Reporting System of Biocidal Vigilance

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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
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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

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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.

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Biocidal Vigilance Rule
BVD Rule
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Reporting System

Regulatory Authority (BVD)
Incident (ARs)
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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.

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

• .

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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.

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What to report?
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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_at_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.

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• 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.

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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

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N. B.

• We would like to confirm that there is no any
  legal responsibility or 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

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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.

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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.

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Confidentiality Statement

• Any information related to the identity of
  persons will be protected, any unsolicited
  information will be destroyed

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

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• 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

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• 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

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• 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?

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• 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.

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

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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?????????????????????

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• 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

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• Part I Antiseptic Disinfectant Reporting Forms

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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.

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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.

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Requirements of Antiseptic Disinfectants
Incident Report Form (Blue Card)

• Patients Details Name/ Initials (Optional), Sex
  (Male or Female), Age Weight in Kg.
• Suspected Antiseptic or Disinfectant(s)

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• 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

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• 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.

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• Type of registration Provide the type of
  registration e.g. Local, Toll, Imported, Under
  license, Bulk or Toll.
• Frequency of use Provide the frequency 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.

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• 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.

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

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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.

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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

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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.

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D- In case of Medical device Incident

• Describe the type of the medical device
• Describe what the reaction was happened
  Corrosion, Spotting, Whitening,etc.

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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
  eyesEtc.
• 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?

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• Reporters 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.

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• 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.

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• PART (II) Pesticides Reporting Forms (Blue
  Card)

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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.

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• 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.

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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

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• 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

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Patient Details (If the affected subject is human)

• Name/ Initials (Optional) Name/ Initials
  (Optional), Sex (Male or Female), Age Weight in
  Kg.

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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.

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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.

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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.

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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

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• animal was exposed to, and how long or how often
  the animal was exposed to it.

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D- In case of Environmental Incident

• Describe what happened to the animal(s) or
  plant(s) after the initial observation?
• Provide the total number of animals or plants
  affected (estimate if not counted)
• Provide were environmental samples collected and
  analyzed.

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Incident's Details

• Date incident occur dd/mm/yyyy.
• Are you the first observer of the event or not?
  
• What was the outcome of the incident? i.e. Life
  threatening, Hospitalization,
  Permanent Disability,
  Died, Required intervention to prevent
  Damage,....etc.
• Has this incident been reported to the
  manufacturer or not?
• How was the person exposed to the pesticide?
  Include, if available, the amount of the
  pesticide the person was exposed to, and how long
  or how often the person was exposed to it
• Describe symptom(s) appeared the date

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Reporters 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.

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• 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.

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• Thank You