3 HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION

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1 1 PURPOSE The purpose of this procedure is to describe the method by which Adverse Events (AE)/relevant Safety Information and Product Quality Complaints (PQC) will be received, triaged, and documented by UCB, Inc s (UCB) Medical Information Department via UCBCares TM. 2 SCOPE This procedure applies to how the U.S. Medical Information (MI) Department via UCBCares handles Adverse Event reports/additional Safety Information and Product Quality Complaints for UCB marketed products received via phone, mail, , in person (e.g., at Medical Congress exhibit booth), social media or fax from any source (including for example health care professionals (HCPs), health authorities, advocacy groups, registries, license partners, vendors and consumers). This procedure applies to marketed products only. 3 HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION There are no significant hazards or special instructions relating to the arrangements described that need to be detailed in this SOP. 4 RESPONSIBILITIES Director, Medical Information Oversee the daily functions of the U.S. MI Department; and ensure the Sr. Manager, UCBCares employs procedures and training to ensure appropriate collecting and transfer of AEs and PQCs in accordance with applicable Pharmacovigilance and Quality Assurance procedures. Serve as a delegate to Sr. Manager, UCBCares to provide ad hoc reports to Compliance, Drug Safety or QA as required. Sr. Manager, UCBCares Manage all aspects of UCBCares Center activities to ensure accurate and timely receipt and processing of AEs and PQCs. Ensure quality checks are performed for AEs and PQCs handled by MI and UCBCares personnel. Oversee the training of MI and UCBCares Center personnel regarding AE and PQC handling. In conjunction with the Director, Medical Information, ensure quality checks are performed for AEs and PQCs handled by MI and UCBCares personnel. Page 1 of 11

2 Serve as delegate for the Director, Medical Information, to provide requested report statistics to Compliance for monitoring, as required. Ensure trn U.S. Medical Information Call Handling Training Document for specific workflow instructions are consistent with this SOP and are utilized in training of MI Personnel. Medical Information Personnel and UCBCares Document and accurately complete any AE, PQC or combined AE + PQC report in the Inquiries Database and forward case to U.S. Drug Safety and the Quality Assurance (QA) Departments as appropriate. Follow trn U.S. Medical Information Call Handling Training Document for specific workflow instructions. Compliance Monitor request statistics (and supporting individual requests) to identify non- compliance with this procedure. Investigate potential non-compliant activity identified through Medical Information and Compliance monitoring. 5 PROCEDURE 5.1 Receiving and Handling Adverse Event Reports UCBCares may receive AE reports from various sources, including consumers, health care providers (HCPs), field representatives, health authorities, advocacy groups, registries, licensed partners, social media or any UCB employee or contractor working on behalf of UCB. Each case documented in the inquiries database will receive an automatically generated unique case number which can be used for tracking and reconciliation purposes. The following steps should be followed when a Spontaneous AE is received: 1. Utilize the form sop-af U.S. Adverse Event Report Form to capture all data received. A scanned copy of any written information pertaining to the report shall be scanned and attached to the case created in the inquiries database. Page 2 of 11

3 At minimum, attempts shall be made to collect and document the following information: Reporter Contact Information Indication of use for product Patient name/initials Drug dosage form Date of Birth Drug dosing instructions Sex Has AE been previously reported? Description of AE Product Lot# Drug Name Product Expiration Date Drug Strength We recognize that in certain instances all of this information may not be available (e.g., certain product information is not available, or consumer/hcp refuses to provide their contact information, etc.). In those instances where part or all of the information is not available, this should be clearly noted in the respective field within the Inquiries Database by indicating Not Reported, Unknown (if the reporter cannot recall or find the information), Refused, or N/A (if the information does not apply to the specific case). All information should be reported verbatim from the reporter and documented in accordance with sop U.S. Affiliate Good Documentation Practices. In instances where information is not obtained from a live person (e.g., report received via fax) the information will be recorded in the Inquiries Database, and any associated documents received will be scanned and/or attached to the case created. 2. For all callers who have previously reported an AE and are calling to provide followup information, a warm transfer to UCB s U.S. Drug Safety Department should be attempted. 3. Within 24 hours of receipt, or the next business day (if received on a weekend or holiday), all AEs will be documented in the Inquiries Database and a case snapshot of this information will be sent to U.S. Drug Safety via at DS.US@ucb.com. If unable to document the information within the Inquiries Database within 24 hours, details of the Adverse Event will be fully communicated to UCB U.S. Drug Safety within 24 hours either verbally or via in accordance with UCB policy. 4. Adverse Event reports received via Social Media will be documented within the Inquiries Database within 24 hours of receipt by UCB and forwarded to U.S. Drug Safety via at DS.US@ucb.com. A screen shot of the site where the AE was recorded will be obtained and attached to the case in the Inquiries Database as source document for Drug Safety. 5. Adverse Event reports related to Clinical Trials will be documented within the Inquiries Database with 24 hours of receipt by UCB and forwarded to U.S. Drug Safety via at DS.US@ucb.com. Page 3 of 11

4 The following information will be collected: Patient Identifier (Initials, Age, Sex) Reporter s contact information UCB Product/formulation Description of the AE Indication of use for the product Study Information (Study ID and title) 5.2 Adverse Event Reconciliation On a weekly basis, the Medical Information Department will forward to U.S. Drug Safety a list of Adverse Event Report" cases (AEs and AEs + PQCs) received by Medical Information via UCBCares and support resolutions of discrepancies identified by U.S. Drug Safety as needed. Additional reconciliations will be carried out in accordance with sop-ai Management and Handling of Information Received via the U.S. Local Safety Office and it s associated document q U.S. Local Safety Office Reconciliations. 5.3 Product Quality Complaints Product Quality Complaints regarding UCB products will be documented in the Inquiries Database and sent within 24 hours or the next business day to UCB's QA Department. Additionally, any PQC also containing an AE will be forwarded to UCB's Drug Safety and QA departments. Each case documented in the inquiries database will receive an automatically generated unique case number which can be used for tracking and reconciliation purposes. All PQCs should be documented in the Inquiries Database and transmitted to the QA Department. A scanned copy of any written documentation related to the complaints should be imported into the Inquiries Database as an attachment to the corresponding case. 1. UCBCares and MI Personnel are responsible for obtaining the following information if performing intake of PQCs: Date the complaint was received Name of product Product available for return Dosage Form Product location Strength Has the reporter previously reported Lot# the potential PQC to UCB Expiry date Date the issue was first noticed NDC# Date of next scheduled dose Quantity Patient name Description of complaint Patient Phone Pharmacy Name/Phone# Patient Address Page 4 of 11

5 If Lot#, Exp Date and NDC# are not available: o Is the original packaging available? o Pharmacy Name and Store# o Pharmacy Phone# o Wholesaler Name o Wholesaler City and State o Pharmacy Account Number (with Wholesaler) 2. Employees will determine the type of complaint as a quality, medical, combination, or shipping complaint. In the event of an AE, the employee will appropriately document and notify U.S. Drug Safety within 24 hours of receipt or the next business day (if received on a weekend or holiday). If the complaint is questionable, regarding the type of complaint, a determination will be made in consultation with the U.S. QA and U.S. Drug Safety. Note: The complainant should be instructed to hold the product for 30 days in case return of the product is required for investigation. Any follow-up information to an existing complaint case forwarded from MI will be added to the original complaint record in the complaint database. 5.4 Product Quality Complaint Reconciliation On a weekly basis, the MI Department will forward to QA for reconciliation a list of PQC and PQC + AE cases received by Medical Information via UCBCares as outlined in sop U.S. Affiliate and Product Quality Complaint Process and Reconciliation. Additional reconciliations will be carried out in accordance with sop-ai Management and Handling of Information Received via the U.S. Local Safety Office and it s associated document q U.S. Local Safety Office Reconciliations. 5.5 UCBCares Staffing The UCBCares Center operational hours are from 8 am to 5 pm Monday through Friday during UCB hours of operations with the exception of UCB observed Holidays. Afterhours on call service is provided by the MI personnel for emergent needs on nights, weekends and holidays Missed Calls during Business Hours In case of missed phone calls that are reporting an AE or PQC, an option to leave a voic message will be available to the reporter. The voic system will be continuously monitored and phone calls will be returned. Two attempts within one business day will be made (and documented) in order to collect additional information. Page 5 of 11

6 If the attempts are unsuccessful, any potential AE information, including any source documentation and any PQC information will be forwarded to U.S. Drug Safety and U.S. Quality Assurance per section 5.1 and 5.3 respectively Twenty-four Hour Coverage Calls received outside of normal business hours regarding an AE or PQC which may be identified as urgent by the reporter will be returned as soon as possible and in any event no later than 24 hours. An attempt to collect information will be made as per section 5.1 and 5.3. Non-urgent messages will be reviewed on the next business day and processed in accordance with section 5.1 and 5.3. Calls received outside normal business hours regarding all other urgent safety related issues will be escalated immediately to the Head of the U.S. Drug Safety (Local Safety Officer). Contact information for the Local Safety Officer can be obtained by accessing the following link on the UCB plaza: Holiday Coverage For holiday coverage, on call service will be provided as stated in section For closures greater than one day, an alternate staffing model will be utilized in line with that indicated in sop U.S. Medical Information Contingency Plan. All information collected will be forwarded as specified in section 5.1 and Phone and IVR System Checks The Phone system and IVR system checks will be performed in accordance with the policies and procedures outlined in section 6.2 of sop U.S. Medical Information Contingency Plan. 6 ABBREVIATIONS AND DEFINITIONS Abbreviations and definitions used in this document are in accordance with the UCB Glossary. To the extent that these definitions differ from those contained in the UCB Glossary, these definitions will take precedence for the purpose of this policy / procedure. 6.1 Abbreviations AE HCP MIS MI Adverse Event Health Care Professional Medical Information Specialist Medical Information Page 6 of 11

7 PQC QA Product Quality Complaint Quality Assurance 6.2 Definitions Adverse Event / Additional Safety Information (Medical Complaint) Healthcare Professional Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which may or may not have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding),symptoms or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (ICH E6, E2D). Additional safety information includes the following report types: use during pregnancy (i.e. drug exposure to a fetus in utero, whether the fetus is exposed via the mother taking the product or transmission via semen following paternal exposure) exposure to a drug during breast-feeding / lactation overdose (whether intentional, accidental or prescribed) drug abuse or misuse medication errors (including dispensing errors, accidental exposure, maladministration, etc.) unapproved or off-label use (i.e. intentional medical use of a product not in accordance with the authorized product information) lack of therapeutic effect/lack of efficacy withdrawal reactions / rebound effects unusual disease progression / exacerbation of existing disease suspected use of counterfeit/ falsified medicines/tampering drug-drug / drug-food interactions suspected transmission of an infectious agent via a medicinal product occupational exposure (as a result of one s professional or non-professional occupation) unexpected benefit counterfeits Any individual who may directly or indirectly purchase, recommend, use, prescribe, or arrange for the use of UCB products. This includes individuals such as physicians, nurses, nurse practitioners, physician assistants, pharmacists, other allied Page 7 of 11

8 Medical Information Personnel/Specialist Medical Information System ( Inquiries Database ) Product Complaint Product Quality Complaint UCBCares healthcare professionals, health plan administrators, Formulary/Pharmacy & Therapeutics Committee members, scientists, researchers, research coordinators and technicians. Employee within U.S. Medical Affairs responsible for handling medical and scientific information provided in response to Unsolicited Requests for Medical Information regarding UCB products and/or related disease states. A database (referred to as Inquiries Database ) in which UCBCares TM and Medical Information Personnel log and track all Unsolicited Requests for Medical Information regarding UCB products or related disease states, in compliance with applicable data privacy laws and regulations. Any verbal, written or electronic expression of dissatisfaction with a product's identity, quality, stability, reliability, safety, effectiveness, performance or usage. The report could be made by a patient, pharmacist, healthcare professional, or health authority. A Product Complaint regarding suspected defective products or suspicion of counterfeiting. The U.S. single source customer solution center. Page 8 of 11

9 7 RELATED DOCUMENTS 7.1 Associated Documents sop-af , U.S. Adverse Event Report Form 7.2 References trn , U.S. Medical Information Call Handling Training Document sop , U.S. Field Personnel Handling of Unsolicited Requests for Medical Information sop , U.S. Affiliate Product Quality Complaint Process and Reconciliation sop , U.S. Handling of Unsolicited Requests for Medical Information sop , U.S. Affiliate Good Documentation Practices sop , U.S. Affiliate Product Quality Complaint Process Reconciliation sop , U.S. Medical Information Contingency Plan sop-ai , Management and Handling of Information Received via the U.S. Local Safety Office q , U.S. Local Safety Office Reconciliations Complaint files U.S. 21 CRF600.80, as amended. Post-marketing reporting of adverse experiences U.S. 21 CFR , as amended. Post-marketing reports U.S. 21CFR314.80, as amended. Post-marketing reporting of adverse drug experiences U.S. 21CFR312.32, as amended. IND safety reports U.S. 21CFR , as amended. Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications (pre-1938 marketed drugs) Public Law (December 22, 2006) U.S. Guidance for Industry Post-marketing Safety Reporting of Human Drug and Biological Products Including Vaccines (March 2001) U.S. Guidance for Industry Post-marketing Adverse Event Reporting for Nonprescription Human drug products marketed without an Approved Application (October 2007) 8 LIST OF APPENDICES N/A Page 9 of 11

10 9 SOP HISTORY Supersedes SOP(s) (SOP number and version) sop Changes New document. Procedure formerly captured in sop and is now included in this separate SOP as part of the UCBCares TM organizational restructure. Page 10 of 11

11 DOCUMENT APPROVAL ELECTRONIC SIGNATURES Signed by Meaning of Signature Server Date (dd-mmm-yyyy HH:mm:ss TZ) SANFORD Kristi Subject Matter Expert Approval 20-Oct :32:10 CEST BASSING Adam Legal Approval 20-Oct :44:37 CEST BESS Christopher Author Approval 21-Oct :55:26 CEST COCHRAN Tyler Quality Approval 22-Oct :19:23 CEST MARSH Christi Management Approval 23-Oct :04:40 CEST PATEL Shalini Subject Matter Expert Approval 23-Oct :25:49 CEST Page 11 of 11