Q: What are Adverse Drug Reactions ?

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World Health Organization (WHO) defines Adverse Drug Reactions (ADRs) as a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.  ADRs are classified into six types as below:

• Dose-related (Augmented)

• Non-dose-related (Bizarre)

• Dose-related and time-related (Chronic)

• Time-related (Delayed)

• Withdrawal (End of use)

• Failure of therapy (Failure)

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Q: What are Adverse Events ?

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World Health Organization (WHO) defines Adverse Events (AE) as a medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related

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FDA defines ​Adverse event (AE) as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. ... Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event.

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Q: What is difference between a Adverse Event and Side Effects ?

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Side effects are predictable and known for a given drug dosage. ADRs however are unpredictable and are not expected for a given drug dosage

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Q: Is SafeRxp a website with healthcare content ?

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SafeRxp is not a website. It is a Clinical Decision Support System built using microservices based big data and machine learning architecture.  The complexity and technology prowess is hidden from the user, who uses a simple web browser such as chrome to access this system 24x7 from smartphone, laptop or from EHR system when integrated.

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Q: How can i access SafeRxp ?

 

SafeRxp can be directly accessed at https://cdss.saferxp.com. You can create an account by clicking the register link and picking an appropriate subscription. You can compare various subscription options on our subscription page. 

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Q: How does SafeRxp work ?

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SafeRxp uses machine learning  and natural language processing algorithms to mine million of real world adverse drug reactions that have been validated and recorded by the FDA for patterns. Based on a patient's age, gender, current disease, current proposed drug(s), comorbidities and concomitant medications, SafeRxp predicts the risk of top 10 adverse reactions that are possible for that individual patient. 

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It has the latest list of approved drugs and medical devices by FDA. 

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Q: What standards are followed in SafeRxp ?

• SNOMED CT controlled terminologies for diagnostics

• MedDRA terms for adverse events

• UNC drug classes 

• All FDA approved generic and brand name drugs

• All FDA approved medical devices

• HIPAA and CFR Part 11

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Q: What are Clinical Decision Support Systems (CDS / CDSS)  and what is FDA's position on them ?

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Clinical decision systems are a new breed of sophisticated clinical systems that use artificial intelligence or other similar technologies. They help healthcare providers to diagnose, prescribe, monitor, triage adverse events and several other specific functions to improve overall patient safety and outcomes.

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Check out FDA's article Clinical Decision Support Promotes Patient Safety.

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