3. HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION

Transcription

1 1. PURPOSE The purpose of this procedure is to describe the method by which Unsolicited Requests for Medical Information will be received, triaged, processed, and documented by the UCB, Inc. (UCB) Medical Information Department. 2. SCOPE This procedure applies to how U.S. Medical Information Department Personnel responds to Unsolicited Requests for Medical Information from the following sources in general including, but not limited to: phone, mail, , in person (e.g., at Medical Congress exhibit booth), social media, on demand chat, online webform, or fax from any Customer type including, but not limited to, health care professionals (HCPs), health authorities, advocacy groups, registries, license partners and consumers). This procedure applies U.S. marketed products and investigational products registered to UCB, Inc. and subsidiaries. 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. Medical Information Department Ensure quality checks are in place to be followed by responsible delegates within the Medical Information Department including the Sr. Manager, UCBCares, UCBCares Managers, and the MISs Provide requested report statistics to Compliance for monitoring Sr. Manager, UCBCares Manage all aspects of UCBCares Center activities to ensure accurate, narrowly tailored, and balanced information is communicated in response to Unsolicited Request for Medical Information in a timely manner Oversee the training regarding Unsolicited Requests and manage quality of customer service In conjunction with Managers UCBCares Director, Medical Information, ensure quality checks are performed for Unsolicited Requests for Medical Information handled by Medical Information personnel Page 1 of 15

2 Serve as delegate for Director Medical Information, to provide requested report statistics to Compliance for monitoring, as required Ensure trn U.S. Medical Information Call Handling Training Binder for specific workflow instructions are consistent with this SOP and are utilized in training of Medical Information Personnel Medical Information Personnel Provide requestor with a written and/or verbal response to Unsolicited Requests Accurately and completely document any Adverse Event (AE/additional safety information), Product Quality Complaint (PQC) or combined AE + PQC in accordance with sop U.S. Medical Information Handling of Adverse Event Reports and Product Quality Complaints Handle or transfer other non medical requests as needed to the appropriate function or department Document the Unsolicited Request for Medical Information and related verbal or written response in the Inquiries Database in accordance with data privacy laws and regulations Ensure that materials provided in response to an Unsolicited Request for a specific published article, abstract, or UCB sponsored poster regarding a UCB product or disease state, comply with the requirements of section 5 of this SOP Follow trn U.S. Medical Information Call Handling Training Binder for specific workflow instructions Regulatory Affairs Provides requested product information (e.g. approved components, ingredients) from the approved application (NDA, ANDA, BLA). Compliance Monitoring statistics relating to handling of Unsolicited Requests (and supporting individual requests) to identify non-compliance with this procedure Investigating potential non-compliant activity identified through Medical Information and Compliance monitoring 5. PROCEDURE 5.1 Handling Medical Information Contacts a. Medical Information Inquiries In response to an Unsolicited Request from an HCP, Health Agency, Payor, or other relevant customers, the Medical Affairs Department, including Medical Information Page 2 of 15

3 Personnel may provide Off-Label information about UCB s products. Such responses must be narrowly-tailored to the question asked and must be based on science (i.e., data-driven). The response must also clearly communicate that the information provided relates to an unapproved use and must be presented in comparable format and prominence as the other information provided, such that the approved indication(s) of the product and the nature of information provided may be readily understood. Medical Information employees may not offer any specific patient treatment recommendations to HCPs. All responses provided to HCPs must be accurate, balanced and substantiated by appropriate scientific evidence of appropriate rigor and validity. b. Medical Information Inquiries Forwarded by Field Personnel Field Personnel may not respond to Unsolicited Requests for Off-Label information. Instead, Field Personnel must submit Unsolicited Requests for Medical Information received from a HCP in accordance with SOP U.S. Field Personnel Handling of Unsolicited Requests for Medical Information. The Medical Information department will follow up directly with the HCP. Any confirmed reports of off label use must be forwarded to U.S. Drug Safety in accordance with this SOP. c. Medical Information Inquiries Forwarded by Medical Science Liaison A Medical Science Liaison may submit Unsolicited Requests for Medical Information received from a HCP to the Medical Information Department for follow up. The Medical Information department will follow up directly with the HCP, in accordance with SOP U.S. Medical Science Liaison Activities, for inquiries forwarded by MSLs and will cc: the MSL on the response. d. Medical Information Inquiries from Consumers Medical Information responds to Unsolicited Requests received from consumers only to the extent that the discussion concerns approved product uses in accordance with the approved product Package Insert. The information provided should allow the consumer to have a more meaningful and productive discussion with his or her HCP. The employee should direct the consumer to consult their prescribing HCP. Medical Information personnel may not recommend specific HCPs or make any specific treatment recommendations to consumers. e. Requests from Drug Compendia or Effectiveness Review Agencies For inquiries from any Drug Compendia, the Medical Information department will handle in accordance to SOP U.S. Handling Requests and Interactions with Commercial Drug Compendia and/or U.S. Handling of Requests from Drug Effectiveness Review Agencies.. Page 3 of 15

4 5.2 Intake and Evaluation of Medical Information Requests At a minimum, for each Unsolicited Request received, the following key information must be documented in the Inquiries Database: a. Date of inquiry; b. Form of inquiry (e.g., fax, phone, etc); c. Name of the requesting HCP, HCI, Consumer or other Customer; d. Nature and topic of request (including exact language of the inquiry if made in writing); e. An evaluation of whether the inquiry relates to information about an Off-Label indication for the product; f. Nature/form of the response from UCB (including a record of the materials provided to the HCP, HCI, Consumer or other Customer in response to the request); g. the name of the UCB employee who called on or interacted with the HCP, HCI, Consumer or other Customer; and h. Name of the UCB employee who reviewed the inquiry (if applicable); and i. Date the inquiry was reviewed. The Medical Information Employee must make his or her best effort to obtain all of the information listed above. In the unusual circumstance that required information is not provided, the employee will note in the respective field in the Inquiries Database case record as not reported or refused, as applicable. 5.3 Responding to Inquiries A Medical Information Employee or designee may provide verbal and/or written responses to Unsolicited Requests based on current approved Package Insert, approved Medical Response Documents including Letters, Package Inserts, FAQs, Chat FAQs and Social Response documents housed in the Inquiries Database and approved via US SOP The employee must: a. Seek to narrow the scope of the inquiry if it is overly broad in scope, b. If request is for Off-Label information, Clarify in both the verbal/written response that the information being provided relates to the use of a UCB product that has not been approved by the FDA. For any written response, such response will prominently disclose the approved uses of the product. c. Ensure the response contains only information necessary to respond to the particular request Page 4 of 15

5 d. Ensure the response is otherwise within the parameters set forth in this Policy If a written response is requested, such response may be generated from an approved Medical Response Document (e.g. Letter or Approved Dossier, etc.) in the Inquiries Database. All written responses are accompanied by a cover letter and the approved UCB product Package Insert, when applicable. All responses, including both verbal and written, must be documented in the Inquiries Database. If Medical Response Documents (e.g. Letters, FAQs, etc.) do not exist on the topic of the Unsolicited Request, the MI Personnel will escalate the case for further handling with the appropriate MIS for further research on the topic. For verbal responses, the requestor will be called back and the response given and documented in the Inquiries Database. An FAQ may be created because of such research in accordance with the process detailed in SOP U.S. Preparing & Approving Medical Information Response Documents. If a written response is appropriate or requested, the MIS will develop a Medical Response Letter according to the process detailed in SOP U.S. Preparing & Approving Medical Information Response Documents. 5.4 Timing of Response a. Unsolicited Requests for Medical Information will be responded to promptly, provided the necessary information to answer the inquiry exists in one or more of the following: current approved Package Insert, approved Medical Response Letters and/or FAQ documents housed in the Inquiries Database. For inquiries requiring further research on the topic/issue, the length of response time will depend on the level of research required. Voic messages left in the Medical Information voice mailbox will be returned promptly. A mechanism will be in place to receive after hours pages for urgent messages. For all voic messages, two attempts will be made to reach callers. b. For privacy considerations, UCB Medical Information personnel may not leave a detailed message if a call is unanswered. Medical Information may leave a message inviting a return call. Return call activity (including any message left) must be documented in the Inquiries Database in the record for that inquiry. 5.5 Responding to Requests for Copies of Publications Upon receiving an Unsolicited Request for a specific published article, abstract or UCB sponsored poster regarding a UCB product or disease state, that is included on a medical information/medical director/and legal pre-approved listing, the Medical Information Employee may provide the specifically requested document(s) either in a hard copy (reprint) or electronic format in accordance with all applicable laws, including copyright laws. If the publication requested is not on the pre-approved listing, the employee should have the request approved by Director, Medical Information, (or delegate) and relevant product medical director (or delegate) and legal prior to fulfillment. The employee may Page 5 of 15

6 not provide materials that are false or misleading or are not scientifically rigorous and accurate in accordance with USMA policy, nor may an MIA/MIS provide materials that the MIA/MIS knows are materially contradicted by other sources. In general, requests for non-ucb sponsored posters, abstracts/posters not approved in accordance with procedure SOP Planning, Preparation and Release of Scientific Publications, review articles, and consensus papers will not be fulfilled. Materials requiring copyright permissions for external distribution will only be sent following the purchase of such permissions. Hardcopy documents will be clearly marked regarding the copyright restrictions and permissions. Electronic copies will be sent with appropriate copyright disclaimers. All materials will have an accompanying cover letter as well as the approved UCB product Package Insert and will be documented in the Inquiries Database. 5.6 Responding to Requests for Formulary Dossiers Upon receiving an Unsolicited Request for a Formulary Dossier for a UCB product, the Medical Information employee may provide these documents either in a hard copy or electronic format. All responses related to the AMCP Dossiers will be documented in the Inquiries Database. 5.7 Handling of Other Types of Cases Requests that are outside of the activities of Medical Information will be triaged based on the nature of the request. See associated documents for U.S. Medical Information Call Handling Training Binder and U.S. Medical Information Handling of Adverse Event Reports and Product Quality Complaints. a. Request for Customer Service Any CS requests (e.g. patient assistance, Field Personnel identification, etc.) will be promptly processed by an appropriate member of the UCBCares team. b. Communications from Media and Analysts Any communication from media and analysts should be recorded in the Inquiries Database; case details should be promptly forwarded to the Corporate Communications Department at UCB. c. Requests to Participate in or for Information Regarding Clinical Trials Refer all non-specific requests for information on ongoing UCB Clinical Trials to Narrowly tailored, specific questions should be treated in accordance with this policy. Page 6 of 15

7 d. Questions Regarding UCB Education or Charitable Grants All grant requestors will be instructed to contact the UCB Grants department via their dedicated web site at to initiate their grant request. For additional information they can also contact the UCB Grants department via at or via phone at (toll free). Requestors may also be referred to the UCBCares tab on the UCB home page at to access contact information for the UCB Grants department. e. Questions Regarding Investigator Initiate Studies All inquiries for information on Investigator Initiated Studies (IIS) will be referred to the UCB erequest portal at for additional information. f. Legal Issues Communications to Medical Information that involve potential legal matters should be promptly forwarded to Legal Department at UCB. g. Co-marketed or Co-distributed Products For products co-marketed or co-distributed with another company, direct callers to the appropriate contact as outlined in the co-market or co-distribute agreement. h. UCB Products Sold or Licensed to a Third Party UCB Medical Information will continue to respond to Unsolicited Requests for Medical Information regarding UCB products that have been sold or licensed to a third party for the duration stated in the UCB contract with the purchaser of the product. Once the stated time period has passed, UCB will notify requestors that UCB no longer owns and/or markets the products and direct requests for Medical Information to the new product owner. i. Non-UCB Products For inquiries regarding non-ucb products, Medical Information will inform callers that the product is not a UCB product and instruct callers to contact their HCP or the appropriate company. j. Payment or Disclosure Reports All inquiries regarding UCB, Inc. physician payment disclosure reports or other healthcare professional disclosures should be forwarded to the UCB Compliance Transparency team at transparency@ucb.com 5.8 Training of Medical Affairs Staff All Medical Affairs staff, including the Medical Information Department, Medical Managers, Grant Specialists, Investigator Initiated Studies Coordinators, MSLs and Medical Directors will undergo training on all applicable policies and procedures. This will be overseen by the Director, Medical Information and Sr. Manager, UCBCares or Page 7 of 15

8 delegate. UCB must document when this training occurs. As added reference to this SOP, all Medical Information Employees will be instructed with the associated document titled trn U.S. Medical Information Call Handling Training Binder and U.S. Medical Information Handling of Adverse Event Reports and Product Quality Complaints for specific instructions. 5.9 Documentation, Record Maintenance and Retention All records, information and deliverables related to this procedure will be retained for a period of six (6) years or longer if required by applicable law, contract or regulatory requirement. Records related to this procedure will be maintained by the activity owner unless otherwise specifically directed by the Legal Department. For GxP records retention refer to Corporate SOP Global Archive Procedure for Critical Records. Any Medical Information employees or representatives receiving and processing Unsolicited Requests for Medical Information, must ensure that all requests and responses are properly documented in the Inquiries Database Compliance Monitoring of Unsolicited Requests Compliance will request periodic trending and ad hoc reports of request statistics from Medical Information for monitoring purposes. As part of this monitoring review, Compliance will assess if there is potential evidence of non-compliance with UCB processes and instances that may be indicative of Off-Label promotion. As warranted, Compliance may request additional supporting data to verify concerns identified during routine monitoring. Monitoring results will be captured as part of the UCB, Inc. Compliance Monitoring Program in accordance with SOP U.S. Compliance Program Monitoring Quality Checks for U.S. Handling of Unsolicited Requests to Medical Information Individual Case Monitoring In the routine course of business, each Medical Information Employee will monitor individual requests and will notify the Compliance Department if non-compliance is suspected, and document any required action or follow up accordingly within the case record in the Inquiries Database (e.g., IRMS) Quality Checks for U.S. Handling of Unsolicited Requests for Medical Information On a monthly basis, the Director, Medical Information or Sr. Manager, UCBCares (or delegate) will perform a quality check of a random sampling of Medical Information inquiries to ensure requests are being appropriately documented and handled. The sample inquiries will consist of a sampling of all cases generated from the Inquiries Database and include at least one case for each employee handling inquiries. The Page 8 of 15

9 Director, Medical Information or Sr. Manager, UCBCares (or delegate) will review each sample case to ensure an appropriate response was provided (e.g., appropriate FAQ utilized) and calls requiring further follow-up beyond Medical Information were appropriately triaged (e.g. Quality Assurance or Legal). The review and any subsequent action taken will be documented on the form Medical Information Quality Check Form - Medical Responses-Non Field and Field. On a monthly basis, the Director, Medical Information or Sr. Manager, UCBCares (or delegate) will meet with the Drug Safety Representative to review sample cases to ensure AE or potential safety information was not improperly categorized as a medical information case. The review and any subsequent action taken will be documented on the form Medical Information Quality Check Form - Adverse Events External Call Centers All external call centers contracted by UCB for the purpose of handling requests for UCB s Medical Information Department will handle all calls in accordance with this SOP or as outlined in the contract agreement. 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 Adverse Event CS Customer Service HCP Health Care Professional HCI Health Care Institution MIS Medical Information Specialist MI Medical Information MSL Medical Science Liaison PQC Product Quality Complaint QA Quality Assurance Page 9 of 15

10 6.2 Definitions Adverse Event/Additional Safety Information 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 Page 10 of 15

11 Field Personnel Formulary Dossier Healthcare Professional Medical Information /Specialist MIS Medical Information System ( Inquiries Database ) Medical Science Liaison Off-Label Product Complaint Field based personnel that report into sales, marketing or managed care (e.g., sales representatives, account executives, area business specialists, etc.) A standardized set of clinical and economic evidence prepared by pharmaceutical manufacturers to provide information for consideration during the formulary decision-making process. 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 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 MIA/MIS 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. An employee within the Medical Affairs Department with specialized scientific and medical knowledge who communicates primarily with KOLs, other academics and HCPs on a peer-to-peer basis regarding UCB products and related topics. Any information or data that are not consistent with the Food and Drug Administration (FDA)-approved package insert for a UCB product. Inconsistencies may include, but are not limited to, differences in intended use, special patient populations, dosage and administration, age groups, and/or the safety and effectiveness profile. Any verbal, written or electronic expression of dissatisfaction with a product's identity, quality, stability, reliability, safety, Page 11 of 15

12 effectiveness, performance or usage. The report could be made by a patient, pharmacist, healthcare professional, or health authority. Product Complaints includes Adverse Events and Product Quality Complaints. Product Quality Complaint A product complaint regarding suspected defective products or suspicion of counterfeiting. Unsolicited Request for Medical Information UCBCares Medical Response Document Drug Safety Representative 7. RELATED DOCUMENTS A request for medical and/or scientific information related to UCB Products or related disease states that is not prompted, facilitated, or encouraged by any UCB employee (Unsolicited Request). The U.S. single source customer solution center. Documents created by MI personnel representing an up-to-date summary of the latest UCB product or related disease state information, which must be accurate, balanced, substantiated by appropriate scientific evidence of appropriate rigor and validity and non-promotional in nature. An employee within the U.S. Drug Safety Department with specialized pharmacovigilance knowledge who is involved with the reporting and monitoring of adverse events. 7.1 Associated Documents sop-af , Medical Information Quality Check Form - Adverse Events sop-af , Medical Information Quality Check Form - Medical Responses (Non Field and Field) 7.2 References trn U.S. Medical Information Call Handling Training Binder sop , Planning, Preparation and Release of Scientific Publications sop , Global Archive Procedure for Critical Records sop , Handling of Unsolicited Requests for Medical and Scientific Information sop , U.S. Preparing & Approving Medical Information Response Documents sop , U.S. Field Personnel Handling of Unsolicited Requests for Medical Information sop , U.S. Affiliate Product Complaint Process and Reconciliation Page 12 of 15

13 sop , U.S. Handling Requests and Interactions with Commercial Drug Compendia sop , U.S. Medical Science Liaison Activities sop , U.S. Compliance Program Monitoring sop , U.S. Handling Requests and Interactions with Commercial Drug Compendia sop , U.S. Medical Information Handling of Adverse Event Reports and Product Quality Complaints sop , U.S. Handling and Interactions Related to Comparative Effectiveness Research Requests from Government Entities 8. LIST OF APPENDICES N/A 9. SOP HISTORY Supersedes SOP(s) (SOP number and version) MA-SOP-006 v1.0 sop v1.0 sop v 2.0 Migration into MIKADO CD Reason for change Updated due to changing business requirements Major updates included Section 6.8, Compliance Monitoring methodology and Added sub-section to Section 6.9 to include specific mention of Individual Monitoring of Unsolicited Requests and also how Medical Information will notify Compliance on case by case basis in addition to the report and trending monitoring that is done by Compliance. Minor changes included Section 6.4bclarified the wording around how enclosures are approved for use in responding to Unsolicited Requests for publications. Section 6.5 f, Grants contact information was verified and updated. Added Section 6.5 k, which included Transparency Payment and Disclosure contact information. Updated associated forms sop-af to include information specific to CIA requirements for inquiries database documentation. Added a Reference Document trn U.S. Medical Information Call Handling Training Binder. Page 13 of 15

14 Supersedes SOP(s) (SOP number and version) sop v 3.0 Reason for change SOP updated to reflect organizational changes associated with UCBCares. The AE/PQC components of this SOP were removed and placed in their own separate SOP. Page 14 of 15

15 DOCUMENT APPROVAL ELECTRONIC SIGNATURES Signed by Meaning of Signature Server Date (dd-mmm-yyyy HH:mm:ss TZ) BESS Christopher Author Approval 05-Sep :04:23 CEST SANFORD Kristi Subject Matter Expert Approval 05-Sep :31:30 CEST PORCHER Almisha Quality Approval 08-Sep :25:24 CEST MARSH Christi Management Approval 09-Sep :25:03 CEST PATEL Shalini Subject Matter Expert Approval 15-Sep :45:49 CEST BASSING Adam Legal Approval 26-Sep :20:26 CEST Page 15 of 15