Pharmacovigilance At Cipla Training Assessment 2016

1. Pharmacovigilance activities, if not conducted in line with regulatory requirements can lead to product withdrawal.

True

False

If pharmacovigilance activities are not conducted in accordance with regulatory requirements, it can result in product withdrawal. This is because pharmacovigilance is the practice of monitoring and assessing the safety and effectiveness of pharmaceutical products. If these activities are not carried out properly, potential risks and adverse effects may go unnoticed, leading to harm to patients and a loss of trust in the product. Regulatory requirements ensure that pharmacovigilance activities are conducted in a standardized and thorough manner, reducing the likelihood of product withdrawal.

Explanation

If pharmacovigilance activities are not conducted in accordance with regulatory requirements, it can result in product withdrawal. This is because pharmacovigilance is the practice of monitoring and assessing the safety and effectiveness of pharmaceutical products. If these activities are not carried out properly, potential risks and adverse effects may go unnoticed, leading to harm to patients and a loss of trust in the product. Regulatory requirements ensure that pharmacovigilance activities are conducted in a standardized and thorough manner, reducing the likelihood of product withdrawal.

2. The science related to detection, monitoring and prevention of______________ is termed as Pharmacovigilance.

All Complaints received on medicines

Adverse events

Diseases

Product Quality Complaints

Pharmacovigilance is the science related to the detection, monitoring, and prevention of adverse events. Adverse events refer to any negative or unexpected reactions or side effects that occur after the administration of a medicine or drug. Pharmacovigilance aims to collect and analyze data on adverse events to ensure the safety and effectiveness of medications, and to take necessary actions such as updating product labels or withdrawing drugs from the market if necessary.

Explanation

Pharmacovigilance is the science related to the detection, monitoring, and prevention of adverse events. Adverse events refer to any negative or unexpected reactions or side effects that occur after the administration of a medicine or drug. Pharmacovigilance aims to collect and analyze data on adverse events to ensure the safety and effectiveness of medications, and to take necessary actions such as updating product labels or withdrawing drugs from the market if necessary.

3. Your friend mentions to you that her doctor has prescribed Ginette for treatment of hair loss, even though you are aware that this is not an approved indication/use of the drug. According to your friend's HCP, several patients have seen great results and she is optimistic about the treatment. Do you have to report this?

No, it is not required to forward a report as it is not part of your obligation.

Yes, Forward a product safety report of this off-label use.

No safety report is required because there were no unexpected adverse events.

The correct answer is to forward a product safety report of this off-label use. Off-label use refers to the use of a medication for a purpose that is not approved by regulatory authorities. Reporting this off-label use is important to ensure that any potential adverse events or side effects are monitored and documented. It is necessary to gather data on the safety and efficacy of medications used in off-label indications to inform future prescribing practices and patient safety.

Explanation

The correct answer is to forward a product safety report of this off-label use. Off-label use refers to the use of a medication for a purpose that is not approved by regulatory authorities. Reporting this off-label use is important to ensure that any potential adverse events or side effects are monitored and documented. It is necessary to gather data on the safety and efficacy of medications used in off-label indications to inform future prescribing practices and patient safety.

4. All Adverse Events on Cipla products should be emailed to:

[email protected]

The correct answer is [email protected]. This email address is specifically designated for reporting adverse events related to Cipla products. It is likely monitored by the drug safety team at Cipla, who are responsible for collecting and analyzing information on any negative effects or side effects experienced by patients using their products. By emailing adverse events to this address, individuals can ensure that their reports are being sent to the appropriate department for review and action.

Explanation

The correct answer is [email protected]. This email address is specifically designated for reporting adverse events related to Cipla products. It is likely monitored by the drug safety team at Cipla, who are responsible for collecting and analyzing information on any negative effects or side effects experienced by patients using their products. By emailing adverse events to this address, individuals can ensure that their reports are being sent to the appropriate department for review and action.

5. A patient informs you about having an allergy when she started a Cipla drug, within what time frame should you forward a report the Cipla SA, Drug Safety Unit?

Within 1 business day, or 3 calendar days (whichever is earlier) of when you read the information

Within 1 business day, or 3 calendar days (whichever is earlier) from when the information is first received

Within 48 hours of your awareness

No safety report is required because the AE is mentioned in the Product label

The correct answer is Within 1 business day, or 3 calendar days (whichever is earlier) from when the information is first received. This means that as soon as the patient informs you about their allergy to the Cipla drug, you should forward a report to the Cipla SA Drug Safety Unit within 1 business day or 3 calendar days, whichever comes earlier. It emphasizes the importance of timely reporting and ensures that the necessary actions can be taken promptly to address any potential safety concerns.

Explanation

The correct answer is Within 1 business day, or 3 calendar days (whichever is earlier) from when the information is first received. This means that as soon as the patient informs you about their allergy to the Cipla drug, you should forward a report to the Cipla SA Drug Safety Unit within 1 business day or 3 calendar days, whichever comes earlier. It emphasizes the importance of timely reporting and ensures that the necessary actions can be taken promptly to address any potential safety concerns.