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Drug-Drug Interactions - Safety Alerts as Drivers for Pharmaceutical Opinion Program
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Project Summary
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The Safety Alerts as Drivers for Pharmaceutical Opinion Program is a pilot research study conducted by Certina Ho, Project Manager, at ISMP Canada. It is supported by the Canadian Foundation for Pharmacy (CFP) Innovation Fund Grant. This study aims to examine the effects of utilizing evidence-based drug-drug interactions that are not widely documented in tertiary drug information resources for the prevention of potential adverse events. By offering continuing professional development opportunities to pharmacy practitioners via ISMP Canada safety alerts, this project aims to motivate pharmacists to integrate cognitive services into daily workflow while being recognized and reimbursed by the Pharmaceutical Opinion Program (POP).
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Research Objectives
The objectives of this research study are to:
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Reduce the occurrence of drug-drug interactions that have been associated with potential hospitalizations as supported by pharmacoepidemiologic evidence.
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Offer education or continuing professional development (CPD) opportunities to pharmacy practitioners via ISMP Canada safety alerts on drug-drug interactions that have been shown to be associated with potential hospitalizations.
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Motivate pharmacists to integrate cognitive services into daily workflow by developing a sustainable or financially viable platform through recognition and reimbursement of the Pharmaceutical Opinion Program (POP).
Timeline
The diagram below illustrates the timeline for the different stages of the Safety Alerts as Drivers for Pharmaceutical Opinion Program project.
Stage 1
Preparation
- ISMP Canada applies for research ethics approval. Ethics approval will be sought through the Office of Research Ethics (ORE) at the University of Toronto ISMP Canada recruits staff for this project (e.g. research assistants)
Stage 2
Preparation (continues)
- ISMP Canada prepares safety alerts and standardized POP documentation form to pharmacists for communication to prescribers during implementation of POP
Recruitment of Project Participants
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ISMP Canada recruits participating community pharmacies
Stage 3
Pre-Intervention (Baseline Measure)
- ISMP Canada collects baseline POP data from participating pharmacies
Intervention
- ISMP Canada provides orientation to participating pharmacies.
- Participants review safety alerts, identify drug-drug interactions, and communicate with prescribers using the standardized POP documentation form developed for this project
Stage 4
Post-intervention (Data Collection - Quantitative)
- ISMP Canada follows up with participating pharmacies on a monthly basis and collects POP data
Post-intervention (Data Collection - Qualitative)
- ISMP Canada hosts focus groups with participants
Stage 5
Data Analysis
- ISMP Canada analyzes quantitative data i.e. post-intervention POP data collected from participating pharmacies
- ISMP Canada transcribes and analyzes thematically focus group data
Stage 6
Dissemination & Knowledge Translation of Research Findings
- ISMP Canada disseminates research findings of this pilot study via presentations at conferences, etc.
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About the Project
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Introduction
Background
Adverse drug events can encompass a wide variety of situations leading to harm for example, drug-drug interactions, medication errors and adverse drug reactions. The focus of this study is aimed to reduce drug-drug interactions at the level of community and ambulatory pharmacies. Drug-drug interactions can lead to serious adverse patient outcomes (ISMP Canada, 2008). For example, two population-based studies conducted by researchers at the Institute of Clinical Evaluative Sciences (ICES) examined the association between specific drug-drug interaction pairs and hospitalizations (Juurlink et al., 2003; Jurrlink et al., 2009). Utilizing pharmacoepidemiologic methods, these studies demonstrated a significant positive association between specific drug-drug interactions with hospitalization as a result of the adverse drug event. Summary of drug-drug interactions associated with potential hospitalizations).
This pilot study measures the effect of ISMP Canada safety alerts in facilitating community pharmacists' clinical intervention (via the Pharmaceutical Opinion Program in Ontario). The goals of the pilot study are to show that the proposed intervention by ISMP Canada safety alerts can (1) reduce the number of patients receiving drug pairs associated with potential hospitalizations (2) supplement existing tertiary drug information resources or point-of-care clinical decision support systems (CDSS) that are depended on by many pharmacies across Canada; and (3) facilitate cognitive services that are being recognized and supported by provincial drug programs (i.e. the Pharmaceutical Opinion Program).
References
Impact and Value of ISMP Canada's Activities on Medication Safety
The ISMP Canada Safety Bulletins, which are supported by the Canadian Medication Incident Reporting and Prevention System (CMIRPS) Program, have been widely distributed to health care professionals across Canada since 2001.
- CMIRPS activities that were perceived by stakeholders as having the greatest impact on Canadian health care practice include the ISMP Canada Safety Bulletins and Safety Alerts (Prairie Research Associates (PRA), 2010).
- ISMP Canada's CMIRPS activities increase awareness of hazardous or harmful situations, offer feasible recommendations, and reduce inefficiency and advance safety of medication-use processes.
References
Impact of Research
Significance
Clinically significant outcomes from this pilot study can be derived or extrapolated as recent studies provide clear evidence that drug-drug interactions do occur and potentially contribute to hospital admissions. Drug-drug Interaction Pairs summarizes the incidence of the drug-drug interactions, the risk of adverse events such as hospitalization for patients concurrently taking the interacting medications (and the estimated hospital admission rates that could have been avoided if the interaction was intercepted or prevented). ISMP Canada safety alerts disseminated to pharmacists during this pilot study centralize educational or continuous professional development (CPD) opportunities to practitioners, as drug-drug interactions are inconsistently represented in tertiary references commonly used by community pharmacists in Ontario and other provinces. Being experts in medication therapy management, pharmacists are then placed in the best position to identify and capture these preventable drug-drug interactions and reduce potential hospitalizations associated with these interactions.
Practicality
In April 2011, the first stage of the expanded professional pharmacy service, the Pharmaceutical Opinion Program, was launched. The Ontario Ministry of Health and Long-Term Care acknowledged and reimbursed pharmacist's clinical interventions due to a medication-related concern/drug related problem that required follow-up with the prescriber for Ontario Drug Benefit patients that occurred either at the time of dispensing a prescription or when conducting a MedsCheck medication review. This pilot study offers a unique opportunity to combine "medication safety", "cognitive services", and the "business" aspect of community pharmacy practice. The expected outcomes of this pilot study can benefit community pharmacy practice in terms of:
- Reducing the occurrence of drug-drug interactions that have been shown to be associated with potential hospitalizations.
- Receiving education or continuing professional development (CPD) via ISMP Canada safety alerts on drug-drug interactions that have been shown to be associated with potential hospitalizations and may not have been documented in common tertiary literature or drug information resources.
- Integrating cognitive services into daily workflow while being recognized and reimbursed by the Pharmaceutical Opinion Program.
Research Hypothesis
Potential hospital admissions due to (1) hypoglycemia, (2) digoxin toxicity, (3) hyperkalemia, (4) hemorrhagic complications, (5) hypotension, and (6) phenytoin toxicity as a result of the drug-drug interactions identified can be avoided by clinical intervention of pharmacists through the application of the ISMP Canada safety alerts on drug-drug interactions and the execution of the Pharmaceutical Opinion Program.
Methods
This is an experimental (i.e. with an intervention), non-randomized research project with a pre- and post- study design. Methods of this pilot study are illustrated in the timeline.
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Drug-drug Interactions in the Geriatric Population
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Summary of Selected Pharmacoepidemiological Studies in Ontario (Nested Case-Control, Retrospective Cohort and Case Cross-Over Studies).*
| Drug-Interaction Pair |
Demographics / Background Information |
Comments |
Continuous
Medication |
Added
Medication |
| Glyburide1 |
Trimethoprim-sulfamethoxazole (TMP-SMX) |
Study Population:
Older than 66 years treated with glyburide. A total of 909 cases.
Drug Toxicity/ Adverse Event:
Hypoglycemia
Possible Mechanism of Action:
Sulfamethoxazole can directly cause pancreatic insulin release (at higher doses due to structural similarity to sulfonylurea) in patients with renal impairment.
Sulfonamide antibiotics inhibit CYP 2C9. Glyburide is metabolized by CYP 2C9.
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The concomitant use of TMP-SMX with glyburide was associated with increased risk of hospitalization due to hypoglycemia in the elderly.
Juurlink et al. estimated that patients who were hospitalized due to hypoglycemia while using glyburide were around 6 times more likely to have been treated with TMP-SMX within 1 week.
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| Digoxin1 |
Clarithromycin |
Study Population:
Older than 66 years treated with digoxin. A total of 1,051 cases. A total of 51,896 controls.
Drug Toxicity/ Adverse Event:
Digoxin toxicity
Possible Mechanism of Action:
Clarithromycin inhibits P-glycoprotein which leads to decreased renal clearance of digoxin.
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The concomitant use of clarithromycin and digoxin was associated with increased risk of hospitalization due to digoxin toxicity in the elderly.
Juurlink et al. estimated that patients who were hospitalized due to digoxin toxicities while using digoxin were around 12 times more likely to have been treated with clarithromycin.
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| Digoxin2 |
Macrolide antibiotics |
Study Population:
Over the age of 66 treated with digoxin. A total of 1,659 cases. A total of 6,439 control cases.
Drug Toxicity/ Adverse Event:
Digoxin toxicity
Possible Mechanism of Action:
Macrolide antibiotics can reduce re-circulation of digoxin by reducing Eubacterium lentum in the gut.
Clarithromycin may inhibit P-glycoprotein-mediated tubular secretion of digoxin.
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Concomitant use of digoxin and macrolide antibiotics may lead to increased risk of hospitalization in the elderly.
Gomes et al. estimated that patients who are hospitalized due to digoxin toxicity are 15 times more likely to be taking clarithromycin and 4 times more likely to be taking azithromycin or erythromycin.
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| ACEIs/ Angiotensin receptor blockers (ARBs)3 |
TMP-SMX |
Study Population:
Over the age of 66 years treated with ACEI or ARBs. A total of 369 cases. A total of 1,417 controls.
Drug Toxicity/ Adverse Event:
Hyperkalemia
Possible Mechanism of Action:
ACEIs and ARBs impair urinary potassium excretion
TMP reduces urinary potassium excretion.
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Concomitant use of TMP-SMX and ACEIs or ARBs is associated with increased risk of hospitalization due to hyperkalemia in the elderly.
Antoniou et al. estimated in patients who are hospitalized for hyperkalemia and using ACEIs or ARBs are about 7 times more likely to have received TMP-SMX.
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| Warfarin4 |
TMP-SMX, ciprofloxacin |
Study Population:
Over the age of 66 years treated with warfarin. A total of 2,151 cases. A total of 10,201 controls.
Drug Toxicity/ Adverse Event:
Hemorrhagic complications
Possible Mechanism of Action:
TMP-SMX inhibits CYP 2C9. S-warfarin (active enantiomer) metabolized predominantly by CYP 2C9.
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Concomitant use of TMP-SMX or ciprofloxacin with warfarin increases the risk of hospitalization due to hemorrhagic complications
Fischer et al. estimated patients, who were hospitalized with hemorrhagic complications while using warfarin, are 3 times more likely to have been exposed to TMP-SMX and 2 times more likely to have been using ciprofloxacin
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| Calcium channel blockers (CCBs) (verapamil, diltiazem, nifedipine, amlodipine, or felodipine)5 |
Macrolide antibiotics (erythromycin, clarithromycin, and azithromycin) |
Study Population:
Over the age of 66 years treated with CCBs. A total of 7100 in cohort. A total of 176 cases.
Drug Toxicity/ Adverse Event:
Hypotension
Possible Mechanism of Action:
Two macrolides, erythromycin and clarithromycin, inhibit CYP 3A4. Azithromycin does not inhibit CYP 3A4. Calcium channel blockers are CYP 3A4 substrates.
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Concomitant use of CCBs and macrolide antibiotics are associated with increased risk of hospitalization due to hypotension.
Wright et al. found in patients who are admitted to hospital due to hypotension while using a CCB are more likely to have received clarithromycin or erythromycin prior to hospitalization. Azithromycin was not associated with hypotension.
This is a case cross-over study.
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| Theophylline6 |
Ciprofloxacin |
Study Population:
Over the age of 66 treated with theophylline. A total of 180 cases. A total of 9,000 controls.
Drug Toxicity/ Adverse Event:
Theophylline toxicity
Possible Mechanism of Action:
Theophylline is metabolized by CYP 1A2. Ciprofloxacin is a potent inhibitor of CYP 1A2. Ciprofloxacin is a commonly used antibiotic given to chronic obstructive pulmonary disease (COPD) patients.
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Concomitant use of theophylline and ciprofloxacin may lead to increased risk of hospitalization due to theophylline toxicity.
Antoniou et al. estimated that patients hospitalized due to theophylline toxicity were 2 times more likely to have been treated with ciprofloxacin.
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| Phenytoin7 |
TMP-SMX |
Study Population:
Over the age of 66 years treated with phenytoin. A total of 796 cases. A total of 3,148 controls.
Drug Toxicity/ Adverse Event:
Phenytoin toxicity
Possible Mechanism of Action:
Phenytoin is metabolized by CYP 2C8. TMP-SMX is a potent CYP 2C8 inhibitor and may lead to increase in phenytoin level.
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Concomitant use of phenytoin and TMP-SMX increases the risk of hospitalization due to phenytoin toxicity.
Antoniou et al. estimated patients who are hospitalized due to phenytoin toxicity are 2 times more likely to have received TMP-SMX within 30 days.
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| Spironolactone8 |
TMP-SMX, Nitrofurantoin
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Study Population:
Over the age of 66 years treated with spironolactone. A total of 248 cases (median age, 82 years). A total of 783 controls (median age, 81 years).
Drug Toxicity/ Adverse Event:
Hyperkalemia
Possible Mechanism of Action:
Spironolactone and TMP-SMX both decrease urinary excretion of potassium.
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Concomitant use of TMP-SMX or nitrofurantoin with spironolactone has been associated with increased risk of hospitalization due to hyperkalemia.
Antoniou et al. estimated that patients hospitalized due to hyperkalemia while using spironolactone are 12 times more likely to have been using TMP-SMX and 2 times more likely to have been using nitrofurantoin.
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*The information was taken from the individual drug interaction studies and does not necessarily represent the opinion of ISMP Canada. Health care organizations are encouraged to critically appraise these studies to determine the applicability to their specific practice settings. (Updated April 24, 2013)
Bibliography
1 Juurlink DN, Mamdani M, Kopp A, Laupacis A, Redelmeier DA. Drug-drug interactions among elderly patients hospitalized for drug toxicity. JAMA 2003;289(13):1652-1658.
2 Gomes T, Mamdani MM, Juurlink DN. Macrolide-induced digoxin toxicity: a population-based study. Clin Pharmacol Ther 2009;86(4):383-386.
3 Antoniou T, Gomes T, Juurlink DN, Loutfy MR, Glazier RH, Mamdani MM. Trimethoprim-sulfamethoxazole-induced hyperkalemia in patients receiving inhibitors of the renin-angiotensin system: a population-based study. Arch Intern Med 2010;170(12):1045-1049.
4 Fischer HD, Juurlink DN, Mamdani MM, Kopp A, Laupacis A. Hemorrhage during warfarin therapy associated with cotrimoxazole and other urinary tract anti-infective agents: a population-based study. Arch Intern Med 2010;170(7):617-621.
5 Wright AJ, Gomes T, Mamdani MM, Horn JR, Juurlink DN. The risk of hypotension following co-prescription of macrolide antibiotics and calcium-channel blockers. CMAJ 2011;183(3):303-307.
6 Antoniou T, Gomes T, Mamdani M, Juurlink DN. Ciprofloxacin-induced theophylline toxicity: a population-based study. Eur J Clin Pharmacol 2011;67(5):521-526.
7 Antoniou T, Gomes T, Mamdani M, Juurlink DN. Trimethoprim/sulfamethoxazole-induced phenytoin toxicity in the elderly: a population-based study. Br J Clin Pharmacol 2011;71(4):544-549.
8 Antoniou T, Gomes T, Mamdani MM, Yao Z, Hellings C, Garg AX, et al. Trimethoprim-sulfamethoxazole induced hyperkalemia in elderly patients receiving spironolactone: nested case-control study. BMJ 2011;343:d5228.
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Meet the Team
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Principal Investigator
Certina Ho, R.Ph., B.Sc.Phm., M.I.St., M.Ed.
A graduate of the Faculty of Pharmacy, University of Toronto, Certina Ho is currently a Project Manager at the Institute for Safe Medication Practices Canada (ISMP Canada). In addition, she has experience in community pharmacy practice and management of internet health content. Certina obtained her graduate degrees in Library and Information Science in 1998 and in Education in 2005. In her current position, Certina is responsible for medication safety initiatives related to community pharmacy practice as well as medication incident reporting and analysis at ISMP Canada.
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CFP ISMP Canada Group Picture
From left to right: Sylvia Hyland, Roger Cheng, Atsushi Kawano, Certina Ho, Brett Morphy, Dayle Acorn (Executive Director, CFP), Linda Prytula (Board Member, CFP), Nadine Saby (Board Member, CFP).
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Co-investigators
Sylvia Hyland, RPh, BScPhm, MHSc (Bioethics)
Sylvia Hyland is Vice President and Chief Operating Officer of the Institute for Safe Medication Practices Canada (ISMP Canada). After receiving her baccalaureate pharmacy degree from the University of Toronto, Ms. Hyland completed a clinical pharmacy residency at Women's College Hospital in Toronto. She earned her Master of Health Sciences in Bioethics through the Joint Centre for Bioethics, University of Toronto. Ms. Hyland's professional experience includes positions in clinical and administrative pharmacy in several hospitals in Ontario. In her work for ISMP Canada, she has also assisted with analyses of adverse medication events and has participated in focused reviews of medication use systems in health care.
Roger Cheng, RPh, BScPhm, PharmD
Roger joined ISMP Canada in 2006 as an analyst. His current responsibilities as project leader include conducting Individual and Multi-Incident Analysis from the medication incidents in the ISMP Canada Medication Incident Database. Roger holds a Bachelor of Science in Pharmacy degree (1999) and a Doctor of Pharmacy degree (2003) from the University of Toronto. Roger has worked in both community and hospital pharmacy settings, including staff pharmacist positions at Princess Margaret Hospital and York Central Hospital.
Atsushi Kawano, B.Sc., M.Sc., B.Sc.Phm
Atsushi Kawano is a graduate from the School of Pharmacy, University of Waterloo. In addition, he has received B.Sc. and M.Sc. degrees from the University of Waterloo. He has completed work-term placements with the Ministry of Health and Long-Term Care under the Exceptional Access Program (EAP), Costco Pharmacy, and the Institute for Safe Medication Practices Canada (ISMP Canada). During his work-term placement at ISMP Canada, he completed many projects aimed at improving patient safety in community pharmacies. His most recent project focused on potential errors associated with non-sterile compounding practices and methadone dispensing. Ontario College of Pharmacists (OCP) published his work on non-sterile compounding practices and methadone dispensing in the Spring 2012 issue and the Summer 2013 issue of Pharmacy Connection respectively.
Brett J. Morphy, B.Sc., B.Sc.Phm
Brett J. Morphy is a graduate of the undergraduate Biochemistry program from the University of Guelph and a graduate from the School of Pharmacy, University of Waterloo. Brett has prior experience conducting laboratory research at the University of Guelph, academic / curricular research at the University of Waterloo, and has completed work-term placements at different community pharmacy practices.
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Get Involved!
Are you a community pharmacist seeking to incorporate evidence-based medication safety tools to prevent harm to your patients and be reimbursed by the Pharmaceutical Opinion Program (POP)? You are invited to participate in this study!
Please refer to the following section for information on your participation in this study. For further inquiry, please contact us at ddi@ismpcanada.ca.
What will I need to do in order to participate in this study?
If you decide to participate in this study, you will be asked to:
- Review a copy of ISMP Canada safety alerts regarding evidence-based drug-drug interactions.
- Participate in a brief orientation of this project via teleconference or webinar.
- Implement the Pharmaceutical Opinion Program (POP) accordingly.
- Participate in a focus group to provide feedback and comments of this pilot study.
What POP documentation tools are available to me?
There are two optional POP documentation tools that we have developed for this project. They are available upon request.
- Fax Cover Letter to Prescriber
- POP Documentation Form with drug-drug interactions listed for this project
What do these POP documentation tools include?
These POP tools are prepared to facilitate the identification and documentation of the specific 10 drug-drug interactions that are captured in this study. They are written pdf files that can either be completed on the computer screen or printed out:
- The Fax Cover Letter to Prescriber includes a request along with the information you need to send to the prescriber. Using this form, you only need to fill in the patient's name/birth date, and the name of the interacting drugs and send the letter to the prescriber.
- The POP Documentation Form is similar to the Pharmaceutical Opinion Program form but it already includes a list of the targeted 10 drug-drug interactions in this study that you can easily check off. It also includes sections for patient information, pharmacist information, pharmacist recommendation, and prescriber review and comments.
How can I use these POP documentation tools?
Please contact us at ddi@ismpcanada.ca. Online training clips are currently under development.
Will the information I submit to ISMP Canada be kept confidential?
Any information that you provide us will be kept confidential. All information collected from participants in this study will be aggregated and anonymized. Data will be analyzed and reported in a manner that does not identify individuals. Participants' names will not appear in any report, publication or external presentation resulting from this study.
ISMP Canada received ethics clearance and approval on this project at the end of November 2013 from the University of Toronto, Office of Research Ethics.
Who has access to the information I submit to the ISMP?
Data will only be accessible by the principal investigator, co-investigators, and affiliated research assistants who have signed a confidentiality agreement.
Why should I participate in this study?
This study can help improve patient outcomes by reducing the number of hospital admissions that were associated with preventable drug-drug interactions. It would also help support your pharmacy by establishing a cognitive-based business model with the incorporation of the Pharmaceutical Opinion Program.
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Resources
Tools & Forms
There are a variety of tools that are available to all participating pharmacists:
FAQs
General Information
What is the Safety Alerts as Drivers for Pharmaceutical Opinion Program Project?
The "Safety Alerts as Drivers for Pharmaceutical Opinion Program" project aims to examine the effects of utilizing evidence-based drug-drug interactions to prevent potential adverse events. By offering continuing professional development opportunities to pharmacy practitioners, this project aims to motivate pharmacists to integrate cognitive services into daily workflow that are recognized and reimbursed by the Pharmaceutical Opinion Program. The analysis of the results of this study will allow an assessment of the effects on the utilization of drug-drug interaction knowledge by pharmacy practitioners in preventing adverse drug reactions. What is the rationale behind this study?
The rationale for integrating the use of evidence-based drug-drug interactions from primary literature is to increase awareness about drug-drug interaction pairs that may lead to potential adverse events. The drug-drug interactions targeted in this pilot study are not widely documented in tertiary drug information resources and therefore, not often realized. This rationale supports ongoing efforts to recognize the value of the profession in embracing expanded scope activities and contributing to patient safety efforts by incorporating an effective medication safety initiative that can reduce potential adverse events in community pharmacy settings. What are the objectives of this study?
The objectives of this research study are to:
- Reduce the occurrence of drug-drug interactions that have been associated with potential hospitalizations as supported by pharmacoepidemiologic evidence
- Offer education or continuing professional development (CPD) opportunities to pharmacy practitioners via ISMP Canada safety bulletins on drug-drug interactions that are associated with potential hospitalizations
- Motivate pharmacists to integrate cognitive services into daily workflow by developing a sustainable or financially viable platform through recognition and reimbursement by the Pharmaceutical Opinion Program
Who funds this project?
Who is involved in this study?
The research team is comprised of members from the Institute for Safe Medication Practices Canada (ISMP Canada) and graduates from University of Waterloo School of Pharmacy. Where can I find more information about the research team?
Participation
Who can participate in this study?
Community pharmacists who are looking to incorporate evidence-based medication safety tools to prevent harm to patients and be reimbursed by the Pharmaceutical Opinion Program may participate in this study. Why should I participate in this study?
This study can help your practice by reducing the number of hospital admissions that may be associated with preventable drug-drug interactions. It would also help support your practice in establishing a cognitive-based business model by incorporating the Pharmaceutical Opinion Program. What will I need to do if I decide to participate in this study?
If you decide to participate in this study, you will be asked to:
- Review ISMP safety bulletins regarding evidence-based drug-drug interactions
- Implement the Pharmaceutical Opinion Program (POP)
- Receive monthly follow-ups from ISMP Canada for data collection purposes for a total of 6 months
- Participate in our focus group discussions to provide feedback on this pilot study
How long will I be required to participate?
ISMP Canada will conduct:
- A baseline POP data collection prior to the beginning of this study
- Monthly follow-ups for 6 months
- A post-intervention POP data collection
What tools are available to me?
There are two optional forms that you can use:
What do these tools include?
These tools are prepared to help identify and document the 10 specific drug-drug interactions that are captured in this study. They are PDF files that can either be completed electronically or printed:
- The Fax Cover Letter to Prescriber includes a request along with the information you need to send to the prescriber. Using this form, you only need to fill in the patient's name/birth date, and the name of the interacting drugs and send the letter to the prescriber.
- The POP Documentation Form is similar to the Pharmaceutical Opinion Program form but it also contains a list of the 10 targeted drug-drug interactions in this study for you to easily check off. It also includes sections for patient information, pharmacist information, pharmacist recommendation, prescriber review, and final action plan.
How can I train pharmacists in my store to utilize the POP documentation tools that have been developed for this study?
Please contact us. Online training clips are currently under development. Will the information I submit to ISMP Canada be kept confidential?
All information collected from participants in this study will be kept confidential. All data is aggregated and no individual could be identified from the results. Data will be analyzed and reported in a manner that does not identify individuals. Participants' names will not appear in any report, publication or external presentation resulting from this study. ISMP Canada received ethics clearance and approval on this project at the end of November 2013 from the University of Toronto, Office of Research Ethics. Who will have access to the information that I submit to ISMP Canada?
Data will only be accessible by the principal investigator, co-investigators, and affiliated research assistants who have signed a confidentiality agreement. What if I need to withdraw from the study?
You may withdraw from this study at any point in time by notifying the research assistant with no associated penalty. There are no known or anticipated risks from participating or withdrawing from this study.
Results
How are the results disseminated?
Provincially, ISMP Canada will seek publishing opportunities from the Ontario College of Pharmacists' quarterly publication to all pharmacists in Ontario - Pharmacy Connection - for the sharing of research findings from this pilot project. ISMP Canada has had several medication-safety related articles published in previous editions of Pharmacy Connection in the past (available at ISMP Canada Publications - under the subheading "Publications in Pharmacy Connection").
Similarly, ISMP Canada will seek publishing or speaking opportunities in order to disseminate research findings on a national level, either through ISMP Canada Safety Bulletins, pharmacy journals, or oral/poster presentations at conferences, such as the annual Canadian Pharmacists Association (CPhA) Conference.
When are the results expected to be available?
The results are expected to be available by early 2015. As a participant, can I request a copy of the results?
Resources
Where can I find a list of drug-drug interactions that have been associated with potential hospitalizations?
Where can I find a list of the references that have been used in this study?
List of references are below.
References
Patients who are hospitalized for hyperkalemia using ACEI or ARBs are around 7 times more likely to have received TMP-SMX than Amoxicillin.
Antoniou, T., Gomes, T., Juurlink, D.N., Loutfy, M.R., Glazier, R.H., & Mamdani, M.M. (2010). Trimethoprim-sulfamethoxazole induced hyperkalemia in patients receiving inhibitors of the renin-angiotensin system. Arch Intern Med, 170(12), 1045-9.
Patients are two times more likely to be hospitalized due to phenytoin toxicity if they receive TMP-SMX within 30 days.
Antoniou, T., Gomes, T., Mamdani, M. M., Juurlink, D. N. (2011). Trimethoprim/sulfamethoxazole-induced phenytoin toxicity in the elderly: a population based study. Br J Clin Pharmacol, 71(4), 544-9.
Patients hospitalized due to hyperkalemia while using spironolactone are 12 times more likely to have been using TMP-SMX compared to amoxicillin.
Antoniou, T., Gomes, T., Mamdani, M. M., Yao, Z., Garg, A. X., Weir, M. A., et al. (2011) Trimethoprim-sulfamethoxazole induced hyperkalemia in elderly patients receiving spironolactone: nested case-control study. BMJ, 343, d5228.
Older persons are experiencing more illnesses, resulting in a more than two-fold increase in prescription claims over a 10-year period.
Bajcar, J. M., Wang, L., Moineddin, R, Nie, J. X., Tracy, C. S., & Upshur, R. E. G. (2010). From pharmaco-therapy to pharmaco-prevention: trends in prescribing to older adults in Ontario, Canada, 1997-2006. BMC Fam Pract, 11, 75-80.
The safe use of medication has consistently been identified as a significant area of concern within the realm of patient safety.
Baker, R., Norton, P., Flintoff, V., Blais, R., Brown, A., Cox, J., et al. (2004). The Canadian adverse events study: the incidence of adverse events among hospital patients in Canada. CMAJ, 170(11), 1678-86.
The uptake of MedsCheck service has been significant within one year of the launch of this program.
Can Pharm J (CPJ). (2008). Ontario's MedsCheck continues to grow. Can Pharm J, 141, 1, 21.
Nearly two-thirds of seniors are using five or more types of prescription drugs.
CIHI. (2011). Health Care in Canada: A Focus on Seniors and Aging. Canadian Institute for Health Information (CIHI). (Available at: https://secure.cihi.ca/free_products/HCIC_2011_seniors_report_en.pdf)
Although the uptake within one year on this service has been significant, pharmacists have identified many barriers to providing the MedsCheck services.
Dolovich, L., Gagnon, A., McAiney, C. A., Sparrow, L., & Burns, S. (2008). Initial pharmacist experience with the Ontario-based MedsCheck program. Can Pharm J, 141, 6, 339-345.
Patients who are hospitalized with hemorrhagic complications while using warfarin are 3 times more likely to have been exposed to TMP-SMX and 2 times more likely to have been using ciprofloxacin.
Fischer, H. D., Juurlink, D. N., Mamdani, M. M., Kopp, A., & Laupacis, A. (2010). Hemorrhage during warfarin therapy associated with cotrimoxazole and other urinary tract anti-infective agents. Arch Intern Med, 170(7), 617-21.
Patients are 15 times more likely to be hospitalized due to digoxin toxicity if they are taking clarithromycin and digoxin concomitantly and 4 times more likely if they are taking Azithromycin or Erythromycin.
Gomes, T., Mamdani, M. M., & Juurlink, D. N. (2009). Macrolide-induced digoxin toxicity: a population-based study. Clin Pharmacol Ther, 86(4), 383-386.
The "hierarchy of effectiveness" is a successful patient safety initiative for solution development strategies that can be organized from the most effective to the least.
Grissinger, M. (2003). Medication error-prevention "toolbox." P&T, 28(5), 298.
Patient dies as a result of drug-drug interaction of HIV post-exposure prophylaxis treatment.
ISMP Canada. (2008). Drug interaction incident with HIV post-exposure prophylaxis. ISMP Can Saf Bull, 8(3), 1-2. (Available at https://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2008-03HIVPEP.pdf)
At least 3.3% of the hospital admissions for hypoglycemia in elderly patients receiving glyburide could be avoided if they are not exposed to TMP-SMX within 7 days of treatment.
Juurlink, D. N., Mamdani, M. M., Kopp, A., Laupacis, A., Redelmeir, D. A. (2003). Drug-drug interactions among elderly patients hospitalized for drug toxicity. JAMA, 289(13), 1652-58.
Patients who are hospitalized for a re-infarct and using clopidogrel are likely to be using a PPI within 30 days.
Juurlink, D. N., Gomes, T., Ko, D. T., Szmitko, P. E., Austin, P. C., Tu, J. V., et al. (2009). A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ, 180(7), 713-8.
Use of medications has consistently been identified as a significant area of concern.
Kohn et al. (1999). To err is human. Institute of Medicine.
Lexicomp Online: Interactions. (2012). Lexicomp. (Available at: https://online.lexi.com/lco/action/interact)
ISMP Canada's CMIRPS activities provide value by increasing awareness of hazardous or harmful situations, offering feasible recommendations, and reducing the inefficiency of and advancing safety in medication-use processes.
Prairie Research Associates (PRA). (2010). Evaluation of the Canadian Medication Incident Reporting and Prevention System (CMIRPS) services provided by ISMP Canada: Final report. Prairie Research Associates, 47-50. (Available at https://www.ismp-canada.org/download/cmirps/rptISMPC_CMIRPS_Final_Report.pdf)
2.8% of all hospital admissions occur due to drug-drug interaction that are preventable.
Shapiro, L., & Shear, N. H. (1999). Drug-drug interactions: How scared should we be? Canadian Medical Association Journal, 161(10), 1266-1267.
Tatro, D. S., ed. (2011). Drug interaction facts. St. Louis, Missouri: Facts & Comparisons Publishing Group.
Patients who are admitted to hospital due to hypotension while using a calcium channel blocker are more likely to have received clarithromycin or azithromycin immediately before hospitalization.
Wright, A. J., Gomes, T., Mamdani, M. M., Horn, J. R., Juurlink, D. N. (2011). The risk of hypotension following co-prescription of macrolide antibiotics and calcium-channel blockers. CMAJ, 183(3), 303-7.
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Publications & Presentations
Publications
Pharmacy Connection is the official publication of the Ontario College of Pharmacists.
Presentations
Awards
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Handbook for a Pilot Study to Reduce Potential Hospitalizations due to preventable Drug-Drug Interactions
Drug-Drug Interactions (DDI) Treatment Algorithm Handbook: Overview
The DDI Treatment Algorithm Handbook outlines alternative antibiotic therapies to assist pharmacists in identifying and resolving the evidence-based DDIs that were targeted in this study, along with evidence-based algorithms to help quickly formulate recommendations for prescribers. The following components are included in the Handbook:
Introduction
- Why do older people need special considerations for drug-drug interactions?
- Table 1: Drug-drug interactions leading to potential hospitalizations identified from primary literature
- How did the Institute for Clinical Evaluative Sciences (ICES) group identify drug-drug interactions?
- What drug-drug interactions captured by the ICES group are covered in this guide?
Algorithm to Reduce Potential Hospitalizations Involving Macrolide Antibiotics
- Acute Group A β-hemolytic Streptococcal Pharyngitis
- Outpatient Community-Acquired Pneumonia (CAP)
Algorithm to Reduce Potential Hospitalizations Involving Trimethoprim-Sulfamethoxazole
- Acute Uncomplicated Urinary Tract Infections (UTI)
Appendix
- Table 2 - General information about macrolides and a folate synthesis inhibitor
- Table 3 - General information about alternative antibiotics used to treat community-acquired infections
For more information regarding the background and development of the Handbook, please click here. Orders for the Handbook will include a bound, colour-printed version of the Handbook.
"Resolving Drug-Drug Interactions: A Guide for Community Pharmacies to Reduce Potential Hospitalizations" Education Module: Overview
The Handbook can be purchased alone or in combination with an audio recording of the "Resolving Drug-Drug Interactions: A Guide for Community Pharmacies to Reduce Potential Hospitalizations" educational module, provided as a CD-ROM format.
This module was an output of the pilot study, which aims to provide pharmacists with a continuing education program regarding the DDI pairs that were evaluated during the pilot study. The following are the learning objectives of this module:
- To appreciate the significance of drug-drug interactions (DDIs) in the elderly population
- To understand current challenges in preventing DDIs
- To identify clinically significant DDIs involving commonly used antibiotics that are not consistently caught on clinical decision support systems (CDSS)
- To review alternative therapeutic options for empiric treatment of uncomplicated urinary tract infections (UTIs), group A streptococcal pharyngitis and community acquired pneumonia (CAP)
- To build confidence in mitigating DDIs with structured documentation forms to communicate drug therapy problems (DTPs) and patient-specific therapeutic recommendations to prescribers
Cost and Payment:
Order Form
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