Most Popular Questions
What is MedSafety Scan® (MSS)?
MedSafety Scan® is an internet-based clinical decision support tool that operates on all platforms, e.g. desktop, tablet and mobile devices. It is designed to serve the needs of prescribers, pharmacists, nurses and all other healthcare providers caring for patients who take medications.
MSS maximizes drug safety and is based on more than 20 years of research in drug safety conducted by the Arizona Center for Education and Research on Therapeutics (AZCERT).
MSS addresses two of the leading causes of drug-induced harm to patients as identified by the Centers for Medicare and Medicaid (CMS) and the FDA, i.e. 1) medicines that cause sudden death because they prolong the QT interval on the electrocardiogram (ECG) and 2) drug combinations that when taken together interact to cause harm.
What are MedSafety Scan's core functions?
MSS has several core functions and some are more important than others to health care providers (HCPs) in different use-cases or environments:
- Identifies the 1891 marketed medicines that can prolong the QT interval and increase the risk of sudden death – AZCERT is the recognized international authority for its ongoing process to maintain the online list of these drugs.
- Integrates patient-specific data and the QTdrugs list to calculate/report a patient’s risk score for drug-induced heart arrhythmia.
- Identifies and ranks all major drug interactions that are recommended in FDA drug labels and by CMS
- Provides alternatives for clinicians to consider in order to reduce the risk of harm from their medicines
- Provides warnings when drug pairs are contraindicated by FDA or are potential therapeutic duplicates
- Informs when the label for a drug recommends ECG monitoring or genetic testing to guide therapy.
How does MSS work?
Clinicians can log in, create their own work site (specific for ICU or Non-ICU patients), enter a patient's clinical profile and a list of medications. MSS calculates the patient’s QT risk score and reports any major drug-drug interactions that are relevant to that patient. Importantly, when MSS reports a warning of QT risk, it also suggests management alternatives such as, obtain ECG to check QT, change to alternative drug(s) for high risk drugs or correct low serum potassium before prescribing.
How is MSS better than conventional “Alerts” based on computerized drug surveillance?
The MSS program offers:
- Rapid drug list entry with autocomplete and spell check for greater accuracy
- Tailored management recommendations using each patient’s risk profile and:
- Calculates a risk score based on validated, weighted risk factors
- Can be customized for specific clinical populations (ICU or Non-ICU patients)
- Informs when a drug combination is contraindicated in the FDA label
- Tiered severity of advisories – customizable cut-points for all alerts and notifications
- Management options such as selecting a therapeutic alternative or adjusting the dose
- Guidance for when and how to monitor patients’ ECG and/or electrolytes
- Drill-down capacity for display of greater detail for drug interaction alerts or the specific elements in a patient’s QT risk score
- Tracking of management decisions and plans for each patient
- Report filing, transfer and record storage with HIPAA compliant system
Why is MSS needed in the clinical setting?
Medication Errors that result in Adverse Drug Reactions are the fourth leading cause of death in the US and are mostly preventable.
In the last 20 years, 14 major pharmaceutical products have been removed from the market due to QT prolongation that has been associated with torsades de pointes (TdP), a life-threatening heart rhythm disturbance that can cause sudden death. Over 50 drugs that have this risk remain on the market today and do so because their clinical value exceeds the overall population risk of harm.
Another 137 drugs are known to prolong the QT and are being monitored closely for TdP risk by the FDA. The fact that these drugs are needed but have potential for harm means that prescribers need to use every means possible to reduce the risk of harm by every means possible. MSS is designed to make the use of those drugs safer and remain available on the market.
Why is MSS being offered at no cost to medical professionals now?
AZCERT launched the www.MedSafetyScan.org website and announced to the public the open source “decision support” to assist healthcare providers and manage the risk of QT prolongation and torsades as they treat COVID-19 patients and/or conduct clinical trials.
How long will the free subscription be available?
We plan to make MSS available to single-user professionals as long as possible. We will keep users informed as the policy evolves and will give substantial notice before free use authorizations expire. Currently, no expiration date has been set.
How is data collected at MSS treated? Could it be used or shared without the contributors approval?
Concerning the drug-drug interaction (DDI) threshold? How do you know which number to pick and how does it affect the results?
We have added text to the site creation page that now gives some guidance to the selection of a DDI threshold. Severity values 10 - 8 are for Major Interactions that could be life-threatening; values 7 - 4 are for potential interactions that could alter clinical efficacy of a drug; and values 3 - 0 are potential interactions that could increase the likelihood of side-effects of the drug(s). Please note that, at least for now, once the DDI threshold has been set, it can’t be changed for that site. However, it is easy to create another site with a different threshold. We are working to remove that limitation.
Who created MSS or who is the founder?
MSS was developed by Raymond Woosley, MD, PhD, and a team of scientists and communication specialists. Dr. Woosley is the Flinn Scholar and Professor of Medicine and Biomedical Informatics at the University of Arizona College of Medicine – Phoenix. He is also the founder and president of AZCERT, Inc., a nonprofit organization created with federal funding from the U.S. Dept of Health and Human Services and partially funded by the U.S. Food and Drug Administration to work with the University of Arizona College of Medicine-Phoenix to improve the safe use of medications.
For licensing inquiries regarding commercial use of MSS or to submit questions or feedback on the MedSafety Scan® system, please fill out the form on the contact page: link to https://www.medsafetyscan.org/index.php/contact.
In the introductory video, and also on the website you mention that the new “default“ score is still under validation. You also mention that it is a combination of the Tisdale score and 3 other score-systems. Can you please cite these references?
We have selected and weighted the risk factors in the “non-ICU” configuration based on the scores that have been published for general hospital patients in the three publications cited below. This was done by consensus of our Scientific Review Committee in AZCERT and was not based on any quantitative or statistically-based method. We are in the process of testing the predictive accuracy in specific “non-ICU” populations. The data used to create the distribution of scores for Non-ICU patients comes from a general population of inpatients using data extracted from the electronic medical record.
The three references are:
1. Haugaa KH, Bos JM, Tarrell RF, Morlan BW, Caraballo PJ, Ackerman MJ. Institution-wide QT alert system identifies patients with a high risk of mortality. Mayo Clin Proc 2013;88:315-25.
2. Bindraban AN, Rolvink J, Berger FA, et al. Development of a risk model for predicting QTc interval prolongation in patients using QTc-prolonging drugs. Int J Clin Pharm 2018;40:1372-9.
3. Vandael E, Vandenberk B, Vandenberghe J, Van den Bosch B, Willems R, Foulon V. A smart algorithm for the prevention and risk management of QTc prolongation based on the optimized RISQ-PATH model. Br J Clin Pharmacol 2018;84:2824-35.
How does MedSafety Scan® compare to the alerts generated by conventional EHR surveillance systems?
Most EHR warnings are based on population data and inform that a drug combination “may” cause a harmful interaction. Instead, MSS’s analysis considers the specific patient’s risk factors and sends a message: “this patient is at risk of harm from the following drugs and here is what you can do to reduce that risk”. From 80-95% of general alerts are overridden by prescribers. Surveys have shown that prescribers consider that general alerts are often not relevant to their patient or that the warnings needlessly interrupt their work (resulting in alert fatigue).
How can MSS integrate into the EHR? If it doesn't integrate, won’t acceptance by providers be made more difficult?
MSS can now be integrated into any EHR that allows an internet connection (not all do so for security purposes). Hospital IT programmers have the ability to integrate MSS. Please email email@example.com for more information.