argus product tab screens - katalyst hls

ARGUSPRODUCT SCREEN

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05/03/23Katalyst Healthcares & Life

Sciences

Product Information:

Spontaneous/Literature: At least one Novartis drug should be entered as

suspect Two or more Novartis drugs can be entered as co-

suspect Only one case will be created Concomitant Novartis drugs are coded with WHO drug

dictionary

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Katalyst Healthcares & Life Sciences

Concomitant Medication & Treatments

All co-medications should be entered in the Products screen and marked concomitant

All drugs used to treat the adverse event should be entered in the Products screen and marked treatment

Use the WHO Drug Coding List to select product name - using the encode button for both concomitant and treatment medication

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Coding Medication:

Product Name and Generic Name fields are automatically populated from data entered in the book-in screen

Indication will also be automatically populated as derived from book-in coding if the drug is coded to an indication

Therefore, ensure information is correct prior to product selection

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Trade Name Lookup

The most critical fields are:

• Product

• Ingredient

• Formulation

• Indication

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Trade Name Lookup

The most critical fields are:

• Product

• Ingredient

• Formulation

• Indication

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Coding of Novartis Drugs:

Under country delete the country name and type in

- World1 to look for the local trade name

- World to look for the international trade name

- NH (for Novartis Pharma Headquarters) to look for the generic name

- NCH (Novartis Consumer Health) to look for products ‘owned’ by Consumer Health.

- NVO (Novartis Ophthalmics) or ‘o-‘ to look for Ophtha products.

- NGX (Novartis Generics) to look for products ‘owned’ by Novartis Generics.

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Coding of Novartis Drugs8

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Co-meds and Treatment meds

Therapy Details:

Enter for concomitant and treatment medications Do not enter procedures, surgery, and non-drug

therapy as treatment

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Product Information:

Concentration Units: should be used to capture strength of suspect formulation, if

provided Do not use this field for products which have an indication

linked to the product selection ie. NeoralFormulation: should be left unchanged

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Dosage Information:

Suspect/Concomitant Medication: For all cases enter all dosage information up until the onset

of the event

Treatment Medication: For all cases enter all known dosage information relevant to

the treatment of the event

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Dosage Information:

Multiple dosage regimens: Enter in chronological order Relevant dosage changes leading up to an event/episode

(recurrent events) and during an event/episode can be added up until the final resolution of the event/episode

Dosage range: when citing a range, use the minus key, not a dash (dashes

do not print out on the MedWatch form)

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Dosage Regimens:

Stop dates: should not be entered where the patient has died

while on drug therapy

Dose Description: should always be filled in, if appropriate, as it

maps to regulatory forms

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Dosage Regimens:

Patient Route of Administration: select the appropriate value from the drop down list, which

reflects the patient’s route of administration i.e. oral or type o several times.

Parent Route of Administration: used in Baby cases to enter mother information of route of

administration

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Action Taken

Specifically refers to the suspect product, not the event as a whole

Only one action item can be entered

If more than one action, use most relevant term- the discontinued option should have higher priority

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Dechallenge:

Tick the appropriate checkbox:• Positive: drug was stopped and the event/symptoms

improved/disappeared• Negative: drug was stopped and the event/symptoms

did not improve/go away or patient has sequelae

• N/A: drug was not stopped • Unknown: the result of the dechallenge is unknown

Definition: when the drug has been interrupted because of the event...

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Rechallenge:

Tick the appropriate checkbox:• Positive: drug was re-introduced and symptoms

reappeared• Negative: drug was re-introduced and symptoms did not

reappear• N/A: drug was not re-introduced• Unknown: The result of the rechallenge is unknown

Definition: …if drug is then re-introduced

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Thank YouThank You&&

QuestionsQuestions

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Contact:Katalyst Healthcare’s & Life SciencesSouth Plainfield, NJ, USA 07080.E-Mail: [email protected]

mailto:[email protected]

argus product tab screens - katalyst hls

Health & Medicine