Question 1: (20 marks online)

Rosiglitazone has been implicated in major risk increase of specific cardiovascular events. The product has been withdrawn from various international markets due to concerns about its safety profile. In the United States of America, the Food and Drug Administration (FDA) decided to restrict the use of rosiglitazone to patients with Type II diabetes who cannot control their diabetes with other medications.
You have recently been appointed as a risk management officer for a small generic pharmaceutical company in the USA. You have been tasked to prepare for the launch of a generic oral rosiglitazone product (4 mg) to treat Type II Diabetes Mellitus.
As part of the team your role is to contribute to certain sections of a comprehensive Risk Management Plan (RMP) for the rosiglitazone (4mg) oral tablets.
The core focus of your part of the RMP is to:

a) compile the introduction section and focus on the purpose, product overview, a detailed description of the mechanism of action of rosiglitazone and therapeutic indications,
b) identify the major safety risks,
c) provide a summary of all the safety specifications and concerns,
d) assess the severity of the identified and potential risks,
e) address risk minimisation measures or strategies and how these measures or strategies will be evaluated, monitored and managed. As part of your “Risk Evaluation & Mitigation Strategy (REMS) you can also include relevant and appropriate REMS tools and describe their purpose,
f) provide a concise summary for each of the aspects you were responsible for in this RMP.

You may use your own creativity for the proprietary name of the final product and the pharmaceutical company that you work for.

Question 2: (18 marks: 10 online + 8 upload)

Critically evaluate the reported adverse drug reaction (ADRs) as per the Niedrig et al., 2023 published case study (Rosuvastatin-induce rhabdomyolysis), refer to the attachment. Conduct a suitable causality assessment and address the following points in a written report.

a) What was the type of pharmacovigilance surveillance method used in this case? Expand on the advantages and disadvantages of this specific type of surveillance method to report ADRs in general.
b) Provide a critical overview of the pathogenesis and or possible pharmacological mechanisms involved in rosuvastatin-induced rhabdomyolysis. Indicate and discuss all general causes and risk factors that can contribute to Rhabdomyolysis.
c) Complete both the Naranjo and WHO-UMC causality assessments for this particular published case. Critically interpret and compare the outcomes of both the causality assessments in light of this specific case and existing literature and current body of knowledge. Compile a final conclusion of the outcome of the causality assessments.

Question 3: (10 marks)

You are employed as part of the pharmacovigilance department for a marketing authorisation holder and you are tasked to draw up a press release on the withdrawal of all pholcodine- containing products from the market. Attached is the SAHPRA (https://www.sahpra.org.za/press-releases/sahpra-withdraws-pholcodine-containing-medicines- from-sa-market/) press release associated with this withdrawal in South Africa.
a) Draw up an appropriate press release for the general public explaining the withdrawal of this product. The press release must be clear and understandable to the layman. The press release should contain the what, why, how, which and process(es) to follow. The word limitation of the press release is < 800 words.

Question 4: (12 marks online)

Write a reflective essay (500 – 1000 words) on how you as an individual achieved the learning outcomes of this Pharmacovigilance module. This will provide you with an opportunity to self- reflect on your own achievements and what it means to you. You are invited to be critical of your own achievements, to recognise your own limitations will be a valuable platform for professional growth.
Address the following points in your reflection report:

a) Reflect on what you have learned. (2)
b) Reflect on scenarios (examples) where your understanding or beliefs were challenged and how you resolved the challenges. (2)
c) Reflect on how you applied the learnings from this module (it can be a specific topic, tutorial, assignment or from the discussion forum) in your current workplace or elsewhere. (2)
d) Reflect on how your learning experience may be applied in the future, either in your current job or in a different work position.

Answers to Above Questions on Pharmacovigilance

Answer 1: Risk management plan is important to consider in the event of launching a new product in the market. In the given case scenario, the launch of a new generic oral rosiglitazone product for the treatment of type two diabetes mellitus also requires the consideration of a proper risk management plan. An effective risk management plan would help in outweighing the risk associated with the introduction of the new product by way of identifying, evaluating and mitigating any potential safety concerns.

Get completed answers on the questions above on Pharmacovigilance from the best South African assignment help experts of Student Life Saviour.