Safety Measures, Relief Systems, and Public Awareness

Which of the following statements about emergency safety information (kinkyu anzensei joho) is correct?

1. It is often information transmitted about a prescription pharmaceutical, and emergency safety information related to an over-the-counter medicine or a kampo formula preparation has never once been issued and is never a subject of it.
2. Information transmission is limited to direct distribution from the manufacturing and marketing business operator to medical institutions, pharmacies, and the like, and information is never provided through press releases, the Pharmaceuticals and Medical Devices Information Distribution Service (PMDA Medi-navi), direct mail, fax, email, or the like.
3. It is prepared, based on an order or instruction from the Ministry of Health, Labour and Welfare, or on the voluntary decision of the manufacturing and marketing business operator, when a situation exists requiring measures for urgent and serious attention-calling or use restriction concerning a pharmaceutical, medical device, or regenerative medicine product.
4. It is an A4-size printed document on a blue background, also called a "blue letter," prepared when urgent and serious attention needs to be called for.

Which of the following statements about a safety-update communication (anzensei sokuho) is correct?

1. It is an A4-size printed document on a yellow background, also called a "yellow letter."
2. It is an A4-size printed document on a blue background, also called a "blue letter."
3. It is prepared when a situation exists requiring measures for urgent and serious attention-calling or use restriction.
4. It is prepared based on an order or instruction from the prefectural governor.

Which of the following statements about emergency safety information and a safety-update communication is incorrect?

1. A safety-update communication is prepared when a situation exists requiring more prompt attention-calling, among other things, concerning a pharmaceutical, medical device, or regenerative medicine product, than an ordinary revision of the precautions for use.
2. Emergency safety information is transmitted by direct distribution from the manufacturing and marketing business operator to medical institutions, pharmacies, and the like, and by information provision (within one month) through direct mail, fax, email, and the like.
3. A safety-update communication is an A4-size printed document on a yellow background.
4. Emergency safety information is also called a "yellow letter."

Which of the following statements about the subject and information provision of emergency safety information is correct?

1. The preparation of emergency safety information is limited to cases based on an order or instruction from the Ministry of Health, Labour and Welfare, and is never prepared based on the voluntary decision of the manufacturing and marketing business operator.
2. The deadline for information provision is set at within one year.
3. Emergency safety information is prepared covering only prescription pharmaceuticals.
4. Emergency safety information related to an over-the-counter medicine has also been issued, such as the emergency safety information on interstitial pneumonia caused by Sho-saiko-to (March 1996).

Which of the following statements about the Pharmaceuticals and Medical Devices Safety Information bulletin is correct?

1. The Pharmaceuticals and Medical Devices Agency compiles the information and provides it widely to medical professionals and members of the general public.
2. It is issued as a public relations bulletin for members of the general public, not for medical professionals, and is not widely provided to medical professionals.
3. Its content includes explanatory articles on pharmaceutical safety, the content of revisions to precautions for use, the main target products, reference materials, and the like.
4. The pharmaceuticals covered include only prescription pharmaceuticals, and not over-the-counter medicines.

Which of the following statements about information posted on the Pharmaceuticals and Medical Devices Agency's website is incorrect?

1. Case information regarding a suspected side effect from a pharmaceutical, reported by a manufacturing and marketing business operator or a medical institution, is not posted.
2. Information on the recall of pharmaceutical products, among others, is posted.
3. Approval information for pharmaceuticals is posted.
4. Emergency safety information instructed by the Ministry of Health, Labour and Welfare to manufacturing and marketing business operators, and information on revisions to "precautions for use," are posted.

Which of the following statements about the Pharmaceuticals and Medical Devices Information Distribution Service (PMDA Medi-navi) is correct?

1. For particularly important information concerning safety, it is a service that, in addition to being posted on the website, is delivered in a timely manner by postal mail rather than email.
2. It is a service that, when particularly important information concerning the safety of a pharmaceutical or medical device is issued, delivers that information in a timely manner by email.
3. It is a service run by the Ministry of Health, Labour and Welfare, and the Agency is not involved.
4. Its use is limited to medical professionals, such as a pharmacist or registered seller employed by a pharmacy owner or store-based retailer, and a member of the general public cannot use it.

Which of the following statements about pharmaceutical safety information is incorrect?

1. The Pharmaceuticals and Medical Devices Safety Information bulletin does not introduce an outline of the case reports that formed the basis for a revision concerning an important side effect.
2. The Pharmaceuticals and Medical Devices Safety Information bulletin is posted on the Ministry of Health, Labour and Welfare's website and the Agency's website.
3. A pharmaceutical's manufacturing and marketing business operator, among others, must collect and examine matters concerning the pharmaceutical's efficacy and safety and other information necessary for its appropriate use, and must endeavor to provide it to a pharmacy owner, store-based retailer, home-delivery retailer, and the pharmacists and registered sellers engaged there.
4. The Pharmaceuticals and Medical Devices Safety Information bulletin is sent to each prefecture, each city establishing a health center and special ward, related academic societies, medical institutions, and the like.

Which of the following statements about the Pharmaceuticals and Medical Devices Safety Information Reporting System is correct?

1. The reporting deadline is set at within 15 days from the day on which the occurrence of health harm suspected of being caused by a pharmaceutical's side effect, among other things, became known.
2. When a medical professional learns of the occurrence of health harm suspected of being caused by a pharmaceutical's side effect, among other things, and finds it necessary to prevent the occurrence or spread of harm to public health and hygiene, that professional must report that fact to the Minister of Health, Labour and Welfare.
3. In practice, the report is submitted not to the Pharmaceuticals and Medical Devices Agency but to the prefectural governor of the reporter's location.
4. Even after the introduction of the registered seller system under the June 2006 amendment of the Pharmaceutical Affairs Act, a registered seller is not included among the medical professionals who report under this system, and only a pharmacist, physician, or dentist may report.

Which of the following statements about a report based on the Pharmaceuticals and Medical Devices Safety Information Reporting System is incorrect?

1. It is not necessary to fill in every field of the report form; it is sufficient to report to the extent information can be obtained from the purchaser, among others.
2. Even when the causal relationship with the pharmaceutical is not necessarily clear, it can still be a subject of reporting.
3. Even when multiple professionals are involved in the sale, among other activities, of the pharmaceutical, it is sufficient for a report to be submitted by the one professional who had direct contact with the health harm information.
4. The reporting deadline is set at within 30 days from the day on which the occurrence of the health harm became known.

Which of the following statements about the history of the Pharmaceuticals and Medical Devices Safety Information Reporting System is correct?

1. Reporting of side effects, among other things, by a medical professional such as a physician or pharmacist was made mandatory by the June 2006 amendment of the Pharmaceutical Affairs Act.
2. From August 1978, regular reports began to be made on cases of over-the-counter medicine side effects, among other things, identified at about 3,000 monitoring hospitals.
3. This system started in March 1967 as the "Drug Side Effect Monitor System," in which about 3,000 medical institutions were designated as monitoring facilities and the then Ministry of Health and Welfare received side-effect reports directly.
4. A registered seller is not positioned as a medical professional who reports under this system.

Which of the following statements about how to report a suspected side effect of a pharmaceutical is correct?

1. A report can only be made using information obtained from the person who suffered the health harm.
2. Health harm believed to be caused by overdose or misuse of a pharmaceutical is never a subject of reporting, under any circumstances.
3. From April 2021, electronic reporting by directly entering information on a website became possible.
4. Nothing in particular is issued to a reporter who has submitted a report.

In the corporate reporting system for side effects, among other things, which of the following is the correct reporting deadline for a death case (domestic) that is unpredictable from the precautions for use, among side-effect cases suspected of being caused by a pharmaceutical?

1. Within 7 days
2. Within 30 days
3. Periodic report
4. Within 15 days

In the corporate reporting system for side effects, among other things, which of the following is the correct reporting deadline, among serious (excluding death) side-effect cases predictable from the precautions for use, for a case other than one obtained within two years after approval as a pharmaceutical containing a new active ingredient, or through post-marketing surveillance immediately after launch, among other such means?

1. Within 30 days
2. No reporting obligation
3. Periodic report
4. Within 15 days

Which of the following statements about reporting deadlines in the corporate reporting system for side effects, among other things, is incorrect?

1. Among side-effect cases suspected of being caused by a pharmaceutical, a non-serious domestic case unpredictable from the precautions for use is handled as a periodic report.
2. A serious case (including death) whose occurrence pattern of side effects cannot be predicted from the precautions for use, among other sources, is reported within 30 days.
3. A research report indicating a risk of cancer or another serious disease, disorder, or death occurring due to a side effect or infection is reported within 30 days.
4. A report on measures taken overseas to prevent the occurrence or spread of harm to public health and hygiene, such as discontinuation of manufacture, import, or sale, recall, or disposal, in a foreign country (a report on overseas measures) is made within 15 days.

Which of the following statements about the corporate reporting system for side effects, among other things, is correct?

1. Reporting of side effects, among other things, by a manufacturing and marketing business operator is not a legal obligation, but a duty of effort.
2. A manufacturing and marketing business operator, among others, is obligated, under Article 68-10, Paragraph 1 of the Act, to report to the Minister of Health, Labour and Welfare by a prescribed deadline, upon learning of the occurrence of health harm, among other things, suspected of being caused by a side effect, for a pharmaceutical it has manufactured and marketed, or for which it has obtained approval.
3. This system was first institutionalized by the 2002 amendment of the Pharmaceutical Affairs Act.
4. No provision requiring a pharmacy owner, medicine-sales business operator, or medical professional (including a registered seller) to endeavor to cooperate with information collection for appropriate use of a pharmaceutical carried out by a manufacturing and marketing business operator is established, and these parties have no need to cooperate in information collection.

Which of the following statements about post-approval investigation of an over-the-counter medicine is correct?

1. For a product containing an active ingredient clearly different from an existing pharmaceutical, the reexamination system is applied, under which the manufacturing and marketing business operator, among others, accumulates post-approval usage results, among other data, over a fixed period (roughly 8 years) set by the Minister of Health, Labour and Welfare at the time of approval within a period not exceeding 10 years, and submits it to the Ministry of Health, Labour and Welfare.
2. The investigation period under the reexamination system, which applies to a product containing an active ingredient clearly different from an existing pharmaceutical, is roughly 3 years, as set by the Minister of Health, Labour and Welfare at the time of approval.
3. Unlike a prescription pharmaceutical, a post-approval investigation is not required of the manufacturing and marketing business operator, among others, for an over-the-counter medicine.
4. For a product that, for the first time, includes in an over-the-counter medicine (OTC medicine) an active ingredient that had been used in a prescription pharmaceutical, a safety investigation of roughly 3 years, as set by the Minister of Health, Labour and Welfare at the time of approval within a period not exceeding 10 years, is required as a condition of approval, and it is designated as a Class 1 pharmaceutical.

Which of the following statements about the evaluation and measures concerning side-effect information, among other things, is correct?

1. A partial change to the efficacy/effect or method/dosage of use is never carried out as an administrative measure necessary for safety.
2. The administrative measures necessary for safety do not include recalling a product.
3. The Minister of Health, Labour and Welfare takes administrative measures necessary for safety after hearing the opinion of the prefectural governor.
4. Side-effect information collected through the various systems is examined and studied by the Agency, hearing the opinions of expert committee members.

Which of the following statements about the Relief System for Sufferers from Adverse Drug Reactions is correct?

1. This system began operation in May 1990 as a public system based on the social responsibility of pharmaceutical companies.
2. Various benefits are provided based on the result of a determination made by the Minister of Health, Labour and Welfare, after receiving a claim for benefits from the person who suffered the health harm (or their family), and after deliberation and response by the Pharmaceutical Affairs Council on matters requiring medical and pharmacological judgment.
3. A designated-guidance-required pharmaceutical and an over-the-counter medicine are not included among the pharmaceuticals covered by this system.
4. Relief benefits are provided based on the result of a determination made by the president of the Agency, after receiving a claim for benefits from the person who suffered the health harm (or their family), and after deliberation and response by the Pharmaceutical Affairs Council on matters requiring medical and pharmacological judgment.

Which of the following statements about the cost burden of the Relief System for Sufferers from Adverse Drug Reactions is correct?

1. The benefit costs are covered entirely by the national treasury.
2. Regarding the benefit costs, contributions paid annually by manufacturing and marketing business operators are allocated to them.
3. The administrative costs are covered entirely by contributions from manufacturing and marketing business operators.
4. An amount equal to half of the administrative costs is covered by prefectural burden.

Which of the following is NOT among the types of benefits under the Relief System for Sufferers from Adverse Drug Reactions?

1. Disabled-child rearing pension
2. Bereaved-family lump-sum payment
3. Work-leave allowance
4. Medical allowance

Which of the following statements about the benefits and their claim deadlines under the Relief System for Sufferers from Adverse Drug Reactions is correct?

1. A claim deadline exists for the disability pension, but no claim deadline is set for the disabled-child rearing pension or medical expenses.
2. The claim deadline for medical expenses is within 5 years from when payment of the expenses eligible for the medical-expense benefit was made.
3. Unlike the case for the bereaved-family lump-sum payment or funeral expenses, no claim deadline is set for the bereaved-family pension.
4. Unlike medical expenses, no claim deadline is set for funeral expenses.

Which of the following statements about the disability pension under the Relief System for Sufferers from Adverse Drug Reactions is correct?

1. It is a fixed-amount benefit considered to be provided for the purpose of, among other things, compensating for the living expenses of a person under 18 who is in a certain degree of disability due to a pharmaceutical's side effect, and it is considered that no claim deadline is set.
2. The benefit is a fixed-amount benefit limited to a maximum of 10 years.
3. The claim deadline is set at within 5 years from when the state of disability arose.
4. It is a fixed-amount benefit provided for the purpose of, among other things, compensating for the living expenses of a person aged 18 or older who is in a certain degree of disability due to a pharmaceutical's side effect, and no claim deadline is set.

Which of the following statements about medical expenses and the medical allowance under the Relief System for Sufferers from Adverse Drug Reactions is correct?

1. Medical expenses and the medical allowance are provided for a disease caused by a side effect that is severe enough to require only outpatient treatment.
2. The claim deadline for the medical allowance is within 5 years from the first day of the month following the month in which the medical treatment concerned was provided.
3. The medical allowance compensates, at actual cost, the expenses required to treat a disease caused by a pharmaceutical's side effect.
4. Medical expenses are a fixed-amount benefit.

Among designated-guidance-required pharmaceuticals or over-the-counter medicines, which of the following is NOT covered by the Relief System for Sufferers from Adverse Drug Reactions?

1. A cold remedy
2. An over-the-counter test kit
3. An analgesic/antipyretic
4. A germicide/disinfectant applied directly to the human body

Which of the following statements about the scope of coverage of the Relief System for Sufferers from Adverse Drug Reactions is incorrect?

1. Some pharmaceuticals listed in the Japanese Pharmacopoeia (purified water, petrolatum, etc.) are not covered by the relief system.
2. An insecticide or rodenticide (excluding one applied directly to the human body) is not covered by the relief system.
3. Health harm from the use of an unapproved, unauthorized pharmaceutical (including a pharmaceutical obtained through personal import) is not covered by the relief system.
4. A germicide/disinfectant applied directly to the human body is not covered by the relief system.

Which of the following statements about the scope of eligibility for relief benefits under the Relief System for Sufferers from Adverse Drug Reactions is correct?

1. Even health harm arising from appropriate use of a pharmaceutical is included in the scope of benefits if it is a mild case that resolved without particularly requiring treatment at a medical institution.
2. The scope of relief benefits also includes a case where hospitalization treatment is recognized as necessary but home care was unavoidably chosen instead.
3. When it cannot be determined whether something is a pharmaceutical's side effect, a claim for benefits cannot be made.
4. Health harm from inappropriate use of a pharmaceutical is also eligible for relief benefits.

Which of the following statements about claiming relief benefits for side-effect harm from the use of a designated-guidance-required pharmaceutical or an over-the-counter medicine is correct?

1. For the claim, in addition to a physician's diagnosis and a document certifying the medical expenses incurred (a certificate of treatment), a certificate of sale, among other documents, prepared by the pharmacy owner or medicine-sales business operator that sold the pharmaceutical, among others, is also required.
2. A claim for benefits is limited to the person who suffered the health harm, and cannot be made by that person's family.
3. A professional engaged in the sale of a pharmaceutical need not comply even if a purchaser requests issuance of a certificate of sale.
4. For the claim, a physician's diagnosis and a document certifying the medical expenses incurred (a certificate of treatment) are required, but a document such as a certificate of sale prepared by the pharmacy owner or medicine-sales business operator that sold the pharmaceutical is not required.

Which of the following statements about the Pharmaceutical PL Center is correct?

1. It is a consultation body established by the Agency.
2. For a complaint concerning a pharmaceutical or quasi-drug (including harm other than health harm), it accepts consultations from a consumer negotiating with the manufacturing and marketing company, from a fair and neutral standpoint, and mediates and coordinates the negotiation.
3. It aims to lead the matter to resolution through litigation.
4. For a case where the pharmaceutical company bears liability for damages, such as a defective product, consulting the Pharmaceutical PL Center is not recommended, since the case is covered by the Relief System for Sufferers from Adverse Drug Reactions.

Which of the following statements about relief for health harm is correct?

1. Health harm from an infection, among other things, transmitted via a biological product is to be provided relief through the Relief System for Sufferers from Adverse Drug Reactions.
2. The Relief System for Sufferers from Infections, Etc. via Biological Products provides benefits for a disease, disability, or death caused by an infection, among other things, transmitted despite appropriate use of a biological product, on or after April 1, 2004.
3. Although entrusted by related pharmaceutical companies or the national government, the Agency does not handle the payment of health-management allowances or nursing-care expenses to SMON patients for whom a court settlement has been reached.
4. The Relief System for Sufferers from Adverse Drug Reactions was created by the 1959 amendment of the Pharmaceutical Affairs Act, as a public system based on the social responsibility of pharmaceutical companies, in light of the Thalidomide incident, the SMON incident, and other such events, to provide prompt relief for health harm from a pharmaceutical's side effects.

Which of the following statements about ampule-form cold remedies is correct?

1. An ampule preparation was confirmed to have slower absorption of the active ingredient than other dosage forms (tablets, powders, etc.), so blood concentration never rapidly reaches a high level, and there is no risk of a side effect at the normal dose.
2. The serious side effect that occurred was interstitial pneumonia, with deaths occurring between 1959 and 1965.
3. It was confirmed that there is no risk of a side effect as long as the normal dose is observed.
4. A serious side effect (shock) from the use of an ampule-form cold remedy containing the analgesic/antipyretic ingredients aminopyrine and sulpyrine caused a total of 38 deaths between 1959 and 1965.

Which of the following statements about the response to the side-effect cases from ampule-form cold remedies is correct?

1. In 1965, the then Ministry of Health and Welfare requested the related pharmaceutical companies to recall ampule-form cold remedy products.
2. In 1965, the then Ministry of Health and Welfare instructed the related pharmaceutical companies to distribute emergency safety information.
3. The then Ministry of Health and Welfare instructed the related pharmaceutical companies to promptly switch to an alternative ingredient.
4. It was concluded that immediate suspension of sales was unnecessary, and the response was limited to calling attention.

Which of the following statements about interstitial pneumonia caused by Sho-saiko-to is correct?

1. The patients who developed interstitial pneumonia after using Sho-saiko-to and reached a serious outcome, including death, were patients with chronic renal failure.
2. Because cases occurred in which a patient using Sho-saiko-to reached a serious outcome including death, in March 1996 the then Ministry of Health and Welfare requested the related pharmaceutical companies to recall Sho-saiko-to products.
3. The serious side effect that occurred from concomitant use of Sho-saiko-to and an interferon preparation was shock.
4. Because interstitial pneumonia was reported in cases of concomitant use of Sho-saiko-to and an interferon preparation, in January 1994 the precautions for use were revised to state that concomitant use with an interferon preparation is contraindicated.

Which of the following statements about interstitial pneumonia caused by Sho-saiko-to is incorrect?

1. Interstitial pneumonia caused by Sho-saiko-to had been stated in the precautions for use from April 1991 onward.
2. In March 1996, the then Ministry of Health and Welfare instructed the related pharmaceutical companies to distribute emergency safety information.
3. No case of interstitial pneumonia was reported after the precautions for use were revised to state that concomitant use with an interferon preparation is contraindicated.
4. There were cases in which a patient with chronic hepatitis developed interstitial pneumonia after using Sho-saiko-to and reached a serious outcome, including death.

Which of the following statements about interstitial pneumonia caused by over-the-counter cold remedies is correct?

1. The Ministry of Health, Labour and Welfare came to instruct the related pharmaceutical companies to distribute emergency safety information.
2. The early symptoms of interstitial pneumonia can easily be distinguished from the general symptoms of a cold, which are the efficacy claim of an over-the-counter cold remedy.
3. For only the products for which cases of interstitial pneumonia had been reported by May 2003, the Ministry of Health, Labour and Welfare requested the related pharmaceutical companies in June of that year to recall those products, and no revision of the precautions for use was carried out.
4. Based on a total of 26 cases of interstitial pneumonia suspected of being caused by the use of over-the-counter cold remedies reported by May 2003, an instruction to revise the precautions for use for over-the-counter cold remedies in general was issued in June of that year.

Which of the following statements about the revision of the precautions for use in light of interstitial pneumonia caused by over-the-counter cold remedies is correct?

1. The revision led to the suspension of sales of over-the-counter cold remedies for which cases of interstitial pneumonia had been reported.
2. Because serious symptoms of interstitial pneumonia can rarely occur, and these symptoms are difficult to distinguish from the general symptoms of a cold, attention came to be called for with wording such as "if symptoms worsen, discontinue use and see a physician."
3. Before the revision, no precaution such as "if symptoms do not improve after taking the medicine five or six times, discontinue use and consult a professional" was made at all for over-the-counter cold remedies, and it is considered that no attention was called concerning taking the medicine.
4. In light of the occurrence of interstitial pneumonia, approval standards for over-the-counter cold remedies came to be established in 1970.

Which of the following statements about phenylpropanolamine hydrochloride (PPA) is correct?

1. It was included in oral rhinitis medicines, antitussive/expectorant medicines, cold remedies, and the like, for the purpose of relieving nasal or conjunctival congestion and symptoms such as nasal blockage.
2. In Japan, it had been approved not as an oral rhinitis medicine but as an appetite suppressant.
3. As the alternative ingredient, it was instructed to switch not to pseudoephedrine hydrochloride (PSE) but promptly to aminopyrine.
4. In the United States, a link was reported between the risk of hemorrhagic stroke and use by women at a higher dose than the amount included in Japan, as a diabetes treatment drug.

Which of the following statements about the response to pharmaceuticals containing phenylpropanolamine hydrochloride (PPA) is incorrect?

1. The Ministry of Health, Labour and Welfare instructed the related pharmaceutical companies, among others, to revise the precautions for use, thoroughly provide information, and, as an alternative ingredient, promptly switch to pseudoephedrine hydrochloride (PSE) and the like.
2. In May 2000, in the United States, it was reported that there was a high likelihood of a link between use by women as an appetite suppressant and the risk of hemorrhagic stroke.
3. In Japan, in response to the report from the United States, sales of all PPA-containing pharmaceuticals were immediately suspended in November 2000.
4. Many of the side-effect cases such as cerebral hemorrhage reported by August 2003 resulted from use exceeding the range of the approved method and dosage, or use by a hypertensive patient, for whom it was contraindicated.

Which of the following statements about "Medicine and Health Week" is correct?

1. It aims to contribute to the maintenance and improvement of public health and hygiene by spreading correct knowledge widely among consumers about the characteristics of pharmaceuticals and their use and handling, among other matters, and is held every year for the one-week period from October 17 to 23.
2. It is carried out by the national government, local governments, related organizations, and the like, with the sole aim of promoting the prevention of drug abuse, rather than spreading correct knowledge widely among consumers about the characteristics of pharmaceuticals and their use and handling, among other matters.
3. It is held every year for the one-month period from June 20 to July 19, and aims to promote the prevention of drug abuse.
4. It is carried out only by pharmaceutical companies, with no involvement from the national government, local governments, related organizations, or the like.

Which of the following statements about the "Dame. Zettai." awareness campaign and the prevention of drug abuse is correct?

1. It is held every year for the one-month period from June 20 to July 19, to spread awareness of "6/26 International Day Against Drug Abuse" and further promote the prevention of drug abuse.
2. Drug abuse and drug dependence are limited to those caused by illegal drugs (narcotics, stimulants, etc.), and never arise from an over-the-counter medicine.
3. It is held every year for the one-week period from October 17 to 23.
4. It is considered that awareness activities concerning the importance of a pharmaceutical's appropriate use, among other matters, should not be conducted for elementary and junior high school students.