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  • Side Effect?
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RxISK

Making Medicines Safer for All of Us

Complete a RxISK Report

Step 1 of 9

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I acknowledge that I have read and fully understand the Terms and Privacy Policy (see links below) of Data Based Medicine Global Ltd. and its family of websites. Further, I acknowledge that I have read and fully understand the risks, limitations, and conditions of use of email to send me a copy of the RxISK Report. Other than an email address, I will not provide any personally identifiable information for myself or the person who may have experienced a side effect.
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Share(Required)
We would like your permission to publish some of your comments from the report. These questions are marked [share]. Sharing stories and not just numbers of reports is hugely valuable in allowing others to learn from your experience and understand their own. PLEASE NOTE THAT NO CONTACT DETAILS WILL BE PUBLISHED.

Section 1: Contact details

Contact information is necessary to email you a copy of the RxISK report and RxISK score.
Email(Required)
May we contact you?(Required)
The research team may want to follow up with you to clarify or get additional information.
This field is hidden when viewing the form
Would you like to receive our newsletter?(Required)
Our newsletter contains a recap of posts on RxISK and davidhealy.org, plus any other important news.

Section 2: About the person who experienced the side effect

Who experienced the suspected side effect?

Gender(Required)
Country(Required)
Known medical conditions
Please list one condition per line. Click on the plus sign (+) at the end to add another entry.
Medication allergies (please specify)
Allergic to
Reaction experienced
 
Please list one medication allergy per line. Click on the plus sign (+) at the end to add another entry.

Section 3: About the drug suspected to have caused the side effect

A person who has experienced a side effect should consult a health care practitioner about this and ideally bring this report with them.
Which drug do you suspect is causing (or has caused) the side effect? Please enter only ONE drug.
Suspect drug start date(Required)
Please provide the approximate start date of the suspect drug.
Suspect drug stop date
Please provide the approximate date of stopping the suspect drug (if applicable).

Section 4: About other drugs or medications used at the same time

The side effect may have been caused by other prescription drugs or non-prescription medications, or by the combination of products.
List any other PRESCRIPTION DRUGS the person was taking at the same time as the suspect drug.
Prescription drug name
Reason for taking
How long taking?
Any changes around the date of the primary side effect?
 
Click on the plus sign (+) at the end to add another entry.
List any NON-PRESCRIPTION MEDICATIONS (e.g., supplements, herbals, vitamins, etc.) the person was taking at the same time as the suspect drug.
Non-prescription medication name
Reason for taking
 
Click on the plus sign (+) at the end to add another entry.

Section 5: About the primary side effect

At present the primary side effect(Required)
What impact did the primary side effect have? (select all boxes that apply)
Date of death
List any other side effects you suspect were caused by the drug.
Please list one side effect per line. Click on the plus sign (+) at the end to add another entry.
How is the person feeling now?

Section 6: RxISK causality questions

These questions help assess the likelihood that the primary side effect is linked to the suspect drug.
Do you link the side effect to:(Required)
Did the side effect begin after the person STARTED the drug?(Required)
Did the side effect begin or get worse after a dose INCREASE?(Required)
Did the side effect improve when the person LOWERED the dose?(Required)
Did the side effect improve when the person STOPPED the drug?(Required)
Did the side effect clear up with ANOTHER treatment?(Required)
Did the side effect reappear or get worse when the person RESTARTED the drug?(Required)
Has the person ever experienced this side effect before on any other drug? (If the experience was different in any way answer "No.")(Required)
Has the person ever experienced this side effect when not on a drug? (If the experience was different in any way answer "No.")(Required)
Could anything else be causing this side effect?(Required)
Is the person a poor metabolizer of drugs, does the person need lower doses, or does the person have a history of sensitivity to drugs?(Required)
Could the person have taken too high a dose?(Required)
Have any of the person's blood relatives ever experienced this side effect when on the same or a similar drug?(Required)
If a doctor or pharmacist has reviewed this side effect, does he/she see a link between the side effect and the drug?(Required)
Is this side effect a rare condition in people not on a drug?(Required)
Are there previous reports of this side effect on STARTING the drug in RxISK posts, medical articles, internet forums, or in a drug regulator's database (e.g., FDA, Health Canada, EMA, TGA, Yellow Card)?(Required)
Did the side effect start before or after REDUCING the dose of the drug?(Required)
Was the side effect different from the original condition for which the drug was prescribed?(Required)
Did the side effect start after STOPPING the drug?(Required)
Did the side effect improve or clear up if the person RESTARTED the drug?(Required)
Did the side effect improve if the person INCREASED the dose of the drug?(Required)
How soon after RESTARTING the drug or INCREASING the dose did the problem improve?(Required)
Did the problem improve on a related drug?(Required)
Has the person ever experienced the SAME side effect on STOPPING another drug? (If the experience was different in any way answer "No.")(Required)
Has the person ever experienced any OTHER side effects on STOPPING another drug?(Required)
Could anything else be causing this side effect?(Required)
Are there previous reports of this side effect on STOPPING the drug in RxISK posts, medical articles, internet forums, or in a drug regulator's database (e.g., FDA, Health Canada, EMA, TGA, Yellow Card)?(Required)

Section 7: Impact

What is the overall impact of the primary side effect on the person? This information can be most important in understanding what is happening.
Physical activities:
Did the side effect limit the person's physical activities or ability to do things?
How much of an impact did the side effect have on the person's physical activities or ability to do things?
Mental abilities:
Did the person experience a change in any of his or her mental abilities, psychological state, or behaviour as a result of the side effect?
How much of an impact did the side effect have on the person's mental abilities, psychological state, or behavior?
Work impact:
Was the person's work affected (paid or unpaid) as a result of the side effect?
Is the person paid or unpaid in their primary work role?
Social activities:
Did the person experience any change in his or her usual social activities, friendships, or relationships as a result of the side effect?
Other impacts:
Examples: greater or lesser desire to drink alcohol or take drugs, change in the effects of the person’s usual drugs or alcohol, change of odour affecting the person’s relationship, change in interests, change in political affiliation, good or bad effects on personality or sense of physical or mental well-being, good or bad effects on other conditions, another unrelated condition getting better.

Section 8: Drug review

Considering both the treatment of the person's condition and the side effect(s) they experienced, how would they rate their experience on the drug?
Did the person continue taking the drug?
Did the person or their doctor or pharmacist find ways to reduce the side effect(s) of the drug other than stopping the drug or reducing the dose?

Section 9: Preview your submission

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