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COSMETO-VIGILANCE Adverse event reporting and Causality. There is no definition worldwide of cosmeto-vigilance and adverse events on cosmetics. . Cosmeto-vigilance . Pharmacovigilance is being done in most countries . Pharmacovigilance is the science of collecting, monitoring,
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2. COSMETO-VIGILANCE Adverse event reporting and Causality
3. There is no definition worldwide of cosmeto-vigilance and adverse events on cosmetics.
4. Pharmacovigilance is the science of collecting, monitoring, researching and evaluating data on the effects of medicinal drugs, biological products, herbals and traditional medicines with a view to identifying new information about adverse reactions and preventing harm to patients. The information collected during the pre-marketing phase of a medicinal drug is inevitably incomplete with regard to possible adverse reactions:
5. Test in animals are insufficiently predictive of human safety.
6. Pharmacovigilance is needed in every country, because there are differences between countries (and even within countries) in the occurrence of adverse drug reactions and other drug-related problems. This may be because of differences in:
7. Pharmaceutical quality and composition (excipients) of locally produced pharmaceutical products
8. Any response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
9. An adverse reaction may result from effects of the drug, of illness, and their interaction with each other. Causality between the clinical event and the drug may not always be present although with a reaction (ADR), causality is more definite. For adverse reactions during therapy, remember that they:
10. * Identifying rare adverse effects * Monitoring newly introduced drugs where their safety profile is relatively unknown * Hypothesis generating and raising of signals or flags * Supporting the regulatory policies in the promotion of drug safety
11. It should be emphasized that such reports are neither proof nor admission of causality. ADR monitoring teaches us what we do not know and how to become better healers.
12. Cosmetic products are consumer goods that are basically conceived to make people feel comfortable and happy after its use.
24. The Person in charge of cosmetovigilance contacts the consumer back (by visit/phone/mail) and starts an investigation following a specific questionnaire in order to classify the type of effect encountered by the customer, its causality and the necessity to eventually have this consumer examined by a dermatologist.
25. Companies set up a network of affiliated dermatologists is ready to diagnose specific cases and to inform the company on the health issues linked to the use of their products.
28. PMQCP involves the active systematic scientifically valid collection, analysis and interpretation of data or other information about a marketed product. The data can reveal unforeseen adverse events, the actual rate of anticipated adverse events or other information necessary to protect the public health.
29. The approach shall be based on risk assessment.
30. Products where certain amount of the product may be ingested, inhaled or absorbed through the mucous membranes such as oral hygiene products and products used on lips.
31. Adulterated or misbranded cosmetic products. A cosmetic product is misbranded if its labeling is false or misleading, if it does not bear the required labeling information.
32. Regulatory Authority’s surveillance and compliance activities
