This blog features:
- Definitions between this two terms Suspected and concomitant drugs
- How the drugs (con-Meds) may switch one stage to another stage
Table of Contents:
- Definitions
- Categorization Between Suspected and Concomitant
- Shifting from Concomitant to Suspected including examples
- Tip
- Coding of drugs as suspected
- Significance of Listing Concurrent Drugs as Potential Suspects Alongside Our Product
- Key Takeaways
- Conclusion
Definitions:
Suspected drug(s):
Suspected drugs refer to medications that are believed to have caused a particular adverse reaction. These reactions occur due to the specific drug or drugs administered, thus identifying them as the suspected cause of the adverse event.
Concomitant drug(s):
Concomitant drugs are (con-meds) are prescribed medications administered alongside or in conjunction with other drugs to a patient, typically at approximately the same time. When two or more drugs are administered simultaneously, they are considered concomitant drugs to each other.
Examples of con-meds may also include variety of substances such as dietary supplements, vitamins, antioxidants, and other supplements and the substances that support primary medications.
Drugs in Pharmacovigilance: Categorization Between Suspected and Concomitant
Below are four scenarios discussing situations where concomitant drugs transition to suspected drugs, as well as the management of reported and unreported causalities:
✍️ Note: The following scenarios typically apply to spontaneous reports. Remaining scenarios, such as cases provided in line listings or reports generated by investigators, often present with clear details.
“Amidst the diverse array of drugs and their unpredictable reactions, pharmacovigilance stands as a guiding hand, aiding in the identification of suspects and the mitigation of uncertainties and potential risks.”
Shifting from Concomitant to Suspected:
Scenario 1:
A case has been reported involving an adverse event where a total of five drugs were administered. Among these five drugs, four are from external sources. However, a physician identified two drugs as suspected, with one belonging to our company’s product line.
Clarification:
In this scenario, since two products are considered suspected, the processing should involve categorizing them as two suspected drugs.
Scenario 2:
A case has been reported involving the administration of several products from different companies, with one of the products belonging to our company. However, in this case, the causality for any of the administered products remains unknown and unreported. Unreported causalities pose a significant challenge as they may go unnoticed or undocumented.
Clarification:
In this scenario, our company’s product is considered suspected by default until or unless it is reported otherwise. Any subsequent follow-up reports will determine the addition of any other drug as suspected based on the evolving information provided.
Scenario 3:
In this typical scenario, within the group of administered products, the clearly reported causality is attributed to a concomitant product that does not belong to our company’s product line.
Clarification:
Due to the clear report, the causality attributed to the concomitant medication, hence no additional information is available. You may initiate an inquiry for further details or close the case with appropriate justification in the narratives, until the next follow-up confirms suspectedness related to our company’s product.
✍️ Note: Since our company’s product involved, it’s important to recognize that various conventions may be followed in different processes. Therefore, when encountering typical scenarios, it’s advisable to adhere to company conventions.
Scenario 4:
In another typical scenario, a report may involve the administration of two of our company’s products, with one of them reported as suspected.
Clarification:
Here, it’s evident that one of our products is clearly reported as suspected, while the other one is categorized as a concomitant medication and must be coded using our company’s product dictionary.
Tip:
Observing the four scenarios outlined above, it’s evident that not all reports (included your company product) categorized as reports are automatically deemed suspected.
This logic is straightforward. Conduct a thorough analysis of the case, and if further clarification needed, consult medical professionals within your team for guidance.
It’s advisable to incorporate the medical conclusions in the narrative comments, as the case processing relies on medical judgment.
In situations on the other side of the same case, where our concomitants are considered suspects and our suspected become concomitant.
Coding of drugs as suspected
When coding for suspected drugs, our company’s product coded using the company’s core dictionary. However, the approach differs when considering concomitant drugs.
If the suspected concomitant drug reported in its generic form, you can code it by searching for the corresponding generic product available from your company’s offerings.
Conversely, if it reported under a brand name, you can utilize the World Health Organization Drug Dictionary (WHODD) for coding.
Significance of Listing Concurrent Drugs as Potential Suspects Alongside Our Product
- Possibility of drug interactions
- Reduction of therapeutic effects
- To potentially measure precautions and warnings
- Measure specific dose recommendation
- To measure efficacy of products with con-meds
- They can contribute to the problem of patient enrollment and delays
- Determining the right causality
Key Takeaways:
Even if not our product, concomitant medications also considered suspect in the cases based on information available in the reports.
Sometimes, the case remains valid even if our drug not reported as suspected.
Concomitant medications are primarily code with core company dictionary if reported in generic form.
Conclusion
From this above informative write up you could able to understand considering differences of conmeds and suspects. Sometimes conmeds also becomes suspect by determination from the information available from the report.
By effectively managing the transition from concomitant to suspected drugs and addressing reported and unreported causalities, pharmacovigilance efforts can enhance patient safety and contribute to the ongoing evaluation of drug safety profiles.
Hope definitely this blog have feed you some crucial information within case processing.
Feel free to comment below if i overlook or miss any crucial information to add.
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