Pharmacovigilance (PV) Systems and Standards Part 2

Question 1

Key features of the restricted assess scheme

Answer 1

• for a selected group of patients
• requires physician’s undertaking
• requires patient’s informed consent
• requires pharmacists’s undertaking
• supply of product only to physicians who have “registered”
• provide regular sales data and updated physician’s list to HSA

Question 2

What is restricted use/access implemented form, and what are the conditions for product supply?

Answer 2

Implemented for products with serious potential risks where it still has an important role in therapy:

• Restricted for use in specific groups of patients where there is no suitable alternatives.
• Restricted for use by certain medical specialties (e.g. cardiologists, infectious disease experts)

Product supply is bound by special licensing conditions:
- e.g. for patients who have undergone specific blood tests, physicians who have undergone training programs

Question 3

Types of restricted use/access programs:

Answer 3

1. Restriction on use (e.g. tegaserod, aprotinin, rosiglitazone)
2. Pregnancy prevention program (e.g. pomalidomide, isotretinoin)

Question 4

Characteristics of the Thalomid REMS Program

Answer 4

• concerns over risk of teratogenicity

- risk management plan: Thalomid Risk Evaluation and Mitigation Strategy (REMS) Program (in US)

Question 5

What drugs are the i-access program for?

Answer 5

• revlimid and pomalyst

Question 6

i-access program overview

Answer 6

Before prescribing/ dispensing:

• prescribers and pharmacy/dispensing clinic need to register manually or via i-access online.
• a one-time registration with Celgene is required before prescribing or dispensing of Revlimid / Pomlayst is allowed.

Two scenarios for prescription:
A. Women of Child Bearing Potential
Signed patient agreement form for first prescription, negative pregnancy test –> prescribing revlimid/pomalyst –> refer patient with a prescription to an i-access registered pharmacy/dispensing clinic –> prescription of max 1 box (21 caps) of Revlimid / Pomylast required.

B. Men / Women of Non-childbearing potential
Signed patient agreement form (for 1st prescription) –> prescribing revlimid / pomalyst (submit prescription form) –> refer patient with a prescription to an i-access registered pharmacy/dispensing clinic (dispensing allowed only after authorisation by Celgene) –> prescription of max 2 boxes (42 caps) of Revlimid/Pomylast allowed.

Question 7

Which aspects of science need to be in place to ensure the quality and safety of products?

Answer 7

A. science, immunology, study designs
» deep understanding of science and pharmacology of innovative therapies
» new trial designs

B. product and manufacturing science
- product characterisation, validation of manufacturing process, quality control and stability testing, supply chain tissues

C. Pharmacovigilance

• Follow up of long term safety
• Long term efficacy
• Dealing with real world data