Compliance and Best Practices. 2. Quick regulatory review. 3. Global Cosmetics Vigilance diagram, example of in-house operational logogram
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1 Personal Care Products Council Safety seminar Oct. 27, 2011 Cosmetics Vigilance in the EU Compliance and Best Practices 1. Introducing IRIS 2. Quick regulatory review 3. Global Cosmetics Vigilance diagram, example of in-house operational logogram 4. Focus on SUEs (Serious Undesirable Effects) 5. Case studies 6. EU Competent Authorities reports in Conclusion 2 1
2 Introducing IRIS Service provider engaged by Brands to manage their consumers health-related complaints (IRIS Call center) 1st company to offer Cosmetovigilance services (1992) Unipex group s affiliate ( Expertise in dermatology and allergy Linguistic skills (covering approx. 50 countries worldwide) Network of physicians deployed across the EU, Asia Member of Cosmetics Vigilance Task-Force group (FEBEA) CURRENT & UPCOMING COSMETIC REGULATIONS IN EUROPE MAIN COSMETICS VIGILANCE OBLIGATIONS - Directive 76/768/EEC : Register Undesirable Effects to the Product Information File and make these information easily accessible to local competent authorities and to the Public - Regulation (EC) 1223/2009 : Notify local competent authorities about any Serious Undesirable Effect occurring in Europe (applicable as from July 11, 2013) 4 articles addressing Post Market Surveillance in Reg. EC 1223/2009 Art. 10 & 11 (cosmetic product safety report appendix 1, section 9- to be kept up-to-date with CV data, Product Information File content includes this product safety report) Art. 21 (Access to information for the public) Art. 23 (Communication of serious undesirable effects) 2
3 Mail, Fax Telephone Consumers, Health Professionals, Authorities Inform the person responsible for placing the product on the market (manufacturer, distributor) about a health-related complaint Global PMS process in the EU Direct contact Undesirable event (alleged) Criteria requested to confirm a case => - Identification of the cosmetic product(s) - Identification of the notifier or consumer - Description of the undesirable event - Date of onset (undesirable event) Undesirable event (confirmed) Actions Step 1 : Data collection & analysis Step 2 : Assess the causality Tools 1. Standard questionnaire (+/- data) 2. Decision tree Undesirable effect Causality assessments = VERY LIKELY or LIKELY (??) Registration to the Product Information File Information to the public (on request) Other causality assessments To be kept May be reviewed (occurrence) Summarized step-by-step actions Upon receipt of an Undesirable Event Action 1 => Register the case under a unique reference and indicate the date of receipt Action 2 => Fill out a standard questionnaire or send this questionnaire over to the consumer (mail/ ) A standard Undesirable Event Questionnaire should at least contain : Consumer s identification & contact details Product identification Description of the Undesirable event Chronology (dates of onset, of disappearance) Information about associated factors (concomitant use of other cosmetics ) Consequences of the UE (is there any criterion of seriousness? ) Action 3 => Check if the data gathered are sufficient to confirm the Undesirable Event into an Undesirable effect Action 4 => Complementary, data deemed necessary? if not directly assess the causal relationship product/ue Next actions => Closing process (anonymize personal data), Diffusion within the company, Archiving, Data compiling & interpretation 3
4 In-house Operational Logogram (example) A Standard Operation Procedure for UEs management should detail What are these services requested to do then, when (timeframe) and how Undesirable Event Questionnaire / script 4 criteria : -Pdct identified -Cons./Not. Identified -UE described -Date of onset In-house Operational Logogram (example) Case management (which are the conditions that request further documented data ) Decision tree 4
5 In-house Operational Logogram (example) UE is NOT confirmed Closing process, Diffusion list, Personal data anonymization, Archiving, Data compiling Example of a decision tree (Colipa Guidelines, 2005) Symptoms It is important to note that a causality assessment can only be performed if there is sufficient information on the case history (in particular symptoms and chronology). Chronology compatible Chronology not clearly compatible or unknown not performed, or not performed or Not clearly attributable Questionable Likely Very likely Likely Questionable Unlikely Symptoms : if the symptoms are not evocative (i.e. not suggestive of the product effect) the final level of causal relationship is decreased by one degree (very likely to likely, likely to questionable,questionable to unlikely) Compatible chronology : A time sequence between product use and the occurrence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible from a viewpoint and can be reasonably anticipated for this kind of product use and undesirable event. If the chronology is not compatible the causal relationship is excluded. Rechallenge : Controlled re-exposure to the product, considering the exposure conditions of the time when the event occurred. 5
6 Focus on SUEs / Definitions, Criteria To be noted : Serious (consequences of UE) Severe (intensity of UE) Definition (cf. Regulation 1223/2009) Temporary or permanent functional incapacity Disability Hospitalisation Information to provide Duration, +/- Medical certificate, +/- expert evaluation % of disability, +/- Medical certificate, +/- expert evaluation Duration, hospital address, treatments Congenital anomalies Detected during pregnancy or after delivery, +/- expert evaluation Immediate vital risk Treatment, specific measures Death Date, diagnosis, +/- death certificate Focus on SUEs / Reporting procedure for SUEs received by RP or Distributor Initial receipt 20 calendar days Report to local Comp. Authority Level of data is complete No Yes Report mentions «Initial» and «Final» + Causality assessment Report mentions «Initial» New, relevant information No Yes Report mentions «Final» + Causality assessment Report mentions «Follow Up» OR «Final» + Causalilty assessment 6
7 Focus on SUEs / Notification Form (for RP, Distrib.) To date, consist of a 3-page form with 13 sections to fill out (if info available) Case report Company Seriousness criteria Primary reporter End user Suspected product Description of SUE (type, location) Outcome of SUE Relevant underlying conditions ( condition, treatments ) Relevant history Case management Complementary (allergy tests ) Summary Incriminated pdct : Hair balsam Consumer : 8-year old girl Country : Denmark Case study#1 Description of UE: Itching, swelling, redness and spots in scalp + behind the ears Use of the pdct: 1 st purchase. 1 unique use Chronology: 12 hours after use. Took 1 week to settle down Consequences: Advice taken from GP and self-medication with topical dermocorticoids Medical Investigation: Positive Patch-test to finished pdct. PT with detailed ingredients showed to 1 ingredient Diagnosis: Allergic contact dermatitis 7
8 Case study#1_hair balsam Chronology compatible Symptoms Symptoms are evocative It is important to note that a causality assessment can only be performed if there is sufficient information on the case history (in particular symptoms and chronology). Chronology not clearly compatible or unknown not performed, or not performed or Questionable Likely Very likely Likely Questionable Unlikely Symptoms : if the symptoms are not evocative (i.e. not suggestive of the product effect) the final level of causal relationship is decreased by one degree (very likely to likely, likely to questionable,questionable to unlikely) Compatible chronology : A time sequence between product use and the occurrence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible from a viewpoint and can be reasonably anticipated for this kind of product use and undesirable event. If the chronology is not compatible the causal relationship is excluded. Rechallenge : Controlled re-exposure to the product, considering the exposure conditions of the time when the event occurred. Incriminated pdct : Lip care (balsam) Consumer : 47-year old women Country : France Case study#2 Description of UE: Feeling of swollen lips (but no visible signs). During the 3 rd week of use, she noticed the skin of her lower lip was cracking, just in the right corner. Use of the pdct: 1 st purchase. Used for approx. 3 weeks with intermittent discontinuations. Chronology: Immediate after first application. Use continued over 10 days, then stopped for 3 days and reused until cracks appeared Consequences: Attended a consultation with her GP Medical Investigation: No Diagnosis: Labial herpes 8
9 Case study#2_lip care Symptoms It is important to note that a causality assessment can only be performed if there is sufficient information on the case history (in particular symptoms and chronology). Chronology compatible Chronology not clearly compatible or unknown not performed, or not performed or Questionable Likely Very likely Likely Questionable Unlikely Reason : labial herpes is a viral infection which cannot be caused by a cosmetic Symptoms : if the symptoms are not evocative (i.e. not suggestive of the product effect) the final level of causal relationship is decreased by one degree (very likely to likely, likely to questionable,questionable to unlikely) Compatible chronology : A time sequence between product use and the occurrence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible from a viewpoint and can be reasonably anticipated for this kind of product use and undesirable event. If the chronology is not compatible the causal relationship is excluded. Rechallenge : Controlled re-exposure to the product, considering the exposure conditions of the time when the event occurred. Incriminated pdct : Facial skin care (anti-ageing) Consumer : 42-year old women Country : Italy Case study#3 Description of UE: Tingling sensations and itching on the entire face, together with red blotches and papules localized on right cheek only. Use of the pdct: 1 st purchase. Daily applications during 10 consecutive days. Chronology: UE occurred after 4 days. Product continued for a further 6 days before definitive discontinuation. Skin returned to normal after 6 weeks Consequences: None Medical Investigation: No 9
10 Case study#3_skin care Symptoms It is important to note that a causality assessment can only be performed if there is sufficient information on the case history (in particular symptoms and chronology). Chronology compatible Symptoms are not evocative (visible signs localized on 1 cheek whereas pdct applied to the entire face) Chronology not clearly compatible or unknown 6 weeks to clear up after the pdct was discontinued not performed, or not performed or Questionable Likely Very likely Likely Questionable Unlikely Symptoms : if the symptoms are not evocative (i.e. not suggestive of the product effect) the final level of causal relationship is decreased by one degree (very likely to likely, likely to questionable,questionable to unlikely) Compatible chronology : A time sequence between product use and the occurrence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible from a viewpoint and can be reasonably anticipated for this kind of product use and undesirable event. If the chronology is not compatible the causal relationship is excluded. Rechallenge : Controlled re-exposure to the product, considering the exposure conditions of the time when the event occurred. EU Competent Authorities reports in FRANCE 219 UEs notified, 13% of serious cases Population : women (71%), men (14%) and children (15%) Main cosmetic categories : Sun care, Body care (l-o), F&E makeup + removers Notifications by Health Professionals, health institutions (92%), Industry (6%) 2. THE NETHERLANDS 1250 UEs notified, no information about serious cases Population : women (90%), hardly any report involving babies/young children Main cosmetic categories : Face care, Hair care and Makeup Notifications by consumers (hotline, internet questionnaire) + Health Prof. 3. NORWAY 96 UEs notified between No information about serious cases Population : women (83%), Children up to 9 yrs old (7%) Main cosmetic categories : Moisturizers, Sun care and Hair dyes, bleaches Notifications made by Health Professionals 10
11 FRANCE, 10 days ago Conclusion To properly handle UE complaints, a company should 1. Develop an internal SOP (Standard Operation Procedure) to organize this activity 2. Inform and train all the people who may be involved in the process (distributors, in-house staff ) about what they have to do, how and when 3. Audit the system to check it duly works (ex. false cases) 4. Ensure the causality assessment is done by someone who is experienced and has appropriate professional background => reliability of the results THANK YOU 11
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