March 29, 2024

Importance of safety monitoring of Medicine: Pharmacovigilance Theory Notes, PDF Books

Importance of safety monitoring of Medicine: Pharmacovigilance Theory Notes, PDF Books

Drug safety monitoring is a risk mitigation exercise in which the ADRs caused by therapeutic drugs, biologicals or devices can be explored, prevented or minimized. It is the process of identifying expected and unexpected adverse reactions resulting from the use of medicines in the post-marketing phase. 

It is known, that the medicines developed for treatment of diseases, have also side effects, sometimes dangerous for life. There are no absolutely safe medicines! Moreover, the use of medicines in a wide exposition may cause various adverse reactions of drugs (ADR) which were not registered during clinical trials because of the limited quota of the patients. Revealing, registration and analysis of the ADR (Pharmacovigilance) are necessary for the subsequent specification of the drugs’ indications, contra-indications, side effects, dosages, etc. 

“Health care institutions, drugstores, institutions and the organizations which are consuming and using medicines, are obliged to inform the authorized governmental body about all cases of development of unknown adverse reactions immediately”. 


Other relevant issues:

  1. Substandard medicines
  2. Medication errors
  3. Lack of efficacy reports
  4. Use of medicines for indications that are not approved and for which there is inadequate scientific basis
  5. Case reports of acute and chronic poisoning
  6. Assessment of drug-related mortality
  7. Abuse and misuse of medicines
  8. Adverse interactions of medicines with chemicals, other medicines, and food

Report Form

  • The Report Form has four sections: 

    A. INFORMATION ABOUT PATIENT. 
    This section includes the personal information of the patient: 
  • Name, surname (may be encoded in purpose of keeping confidentiality) 
  • Age or date of birth 
  • Sex 
  • Weight 

    B. ADVERSE DRUG REACTION OR MANUFACTURING PROBLEM 
    This section is for the description of the adverse drug reaction or manufacturing problem and includes the following information: 
  • Marking of adverse reaction or manufacturing problem 
  • Date of event 
  • Date of report 
  • Motivation for sending the report (death, life-threatening, hospitalization, disability, congenital anomaly, other) 
  • Description of adverse reaction or manufacturing problem 
  • Used diagnostic methods 
  • Short description and peculiarities of the disease 


    C. SUSPECTED DRUG(S) 
    This section is for pointing out the suspected drug or drugs that are related to the adverse reactions. The section includes the following information: 
  • Name, drug form, manufacturer, batch 
  • Dose 
  • Indications for use 
  • Duration 

    D. INFORMATION ABOUT THE REPORTER 
    This information has to be introduced completely, in case it is necessary to contact the reporter for getting detailed data of the case. The section includes the following information: 
  • Name, address, phone 
  • Profession 
  • Occupation 

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