Learn how to write a SOP for Pharmacovigilance Surveillance Procedure as per Good Pharmacovigilance Practice (GVP) guideline.
1. INTRODUCTION
Pharmacovigilance (PV) may be defined by the World Health Organization as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects and other drug-related problems.” An adverse event is any clinical experience that occurs after beginning pharmaceutical therapy, regardless of how severe or dangerous it is or whether it can be shown to be the cause. Observation of any adverse medical events that may occur during treatment due to a pharmaceutical product but do not necessarily have a causal link with this treatment is necessary for active safety medication monitoring. Adverse events are identified by active surveillance, and they are monitored through active follow-up following therapy.
As per the “ National Guidelines on the Pharmacovigilance System “, it is essential for all pharmaceutical Manufacturers and Marketing Authorization Holders to set up a system of pharmacovigilance to monitor different pharmacological facets of drug delivery and ensuing patient adherence. Therefore, a central Pharmacovigilance team will address regular Pharmacovigilance issues for all marketed medicinal product of this Pharmaceutical company.
2. PURPOSE
The purpose of this standard operating procedure is to outline a step-by- step approach for undertaking active drug safety mentioning for any marketed product of this Pharmaceutical. The central PV team will generate awareness about the need of identifying & reporting of Adverse Drug Reactions (ADR) amongst all sections of health care providers and alt the staff of this Pharmaceutical to identify ADR occurring in patients related to any product marketed by this company & report the same to the appropriate authorities.
3. SCOPE
The procedure applies to the active drug safety monitoring for any marketed product of this Pharmaceutical to support handling issues regarding Pharmacovigilance.
Scope of the Central Pharmacovigilance Team
The Central Pharmacovigilance Team shall meet once in 03 months. The team shall be responsible for planning, implementation and monitoring of various activities regarding Pharmacovigilance they will work as mentors & facilitators.
PHARMACOVIGILANCE STRUCTURE
A schematic diagram (figure-1) depicts the structures and stakeholders involved in the active PV surveillance active drug safety monitoring for this Pharmaceutical.
4. RESPONSIBILITIES
4.1 The main activates are detection, management and reporting of adverse events, whereas central PV team is responsible for the coordination, monitoring, casualty analysis, and decision-making.
4.2 Roles central PV team
| Sl. No. | Name | Designation | Post at PV Team |
| 01 | Managing Director | Chairman | |
| 02 | Manager, MA & PV (Doctor) | Member Secretary | |
| 03 | Department Head, PMD | Member | |
| 04 | Department Head, QA | Member | |
| 05 | Department Head, Production | Member | |
| 06 | Department Head, QC | Member | |
| 07 | Department Head, PD | Member |
4.3 Roles central PV team
–Chairman: The Chairman will chair & conduct all meetings & will function as administrative head of the committee.
–Member Secretary: The Member Secretary will play the pivotal role & shall undertake various activities of the committee.
–Members: Members well work as subject experts & will also do the mentoring of employee/ doctors/ and other relevant stakeholders in the area of ADR.
4.4 General Guidelines:
The following general rules have been established for committee operations:
-Committees shall meet regularly in every quarter of the year and shall determine the next date of meeting at every meeting.
-All committee members will be informed in advance of the meeting’s agenda, which will be decided upon based on its scope.
-Committees shall discuss, analyze take a unanimous decision and communicate the decision for implementation to appropriate department/personnel.
-Chairperson and convener of the committee shall bear the responsibility of committee functioning.
-The Committee shall determine the protocols of functioning and all committee members shall abide by it.
-A separate record of any thorough investigation of the particular agenda matter under discussion must be kept and recorded in the committee file.
– It is advisable that a specific member of the committee shall be given the responsibility of maintaining all the records of committee functioning and communicates it to concerned personnel in the organization.
-Committee shall monitor the implementation of decision taken through physical monitoring/ assessments/ review etc. The chairman will choose the proper intervals for the committee to examine and evaluate their functioning.
5. ACCOUNTABILITY
Head of the Quality Assurance Department
6. ASSOCIATED DOCUMENTS / REFERENCES
6.1 Good Pharmacovigilance Practice (GVP)
7. PROCEDURE
7.1 The basic active drug safety monitoring procedures includes:
7.1.1 Detecting, managing, recording adverse events experienced by patients during & after medicine exposure.
7.1.2 All adverse events experienced by each patient should be recorded. This includes unexpected improvement of concomitant disease as well as adverse events.
7.1.3 All adverse events (even if minor) shall be recorded, not only suspected adverse reaction. Clinicians or data collector should make no judgment regarding causality.
7.1.4 At follow-up visits, any new events or worsening of pre-existing conditions that have occurred since the start of the treatment should be reported.
7.1.5 These events will be recorded on the specified form (Annex-1: suspected adverse events).
Normal clinical terms or description should be used.
7.1.6 A brief description of each event should be recorded. The event descriptions should be reviewed by the Medical Department, and standard adverse event terminology will be applied.
7.2 Essential Data Elements
7.2.1 The following data elements for PV should be included in the reporting forms. All adverse events (even if minor) shall be recorded, not just suspected adverse reaction. Clinicians or data collector should make no judgment regarding causality.
7.2.2 Patient details
Full name (patient identification is important for follow-up purposes & avoidance of duplication).
Complete address (for follow-up & accurate identification).
-Sex.
-Date of birth or age.
-Weight & height.
-Past medical history.
-Pregnancy status.
7.2.3 Details of medicine
-Name (brand & generic)
-Formulation (e.g., Ointment, Balm).
-Indication(s) for use.
-Dose (size & frequency).
-Date of treatment start.
-Date of withdrawal.
-Duration of use.
All medicine being taken at the time of consultation should be listed. Any suspected medicine can be identified by an asterisk or other notation.
Batch no; Lot no; Mfg. date; Exp. date should be included.
7.2.4 Details of adverse event
-Full description of reaction/s including body site
-Description of sign & symptoms
-Specific diagnosis for the reaction Onset date & time of reaction.
7.2.5 Reporter details
-Name (full name or initials).
-Address.
-Telephone number & or other contact details.
-Profession
7.2.6 Data flow
Through active interviews & initial assessment by this company staff & also from clinician, pharmacist, nurses & other health worker a PV report will be generated & sent to the central PV team. Central PV team will collate the data submit reports to the National Drug Control Authority according to timelines. The central PV team shall conduct initial analysis to initiate the risk management.
7.2.6.1 Reporting of adverse events
Reporting flow for all adverse events is described below:
-All adverse events with initial assessment to be send to central PV team is hard copies (Annex-1).
-The central PV team will also conduct preliminary causality assessment of the adverse events.
-The central PV team will submit all adverse event report monthly to the National Drug Control Authority.
7.2.6.2 Reporting of serious adverse effect
If there is a serious adverse effect event: within 24 to 48 hours upon identification. The central PV team will report to the National Drug Control Authority within timeline upon the identification of a serious adverse event.
8. DEFINITIONS / ABBREVIATIONS
8.1 Pharmacovigilance: Pharmacovigilance is “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem,” according to the World Health Organization.
8.2 Central Pharmacovigilance Team: The Central Pharmacovigilance Team unit of is responsible for meeting the requirements for PV of all medicines, and is a unit of expertise for the art and science of monitoring and analysis, and use of the analyzed information for the benefit of patients.
8.3 Adverse Drug reaction: A reaction to a medication that is unpleasant and unexpected, and that happens at dosages typically used in humans for disease prevention, diagnosis, or treatment, or for the restoration, adjustment, or alteration of physiological function.
8.4 Serious Adverse reaction: Any untoward medical occurrence that at any dose results in death, is life threatening, requires or prolongs patient hospitalization, results in persistent disability/incapacity, or is a
congenital anomaly/birth defect. The term “life-threatening” describes an incident where the patient was
at risk of death at the Annex-1 of the event: it does not refer to an event that hypothetically might
have caused death if it were more severe.
8.5 Adverse event: Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.
8.6 HCPs: Healthcare providers
8.7 PV: Pharmacovigilance
8.8 SOP: Standard Operating Procedure
8.9 MA: Medical Afire
8.10 PMD: Product Management Department
8.11 PD: Product Development
8.12 QA: Quality Assurance
8.13 QC: Quality Control
8.14 ADR: Adverse Drug Reaction
9. ANNEXES
9.1 Annex-1: Suspected Adverse Event Reporting Form
9.2 Annex-2: Central Pharmacovigilance Team
10. REVISION HISTORY
| Version | Date | Description of Change | Reviewed By | Approved By |
| 1.0 |
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the Bangladeshi pharmaceutical blogger since 2019.
