2. Do you have any other recommendations with regard to the scope of reportable events? Please explain.

Transcription

1 Respnses frm the Canadian Sciety f Hspital Pharmacists t Questins related t Mandatry Reprting f Adverse Drug Reactins and Medical Device Incidents by Prvincial and Territrial Healthcare Institutins Questins related t Types f Reprtable Events: 1. What culd be the peratinal impacts f reprting all serius adverse drug reactins and medical device incidents? The Canadian Sciety f Hspital Pharmacists very much appreciates that Health Canada envisins t peratinalize the prpsed new legislatin by making full use f existing infrmatin management systems t cllect prescribed infrmatin abut serius adverse drug reactins frm prescribed health care institutins. Hwever, existing systems are limited and this infrmatin is nt currently cded in health recrds. The reprting f all serius adverse drug reactins and medical device incidents will impse a significant peratinal burden n prescribed health care institutins, namely n frnt-line health care prfessinals and n health infrmatin management technicians and related wrkers. Mandatry reprting, by the prescribed health care institutins, f all prescribed infrmatin n serius adverse drug reactins and medical device incidents, within a prescribed time and in a prescribed manner, will place cnsiderable strain n the pharmacists, physicians, nurses and ther health prfessinals wh wrk in these institutins. The requirement t reprt all serius adverse drug reactins will add t the already heavy wrklads f Canadian health care prfessinals, which is ften cmpunded by labur shrtages. The wrklad related t mandatry reprting f all serius adverse drug reactins by the prescribed health care institutins will have a negative impact n budget and quality f care t patients, and thus n fulfilling the health care mandate and public purse f prvinces and territries. Withut additinal resurces, human and financial, institutins will be required t divert persnnel frm direct patient care t the reprting f prescribed infrmatin n all serius adverse drug reactins in rder t cmply with the regulatins. The Canada Health Transfer payments frm the federal gvernment t prvinces and territries shuld be adjusted t address allcatin f the supplemental funding necessary fr the prescribed institutins t meet the requirements f the regulatins. Otherwise, the regulatins wuld set these institutins fr failure t cmply with the Act. Furthermre assessing the causality f serius adverse drug reactins by using f existing infrmatin management systems will be very challenging since there may be a number f active cnditins being treated with a number f medicatins in any affected patient. Therefre it can be difficult t determine if a serius clinical reactin is attributable t ne particular drug amngst all thers r t the deteriratin in the patient s primary cnditin. The cnclusin is ften based n clinical judgment alne, yet studies have shwn that the assessment based n judgment ften vary greatly between clinicians. 2. D yu have any ther recmmendatins with regard t the scpe f reprtable events? Please explain. The reprting f all serius adverse drug reactins will create an avalanche f data that will make sieving thrugh and finding the critical infrmatin within that data mre difficult and 2016 January Page 1

2 mre time-cnsuming. Pharmacists and physicians are aware f knwn serius adverse reactins and expect their ptential ccurrence as an extensin f the drug s therapeutic effect. These risks are managed and mnitred accrdingly. It is knwn, fr example, that patients wh receive warfarin a cmmnly used bld thinner may experience an increased risk f serius hemrrhage (bleeding) r that patients underging chemtherapy may experience bne marrw suppressin (lw bld cell cunts). Reprting n such well knwn and expected serius adverse reactins t medicatins wuld cntribute little t the verall bdy f knwledge and better management f patients. The Canadian Sciety f Hspital Pharmacists calls fr a mre fcused reprting that specifically targets new (unexpected) serius adverse reactins fr lng-marketed select therapeutic prducts and all serius adverse reactins fr new select prducts. Fcusing n these tw types f adverse reactins will prvide Health Canada, health care prfessinals and cnsumers with quality infrmatin they can use, and allw t identify and respnd t emerging risks mre quickly. Regardless f the scpe f reprtable reactins, prvisins shuld be made t ensure Health Canada is adequately resurced t handle the influx f reprts. An expanded educatin and awareness prgram targeting health care prfessinals and students shuld be designed t reduce r eliminate many f the mtivatinal barriers t the reprting f adverse drug reactins, such as the fear f negative feedback r legal actin, questining the purpse and usefulness f reprting, r the desire t publish findings independently. The awareness cmmunicatin shuld include the purpse f the data cllectin frm a quality imprvement and patient care utcmes perspective and the prcess by which the findings will be shared with relevant stakehlders (including (healthcare prviders, the public, pharmaceutical manufacturers) and hw it will be used t imprve patient safety. Withut a thrugh lack f understanding f the value f reprting there is a risk f avidance and nn-cmpliance with reprting requirements. Questins related t Applicable Healthcare Institutins: 1. What are yur thughts n Health Canada s prpsed apprach t nly apply this requirement t all institutins that prvide acute care services? Please explain. What cnsideratins wuld yu anticipate in establishing a federal definitin f acute care? Reactins ccurring in the acute care setting represent nly the tip f the iceberg. Fr example, a medicatin-related death in the cmmunity might invlve slely the crner and never be reprted t Health Canada. The definitin f acute care varies between prvinces. Furthermre the fllwing definitin f hspital-based acute inpatient care frm the Canadian Institute fr Health Infrmatin des nt help in determining the prescribed institutin: prvides necessary treatment fr a disease r severe episde f illness fr a shrt perid f time. The gal is t discharge patients as sn as they are healthy and stable. Hw abut free-standing emergency centres that are structurally separate and distinct frm an acute hspital and prvide emergency care? Wuld the requirement apply t these centres? The regulatins shuld clearly stipulate if a reactin that ccurs in the cmmunity and leads t hspitalizatin is reprtable by the acute care institutin January Page 2

3 Adverse drug reactins initiated in nn-acute healthcare facilities may lead t acute care admissins. There wuld be value t understanding the cntributing factrs. One culd argue that lng-term care facilities might be a better setting fr applicatin f the requirement: vulnerable, plymedicated ppulatin; mre time t bserve evlutin f the reactin and t reprt it. 2. Within these institutins, are there different cnsideratins fr medical device incident reprting and adverse drug reactin reprting? Cnsideratins culd include wh wuld be respnsible fr reprting, when they wuld reprt, hw reprting is dne, etc. This questin implies that the burden f reprting falls t individual healthcare wrkers, nt reprting by the institutins in accrdance with article 21.8 f the Fd and Drugs Act as amended by Vanessa s Law. Incident reprting n medical device might invlve many mre grups than reprting f drug reactins, e.g., materiels management, bimedical engineering, and clinical practitiners. Furthermre, while drug use is verseen by a hspital pharmacy and therapeutics cmmittee, typically n institutinal cmmittee versees the use f medical devices. Questins related t Data Fields fr Reprting: 1. With regard t the attached data fields fr reprting, d yu fresee any challenges in cmpleting any f the fields giving cnsideratin t yur existing r develping reprting capacity (e.g. paper reprting, electrnic health recrd)? The current reprting f individual serius adverse drug reactins t the Canada Vigilance Prgram cntinues t be cumbersme. Fr example the nline reprting culd be accelerated by gruping the mandatry fields n the first screen, with a nte at the bttm encuraging the reprter t cntinue nt the fllwing sectins t cmplete the ptinal items. In additin the nline reprting shuld make use f cntemprary technlgy, such as an app designed fr mbile devices. Healthcare prfessinals need a mre accessible and user-friendly platfrm t reprt individual serius adverse drug reactins. The prcess needs t be simple and straightfrward enugh t nt discurage reprting. The time cmmitment t reprt a single reactin with the level f details expected frm the attached data fields is daunting and can be as lng as minutes. The prescribed infrmatin shuld be narrwed dwn t critical data fields, which, ne culd argue, are simply the patient s age and sex, the drug r device name, and the reactin r incident. Once a sentinel reactin r incident has been identified, the Minister can issue an rder fr further details. Althugh Vanessa s Law makes prvisin fr the Minister taking int accunt existing infrmatin management systems, with a view t nt recmmending the making f regulatins that wuld impse unnecessary administrative burdens, it shuld be recgnized at the utset that all f the data t glean infrmatin in rder t cmplete the attached fields abut a specific reactin are nt currently cded in the health recrd. Fr reactins that ccurred prir t admissin t the institutin, the cllectin f infrmatin n many data fields wuld be much mre invlved, e.g., manufacturer, lt number, prduct start date, and ther health prducts taken at the time f the reactin January Page 3

4 2. Des the disclsure t Health Canada f any f these fields present privacy cncerns fr yur jurisdictin? Please elabrate. Even thugh there is n field fr patient name, ther data fields can allw identificatin f patients. Sme devices (e.g., pacemakers) are patient-specific (i.e., unique device identifier). The public reprting f the reactins and incidents shuld be in an aggregated frmat and nt specify the reprting institutins. Questins related t Reprting Systems and Prgrams: 1. Des yur prvince r territry have infrmatin management systems, such as critical incident reprting r electrnic medical recrds, that currently capture adverse drug reactins and medical device incidents? If nt, culd these systems be adapted t capture adverse drug reactins and medical device incidents? Current cding presents challenges in using an electrnic medical recrd t reprt adverse drug reactins. A pilt prject is currently under develpment in Vancuver t explre the feasibility f an integrated electrnic reprting system that wuld allw reprters t chart in the electrnic health recrd and autmatically feed t Health Canada and PharmaNet. Sme prvinces have access t an infrmatin management system that accmmdates reprting f adverse drug reactins and medical device incidents which are then reprted t Health Canada. Other jurisdictins rely n extracting this infrmatin frm either critical incident reprting systems r health recrds. Critical incident reprting systems are nt intended specifically fr the reprting f serius adverse drug reactins (i.e., drug txicity), but rather t reprt and learn abut clinically serius adverse events (i.e., patient safety events, near misses and hazards = medicatin errrs). Althugh sme adverse drug reactins when dcumented prir t the administratin f the respnsible drug can becme adverse events, a first-time adverse drug reactin wuld be deemed an unpreventable adverse event. Critical incident reprting systems typically stand alne and d nt interface with health recrds. The data in critical incident reprting systems are entered manually. In a natinal survey f hspitals with 50 r mre acute care beds, 54% (87/162) f respndents indicated that their hspitals use an electrnic health recrd. It is unknwn whether all f the data t cmplete the attached fields abut a specific reactin are currently cded in these electrnic medical recrds. The existing infrmatin management systems cannt be easily adapted t capture adverse drug reactins and medical device incidents. Making large-scale functinal changes t these systems can be cumbersme and cmprmise the integrity f histrical data. Electrnic health recrds are nt set up fr easy data mining. Health Canada is advised t speak with health infrmatin management supervisrs t learn abut the current state f affairs. 2. If mre than ne system culd be applicable fr reprting adverse drug reactins and medical device incidents, please elabrate. In additin, please indicate if there is a preferred system January Page 4

5 The abslutely critical data fields first need t be defined, then the preferred system shuld be adjusted accrdingly. Health Canada shuld facilitate an pen architecture apprach that enables autmatic dwnlad f data fields frm the healthcare rganizatin incident reprting systems t the Ministry database. 3. What are yur current prtcls fr prviding reprts f serius adverse drug reactins and medical device incidents t manufacturers? Prcesses vary amng health authrities. Questins related t Reprting Timelines: 1. Please elabrate n the factrs that culd affect the develpment f apprpriate timelines fr mandatry reprting f serius adverse drug reactin and medical device incidents t Health Canada (fr example, the steps that wuld be invlved after an event is identified by a reprter within an institutin until a reprt is eventually received by Health Canada.) This questin suggests manual reprting rather than electrnic reprting. If the reprting is electrnic, the reprt shuld be received instantaneusly by Health Canada as sn as the infrmatin abut the reactin r the incident is inputted int the institutin s infrmatin management system. The infrmatin management system shuld allw t update data fields abut a specific reactin r incident as additinal infrmatin (e.g., end date f adverse drug reactin) becmes available. A lng time can elapse between the suspicin f an adverse drug reactin, its cnfirmatin, and its reslutin after the discntinuatin f the drug. The end date f an incident frm a medical device may be mre immediate after the remval f the device. The timelines will be dependent n the number and type f data elements t be reprted. In sme jurisdictins, it is expected that health practitiners reprt any critical incident (nt limited t an adverse drug reactin) within 24 hurs f discvery. Questins related t Value t Healthcare Systems and Institutins: 1. What infrmatin wuld yu like t see generated frm Health Canada t supprt an institutin s ability t prvide safe and effective care t their patients? Health Canada shuld peridically reprt n sentinel reactins and incidents t institutins, such as thrugh the existing summary safety reviews. Institutins and healthcare practitiners shuld be able t search the database. 2. What grups within yur healthcare envirnments wuld find value in having access t this infrmatin? Public and patients Anyne wh is making decisins in the selectin and use f drugs and medical devices (e.g., buyers frm the purchasing department, healthcare prfessinals) 2016 January Page 5