Reporting System of Biocidal Vigilance

1. Egyptian Drug Authority (EDA) Egyptian Pharmaceutical Vigilance Center (EPVC) Biocides Vigilance Department (BVD) Reporting System of Biocidal Vigilance Hend Al-Hussieny BSc. Pharm, MSc. Head of the Biocides Vigilance Department

2. Establishment BVD has been established in the Egyptian Drug Authority (EDA), Ministry of Health & Population (MOHP) to be responsible for the collection and evaluation of information on biocidal products marketed in Egypt with particular reference to adverse reactions (Incidents). Furthermore, BVD is taking all appropriate measures to

3. Aims of Reporting 1. Early detection of Adverse Reaction (Incident) & other problem related to the use of Biocidal Products.2. Detection of increased frequency of Adverse Reaction (Incident) .3. Identification of predictors and possible mechanisms underlying Adverse Reaction (Incident) .4. Quantitative Estimation of risk/benefit profiles of Biocidal Products and dissemination of information needed to improve  its use.5. Prevention of preventable Adverse Reaction (Incident) .6. Encouraging rational and safe use of Biocidal Products.7. Communication and dissemination with international institutions working in Biocidal Products.

4. Biocidal Vigilance Rule BVD Rule

5. Reporting System Regulatory Authority (BVD) Incident (ARs)

6. Spontaneous Reporting System Procedure • A HCPs, MAHs or Users reports a suspected adverse reaction (Incidents) related to one or more biocidal products, to The (BVD). • Reports are collected, collated, and validated by the (BVD) and are usually entered into a database. • The database is used to identify potential signals and analyze data in order to clarify risk factors, apparent changes in reporting profiles etc.

7. N. B. Serious reactions are handled with the highest priority .

8. How do I report the Biocidal Product incident? You do not have to be certain that biocidal product caused the effect in order to report it. There are two ways you can report biocidal product incident: • The biocidal product company (MAHs) as listed on the product label. They are required by ministerial decree to report all ARs (Incidents) related to their products to BVD. Or, 2. BVD has biocidal products incident reporting forms (Blue Cards). Please use the form of report to report the adverse reaction (incident) you face and mail it to the address on the form. You must provide information about the product (name, registration number or active ingredient found on the label) and a description of the effect.

9. What to report?

10. How to submit Blue Card Report? • After filling the blue card; All AR (Incident) reports can be sent to the BVD by: 1. Fax: Special number for the AR (Incident) reporting 2. Postal mail (regular letters) 3. E-mail : Special account for AR(Incident) reporting, biocides.epvc@eda.mohealth.gov.eg 4. By Hand: Contact person in hospitals, by biocidal distribution companies…. There is collaboration between BVD and some biocidal distribution companies to participate in collecting the filled Pesticides Incident Safety Report (PISR) then forward them to BVD.

11. Serious reports: should be submitted in expedited manner i.e. as soon as possible & no later than 15 calendar days While other reports can be submitted on regular basis (every month) by any means.

12. Spontaneous Reporting of Adverse Reactions (Incidents) • The Spontaneous reporting structure is the voluntary and the most common way through which the regulatory bodies collect AR (incident) information for biocidal products once they are on the market

13. N. B. We would like to confirm that there is no any legal responsibilityor any liability whatsoever on the reporter of the ARs (Incidents), also the information in the report is confidential and totally protected including both consumer (user) and reporter identity. Moreover, this voluntarily reporting help to evaluate the safety of the products

14. How do I report the Biocidal Product incident? You do not have to be certain that biocidal product caused the effect in order to report it. There are two ways you can report biocidal product incident: • The biocidal product company (MAHs) as listed on the product label. They are required by ministerial decree to report all ARs (Incidents) related to their products to BVD. Or, • BVD has biocidal products incident reporting forms (Blue Cards). Antiseptic & Disinfectants Incident Reporting Form and Pesticide Incident Reporting Form. Please use the form of report to report the adverse reaction (incident) you face and mail it to the address on the form. You must provide information about the product (name, registration number or active ingredient found on the label) and a description of the effect.

15. Benefits of reporting • Improvement on the quality of care offered to users • Reduction of biocidal product related problems leading to better outcome • Improved knowledge • Access to feedback information on biocidal product related problems reported within the country and internationally • Satisfaction for the fulfillment of a moral and professional obligation.

16. Confidentiality Statement Any information related to the identity of persons will be protected, any unsolicited information will be destroyed

17. It is important to provide as much information as possible. The more information collected, the better understanding (BVD) will have of the incident.

18. It is important to appreciate • Firstly, that BVD database for IISRs & ADISRs can detect duplicate reports. Therefore, if healthcare professional deems it necessary to submit a report they should do so even if there is a possibility that someone else might have done the same. • Secondly, different people will include different information when they complete a Blue Card, all of which is useful in creating a full picture of the reaction that has taken place.If there is not enough space provided for you to answer the question, you may attach a separate sheet with the text on it

19. How will the provided information be used by the BVD? • We use all available information to assess if the biocidal product was the cause of the reported effect. If so, we assess what the risk to Egyptians is and how similar incidents can be prevented. We do this by attempting to answer these questions:

20. When and how did exposure happen? • Are the effects expected? • How many other incidents of this kind have been reported? • How complete is the information in the report? • Was the product used according to the label instructions? • Is the product used a lot in Egypt?

21. Causality assessment • Causality assessment is the method by which the extent of relationship between the biocidal product and a suspected reaction is established. • Causality assessment • The evaluation of the likelihood that the biocidal product was the causative agent of an observed adverse reaction (incident). Causality assessment is usually made according established algorithms.

22. four sections to validate the biocidal product incident safety report • An identifiable user • An identifiable reporter • Suspected Product • Suspected adverse reaction (incident)

23. Seriousness of Adverse reactions (Incidents) • A serious adverse event or reaction is any untoward medical occurrence associated with the use of a biocidal product in a user that, the consumer outcome is one of the following Examples of serious Ars • Death • Life-Threatening?????????????????????

24. As soon as possible Reports on all suspected adverse reactions(incident) known or not, serious or not are welcome and useful If there is any doubt about whether or not it is an AR (incident); always it is best practice to submit a report

25. Part I Antiseptic & Disinfectant Reporting Forms

26. What to report? • All suspected adverse reactions should be reported, especially those that are: • Unexpected, regardless of their severity, i.e., not consistent with product information or labeling; or • Serious, whether expected or not; or • Reactions to recently marketed antiseptic & disinfectants products, regardless of their nature or severity.

27. What is a serious adverse reaction? • A serious AR (Incident) is one that requires in-patient (user) hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. ARs that require significant medical intervention to prevent one of these listed outcomes are also considered to be serious.

28. Requirements of Antiseptic & Disinfectants Incident Report Form (Blue Card) • Patient’s Details: Name/ Initials (Optional), Sex (Male or Female), Age & Weight in Kg. • Suspected Antiseptic or Disinfectant(s):

29. Product name: Detailed name of suspected antiseptic or disinfectant must be provided. • Was the product effective as an antiseptic or disinfectant or not? • Active ingredient(s): The name of the active ingredient(s) of the suspected Antiseptic & Disinfectants. e.g. Hydrogen peroxide. • Concentration: The name of active ingredient(s) of the suspected Antiseptic or Disinfectants should be provided. • Minimum purity: This item referred to the extent of active ingredient(s) purity e.g. 97% -90% • Product type: Either Antiseptic or Disinfectant. • Dilution: provide the dilution of the product if it is applicable

30. Uses of the suspected Antiseptic & Disinfectants: • • Disinfectant: Critical use, Semi critical use and Non critical use. • • Antiseptic: • a. Personal use: Personal Domestic use & Personal Commercial use. • b. Professional use: Professional Healthcare & Food Premises. • Registration No.: Provide the product MOHP registration number: • Registration number examples: 2213/2011.

31. Type of registration: Provide the type of registration e.g. Local, Toll, Imported, Under license, Bulk or Toll. • Frequency of use: Provide thefrequency of use of the suspected Antiseptic or Disinfectants. Include the amount of Antiseptic & Disinfectants applied (application rate), the location that the Antiseptic & Disinfectants was applied to and the method of application. Application rate examples: 10 ml of Antiseptic & Disinfectants /100CM 3.

32. Location of incident examples: Home, Hospital, Lab,………………………..etc. • Method of application examples: Spray, Paint, Prose, Bait,………………… etc. • Pharmaceutical form: Describe the type of formulation: e.g. Solution, Wipes, Foam, Spray, Gel, Shampoo, ………………………………………..…..…..….etc.

33. Type of Incident: There are four types of incidents: • Human Health Incident. • Hard Surface Incident. • Veterinary Incident. • Medical device Incident.

34. A- In case of Human Health – Incident: • Describe what was exposed? • e.g. Eye, Skin, Oral, Respiratory (inhalation),………………………………….. etc. • Describe all symptoms. Include the length of time the symptom(s) lasted, the severity of the symptom(s), and how often the symptom(s) occurred. Also describe any medical treatment received, including medication prescribed, test results and length of hospitalization (if applicable). • Examples of user's reaction to Antiseptic & Disinfectants exposure: e.g. Dizziness, Headache, Blurred vision, Convulsion, Nausea/Vomiting, Itching, …...….…..…. etc.

35. B- In case of Hard Surface – Incident: • Describe what was exposed: Floors, Benches, ……………………………….... etc. • Describe what happened to surface: Spotting, Bleaching (discoloration), Whitening…………………………………………………………………………..etc. • Describe how the incident happened, as well as any additional information concerning the incident:

36. C- In case of Veterinary – Incident: • Mention who was observing this incident; e.g. Animal owner, Veterinary professional, Witness, ….. etc. • Describe all symptoms. Include the length of time the symptom(s) lasted, the severity of the symptom(s), and how often the symptom(s) occurred. Also describe any medical treatment that the animal received, including medication prescribed or test results. • Provide No. of animals affected: • Mention the type of animal affected: Dog, Cat, Bird, Horse, ………….……...... etc. • Describe how was the animal exposed to the antiseptic or disinfectant? Include the amount of product the animal was exposed to, and how long or how often the animal was exposed to it.

37. D- In case of Medical device Incident: • Describe the type of the medical device: • Describe what the reaction was happened: Corrosion, Spotting, Whitening,………………………etc.

38. Incident's Details: • Describe symptom(s) that appeared: i.e. Itching, Severe headache that lasted for 2 days, Rash on forearms and hands that lasted 1 week. Saw doctor 2 days after incident and was given a prescription for medication X, Vomited 3 times, approximately every 2 hours, burning eyes………………………………Etc. • Date of incident: Provide Day, Month & Year (dd/mm/yyyy). • Are you the first observer of the event? • Do the symptoms reappear after reusing the product? • What was the outcome of the incident? Require Hospitalization, • Life threatening, Permanent disability, Died, Congenital abnormalities, Required intervention to prevent damage,………………………….………..etc. • Has this incident been reported to the manufacturer?

39. Reporter’s Details: The One who filled in this form: Patient, Physician, Pharmacist, Nurse,……………………………………………………………….…..etc. • Name: See confidentiality statement • Specialty (If physician, Address: See confidentiality statement, E-mail, Telephone/ Mobile, Date of reporting &Signature.

40. Any More Comments: • Any additional information can be provided in this space, or on a separate sheet. • Confidentiality Statement: Any information related to the identity of persons will be protected. Any unsolicited personal information will be destroyed.

41. PART (II) Pesticides Reporting Forms (Blue Card):

42. Consumer Product Safety • Pesticides are tested and evaluated for environmental and health risks before they are registered by the CAPA. However, some adverse effects may not become evident until the product is used under "real-life" circumstances. The information you are about to report will provide the BVD with valuable data regarding potential risks to humans from the use of pesticides in "real-life" circumstances.

43. If you require immediate medical attention, if you are experiencing symptoms, consult the First Aid instructions on the product label and contact your health care provider or call the nearest poison center. For environmental emergencies, contact your local authorities or the Biocidal Vigilance Department (BVD). All pesticides are tested and evaluated for safety before being registered for use by Egyptians. To continue to monitor for safety after they are registered, BVD collects pesticide incident reports from Egyptians.

44. Requirements of Pesticide Incident Reporting Form (Blue Card) • Suspected Pesticide(s): • Product Name: Detailed name of suspected Pesticide must be provided. • Active ingredient(s): The name of the active ingredient(s) of the suspected Pesticide e.g. Deltamethrin • Product type: Public Health or House Hold • Uses: e.g. to control rodents, mosquito, ..………………………..………...……etc. • Application rate: e.g. 10cm/100m2 • Location of incident: location where the incident occurred (see Confidentiality Statement) e.g. city, governorates

45. Type of formulation: e.g. Liquid, Wettable Powder (WP), Dustable powder (DP), Aerosol, Pellets/bait, Tablet (TB)/ Balls, Granules, …….......…..……..…….....etc. • Method of application: Spray, Bait, Prose,……….….………………….…..…etc. • Type of pack: Can, Aluminum sachet, Plastic ……………………………...…..etc. • Is it registered at Ministry of Health: If Yes (Write the CAPA Registration No……….). • Was the product effective as an pesticide: Yes or No

46. Patient Details (If the affected subject is human) • Name/ Initials (Optional): Name/ Initials (Optional), Sex (Male or Female), Age & Weight in Kg.

47. Types of Incident: • Human Health Incident: • What was exposed? E.g. Eye, Respiratory (inhalation), Skin, ……….…....etc. • 2- Domestic Animal Incident: No. of animals affected: e.g. 2,4,……………..…etc. • Type of animal affected? i.e. cat, horse, chicken,……………………….….etc. • Environmental Incident: What happened to the animal(s) or plant(s) after the initial observation? • Packaging Incident: Was the pesticide in its original container or not? • When did the packaging failure occur? e. g. During storage, Use of product, Transportation,………………………………………………………….………etc.

48. A- In case of Human Health – Incident: • Describe what was exposed? • Eye, Skin, Oral, Respiratory (inhalation),………………………………...……….. etc. • Describe all symptoms. Include the length of time the symptom(s) lasted, the severity of the symptom(s), and how often the symptom(s) occurred. Also describe any medical treatment received, including medication prescribed, test results and length of hospitalization (if applicable). • Example of patient's reaction to pesticide exposure • Dizziness, Headache, Blurred vision, Convulsion, Nausea/Vomiting, …….….….. etc.

49. B- In case of Packaging Failure – Incident: • Provide what was type of pack? • e.g. Can, Aluminum sachet, Plastic bottle , Glass,……………………..….…….… etc. • Was the pesticide/chemical in its original container? • Provide when did the packaging failure occur? • e.g. (During storage, Use of product, Transportation, ………………….…………. etc. • Describe how the packaging failed, as well as any additional information concerning the incident.

50. C- In case of Domestic Animal – Incident: • Who is observing this incident? • e.g. Animal owner , Witness, Veterinary professional,…………..….……….……. etc. • Describe all symptoms. Include the length of time the symptom(s) lasted, the severity of the symptom(s), and how often the symptom(s) occurred. Also describe any medical treatment that the animal received, including medication prescribed or test results. • No. of animals affected. e.g. 2animals, 30 animals, ……………………..………etc. • Type of animal affected: Provide the type of affected animal, e.g. Cat, Bird, Horse…………………………………………………………………...………….. etc. • How was the animal exposed to the pesticide? Include the amount of pesticide the