Guidelines on Virtuous Pharmacovigilance Practices

In-Brief:

• Does the need for protection of patients and public health increasing? Unquestionably yes. The science of regulating and understanding this process is known as pharmacovigilance for all clinical research organization.
• Medical-related problems for the Clinical trial Monitoring Services have a considerable impact on the pharmacovigilance process as it detects, monitors and analyze the medical activities says the world health organization(WHO).
• Pepgra explains the general guidelines that apply to the EU legislation to promote the regulations in health care sectors.

Introduction

Pharmacovigilance system is an organization that fulfils all the legal process and regulations that are related to medicinal products and detecting its adverse effects. This system is responsible for the safety authorization for all medical products. For every specific process pharmacovigilance, there are several guidelines and safety measures and a committed module. Pepgra lists the basic ad general guidelines for these practices included in GVP with the help of Clinical Biostatistics services.

Quality cycle

The quality system must be having the following activities a pharmaceutical regulatory consulting services should look after,

• Planning of quality- creating new structures and integral planning for consistent processes
• Adherence of quality- Perform the tasks and duties according to the available quality requirements for the processes.
• Quality assurance and control- investigating and evaluating the structure of the processes should be practical and useful in medical care sectors.
• Improvements in quality- improving and correcting the procedure wherever it is necessary for healthcare data analytics services.

Quality objectives of pharmacovigilance (GVP)

• Documenting the legal requirements that are required to perform pharmacovigilance tasks and duties
• Protecting humans from the adverse effects causing from authorized medical products inside or outside the marketing exposure
• Building safe and practical applications of medical products to the patients and the public using pharmacovigilance literature search services.

Principles of pharmacovigilance guidelines

The principles listed are a few basic principles that should be processed during the design of structures while conducting all tasks in pharmacovigilance processes.

• To meet the needs of patients, medical professionals and the common public to analyze the safety regulations of medicines in the clinical study design process
• Provide guidelines for GVP ( Good Pharmacovigilance Practices)
• The hierarchies should give leadership for implanting quality system and motivate all the employers to the quality objectives for pharmacovigilance processes
• All persons in the organization must be involved in and encourage the pharmacovigilance processes based on task ownership and responsibility in a degree to their tasks and assigned duties accordingly.
• All staff members involved with the entire company should apply in continuous quality improvement according to their quality system cycle
• Resources and tasks must be organized as a structure and proceed in a manner that supports the risk-proportionate, proactive, continuous and integrated process of the pharmacovigilance Literature review search.
• The available evidence for the risk-benefit balance of medical products must be sought and  relates to the aspects, that could impact on the risk-benefit ratio, and product users must be considered for any decision-making processes
• A good organization must be foster to all the healthcare professionals, marketing authorization holders, public health organizations, patients, competent authorities, learned societies and other relevant bodies following the applicable legal provisions.

Responsibilities for the quality system of a pharmacovigilance organization

An adequate number of well-qualified professionals should be available for performing the pharmacovigilance tasks. They must possess certain qualities and fulfil specific duties for a systematic approach in the qualitative medical practices accordingly to quality cycle. They are

• To ensure that the documents providing quality check are relevant to the papers controls the approval and implementation of subjects.
• To check that sufficient resources are available for training is provided.
• To ensure that the premises, facilities and equipment are readily available for the processes.
• To verify that the given compliance management is sufficient.
• To provide adequate management of records.
• To review the pharmacovigilance is verifying the risk and adverse effects of the medicinal products and increasing quality system.
• To introduce the control measures wherever necessary.
• To guarantee that the given mechanisms and clinical study protocol exist timely.
• To escalate the safety concerns of the healthcare products.
• To identify the medical errors and non-adherence documents of the quality systems
• To investigate the requirements and action plan regularly
• To check the audits are cleared
• Motivating and creating interests to all the staff members based on shared values
• To appoint a good leader
• To provide freedom and right to speak to all the staff members
• To fulfil the staff’s requirements by investigating their contributions to the organization assign roles accordingly
• To check their potential abilities and give promotions for the development of the organization
• To check the functioning of the quality system and to make sure that the organization implements quality in the pharmacovigilance practices with a systematic approach

Conclusion

These are a few essential guidelines essential for in therapeutics clinical research acceptable pharmacovigilance practices. Patient’s health and safety is the most critical and challenging task for all the medical sectors. These can be achieved with the systematic approach of the pharmacovigilance services with the help of this Pepgra blog.

References:

1. Edwards, I. R. (2012). Good pharmacovigilance practice and the curate’s egg.
2. Xie, Y. M., & Tian, F. (2013). Interpretation of guidelines on good pharmacovigilance practices for European Union. Zhongguo Zhong Yao za zhi= Zhongguo Zhongyao Zazhi= China Journal of Chinese Materia Medica, 38(18), 2963-2968.
3. Naik, P., Umrath, T., van Stekelenborg, J., Ruben, R., Abdul-Karim, N., Boland, R., … & Stergiopoulos, S. (2015). Regulatory definitions and good pharmacovigilance practices in social media: challenges and recommendations. Therapeutic Innovation & Regulatory Science, 49(6), 840-851.