Factors Affecting Efficacy

Which of the following statements about the World Health Organization's (WHO) definition of a medicine's side effects is correct?

1. It is defined as 'a beneficial and unintended response to a medicine, occurring at doses normally used in humans,' and does not include noxious responses among side effects.
2. It is defined as 'a noxious and unintended response to a medicine, occurring at doses normally used in humans for the prophylaxis, diagnosis, or treatment of disease, or for the modification of physiological function.'
3. It is defined as 'any response to a medicine, occurring regardless of the dose used, for the prophylaxis, diagnosis, or treatment of disease,' and includes non-noxious responses as well.
4. It is defined as 'a noxious response to a medicine, occurring in humans in excess of the doses normally used, solely for treatment of disease,' and does not cover prophylaxis or diagnosis.

Which of the following statements about the side effects of medicines is incorrect?

1. Under the WHO definition, a medicine's side effects are limited to responses that appear when it is used in excess of the doses normally used in humans.
2. Because not all the actions medicines exert on the human body have been elucidated, side effects can occur even when a medicine is used with sufficient care and appropriately.
3. From the standpoint of their cause, side effects of medicines can be broadly divided into those due to pharmacological action and those due to allergy (hypersensitivity).
4. Side effects range widely, from relatively common ones such as drowsiness or dry mouth, to serious ones causing health damage severe enough to disrupt daily life.

Which of the following statements about pharmacological action and side effects is correct?

1. The influence that a drug, the active ingredient of a medicine, exerts on the body's physiological functions is called pharmacological action, and among responses other than the expected beneficial response (the main action), an undesirable one is generally called a side effect.
2. Any response other than the main action is treated as a side effect in every case, provided it affects the body's physiological functions, even if it causes no particular inconvenience.
3. For a person with multiple diseases, a medicine used for one disease shows only its main action against that disease, and never worsens the symptoms of, or interferes with treatment for, another disease.
4. Because a drug normally has only a single pharmacological action, using a medicine never produces any response other than the expected beneficial response (the main action).

Which of the following statements about allergy (hypersensitivity) is incorrect?

1. Even a person who has never had an allergic reaction to a medicine before can unexpectedly develop an allergy under conditions such as reduced resistance to illness.
2. Allergy is caused by oral medicines, and is never caused by topical medicines.
3. Allergy can occur regardless of a medicine's pharmacological action and the like.
4. The inflammation and other reactions that allergy produces in various parts of the body are called allergic symptoms, and conjunctivitis symptoms, rhinitis symptoms, and skin symptoms such as hives or eczema, among others, commonly occur.

Which of the following is listed in the Guide as an additive in medicines that can serve as a causative substance (allergen) of allergy?

1. Vitamin A
2. Yellow No. 4 (tartrazine)
3. Caffeine
4. Acetaminophen

Which of the following statements about allergy and constitution and the like is correct?

1. Some medicines are made using ingredients such as hen's eggs or cow's milk, so a person allergic to these may sometimes need to avoid using them.
2. Because allergy has no constitutional or hereditary component, there is no need for caution even if a close relative has an allergic constitution.
3. Even a person who has had an allergic reaction to a medicine may use the medicine that caused it again without any problem.
4. While a medicine's active ingredients can serve as allergens, an additive without pharmacological action can never become an allergen.

Which of the following statements about the improper use of medicines is incorrect?

1. Continuing indefinitely to merely relieve symptoms temporarily with an OTC drug, without the underlying disease being properly treated or lifestyle improvements made, readily leads to a lost opportunity for appropriate treatment.
2. Even a medicine that should be avoided for use in children can be used safely on a child if an adult dose is simply halved.
3. Improper use of medicines can be broadly divided into that stemming from the user's misunderstanding or insufficient awareness, and that where a medicine is used for a purpose other than its intended one.
4. Thinking casually that 'taking more will work faster', and taking a dose exceeding the prescribed amount, carries a high risk of leading to side effects.

Which of the following statements about the long-term continued use of OTC drugs is correct?

1. Laxatives, general cold remedies, and analgesic/antipyretics carry no risk of harming organs such as the liver or kidneys even with long-term continued use.
2. Suppressing symptoms through long-term continued use never delays the discovery of a serious underlying disease.
3. As long as the amount used is as directed, psychological dependence never occurs even when the medicine is continuously used almost every day over a long period.
4. Cases have been seen where long-term continued use leads to psychological dependence, with the amount used increasing and the economic burden of purchasing it also growing larger.

Which of the following statements about drug dependence is correct?

1. As long as it is used appropriately, a safe and effective medicine never produces drug dependence, and is not subject to abuse, even if taken continuously or periodically to experience its psychological effect.
2. Once drug dependence has formed, withdrawing from it is easy simply by stopping intake of the drug.
3. Drug dependence refers only to a physical state characterized by behavior and the like that is always accompanied by a compulsion (craving) to take a certain drug continuously or periodically, and does not include a psychological state.
4. Drug dependence refers to a psychological and physical state characterized by behavior and the like that is always accompanied by a compulsion (craving) to take a certain drug continuously or periodically in order to experience its psychological effect.

Which of the following statements about the abuse of medicines and the like is incorrect?

1. Abuse, such as intentionally taking a dose exceeding the prescribed amount or carelessly taking it together with other medicines or alcoholic beverages, raises the risk of acute poisoning from overdose.
2. Because no OTC drug contains an ingredient with habit-forming or dependence-forming properties, there is no need to consider the risk of abuse.
3. Adolescents do not necessarily have sufficient awareness or understanding of the danger of drug abuse, and may abuse out of curiosity a drug that is readily available nearby.
4. A suspicious person attempting to buy an unnecessarily large amount or to purchase frequently should be dealt with cautiously, and it is desirable to actively ask about the circumstances or, depending on the situation, to refrain from selling.

Which of the following statements about the interaction of medicines is correct?

1. Interaction occurs only when multiple medicines are used together, and never occurs between a medicine and food, including foods with health claims (Foods for Specified Health Uses, Foods with Nutrient Function Claims, and Foods with Function Claims) or so-called health foods.
2. When a medicine's action is weakened due to interaction, because there is no concern about a side effect appearing, no inconvenience such as failing to obtain sufficient effect arises, and no particular attention need be paid.
3. Interaction refers to a medicine's action being strengthened or weakened when multiple medicines are used together, or when it is taken together with a particular food, including foods with health claims or so-called health foods.
4. Interaction refers only to cases where a medicine's action is strengthened when multiple medicines are used together, and does not include cases where it is weakened.

Which of the following statements about the interaction of medicines is incorrect?

1. To avoid interaction, it is ordinarily necessary to refrain, throughout the period a medicine is being used and before and after it, from taking other medicines or food that could interact with it.
2. Some interactions occur during the process by which a medicine is absorbed, distributed, metabolized, or excreted.
3. Some interactions occur at the site where a medicine produces its pharmacological action.
4. Metabolism refers to a medicine's ingredients being excreted out of the body.

Which of the following statements about combining medicines is correct?

1. Whether a medicine dispensed by a medical institution or pharmacy may be combined with an OTC drug is something the registered seller who sold the OTC drug should judge on their own.
2. When the symptom one wishes to relieve is clear, it is preferable to choose a medicine containing as many ingredients as possible, rather than one containing only the ingredient suited to that symptom.
3. Because an OTC drug consists of only a single active ingredient, combining a cold remedy, analgesic/antipyretic, antitussive/expectorant, or antiallergic drug with another medicine never causes ingredients or actions to overlap.
4. In classes such as cold remedies, analgesic/antipyretics, sedatives, antitussive/expectorants, and antiallergic drugs, ingredients and actions often overlap, so combining medicines within these classes is ordinarily to be avoided.

Which of the following statements about the interaction between alcoholic beverages (alcohol) and medicines is correct?

1. People who habitually drink alcoholic beverages (alcohol) often have heightened liver metabolic function, and for a medicine such as acetaminophen that is metabolized in the liver, it tends to be metabolized more readily than usual, so it may be cleared from the body faster and sufficient medicinal effect may not be obtained.
2. Because alcohol is mainly metabolized in the kidneys, people who habitually drink alcoholic beverages often have heightened kidney metabolic function.
3. Alcohol can affect a medicine's absorption from the digestive tract, but because it is mainly metabolized in the kidneys, even a person who habitually drinks alcoholic beverages sees no effect on the metabolism of a medicine such as acetaminophen that is metabolized in the liver.
4. People who habitually drink alcoholic beverages (alcohol) often have reduced liver metabolic function, and for a medicine such as acetaminophen that is metabolized in the liver, it tends to be metabolized less readily than usual, making it harder to clear from the body and causing its action to appear excessively strong.

Which of the following statements about the metabolism and interaction of medicines is correct?

1. Because a medicine's metabolism is determined solely by liver function, it is never affected by the intake of food.
2. For a medicine whose substance produced by metabolism (metabolite) has medicinal effect, if liver metabolic function is heightened, that metabolite is also excreted promptly, so the medicine's action is always weakened.
3. For a medicine whose substance produced by metabolism (metabolite) has medicinal effect, its action can appear excessively strong, while for a medicine whose metabolite adversely affects the body, side effects can become more likely to appear.
4. For a medicine whose metabolite adversely affects the body, because that metabolite is processed promptly once it becomes more readily metabolized, side effects instead become less likely to appear and require no particular attention.

Which of the following statements about the combination of food and medicine intake is correct?

1. Because a substance identical to a medicine's ingredient, such as caffeine or vitamin A, is never present in food, there is no need to be concerned about what is taken with what.
2. Because a substance identical to a medicine's ingredient, such as caffeine or vitamin A, is present in food, taking a medicine containing it (e.g., a general cold remedy) together with such food (e.g., coffee) can in some cases result in excessive intake.
3. Taking a medicine containing caffeine (e.g., a general cold remedy) together with coffee never results in excessive intake of caffeine.
4. Interaction between food and medicine is mainly assumed to occur between a topical medicine applied to the skin and food, not between an orally taken medicine and food, so it is never described as a matter of 'what to take with what'.

Which of the following statements about crude drug ingredients and food is correct?

1. For a medicine containing a crude drug ingredient, only interactions between medicines need be considered, and interaction with food need not be considered.
2. As long as no medicinal efficacy is claimed or implied, some crude drug ingredients and the like can be distributed as food (such as herbs), and taking such food together with a medicine containing the crude drug ingredient can strengthen the medicine's effect or side effects.
3. Even if an herb distributed as food is taken together with a medicine containing a crude drug ingredient, it never affects the medicine's effect or side effects, since no medicinal efficacy is claimed.
4. A crude drug ingredient can never be distributed as food (such as herbs) under any circumstances, even where no medicinal efficacy is claimed or implied.

Which of the following statements about interaction and combination intake is incorrect?

1. For a person with multiple diseases, a medicine is often used for each disease individually, so particular attention is needed regarding interactions between the medicines themselves.
2. A topical medicine or injectable medicine is never affected by food in its action or metabolism.
3. From the standpoint of reducing the risk of side effects due to interaction, when the symptom one wishes to relieve is clear, it is preferable to choose, as far as possible, a medicine containing only the ingredient suited to that symptom.
4. When a patient is using a medicine dispensed by a medical institution or pharmacy, an explanation should be given urging consultation with the physician or dentist who provided the treatment, or the pharmacist who dispensed it.

Which of the following statements about the age ranges used as rough guides in the 'Points to Note on the Notation Guidelines for Prescription Drug Package Inserts, etc.' is correct?

1. A rough guide is given defining an infant as 1 year of age or older and under 3 years of age.
2. An infant is defined as 4 weeks of age or older and under 1 year of age.
3. An infant is defined as 4 weeks of age or older and under 2 years of age.
4. An infant is defined as 8 weeks of age or older and under 1 year of age.

Which of the following statements about the rough guides for age ranges in the use of medicines is incorrect?

1. A rough guide is given defining a child as 7 years of age or older and under 15 years of age.
2. A rough guide is given defining a neonate as under 4 weeks of age.
3. A rough guide defines an elderly person as 75 years of age or older.
4. A rough guide is given defining a young child as 1 year of age or older and under 7 years of age.

Which of the following statements about the age classification of children and the like is correct?

1. A neonate is defined as under 8 weeks of age, and in precautions for use of a medicine, even where the specific age is clear, it is never expressed using the specific age.
2. A young child is defined as 4 weeks of age or older and under 1 year of age, and this age classification is used distinctly from 'infant'.
3. A child is defined as 5 years of age or older and under 18 years of age, and it is an age classification for which precautions for use of a medicine may, where the specific age is clear, express it as, for example, 'a child under 5 years of age'.
4. Under 15 years of age is sometimes generally treated as 'child', and where the specific age is clear, precautions for use of a medicine may express it as, for example, 'a child under 3 years of age'.

Which of the following statements about the physiological characteristics of children when using medicines is correct?

1. Compared with adults, children have a shorter intestine relative to body size, so the absorption rate of a medicine taken is relatively lower.
2. Compared with adults, children have a longer intestine relative to body size, so the absorption rate of a medicine taken is relatively higher.
3. Because children have a lower absorption rate for medicines than adults, they need to be given a larger amount of an adult medicine.
4. Because the physiological functions that receive a medicine are sufficiently developed in children, no particular consideration is needed when using medicines on them.

Which of the following statements about children and medicines is correct?

1. Because children have an undeveloped blood-brain barrier, a medicine's ingredients that are absorbed and enter the circulating blood readily reach the brain, and side effects readily occur with medicines that affect the central nervous system.
2. In children the blood-brain barrier is undeveloped, so a medicine's ingredients that are absorbed and enter the circulating blood readily reach the brain, but this has no relation to the likelihood of side effects with medicines that affect the central nervous system.
3. The blood-brain barrier is a mechanism in the placenta that prevents the fetus's blood and the mother's blood from mixing.
4. Because children have a developed blood-brain barrier, a medicine's ingredients that are absorbed and enter the circulating blood have difficulty reaching the brain, and side effects never occur with medicines that affect the central nervous system.

Which of the following statements about the use of medicines in children is correct?

1. Because a child's liver and kidney functions are sufficiently developed, metabolism and excretion of a medicine's ingredients is faster than in an adult, so the action is less likely to appear and side effects are never strong.
2. Because a child's liver and kidney functions are as developed as an adult's, the time needed to metabolize and excrete a medicine's ingredients is no different from an adult's, and its action never appears excessively strong.
3. Because a child's liver and kidney functions are undeveloped, metabolism and excretion of a medicine's ingredients takes time, and the action may appear excessively strong or side effects may appear more strongly.
4. Tablets and capsules carry no risk of getting stuck in the throat when taken, even by a young child under 5 years of age.

Which of the following statements about the use of medicines in infants and young children is correct?

1. For tablet or capsule medicines used in young children under 5 years of age, because it is assumed that an adult dose will simply be halved for them to take, no caution about their readily getting stuck in the throat when taken is stated on the package insert.
2. To prevent accidental ingestion or misuse by infants and young children, it is preferable to keep medicines within easy reach of children so they can be taken out and used immediately.
3. Because infants and young children can properly convey their own physical condition, there is no need for a guardian or other caregiver to closely observe their condition after a medicine is used.
4. Even for a medicine with a set dosage and administration for infants, because infants are readily affected by medicines and their condition can change suddenly, it is preferable, in principle, to prioritize receiving medical care from a doctor and to keep treatment with an OTC drug to a minimum.

Which of the following statements about elderly people and medicines is correct?

1. In elderly people, even if liver or kidney function has declined, this has no effect on how a medicine's action appears.
2. Because individual differences in the degree of decline in basic physical strength and physiological function are small among elderly people, the degree of risk can easily be judged from age alone.
3. Elderly people may have weakened throat muscles reducing their ability to swallow food and drink (dysphagia), making them prone to choking when using oral medicines.
4. The (Points to Note on the Notation Guidelines for Prescription Drug Package Inserts, etc.) gives 70 years of age or older as a rough guide for (elderly person).

Which of the following statements about the use of medicines by pregnant women or women thought to be pregnant is correct?

1. The placenta has a mechanism (the blood-placenta barrier) that prevents the fetus's blood and the mother's blood from mixing, and the extent to which it blocks a medicine's ingredients from transferring to the fetus has been fully elucidated.
2. Laxatives never risk inducing miscarriage or premature birth, regardless of their combined ingredients or dosage.
3. Some products, such as vitamin A-containing preparations, are held to raise the risk of causing congenital abnormalities in the fetus if taken in excess of the normal dose during a certain period before and after pregnancy.
4. Because evaluating the safety of an OTC drug when used by a pregnant woman is easy, few OTC drugs list 'consult a doctor' regarding use by pregnant women.

Which of the following statements about women who breastfeed and medicines is correct?

1. Because an infant never ingests, via breast milk, a medicine's ingredients that have transferred into breast milk, there is no need to provide information about medicine use during the breastfeeding period.
2. Depending on the type of medicine, part of the ingredients of a medicine used by a breastfeeding woman are known to transfer into breast milk, and for a medicine known to have an undesirable effect on infants and young children, active information must be provided so that use during the breastfeeding period, or breastfeeding for a while after use, can be avoided.
3. Because a medicine's ingredients never transfer into breast milk, no particular consideration regarding the effect on the infant is needed even when a breastfeeding woman uses a medicine.
4. Depending on the type of medicine, part of the ingredients of a medicine used by a breastfeeding woman are known to transfer into breast milk, but even for a medicine known to have an undesirable effect on infants and young children, there is no need to provide information advising avoidance of use during the breastfeeding period or of breastfeeding for a while after use, and the decision can be left to the purchaser.

Which of the following statements about the placebo effect is correct?

1. The responses or changes brought about by the placebo effect include only desirable ones (effects), never inconvenient ones (side effects).
2. Because the placebo effect is reliable, medicines should be used with it as the aim.
3. The placebo effect refers to the main action produced by a medicine's pharmacological action.
4. When a medicine is used, an effect arising as a result or by chance, and not due to pharmacological action, is called the placebo effect (dummy-drug effect).

Which of the following statements about the placebo effect is incorrect?

1. The placebo effect appears only as a subjective change, and never as an objectively measurable change.
2. The responses or changes brought about by the placebo effect also include both desirable ones (effects) and inconvenient ones (side effects).
3. The placebo effect is unreliable, and medicines should not be used with it as the aim.
4. The placebo effect is thought to be brought about by factors such as an optimistic expectation of results from the mere fact of having used a medicine (a suggestion effect), a conditioned physiological response, and a spontaneous change over time (such as spontaneous remission).

Which of the following statements about the quality of medicines is incorrect?

1. As long as a medicine is properly stored and displayed, quality deterioration from the passage of time can be avoided.
2. Many of the ingredients formulated in a medicine (both active ingredients and additive ingredients) are prone to quality deterioration (change or decay) from high temperature, high humidity, light (ultraviolet), and the like.
3. Because OTC drugs are often purchased as a household stock medicine, it is also important that they be sold with sufficient margin remaining before the expiration date printed on the outer box and the like.
4. The place where a medicine is stored and displayed needs to be kept clean and attention paid to ensuring it is not left in high temperature, high humidity, direct sunlight, or the like.

Which of the following statements about the expiration date of medicines is correct?

1. The 'expiration date' printed is the date by which quality is maintained when stored in an opened state, and if stored unopened, quality is considered assured even after that date has passed.
2. The 'expiration date' printed is the date by which quality is maintained when stored unopened, and for a liquid preparation and the like, quality may not be assured until the printed date once it has been opened.
3. Because OTC drugs are used soon after purchase and are never purchased as a household stock medicine, there is no need to sell them with sufficient margin remaining before the expiration date.
4. Even once opened, a liquid preparation's quality is assured until the expiration date printed on the container.

Regarding the definition of an OTC drug, which of the following is the correct wording to fill the blank? 'Among medicines, those whose action on the human body in terms of their indications and effects is not ( ), and which are intended to be used based on the purchaser's own selection, made on the basis of information provided by a pharmacist or other person engaged in the medical field (excluding drugs requiring guidance)'

1. small
2. mild
3. recognized
4. marked

Which of the following statements about OTC drugs is incorrect?

1. The legal definition of an OTC drug includes drugs requiring guidance.
2. An OTC drug is one whose action on the human body in terms of its indications and effects is not marked.
3. An OTC drug is intended for members of the public to treat or prevent their own illness, or to improve or enhance their quality of life, for a physical ailment not severe enough to require treatment at a medical institution, in an early stage of a disease, or in daily life.
4. An OTC drug is intended to be used based on the purchaser's own selection, made on the basis of information provided by a pharmacist or other person engaged in the medical field.

Which of the following statements about the role of OTC drugs is incorrect?

1. Improving or enhancing quality of life (QOL) and self-testing one's health status are included in the role of OTC drugs, alongside improving symptoms accompanying a mild illness.
2. Maintaining or promoting health, and other public health and hygiene matters, are listed as one of the roles of OTC drugs.
3. Preventing the onset of symptoms accompanying a lifestyle disease and the like is included in the role of OTC drugs, regardless of whether the effect can scientifically and reasonably be expected.
4. Improving symptoms accompanying a mild illness is listed in the Guide, alongside maintaining or promoting health and other public health and hygiene matters, as one of the roles of OTC drugs.

Which of the following statements about self-medication is correct?

1. According to the World Health Organization (WHO), self-medication is defined as 'taking responsibility for one's own health and treating mild physical ailments by oneself'.
2. According to the World Health Organization (WHO), self-medication is defined as 'treating even a severe illness by oneself', and does not cover mild physical ailments.
3. The leading role in self-medication is not the ordinary member of the public but the professional engaged in the sale of medicines, and the member of the public is merely in the position of using a medicine following that professional's instructions.
4. Information provided by a professional engaged in the sale of medicines must always lead to the sale of a medicine.

Which of the following statements about the scope of symptoms and the like treatable with OTC drugs is correct?

1. Even when symptoms are severe, such as a high fever or intense abdominal pain, it is still appropriate to first use an OTC drug.
2. No OTC drug contains an ingredient that would count as doping if used by a competitive athlete.
3. If no improvement in symptoms is seen after using an OTC drug for a set period, it is preferable not to visit a medical institution and instead to continue use while watching how things go.
4. The scope treatable with OTC drugs varies depending on the person using the medicine, and for infants, young children, pregnant women, and the like, that scope is more limited than for an ordinary adult.

Which of the following statements about appropriate selection of medicines and recommending a doctor's visit is incorrect?

1. When a physical ailment or mild symptom has been treated using an OTC drug, if there is no improvement in symptoms but the condition has not worsened, it is fine to continue use while watching how things go.
2. When a competitive athlete has a question about medicine use, confirmation with a pharmacist or other person with specialized knowledge is necessary.
3. In light of the role of OTC drugs, using an OTC drug when symptoms are severe (for example, when there is a high fever, intense abdominal pain, or an affected area that is extensive) is not an appropriate response.
4. Information provided need not always lead to the sale of a medicine; there are cases where recommending a visit to a medical institution (recommending a doctor's visit) or recommending a response not involving the use of a medicine is appropriate.

Which of the following statements about the basic points a professional engaged in the sale of medicines should try to confirm from the purchaser and others is correct?

1. Whether the medicine will be used by the person receiving the information, or is expected to be used by a family member or the like, is one of the basic points to try to confirm.
2. Whether the person who will use the medicine is currently receiving treatment at a medical institution is not among the matters to be confirmed.
3. Whether the person who will use the medicine has had an allergy or a medicine side effect in the past is not among the matters to be confirmed.
4. There is no need to confirm what the medicine is being purchased for (the purchaser's needs, the motive for the purchase).

Which of the following statements about communication at the time of sale is correct?

1. When selling a Class 1 OTC drug, the matters (3)-(5)—such as whether use by a child, elderly person, pregnant woman, or the like is expected as the user—must be confirmed by the registered seller selling the medicine.
2. Because the situation in which the purchaser and others use the medicine does not change, there is no need for particular consideration of the quantity sold, and it may be sold in bulk.
3. Because the situation in which the purchaser and others use the medicine may change from time to time, it is also important to give consideration such as setting the quantity sold to the amount needed for a given period, so that opportunities for communication at the time of sale continue to be secured.
4. Because an OTC drug is always used by the very person who received the information, communication at the time of sale can be considered based solely on that person's condition.