Analysis Of Risk Factors Of MAH Pharmacovigilance Outsourcing

Object:With the establishment of the national pharmacovigilance system,MAH,as the first person responsible for drug safety,should establish a pharmacovigilance system and carry out pharmacovigilance work in accordance with relevant requirements.However,for most MAHs,on the one hand,pharmacovigilance work is not their business expertise.On the other hand,due to the continuous refinement of pharmacovigilance activities and increasing labor costs,the staffing of the MAH pharmacovigilance department has become relatively limited.Therefore,MAH will prefer to choose to delegate part of the pharmacovigilance work to an external professional pharmacovigilance service provider for completion.At the same time,the risks brought by pharmacovigilance outsourcing in the specific implementation process cannot be ignored.How to correctly and scientifically identify,evaluate and control the risk factors of pharmacovigilance outsourcing remains to be explored.This research is based on the basic steps of risk management theory,and adopts the research path of risk identification → risk assessment → risk control to conduct research and analysis on the risk factors of pharmacovigilance outsourcing,hoping to implement pharmacovigilance outsourcing for MAH and formulate corresponding supervision by regulatory authorities Provide reference basis for strategies and operation guidelines.Method:1.Literature research:Detailed access to multiple literature search data databases at home and abroad,based on keywords such as "pharmacovigilance outsourcing","marketing authorization holder","pharmacovigilance" and "outsourcing risk factors" to find and sort out the corresponding literature data And analysis,understand the research status of pharmacovigilance outsourcing,a new thing,and clarify the research ideas and research methods of this research by learning from the identification and evaluation methods of outsourcing risk factors in other industries.2.The principal-agent theory:Based on the five basic assumptions of the principal-agent theory,this study initially identified the risk factors of pharmacovigilance outsourcing from a theoretical level,and then initially obtained 16 risk factors of pharmacovigilance outsourcing.3.Brainstorming:This study used the brainstorming method to invite 13 MAH pharmacovigilance department personnel who have already carried out pharmacovigilance outsourcing to hold a brainstorming group seminar,and let the participants combine their own actual situation of pharmacovigilance work and work experience to further propose pharmacovigilance outsourcing.Based on this,the 16 pharmacovigilance outsourcing risk factors that were initially identified were revised and improved,and 28 pharmacovigilance outsourcing risk factors were finally summarized,which laid an important foundation for the next step of designing questionnaires and conducting questionnaire surveys.4.Questionnaire survey:This study designed a questionnaire based on the 28 pharmacovigilance outsourcing risk factors obtained above.Random sampling was used to conduct a questionnaire survey on200 MAHs in Guangdong Province;the questionnaire was sent directly to MAH pharmacovigilance by email The staff of the department invited them to evaluate and score the impact of each pharmacovigilance outsourcing risk factor on the risk.In this study,a total of 200 questionnaires were distributed and 173 questionnaires were returned.After excluding invalid questionnaires,there were 154 valid questionnaires,and the effective response rate of questionnaires reached77.0%.5.Factor Analysis:This study uses factor analysis to analyze the returned questionnaire survey results,find out risk factors with higher correlation coefficients,and summarize and sort them according to their correlation.Result:After analyzing the recovered valid questionnaire data using SPSS 24.0 software,the following results were obtained:(1)The weighted average of the 28 identified risk factors is basically greater than3.5;(2)The factor analysis method can be further used to reduce the dimensions of the 28 identified pharmacovigilance outsourcing risk factors.The 4 comprehensive risk factors and their respective factor scores are summarized.The results are: service provider And management factors(51.861),MAH factors(7.888),regulatory factors(5.189)and market factors(4.091).Conclusion : The result of factor analysis shows that the factor scores of service providers and management factors are the highest,and are far higher than the other three comprehensive factors,which means that this factor has the greatest impact on the risk of the entire pharmacovigilance outsourcing activities,and MAH is required to develop drugs In the process of vigilant outsourcing,MAH is the second most important factor,and the third is the regulatory factor and the least influential is the market factor,.At the same time,after further analysis,it can be found that the two comprehensive risk factors ranked first and second in factor scores are both internal factors of drug outsourcing,while the two comprehensive risks ranked third and fourth in factor scores The factors are all external risk factors of pharmacovigilance;this indirectly shows that for pharmacovigilance outsourcing,the degree of influence of internal risk factors is greater than the degree of influence of external risk factors.Therefore,MAH should focus on the internal risk factors of pharmacovigilance outsourcing in the process of pharmacovigilance outsourcing in the future,and may adopt the following risk control measures:(1)Clarify the communication mechanism between the outsourcing parties and strengthen communication during the entire process of pharmacovigilance outsourcing to find and solve problems.(2)Strengthen the audit and management of service providers,and ensure that the work results meet the requirements by formulating evaluation indicators and increasing the frequency of spot checks.(3)Strengthen its own pharmacovigilance system and capacity building,and continuously improve its own pharmacovigilance level.(4)Choose suitable pharmacovigilance services for outsourcing and conduct adequate investigations on service providers.At the same time,regulatory authorities and market entities in the outsourcing industry should also take a series of measures for the emerging industry of pharmacovigilance outsourcing,including:(1)Formulate specific guidelines for the operation of laws and regulations,and strengthen the publicity of relevant laws and regulations.(2)Explore the supervision of pharmacovigilance service providers and their pharmacovigilance work,and reduce the occurrence of outsourcing risks.(3)Establish a pharmacovigilance outsourcing industry association to standardize industry behavior and promote the healthy development of the industry.