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INTRODUCTION:

Pharmacovigilance also called Drug safety. In post-marketing surveillance, you will test the drug to detect and monitor if any unwanted effects of the drug will harm the patients. Then report it to pharmacovigilance. The process of Pharmacovigilance has several steps:

1.  COLLECTION:

Example: Any drug that cause a new side effect for the patient, will be immediately reported to Pharmacovigilance.

Then collect all data of the particular drug, how many patients use this drug. if there is any variation between the effects from the patients.

Collecting data:

·      How many clients use this drug?

·      Client age group?

·      What are the side effects of this drug?

·      What is the new side effect of this drug?

·      Did the new side effect cause any harm to the client?

·      Is this new side effect present on all clients who used this drug?

2.  DETECTION:

The pharmacovigilance team members will detect the effect on the client.

 Detecting data:

·      Why did the drug cause harm to the client?

·      Is this drug only harmful to this client only or several clients?

·      How will it be treated?

·      Detect the lab values of the clients?

·      Detect the therapeutic index?

·      Detect the age group of clients who used this drug?

3. ASSESSMENT:

The Pharmacovigilance team members like Drug safety associate will assess the lab values of clients.

Assessment method:

·      How many days did the client use this drug?

·      How long the new reaction of this drug appeared?

·      Is this reaction mild or severe?

·      Did the withdrawal of this drug stop the reaction?

·      Any Expiry of this drug?

·      Administer method of this drug?

·      Does different temperature change this drug to cloudy form?

·      Food interaction of this drug?

4. MONITORING:

Monitor the clients in daily routine,

Monitor process:

·      Whomever consumed this drug cause any rather side effects?

·      Does this drugs new side effect only caused particular client or all kind of clients?

·      Is the drug continued for client treatment?

·      Whether the drug produce any drug interaction?

·      Is this effect comes in the drug or patient signs?

5. PREVENTION:

  Prevention of adverse effects with pharmaceutical products.

  Prevention process:

·      Whether the drug will continue for client treatment?

·      Report the pharmaceutical industry the drug is harmful for patient?

·      Whether there is any adjunctive solution added for this drug to continue the treatment?

·      Will concentration of this drug be changed or not?

·      If it is possible did the concentration of solution change the new effect.

PROCESS OF PHARMACOVIGILANCE:

Basic steps:

The drug has gone through all the three phases of clinical trials and has been approved by Food Drug Administration to post marketing surveillance.

 One of the ways of collecting data for pharmacovigilance purposes is by providing the portal of drug information. The leaflet of drug information contains the main sources of the drug like action, side effects, dosages. The physician will be monitoring the patient if the drug caused any serious illness.

Data collection:

Nature of the drug: Example: Stimulants, Depressants. The nature of the drug indicates the class of drug.

Intensity of the drug effect: Example: Hyperactive or hypoactive. The intensity of the drug indicates the side effect of the drug, it may be a mild effect or severe effect.

Outcome of the event: Example: Positive outcome or negative outcome. The outcome of the event indicates the new effect of the drug produce.

Clinical course leading to the event: Example: The patient signs and symptoms, During the treatment in hospital, and recovery of the diagnosis.

Indication of timing relevant to study drug administration: Timing, Dosing, Duration all are important factors of medication. Five basic rules for Drug administration: Right patient, Right drug, Right time, Right dose, Right dose. These rights are indicates the timing.

Relevant laboratory measures: If the drug cause any unwanted effects in the lab values. Detect complete blood count and therapeutic index.

Action taken with study drug (and timing) in relation to the event: What action should be taken? It may be stopped or the drug continuous for treatment at a low therapeutic dose.

Treatment or intervention:

The person in charge drug should identify the effect of the patient, whether the new effect will affect the patient’s treatment. How long the patient continues the drug even it occur any side effects.

Physician/Nurses/Pharmacist should identify the intervention of this drug cause any harm or harmless.

Identify the effect of this drug is life threatening illness and report to the regulatory authorities.

PHARMACOVIGILANCE JARGONS:

ADVERSE EVENT:

Adverse event is harmful effect to the patient. These reactions tend to be more serious illness but typically occur in a very small number of people. This reaction is not a causal relationship with this treatment. This harmful effects cause undesirable outcomes.

Example: The patient was admitted for fever and cough. The management of the drug are Antibiotics, Antipyretic and Expectorants. If the Antibiotic of ceftriaxone cause any serious illness like Anaphylaxis without causal relationship of the drug. This event is called Adverse event.

ADVERSE DRUG REACTION:

Adverse drug reaction is considered having a possible causal relationship. Adverse drug reaction is already known in the clinical trials.

Example: Paracetamol side effects: loss of appetite, dark urine, clay-coloured stools, jaundice. These effects are causal relationship and not affect the treatment.

ADVERSE EVENT OF SPECIAL INTEREST:

Some classes of drugs are to be monitored by the sponsor, which may cause serious illness or non-serious illness.

The drug was examined the clinical trial and noted the side effects after the post marketing surveillance the drug may cause new effect or harm effect, it must be report to the sponsor immediately. These drugs mainly in chemotherapy and long-term treatment.

CASE PROCESSING:

Case processing of basic steps:

1.Collecting the patient data like a case presentation. The date must be included in Patient examination, Medical history, Analysis of test results, Appropriate plan, and analysis.

2.Duplicate search

3. Data entry mainly included in Diagnosis, Treatment, complications, case causality assessment

4.Coding of adverse reaction descriptions.

5.Coding of drugs.

SAE SHEET OF NARRATIVE WRITING WITH EXAMPLE:

PATIENT DETAILS:

Name: Mr.X

Gender: MALE

Age: 54 years

Event complaints: Severe rash like pruritis

Weight: 68kg

STUDY DETAILS:

Administered drug: Metronidazole

Administered dose:500mg/100ml- Infusion solution

Drug expiry date:5/15/22

Any contamination of the drug: no

Temperature of the drug: under refrigerator 5˚c

Drug stopped or continued: stopped

PATIENT HISTORY:

Past medical history: Type 2 DM

Past medication history: Metformin 500mg

Family history: No genetic disorders

Current diagnosis: Inflammatory bowel disease

Current complaints related to the new effects: Severe rashes

DETAILS OF THE STUDY DRUG:

Drug interaction of the identifiable drug: No medication involved in the treatment.

Food interaction of the identifiable drug: Alcohol not consumed by the patient during the treatment.

Identifiable drug administer the start date and end date:3/5/21-4/5/21

EVENT DESCRIPTION AND TREATMENT DETAILS:

Adverse event: Anaphylactic shock

Adverse drug reaction: Dizziness, headache, stomach upset, loss of appetite, metallic taste, these effects are not mentioned by the patient.

Event is recovered or life threatening: Recovering

Treatment provided to the event: Drug stopped, the reaction cured by the another antibiotic

LABORATORY TESTS INFORMATION:

Parameters:

WBC count:3200 million cells microliter

RBC count:4.5 million cells microliter

Creatinine clearance test: taken the sample

ACTION TAKEN WITH THE STUDY DRUG:

Identified drug : METRONIDAZOLE

Replacing the drug: TINIDAZOLE

Continuous the drug or treat the event with another drug: Event treated with another drug

OUTCOME OF EVENTS:

Recovered: RECOVERED

Not yet recovered: —-

Recovered with sequelae: —–

Unknown: —–

Fatal:      ——-

CASUALITY ASSESSMENT BY INVESTIGATOR:

Reasonable causal relationship:

Unreasonable causal relationship: This event not involved in clinical trials of the studies. This event was harmful to the patient and has recovered.

This may help you in interview. read article on Pharmacovigilance Interview Questions.

REFERENCES:

1.GPV Com: 001.MCC.05.001_RD.120(4.0)/Serious Adverse Event Form in Clinical Trials – Instructions for Completion of SAE. [Last accessed on 2017 Jun 12]. Available from: https://www.boehringer-ingelheim.com/contact-form .

2. Uppsala Monitoring Centre. [Last accessed on 2018 Mar 28]. Available from: https://www.who-umc.org/global-pharmacovigilance/communication-in-pharmacovigilance/patient-centered-communications/.

3. [Last accessed on 2016 Nov 17]. Available from: https://www.eupati.eu/safety-of-medicines/safety-communication/#Why_is_safety_communication_important.

4. International Conference on Harmonisation (ICH) Tripartite Guideline on the Structure and Content of Clinical Study Reports (CSRs) E3 (Section 12.3.2)

Prepared by:

Dr.Mubashira Pharm.D.