PV Interface
Choose the correct answer:
PV reconciliation with the different NBP internal functions is performed....
A) Monthly
B) Bimonthly
C) Quarterly
Monthly
What are the four minimum criteria for reporting a valid Adverse Event/ Case Report to NBP safety mailbox?
1- An identifiable patient
2- An identifiable reporter
3- An AE/Special situation
4- A product
What does PQC stand for?
Product Quality Complaint
A patient has been admitted to the hospital for an overdose of Latuda, he is a bit drowsy but still very responsive and healthy.
This case is considered as
A) a serious adverse event
B) non-serious adverse event
C) a special situation
D) A & C
E) B & C
F) other, please specify...
A & C
This is considered a serious adverse event since the patient is hospitalized because of a special situation- “overdose".
A patient reported to his treating physician that he tried the release button of the "Plegridy" injection device, but it did not release properly.
He then discovered that the device is a counterfeit one.
What will be your action?
1-Report to QA
2-Report to PV
3-Report to both PV and QA
This must be reported to PV as there is a patient involved, the patient may have injected himself with the counterfeit medicine and may have missed a dose as well, which is a (medication error).
As well as to QA, as all counterfeits must be reported to the QA department.
The NBP PV team performs regular reconciliations with several internal functions/departments.
Name at least 2 functions/departments
1-
2-
1-Quality Assurance (for any quality complaint received accompanied by an Adverse Event)
2-Business development, Compliance and Legal
(as the BD, Compliance and Legal emails are publicly accessible on NBP website, so these are potential source of AEs)
3- Medical Affairs (for any medical inquiry received accompanied by an Adverse Event)
4- NBP Front Desk Receptionist (As the receptionist checks NBP general information mailbox that is publicly accessible on NBP website, so it is a potential source of AEs)
5-IT Department as the IT team shares a consolidated CRM Reporting Tool call notes which captures any reported AE.
A female patient reported that while taking Cimzia for 2 months, she noticed that her nails grew faster, and her hair became softener.
Is this considered valid and reportable?
Yes, this is an unexpected therapeutic (beneficial) effect which is also considered a special situation, that should be reported to PV.
What does RMM stand for?
Risk Minimization Measures
A patient took his Cimzia injection intramuscularly instead of subcutaneously as the nurse who usually gives him the dose was absent. This is a special situation that must be reported to NBP safety. Please specify the special situation which this example resembles.
Medication Error
What actions will be taken internally if you missed to report to the NBP PV team an AE case within 24 hours?
The NBP PV team will raise a deviation to identify the root cause of the miss, and retrain you on the requirements of PV reporting.
An HCP contacted you to tell you that his 45 years old patient developed nausea while on Epidyolex®, which was not registered in your country. What do you do?
1-Report to NBP safety mailbox within 24 hours.
2-Inform the relevant NBP Franchise head to report to NBP safety mailbox within 24 hours.
3-Other, please specify.
Report to NBP safety mailbox within 24 hours.
For data privacy, please do not share any case report received with anyone.
The NBP safety team provides the local distributors in each territory the following: (choose all applicable)
A) An induction PV training to the newly hired PV responsible person at the local distributor
B) An annual PV refresher training to the main PV responsible person at the local distributor
C) An annual quiz of a minimum passing score of XX% to the main PV responsible person
D) The local distributor PV team are qualified, and it is their responsibility to be trained on PV on their own.
E) Other, please specify....
A, B & C
A) An induction PV training to the newly hired PV responsible person at the local distributor
B) An annual PV refresher training to the main PV responsible person at the local distributor
C) An annual quiz of a minimum passing score of XX% to the main PV responsible person
On Tuesday February 14th, Dr Ahmed informed you that a male patient that visited him a week ago, suffered from nausea while taking Abstral. You then reported to NBP Safety mailbox on Feb 16th.
Did you take the right action? Why?
3- Yes, you must report the AE, since it is a specific patient, but you reported it late, not within the 1st 24 hours of being notified on the 14th of February.
"Transmission of infectious agents" is considered as
A) Serious adverse event
B) Non-serious adverse event
C) Special situation
D) A & C
E) B & C
F) other, please specify...
A & C
A) Serious adverse event
C) Special situation
The minimum passing score for the PV annual quiz is .... % while for the PV SOP quizzes it’s ..... %
80% & 100%
If you did not pass, the PV training will be repeated, and you will retake the quiz.
In certain situations, Risk Minimization Measures are required to be performed, which may include the distribution of a "Patient Card" to HCPs. The creation of a distribution plan in this case is necessary, what does the distribution plan consist of?
1-
2-
3-
1-An HCP distribution list
2-A distribution timeframe
3-A distribution mechanism (by hand, be, email, by courier)
The NBP PV team received the below email:
"Dear Colleagues, Kindly note that yesterday, Dr. Mohamed Ahmed reported that Ms. Manal Mohamed, a 60-Year-old patient informed him that she suffered from a mild headache after receiving her Tysabri dose, which is already mentioned as a common side effect in the patient information leaflet."
Is this a valid reportable AE, that should be reported to the NBP PV team? if yes, please extract the 4 minimum criteria that are reportable from the email.
2-There is a mistake in the above case report, please specify.
1-Yes, this is a valid case.
The four minimum criteria are:
Reporter identifiers: Dr. Mohamed Ahmed
Patient identifiers: a 60-Year-old patient
AE: mild headache
Product: Tysabri
2- Patient's name must not be shared. (Data Privacy)
An invalid AE report, is one where:
A- One or more of the 4 minimum criteria are missing and will not be shared with NBP safety team.
B- One or more of the 4 minimum criteria are missing and will be shared with NBP safety team.
C- One or more of the 4 minimum criteria are missing and will be shared with NBP safety team but not with the Health Authority.
D- One or more of the 4 minimum criteria are missing and will be shared with NBP safety team and with the Health Authority.
C- One or more of the 4 minimum criteria are missing and will be shared with NBP safety team but not with the Health Authority.
Special situations are reportable whether accompanied by Adverse Events or not,
State 5 special situations:
1-
2-
3-
4-
5-
1-Offlabel use
2-Overdose
3-Medication Error
4-Paternal drug exposure
5-Lack of efficacy
As part of the oversight required on our local distributors/service providers, the NBP PV team conducts Routine PV Audits, at minimum, every:
1- 6-12 months
2- Year
3- 3 years
3- Other, please specify..
3 years
During the implementation of any risk minimization measure, which involves the distribution of Educational Material, the NBP PV team communicates with these three functions to do these three tasks,
The .... function to ....
The... function to ...
The ... function to ....
Medical Affairs function to review the medical content of the material.
Regulatory Affairs function to review the global label vs the local label.
Commercial team to provide the HCP distribution plan (list contact details, mechanism of distribution, timeframe, etc).
The NBP Commercial teams need to provide the NBP PV team with product sales data to prepare.... which is required for the local periodic safety reports in Egypt & Saudi Arabia.
Patient Exposure Data Calculation.
While visiting an Oncologist to discuss Lenvima® use in Renal Cell Carcinoma, she informed you that she has prescribed it at half the locally approved dose, as she doesn’t want the patient to develop side effects. Is this reportable? And why?
Yes, please report.
As prescribing a medicine at a dose that is different from the locally approved is considered off-label use which is a reportable special situation.
A patient reported to his physician that while taking his Tecfidera tablet, he noticed that it had a bad smell as well as the rest of remaining tablets in the pack.The Physician advised him not to take it anymore.
This case is considered reportable to which function(s)....... and reported as .....
PV & QA .... Product Quality Complaint and special situation (misuse as the patient intentionally missed a dose)
If you receive an Adverse Event from an HCP and report it to the NBP safety mailbox within 24 hours, what is the reporting flow of this AE once you’ve sent it to the NBP safety team?
Once received in the NBP safety mailbox, the safety team sends it to the concerned MAH for assessment.
The MAH proceeds with the assessment sends back special formats for the case.
The NBP safety team sends the special formats to the concerned local distributor in the concerned country.
The local distributor submits the case to the Health Authority.