Introduction to Argus Product Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods. Contact: "Katalyst Healthcares & Life Sciences" South Plainfield, NJ, USA info@KatalystHLS.com

1. ARGUS
PRODUCT SCREEN
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2. 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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3. 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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4. 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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5. Trade Name Lookup
 The most critical fields are:
• Product
• Ingredient
• Formulation
• Indication
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6. Trade Name Lookup
 The most critical fields are:
• Product
• Ingredient
• Formulation
• Indication
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7. 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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8. Coding of Novartis Drugs
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9. 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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10. 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. Neoral
Formulation:
 should be left unchanged
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11. 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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12. 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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13. 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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14. 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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15. 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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16. 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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17. 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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18. Thank YouThank You
&&
QuestionsQuestions
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Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com