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Article ; Online: A big leap in prescription drug promotion in Canada.

Lau, Catherine Y

Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques

2024 Volume 27, Page(s) 12666

MeSH term(s)	Prescription Drugs ; Advertising ; Canada
Chemical Substances	Prescription Drugs
Language	English
Publishing date	2024-01-24
Publishing country	Switzerland
Document type	Editorial
ZDB-ID	1422972-9
ISSN	1482-1826 ; 1482-1826
ISSN (online)	1482-1826
ISSN	1482-1826
DOI	10.3389/jpps.2024.12666
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Article ; Online: Impact of Regulatory Approval Status on CADTH Reimbursement of Oncology Drugs and Role of Real-World Evidence on Conditional Approvals from 2019 to 2021.

Lau, Catherine / Dranitsaris, George

Current oncology (Toronto, Ont.)

2022 Volume 29, Issue 11, Page(s) 8031–8042

Abstract: Real-world evidence (RWE) is health and outcomes data generated from a patient's journey through the health care system or disease process (i.e., real-world data). RWE is now having an increasingly important role in regulatory/reimbursement decisions. ... ...

Abstract	Real-world evidence (RWE) is health and outcomes data generated from a patient's journey through the health care system or disease process (i.e., real-world data). RWE is now having an increasingly important role in regulatory/reimbursement decisions. This article examines reimbursement recommendations by the Canadian Agency for Drugs and Technology in Health (CADTH) on oncology drugs approved between 2019 and 2021. Oncology drugs with a Summary Basis of Decision (SBD) for original marketing approvals were used to generate a corresponding list of CADTH final clinical recommendations for review. Of the 45 oncology drugs approved by Health Canada, CADTH granted positive funding recommendations to all 11 drugs that had priority review approvals. Two of the 17 drugs with standard reviews did not file to CADTH and 3 received a negative recommendation. Of the 17 drugs with Notice of Compliance with Conditions (NOCc) status, three were not filed to CADTH and four were under active reviews. Of the ten completed NOCc reviews, all contained RWE from sponsors and six received a negative decision on their first review. No significant differences in review times were found between the three approval statuses. Regulatory approval status appeared to influence reimbursement outcomes in Canada and evaluation of 10 NOCc approvals provided little insight regarding robustness of RWE required for more favorable considerations.
MeSH term(s)	Humans ; Canada ; Drug Approval ; Evidence-Based Practice
Language	English
Publishing date	2022-10-26
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	1236972-x
ISSN	1718-7729 ; 1198-0052
ISSN (online)	1718-7729
ISSN	1198-0052
DOI	10.3390/curroncol29110635
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Article ; Online: Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information.

Lau, Catherine / Jamali, Fakhreddin / Loebenberg, Raimar

Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques

2022 Volume 25, Page(s) 227–236

Abstract: Purpose: Between January 2020 and December 2021, Health Canada provided a Summary Basis of Decision (SBD) for each of 110 products approved, including 29 oncology products and 21 non-oncology orphan drugs. This review sought to gain insight into how ... ...

Abstract	Purpose: Between January 2020 and December 2021, Health Canada provided a Summary Basis of Decision (SBD) for each of 110 products approved, including 29 oncology products and 21 non-oncology orphan drugs. This review sought to gain insight into how Real Word Evidence (RWE) impacts regulatory decision making. Methods: SBDs for oncology drugs and non-oncology orphan drugs were reviewed for evidence of use of the RWE or historical data to support regulatory decisions. This information was compared with both FDA and EMA reviews. Results: For the 29 Health Canada-approved oncology products, 11 were approved with Notice of Compliance with Conditions (NOCc) status. Two NOCc approvals received extensive RWE reviews, while two other approvals briefly mentioned the use of RWE/historical data. Of the 12 NOC approvals, one received RWE reviews. FDA also approved all 29 drugs, 14 of which received extensive comments on RWE and/or historical data and 8 of which mentioned RWE or historical data. EMA approved 25 of the 29 products and provided extensive comments on 10. Four products received a mention of RWE review. The percentages of submissions with RWE/historical reviews conducted by Health Canada, FDA and EMA were 24.1, 75.9 and 56.0 respectively. Of the 21 non-oncology orphan drugs, Health Canada provided priority review status to 11, with extensive RWE comments in 5 and the mention of RWE in 2 of the regular approvals. Two approvals that used third-party data were not included in the comparison. FDA approved 19, and provided extensive RWE assessment on 5 and mentioned use of historical data in 8. EMA approved 17 and provided extensive RWE and historical comments in 7 and mentioned historical data in 4. The percentages of submissions with RWE/historical reviews by Health Canada, FDA and EMA were 36.8, 68.4 and 64.7 respectively. Conclusions: Use of Real World Data is common among FDA/EMA reviews and Health Canada used RWE in recent NOCc and orphan drug approvals.
MeSH term(s)	Canada ; Decision Making ; Drug Approval
Language	English
Publishing date	2022-06-22
Publishing country	Canada
Document type	Journal Article ; Review
ZDB-ID	1422972-9
ISSN	1482-1826 ; 1482-1826
ISSN (online)	1482-1826
ISSN	1482-1826
DOI	10.18433/jpps32715
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Article ; Online: Quality improvement tools and processes.

Lau, Catherine Y

Neurosurgery clinics of North America

2015 Volume 26, Issue 2, Page(s) 177–87, viii

Abstract: The Model for Improvement and the Plan-Do-Study-Act cycle is a popular quality improvement (QI) tool for health care providers to successfully lead QI projects and redesign care processes. This tool has several distinct components that must be addressed ... ...

Abstract	The Model for Improvement and the Plan-Do-Study-Act cycle is a popular quality improvement (QI) tool for health care providers to successfully lead QI projects and redesign care processes. This tool has several distinct components that must be addressed in sequence to organize and critically evaluate improvement activities. Unlike other health sciences clinical research, QI projects and research are based on dynamic hypotheses that develop into observable, serial tests of change with continuous collection and feedback of performance data to stakeholders.
MeSH term(s)	Humans ; Neurosurgical Procedures/standards ; Outcome and Process Assessment (Health Care) ; Quality Improvement
Language	English
Publishing date	2015-04
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1196855-2
ISSN	1558-1349 ; 1042-3680
ISSN (online)	1558-1349
ISSN	1042-3680
DOI	10.1016/j.nec.2014.11.016
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Article ; Online: The role of the behavior analyst on interprofessional mental health teams: opportunities for collaboration and enhancing patient care.

Summers, Jane / Busch, Louis / Kako, Milena / Lau, Catherine

Journal of interprofessional care

2021 Volume 36, Issue 3, Page(s) 434–440

Abstract: Patients living with mental illness have needs that span a range of professional disciplines, settings, and service systems. These needs are best addressed through interprofessional collaboration. Behavior analysts can play a valuable role in enhancing ... ...

Abstract	Patients living with mental illness have needs that span a range of professional disciplines, settings, and service systems. These needs are best addressed through interprofessional collaboration. Behavior analysts can play a valuable role in enhancing patient care as part of the interprofessional mental health team. We provide information about the field of applied behavior analysis and its contribution to the assessment and treatment of patients living with mental health and substance use challenges. We outline how behavior analysts are trained and touch upon the practice of behavior analysis in North America and beyond. We describe collaborative relationships with other mental health professionals and, as an example, review the role of the behavior analyst on interprofessional teams in our mental health and addiction teaching hospital in Canada. We highlight some of the challenges faced by behavior analysts working in the mental health field and offer suggestions to increase their profile and opportunities for collaboration in clinical programs.
MeSH term(s)	Cooperative Behavior ; Humans ; Interprofessional Relations ; Mental Health ; Patient Care ; Patient Care Team
Language	English
Publishing date	2021-09-12
Publishing country	England
Document type	Journal Article
ZDB-ID	1099758-1
ISSN	1469-9567 ; 0884-3988 ; 1356-1820
ISSN (online)	1469-9567
ISSN	0884-3988 ; 1356-1820
DOI	10.1080/13561820.2021.1969345
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Article ; Online: A behavioral intervention to promote use of multimodal pain medication for hospitalized patients: A randomized controlled trial.

Bongiovanni, Tasce / Pletcher, Mark J / Lau, Catherine / Robinson, Andrew / Lancaster, Elizabeth / Zhang, Li / Behrends, Matthias / Wick, Elizabeth / Auerbach, Andrew

Journal of hospital medicine

2023 Volume 18, Issue 8, Page(s) 685–692

Abstract: Background: The use of nonsteroidal anti-inflammatory drugs (NSAIDs) can reduce pain and has become a core strategy to decrease opioid use, but there is a lack of data to describe encouraging use when admitting patients using electronic health record ... ...

Abstract	Background: The use of nonsteroidal anti-inflammatory drugs (NSAIDs) can reduce pain and has become a core strategy to decrease opioid use, but there is a lack of data to describe encouraging use when admitting patients using electronic health record systems. Objective: Assess an electronic health record system to increase ordering of NSAIDs for hospitalized adults. Designs, settings and participants: We performed a cluster randomized controlled trial of clinicians admitting adult patients to a health system over a 9-month period. Clinicians were randomized to use a standard admission order set. Intervention: Clinicians in the intervention arm were required to actively order or decline NSAIDs; the control arm was shown the same order but without a required response. Main outcome and measures: The primary outcome was NSAIDs ordered and administered by the first full hospital day. Secondary outcomes included pain scores and opioid prescribing. Results: A total of 20,085 hospitalizations were included. Among these hospitalizations, patients had a mean age of 58 years, and a Charlson comorbidity score of 2.97, while 50% and 56% were female and White, respectively. Overall, 52% were admitted by a clinician randomized to the intervention arm. NSAIDs were ordered in 2267 (22%) interventions and 2093 (22%) control admissions (p = .10). Similarly, there were no statistical differences in NSAID administration, pain scores, or opioid prescribing. Average pain scores (0-5 scale) were 3.36 in the control group and 3.39 in the intervention group (p = .46). There were no differences in clinical harms. Conclusions and relevance: Requiring an active decision to order an NSAID at admission had no demonstrable impact on NSAID ordering. Multicomponent interventions, perhaps with stronger decision support, may be necessary to encourage NSAID ordering.
MeSH term(s)	Adult ; Humans ; Female ; Middle Aged ; Male ; Analgesics, Opioid/therapeutic use ; Practice Patterns, Physicians' ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Pain/drug therapy ; Patients
Chemical Substances	Analgesics, Opioid ; Anti-Inflammatory Agents, Non-Steroidal
Language	English
Publishing date	2023-06-25
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2233783-0
ISSN	1553-5606 ; 1553-5592
ISSN (online)	1553-5606
ISSN	1553-5592
DOI	10.1002/jhm.13153
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Zs.A 6276: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 542: Show issues

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Article ; Online: The Development and Implementation of the Fast-Pace Assessment Framework and Tiered Analgesic Orders for Opioid Optimization.

Bazinski, Marilyn / Lau, Catherine / Clemons, Brooke / Purser, Lisa / Kangwankij, Amy / Ngo, Lena / Lang, Michael / Besen, Brianna / Gross, Kendall / Borucki, Amber / Behrends, Matthias / Miaskowski, Christine / Schell-Chaple, Hildy

Pain management nursing : official journal of the American Society of Pain Management Nurses

2024

Abstract: Background: Within the context of the opioid epidemic, changes needed to be made in the prescription and administration of analgesics. The purpose of this paper is to describe the development and implementation of a project that utilized a holistic pain ...

Abstract	Background: Within the context of the opioid epidemic, changes needed to be made in the prescription and administration of analgesics. The purpose of this paper is to describe the development and implementation of a project that utilized a holistic pain assessment framework and introduced new order sets to guide the integration of nonopioid, opioid, and co-analgesics in a quaternary care medical center. Methods: An interdisciplinary team updated policies and procedures for pain assessment and opioid administration and created new analgesic order sets for both adult and pediatric patients. Following requisite approvals, these order sets were integrated into the electronic health record. Education of clinicians, patients, and caregivers was provided to facilitate implementation of these new clinical practices. Results: Prescribers' levels of adherence with the use of the pain order sets ranged from 80% to 90% and no adverse effects were reported. Education of nursing staff was incorporated into hospital orientation. Ongoing evaluations are providing insights into how the new policies and procedures can be optimized to ensure reliable, safe, and effective pain management. Conclusions: Since the implementation of the opioid optimization project, adherence with the tiered, multimodal approach to analgesic prescribing is high. Next steps include both qualitative and quantitative evaluations of the benefits and challenges associated with this practice change. For example, systems will be developed to monitor nurses' adherence with the implementation of the pain order sets and the use of both pharmacologic and nonpharmacologic pain management interventions.
Language	English
Publishing date	2024-03-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	2213260-0
ISSN	1532-8635 ; 1524-9042
ISSN (online)	1532-8635
ISSN	1524-9042
DOI	10.1016/j.pmn.2024.01.003
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Zs.A 6269: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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Article: Effect of mortgage indebtedness on health of U.S. homeowners

Leung, Leigh Ann / Lau, Catherine

Review of Economics of the Household Vol. 15, No. 1 , p. 239-264

2017 Volume 15, Issue 1, Page(s) 239–264

Author's details	Leigh Ann Leung, Catherine Lau
Keywords	Mortgage debt ; Health ; Financial stress ; Panel data ; Instrumental variables
Language	English
Publisher	Springer Science + Business Media B.V
Publishing place	Norwell, Mass
Document type	Article
ZDB-ID	2108192-X ; 2099806-5
ISSN	1573-7152 ; 1569-5239
ISSN (online)	1573-7152
ISSN	1569-5239
Database	ECONomics Information System

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Article: Submucosal Intraglossal Fish Bone Extraction: A Case for the Multidisciplinary Team.

Olley, Benjamin M / Zhu, Yinan / Ozbek, Leyla / Ringrose, Thomas / Lau, Catherine

Cureus

2021 Volume 13, Issue 12, Page(s) e20263

Abstract: Most impacted fish bones in the aerodigestive tract are easily removed or managed in the emergency department. Occasionally, they present as a diagnostic and surgical challenge. We present a case of a submucosal intraglossal fish bone extraction in a 38- ... ...

Abstract	Most impacted fish bones in the aerodigestive tract are easily removed or managed in the emergency department. Occasionally, they present as a diagnostic and surgical challenge. We present a case of a submucosal intraglossal fish bone extraction in a 38-year-old male who presented with localized pain in his tongue. This case highlights several key factors contributing to the successful outcome, including multidisciplinary input from anaesthesiology, radiology, and the oral and maxillofacial surgical team. The use of a pre-operative computed tomography (CT) scan, nasal intubation, and intra-operative ultrasound scan potentially minimised the risk of associated complications.
Language	English
Publishing date	2021-12-08
Publishing country	United States
Document type	Case Reports
ZDB-ID	2747273-5
ISSN	2168-8184
ISSN	2168-8184
DOI	10.7759/cureus.20263
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Article ; Online: Evaluation of a novel metric for personalized opioid prescribing after hospitalization.

Iverson, Nicholas R / Lau, Catherine Y / Abe-Jones, Yumiko / Fang, Margaret C / Kangelaris, Kirsten N / Prasad, Priya / Shah, Sachin J / Najafi, Nader

PloS one

2020 Volume 15, Issue 12, Page(s) e0244735

Abstract: Background: The duration of an opioid prescribed at hospital discharge does not intrinsically account for opioid needs during a hospitalization. This discrepancy may lead to patients receiving much larger supplies of opioids on discharge than they truly ...

Abstract	Background: The duration of an opioid prescribed at hospital discharge does not intrinsically account for opioid needs during a hospitalization. This discrepancy may lead to patients receiving much larger supplies of opioids on discharge than they truly require. Objective: Assess a novel discharge opioid supply metric that adjusts for opioid use during hospitalization, compared to the conventional discharge prescription signature. Design, setting, & participants: Retrospective study using electronic health record data from June 2012 to November 2018 of adults who received opioids while hospitalized and after discharge from a single academic medical center. Measures & analysis: We ascertained inpatient opioids received and milligrams of opioids supplied after discharge, then determined days of opioids supplied after discharge by the conventional prescription signature opioid-days ("conventional days") and novel hospital-adjusted opioid-days ("adjusted days") metrics. We calculated descriptive statistics, within-subject difference between measurements, and fold difference between measures. We used multiple linear regression to determine patient-level predictors associated with high difference in days prescribed between measures. Results: The adjusted days metric demonstrates a 2.4 day median increase in prescription duration as compared to the conventional days metric (9.4 vs. 7.0 days; P<0.001). 95% of all adjusted days measurements fall within a 0.19 to 6.90-fold difference as compared to conventional days measurements, with a maximum absolute difference of 640 days. Receiving a liquid opioid prescription accounted for an increased prescription duration of 135.6% by the adjusted days metric (95% CI 39.1-299.0%; P = 0.001). Of patients who were not on opioids prior to admission and required opioids during hospitalization but not in the last 24 hours, 325 (8.6%) were discharged with an opioid prescription. Conclusions: The adjusted days metric, based on inpatient opioid use, demonstrates that patients are often prescribed a supply lasting longer than the prescription signature suggests, though with marked variability for some patients that suggests potential under-prescribing as well. Adjusted days is more patient-centered, reflecting the reality of how patients will take their prescription rather than providers' intended prescription duration.
MeSH term(s)	Adult ; Aged ; Analgesics, Opioid/therapeutic use ; Drug Prescriptions ; Electronic Health Records ; Female ; Hospitalization ; Humans ; Male ; Middle Aged ; Pain, Postoperative/drug therapy ; Patient Discharge ; Practice Patterns, Physicians' ; Precision Medicine ; Retrospective Studies
Chemical Substances	Analgesics, Opioid
Language	English
Publishing date	2020-12-31
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0244735
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