UNIT 20: PRESCRIPTION INSERTS

A prescription insert or a Patient Package Insert (PPI) is a printout that contains specific
information on particular prescription drug. There are many online resources that allow
patients to print out inserts for all prescription drugs at no cost. Companies may use different
insert styles to convey drug information, but usually include related sections in a similar
order. Common sections include:
● Description. This section includes general information about the prescription drug.
People with drug allergies can review this section to ensure that they are not taking a
medication that may trigger allergic reaction. This section contains:
o Generic name (the scientific or chemical name)
o Brand name
o Type of dosage (e.g., liquid, tablets, capsules)
o Administration method (e.g., oral, intravenous, rectal)
o Pharmacological or therapeutic class (e.g., analgesics, antibiotics)
o Chemical information, including names, structural formulas and other
information.
● Clinical pharmacology. Here they state how the drug actually works (e.g., how the
medicine acts in the body, how it is absorbed and eliminated, its effects with different
concentrations).
● Indications and usage. Information about the condition(s), diagnosis or symptom(s)
is declared in this section following the approval obtained. However, drugs can
sometimes be prescribed for reasons other than for what they were approved initially
(off-label use).
● Contraindications. This section describes those circumstances in which the drug
should not be used or should be used with caution because the potential risks may
outweigh any potential benefit. For example, using the drug at a particular age, by a
particular gender, with pre-existing diseases or mixing it with other drugs may cause
a serious risk. This section may also urge not to use the drug in an individual with an
allergy or known hypersensitivity to specific substances.
● Warnings. Adverse reactions and possible hazards are indicated here and what to do
if they occur.
● Precautions. Vital information about precautions for most people taking the drug is
displayed in this section. Special groups of people, such as children, pregnant women
and nursing mothers, may also have information specifically adapted for them. This
section includes also advice and instructions for special care to be taken by the
physician. (e.g., precautions when using alcohol or other drugs). Information about
laboratory tests and possible adverse reactions will be listed here.
● Adverse reactions (commonly called "side effects'"). Any unwanted effect that may
be connected with the use of the drug is listed here. Adverse reactions can be caused
by medication errors (e.g., overdosage), drug or food interactions, allergic reactions
or other causes. Information about adverse reactions with drugs in the same class
(e.g., antihistamines, bronchodilators, corticosteroids) may be in this section of the
package insert.
 ● Drug abuse and dependence. It will be clearly stated in this section if a drug is
thought to have a potential for abuse, dependence or withdrawal symptoms.
● Overdosage. Any information referring to signs, symptoms and laboratory findings
associated with an overdosage of a drug will be confirmed here.
● Dosage and administration. Under this section heading, the recommended dose is
stated along with the usual dosage range allowed, and perhaps an upper limit beyond
which safety and effectiveness have not been established. Also included in this
section is information about the intervals recommended between doses, the usual
duration of treatment and any changes of dosage needed for special patients such as
children, the elderly or patients with a disease.
● How supplied. This section includes information about available dosage forms. The
strength of the dosage forms is indicated here along with the units in which the dosage
form is usually available for prescribers, the description or appearance of the dosage
form and special handling and storage conditions.
● Additional sections. This section will include additional information if appropriate.
The package insert contains important information and instructions but it should not take the
place of instructions from a physician or healthcare professional. It is important, however, to
review the inserts for details regarding patient-specific conditions (e.g., allergies, adverse
effects to medications). Studying the
information in the inserts will help avoid errors and increase patient awareness of potential
problems.

EXERCISE 1

Overdosage Antihistamine Bronchodilator Corticosteroid Drug abuse

Take the place Withdrawal Sign Laboratory

of symptom

1……… work by locking the receptors that trigger itching, nasal irritation, sneezing, and
mucous production.
2. …….. work by relaxing the muscles in the airways. The relaxation causes the airways to
open up and the bronchial tubes to widen.
3. Commonly referred to as steroids, ……. are a type of anti-inflammatory drug. They are
typically used to treat rheumatologic diseases, like rheumatoid arthritis, lupus or vasculitis
(inflammation of the blood vessels)
4. In the section abuse, dependence and………… associated with ……..are clearly stated.
5. Any information referring to ………., symptoms and laboratory finding associated with
an……… of a drug will be confirmed here.
6. In the section “overdosage”, any information referring to results from…….test are
confirmed.
7. Sending e-mail has almost …………… writing letters.

KEY AND MEANING

1.Overdosage (n): Quá liều
1.Antihistamine: Thuốc kháng histamine
2.Bronchodilator: Thuốc giãn phế quản
3.Corticosteroid: Thuốc kháng viêm
4.Drug abuse: Lạm dụng thuốc
7.Take the place of : thay thế
4.Withdrawal symptom: triệu chứng ngưng thuốc
5.Sign : dấu hiệu
6.Laboratory : phòng thí nghiệm

EXERCISE 2

Dosage Intravenous Capsule Allergy

Prescription

Analgesic Antibiotic Prescription Trigger Rectal

drug

1. ………. is a piece of paper on which a doctor writes the details of the medicine or
drugs that someone needs
2. People with drug allergies can review this section to ensure that they are not taking a
medication that may………. allergic reaction.
3. Furthermore, the only reported contraindication to the use of a povidone iodine
mouthwash solution in humans is a known to ………. iodine
4. The physician stops the………. feeding, and the patient dies soon thereafter.
5. Paracetamol is one of the most commonly used ………. in Britain
6. In spite of lower ………. with the spray, the effect seems to be favorable, probably
due to better absorption in the nasal mucosa.
7. ………. is the term for a hollow gelatin container that holds a powdered medication.
8. There are many online resources that allow patients to print out inserts for all ……….
at no cost
9. Bacteria are becoming resistant to ……….
10. In the trial, all 18 patients had complete resolution of their early ………. cancer, were
cancer-free for up to two years and did not need to have standard treatments of
radiation chemotherapy or surgery.

KEY AND MEANING

1. Prescription (n) : đơn thuốc, toa thuốc
2. Trigger (v): gây ra
3. Allergy (n): dị ứng
4. Intravenous (adj): thuộc về tĩnh mạch
5. Analgesic (n): thuốc giảm đau
 6. Dosage (n): liều lượng
7. Capsule (n): viên thuốc con nhộng
8. Prescription drug: thuốc kê đơn
9. Antibiotic (n): thuốc kháng sinh
10. Rectal (adj): thuộc về trực tràng

EXERCISE 3

Clinical Pre-existing Hypersensitivity Precaution Adverse

disease reactions

Contraindication Allergic Hazard Nurshing

reactions mothers

1. Patients with typical ………….. signs suspicious of COVID-19 such as fever, cough, sore
throat, loss of taste or smell.
2. Biological ………….. are organisms, or substances produced by organisms, that pose a
threat to human health.
3. ……………….. occur when your immune system reacts to a foreign substance — such as
pollen, bee venom or pet dander — or a food that doesn't cause a reaction in most people.
4. No evidence suggests that women receiving a vaccine against SARS-CoV-2 is harmful to
either the …………………… or the breastfed infant
5. ………………. is a sign that someone should not continue with a particular medicine or
treatment because it is or might be harmful.
6. ………………. are usually referred to as an over-reaction of the immune system and these
reactions may be damaging and uncomfortable.
7. …………………… is a medical condition that already exists when one is purchasing a
health insurance policy.
8. For young children, the best safety …………… is to cross the road under adult
supervision.
9. …………………., also known as side effects, are unwanted undesirable effects that are
possibly related to a drug.

KEY AND MEANING

1. Clinical (adj): thuộc về lâm sàng

2. Contraindication (n): Chống chỉ định
3. Pre-existing disease: Bệnh nền (Bệnh đã tồn tại từ trước)
4. Allergic reactions: Phản ứng dị ứng thuốc
5. Hypersensitivity (n): Mẫn cảm với thuốc
6. Hazard (n): Rủi ro, nguy hiểm
7. Precaution (n): Phòng tránh
8. Nursing mothers: Mẹ cho con bú
9. Adverse reactions: Phản ứng phụ không mong muốn (có hại)