Pharmacovigilance. Marta D. Puente Navazo January 2017 презентация

Pharmacovigilance Marta D. Puente Navazo

Agenda Pharmacovigilance Definitions Reporting details Local literature surveillance

Pharmacovigilance Pharmacovigilance Definitions Reporting details Local literature surveillance

Why is Pharmacovigilance important? To identify: Risks and benefits of medicines to improve their safe use Changes in the patterns of adverse effects (frequency, severity) Pharmacovigilance is a legal obligation for all MAH’s and is subject to strict requirements under national and regional legislation. Please let us know as soon as you become aware (within one working day) of new pharmacovigilance requirements in your country! If we become aware of any pharmacovigilance requirements changes in your country, we will let you know and you should take action immediately.

Why is Pharmacovigilance important? CSL has a regulatory requirement to provide an appropriate system of Pharmacovigilance (PV), in order to provide assurance for the safety and liability of its products throughout their lifecycle

Definitions Pharmacovigilance Definitions Reporting details Local literature surveillance

Definitions: Adverse Drug Reaction (ADR) A response to a medicinal product which is noxious and unintended.

Definitions- Adverse Event or Adverse Experience (AE) Is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment (ICH). Please inform CSL as soon as you become aware of an Adverse Event

Definitions – Adverse Event Report In addition to Adverse events, the following events should be reported to CSL: reports of drug exposure via mother (e.g. exposure during pregnancy, breastfeeding) lack of drug effect medication errors/maladministration (including wrong route or unknown route of administrations) overdose (accidental or intentional) off-label use drug abuse, Drug misuse, drug dependency occupational exposure pre-existing condition improved (unexpected therapeutic benefits were observed)

Additional guidance on medication errors

EXAMPLES

Need to be reported? Midwife administered a dose of Rhophylac that had passed the expiry date to a patient as post partum prophylaxis.

Need to be reported? Pregnant women receives Privigen

Need to be reported? The patient had a poor response to the drug after 2 days of treatment with sandoglobulin

Need to be reported? Treatment with Kybernin of preeclampsia in pregnant woman

Need to be reported? US case: Treatment of dermatomyositis with IVIG (brand name not known)

Need to be reported? Breastfeeding baby was exposed to Privigen

Need to be reported? Haemate was transferred into the syringe and kept for 8 hours until it was administered to a patient

Adverse Reactions – Some examples Non-serious – e.g. rash, headache Serious – death, hospitalisation, virus transmission, results in persistent or significant disability or incapacity

Definitions

Individual Case Safety Report (ICSR)

Spontaneous ICSR

Minimum Criteria for a valid ICSR

ICSR reporting

Reporting details Pharmacovigilance Definitions Reporting details Local literature surveillance Reconciliation process Product Technical Complaints Setting a SharePoint alert

Pharmacovigilance – LSO/RSO Contacts Regional Safety Officer (RSO) ECI: Marta D. Puente Navazo (marta.puente@cslbehring.com) Local Safety Officer Russia: Olga Kalinina (olga.kalinina@cslbehring.com) Please send any information to our PV e-mail address: PhV-ECI@cslbehring.com

An Adverse Drug Reaction (ADR) – What Should I Do? Post and faxes should be scanned and e-mailed and e-mails and phone calls forwarded to RSO PhV-ECI@cslbehring.com This must all be done within one business day Information must be in English

Adverse Reactions – What Should I Do? If phone calls cannot be forwarded to RSO obtain the following information : contact details of reporter Suspected drug + lot number Suspected adverse reaction Patient details (e.g.* initials, DOB, age, sex, patient no., etc.) Note the date of call day zero E-mail details to RSO within one Business day

Important to know: Every information on a potential AE must be forwarded to the RSO within one business day, even if not all minimum criteria are known RSO is then in charge of the follow up

Adverse Reactions – Reporting Timelines All adverse reactions (ADR) must be reported to RSO within one business day ADRs are then reported to the Pharmacovigilance department at CSL, who then report to worldwide regulatory authorities for which there are strict timelines for compliance

Product Exposure during Pregnancy Pregnancy reports should be monitored until the pregnancy outcome is known Attempts should be made to follow-up cases Scope of report does not end at birth –for ICSRs of congenital anomalies, the reporter shall be asked to provide an assessment of the severity of the malformation, and a final diagnosis

An example

If you suspect an ADR… If you suspect an ADR…

Conference:

“European Journal of Neurology” Attending a conference you come across an abstract reporting an ADR or other safety relevant observation (remember earlier slides) What do you do with this information and why? Pass the abstract to RSO CSL Behring has a duty to follow up May not have been picked up by regular Global Literature Search, as conference abstracts are difficult to locate by online searching

Local Literature surveillance Pharmacovigilance Definitions Reporting details Local literature surveillance Reconciliation process Product Technical Complaints Setting a SharePoint alert

Why local literature surveillance? Information on safety relevant observations in local journals may not be missed 1. Search for local peer reviewed scientific journals, which are not listed in Embase 2. Screen abstracts of local journals for ADRs involving CSL Behring products Use key words (e.g. product names, active substances,) provided by RSO

Local literature surveillance 3. If you find an abstract mentioning a key word, read the full article 4. Pass relevant articles to RSO within one Business day and short summary in English if article is not in English 5. Provide English translation of the full article Frequency of screening depends on publication frequency

Local literature surveillance Example Rhophylac: Global literature search uses following key words: rhesus d antibody ● side effect rh immune globulin ● adverse drug reaction rh d immunoglobulin ● drug safety rho d immunoglobulin ● case report rho d antibody rhesogamma rhophylac needs to be adapted to local needs