AVCN2 GV.

Huỳnh Thanh Tùng

Session 5 - Drug safety and regulatory affairs

I. DRUG SAFETY AND REGULATORY AFFAIRS – STARTER PG. 51
Tick the department which 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 effects.
4. Responding to a physician’s report.
5. Compiling dossiers for submission to authorities.
6. Writing the drug information for the patient.

What is pharmacovigilance? (Cảnh giác dược)

1.
Pharmacovigilance = Pharmaco (medicine/ Dược phẩm) + Vigilantia (watchfulness/ sự thận trọng)
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.
2. Additional effects of taking drugs

Adverse event

Adverse drug
reaction

Side effect Adverse drug reaction Adverse event Serious adverse event (SAE)
(Tác dụng phụ) (Phản ứng có hại của thuốc) (Biến cố bất lợi)* (Biến cố bất lợi nghiêm trọng)
any unintended reaction all abnormal and unintended an unwanted medical an adverse event that
caused by a drug or medical responses to an medicinal occurrence which a patient threatens life, requires or
treatment. This term is used product related to any dose experiences during treatment. prolongs hospitalization, or
by the general public, but is administered. This may or may not be a side results in death.
often avoided by medical effect of a drug.
authorities
Bất kỳ phản ứng không tất cả các phản ứng bất Là một sự cố y học không Là một biến cố đe dọa mạng
mong muốn gây ra bởi thường và không mong muốn mong muốn mà bệnh nhân trải sống, cần nằm viện trong thời
thuốc hoặc điều trị bằng đối với một sản phẩm thuốc qua trong quá trình điều trị. gian dài, hoặc gay tử vong.
thuốc. Thuật ngữ này được liên quan đến bất kỳ liều nào. Điều này có thể hoặc không
sử dụng phổ biến bởi công phải là một tác dụng phụ của
chúng, nhưng cơ quan y tế thuốc
thường tránh sử dụng thuật
ngữ này.
*Trung tâm DI & ADR Quốc Gia: http://canhgiacduoc.org.vn/CanhGiacDuoc/phanungcohai.aspx
TU
7
3 T
7
3
U

1
 AVCN2 GV. Huỳnh Thanh Tùng
3. Doctor case report – exercise 1 pg.52
Before hospital admission Fainted - ngất xỉu
T
0

On 24 Dec 2010, a woman of unknown age, Maria Gallois, fainted Rash - phát ban
after developing a sudden, severe skin rash and inflammation all Inflammation - viêm
over her body. Ms Gallois, the well-known opera singer, lost Lost consciousness – bất tỉnh
consciousness 30 minutes before she had planned to go on stage.
She was taken to hospital and regained consciousness an hour Small, red, itching spots – đốm nhỏ, màu đỏ, ngứa
later. She reported that she had not had anything to eat except Racing heart – tim đập nhanh
some chocolate four hours before. In addition to small, red, Headache – đau đầu
itching spots all over her body, she also reported a racing heart, a Insomnia – mất ngủ
headache, and insomnia after starting on Mensamint three weeks
previously.
Vital signs: temperature 100 °F (38.8 °C) and blood Vital sign – dấu hiệu sinh tồn
pressure 160/110 Oral contraceptive - thuốc ngừa thai
Known allergies: peanuts, penicillin Hypertension - huyết áp cao
Medications: two 100 mg Mensamint lozenges taken once Heart palpitations - tim đập nhanh
daily for improved short-term and long-term
memory. 1. What were the patient’s symptoms before she was
Mimifem oral contraceptive 0.2 mg daily. admitted to hospital?

The patient has a history of hypertension, mild heart palpitations,

high adrenalin levels, and often suffers from insomnia.

During hospital admission Hyperactivity - sự hiếu động

At the hospital, the patient showed evidence of hyperactivity, Confusion – sự nhầm lẫn
accompanied by confusion and agitation. Subsequently, Agitation – sự kích động
Mensamint was discontinued, but the symptoms persisted until a Persist – kéo dài
strong sedative was administered. Sedative - thuốc an thần

2. How was she treated by her physician?

After hospital admission mild skin irritation – rát da

After 24 hours, all symptoms except for a mild skin irritation had subside – giảm xuống
subsided and the patient was discharged from hospital. Some discharge from hospital – xuất viện
symptoms are suspected side effects of Mensamint.
3. What was her condition when she was discharged
from the hospital?

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

• Her symptoms occurred after taking Mensamint and stopped 24 hours after she discontinued it.
• Some of her symptoms are known side effects of Mensamint: 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 could have contained peanuts.
• She is taking another drug, an oral contraceptive, and has a history of hypertension, mild heart palpitations, high
adrenaline, and insomnia.

2
 AVCN2 GV. Huỳnh Thanh Tùng
4. Exercise 2 pg. 52 - Match the symptoms with their definitions.
HYPERTENSION- cao huyết áp RASH-phát ban PALPITATION- tim đập nhanh INSOMNIA- mất ngủ
INFLAMMATION- viêm ITCHING-ngứa IRRITATION- rát/ khó chịu
Symptoms Definition
INSOMNIA a) sleeplessness
IRRITATION b) general discomfort, bad feeling
INFLAMMATION c) red, warm, and swollen
ITCHING d) you feel like you want to scratch
PALPITATION e) heart racing
HYPERTENSION f) high blood pressure
RASH g) a lot of spots on the skin

5. Exercise 3. Pg.52
Choose the correct half to complete the following sentence

1. A report received from the patient’s sister 2. After having taken Mensamint,
a. indicated that she had a history of hypertension. a. indicated that she had a history of hypertension.
b. the patient experienced headaches and insomnia. b. the patient experienced headaches and insomnia.
c. and the symptoms cannot be ruled out. c. recovered and is back on stage.
d. recovered and is back on stage. d. and the symptoms cannot be ruled out.
3. A correlation between Mensamint 4. The patient has now completely
a. the patient experienced headaches and insomnia. a. indicated that she had a history of hypertension.
b. the attending physician reduced the dosage to 10 mg/ day. b. the patient experienced headaches and insomnia.
c. recovered and is back on stage. c. recovered and is back on stage.
d. and the symptoms cannot be ruled out. d. and the symptoms cannot be ruled out.

5. After examining the patient,

a. indicated that she had a history of hypertension.
b. the attending physician reduced the dosage to 10 mg/ day.
c. recovered and is back on stage.
d. and the symptoms cannot be ruled out.

Rewrite the above sentence to make a case report.

1. Symptoms after taking the

medication

2. Patient medical history

3. Doctor treatment

4. Patient condition after

treatment

5. Assessment

3
 AVCN2 GV. Huỳnh Thanh Tùng

II. REPORTING SERVERE ADVERSE EVENTS TO HEALTH AUTHORITIES

Pharmaceutical companies use details from doctors’ reports to inform the authorities in a case report

Patient history Lịch sử bệnh nhân

The patient has a history of... Bệnh nhân có tiền sử..
A report was received from the physician indicating that ... Báo cáo nhận được từ bác sĩ chỉ ra rằng/ cho biết ...
Before the event, the patient was on the following Trước sự kiện, bệnh nhân đã dùng thuốc sau đây: ...
medication:...
Description of adverse event Mô tả biến cố bất lợi
After examining the patient, the physician... Sau khi khám bệnh nhân, bác sĩ ...
After taking (drug), the patient experienced... Sau khi dùng thuốc, bệnh nhân bị ...
At the time of the report, the patient’s condition Vào thời điểm báo cáo, tình trạng của bệnh nhân đã / vẫn
was/remained unchanged. không thay đổi.
At the time of the report, the patient was recovering/had Vào thời điểm báo cáo, bệnh nhân đang hồi phục / đã hồi
completely recovered. phục hoàn toàn.
This event led to the patient’s death. Sự kiện này dẫn đến cái chết của bệnh nhân.
Drug information Thông tin thuốc
... are known/suspected side effects of this drug. ... được xem / bị nghi ngờ là tác dụng phụ của thuốc này.
(Drug) was administered for (condition). (Thuốc) được dùng cho (bệnh).
Eye drops were instilled. Thuốc nhỏ mắt đã được nhỏ.
A bandage/cream/lotion/ointment was applied (to the skin). Một sự bang bó / kem / lotion/ thuốc mỡ đã được áp dụng
(lên da).

Assessment of adverse event Đánh giá sự kiện bất lợi

(Drug) is (not) believed to be related to the event. (Thuốc) được cho là/ (không được cho là) liên quan đến sự
An interaction between (drugx) and (drugy) was suspected. kiện.
A correlation between (drug) and (symptom) can/ cannot be Sự tương tác giữa (thuốc x) và (thuốc y) đã bị nghi ngờ.
ruled out Có thể / không thể loại trừ tương quan giữa (thuốc) và (triệu
chứng)
1. Exercise 4 Pg.53 - DESCRIBE EVENT, PROBLEM OR PRODUCT USE ERROR
__________ (1) from a physician indicating that a woman had fainted after developing a sudden, severe skin rash and
inflammation all over her body. She was taken to hospital and regained consciousness 30 minutes later. __________
(2) not having had anything to eat but a chocolate candy bar 4 hours beforehand. In addition to small, red, itching
spots all over her body, she also reported suffering from mild heart palpitations, headaches, and insomnia after
starting on Mensamint three weeks previously. The patient __________ (3) the following medication: Mimifem oral
contraceptive pill 0.2 mg daily. As to her emotional state after hospital admission, the patient __________ (4)
hyperactivity, accompanied by confusion and a feeling of agitation. __________ (5), the attending physician
discontinued Mensamint and administered a strong sedative. After 24 hours, __________ (6) except for a mild skin
irritation and the patient was released from hospital. Symptoms are __________ (7) of Mensamint, although a
__________ (8) her peanut allergy, Mensamint and this event cannot __________ (9).

__________ (10) : temperature 38.8°C;blood pressure 150/110.

Known allergies: peanuts, penicillin.
The patient has __________ (11) hypertension, heart trouble, and insomnia.

Choose the correct answer to fill in the blanks

Hint: using useful phrases - reporting severe adverse events to health authorities and the doctor case report

1 A. a report was received B. the patient reported C. vital signs D. suspected side effects
2 A. the patient B. the patient reported C. the patient report D. the patient reporting
3 A. was in B. was on C. was off D. was at

4
 AVCN2 GV. Huỳnh Thanh Tùng
4 A. showed side effects of B. showed evidence off C. showed evidence of D. has side effects
5 A. after releasing the patient B. after discharging the patient C. after sending the patient home D. after examining the patient
6 A. all drugs had subsided B. all medications had subsided C. all symptoms had subsided D. all dosages had subsided
7 A. suspected side effects B. suspected side affects C. suspected side actions D. suspected side reactions
8 A. correlation between B. correlation in C. correlation of D. correlation on
9 A. be out B. be ruled C. ruled out D. be ruled out
10 A. vital affects B. vital effects C. vital symptoms D. vital signs

2. Health authorities and useful terms

III. DISCUSSING CAUSES OF SAES & ASKING ABOUT IMPLICATIONS FOR A DRUG
DISCUSSING CAUSES OF SAES ASKING ABOUT IMPLICATIONS FOR A DRUG
It could have been due to... How did the clinical trials go?
Nó có thể là do ... Các thử nghiệm lâm sàng đã tiến hành như thế nào?
It is due to pre-existing conditions. What is the status of approval?
Đó là do bị bệnh từ trước. Tình trạng xin giấy phép như thế nào?
The evidence is conclusive/inconclusive. How far is it from approval?
Bằng chứng thuyết phục / không thuyết phục. Còn bao lâu nữa sẽ được cấp phép
A reaction to the product cannot be ruled out. Could it jeopardize other products?
Không thể loại trừ phản ứng với sản phẩm. Nó có thể gây nguy hiểm cho các sản phẩm khác không?
What does it mean for the products in the pipeline?
Nó có ý nghĩa gì với các sản phẩm thuốc trong tương lai?

1. Exercise 7 Pg. 57
Choose the statement with similar meaning

1. It resulted from an old illness. 2. Will it cause problems for other products?
A. It could have been due to... A. Could it jeopardize other products?
B. It is due to pre-existing conditions. B. How far is it from approval?
C. The evidence is conclusive/inconclusive. C. What does it mean for the products in the pipeline?
D. A reaction to the product cannot be ruled out. D. How did the clinical trials go?
3. Maybe the side effect was a result of taking this product. 4. How soon will we get permission to put the product on the
A. The side effect could have been due to taking this market?
product. A. Could it jeopardize other products?
B. The side effect is due to pre-existing conditions. B. How far is it from approval?
C. The evidence of the side effect is conclusive. C. What does it mean for the products in the pipeline?
D. A reaction to the product cannot be ruled out. D. How did the clinical trials go?
5
 AVCN2 GV. Huỳnh Thanh Tùng
5. Were the clinical trials successful? 6. The facts neither prove nor disprove this.
A. Could it jeopardize other products? A. It could have been due to...
B. How far is it from approval? B. It is due to pre-existing conditions.
C. What does it mean for the products in the pipeline? C. The evidence is inconclusive.
D. How did the clinical trials go? D. A reaction to the product cannot be ruled out.
7. How will this affect other products which are not yet on the This product may or may not have caused the reaction.
market? A. It could have been due to...
A. Could it jeopardize other products? B. It is due to pre-existing conditions.
B. How far is it from approval? C. The evidence is conclusive/inconclusive.
C. What does it mean for the products in the pipeline? D. A reaction to the product cannot be ruled out.
D. How did the clinical trials go?

IV. Documentation required by the drug authorities

1. Exercise 8 Pg. 58
In order to get approval to sell a new drug, a company has to compile detailed documentation with all the information required by
the drug authorities. Match the following sections with their descriptions.

Quality a. biological, chemical, and pharmaceutical documentation with manufacture,

quality control, and testing data
Common Technical b. overviews of quality, clinical, and non-clinical data
Document Summaries
Clinical Study Reports c. documentation about clinical trials and post-marketing information
Administrative Data d. general information, such as the marketing authorization application form, as
well as product characteristics and labelling
Non-clinical Study Reports e. study reports, pharmacology, pharmacokinetics, toxicology, and references
V. PATIENT INFORMATION
1. PIL VS. PILL
Important information for any person taking a drug can be found in the ‘PIL’ or patient information leaflet (tờ
hướng dẫn cho bệnh nhân). Such information is also called the patient leaflet, patient packet, or package insert. In
the US, it is also referred to as a patient information sheet (PIS), or medication guide.
Note: When you talk about PILs, say each letter. If not, it might be confused with ‘pills’.

2. Exercise 9 Pg. 59
Dear RA staff Self-inspection – kiểm tra nội bộ
I just wanted to give you a brief update on the self-inspection conducted last week by
QA. Most of the results were very positive. It seems our documentation is of a high 1. What are the strong points in this
standard, especially with respect to completeness and technical details. department’s documentation?

However, in terms of readability, we can still make some improvements in future Readability – tính dễ hiểu (đọc)
patient information leaflets. We need to remember that not only healthcare Healthcare professionals - Các cóc sức
professionals read these PILs, but also patients To alarm – cảnh báo
Products in the pipeline – thuốc trong
In addition, I have noticed something which, I think, some of you can improve on. It To differentiate – phân biệt
has to do with drug warnings. Yes, we do need to let patients know of any possible Frequent and rare risks – tác dụng/ rủi
side effects. But, no, it is not necessary to alarm them unnecessarily. In other words, ro thường thấy và hiếm thấy
in future when describing possible side effects for products in the pipeline, we will 2. How could it improve its
need to differentiate more clearly between frequent and rare risks. In the case of the documentation?
latter, we will need to be less direct in order to increase patient compliance.

3. What effect could a change in the

style of language have on patients?

6
 AVCN2 GV. Huỳnh Thanh Tùng
Let’s talk about these two points at our department meeting on Friday. I will also be to coach – huấn luyện
asking Wendy, our senior medical writer, to coach junior staff members.
4. Exercise 10 Pg. 60
Add the following headings to the PIL for Mensamint .

A. Before you take this product

B. Further information
C. How to store
D. How to take/use
E. Read this leaflet carefully because it contains information you need to know
F. Possible side effects
G. What the product is, and what it is used for

7
 AVCN2 GV. Huỳnh Thanh Tùng
5. Giving general advice and strong warning
Giving general advice Lời khuyên chung
Mensamint may cause dizziness. Mensamint có thể gây chóng mặt.
Mensamint can interact with other medicines. Mensamint có thể tương tác với các loại thuốc khác.
Like all drugs, this medicine can cause side effects. Giống như tất cả các loại thuốc, thuốc này có thể gây ra phản
ứng phụ.
Use Mensamint with caution while driving or Sử dụng Mensamint thận trọng khi lái xe hoặc
undertaking dangerous activities. tham gia các hoạt động nguy hiểm.
It is possible that you may receive this medicine, or Có thể bạn có thể nhận được loại thuốc này, hoặc
an alternative may be used. một loại thay thế khác.
Strong warning Cảnh báo mạnh mẽ
Do not use/take Mensamint if... Không sử dụng / dùng Mensamint nếu ...
Stop use and ask a doctor if... Ngừng sử dụng và hỏi bác sĩ nếu ...
Keep out of reach of children. Để xa tầm tay trẻ em.
Tell your doctor immediately/right away if... Báo cho bác sĩ của bạn ngay lập tức nếu ...
You must not drive while taking this drug. Bạn không được lái xe trong khi dùng thuốc này.
You should not take Mensamint if you have Bạn không nên dùng Mensamint nếu bạn có lịch sử bệnh ...
a history of...

6. Exercise 11 Pg. 61

VI. COUNTERFEIT MEDICINES

Fake drugs may contain Thuốc giả có thể chứa
• a worthless placebo • một giả dược vô giá trị
• a lower concentration of the same active ingredient • nồng độ thấp hơn của cùng một hoạt chất
• a similar, but different substance • một chất tương tự nhưng khác biệt
• a totally different, potentially dangerous substance. • một chất hoàn toàn khác, có khả năng nguy hiểm.
Pharmacopia – dược điển

VII. REVIEW QUESTIONS

Quizlet flash cards – Unit 5: https://quizlet.com/avcn101/folders/avcn2/sets

8
AVCN2 GV. Huỳnh Thanh Tùng

9
 AVCN2 - Unit 5
Study online at quizlet.com/_3z6xc8

1. Active The __________ of Mensamint TM is 17. Inflammation Symptoms of __________ include: red,
substance mensagitatum. Other ingredients are warm, and swollen.
peppermint, oil, sugar, talcum, and a
18. Insomnia __________ is the condition of being unable
preservative.
to sleep.
2. Administrative _______ include(s) the general information, such
19. Irritation __________ means general discomfort, bad
Data as the marketing authorization application
feeling.
form, as well as product characteristics and
labeling. 20. Itching __________ is when you feel like you want
to scratch.
3. Adverse __________ is an unwanted medical occurrence
event which a patient experiences during 21. MHRA The ________ is an executive agency of the
treatment. This may or may not be a side Department of Health in the United
effect of a drug. Kingdom which is responsible for
ensuring that medicines and medical
4. Allergic Do not take Mensamint TM if you are _______ to
devices work and are acceptably safe.
peanut.
22. Non-clinical Study _______ include(s): study reports,
5. API _________ stands for (active pharmaceutical
Reports pharmacology, pharmacokinetics,
ingredient)
toxicology, and references
6. Clinical Study _______ include(s): documentation about
23. Out of reach Keep _________ of children.
Reports clinical trials and post-marketing information.
24. Palpitations __________ are the conditions of heart
7. Common _______ include(s) overviews of quality, clinical,
racing.
Technical and non-clinical data.
Document 25. Pharmacopeia ____________ is an official publication
Summaries containing a list of medicinal drugs with
their effects and directions for their use.
8. Counterfeit _________ drugs may contain: a worthless
placebo; a lower concentration of the same 26. Pharmacovigilance Government agencies, pharmaceutical
active ingredient; a similar, but different companies, and healthcare
substance; a totally different, potentially professionals work together to monitor
dangerous substance. and evaluate suspected side effects of
medicines to improve the safety of
9. Drug Safety __________ department is responsible for
drugs in use.
reporting an adverse drug reaction to health
authorities. 27. 'PILs' _________ means patient information
leaflets.
10. Drug Safety __________ department is responsible for
monitoring and evaluating suspected side 28. QPPV __________ stands for Qualified Person
effects Responsible for Pharmacovigilance.

11. Drug Safety __________ department is responsible for 29. Quality _______ include(s): biological, chemical,
responding to a physician's report. documentation and pharmaceutical documentation
with manufacture, quality control, and
12. EMEA The ___________ is a European Union agency for
testing data.
the evaluation of medicinal products.
30. Rash Someone has a ___________, that person
13. Excipients an inactive substance that serves as the
has a lot of spots on the skin.
vehicle or medium for a drug or other active
substance. 31. Regulatory Affairs __________ department is responsible for
submitting documents needed to
14. FDA The __________ is the Food and Drug
obtain marketing approval for a drug.
Administration (US) It is responsible for
ensuring that food, drugs, and certain other 32. Regulatory Affairs __________ department is responsible for
products and processes are safe for writing the drug information for the
consumers. patient.

15. Hypertension __________ is when blood pressure is higher than 33. Regulatory Affairs __________ department is responsible for
normal (e.g. A blood pressure of 140/90) compiling dossiers for submission to
authorities.
16. Hypotension __________ is when blood pressure is lower than
normal (e.g. A blood pressure of 65/70).
34. Serious __________ (SAE) is an adverse event that threatens life, requires or prolongs hospitalization, or results in death.
adverse
event
35. Side effect __________ is any unintended reaction caused by a drug or medical treatment. This term is used by the general public, but is
often avoided by medical authorities.
36. Vital signs The patient's normal __________ (pulse, blood pressure, respiratory rate and temperature) are established in the pre-
operative period and variations 10% above or below the pre-operative measurement should be reported immediately.
Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test

PART 1

1 of 6 13/11/2017, 21:45 2 of 6 13/11/2017, 21:45

Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test

3 of 6 13/11/2017, 21:45 4 of 6 13/11/2017, 21:45

Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test

5 of 6 13/11/2017, 21:45 6 of 6 13/11/2017, 21:45

Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test

PART 2

1 of 7 13/11/2017, 21:46 2 of 7 13/11/2017, 21:46

Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test

3 of 7 13/11/2017, 21:46 4 of 7 13/11/2017, 21:46

Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test

5 of 7 13/11/2017, 21:46 6 of 7 13/11/2017, 21:46

Test: AVCN2 - Unit 5 | Quizlet https://quizlet.com/240508232/test

7 of 7 13/11/2017, 21:46