Pharmacovigilance and Risk Management

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1 Pharmacovigiance and Risk Management Suzanne Gagnon*, Peter Schueer**, James (Dachao) Fan y *ICON Cinica Research, North Waes, Pennsyvania, USA **ICON Cinica Research, Langen, Hessen, Germany y ICON Cinica Research Pte Ltd/Asia Pacific, Singapore CHAPTER OUTLINE Definition of Pharmacovigiance and Risk Management 142 The Importance of Impementing a Systematic Pharmacovigiance Approach in Goba Cinica Trias 142 Operationa Overview of Pharmacovigiance 143 Components and Capabiities of a Compete Pharmacovigiance System 144 Pharmacovigiance Poicies, Reguations, and Guidance Documents 145 Adverse Event Reporting 145 Standard Operating Procedures, Study- Specific Procedures, and Safety Pans 147 Quaity Management System 147 Organizationa Structure of a Pharmacovigiance Department 148 Departmenta Organization 148 Coaboration and Teamwork on Goba Cinica Trias 148 Roe of The Medica Monitor 149 Roes and Responsibiities of the Pharmacovigiance Team 150 Head of Pharmacovigiance 150 Drug Safety Physician/Directors of Drug Safety 150 Quaified Person for Pharmacovigiance in Europe 150 Pharmacovigiance/Drug Safety Product Manager 151 Drug Safety Associate 151 Medica Assistant 151 Safety Systems Speciaists 151 Pharmacovigiance Trainer 152 Appropriate Faciities for Pharmacovigiance 152 Safety Databases 152 Safety Case Processing and Review 152 Steps in Serious Adverse Event Case Processing 153 Goba Safety Reporting 153 Safety Data Review and Assessment 154 Individua Subject Data 154 Subject Profies 154 Review of Aggregate Data 155 Signa Detection and Anaysis 155 Managing Risk 157 Risk Management Pans and Risk Evauation and Mitigation Strategies 157 Outsourcing Whie Buiding Pharmacovigiance Capacity 158 Genera Considerations and Concusions 158 References Goba Cinica Trias Paybook. DOI: /B Copyright Ó 2012 Esevier Inc. A rights reserved.

2 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity DEFINITION OF PHARMACOVIGILANCE AND RISK MANAGEMENT The Word Heath Organization (WHO) defines pharmacovigiance as the science and activities reating to the detection, evauation, understanding, and prevention of adverse reactions to medicines or any other medicine-reated probems. The definition and scope of pharmacovigiance have evoved to recognize the importance of a systems approach for monitoring and improving the safe use of medicines. 1 A simper definition describes pharmacovigiance as the processes and science of monitoring the safety of medicines and taking action to reduce risk and increase benefit. 2 Therefore, the assessment of benefit versus risk must begin during the precinica evauation of a medicina product and must extend throughout its fu ife cyce. As a resut, there is now added focus on safety and risk assessment after a product has received reguatory approva, when it is paced on the market and prescribed to arge popuations. Athough there is no internationa standard that dictates the components of an adequate pharmacovigiance system or the processes to be engaged in risk management, there is consensus among the major reguators that pharmacovigiance is necessary and important in the deveopment and commerciaization of medicina products. Therefore it is essentia in buiding capacity for cinica trias to understand the components, the functions, and the processes required for fu and effective pharmacovigiance and risk management. 142 THE IMPORTANCE OF IMPLEMENTING A SYSTEMATIC PHARMACOVIGILANCE APPROACH IN GLOBAL CLINICAL TRIALS The amount and variety of safety-reevant data gathered from different patient popuations in goba cinica trias are enormous; therefore it is crucia that a concise and systematic approach to pharmacovigiance be impemented. Systematic safety monitoring is needed to identify previousy recognized and unrecognized adverse drug reactions and to evauate the safety and efficacy of medicina products during cinica trias and in the postmarketing period. It is important that pharmacovigiance not be perceived as a burden put upon the pharmaceutica product deveopment industry by the reguating bodies. Ongoing pharmacovigiance shoud be understood as essentia to the ony appropriate way to deveop safe medicines, introduce them into the market, and have them survive in the market once approved. Not ony does the faiure to perform ongoing safety assessment activities increase the chances of pacing subjects at risk unnecessariy, it aso increases a company s risk of investing in the deveopment of the wrong moecues. The foowing exampe iustrates the vaue of ongoing systematic pharmacovigiance. Figure 13.1 dispays aggregate aanine aminotransferase (ALT) data reported during a cinica tria performed to evauate a new oncoogy compound. The product was dosed cycicay, administered intravenousy every 21 days. Review of aggregate data from the initia eight patients suggested that the product caused a transient hepatitis, particuary apparent after the first dose, as shown by the spiking ALT eves. It was thus advisabe to re-evauate the initia dosing and the dosing intervas, and cosey monitor iver function in a patients to avoid unacceptabe toxicity and to better assess the benefit/risk vaue and the appropriate popuation for the drug. Because the review was part of ongoing pharmacovigiance during the cinica tria, the safety issue was identified and addressed eary in cinica deveopment. Such aboratory trend anaysis yieds maximum benefit when part of a systematic approach to safety monitoring. Capacity buiding for pharmacovigiance and medicine safety shoud address a processes for deveoping individua and system capacity and enabe achievement of sustainabe abiity to

3 Pharmacovigiance and Risk Management FIGURE 13.1 Ongoing surveiance and trend anaysis of iver function tests showing potentiay iver-toxic effects in a cycic dosing scheme. Source: IMRAeICON Medica Review Appication. (Pease refer to coor pate section) manage effectivey the safety of patients and heath products. 3 Performing systematic pharmacovigiance requires a fu understanding of the scope of pharmacovigiance, which incudes both active safety reporting and postmarketing surveiance. It invoves the ongoing processes of risk identification, risk assessment, and risk mitigation. A of these processes are equay important to the pharmaceutica company, the reguatory authorities, the investigator, and the patient. There are many ways of buiding pharmacovigiance capabiity, and many differences in how pharmacovigiance systems are created. Historicay, companies created pharmacovigiance functionaity as the need arose to assess their products under deveopment. Since there are variations in the required sampe size of studies, geographica site distribution, adjuvant or comparator products used, and in the definition of standard treatment in different countries, differences naturay evoved. Goba pharmacovigiance is an ongoing process of harmonization. Currenty, there are many nationa, cutura, and reguatory differences among countries in how pharmacovigiance is impemented. The goa is aways the accurate assessment of the benefit versus the risk of a product in the popuations who receive it, and mature pharmacovigiance systems are abe reach accurate concusions despite different types of data. 143 OPERATIONAL OVERVIEW OF PHARMACOVIGILANCE An operationa overview of pharmacovigiance begins with safety information coming from a variety of sources, incuding cinica trias data, safety ca centers, spontaneous reports, and iterature searches, each of which has the potentia to create an individua case. Within the pharmacovigiance department each case is processed, assessed as to its reationship (causaity) to the investigationa product, and reported to the reguatory authorities and other stakehoders, either as an expedited report or as part of an aggregate report, based upon pharmacovigiance poicies, reguations, and guidance documents. In addition, each case becomes part of the tota safety dataset for that medicina product. Aggregate data are systematicay anayzed for safety issues and assessed for benefit versus risk, and periodic safety update reports (PSURs) are submitted to the reguatory authorities as additiona safety information is coected. This continues throughout the product s ife cyce. Safety findings are addressed in order to mitigate risk. This may incude modification to a cinica tria design, changes in proposed abeing, impementation of a risk mitigation pan,

4 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity FIGURE 13.2 Summary of the major activities associated with pharmacovigiance. SAE: serious adverse event; QC: quaity contro. (Pease refer to coor pate section) or discontinuation of deveopment or use of a marketed product. A fow diagram summarizing the major activities associated with pharmacovigiance is shown in Figure COMPONENTS AND CAPABILITIES OF A COMPLETE PHARMACOVIGILANCE SYSTEM Based upon the intent and scope of pharmacovigiance, there are certain components and capabiities that are essentia to a fuy functioning pharmacovigiance system, regardess of how a company s safety department is constructed (Figure 13.3). These incude: a quaified person for pharmacovigiance (QPPV) (Europe) safety systems (database) support. safety case processing and review medica writing and aggregate reporting a sound quaity management system incuding standard operating procedures (SOPs), quaity standards, metrics, and training signa detection and risk anaysis goba safety reporting FIGURE 13.3 Components and capabiities of a fuy functiona pharmacovigiance system. QPPV: quaified person for pharmacovigiance; EU: European Union; SOP: standard operating procedure.

5 Pharmacovigiance and Risk Management In some companies some activities may be performed by different departments, for exampe, safety reguatory reporting may be part of reguatory affairs, or aggregate report writing may be done within a company s medica writing department. Some activities may be outsourced to contract research organizations (CROs) or safety niche providers, whie others are kept inhouse, but a must be covered for compete pharmacovigiance capacity. PHARMACOVIGILANCE POLICIES, REGULATIONS, AND GUIDANCE DOCUMENTS In the major regions of the word where medicina products are deveoped, pharmacovigiance is highy reguated. Structures, systems, and roes are determined by aws, reguations, guidances, and guideines; it is within this context that the department s organizationa structure is estabished, the individua roes and the systems required are defined, the ski sets necessary are determined, and the toos to perform pharmacovigiance effectivey are created. The major reguatory stakehoders driving the formation of goba pharmacovigiance reguation are the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan s Pharmaceuticas and Medica Devices Agency (PMDA). In the USA, the Code of Federa Reguations is egay binding, as are the European nationa aws and ordinances. Directives refect current thinking on a topic and bind member states to common objectives, which must be impemented into nationa aw within a given timeframe. Guidance documents, guideines, and recommendations are not egay binding, but shoud be respected and pay an important roe in actua practice. Goba principes are harmonized through the Internationa Conference on Harmonisation (ICH). ICH E1eE2F focus on cinica safety. Direction is provided in ICH E2AeC (Cinica Safety Data Management), E2D (Post-Approva Safety Data Management: Definitions and Standards for Expedited Reporting), E2E (Pharmacovigiance Panning), and E2F (Deveopment Safety Update Report). 145 ICH E6 (Good Cinica Practice) describes the responsibiities and expectations of a stakehoders in the conduct of cinica trias. However, even as efforts to harmonize pharmacovigiance processes continue, companies must sti compy with nationa aws and oca reguations. As in other areas of deveopment, companies shoud have SOPs around pharmacovigiance processes in order to ensure consistency, compiance, and quaity. Adverse Event Reporting DEFINITIONS Reporting of adverse events is the cornerstone of pharmacovigiance, and therefore cosey supervised by reguatory authorities. ICH E2A defines the foowing adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) as foows: Adverse event (or adverse experience) Any untoward medica occurrence in a patient or cinica investigative subject administered a pharmaceutica product and which does not necessariy have to have a causa reationship with this treatment. An adverse event (AE) can therefore be an unfavorabe and unintended sign (incuding an abnorma aboratory finding, for exampe), symptom or disease temporay associated with the use of a medicina product, whether or not considered reated to the medicina product.

6 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity Adverse drug reaction In the pre-approva cinica experience with a new medicina product or its new usages, particuary as the therapeutic dose(s) may not be estabished: a noxious and unintended responses to a medicina product reated to any dose shoud be considered adverse drug reactions. The phrase responses to a medicina product means that a causa reationship between a medicina product and an adverse event is at east a reasonabe possibiity, i.e. the reationship cannot be rued out. Regarding marketed medicina products, a we-accepted definition of an ADR in the postmarketing setting is found in WHO Technica Report 498 (1972) and reads as foows: Unexpected adverse drug reaction An adverse reaction the nature or severity of which is not consistent with the appicabe product information (e.g. the Investigator Brochure for an unapproved investigationa medica product). Adverse events are defined as serious based upon patient event outcome or action criteria usuay associated with events that pose a threat to a patient s ife or functioning. Seriousness (not severity) serves as a guide for defining reguatory reporting obigations. A serious adverse event (experience) or reaction is any untoward medica occurrence at any dose which: 146 resuts in death, is ife threatening, requires inpatient hospitaization or proongation of existing hospitaization, resuts in persistent or significant disabiity/incapacity or is a congenita anomay/birth defect. Medica and scientific judgment shoud be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medica events that may not be immediatey ife-threatening or resut in death or hospitaization but may jeopardize the patient or may require intervention to prevent one of the other outcomes isted in the definition above. These shoud aso usuay be considered serious. ADVERSE EVENT REPORTING TIMELINES According to ICH E6, a SAEs shoud be reported to the sponsor immediatey, except for those identified in the protoco or other document as not needing immediate reporting. Fata or unexpected ADRs occurring in cinica investigations shoud be reported to the reguatory authorities as soon as possibe, but no ater than seven caendar days after knowedge of the event by the sponsor, foowed by as compete a report as possibe within eight additiona caendar days. Serious unexpected reactions (ADRs) which are not fata or ife threatening must be fied as soon as possibe but no ater than 15 caendar days after first knowedge by the sponsor that the case meets the minimum criteria for expedited reporting. Adverse events that do not meet the requirements for expedited reporting are reported at the end of the cinica tria as part of the marketing appication or in PSURs. EUROPEAN DIRECTIVE ON UNBLINDING Voume 10 of the pubication The Rues Governing Medicina Products in the European Union provides guidance on unbinding the treatment aocation when suspected unexpected

7 Pharmacovigiance and Risk Management serious adverse reactions (SUSARs) occur. In the European Union (EU) SUSARs must be unbinded prior to submission to the reguatory authorities; this is not required by other reguatory authorities in Asia or the USA. Recenty, the FDA acknowedged the potentia need for unbinding some expedited safety reports, but recommends aternatives to unbinding be undertaken if possibe; this rue came into effect on March 28, Procedures reated to unbinding must ensure that ony those who need to review unbinded data have access to them, and that everyone ese invoved in the tria remains binded as to treatment assignment. This is required to preserve the integrity of the study. Standard Operating Procedures, Study-Specific Procedures, and Safety Pans The number of SOPs reated to pharmacovigiance may vary from few in number to many, depending upon the ength and compexity of the processes invoved. Companies with few SOPs may write individua study-specific procedures (SSPs) consistent with their SOPs, but which provide more detai in reation to a specific product under deveopment. Sometimes a of the pharmacovigiance procedures are combined into a safety pan, or pharmacovigiance pan, which becomes a summary of a of the processes to be foowed by the assigned staff in conjunction with the cinica tria or across trias. In Europe, a detaied description of the pharmacovigiance system must be incuded in the marketing authorization appication. At a minimum, SOPs/SSPs shoud cover the foowing activities: serious adverse event reporting safety case handing (intake, process fow, assessment, documentation, archiving) safety database safety data conventions review of patient (cinica/aboratory) data aggregate data review signa detection unbinding reguatory reporting of safety information and 24 hour safety coverage. Other SOPs/SSPs are deveoped as reevant to the specific product or therapeutic area. At the beginning of each tria safety reporting timeines shoud be reviewed, the timeframes for ongoing review and assessment of patient data shoud be agreed upon, and the assignment of any unbinded staff shoud be determined. Studies utiizing a drug safety monitoring board (DSMB) or cinica endpoint committee (CEC) wi have additiona SOPs/SSPs or charters created to ceary define the roes and processes to be performed by these groups. In addition to written procedures, reguar teeconferences and/or meetings shoud be hed to ensure adequate communication of information, make modifications in best practices as needed during the study, and maintain compiance and audit readiness. Because processes may change during a cinica tria, training is an important part of pharmacovigiance and risk management. 147 Quaity Management System Pharmacovigiance departments shoud incude a quaity management system (QMS) for safety reporting processes, data review, and documentation. The purpose of a QMS is to ensure that a pharmacovigiance activities are performed to the highest ethica standards and conform to reevant reguatory requirements and contractua obigations to any icensing partners. Key eements incude a quaity poicy, an approved documented ibrary of SOPs, quaity contro procedures, key performance indicators (KPIs), job descriptions, and training pans. A QMS is part of continuous process improvement. Within the QMS each process is reviewed through quaity contro steps within the process. The resut of the quaity contro is measured

8 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity against defined KPIs. Deviations from defined processes are identified, and those suggesting a quaity issue are addressed through a root cause anaysis foowed by the creation of a corrective action and preventive action (CAPA) pan. Quaity assurance can then check to ensure that quaity is being managed within the pharmacovigiance department and that a quaity issues are being addressed. ORGANIZATIONAL STRUCTURE OF A PHARMACOVIGILANCE DEPARTMENT Departmenta Organization The basic functiona unit within the pharmacovigiance department is comprised of the drug safety physician (DSP), drug safety associate (DSA), and medica assistant. A team may consist of severa DSAs, a singe physician providing medica review, and one or two medica assistants for administrative support. Depending on the size of the company and the number of empoyees, pharmacovigiance teams may be organized by product or by therapeutic area, or may be separated into premarketing and postmarketing groups. Matrix structures are common. Goba pharmacovigiance departments may exist in a imited number of regiona hubs, with each hub having a senior pharmacovigiance member who provides oversight. An exampe of a pharmacovigiance organizationa chart is depicted in Figure Figure 13.5 shows an exampe of a matrix structure within pharmacovigiance. 148 Coaboration and Teamwork on Goba Cinica Trias Successfu pharmacovigiance requires cross-functiona, cross-regiona, and cross-cutura coaboration. For exampe, within the pharmacovigiance department itsef, safety case processing and assessment may occur in severa ocations, particuary if some steps in the FIGURE 13.4 Sampe organizationa structure of a mid-sized pharmacovigiance (PV) department. RM: risk management; DSMB: drug safety monitoring board; CEC: cinica endpoint committee; IT: information technoogy.

9 Pharmacovigiance and Risk Management FIGURE 13.5 Sampe matrix structure in pharmacovigiance (PV) by product. DSPM: drug safety product manager; DSA: drug safety associate; IT: information technoogy. workfow are provided in ow-cost centers. Goba pharmacovigiance capacity can aow round-the-cock pharmacovigiance, but can ony be successfu with goba systems, consistent processes and workfows, adequate and ongoing training, and exceent communication across regions. 149 As members of the cinica deveopment team, pharmacovigiance staff aso interact reguary with site investigators, cinica research associates (CRAs), cinica project managers (CPMs), cinica data managers (CDMs), biostatisticians, and medica writers. In addition, for projects using DSMBs or CECs, pharmacovigiance staff independent of the cinica team may work with the committee members to provide or carify the safety information needed for cinica endpoint review or for periodic DSMB meetings. ROLE OF THE MEDICAL MONITOR ICH-GCP does not define or describe the responsibiities of a medica monitor. A practica definition might be a physician or other quaified individua, separate from the principa investigator, who is responsibe for medica and safety monitoring of research subjects for conditions that may arise during the conduct of a cinica tria. The roe of the medica monitor is to be the cinica team s advocate for subject safety and webeing. This extends beyond individua patient safety monitoring and may incude medica assessment of the cinica study protoco for feasibiity, upfront risk anaysis, input into decisions on study design, treatment regimens, comparator seection, medica interpretation of data, and input into data anaysis and report generation. During the study the medica monitor is an important member of the cinica project team. Responsibiities incude interaction with site investigators to provide them with known information on the product under study, ongoing assessment of the medica and safety aspects of the medicina product, serving as the medica consutant to the project team by providing

10 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity medica and therapeutic area expertise, participating in data review and interpretation, and heping to ensure overa project success. Despite reguar interaction with cinica site personne, the medica monitor shoud not interfere with the investigator s responsibiity for medica assessment and treatment of individua subjects, but shoud provide the investigator with a medica information known by the company to ensure that the best assessment and treatment decisions may be made. In essence, the medica monitor pays a unique roe that bridges the site, the pharmacovigiance department, and the rest of the cinica deveopment team. ROLES AND RESPONSIBILITIES OF THE PHARMACOVIGILANCE TEAM In different regions of the word, job tites vary for simiar roes on the pharmacovigiance team. The tites drug, or product, safety associate or safety speciaist may be used interchangeaby with pharmacovigiance associate; the tite drug safety physician is commony used when referring to the physicians providing pharmacovigiance. 150 Head of Pharmacovigiance The head of pharmacovigiance pays a critica roe in the pharmacovigiance department, and is the person utimatey responsibe for a of the safety and risk management activities performed within the department. Typicay, he or she wi have many years of experience in pharmacovigiance and be an authority on pharmacovigiance reguations and reporting requirements. In addition to providing eadership and oversight within the department, the head of pharmacovigiance acts as a senior resource throughout the company on matters such as safety strategy, reguatory and safety risk management, safety compiance, and safety quaity assurance. The head of pharmacovigiance may be identica with the QPPV in smaer European companies. However, typicay the roe is separate from the QPPV to ensure the independence of the QPPV from the daiy operationa tasks. Drug Safety Physician/Directors of Drug Safety It is frequenty necessary for the medica monitor to remain binded as to the medicina product causing an adverse reaction in a cinica tria. Knowedge of the treatment arm may bias the medica monitor in decisions affecting other aspects of the study. In such cases, a physician not otherwise associated with the study wi be assigned to assess adverse events, possiby as an unbinded medica reviewer. In arge, goba pharmaceutica companies, these DSPs exist in the pharmacovigiance department competey separate from the medica monitors on the cinica team. In smaer companies where physicians may pay mutipe roes, it is important to firewa binded and unbinded medica staff in order to protect the integrity of the cinica data. Other responsibiities of the DSPs incude medica review of aggregate data and reports. More experienced DSPs or directors of drug safety are invoved in signa detection and anaysis. Some may be responsibe for creating and impementing deveopment risk minimization pans (Europe) or risk evauation and mitigation pans (USA), which are now required by many reguatory authorities. Quaified Person for Pharmacovigiance in Europe The QPPV is a required roe for a pharmaceutica companies in Europe, but not yet required in other regions of the word. A named person is responsibe for a aspects of pharmacovigiance for a medicina product. The QPPV must be a physician or someone acting under the supervision of a quaified physician. He or she ensures the adequacy of the pharmacovigiance system and fu compiance with meeting reguatory obigations and timeines for safety

11 Pharmacovigiance and Risk Management reporting. Therefore, the QPPV must be very experienced in cinica tria safety as we as safety reguations, compiance, and poicy. The QPPV oversees the pharmacovigiance pan deveopment and proactive risk minimization strategies. He or she is the singe point of contact for safety with the reguatory authorities. Pharmacovigiance/Drug Safety Product Manager The pharmacovigiance or drug safety product manager (DSPM) is an experienced member of the pharmacovigiance department assigned to oversee specific safety products, usuay when arge numbers of safety staff are required. Exampes of projects requiring a DSPM incude studies with arge numbers of SAEs, case reports, studies with cinica endpoints that are aso SAEs, projects invoving a number of different safety functions (e.g. case reporting and reguatory submission, iterature review, and aggregate reporting), and other safety projects of specia interest. A DSPM may aso organize and coordinate DSMBs and CECs, utiizing key opinion eaders and medica and statistica experts. Drug Safety Associate The roe of a DSA is to monitor and track SAEs, serious and non-serious ADRs, and other medicay reated product information. It is paramount to ensure the timey processing and reporting of such information in accordance with company and reguatory reporting timeines. The DSA usuay has an educationa background in one of the ife sciences; it is aso advantageous to have a working knowedge of medica terminoogy. Many DSAs are nurses, pharmacists, or other aied heath professionas. The DSA works under the supervision of the DSPM, director of drug safety, QPPV, or medica monitor. Some of the other functions performed by the DSA incude, but are not imited to, deveoping safety pans and other SSPs; providing input to and reviewing study safety tracking reports for accuracy and quaity; maintaining eectronic and paper fies; assisting the medica monitor with the documentation and processing of routine exceptions and rescreen approvas; performing safety review of cinica [case report forms (CRFs)] and patient aboratory data; iaising with sponsors, investigationa sites, and/or reporters regarding safety issues; and participating in project team meetings and teeconferences. 151 Medica Assistant The medica assistant pays an important roe in maintaining efficient and accurate organization of documents and information within the department by providing administrative support to the pharmacovigiance team. Duties of the medica assistant incude fiing; faxing; assisting with the panning and organization of meetings, teeconferences, and training sessions; maintaining meeting minutes; handing maiing activities; answering SAE hotine and other departmenta teephone ines; documenting contacts and submitting to appropriate personne; maintaining office suppies and equipment; creating, maintaining and auditing work tracking systems; and ensuring accuracy and audit readiness of the departmenta fies and fie room. In some cases, medica assistants may be trained as data entry personne and can assist in the data entry of safety information into appropriate safety databases. Safety Systems Speciaists Owing to the arge amounts of data invoved, numerous databases and technoogy systems are required to manage the daiy workfow associated with pharmacovigiance, incuding individua case management and aggregate data anaysis. This requires staff who have backgrounds in information technoogy (IT). In some cases, these staff are further speciaized in the creation, vaidation, and maintenance specificay of safety systems. In smaer companies, the safety systems speciaist may be part of the IT department, assigned as needed to support pharmacovigiance.

12 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity Pharmacovigiance Trainer In the current dynamic environment surrounding pharmacovigiance and risk management, ongoing training for pharmacovigiance staff is essentia to maintain awareness of current goba and oca reguations, poicies, and guideines. Pharmacovigiance training incudes subject matter training on the therapeutic area of the product under deveopment and specific training on the science reated to the investigationa product. Often the medica monitor or an expert in another therapeutic area suppies this training. Training reated specificay to pharmacovigiance is continuous, with more senior staff reviewing and mentoring the junior staff. Beyond a certain size, however, staff specificay dedicated to performing pharmacovigiance training is usuay necessary. A training shoud be documented and fied appropriatey. Pharmacovigiance staff shoud be audit ready in terms of their knowedge of the rues, reguations, SOPs, and confidentiaity requirements surrounding the specific protoco or project, as we as safety reporting requirements and genera confidentiaity requirements regarding cinica research subjects and their data. APPROPRIATE FACILITIES FOR PHARMACOVIGILANCE No specific requirements exist for the physica structure of a pharmacovigiance department. However, it is imperative that a subject data be kept confidentia, and that there is adequate storage area with appropriate security, imited data access, and adequate disaster recovery. Infrastructure that enabes documenting receipt and forwarding of time-sensitive safety information must be in pace. It is crucia that unbinded safety information is not accessibe to staff who must remain binded during the cinica tria. This may be achieved through physica separation or through appropriate security measures for system and data access. 152 Athough not required by reguation in most countries, many pharmacovigiance departments maintain a 24 hour emergency teephone system to aow prompt interaction with the investigative sites in fata or ife-threatening situations and to faciitate expedited case assessment and reporting. In the EU, a QPPV must be readiy avaiabe at a times for any crisis situation. SAFETY DATABASES A safety database aows the pharmacovigiance department to monitor, assess, and report to the reguatory authorities serious safety information. The utiization of any specific safety system is not a direct ega requirement. However, under most circumstances, a more powerfu database is needed, therefore the use of safety databases is currenty standard. Specificay deveoped commercia safety databases are avaiabe. The database owner may maintain the system on their servers or insta the fu system on a company server and aow access through icenses. Aternativey, access to a safety database can be provided though a CRO or safety niche provider. This may be a more attractive soution financiay for imited case voumes. The database must be vaidated (e.g. CFR 21 compiant) and acceptabe to a reguatory authorities on the goba eve. A recenty estabished requirement is to have the capabiity for reporting expedited cases eectronicay. The specifications for eectronic reporting are detaied in ICH E2B. Such an E2B compiant gateway aows direct export of such expedited cases to the authorities databases such as EudraVigiance in Europe. For smaer companies not having their own safety database, expedited cases may be entered directy (manuay) into any authority database. In the USA, eectronic safety reporting is not yet mandatory. SAFETY CASE PROCESSING AND REVIEW Most commercia safety databases provide the functionaity of a paperess workfow, aowing a case processing steps to be performed within the system. The company s process shoud be

13 Pharmacovigiance and Risk Management FIGURE 13.6 Exampe of a serious adverse event case processing workfow within a safety database. CRA: cinica research associate; QC: quaity contro. described in an SOP avaiabe to auditors. Even if no safety database is used, the case processing workfow shoud aways be detaied in an SOP, SSP, or safety pan to ensure cear assignment of roes and responsibiities. This is especiay important when various steps in the workfow are distributed among different goba ocations. Updating cases as new information is obtained requires a cear audit trai to a prior information. An exampe of such a workfow is depicted in Figure Steps in Serious Adverse Event Case Processing 1. When an investigator, heathcare provider, or cinica site monitor identifies a potentia SAE, the event is reported to the sponsor immediatey. 2. Upon receipt of an SAE at the pharmacovigiance department, the report is assessed as to whether it fufis the minimum requirements for reporting. 3. A vaid case is checked for dupication, i.e. whether the same case was previousy reported, or whether this is foow-up information on a previousy opened case. 4. If the case is identified as vaid for initia data entry, it wi undergo a triage step, being reviewed for expectedness, reatedness, and seriousness, with specia attention as to whether the case is fata or ife threatening. This determines the appropriate timeine for processing and reporting to the reguatory authorities. 5. The case then undergoes data entry, a case narrative is created and the case undergoes medica review. Any missing or uncear information is queried and added to the case. 6. Once a of these activities are competed and quaity checked, the case is finaized within the aotted timeframe and if expedited reporting is required the information is sent to the appropriate recipients. 7. The process is repeated as additiona information becomes avaiabe unti the event is resoved or no further information can be obtained. 153 GLOBAL SAFETY REPORTING Since the main objective of pharmacovigiance is the identification of information that may affect the safety of patients, once a potentia risk is noted, it must be communicated to a stakehoders. The distribution foows we-defined rues described in ICH E2A: Cinica Safety Data Management: Definitions and Standards for Expedited Reporting. According to ICH E2A, A adverse drug reactions (ADRs) that are both serious and unexpected (SUSARs ¼ Suspected Unexpected Serious Adverse Reactions) are subject to expedited reporting. This appies to reports from spontaneous sources and from any type of cinica or epidemioogica investigation, independent of design or purpose.

14 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity Initia reports shoud be submitted within the prescribed timeframe providing the foowing minimum criteria are met: an identifiabe patient a suspect medicina product an identifiabe reporting source, and an event or outcome that can be identified as serious and unexpected, and for which, in cinica investigation cases, there is a reasonabe suspected causa reationship. During goba cinica trias, a SUSAR that occurs in one country may require expedited reporting to reguatory authorities, institutiona review boards/ethics committees, and investigators in a participating countries. This must be done in accordance with each country s oca aws and reguations. Unfortunatey, countries vary in their requirements as to the format and timeframe for the reporting of cases. In addition, reporting requirements are frequenty changing at the country eve. Keeping aware of the reporting requirements in various countries is a time-consuming task, which requires staff that fuy understand the goba pharmacovigiance reporting requirements. There are commercia databases avaiabe to provide up-to-date reguatory reporting inteigence. In some companies staff within the pharmacovigiance department perform safety reguatory reporting; this may be part of the eectronic workfow. In other companies a team that is part of the reguatory department may perform this activity. 154 SAFETY DATA REVIEW AND ASSESSMENT During a cinica tria, safety data wi be coected from a number of different sources. These incude the subject CRF, aboratory reports, SAE reports, and information specific to a particuar study or therapeutic area such as eectrocardiographic or radiographic imaging data. A safety data shoud be reviewed in an ongoing manner with the intent of minimizing risk to the participating and future subjects, and determining whether the benefit exceeds the risk if the product becomes commerciay avaiabe (i.e. whether the product is safe enough for genera use). This is done through the combined processes of individua subject data assessment and aggregate data review and assessment. Individua Subject Data The scope of individua data review begins with information on the subject CRFs. Screening and baseine information such as demographics, significant past medica history, concomitant diseases and medications, and prior treatment regimens are recorded and become part of the cinica database for the study. Laboratory and other anciary information are aso coected. Prior to the start of each study, aert triggers are determined in order to fag potentia safety issues, and criteria for withhoding or discontinuing treatment due to adverse events are written into the study protoco. When a subject experiences a serious adverse event or a safety aert is triggered, a avaiabe safety information on that subject shoud be reviewed in order to minimize harm to the subject under study. Subject Profies Reviewing individua subject data effectivey requires that either repetitive data cuts be reviewed or the pharmacovigiance staff must be abe to ook at cumuative data in rea time. Commercia toos are avaiabe which enabe cumuative data to be reviewed for each individua subject as we as in aggregate. Figure 13.7 shows an exampe of a subject profie depicting tempora information between an adverse event (vertigo), the receipt of medications, and seected aboratory resuts. An individua subject s safety parameters can be reviewed in context throughout his participation in the study. This heps to ensure maximum safety monitoring of individua subjects.

15 Pharmacovigiance and Risk Management FIGURE 13.7 Subject profie. Source: TIBCO Spotfire. (Pease refer to coor pate section) Review of Aggregate Data The scope and timing of aggregate data review activities vary among cinica trias. These shoud be determined before the start of the study. Parameters to be determined incude the objectives of the review; data fieds to be reviewed; the frequency of the review; the process for raising, monitoring, and resoving queries generated; and how the review and any findings wi be documented. 155 The main safety objective of ongoing review is the timey identification of potentia safety issues. Other objectives may incude identifying subjects incuded in a study inappropriatey who may be paced at unintentiona risk, or other systemic protoco vioations that may be recurring. Aggregate data review may aso identify training needed at sites or by the cinica study team in order to minimize subject risk, which may occur owing to uncear or misinterpreted direction in the protoco. Review of aggregate data may be done in-house or by an externa and independent team of experts such as a DSMB or data monitoring committee (DMC). If a DSMB or DMC is used, pharmacovigiance staff are often invoved in the organization of the data aong with an assigned (unbinded) statistician. Figure 13.8 shows an exampe of a decision tree for the use of a DSMB for a cinica tria. Signa Detection and Anaysis The WHO defines a safety signa as reported information on a possibe causa reationship between an adverse event and a drug, the reationship being unknown or incompetey documented previousy. 1 When a signa is detected, further investigation is warranted to determine whether an actua causa reationship exists. Signa detection uses data imports from the safety database or other cinica, aboratory, or epidemioogica databases, as we as reguatory data sources. A compiant and suitabe safety database shoud be abe to process data reated to signa detection. Signas can be suggested by aerts or trends in incoming data.

16 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity FIGURE 13.8 Decision tree for the use of a data safety monitoring board (DSMB, DMC) for a cinica tria. Source: Day, S. (2010). Data monitoring committees e not for the faint-hearted. Pharmacovigiance Review 4(2), 9e12. Signas can aso be identified by major statistica agorithms and advanced anaysis in conjunction with biostatistics. Commercia toos are aso avaiabe for data mining and signa detection and anaysis. Signa detection consists of severa activities: 156 Signa detection toos: e singe case evauation, incuding iterature surveiance e aggregate report creation e software toos for arge case voumes and trend anaysis Signa generation/detection procedure: e permanent monitoring of singe case reports/report series e periodic report review e ad hoc anaysis of reports from externa sources, e.g. iterature reports, requests from competent authorities (CAs) on report/reports Signa work-up and documentation: e quaity of the information e other risk factors (e.g. natura history of the underying disease/severity, specificity and outcome) e bioogica and pharmaceutica pausibiity e cass effect e epidemioogica context e frequency e drug utiization/popuation exposure/age, gender and indication Signa assessment and documentation: e QPPV or other senior pharmacovigiance invovement/decision signa not confirmed (no further actions, ony documentation) signa doubtfu (specia scrutiny for future cases) signa confirmed. Upon confirmation of a safety signa, the subsequent course wi be variabe but may invove action by company executives and/or the reguatory authorities, depending on the magnitude of risk. It is important that action is taken prompty in order to avoid any unnecessary harm; therefore, an ongoing and systematic approach is essentia.

17 Pharmacovigiance and Risk Management For safety findings that have ow or minima safety impact, these wi be reported in the cinica study report (cinica trias), in updates to the investigator brochure, in the core data sheet, or in periodic safety update reports required by the reguatory authorities. The concusion of any update report must comment on any new safety issue. Reports may be written within the pharmacovigiance department or by a medica writing team, with input from pharmacovigiance staff. In the case of marketed products, changes to abeing may be required. A of this is part of the communication of any safety risk to those who might use the product. MANAGING RISK Consequences of finding a significant safety issue may incude any of the foowing activities: Amending the protoco Temporariy suspending enroment Discontinuing the study Discontinuing deveopment of the medicina product Impementing a deveopment risk management pan (RMP) or risk evauation and mitigation strategy (REMS). Risk management represents the top of the pharmacovigiance activity pyramid (Figure 13.9). These activities are the cumination of the processing and review of individua adverse events and other safety data, the review and assessment of aggregated data, and the identification, anaysis, and interpretation of safety signas. Risk Management Pans and Risk Evauation and Mitigation Strategies The RMP (EU) and the REMS (USA) are now a standard part of pharmacovigiance panning. ICH E2E (Pharmacovigiance Panning) was originay created to achieve consistency and harmonization, particuary during the eary postmarketing period of medicina products. Within the past few years, the US and European reguatory agencies have increased their guidance on benefit risk assessment and risk minimization. 157 FIGURE 13.9 Pharmacovigiance activity pyramid. (Pease refer to coor pate section)

18 SECTION 4 How to Buid and Enhance Pharmacovigiance and Risk Management Capacity and Capabiity The intent of both the RMP and the REMS is to minimize risks reated to a medicina product through interventions and to communicate those risks to patients and heathcare providers. Eements may incude medication guides or patient package inserts, a detaied communication pan about safety issues, specific eements to assure safe use of a product such as required aboratory testing or prescriber training, an impementation pan and a timetabe for assessment. Currenty, the RMP or REMS may be created at any time during cinica deveopment, but most often they are submitted as part of the marketing appication. In the EU, RMPs are routiney required as part of the detaied description of the pharmacovigiance system. In the USA, the reguatory authorities can request a pan if there is a reason to suspect that one may be necessary, based upon non-cinica data, eary use data, cass data for the medicina compound, or other factors. If new safety information becomes avaiabe after reguatory approva, the reguatory authorities may request a REMS or an updated RMP. Additiona pharmacovigiance such as active surveiance, other cinica or epidemioogica trias, speciaized training, or restricted access may be incuded in the pan. The activities must be sufficient to minimize the ikeihood of harm so that benefits sti outweigh risks, and to ensure that the risk reduction procedures are communicated and impemented. 158 OUTSOURCING WHILE BUILDING PHARMACOVIGILANCE CAPACITY Large, goba pharmaceutica companies usuay have we-estabished pharmacovigiance systems. In countries where pharmacovigiance is not we estabished there may be a need to buid pharmacovigiance capacity. For exampe, some companies ony have medica affairs departments whose function is mainy to provide medica input to marketing strategy and ensure that product iterature and marketing brochures meet ega and ethica requirements. They ack the capacity for compete, product ife-cyce pharmacovigiance and risk management. To have a compete and systematic approach to pharmacovigiance requires the abiity to perform a of the defined pharmacovigiance activities. Outsourcing some aspects of pharmacovigiance to a CRO or safety niche equivaent whie buiding interna capacity may be an option. Wordwide pharmacovigiance can be centraized in a few regions, or hubs, if the systems are goba and there is good communication and process fow between regions. Some of the functions may be competenty performed in ow-cost regions. If outsourcing, sponsors must ensure that any vendors performing pharmacovigiance and risk management have the experience and capacity to perform those services, and that they are sufficienty knowedgeabe in the reguations associated with pharmacovigiance. Outsourcing those functions best performed by pharmacovigiance experts such as signa detection, aggregate data interpretation, and risk evauation and mitigation, requires carefu seection of vendors. Many CROs are abe to provide compete safety services and resources, acting as a smaer company s pharmacovigiance department permanenty or unti such time as the company is abe to manage the expense on its own. These services incude performing safety audits; creation of SOPs and SSPs; medica and safety monitoring; individua case management; creating and maintaining pharmacovigiance databases; signa detection; trend anaysis; organizing and managing DSMBs, DMCs, and CECs; and reporting of expedited and periodic safety reports to reguatory authorities, principa investigators, and institutiona review boards. GENERAL CONSIDERATIONS AND CONCLUSIONS Pharmacovigiance and risk management are an essentia part of pharmaceutica product deveopment and commerciaization, the activities of which are highy reguated in many parts

19 Pharmacovigiance and Risk Management of the word. Rare adverse events may not be identified unti arge numbers of patients receive the product, so pharmacovigiance and risk management must extend throughout the product s ife cyce. Benefit and risk must be continuay assessed as more is earned about the product through its use. Buiding pharmacovigiance and risk management capacity requires a systematic approach to ensure that a safety aspects are monitored and addressed propery. Since capacity buiding takes time and resources, outsourcing of certain activities may enabe capacity buiding to proceed before a capabiities can be done in-house. The use of a imited number of safety centers is a viabe and cost-effective option, provided there are good processes, good toos, and good communication of responsibiities and events. References 1. Word Heath Organization. The Importance of Pharmacovigiance: Safety Monitoring of Medicina Products. Geneva: WHO, European Commission. Assessment of the European Community System of Pharmacovigiance: Fina Report e Fina version, January 25. Submitted by Fraunhofer Institute Systems and Innovation Research, Karsruhe, Germany, to the European Commission Enterprise and Industry Directorate-Genera, Unit F2, Pharmaceuticas, enterprise/pharmaceuticas/pharmacovigiance/docs/acs_consutation_fina.pdf; Nwokike J. Technica Assistance for the Estabishment of a Pharmacovigiance and Medicine Safety System in Rwanda. Submitted to the US Agency for Internationa Deveopment by the Strengthening Pharmaceutica Systems (SPS) Program. Arington, VA: Management Sciences for Heath; US Food and Drug Administration. 21 CFR Parts 312 and 320, Fina Rue: Investigationa New Drug Safety Reporting Requirements for Human Drug and Bioogica Products and Safety Reporting Requirements for Bioavaiabiity and Bioequivaence Studies in Humans, DeveopmentApprovaProcess/HowDrugsareDeveopedandApproved/ApprovaAppications/ InvestigationaNewDrugINDAppication/ucm htm. 159

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