1. PURPOSE 2. SCOPE 3. RESPONSIBILITIES

Transcription

1 1. PURPOSE The purpose of this standard operating procedure (SOP) is to inform all Alexion personnel, and applicable service providers who become aware of a Pharmacovigilance (PV) Event of their responsibility to report the PV Event. 2. SCOPE This standard operating procedure (SOP) applies to reporting PV Events when Alexion personnel, and applicable service providers become aware of PV Event associated with Alexion marketed products. 3. RESPONSIBILITIES All Alexion Employees, and applicable service providers: Report Pharmacovigilance Events as soon as possible but within 24 hours of knowledge to Alexion Global Pharmacovigilance (GPV) or designee as described in section 4 below. Complete Pharmacovigilance training at least annually and additionally as assigned by Global Pharmacovigilance. Training must be completed within the assigned timeframe. Global Pharmacovigilance or designee: Manages reported PV Event information and conducts any necessary follow-up to obtain additional information in accordance with established procedures. Vice President GPV and EU QPPV approve the PV Event training within the scope of this procedure.

2 4. PROCEDURE PV Event Reporting: All Alexion personnel and applicable service providers who become aware of a Pharmacovigilance Event, regardless of the source of the PV Event report (e.g. patient, healthcare provider, caregiver, corporate website or social media), must report the information to Global Pharmacovigilance or designee according to local reporting requirements as soon as possible but within 24 hours, even when there is minimal information. PV Events can be reported using any of the following methods: AdverseEventReporting@alexion.com Fax: Reporting to a Local Drug Safety Officer (LSO) or designee Alexion PV Event Reporting Tool (SOP-G-PV-0020), where available PV Event information can be reported using the Global Pharmacovigilance Event Reporting Form (FRM ) To report a PV event, the following information should be obtained and reported to GPV using a method described in section : Patient identifying information (e.g. initials, patient identification number, date of birth, age, age group or gender) Primary reporter identifying information (e.g. qualification (e.g. physician, pharmacist, other healthcare professional, lawyer, consumer or other nonhealthcare professional) name, initials or address). The reporters contact information should also be provided when possible ( e.g. address, mailing address) An Alexion suspect product including dose and lot number, if known Pharmacovigilance (PV) Event (adverse experience) PV Events should be reported even if one or more of the above pieces of information are missing. Additional steps may be taken by Global Pharmacovigilance or designee to follow-up to obtain additional information according to established procedure.

3 Acknowledgment of receipt will be sent by GPV depending on the route of transmission of the PV Event

4 5. DEFINITIONS PV Event (AE): Any untoward medical occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not considered related to the use of a medicinal product is considered a PV event. The following scenarios are also to be captured as PV events and need to be reported to GPV in accordance with this procedure. Breastfeeding: Exposure to medicinal product during breast feeding Lack of therapeutic efficacy: Lack of desired therapeutic effect after product administration (e.g., patient, HCP or family stating the medicinal product is not working) Medication error: A medication error is considered an unintentional error in prescribing, dispensing or administration of medicinal product while in the control of a health care professional, patient or consumer. (e.g. incorrect route of administration - Soliris given as IV push) Occupational exposure: An exposure to a medicinal product during one's professional or non-professional occupation (e.g., nurse with accidental needle injection while arrange patient infusion or a vial breaks and splashes on someone) Off label use: Use of the product intentionally for indication (medical purpose) not in authorized product label (e.g., use of Soliris in dense deposit disease) Pregnancy: Product use during pregnancy, where embryo or fetus may have been exposed to medicinal product (either through maternal exposure or transmission of a medicinal product via semen following paternal exposure) Product overdose: Administration of a quantity of the medicinal product given per administration or cumulatively, which is above the labeled recommendation Product abuse: Intentional excessive (persistent or sporadic) use of medicinal product which is accompanied by harmful physical or psychological effects, (e.g., substance abuse) Product misuse: A product misuse is an intentional or inappropriate use of product not according to product labeled recommendation (e.g. dosing and dosing interval, contraindication, route of administration) Suspected transmission of an infectious agent: Transmission of an infectious agent via the medicinal product

5 Service Providers: Any appropriate worker ( e.g. non-employee) who is retained by Alexion, including affiliate locations to provide services to Alexion, including temporary staff and contracted agents. 6. REFERENCES Document Number Guideline on Good Pharmacovigilance Practices (GVP) Title Module VI Management and reporting of adverse reactions to medicinal products. European Medicines Agency Title 21 CFR Part Title 21 CFR Part Biological Products PRC (SOP-G-PV-0002) Post-marketing Reporting of Adverse Drug Experiences Post-marketing Reporting of Adverse Experiences Management of Post-marketing Individual Pharmacovigilance Cases SOP-G-PV-0020/ PRC Alexion Pharmacovgilance (PV) Event Reporting Tool 7. ASSOCIATED DOCUMENTS Document Number Title FRM Global Pharmacovigilance (PV) Event Reporting Form 8. APPENDICES Not applicable 9. REVISION HISTORY Document Number/ Version Effective Date Description of Change

6 Document Number/ Version Effective Date Description of Change PRC v1.0 (.00) PRC v2.0 (.01) PRC v3.0 (.02) 20 Apr 2010 Initial Release 08 Aug 2013 Reformat to current SOP format (SOP-G-CQA- 0001) Addition of Special Situations 22 May 2014 Addition of definition of Pharmacovigilance (PV) Event; update title to reflect PV Event Reporting PRC v4.0 () see effective date Addition of annual PV training requirement Update to PV Event reporting methods to include PV Event Reporting Tool and Global PV Event Reporting Form Addition of Associated Document: FRM ; Global PV Event Reporting Form