Introduction to Pharmacovigilance

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.

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.

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

<p>Individual Case Safety Report</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>True</p> Signup and view all the answers

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

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers