At a time of growing demand for more accurate and timely
drug safety evidence, a landmark study supports the value of
electronic medical records (EmR) for detecting new adverse
reactions.
Medication nonadherence cost and noncompliance in clinical trialsSynegys
Drug development has reached over $2.6 B and is driven by a clinical trial's success rate, out-of-pocket study costs and study timescales. However, medication nonadherence is a hidden cost which heavily influences these cost drivers. We discuss how medication nonadherence introduces data variability, requiring trial managers to enrol more patients to maintain statistical power, which in turn extends trial timelines. Cost savings are described based on improving study noncompliance with a compliance tool such as Synegys' mComply. This mHealth tool reduces costs as a result of improved statistical power, lower enrollment and shorter trial duration.
Advanced Diagnostics in the Post-PAMA EraJohn Hanna
Presentation given at the Q1 Diagnostics Summit in Boston MA December 6, 2016 discussing considerations for advanced diagnostics commercialization following the implementation of the Protecting Access to Medicare Act (PAMA) provisions for diagnostics pricing and reimbursement in the Medicare program.
The value of real-world evidence for clinicians and clinical researchers in t...Arete-Zoe, LLC
In the midst of a rapidly spreading global pandemic, real-world evidence can offer invaluable insight into the most promising treatments, risk factors, and not only predict but suggest how to improve outcomes. Despite overwhelming news coverage, significant knowledge gaps regarding COVID-19 persist. The current uncertainties regarding incidence and the case fatality rate can only be addressed by widespread testing. But the paucity of testing, and diversity of approaches implemented in different countries, particularly among the general asymptomatic public, perpetuates a lack of understanding about spread and infectivity. The essential indicators that would describe the pandemic more accurately can be obtained using real-world data (RWD). To that purpose, we designed a data collection tool to collect data from hospitals that treat COVID-19 patients. The captured data will enhance our understanding of the COVID-19 pandemic, identify risk factors relevant for triage, relate to other similar seasonal infections and gain insight into the safety and efficacy of experimental and off-label therapies. Knowledge derived from a focused data collection effort will enable clinicians to adjust rapidly clinical protocols and discontinue interventions that turn out to be ineffective or harmful. By deploying our elegantly designed survey to capture routine clinical indicators, we avoid placing an additional burden on practitioners. Systematically generating real-world evidence can decrease the time to insight compared to randomized clinical trials, improving the odds for patients in rapidly changing conditions.
Medication nonadherence cost and noncompliance in clinical trialsSynegys
Drug development has reached over $2.6 B and is driven by a clinical trial's success rate, out-of-pocket study costs and study timescales. However, medication nonadherence is a hidden cost which heavily influences these cost drivers. We discuss how medication nonadherence introduces data variability, requiring trial managers to enrol more patients to maintain statistical power, which in turn extends trial timelines. Cost savings are described based on improving study noncompliance with a compliance tool such as Synegys' mComply. This mHealth tool reduces costs as a result of improved statistical power, lower enrollment and shorter trial duration.
Advanced Diagnostics in the Post-PAMA EraJohn Hanna
Presentation given at the Q1 Diagnostics Summit in Boston MA December 6, 2016 discussing considerations for advanced diagnostics commercialization following the implementation of the Protecting Access to Medicare Act (PAMA) provisions for diagnostics pricing and reimbursement in the Medicare program.
The value of real-world evidence for clinicians and clinical researchers in t...Arete-Zoe, LLC
In the midst of a rapidly spreading global pandemic, real-world evidence can offer invaluable insight into the most promising treatments, risk factors, and not only predict but suggest how to improve outcomes. Despite overwhelming news coverage, significant knowledge gaps regarding COVID-19 persist. The current uncertainties regarding incidence and the case fatality rate can only be addressed by widespread testing. But the paucity of testing, and diversity of approaches implemented in different countries, particularly among the general asymptomatic public, perpetuates a lack of understanding about spread and infectivity. The essential indicators that would describe the pandemic more accurately can be obtained using real-world data (RWD). To that purpose, we designed a data collection tool to collect data from hospitals that treat COVID-19 patients. The captured data will enhance our understanding of the COVID-19 pandemic, identify risk factors relevant for triage, relate to other similar seasonal infections and gain insight into the safety and efficacy of experimental and off-label therapies. Knowledge derived from a focused data collection effort will enable clinicians to adjust rapidly clinical protocols and discontinue interventions that turn out to be ineffective or harmful. By deploying our elegantly designed survey to capture routine clinical indicators, we avoid placing an additional burden on practitioners. Systematically generating real-world evidence can decrease the time to insight compared to randomized clinical trials, improving the odds for patients in rapidly changing conditions.
Slides from the presentation on extrapolation from progression free survival to overall survival in oncology given at the 2017 HTAi Annual Meeting in Rome
The usability of STAMP in drug development Arete-Zoe, LLC
Arete-Zoe in cooperation with Stuttgart University
Study authors: Veronika Valdova, Ronald L Sheckler, Asim Abdulkhaleq and Stefan Wagner (Jonathan M Fishbein)
Presentation of synopsis: Veronika Valdova
Presented at STAMP team meeting, PSCI, ACRES on February 26, 2016
Twenty-first century technologies will create significant opportunities and challenges for all healthcare stakeholders. Pharmacovigilance (PV) too is in transition, with new sources of medical information and methods for its analysis that will transform today's largely reactive system into proactive benefit-risk management for all medication users.
Avoidable Patient Harm and Resulting Liability Arete-Zoe, LLC
Avoidable Patient Harm and Resulting Liability
What would it take to improve our insight into the cost of avoidable patient harm?
Medications are the most frequent cause of adverse events in clinical settings.
Some of the most devastating drug-related injuries include Steven-Johnson Syndrome, drug-related liver injury or bone marrow failure. These events, however rare, are among those that are very expensive to treat and often leave long-lasting damage.
The substantial consequences of adverse drug events are hospital admissions and readmissions, prolonged hospital stay, additional therapeutic interventions and increased demand on staff. For the patient, in addition to all the misery and pain they suffer, adverse drug events mean time away from work, loss of income and additional medical expenses.
Patient input to HTA Europe, Dolon LTD, European conference on rare diseases ...richsear
Incorporating patient perspective in funding
decisions for rare disease treatments:
a review of international payer systems, poster session, Dolon LTD, European Conference on Rare Diseases and Orphan Products, 2016
The Survivor community can learn more about the state of the art in new tests available in cancer centres, which pinpoint specific types of tumours that will respond best to treatments.
Presentation - The Economics of the Market for Medicines, Jorge Mestre-Ferran...Office of Health Economics
Jorge Mestre-Ferrandiz also presented a guest lecture at City University, London, on 17 March 2016, on the topic of the economics of the market for medicines.
The first half of the lecture included an overview of the global challenges facing medicines manufacturers, discussion of the ‘supply side’ (focusing on research and development of new drugs), and evidence relating to the ‘demand side’ which suggests that UK spending on medicines as a percentage of GDP is already amongst the lowest in developed countries.
The second half of the lecture looked at NICE and the ‘hurdle’ of demonstrating cost-effectiveness, as well as an overview of pricing regulation, and specific characteristics of the UK market.
Slides from the presentation on extrapolation from progression free survival to overall survival in oncology given at the 2017 HTAi Annual Meeting in Rome
The usability of STAMP in drug development Arete-Zoe, LLC
Arete-Zoe in cooperation with Stuttgart University
Study authors: Veronika Valdova, Ronald L Sheckler, Asim Abdulkhaleq and Stefan Wagner (Jonathan M Fishbein)
Presentation of synopsis: Veronika Valdova
Presented at STAMP team meeting, PSCI, ACRES on February 26, 2016
Twenty-first century technologies will create significant opportunities and challenges for all healthcare stakeholders. Pharmacovigilance (PV) too is in transition, with new sources of medical information and methods for its analysis that will transform today's largely reactive system into proactive benefit-risk management for all medication users.
Avoidable Patient Harm and Resulting Liability Arete-Zoe, LLC
Avoidable Patient Harm and Resulting Liability
What would it take to improve our insight into the cost of avoidable patient harm?
Medications are the most frequent cause of adverse events in clinical settings.
Some of the most devastating drug-related injuries include Steven-Johnson Syndrome, drug-related liver injury or bone marrow failure. These events, however rare, are among those that are very expensive to treat and often leave long-lasting damage.
The substantial consequences of adverse drug events are hospital admissions and readmissions, prolonged hospital stay, additional therapeutic interventions and increased demand on staff. For the patient, in addition to all the misery and pain they suffer, adverse drug events mean time away from work, loss of income and additional medical expenses.
Patient input to HTA Europe, Dolon LTD, European conference on rare diseases ...richsear
Incorporating patient perspective in funding
decisions for rare disease treatments:
a review of international payer systems, poster session, Dolon LTD, European Conference on Rare Diseases and Orphan Products, 2016
The Survivor community can learn more about the state of the art in new tests available in cancer centres, which pinpoint specific types of tumours that will respond best to treatments.
Presentation - The Economics of the Market for Medicines, Jorge Mestre-Ferran...Office of Health Economics
Jorge Mestre-Ferrandiz also presented a guest lecture at City University, London, on 17 March 2016, on the topic of the economics of the market for medicines.
The first half of the lecture included an overview of the global challenges facing medicines manufacturers, discussion of the ‘supply side’ (focusing on research and development of new drugs), and evidence relating to the ‘demand side’ which suggests that UK spending on medicines as a percentage of GDP is already amongst the lowest in developed countries.
The second half of the lecture looked at NICE and the ‘hurdle’ of demonstrating cost-effectiveness, as well as an overview of pricing regulation, and specific characteristics of the UK market.
How patient subpopulations are changing the commercialization of oncology pro...IMSHealthRWES
An excerpt from the latest issue of AccessPoint, looking at how genomic profiling data is transforming our understanding of patient subpopulations - a key to targeting treatments with greater precision
IMS Health Clinical Trial Optimization SolutionsQuintilesIMS
IMS Health's Linda T. Drumright, general manager, Clinical Trial Optimization Solutions presents at the 3rd Annual Patient Recruitment & Retention Summit 2014 - San Francisco, CA
The Increasing Importance of Patient Reported Outcomes and the Patient Voice ...Covance
Over the past few years there has been a paradigm shift in the overall approach to pharmacovigilance from that of pure safety analysis to overall benefit-risk evaluation of products. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
The World Health Organization defines pharmacovigilance as the science and actions connected to the detection, evaluation, understanding, and prevention of adverse effects or any other drug related problem. Pharmacovigilance is critical in ensuring that patients receive safe pharmaceuticals. We can learn more about a drugs side effects through a variety of methods, including spontaneous reporting, diligent monitoring, and database research. Novel mechanisms are being established at both the regulatory and scientific levels to increase pharmacovigilance. They include conditional approval and risk management strategies on a regulatory level, and openness and increasing patient engagement on a scientific one. OBJECTIVE To review and discuss various aspects of pharmacovigilance, including new methodological developments. V Sai Kruthika | Sarvani Ekathmika | Prathamesh Golapkar "Advanced Methodologies in Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55052.pdf Paper URL: https://www.ijtsrd.com.com/other-scientific-research-area/other/55052/advanced-methodologies-in-pharmacovigilance/v-sai-kruthika
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
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SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
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COMPUTERS
MAHINDRA
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As pharmaceutical manufacturers look for ways to build
stronger relationships with their Integrated Delivery Network
(IDN) clients, RWE is emerging as a desired infrastructure
capability, presenting a window of opportunity to support and
collaborate on IDN efforts. If done well, these RWE-related
partnerships should provide value for both parties involved
but require pharma to expand its mindset beyond
product-specific approaches.
Building innovative, effective RWE platformsIMSHealthRWES
As more pharmaceutical companies pursue RWE as a core
capability in their organization, they have been increasing their
investment in integrated evidence platforms.
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
IMS Health Real-World Evidence Solutions at ISPOR November 2015IMSHealthRWES
Welcome to the IMS Health Real-World Evidence (RWE) Solutions program of activities at the forthcoming ISPOR 18th Annual European Congress in Milan. We invite you to join us at more than 70 presentations that spotlight exciting innovations and applications of outcomes research and RWE. And please visit us at our booth to learn more about our pioneering efforts including the e360TM technology suite, RWD Catalogue with 1,800+ data sources identified, and the newly launched RWE Dictionary. Full details of our ISPOR schedule can be found in the brochure.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
QA Paediatric dentistry department, Hospital Melaka 2020Azreen Aj
QA study - To improve the 6th monthly recall rate post-comprehensive dental treatment under general anaesthesia in paediatric dentistry department, Hospital Melaka
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
1. ACCESSPOINT • VOLUME 5 • ISSUE 10 PAGE 35
The author
David Ansell, mb, CHb, mRCS, PHD
is Associate Director, RWE Solutions, IMS Health
Dansell@uk.imshealth.com
Prospective identification of drug
safety signals from primary care EMR
At a time of growing demand for more accurate and timely
drug safety evidence, a landmark study supports the value of
electronic medical records (EmR) for detecting new adverse
reactions. It also shows that statistical associations in EmR must
be treated with as much caution as those from individual case
reports − and be subjected to clinical and epidemiological
review. A deep understanding of the methodologies, data
collection and clinical practice involved is implicit.
2. PAGE 36 IMS HEALTH REAL-WORLD EVIDENCE SOLUTIONS
INSIGHTS HEOR, PHARMACOEPIDEMIOLOGY & DRUG SAFETY
Insights from The Health Improvement Network (THIN) database
Increasingly stringent regulatory requirements
for pharmaceutical risk management and
safety surveillance have accelerated research
to improve the detection of new adverse drug
reactions (ADRs) under conditions of normal
product use.
For many years, the process of identifying potential signals
and the existence of previously unknown risk has relied
mainly on individual case safety reports (ICSRs). More
recently the use of longitudinal health data (LHD) has been
explored, both to complement ICSR information and
overcome some inherent limitations. Most studies looking
to apply LHD have investigated its ability to distinguish
established ADRs from unrelated adverse events; few have
attempted to examine a role for this data in detecting
emerging safety signals.
leveraging EmR in pharmacovigilance
Marking an important milestone in efforts to apply EMR in
day-to-day pharmacovigilance, a new study has sought to
evaluate a process for assessing temporally associated drugs
and medical events (adverse events) in this data.1
Specifically, the researchers aimed to determine (1) to what
extent exploratory analysis of EMR would identify
important potential safety signals and (2) what proportion
of false alarms could be expected if the temporal
associations were taken at face value rather than subjected
to epidemiological review.
Utilizing the Uppsala Monitoring Centre’s vigiTrace™
framework for health data exploration, the study
comprised integrating the vigiTrace™ software framework
with the primary care EMR and performing a structured
assessment of more than 500 pairs of drugs and medical
events in THIN (The Health Improvement Network) – an
electronic medical records resource from primary care in
the UK. THIN includes more than 12 million patients, with
over 3.8 million being currently active patients. The EMR
are collected from general practices and are representative
of the entire UK population in terms of age, gender,
medical conditions and death rates. The data extract for the
current evaluation was from January 2011 and covered 7.7
million patients.
A key element of vigiTrace™ is a graphical display
(chronograph) which summarizes and visualizes temporal
associations between two events. In this case, the
chronograph focused on the cohort of patients with new
prescriptions (Rx) of the drug in question and explored
variation over time in the recording of a medical event
relative to those new Rx. Further, it contrasted the observed
number of patients with a record of the particular event to
an expected value in each time period, based on an external
control group. VigiTrace™ also provided analytics to
support the structured assessment with a calibrated
self-controlled cohort analysis.
Evaluation process
Over 40 drugs were randomly selected from THIN on the
basis of specified inclusion/exclusion criteria, key amongst
which was the presence of more than 5,000 new Rx. Medical
events (up to 20 per drug) chosen at random from those
identified as temporally associated with a new Rx of the
drug in question, were assessed for relevance prior to
undergoing in-depth analysis.
The in-depth assessment was based on a structured
questionnaire and included a review of the UK Summary of
Product Characteristics (SPC) document as well as
additional exploration of data in THIN. Among factors
addressed as part of this appraisal were: the nature of the
temporal pattern; demographics of the cohort; use of
concomitant medicines; previous signs and symptoms; and
potential confounding by underlying disease.
Results
From the more than 500 relevant drug-event combinations
that were identified, 25% were categorized as known ADRs,
based on the SPC review (eg, sleep disturbance for a drug
with insomnia listed, glaucoma for a drug with acute
glaucoma listed).
Close to 100 of the remaining combinations were classified
as meriting full clinical review, beyond the restricted scope
of the study assessment. Examples include multiple organ
failure with a selective serotonin reuptake inhibitor (SSRI);
skin sensation disturbance (eg, paresthesia, numbness,
tingling) with a long-acting beta-2 agonist; and an
ophthalmic condition with a diuretic. The strength of
evidence for these combinations varied: most of them
merely lacked alternative explanations to suggestive
temporal patterns, whereas a few also had support in
experimental evidence or regulatory information from
other countries than the UK.
In contrast, the majority (approaching 300) of the
highlighted drug-event pairs were deemed unlikely to
reflect direct causal relations and hence dismissed from
further review. The most common reasons for this were
confounding by the underlying disease or earlier signs and
symptoms indicating that the onset of the medical event
preceded the start of drug treatment. Examples include
endometriosis with a drug for the relief of IBS where the
prior diagnosis of IBS (based on abdominal pain) was later
shown to be endometriosis, and eustacian tube dysfunction
with antibiotic drops utilized for treating an ear infection.
Examples of the chronograph outputs are shown in
Figure 1 opposite.
Prospective identification of drug
safety signals from primary care EmR
3. ACCESSPOINT • VOLUME 5 • ISSUE 10 PAGE 37
That said, the fact that 76% of the drug-event pairs were
dismissed from further evaluation following initial review,
indicates that signal detection using LHD should form part
of a wider, comprehensive process of detailed clinical and
epidemiological review. This is an important area for further
research to inform the future role of LHD in signal
detection. It would include examination of individual
patient histories, evaluation of more detailed information in
THIN (eg, temporal patterns for similar drugs and medical
events) as well as exploration of alternative, complementary
information sources such as the scientific literature and
collections of individual case reports. A broader, contextual
understanding of the methodologies employed, approaches
to data collection, and the prevailing medical practice in the
setting being studied would be a key part of this process.
Implications
With this study has come a clear demonstration that
exploratory analysis of EMR is a valid and feasible approach
for detecting important drug safety signals. If a primary care
EMR such as THIN is utilized as the source, then signal
detection will be confined to those drugs prescribed within
the primary care setting. The initial epidemiological review
revealed a considerable number of temporally associated
drugs and medical events, ranging from significant, life-
threatening conditions to less serious but potentially
problematic events for patients. Importantly, some of these
were conditions that the current pharmacovigilance system,
with its reliance on individual ADR case reporting, may be
challenged to capture. Some of the identified events have
not been previously linked to these therapeutic agents and
have highlighted the requirement for further investigation.
1
Cederholm S, Hill G, Asiimwe A, Bate A, Bhayat F, Persson Brobert G, Bergvall T, Ansell D, Star K, Norén GN. Structured assessment for
prospective identification of safety signals in electronic medical records: Evaluation in the Health Improvement Network. Drug Saf, 2015; 38:
87-100
Figure 1: Sample outputs from the vigiTrace™ chronograph
The study referenced in this article was performed in collaboration with scientists from Eli Lilly, Pfizer, Takeda, Bayer and Cegedim UK,
within the public-private partnership PROTECT, which is funded through the European Innovative Medicines Initiative.
509
Temporally
associated
drug-event
pairs
382
New
127Already known 291Dismissed
91Merit further evaluation
25%
75%
76%24%
Source: Cederholm S, Asiimwe A, bate A, bhayat F, brobert G, Hill G, Star K, Norén GN. Structured assessment for prospective identification of potential
safety signals in electronic health records (Poster). 30th International Conference on Pharmacoepidemiology and Therapeutic Risk management (ICPE)
24-27 October, 2014 Taipei, Taiwan
Cannot sleep – insomnia is temporally associated with new
prescriptions of reboxetine and was classified as already
known since insomnia is listed as a very common adverse
reaction to reboxetine in the UK SPC.
Endometriosis is temporally associated with new
prescriptions of hyoscine but was dismissed from further
review on account of suspected protopathic bias. Hyoscine
is given to treat abdominal cramps, which are a common
symptom of endometriosis.
Epiphora is temporally associated with new prescriptions of
amiloride and was classified as meriting further review on
account of the suggestive temporal pattern.