PHARMACOVIGILANCE MANAGEMENT IN MPDM INDUSTRY: Describing about the roles and responsibilities of the team players and how effectively can be performed for minimizing the risks.

ANNOTATED BIBLIOGRAPHY

 

            PHARMACOVIGILANCE MANAGEMENT IN MPDM INDUSTRY

 

1. 1. Asima, P. (2014). In PMI Global Congress. Dubai, United Arab Emirates.

Retrieved from:

https://www.pmi.org/learning/library/project-management-complexity-pharmaceutical-industry-1487

This article discusses about the complexities of project management in the pharmaceutical industry. It adds by saying that the challenges faced by the project team members because of the recent strict protocols and how to tackle it efficiently. This is done by proper team communication, analysis of critical role of each of the team players like the project manager, stakeholders and focuses on various strategies to address the issues. This is one of the best sources for describing about the roles and responsibilities of the team players and how effectively can be performed for minimizing the risks.

 

2. Chazin, H. D., Peters, J. R., Catterson, D. M., Osterhout, J. L., Forsyth, L. M., Lee, J. E., …

Feibus, K. B. (2018). Drug Information Association Pharmacovigilance and Risk      Management Strategies 2017: Overview of the Generic Drug Program and Surveillance. Therapeutic Innovation & Regulatory Science. https://doi.org/10.1177/2168479018774557

 

This article explores about the risk management strategies. It focuses on the effective quality of generic drugs in the market as it is low in cost compared to the branded drugs. Hence, drugs can be easily available to the public with less price and less adverse events. The article explains about the efforts been applied in the field by giving two examples of clonidine transdermal patch and Lansoprazole. Also, how clinical safety Surveillance Staff involved in the processes of safety in regard to the generic drugs. This source can be used for the explaining how FDA office of generic drugs developed the safety and surveillance of generic drugs in the market.

 

3. Gagnon, S., Schueler, P., & Fan, J. (2012). Pharmacovigilance and risk management, Global

Clinical Trials Playbook, 141-159.

Retrieved from: https://www.elsevier.com/__data/assets/pdf_file/0010/96967/Pharmacovigilance-and-risk_link.pdf

 

This book is about the pharmacovigilance and risk management of medical product throughout their life cycle even after the product is delivered.  It includes all aspects of safety monitoring proper addressing the issues associated usage of medical products. This source is effective for writing about the definition, overview, policies, regulations, team players, responsibilities of team players, safety data bases, reporting, assessing and managing pharmacovigilance management.

 

4. Maennl, U. (2008). Pharmacovigilance: A company-wide challenge.Applied Clinical

Trials, 17(2), 50-52,54,56,58. Retrieved from   http://search.proquest.com.libaccess.sjlibrary.org/docview/201431893?accountid=10361

 

This article discusses about the measures to manage the risks associated with drug safety by implementing risk management plans, safety surveillance, signal detection, continuous monitoring of the benefit-risk relationship in all pharmaceutical companies. It also implies that latest risk management in the companies makes proactive measures to reduce the risk and safety management well before the clinical trials initiated and made aware to the public and the regulators. This is a helpful source for writing about the measures taken by the regulators for pharmacovigilance management.

 

5. Pal, S. N., Olsson, S., & Brown, E. G. (2015). The monitoring medicines project: a

multinational pharmacovigilance and public health project. Drug safety, 38(4), 319-28.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4544540/

 

This article discusses about a project called Monitoring Medicines Project carried out in the years 2009-2013 funded by the Framework Program by European research council. This project involves methodologies in assessing the adverse drug reactions through patient reporting, medication errors, detection of drug dependence &counterfeit. This source can be used for writing about the benefits of applying this project in the companies for effective risk management.

 

6. Pietrek, Monika, MD,PhD., M.Sc, Coulson, Rosalind,M.Sc, F.R.PharmS., & Czarnecki,

Andrzej, MD,PhD., D.Sc. (2009). Good pharmacovigilance practice: The way forward? Drug Information Journal, 43(5), 623-632. Retrieved from http://search.proquest.com.libaccess.sjlibrary.org/docview/274933875?accountid=10361

 

This journal talks about the good pharmacovigilance practices in the pharmaceutical industry. The international conference of Harmonization (ICH) has taken these steps to improve the quality management in the drug development. It addresses the issues of different worldwide regulations and policies in large scale and in small scale of addressing issues like databases, quality control, internal audits, scientific analysis which eventually solves the needs for safety assessment in the pharmacovigilance department. This source is helpful in describing the about the ethics to be followed for good pharmacovigilance practices and complexities implicated in the management of the pharmacovigilance.

 

7. Santoro, A. (2018). Overview of the EU Pharmacovigilance System. Presentation, 2nd

International Awareness Session.

https://www.ema.europa.eu/documents/presentation/presentation-module-10-patient-safety-pharmacovigilance_en.pdf

This presentation from European pharmacovigilance (PV) system in the international awareness sessions talks about the detailed PV system such as overview, goals, pre to post marketing, monitoring the safety, stakeholders, risk management plan & measures, how to implement the risk minimization measures. The presentation can be used for writing about the risk management plan and measures in PV.

 

8. Santoro, A., Genov, G., Spooner, A., Raine, J., & Arlett, P. (2017). Promoting and Protecting

Public Health: How the European Union Pharmacovigilance System Works. Drug safety, 40(10), 855-869.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5606958/

 

This article discusses about the Pharmacovigilance (PV) risk management implemented in the patient’s centered safety approach by giving the clear picture behind PV industry. This source can be used for writing the about the goals, objectives, principles involved in protecting the public against the risks of medical products through proper legislation and policies.

 

9. Suke, S. G., Kosta, P., & Negi, H. (2015). Role of Pharmacovigilance in India: An

overview. Online journal of public health informatics, 7(2), e223. doi:10.5210/ojphi.v7i2.5595

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576445/

 

This article gives detailed explanation in regard to role of pharmacovigilance. It talks about the adverse drug reactions associated with drugs and medical devices and how to manage the risk involved from early stages right from development of the product. It also discusses about the risk management methods performed in India and how it can be used in practices. This source can be used for elaborative overview, scope, explanation by giving examples in connection to the risk management plans applied in some medical products and futures hopes of pharmacovigilance.

 

10. Risk-management plans | European Medicines Agency. (2018).

Retrieved from:  https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans

 

This guidance is about the risk management plan in PV. It gives the outline of assessing and checklist writing in the risk management plan (RMP). This is a good source for summarizing the check list and safety specifications for RMP.

 

11. Systems for improved access to pharmaceuticals and services.. 2013. Development of a Risk

Based Approach and Tools for Improving Safe and Rational Use of Tuberculosis Medicines. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.

 

http://apps.who.int/medicinedocs/documents/s21931en/s21931en.pdf

 

This report discusses about the risk-based approach of improving the safe use of Tuberculosis (TB) medicines. It talks about the prevalence of adverse reactions and side effects of TB medicines in Asia and how risk management plan (RMP) has been established and implemented in the practices. The RMP involves risk assessment, confrontation, invention. The risk management system involves group of PV activities and interventions to prevent and overcome the adverse effects. This report can be used for writing about the RMP with a specific example of TB medicines to get a clear picture how it can used in MPDM industry.