Introduction to Pharmacovigilance

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Questions and Answers

What does "pharmacovigilance" mean?

Pharmacovigilance refers to the science and activities related to the detection, evaluation, understanding, and prevention of adverse drug reactions or any other drug-related problems.

What are the primary aims of pharmacovigilance? (Select all that apply)

Identification of risk factors associated with drug use (correct)
Quantifying the risks associated with drug use (correct)
Preventing patients from being affected unnecessarily by adverse drug reactions (correct)
Detection of increases in frequency of adverse events (correct)
Early detection of unknown safety problems (correct)

What event led to the passing of the Biologics Control Act in 1902?

The death of multiple children due to contaminated vaccines, which were produced from horses, led to the passing of the Biologics Control Act in 1902.

What event led to the passing of the Federal Food, Drug, and Cosmetic Act in 1938?

The deaths of over 100 people, primarily children, caused by the poisonous solvent diethylene glycol (DEG) in the Elixir of Sulfanilamide led to the passing of the Federal Food, Drug, and Cosmetic Act in 1938. Signup and view all the answers

What was the core issue of concern surrounding the use of Thalidomide?

Thalidomide, initially marketed as a safe and effective sedative and hypnotic, was later found to be associated with severe birth defects in infants, specifically phocomelia, due to its teratogenic effects during pregnancy. Signup and view all the answers

Explain the significance of Dr. William McBride's role in the Thalidomide tragedy.

Dr. William McBride discovered that Thalidomide could alleviate morning sickness in pregnant women, leading to widespread off-label use of the drug for this purpose. He also played a crucial role in raising awareness about the severe birth defects caused by the drug, ultimately leading to its withdrawal from the market. Signup and view all the answers

The "Declaration of Helsinki" is focused on establishing ethical principles for human medical research and experimentation.

True (A) Signup and view all the answers

What does "ICSR" stand for in the context of pharmacovigilance?

Individual Case Safety Report (B) Signup and view all the answers

What are the four minimum criteria for a valid adverse drug reaction report?

The four minimum criteria for a valid adverse drug reaction report are an identifiable reporter, an identifiable patient, a suspect adverse reaction, and a suspect medicinal product. Signup and view all the answers

What are "spontaneous reports" in the context of pharmacovigilance?

Spontaneous reports are unsolicited communications from healthcare professionals or consumers to the Agency or the marketing authorization holder, describing suspected adverse reactions in a patient who was given one or more medicinal products. These reports do not come from a study or organized data collection program. Signup and view all the answers

What is the role of the marketing authorization holder in managing reports from non-medical sources?

If a marketing authorization holder becomes aware of a report of suspected adverse reactions from a non-medical source, such as the press or other media, it should be treated as spontaneous report. They should attempt to follow up the case to obtain a valid ICSR. Signup and view all the answers

What are "solicited reports" in the context of pharmacovigilance?

Solicited reports of suspected adverse reactions are those derived from organized data collection systems, such as clinical trials, non-interventional studies, registries, off-label or named patient use, other patient support and disease management programs, surveys of patients or healthcare providers, compassionate use programs, or information gathering on efficacy or patient compliance. Signup and view all the answers

What are the specific types of cases that are considered particularly relevant for follow-up?

Cases that are considered particularly relevant for follow-up include monitored events of special interest, prospective reports of pregnancy, cases notifying the death of a patient, and cases reporting new risks or changes in the known risks. Signup and view all the answers

What is the primary importance of identifying the name and batch number of a product in a suspected adverse reaction report?

Identifying the name and batch number of a product is crucial for ensuring the accurate identification of the concerned product and its manufacturing details, especially for biological medicinal products, in a suspected adverse reaction report. This information is essential for investigating the source of the adverse reaction and taking appropriate actions to ensure drug safety. Signup and view all the answers

How should electronic and paper reports of suspected adverse reactions be treated?

Electronic and paper reports of suspected adverse reactions should be stored and treated in the same way as other medical records, with appropriate respect for confidentiality rules regarding patients' and reporters' identifiability. Signup and view all the answers

What steps should be taken when a report containing identifiable personal details is submitted?

If identifiable personal details are included in reports submitted to the marketing authorization holder, the reporter's identifiable details and contact information should be provided. However, when transmitting case reports from TÜFAM to the marketing authorization holder, confidentiality rules should always be respected. Signup and view all the answers

How should reports involving exposure of pregnant women to medicinal products be managed?

Reports where the embryo or fetus may have been exposed to medicinal products should be followed up to collect information on the outcome of the pregnancy and development of the child after birth. Additionally, when an active substance or metabolite has a long half-life, the possibility of exposure to the embryo before conception should be considered during assessment. Signup and view all the answers

Why are reports of exposure to medicinal products during pregnancy considered serious?

Individual cases with an abnormal outcome associated with a medicinal product following exposure during pregnancy are classified as serious reports. These reports require special attention and should be reported promptly. Signup and view all the answers

What is the importance of collecting information on the age or age group of patients in pharmacovigilance?

Collecting information on the age or age group of patients is crucial for identifying potential safety signals specific to a particular population, especially in pediatric or elderly patients. This type of data is essential for understanding the nuances of medication use in different population groups and for ensuring appropriate safety measures are taken. Signup and view all the answers

What type of reports should be considered in periodic safety update reports, rather than being reported as ICSRs?

Reports of overdose, abuse, off-label use, misuse, medication error, or occupational exposure without associated adverse reactions should be considered in periodic safety update reports, rather than being reported as ICSRs. Signup and view all the answers

What is the general timeframe for reporting serious valid ICSRs?

The reporting of serious valid ICSRs is required as soon as possible, but no later than 15 calendar days after initial receipt of the information by personnel of the marketing authorization holder. Signup and view all the answers

If a case initially reported as "serious" becomes "non-serious" based on follow-up information, this updated information should be reported within 15 days.

True (A) Signup and view all the answers

Explain the concept of "biosimilars" in pharmacovigilance.

Biosimilars are biotechnological products that are similar to already licensed reference biotherapeutic products in terms of quality, safety, and efficacy. Signup and view all the answers

What are the key considerations in pharmacovigilance for biosimilars compared to originator biologics?

The key considerations in pharmacovigilance for biosimilars include clinical studies for each indication and non-clinical comparability exercises in chemistry, manufacturing and control. This is in contrast to originator biologics where extrapolation of safety data is often possible. Signup and view all the answers

What should a pharmacist do when they notice a turbidity in an ampoule of a drug?

A pharmacist should report the turbidity in the ampoule to ensure the safety and quality of the drug. An investigation of the product is important to determine if the turbidity is due to the drug or due to contamination. The pharmacist should not dispense the drug unless the investigation suggests that the drug is safe. Signup and view all the answers

What should a pharmacist do when a pregnant patient comes to the pharmacy with a prescription for Aspirin?

A pharmacist should consult with the physician or healthcare professional who prescribed the Aspirin to confirm the appropriate use of this drug during pregnancy. Pregnancy is a critical factor to consider for medication safety, and a pharmacist's role is to ensure that patients are receiving safe and appropriate medication. Signup and view all the answers

What should a pharmacist do when a physician consults them about a metastatic breast cancer patient who has experienced unexpected progression of disease while on trastuzumab?

A pharmacist should consult with the physician to gather information about the patient's medical history, the progression of the disease, and the specific circumstances of the treatment. They should encourage the physician to document this adverse event in a formal case report and submit it for review, if appropriate. Signup and view all the answers

What should a pharmacist do when a patient's daughter shares the news of her mother's death and informs the pharmacist that her mother was always taking medications from the pharmacy, including GLP-1 analogs, barbiturates, and low-dose aspirin?

The pharmacist should offer condolences to the daughter and acknowledge the loss. They should offer to discuss the mother's medication history, including the rationale for each medication and potential interactions. If appropriate, the pharmacist can refer the daughter to the prescribing physician to discuss the mother's medical care and to ensure the daughter has access to any necessary information and support. Signup and view all the answers

What should a pharmacist do when a colleague expresses concerns about insufficient information on the preparation of benzamycin and doubts about making the wrong application?

The pharmacist should discuss the colleague's concerns openly and encourage them to share any specific questions or concerns they have. Additional research or consultation with the manufacturer would be helpful to clarify the concerns. The pharmacist should also emphasize the importance of following the instructions provided in the product information carefully and of seeking clarification when needed. Signup and view all the answers

What action should a pharmacist take when a patient wants to take propranolol for preventing anxiety before a presentation?

A pharmacist should encourage the patient to consult with their healthcare professional before taking propranolol for this purpose. The pharmacist should explain the risks and benefits of propranolol, and the importance of medical advice to ensure appropriate and safe medication use. Signup and view all the answers

What action should a pharmacist take when a colleague expresses concerns about the preparation of benzamycin?

The pharmacist should encourage the colleague to discuss their concerns openly and seek clarification. The pharmacist should also emphasize the importance of following the instructions provided in the product information carefully and of seeking clarification when needed. Signup and view all the answers

What is the role of TÜFAM in the pharmaceutical industry?

TÜFAM is the national pharmacovigilance center responsible for monitoring, collecting, and analyzing reports of adverse drug reactions within Turkey. This organization also collaborates with the World Health Organization and other international organizations to ensure the safety and effectiveness of medications. Signup and view all the answers

What is the main reason for the strict regulation of retinoid drugs?

Retinoids are teratogenic, meaning they can cause birth defects in a developing fetus if administered to a pregnant woman. Therefore, their use requires strict regulation to protect the safety of pregnant women and their babies. Signup and view all the answers

What should a pharmacist do when they receive a report of an adverse event that relates to the use of a medication during pregnancy?

Pharmacists are required to document the adverse drug event, ensure it is reported to the appropriate authority (like TÜFAM), and follow up closely with the healthcare professional. The report should include information about the pregnancy, the medication, and the adverse event. In addition, the pharmacist should ensure that the patient understands the risks and benefits of the medication, and refer the patient to a healthcare professional as needed. Signup and view all the answers

Flashcards

Adverse Drug Reaction (ADR)

Any harm associated with the use of drugs at normal dosages during normal use.

Adverse Drug Event (ADE)

Any untoward medical occurrence that may present during treatment with a medicine, but might not have a causal relationship with this treatment.

Side Effect

An unintended effect of a pharmaceutical product at normal doses, related to the pharmacological properties of the drug.

Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with domestic labeling or market authorization, or expected from the characteristics of the drug.