satisfaction

with an existing situation, condition, etc.) Fear of litigation (A controversy before a court )

Guilt because the patient may have been harmed bythe treatment

Ambition to collect and publish a personal series ofcases

Ignorance of how to report

Diffidence about reporting mere suspicions

Lethargy


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An AE signal is defined as a potentialproduct-AE relation that deservesfurther attention.

which includes developing more detailedinformation about an already known product-AE relation.


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1. identify new causal relations.2. identification of non-causal associations.3. the clinical spectrum of a drug-AE pair.4. the patient subtypes and medical

circumstances associated with a product-induced adverse reaction.

5. clues to the mechanism of action by whichproduct exposure leads to an adverse

reaction6. factors associated with the initiation of

reporting behavior


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Spontaneous AE signals are generated whenstatistical or non-statistical methods areapplied to spontaneous AE data.

signaling methods are better defined asprocedures that are independent of content.


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AE signaling methods can be termed asreport/case sets of one to thousands

the detection of AE signals. An AE signal isdefined as a

potential product-AE relation thatdeserves further attention.

Includes a variety of functions from simple

sorting procedures for creating workablesubsets of reports complex analyses of caseseries .


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Information sources used for pharmacovigilanceInformation from many sources is used forpharmacovigilance. These include:

1. spontaneous adverse drug reaction (ADR)reporting schemes, for example, the Yellow Card

Scheme;2. clinical and epidemiological studies;

3. worldwide published medical literature;

4. information from pharmaceutical companies;

5. information from worldwide regulatoryauthorities; and

6. morbidity and mortality databases.


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Thalidomide tragedy-1960s resulted inestablishment of drug regulatory agencies. In UK- Committee of Safety of Drugs- Sir Derrik

Dunlop- reconstituted to committee for Safety of

Medicine (1968). Medicine Control Agencies receives 20,000

reports/year

Advantage

New ADR hypothesis Identifying and characterizing new ADR


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The aim of the Yellow Card Scheme is toimprove patient safety by finding out as muchas possible about adverse reactions bypooling health professionals experience and

suspicions.

To use this information to

Provide early warning of unrecognised ADRs

Identify predisposing factorsCompare drugs in the same therapeutic class

Continuously monitor the safety of all drugs


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The MHRA and the Commission on HumanMedicines (CHM) run the UK's spontaneous adversedrug reaction reporting scheme - called the YellowCard Scheme

These reports are regularly evaluated with clinicaltrial data and other medical literature to highlightany safety issues or any previously unk

This receives reports of suspected adverse drug

reactions (ADRs) from healthcare professionals.More recently the scheme was extended to includedirect reporting by patients.nown side effects.


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prescription medicines; herbal remedies; and

over-the-counter (OTC) medicines.


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The MHRA and CHM also have five Yellow Card Centres whoserole focuses on follow-up of reports in their areas as this hasbeen shown to improve follow-up rates.

1. Yellow Card Centre Mersey, Freepost, Liverpool. L3 3AB.

2. Yellow Card Centre Wales, Freepost, Cardiff, CF4 1ZZ.

3. Yellow Card Centre Scotland, 51 Little France Crescent, OldDalkeith Road, Edinburgh. EH16 4SA.

4. Yellow Card Centre Northern and Yorkshire, Freepost,Newcastle-upon-Tyne. NE1 1BR.

5. Yellow Card Centre West Midlands, Freepost, Birmingham.B18 7BR.


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As the Yellow Card Scheme has been runningfor more than 40 years, it has been necessaryto make some changes in order to reflectchanges in the healthcare system.

More recently, patients, parents and caregivers (nurses) are also now encouraged toreport suspected adverse drug reactionsdirectly to the MHRA through the Yellow CardScheme.


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Acknowledgment and registration Data entry

Evaluation of reports

Regulatory action


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Doctors Dentists

Pharmacists

Nurses, midwives and health visitors fromOctober 2002


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Routine issuesThe Summary of Product Characteristics (SPC)and patient information leaflets (PILs) areupdated appropriately when there are new

safety concerns Serious issues

Three to four times each year the MHRApublishes the bulletin, 'Current Problems inPharmacovigilance', which is mailed to alldoctors, dentists, pharmacists
http://www.mhra.gov.uk/Publications/Safetyguidance/CurrentProblemsinPharmacovigilance/index.htmhttp://www.mhra.gov.uk/Publications/Safetyguidance/CurrentProblemsinPharmacovigilance/index.htmhttp://www.mhra.gov.uk/Publications/Safetyguidance/CurrentProblemsinPharmacovigilance/index.htmhttp://www.mhra.gov.uk/Publications/Safetyguidance/CurrentProblemsinPharmacovigilance/index.htm


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Urgent issuesOccasionally healthcare professionals must beimmediately informed about a safety issue.

This may be because of the seriousness of a newly

identified ADR, because a drug is being withdrawnon safety grounds, or because a quality defect hasoccurred.


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Urgent safety issues health professionals may receive aletter from the Chairman of the Committee on Safety ofMedicines which:

outlines the issue;

outlines the action being taken; and provides advice on the implications for patient treatment.

These letters are usually distributed via the MHRA's direct faxsystem for drug alerts or via the Chief Medical Officer's Public

Health Link and are also published on the MHRA website.

Alternatively, health professionals may receive a letter fromthe pharmaceutical company responsible for the medicine.


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Reports are received by the Yellow CardScheme in strict confidence.

Information revealing the patients identity isnever released without consent.

No patient personal information is stored i.e.name or date of birth unless this is a directreport from a patient about their experience.

Data is held securely.


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A Yellow Card requests an identificationnumber for the patient; for example apractice or hospital number.

This enables the patient to be identifiable to

the reporter but not to anyone else andallows the reporter to know whom the reportis referring to for any potential futurecorrespondence.


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Very rarely, if the risks of a medicine are found tooutweigh the benefits, it may be necessary toremove the medicine from the market

More usually, the risk of a side effect may be

avoided or reduced by the following:1. including warnings in the product information or

on the package label;

2. restricting the indications for use of a medicine;

and3. changing the legal status of a medicine, for

example, from pharmacy to prescription only.


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1. Patient Information Leaflets (PILs) and Summariesof Product Characteristics (SPCs) for medicines areupdated when new safety issues are identified.

2. For urgent warnings about drug hazards, letters

are sent to all doctors and pharmacists by post orelectronic cascade.

3. The regular drug safety bulletin, 'Drug SafetyUpdate', produced by the MHRA and CHM aimed

at all healthcare professionals.4. Fact sheets are produced for major safety issues

for both healthcare professionals and patients

5. Safety alerts are published on the MHRA website
http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/index.htmhttp://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/index.htmhttp://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/index.htmhttp://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/index.htm


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Documents

Yellow Card Spontaneous Monitoring