Unit 3 Drug Safety And Regulatory Affrairs (Technical English )

1. To differentiate between side effects and adverse events. 2. To describe some symptoms occurring as drugs’ side effects or adverse events. 3. To familiarize with giving general advice and strong warnings.

Lesson : Drug safety and regulatory affairs

KHOA Y DƯỢC – ĐẠI HỌC ĐÀ NẴNG

KHÓA: 2020 – 2025

HỌC PHẦN: ANH VĂN CHUYÊN NGÀNH

Objectives

1 To differentiate between side effects and

adverse events

2 To describe some symptoms occurring as

drugs’ side effects or adverse events

3 To farmiliarize with giving general advice

and strong warnings

Drug safety & Regulatory affairs

3

Drug safety (Pharmacovigilance)

Collecting information and preventing of adverse effects

Improving the safety

Which department is responsible for each of the

following tasks

Drug safety Regulatory affairs

1 Reporting an adverse drug reaction

to health authorities

2 Submitting documents needed to

obtain marketing approval for a drug

3 Monitoring and evaluating

suspected side effect

4 Responding to a physician’s report

5 Compiling dossiers for submission

Taking drugs: additional effects

(beside desired effects)

5

• An unintended reaction caused by a drug or medical treatment

• Generally used by public, however, avoided by medical authorities

Side effect

• An unwanted medical occurrence which a patient experiences during treatment

• May or may not be a side effect of

a drug

Adverse event

(adverse experience)

• An adverse event that threatens life, requires

or prolongs hospitalization, or results in death

Serious adverse event

Match each phonetic spelling to one of the words

Put one of the vocabulary items from the box into the

sentences belowevaluate – hospitalization – suspected – dossiers – authorities – approval

1 Is there a(n) ……… for Molnupiravir from FDA as an effective treatment

for SARS-CoV-2?

2 Lots of ……… need to be submitted by the end of the day, so you'd

better hurry up!

3 Clinical trials will ……… the effectiveness of different vaccines

approval

dossiers

evaluate

Put one of the vocabulary items from the box into the

sentences below

4 Thalidomide was immediately under investigation after its serious adverse events

were reported to health ………

5 If you’re concerned that you have had a ……… adverse reaction to a

medicine, you may need to contact your healthcare professional

6 Study’s results illustrated that the number of patients requiring ………

was significantly lower in the fully vaccinated group

Read the following doctor’s report

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

 She fainted and had a skin rash, and inflammation; small, red, itching spots

all over her body; a racing heart, a headache, and insomnia

How was she treated by her physician?

 The physicain/doctor gave her a strong sedative and took her off the

medication

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

 She only had a mild skin irritation

Answer the following questions

What evidence points to Mensamint TM as the cause of the symptoms?

 Her symptoms occurred after taking MensamintTM and stopped 24 hours

after she discontinued it

 Some of her symptoms are known side effects of MensamintTM: loss of

sleep if taken in the late afternoon or evening, increase in blood pressure, heart palpitations and headaches

What evidence suggests that other factors may be responsible for the symptoms ?

 Patient is allergic to peanuts and penicillin and had eaten a candy bar,

which would have contained peanuts

 She is taking another drug, an oral contraceptive and has a history of

hypertension, mild heart palpitations, high adrenaline and insomnia

Answer the following questions

hypertension /ˌhaɪpəˈtenʃn/

• blood pressure that is higher than is normal (high blood pressure)

rash

/ræʃ//

• an area of red spots on a person’s skin, caused by

an illness or a reaction to something (a lot of spots

on the skin)

palpitations

/ˌpælpɪˈteɪʃnz/

• a physical condition

in which your heart

beats very quickly

and in an irregular

way (heart racing)

insomnia

/ɪnˈsɒmniə/

• the condition of being unable to sleep (sleeplessness)

inflammation

/ˌɪnfləˈmeɪʃn/

• a condition in which a part of the body becomes red, warm, painful and swollen because of infection or injury (red, warm, painful and swollen)

itch

/ɪtʃ/

• an uncomfortable feeling on your skin that makes you want

to scratch yourself

diarrhoea

/ˌdaɪəˈrɪə/

• an illness in which waste matter is

emptied from the bowels much more frequently than

normal, and in liquid form

continuously does or

by something that continuously happens

Connect the following sentence halves then reorder them to

make a fully case report

1 A report received from the

patient’s sister

_ the attending physician reduced the dosage to 10 mg per day

2 After having taken MensamintTM ,

the patient experienced

_ and the symptoms cannot be ruled out

3 A correlation between

MensamintTM

_ headaches and insomnia

4 The patient has now completely _ indicated that she had a history of

Reporting servere adverse events to

health authorities: sentences often used

The patient has a history of … … are known/suspected side effects of this

Reporting servere adverse events to

health authorities: sentences often used

After examining the patient, the physician

This event led to the patient’s death

Listen to the meeting to discuss the severse adverse event and

its implications for the company

Decide if the following statements are true (T) or false (F)?

1 There are two dosage forms of MensamintTM currently on the market

2 The serious adverse event is clearly linked to MensamintTM

3 The documentation for the new dosage form of MensamintTM will be

submitted to the authorities soon

4 Heart trouble is a known side effect of MensamintTM

F

F

T

T

Severe adverse event (SAE): discussing causes and asking about its implications

drug

It could have been due to … How did the clinical trials go?

It is due to pre-existing conditions What is the status of approval?

The evidence is conclusive/inconclusive How far is it from approval?

A reaction to the product cannot be ruled

out

Could it jeopardize other products?

What does it mean for the products in the pipeline?

Rewrite the following statements and questions using the

phrases from SAE slide

1 It resulted from an old illness

It is due to pre-existing conditions

Could it jeopardize other products?

The side effect could have been due to (taking) this product

How far is it from approval?

5 Were the clinical trials successful?

How did the clinical trials go?

The evidence is inconclusive

What does it mean for the products in the pipeline?

A reaction to the product cannot be ruled out

Match the following sections with their descriptions

1 Administrative Data _ biological, chemical and pharmaceutical

documentation with manufacture, quality control and testing data

2 Common Technical Document

4 Non-clinical Study Reports _ general information, such as the

marketing authorization application form,

as well as product characteristics and labelling

5 Clinical Study Reports _ study reports, pharmacology,

pharmacokinetics, toxicology and references

PIL – Patient information leaflet

Important information for any person taking a drug can be found in the “PIL” or patient information leaflet Such information is also called the patient leaflet, patient packet

or patient insert In the US, it is also referred to as a patient information sheet (PIS) or medication guide

Note: In order not to be confused with “pill”, you should say each letter when you talk about PIL

Read the

email from the Head of Regulatory Affairs

What are the strong points in this department’s documentation?

 The strong points are its completeness and technical details

How could it improve its documentation?

 They could improve readability and differentiate when describing frequent

and rare risks by being more or less direct in language

What effect could a change in the style of language have on patients?

 Better style could increase patient compliance

Answer the following questions

Listen to the dialogue between Wendy, the senior medical writer in the Regulatory Affairs department, and Mark, a

junior staff member about writing patient information leaflets

Add the headings in the box to the PIL for

you need to know

(5) Possible side effects

(2) What the product is,

and what it is used for

Match the following sentence halves to complete the

information from the PIL of PogoloxTM

1 PogoloxTM may cause _ are allergic to any antibiotics

2 Tell your doctor right away if _ your temperature continues to rise

3 You must not _ operate machinery while taking this

drug

4 Do not take PogoloxTM if you _ this medicine can cause diarrhoea

5 Stop use of PogoloxTM

immediately

_ serious liver damage

6 Like all antibiotics, _ if you experience any chest pain

General advice (GA) & Strong warnings (SW):

sentences often used

…(Drug)/this medicine can interact with

other medicines

Stop use and ask a doctor if …

Like all drugs, …(drug)/this medicine can

cause side effects

Keep out of reach of children

Use …(drug)/this medicine with caution

while …

Tell your doctor immediately/right away

if …

It is posible that you may receive

…(drug)/this medicine, or an alternative

may be used

You must not … while taking …(drug)/this medicine

Give examples of general advice and strong

warnings

Read the article about different classes of drugs

In your opinion, how high is the risk of counterfeit prescription drugs?

Who should try to stop such criminal activity? The industry? The government?

Should online pharmacies be banned, or more tightly regulated?