anh văn chuyên ngành dược 2 unit 5

anh văn chuyên ngành dược 2 unit 5 anh văn chuyên ngành dược 2 unit 5 anh văn chuyên ngành dược 2 unit 5 anh văn chuyên ngành dược 2 unit 5 anh văn chuyên ngành dược 2 unit 5 anh văn chuyên ngành dược 2 unit 5 anh văn chuyên ngành dược 2 unit 5

Monitoring and evaluating

suspected side effects

Responding to a

physician's report

Submitting documents needed

to obtain marketing approval for a drug

Compiling dossiers for submission to authorities

Writing the drug information for the patient

Drug Safety department Regulatory Affairs department

Reporting an adverse drug

reaction to health authorities

QUESTION 1: WHAT IS THE DIFFERENCE BETWEEN DRUG SAFETY DEPARTMENT AND REGULATORY

AFFAIRS?

We are group 7

QUESTION 2: WHY DO HEALTHCARE PROFESSIONALS AND PHARMACEUTICAL COMPANIES KEEP RECORDS

OF UNEXPECTED REACTIONS TO DRUGS?

Because healthcare professionals and

pharmaceutical companies work together to research, monitor and evaluate suspected side effects to improve the safety of drugs in use, minimize adverse effects

QUESTION 2: HOW MUCH SHOULD PATIENTS KNOW ABOUT POSSIBLE SIDE EFFECTS BEFORE TAKING

MEDICATION?

The patient should be known about all of possible side effects before taking medication

See you later

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other

drug-related problem

QUESTION 3: WHAT IS

PHARMACOVIGILANCE?

Government agencies,

Pharmaceutical companies, and Healthcare professionals work together

to monitor and evaluate suspected side effects of medicines to improve the safety of drugs in use

QUESTION 3: WHICH AGENCIES ARE RELATED TO PHARMACOVIGILANCE? WHAT ARE THEIR ROLES?

They are known or can be

determined

They happen based on medication

alone and no need of treatment

is an undesired harmful effect resulting from a medication or other intervention such as

surgery

They are unexpected and hard to determine.

They happen due to incorrect dosage or surgery and require treatment

Adverse effects

Any unintended reaction caused by

a drug or medical treatment

EFFECT, ADVERSE EFFECT

Side effects

This may or may not be a side effect of a drug

easily tolerated and are of minor irritant type, interfere or interrupt the patient’s normal daily activities

an adverse event that threatens life, requires or prolongs

hospitalization, or results in death

any untoward medical occurrence that at any dose

Death, Life-threatening, Hospitalization, Congenital anomaly, Impairment, damage or disruption in the patient's body function

Adverse

an unwanted medical occurrence which a patient experiences during treatment This may or may not be

a side effect of a drug

QUESTION 4: WHAT IS THE DIFFERENCE AMONG ADVERSE

EVENT AND SERIOUS ADVERSE EVENT

A similar, but different substance

A totally different, potentially dangerous

substance

A worthless placebo

A lower concentration of the same active

ingredient

QUESTION 5: WHAT IS FAKE DRUGS

Counterfeit medicines are manufactured in one of the

following cases:

01 02

Treatment failure and even death can result with

the use of counterfeit drugs

End organ damage: Ingestion of counterfeit drugs

can result in damage to the liver, kidneys, heart and the central nervous system

03

04

Loss of confidence: The reputation of the original

product is damaged Patients may lose confidence in the health care professionals

Economic loss: Many pharmaceutical companies lose

large amounts of money because their products are being counterfeited and sold at cheaper rates

QUESTION 5: HOW DO FAKE DRUGS

AFFECT US?

The Patient Information

Leaflets (PILs) are the

leaflets containing specific

information about medical

conditions, doses, side

effects that packed with

medicines to give the user

information about product

Pills were powdered drugs that featured the active ingredients mixed with adhesive substances to create small dosage forms for oral administration

QUESTION 6: DISTINGUISH PIL AND PILL

s

QUESTION 6: DISTINGUISH PIL AND PILL

The Patient Information Leaflets (PILs) Pills

Faint, severe skin rash and inflammation, lost consiousness

Mensamint was discontinued, a strong sedative was

administered to reduce the symptoms

All symptoms except for a mild skin irritation had subsided

What were the patient’s symptoms before she was admitted to hospital?

How was she treated by her physician?

What was her condition when she was discharged from the hospital?

QUESTION 7: READ THE DOCTOR’S REPORT

IN PART 1