promoting additional research on prescription drug abuse.

Câu 17. Different pharmaceutical dosage forms are created to helps

patients take their medication in the most effective way possible.
Câu 18. Smallpox is universal considered one of the most dreadful
scourges of humanity.
Câu 19. It is important that you pay attention for these warnings,
therefore, you will recognize any symptoms that could suggest a serious problem.
Câu 20. Although most people take prescription medications responsible,
an estimated 52 million people have used prescription drugs for nonmedical
reasons, at least, once in their lifetimes.

PART 4: GAP FILLING

PARAGRAPH 1: You can buy some drugs “over the counter” (OTC) (1) are usually intended
to relieve symptoms or to treat minor illness. For maximum benefit and (2) in the use of these
drugs, you should follow the directions on the label while other drugs may be obtained only with a
physician’s prescription. (3) these drugs usually are for treatment of specific diseases and
generally are more powerful than OTC medicines, they should be taken only on the advice and (4)
the supervision of a doctor. Along with the benefits, they have a potential for harm or undesirable
(5) can occur.
1. A. who B. whom C. whose D. which
2. A. safe B. unsafe C. safety D. unsafety
3. A. But B. Because C. Or D. And
4. A. on B. in C. above D. under
5. A. site effects B. site affects C. side affects D. side effects

PARAGRAPH 2: A competent (1) should have a working knowledge and (2) of the
physical and chemical characteristics of drugs and drugs (3) of the physical-chemical
principles and processes (4) in drug product formulation and the composition of dosage
forms, of the (5) characteristics (physical, chemical, and microbiologic) and (6)
requirements of drugs and drug products, of the factors (7) may influence the physiologic
availability and (8) activity of the drugs from their (9) forms, and of the factors
underlying the chemical equivalency and bioequivalency evaluation of (10) drug products.
Câu 1.A. pharmacy B. pharmacist C. pharmaceutics D. pharmacity
Câu 2. A. understand B. understood C. understands D. understanding
Câu 3. A. stable B. unstable C. stability D. unstability
Câu 4. A. involve B. involves C. involved D. involving
Câu 5. A. product’s B. a product’s C. products D. products’
Câu 6. A. store B. storage C. storing D. storaging

7
Câu 7. A. who B. whom C. whose D. that
Câu 8. A. biology B. biologist C. biologic D. biologics
Câu 9. A. dose B. doses C. megadose D. dosage
Câu 10. A. mono-source [Link]-source [Link]-source D. multisource

PARAGRAPH 3: The information in a package insert is written in ______ (1) language. It is usually
very long and can be _____ (2) to understand. It is a good idea to look through it, because it ______ (3)
important information about the drug. The package insert ______ (4) a standard format for every drug.
After some identifying information, such as the drug's brand name, generic name, and year when the
drug was first _____ (5) by the FDA, most to all of the following sections appear: Highlights of
Prescribing Information: This first section is a _____ (6) summary of the information that is most
important for readers to know. Dosage Forms and ________ (7): This section describes the drug's color
and form (e.g., capsule, ointment). It also lists amount of medication in that form. Drug Interactions: This
section lists the effects that this medicine may have on other prescription or ______ (8) medicines you
may be taking. Warnings and Precautions: This section discusses ______ (9) side effects that may occur
in people who take this medicine. It does not mean that every side effect will happen to you. It is
important that you pay attention to these warnings, therefore, you will _______ (10) any symptoms that
could suggest a serious problem.
Câu 1. A. local B. technical C. colloquial D. informal
Câu 2. A. difficult B. easy C. comfortable D. nice
Câu 3. A. suggest B. shown C. marks D. lists
Câu 4. A. follows B. recommends C. approves D. suggests
Câu 5. A. considered B. approved C. investigated D. decided
Câu 6. A. long B. short C. brief D. detailed
Câu 7. A. strengths B. methods C. intervals D. limits
Câu 8. A. recommended B. OTC C. supplements D. potential
Câu 9. A. seriousness B. wanted C. allergic D. severe
Câu 10. A. realise B. identify C. misunderstand [Link]

PARAGRAPH 4: A pharmacist as a healthcare professional (1) specializes in the

preparation, dispensing, and management of medications and provides pharmaceutical advice and
guidance. Pharmacists often serve (2) primary care providers in the community and may offer
other services listed as health screenings and immunizations. Pharmacists undergo (3) or
graduate-level education to understand the biochemical mechanisms and actions of drugs, drug uses,
therapeutic roles, side (4) , potential drug interactions, and monitoring parameters. This is mated
to anatomy, physiology, and pathophysiology. Pharmacists interpret and communicate this specialized
knowledge to patients, physicians, and (5) health care providers. The (6)
common pharmacist positions are that of a community pharmacist or a hospital pharmacist, (7)
8
they instruct and counsel on the proper use and adverse effects of medically prescribed drugs and
medicines. (8) most countries, the profession is subject to professional regulation.
Depending (9) the legal scope of practice, pharmacists may practice in a (10)
of other settings, including industry, wholesaling, research, academia, formulary management, military,
and government.

Câu 1. A. who B. whom C. which D. why

Câu 2. A. to B. as C. like D. alike

Câu 3. A. highschool B. college C. university D. graduate

Câu 4. A. affect B. effect C. effective D. affecting

Câu 5. A. one B. another C. other D. others

Câu 6. A. many B. much C. more D. most

Câu 7. A. that B. which C. where D. when
Câu 8. A. In B. On C. At D. To
Câu 9. A. In B. On C. At D. To
Câu 10. A. vary B. various C. variety D. varied

PARAGRAPH 5: (1) the authority of the federal food, drug and cosmetic act and (2)
laws, FDA (3) that new drugs (4) by pharmaceutical companies are safe
and effective and supported (5) rigorous scientific research. This typically (6)
pharmaceutical companies to conduct extensive pre-clinical and clinical testing spanning 12 to 15 years
and costing $800 million for (7) new drug. The FDA-approved drug label distills this mountain
of (8) into a clear set of (9) that permits physicians (10) the drug product
safely & effectively.
Câu 1. A. Under B. On C. Due D. Regard
Câu 2. A. others B. other C. the other D. the others
Câu 3. A. ensure B. to ensure C. ensuring D. ensures
Câu 4. A. develop B. developed C. developing D. develops
Câu 5. A. from B. by C. over D. in
Câu 6. A. requires B. has required C. require D. requiring
Câu 7. A. all B. several C. each D. any
Câu 8. A. data B. datum C. datas D. datums
Câu 9. A. guide B. instruction C. assistance D. A/B/C
Câu 10. A. to use B. use C. using D. uses

9
PARAGRAPH 6: A (1) drug (medicine or medication and officially medicinal product) is a
drug used in health care. (2) drugs aid the diagnosis, cure, treatment, or prevention of
disease. Drug therapy or (3) is an important part of the medical field and depends (4)
the science of pharmacology for continual advancement and pharmacy for appropriate management.
Medications (5) classified in various ways. One of the key divisions is by level of control, which
distinguishes prescription or (6) drugs (those that a pharmacist dispenses only on the order of a
physician, physician assistant, or qualified nurse) from (7) drugs (those that consumers can
order for themselves). (8) key distinction is between traditional (9) molecule drugs,
usually derived from chemical synthesis as well as biopharmaceuticals, (10) include
recombinant proteins, vaccines, blood products used therapeutically (IVIG), gene therapy, and cell
therapy (stem cell therapies).
CÂU 1. A. pharmaceutical B. pharmacy C. pharmacist D. pharmacology
CÂU 2. A. This B. That C. These D. Those
CÂU 3. A. pharmacy B. pharmacotherapy
C. pharmacology D. pharmaceutial
CÂU 4. A. in B. at C. on D. with
CÂU 5. A. be B. am C. is D. are
CÂU 6. A. OTC B. BTC C. IVIG D. POM
CÂU 7. A. OTC B. BTC C. IVIG D. POM
CÂU 8. A. One B. Another C. More D. Other
CÂU 9. A. massive B. huge C. small D. big
CÂU 10. A. who B. whom C. that D. which

PARAGRAPH 7: Some drugs are used more (1) off-label than for their original, (2)
indications. A 1991 study by the U.S. General Accounting Office found that (3) of all drug
administrations to cancer patients were off label, and more than half of cancer patients received, at least,
one drug for an (4) indication. A 1997 survey of 200 cancer (5) by the American
Enterprise Institute and the American Cancer Society found that 60% of (6) prescribed drugs off-label.
In some cases, patients may perceive the (7) of treatments for off-label purposes to be
higher than for their indicated purpose. Frequently, the standard of care for a particular type or stage of
(8) involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants
(9) neuropathic pain. This old class of antidepressants is now rarely used for clinical depression due
to (10) , but the tricyclics are often effective for treating pain.
CÂU 1. A. frequent B. frequently C. frequency D. unfrequently
CÂU 2. A. FDA-approved B. FDA-approving C. FDA-approve D. FDA-approves
CÂU 3. A. one-thirds B. one-three C. one-third D. one-threes
CÂU 4. A. off-label B. on-label C. off-labeling D. on-labeling
CÂU 5. A. pharmacists B. nurses C. experts D. doctors
CÂU 6. A. they B. them C. their D. theirs
CÂU 7. A. effect B. effectiveness C. efficacy D. affect
10
CÂU 8. A. condition B. health C. disease D. cancer
CÂU 9. A. to treat B. treat C. treating D. treated
CÂU 10. A. site effects B. side effects C. site affects D. site affects

PART 5: TRUE - FALSE - NOT GIVEN

IDENTIFY WHETHER EACH STATEMENT IS
TRUE if the statement agrees with the text
FALSE if the statement contradicts the text
NOT GIVEN if no information is given in the text

PARAGRAPH 1: The determination of a drug’s efficacy and safety for human use is fraught with
difficulties which are not apparent until one delves deeply into the subject. If toxicity is found in animal
tests, does this mean that the drug will be unsafe in humans? Is there a dose below which a drug may be
administered safely to humans if not given over an extended period of time? What is this dose, and what
is the time limit that allows a satisfactory margin of safety while ensuring the drug’s effectiveness? Life-
saving drugs are denied the patient as a result of overzealous concern about animal tests which uncover
toxicity under conditions not relevant to projected human use. Without a variety of prior animal tests,
human lives might be unprotected against the marketing of teratogenic, mutagenic, and other dangerous
agents.
1. The determination of a drug’s efficacy and safety for human use is a difficulty because these isues
are not apparent until one delves deeply into the subject.
2. If toxicity is found in animal tests, this means that the drug will be unsafe in humans.
3. It is hard to allows a satisfactory margin of safety while ensuring the drug’s effectiveness.
4. Animal tests are to uncover toxicity under conditions not relevant to projected human use.
5. The good news is that human lives might be unprotected against the marketing of teratogenic,
mutagenic, and other dangerous agents.

PARAGRAPH 2: The non-medical use and abuse of prescription drugs is a serious public health
problem in this country. Although most people take prescription medications responsibly, an estimated
52 million people have used prescription drugs for nonmedical reasons, at least, once in their lifetimes.
Young people are strongly represented in this group. The National Institute on Drug Abuse's (NIDA)
Monitoring the Future (MTF) survey found that about 1 in 12 high school seniors reported past-year
nonmedical use of the prescription pain reliever Vicodin in 2010. What is more, 1 in 20 reported abusing
OxyContin, making these medications among the most commonly abused drugs by adolescents. The
abuse of certain prescription drugs - opioids, central nervous system (CNS) depressants, and stimulants
- can lead to a variety of adverse health effects, including addiction. The number of prescriptions for

11
some of these medications has increased dramatically since the early 1990s. Moreover, a consumer
culture amenable to “taking a pill for what ails you” and the perception of prescription drugs as less
harmful than illicit drugs are other likely contributors to the problem. It is an urgent one: unintentional
overdose deaths involving opioid pain relievers have quadrupled since 1999, and by 2007, outnumbered
those involving heroin and cocaine. NIDA hopes to change this situation by increasing awareness and
promoting additional research on prescription drug abuse. Prescription drug abuse is not a new problem,
but one that deserves renewed attention. It is imperative that as a nation we make ourselves aware of the
consequences associated with abuse of these medications.
Câu 1. The non-medical use and abuse of prescription drugs is a threatening public health problem in
any country.
Câu 2. An estimated 52 million people have used prescription drugs for non-medical reasons, at least,
twice in their lifetime.
Câu 3. The National Institute on Drug Abuse’s (NIDA) Monitoring the Future (MTF) survey found that
approximately 83% of high school seniors reported past-year nonmedical use of the prescription pain
reliever Vicodin in 2010.
Câu 4. Only 5% of those survey participants reported abusing OxyContin, making these medications
among the most commonly abused drugs by adults.
Câu 5. A variety of adverse health effects, including addiction are led by the abuse of certain prescription
drugs (opioids, CNS depressants, and stimulants).
Câu 6. The number of prescriptions for some of these non-medical use and abuse of prescription
medications has doubled dramatically since the early 1990s.
Câu 7. A consumer culture amenable to “taking a pill for what ails you” and the perception of prescription
drugs as more harmless than illicit drugs are other likely contributors to the problem.
Câu 8. The fact that accidental overdose deaths involving opioid pain relievers have quadrupled since
1999 is an urgent issue.
Câu 9. NIDA dettermines to to change this situation by any possible ways.
Câu 10. It is imperative that a nation make citizens aware of the consequences associated with abuse of
these medications.

PARAGRAPH 3: Different pharmaceutical dosage forms are created to help patients take their
medication in the most effective way possible. Depending on the patient’s needs, their doctor will
prescribe a specific dosage form of medication. It is estimated that there are over 10,000 different types
of pharmaceutical dosage forms. The most common dosage forms include tablets, capsules, liquids,
powders, and gels. Each form has its own advantages and disadvantages: Tablets are the most common
type of pharmaceutical dosage form. They are easy to take and can be taken with or without food. Tablets
can be crushed or dissolved in water for patients who have difficulty swallowing them whole. Capsules
are another common type of dosage form. They are typically made of two halves that fit together and
contain a powder or liquid medication. Capsules can be taken with or without food and are usually

12
swallowed whole. Liquids are often used for children or adults who have trouble swallowing pills. They
can be taken with or without food and come in various flavors to make them more palatable. Powders
can be mixed with water or other liquids to create a drinkable solution. They are typically used for
patients who cannot swallow pills or capsules. Gels are thick, sticky solutions that come in tubes or
packets. They can be applied directly to the skin or mucous membranes and are typically used for local
treatments listed as mouth sores or vaginal infections.

Câu 1. If patients can take their medication in the most effective way possible, different pharmaceutical
dosage forms are created.
Câu 2. Ointments are spreadable and greasy preparations.
Câu 3. All these 10,000 different types of pharmaceutical dosage forms are being on the market despite
the fact that each form has its own advantages and disadvantages.
Câu 4. Tablets, the most common type of pharmaceutical dosage form, are not dificult to take.
Câu 5. Tablets can be taken with any kind of liquid.
Câu 6. Tablets can be crushed or dissolved in water for patients who have difficulty swallowing whole.
CÂU 7. Gels are typically made of two halves that fit together and contain a powder or liquid medication.
CÂU 8. Liquids are more preferrable to children compared to adults who have trouble swallowing pills
as various flavors make them more palatable.
CÂU 9. Lotions can be applied directly to the skin or mucous membranes.
CÂU 10. Gels that should be applied directly to the skin or mucous membranes are typically used for
local treatments listed as mouth sores or vaginal infections.

PARAGRAPH 4: Pharmacovigilance is the science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other medicine-related problem. The European
Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and
operates services and processes to support pharmacovigilance in the EU. Before a medicine is authorised
for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are
selected carefully and followed up very closely under controlled conditions. This means that at the time
of a medicine’s authorisation, it has been tested in a relatively small number of selected patients for a
limited length of time. After authorisation, the medicine may be used in a large number of patients, for a
long period of time and with other medicines. Certain side effects may emerge in such circumstances. It
is, therefore, essential that the safety of all medicines is monitored throughout their use in healthcare
practice. EU law, therefore, requires each marketing authorisation holder, national competent
authority and EMA to operate a pharmacovigilance system.
Câu 1. Pharmacovigilance is the science relating to the detection, assessment, understanding and
prevention of any other medicine-related problem.
Câu 2. There is one connection between EMA and EU in terms of services and processes to
support pharmacovigilance in the world.
Câu 3. Clinical trials means the place where patients are selected carefully and followed up very
closely under controlled conditions.
13
Câu 4. Evidence of its safety and efficacy is limited to the results from clinical trials after a
medicine is authorised for use.
Câu 5. After authorisation, the medicine may be used in a limited small number of patients for a
long period of time and with other medicines.
Câu 6. Any side effects is definitely to emerge in such circumstances.
Câu 7. It is, therefore, crucial that the safety of all medicines is monitored throughout their use in
healthcare practice.
Câu 8. EU law requires each marketing authorisation holder and national competent authority.
Câu 9. Vietnam has opened one legislation procedure regarding Pharmacovigilance.
Câu 10. Authorization is different in various nations.

PARAGRAPH 5: The professions, concerned with health care, work together as a team. No where is
this more evident than in the hospital services. A person taking up such career can be assured of a
challenging but interesting job, one that changes rapidly in response to development in the health care
field. The pharmacist must be able to integrate well with co-workers, for example, doctors, nurses or
radiologists. The pharmacist is primarily responsible for supplying medicines as efficiently and
economically as possible, for their secure and proper storage and for their distribution throughout the
hospitals. Quality, safety and use of medicines must be closely monitored by the pharmacist. Hospital
pharmacist is the center of drug information. The pharmacist is expected to lecture nurses and medical
students on the actions of drugs, dose rates, side effects and related problems. They act on the drug
therapeutic committees where overall policy is determined in relation to drug usage, new products,
clinical trials, infection control and the hospital formulary.

Câu 1. Hospital pharmacist is the focus of this text.

Câu 2. The therapeutic committees decide the hospital pharmacists’ activities towards drugs usage.
Câu 3. Drugs’ working mechanism is untaught to the medical students at hospitals.
Câu 4. Drug distribution is the one important duty of a hospital pharmacist.
Câu 5. Hospital pharmacists play multi-roles at the same time.
Câu 6. Information related to medications (the actions of drugs, dose rates, side effects and related
problems) can be found in the hospital pharmacist.
Câu 7. The more medical staff (doctors, nurses, pharmacists, radiologists) integrate with each other, the
better the results are.
Câu 8. Healthcare field must change rapidly at the speed of general development.
Câu 9. Hospital pharmacists are considered as health care experts working in a hospital.
Câu 10. Any staff in any occupation must work together as a team.

14
PARAGRAPH 6: The role of insulin in the body is to allow glucose in the blood to enter cells, providing
them with the energy to function. A lack of effective insulin plays a key role in the development of
diabetes. Insulin assists in breaking down fats or proteins for energy. Insulin is a chemical messenger that
allows cells to absorb glucose, a sugar, from the blood. The pancreas is an organ behind the stomach that
is the main source of insulin in the body. The higher the level of glucose is, the more insulin goes into
production to balance sugar levels in the blood. A delicate balance of insulin regulates blood sugar and
many processes in the body. If insulin levels are too low or high, excessively high or low blood sugar
can start to cause symptoms. If a state of low or high blood sugar continues, serious health problems
might start to develop.
CÂU 1. This reading is mainly regarding insulin and its role.
CÂU 2. 3 main roles of insulin are: to allow glucose in the blood to enter cells, breaking down fats or
proteins for energy as well as being a chemical messenger that allows cells to absorb glucose from the
blood.
CÂU 3. Cells need energy to function from fats and protein that are broken down by insulin.
CÂU 4. Glucose, a sugar, is found in the blood.
CÂU 5. The information regarding the location and the function of the pancreas is found in the reading.
CÂU 6. The level of glucose has no role towards the balance sugar levels in the blood.
CÂU 7. It is the delicate balance of insulin that regulates blood sugar and other processes in the body.
CÂU 8. Disorder can take place in case of the excessively high or low blood sugar.
CÂU 9. Serious health problems definitely develop once this state of low or high blood sugar continues.
CÂU 10. Any insulin found in the body is effective.

PARAGRAPH 7: Different pharmaceutical dosage forms are created to help patients take their
medication in the most effective way possible. Depending on the patient’s needs, their doctor will
prescribe a specific dosage form of medication. It is estimated that there are over 10,000 different types
of pharmaceutical dosage forms. The most common dosage forms include tablets, capsules, liquids,
powders, and gels. Each form has its own advantages and disadvantages: Tablets are the most common
type of pharmaceutical dosage form. They are easy to take and can be taken with or without food. Tablets
can be crushed or dissolved in water for patients who have difficulty swallowing them whole. Capsules
are another common type of dosage form. They are typically made of two halves that fit together and
contain a powder or liquid medication. Capsules can be taken with or without food and are usually
swallowed whole. Liquids are often used for children or adults who have trouble swallowing pills. They
can be taken with or without food and come in various flavors to make them more palatable. Powders
can be mixed with water or other liquids to create a drinkable solution. They are typically used for
patients who cannot swallow pills or capsules. Gels are thick, sticky solutions that come in tubes or
15
packets. They can be applied directly to the skin or mucous membranes and are typically used for local
treatments listed as mouth sores or vaginal infections.

CÂU 1. 05 most common dosage forms (tablets, capsules, liquids, powders, and gels) are listed in the
text.
CÂU 2. If patients can take their medication in the most effective way possible, different pharmaceutical
dosage forms are created.
CÂU 3. Over 10,000 different types of pharmaceutical dosage forms are estimated to be available.
CÂU 4. All these 10,000 different types of pharmaceutical dosage forms are being on the market despite
the fact that each form has its own advantages and disadvantages.
CÂU 5. Tablets, the most common type of pharmaceutical dosage form, are not dificult to take.
CÂU 6. Tablets can be taken with any kind of liquid .
CÂU 7. Tablets can be crushed or dissolved in water for patients who have difficulty swallowing whole.
CÂU 8. Gels are typically made of two halves that fit together and contain a powder or liquid medication.
CÂU 9. Liquids are more preferrable to children compared to adults who have trouble swallowing pills
as various flavors make them more palatable.
CÂU 10. Powders, as a drinkable solution, are typically used for patients who cannot swallow pills or
capsules.
CÂU 11. Gels, as thick and sticky solutions, are stored in tubes or packets.
CÂU 12. Lotions can be applied directly to the skin or mucous membranes.
CÂU 13. Gels are typically used for local treatments, listed as mouth sores or vaginal infections.
CÂU 14. Ointments are spreadable and greasy preparations.
CÂU 15. Gels that should be applied directly to the skin or mucous membranes are typically used for
local treatments listed as mouth sores or vaginal infections.

HIU – FURTHER PARAGRAPHS

16
1. According to the World Health Organization (WHO), almost three hundred million people last year
abused drugs with psychoactive effects. Of those people, about 10% of them reported to have developed
a substance use disorder. This statistic alone shows how much of an issue that drug abuse and misuse
have on societies globally. Substances of abuse are classified into several different types based on their
effects on users. Based on their effects on users, drugs can be classified into about seven different types.
Inhalants are types of addictive drugs administered via the body's respiratory system. This means they are
inhaled through the mouth or "snuffed" through the nose. In this class of drugs, the inhalants have the
fastest onset of action. Once introduced into the body, they immediately gain access to the bloodstream.
This "fast action" is one of the major reasons why inhalants are so commonly abused.
2. Applying medication to the skin or mucous membranes allows it to enter the body from there. Medication
applied in this way is known as topical medication. It can also be used to treat pain or other problems in
specific parts of the body. Topical medication can also be used to nourish the skin and protect it from
harm. Some topical medications are used for local treatment, and some are meant to affect the whole body
after being absorbed through the skin. Ointments: They are mixtures of various fats that can be easily
spread. They are made of fat, oil or wax or a combination of these. Common examples are fatty antiseptic
ointments and healing ointments. Oils are made of fat that is liquid at room temperature. They are used as
additives for oil baths, as massage oils, or as essential oils such as peppermint oil. Creams are mixtures of
fat and water that can be easily spread. Because fat and water normally won't readily mix, an emulsifying
agent is added to combine these two ingredients and keep them stable.
3. The Package Insert – PI: The 1966 Fair Packaging and Labeling Act requires all consumer products in
interstate commerce to be honestly and informatively labeled, with the FDA enforcing these provisions
on foods, drugs, cosmetics, and medical devices. When the format of the PI was amended in 2006, it was
the first such change since 1979, when a standard format was first promulgated by the FDA. The primary
reason for the 2006 amendment was the increase in the amount and complexity of information included
in the PI, which made it difficult to use effectively. The modifications to the PI format were made through
FDA research and after consultation with healthcare professionals. The information included in the PI
must be supported by substantial evidence. Such data and their supporting evidence are provided to the
FDA by the manufacturer as part of the New Drug Application (NDA) and may be included in the PI only
after they are reviewed and approved by the FDA. The current PI format contains two main components:
the highlights of prescribing information (HPI) and the full prescribing information (FPI). The purpose of
the HPI is to “provide immediate access to the information to which practitioners most commonly refer
and regard as most important,” according to the FDA.
4. Medicines for oral administration are often complex and carefully designed to effectively treat a
patient’s condition. Tablets are the most commonly prescribed format of medication as most patients find
them convenient. Tablets are also cost effective to produce. Patients are commonly still prescribed
medicine in the form of tablets and capsules, despite difficulties swallowing these types of medications
being common. A common response to not being able to swallow tablets is to crush them or open capsules.
The FDA advise that you shouldn't chew, crush and break tablets, or open and empty powder out of
capsules, unless your doctor or another healthcare professional has told you to do so. Some tablets and
capsules don’t work properly or can become harmful when crushed or opened. Liquid medicines can be
the most appropriate alternative to tablets or capsules for patients who have difficulty swallowing. A liquid
medication is designed to be both acceptable to the patient and palatable. A liquid medicine can come in
many forms which includes solutions, suspensions and syrups.

17
5. An antibiotic is a selective poison. It has been chosen so that it will kill the desired bacteria, but not the
cells in your body. Each antibiotic is effective only against certain bacteria. For some infections, doctors
know that only certain types of bacteria may be responsible. If there is one antibiotic that is predictably
effective against all of these bacteria, testing is not needed. On the contrary for specific infections that
may be caused by many different types of bacteria or by bacteria whose susceptibility to antibiotics is not
predictable, a laboratory test will be needed to identify the infecting bacterium from samples of blood,
urine or tissue taken from the body. However, antibiotics that are effective in the laboratory do not
necessarily work in an infected person. The effectiveness of the treatment depends on how well the drug
is absorbed into the bloodstream, how much of the drug reaches the sites of infection in the body, and how
quickly the body eliminates the drug. In selecting which antibiotic to use, a doctor also considers the
nature and seriousness of the infection, the drug’s possible side effects, the possibility of allergies or other
serious reactions to the drug and the cost of the drug. Combinations of antibiotics are sometimes needed
to treat severe infections, particularly in the first days when the bacterium’s sensitivity to antibiotics is not
known. Combinations are also important for certain infections in which the bacterium rapidly develops
resistance to a single antibiotic.
6. A pharmaceutical drug is a drug used in health care. Such drugs aid the diagnosis, cure, treatment, or
prevention of disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies
on the science of pharmacology for continual advancement and on pharmacy for appropriate management.
Medications are classified in various ways. One of the key divisions is by level of control, which
distinguishes prescription or POM drugs (those that a pharmacist dispenses only on the order of a
physician, physician assistant, or qualified nurse) from over-the-counter drugs (those that consumers can
order for themselves). Another key distinction is between traditional small molecule drugs, usually derived
from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood
products used therapeutically (listed as IVIG), gene therapy, and cell therapy (stem cell therapies).
7. Drug Forms: Different pharmaceutical dosage forms are created to help patients take their medication in
the most effective way possible. Depending on the patient’s needs, their doctor will prescribe a specific
dosage form of medication. It is estimated that there are over 10,000 different types of pharmaceutical
dosage forms. The most common dosage forms include tablets, capsules, liquids, powders, and gels. Each
form has its own advantages and disadvantages. Tablets are the most common type of pharmaceutical
dosage form. They are easy to take and can be taken with or without food. Tablets can be crushed or
dissolved in water for patients who have difficulty swallowing them whole. Capsules are another common
type of dosage form. They are typically made of two halves that fit together and contain a powder or liquid
medication. Capsules can be taken with or without food and are usually swallowed whole. Liquids are
often used for children or adults who have trouble swallowing pills. They can be taken with or without
food and come in various flavors to make them more palatable. Powders can be mixed with water or other
liquids to create a drinkable solution. They are typically used for patients who cannot swallow pills or
capsules. Gels are thick, sticky solutions that come in tubes or packets. They can be applied directly to the
skin or mucous membranes and are typically used for local treatments listed as mouth sores or vaginal
infections.
8. The role of insulin in the body is to allow glucose in the blood to enter cells, providing them with the
energy to function. A lack of effective insulin plays a key role in the development of diabetes. Insulin also
assists in breaking down fats or proteins for energy. Insulin is a chemical messenger that allows cells to
absorb glucose, a sugar, from the blood. The pancreas is an organ behind the stomach that is the main

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 source of insulin in the body. The higher the level of glucose, the more insulin goes into production to
balance sugar levels in the blood. A delicate balance of insulin regulates blood sugar and many processes
in the body. If insulin levels are too low or high, excessively high or low blood sugar can start to cause
symptoms. If a state of low or high blood sugar continues, serious health problems might start to develop.
9. The information in a package insert is written in technical language which is usually very long and
can be difficult to understand. The package insert which lists important information regarding the drug
follows a standard format for every drug. Highlights of Prescribing Information: This first section is a
brief summary of the information that is most important for readers to know. Dosage Forms and Strength:
This section describes the drug’s color and form (e.g., capsule, ointment). It also lists amount of
medication in that form. Drug Interactions: This section lists the effects that this medicine may have on
other prescription or OTC medicines you may be taking. Warnings and Precautions: This section discusses
severe side effects that may occur in people who take this medicine. It does not mean that every side effect
will happen to you. It is important that you pay attention to these warnings, therefore, you will recognize
any symptoms that could suggest a serious problem.

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