REMS

Question 1

Risk assessments are performed:

Answer 1

Not only prior to the approval of a new drug, but also post-approval of the drug and throughout the entire lifecycle.

Question 2

Multaq Sales Professionals can direct Healthcare Professionals to the Multaq REMS website. The web address is:

Answer 2

multaqrems.com

Question 3

Why does MULTAQ have a REMS program:

Answer 3

Due to patient’s two fold increase in mortality in ANDROMEDA

Question 4

In January of 2011, Sanofi sent a “Dear Helalthcare Professional” Letter out to inform HCP’s about:

Answer 4

Serious risks of MULTAQ including signs and symptoms of liver injury and hepatic failure.

Question 5

The REMS for Multaq contains all of the following elements, EXCEPT:

Answer 5

Elements to Assure Safe Use (EASU)

Question 6

To evaluate the effectiveness of the mPACT program in preventing MULTAQ exposure in inappropriate patients with heart failure, the company will conduct:

Answer 6

Knowledge and Understanding Surveys & a Drug Utilization Study

Question 7

The purpose of the Healthcare Provider Checklist is:

Answer 7

To help the physician identify the appropriate patients to treat

Question 8

MULTAQ Sales Professionals can distribute the Healthcare Professional Information Sheet. (T/F)

Answer 8

True

Question 9

Which factors must the FDA take into consideration when making the decision to approve a drug to market?

Answer 9

A) Seriousness of the disease or condition to be treated.B) Patient population.C) Expected benefit of the drug, and duration of treatment.D) Seriousness of the known or potential adverse events, etc.ALL of the above

Question 10

The goal of the REMS is to prevent MULTAQ use in :

Answer 10

Patients in a trial fibrillation who will not or cannot be cardioverted into normal sinus rhythm. In patients with permanent AF.

Question 11

The Healthcare Provider Checklist will be made available:

Answer 11

A) On the MULTAQ REMS WebsiteB) MULTAQ Medical Information Support DepartmentC) Sales and/or Medical RepresentativesD) All of the aboveALL of the above

Question 12

REMS is short for:

Answer 12

Risk Evaluation Mitigation Strategy

Question 13

Which of the following is not an element of the mPACT Program?

Answer 13

Physician certification requirements in order to prescribe the drug.

Question 14

The majority of the physicians targeted for the mPACT program are most be:

Answer 14

Cardiologists

Question 15

Sanofi-aventis has committed to evaluate the effectiveness of the mPact program:

Answer 15

Every year, the first live (5) years and at year seven (7) years post launch.

Question 16

Who is responsible for insuring the safe use of Multaq in the appropriate patient through compliance of the REMS?

Answer 16

Sales ProfessionalsMarketingRML’s

Question 17

In addition to preventing Multaq use in the inappropriate patient, the goal of the MULTAQ REMS is to:

Answer 17

Inform patients about the sefous risks of Multaq including increased mortality in patients with severe, unstable heart failure.

Question 18

The Medication Guide is written in language oriented to:

Answer 18

Provide patients with information on the safe use of Multaq.

Question 19

Examples of Elements to Assure Safe Use (EASU) include:

Answer 19

A) Physician certification requirements in order to prescribe the drug B) Patient enrollment in a central registry. C) Distribution of the drug restricted to certain specialty pharmaciesD) Healthcare Professional Checklist ALL of the above

Question 20

The Food and Drug Administration Amendments Act (FDAAA) was signed into law providing the FDA with expanded authority. Some of the new provisions included the authority to:

Answer 20

A) Require post-approval studies or clinical trials to assess a known serious risk or to learn more about a hypothesized serious risk. B) Require that new safety information be added to the product labelingC) Require that companies submit REMS when deemed necessary to ensure that the benefits outweigh the risks.ALL of the Above