Question

Discuss the adverse event reporting system for medications, outcomes of these adverse report findings, and changes to practice.  

Answer 1

Adverse drug reaction: It is defined as a response to a medicinal product that is noxious and unintended and which occurs at normal dose used in human for prophylaxis,diagnosis or therapy of disease and for modification of physiological function is called as adverse drug reaction. .

Adverse event :It is unfavourable medical occurrence that in coincidence that may be present during treatment with pharmaceutical product,but it does not have a causal relationship with treatment.

Procedure for reporting adverse event for drug: An adverse event is suspected to be associated with the use of drug should be reported.The should include:

• All ADRs as a result of prescribed and non prescribed.
• All suspected ADRs regardless of whether not the product was used in accordance with monogragh provided by company.
• Unexpected reaction,regardless of their nature severity.
• Increase in the frequency of a given reaction. ADRs is a field of drug abuse and drug use in pregnancy and during lactation

Adverse case report include:

1. Patient demographics:
2. Adverse reactions description
3. Information related to the suspected drug.
4. Information on management of the adverse reactions
5. Information about the reporter

Patient demographics: Patient inpatient number,Medical institution,Pharmacy,Age,Gender,weight.

Adverse reaction description: The nature of adverse reaction being reported including the body site site and severity.

Time and date of onset of the adverse reactions: The occurrence of the adverse drug reaction in relation to suspected drug at the onset of time. For example, did the drug reaction appear immediately following drug administration or there was temporal correlation with administration.

Other relevant information: Patient past medical and medication history or laboratory data including dates.Laboratory tests done to the patient and results to confirm the adverse reaction.

Suspected drug:

1.Name of the suspected drug generic name and Strength of the drug

2.Dosage, frequency and route of administration should be clearly notified. For example; i.Dosage ( tablet, capsules, syrup, injection, cream,eye drops),Frequency(mg, ml, mg/kg) .Route of administration (IV,IM,PO,SC).

3.Treatment date:Starting date,ending date and appearing of reaction,

4.Batch number and expiry date

5.Indication

6.Provide relevant information on medical devices.

Who should report?

• Health care professionals including doctors,Pharmacist,Nurse,Medical officers.
• Manufacturer
• All government hospitals,Private hospitals,Health centers.

Reporting can help to decrease the risk of developing adverse event and is also helps in finding the management of the adverse event,

Changes should be made in practice because no one is reporting a adverse event.Every health care professional should be report.

Lack of measuring of adverse event:

Most importantly though is need to move from unsystematic methods such as voluntary reporting.This can involves a combination of several methods including national audit,screening programmees.Implementatin of health record can also provide an opportunity to launch healthcare standardized reporting.

The lack adverse event reporting is likely to have contributed to the absence of clear evidence of an overall decrease in adverse events.

For example: The Medicare Patient Safety Monitoring System found reduced adverse event rates for patients admitted with acute myocardial infarction by analyzing the data