|Year : 2010 | Volume
| Issue : 2 | Page : 70-75
Training in post-authorization pharmacovigilance
Vivek Ahuja1, Varun Sharma2
1 Director-Clinical Operations, CDM & Pharmacovigilance, GVK Biosciences Private Limited
2 Senior Manager - Pharmacovigilance, GVK Biosciences Private Limited
|Date of Web Publication||20-Oct-2010|
Director-Clinical Operations, CDM & Pharmacovigilance, GVK Biosciences Private Limited
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.
Keywords: Training, pharmacovigilance, modalities of training, training effectiveness, post authorization pharmacovigilance, pharmacovigilance training, drug safety training
|How to cite this article:|
Ahuja V, Sharma V. Training in post-authorization pharmacovigilance. Perspect Clin Res 2010;1:70-5
| Introduction|| |
Pharmacovigilance obligations are required to be fulfilled both during the conduct of clinical studies as well as after the approval of a product by a regulatory authority. Postauthorization pharmacovigilance refers to all the activities that are required to be undertaken for fulfilling regulatory obligations that apply in relation to pharmacovigilance, from the time a product gets the authorization to be marketed in a territory
The scale of activities required to fulfill compliance obligations is dependent on the availability of skilled manpower. The skill set required in this respect is also quite different from what one would require in the clinical trials world, be it a Contract Research Organization (CRO) or a pharmaceutical or biotechnology company. Contrary to popular belief, post authorization pharmacovigilance should not be considered a part of the clinical trials, as by definition, its regulations are applicable only after a product gets the authorization for marketing. Clinical trials are essentially a part of pre-authorization process in the drug development lifecycle. The only area which could be considered an exception to the above rule is the Post-Authorization Safety Studies (PASS) where pharmacovigilance is a part of post approval clinical trials.
One unique aspect of the requirement of pharmacovigilance activities is that with the pharmaceutical and biotechnology businesses growing, the requirement of this function will always increase, as even if the products get older in the market, the requirement for pharmacovigilance activities and fulfillment of regulatory obligations continues to exist. As new products get added to company businesses, the function continues to grow. More products lead to higher sales which translate into more prescriptions and therefore wider population exposure. Eventually, it means more number of skilled people required to manage increased number of adverse drug reactions and all the resultant pharmacovigilance activities in relation to reporting these to the regulatory agencies. The supply demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere and large numbers of pharmaceutical companies are looking at off shoring this function to India to capitalize on the cost arbitrage. So, manpower with long term experience and wide exposure is limited at this time point. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour.
The challenges are many though. Stringent regulations and new pharmacovigilance regulations in various countries, strict enforcement and stricter penalties for noncompliance, frequent safety related actions, increased awareness among patient population regarding safe use of drugs are some of the factors leading the pharmaceutical companies to enter into a never ending race of putting together and maintaining a competent pharmacovigilance department.
This article aims to present a comprehensive perspective on the trainings required in the post-authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms.
| Criticality of training|| |
1.Regulatory requirement ,
Regulations and regulatory guidelines of major pharmaceutical markets, define the need for having a suitably trained staff carrying out pharmacovigilance work. Apart from this, certain regulations also lay down the requirement of training staff other than pharmacovigilance to be trained enough to identify Adverse Drug Reactions (ADRs) coming to their knowledge and forward such information to the pharmacovigilance department.
2. Managing complex systems and processes
A typical global pharmacovigilance department carries out following services:
- Customer Call receipt and Triage
- ADR case processing and expedited reporting (electronic or hard copy)
- Periodic Safety Update Reports (PSURs)
- Product Quality Complaints Management (included by some companies)
- Medical Inquiries Management (included by some companies)
- Electronic Safety Database Validation
- Safety Data Exchange Agreement Management
- Signal Detection Benefit Risk Evaluation
- Risk Management Programes
- Literature monitoring for ADR case reports
- Training of company employees on ADR reporting
- Global Compliance monitoring
- Audits & Inspections Management
The primary objective of pharmacovigilance is patient safety and to ensure this, any responsible pharmaceutical company will readily vouch for the importance of each of these activities. Each of the above requires specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties.
| Choice of trainings and management system|| |
How much training is required and whether external trainers are required, who should undergo which type of training, whether all personnel should receive the same set of trainings, whether there should be a separate function in the company which manages the trainings are some of the questions which can be answered after careful assessment of the company's profile and desired objectives. Some of the factors to be borne in mind while making this decision are listed below:
1. Business model - regions/countries
The country or countries where the company operates is the single most important determining factor. The local pharmacovigilance requirements will determine the essential processes to be in place for a company having authorization in a single country. A multinational company, on the other hand, will have to ensure that the responsible personnel are trained to handle the requirements in all the countries where the authorization is. Needless to say, the personnel should be trained on regulations of all countries coming under the scope of pharmacovigilance. This could be challenging, since some of the big pharmaceutical companies may have autheorizations in more than 100 countries which in turn further complicates matters as there is lack of harmonization of regulations across countries.
2. Product portfolio - Number of authorizations
The number of authorizations a company has could have a bearing on the workload. More the number of authorizations, the more is the expected workload. Though this may not always be true; for example an innovator company with one product may receive more ADRs compared to a smaller generic drug company with many authorizations. The requirement of personnel to handle the increased workload shoots up, leading to the need to have a training management system to manage the trainings of a big department.
The number of ADR cases received from all sources, number of PSURs to be generated, literature searches to be done, etc. would determine the size of the pharmacovigilance department. A bigger department would need a stronger training management system.
4. Staff attrition
Attrition of trained staff is a challenge in itself, especially if the size of the pharmacovigilance department is small. If a company is facing a problem of high attrition, then apart from measures to restrict it, a system to ensure appropriate training of the new staff would have to be in place.
5. Changing regulations or New regulatory requirements
Pharmacovigilance is an evolving science. Worldwide, the trend is towards regulations becoming more stringent than earlier. The training system must ensure that the personnel keep abreast with the new regulations.
6. Specific training requirements
Examples include training on commercially available electronic safety databases, E2B reporting (especially if the company has authorizations in the European Union), regulatory database, literature searches, MedDRA (Medical Dictionary for Regulatory Activities), WHO DD (WHO Drug Dictionary), etc.
Types of trainings
1. Training of pharmacovigilance staff
- Training on organizational requirements like computer systems, corporate policies, mission, safety in workplace, etc.
- Job specific pharmacovigilance trainings
2. Training of other company employees ,
As a good pharmacovigilance practice and to fulfill regulatory requirement in many countries, the company needs to ensure that all its employees (including consultants and temporary staff) are trained to identify and report any ADR coming to their notice to the pharmacovigilance department on an expedited basis.
| Topics for the training|| |
The topics for the trainings would have to be tailored to suit the job role and responsibilities of an employee. There would, of course, be certain specific trainings which should be covered for all pharmacovigilance employees. [Table 1] below presents a list of topics to be covered by all pharmacovigilance employees. [Table 2] presents the topics specific to pharmacovigilance job function.
|Table 2 :Topics specific to particular pharmacovigilance job function1, 2, 3, 4, 5, 6, 7|
Click here to view
| Timing the trainings|| |
1. Training new company employees
New employees hired in the pharmacovigilance department or in the company should receive appropriate trainings. The new employees other than those working in the pharmacovigilance department should be trained on the importance and method of reporting ADR cases coming to the notice of the pharmacovigilance department. These trainings can be a part of the induction training given during the time of joining. Periodic refresher trainings should also be undertaken for all employees. The choice of modality, whether face to face or web based, should be done based on the size and location of various offices of the organization, number of employees and travelling considerations.
The trainings of new employees in a pharmacovigilance department should be more elaborate, as presented in [Table 2]. The specific trainings would start after the induction training into the organization (usually taken by the Human Resources department) is completed. A specific training plan should be made for each employee after considering previous job experience and current job expectations. Not all employees, even those recruited for the same pharmacovigilance activity, would require the same level of training.
An assessment test at the end of each training session is a good modality to check whether the requirements have been understood by the employee. Personnel who score less than required in an assessment test should undergo a retraining on that particular topic. These should ideally be done within a couple of weeks of the last training session.
3. Refresher training
All personnel already on the job should receive refresher trainings. The topics can be varied and could include critical SOPs and applicable regulations. The importance of refresher training should not be underestimated. It gives a good opportunity for the team to discuss and clear their doubts and ensure that all team members are 'on the same page'. These should be scheduled depending on the complexity of the process. Suggested frequency is every 6 months. These can be scheduled earlier if the employees express a need for refresher training.
4. New SOP or regulatory requirements
Training sessions on new SOPs, revised SOPs and regulations should be undertaken. The trainings on revised regulations should be as soon as possible and the trainings on SOPs should be completed before effective date of the SOP.
| Modalities of training|| |
There could be several ways to undertake the trainings. The best way is, of course, face-to-face training session. However, this may not be possible each time since trainees may be located in different geographies. Given below are the various modalities which can be used for the training:
1. Internal trainers
- Self training
- Classroom training
- One-on-one training
- Video conferencing
- Web based
2. External trainers
- Web based
- Classroom training
- Video conferencing
| Management of trainings|| |
Trainings can be effectively managed by designating an individual or a team who would be solely responsible for the training needs. Alternatively, in case of a small pharmacovigilance team, line managers of the personnel can draw up the training plan of their direct reports. An SOP on training would be beneficial to define the exact process and ensure the right trainings at the right time. The trainings should be subject to audits and Corrective and Preventive Action plan (CAPA) should be prepared in case of any findings.
| Assessment of training effectiveness|| |
Assessment is as important as the training itself. It is a tool to ensure that the knowledge from the training was absorbed by the trainee and can help identify areas needing more emphasis in future training sessions. Ideally, an assessment test should be conducted at the end of each training session. If not possible, this should be conducted as soon as possible. The assessment should be such that it does not take more than a few minutes to conduct. Multiple choice questions or an interview type assessment are good modalities.
The results of the assessment can be made available to all or shared only with each trainee. A 'pass percentage' can be defined; person scoring less than the required should be retrained.
Even in cases where self training is required, an assessment of that particular topic can be planned.
A feedback mechanism for the trainer can also be put in place. A form having standard set of questions can be designed. The answers to this could be in the form of grading the training on various aspects on a scale of 1 to 5. Few examples of such questions can be:
- Was the course content relevant for your work?
- Was the subject covered adequately?
- Were you satisfied with the subject knowledge of the speaker?
- Was the speaker approachable and able to provide timely feedback?
- Were the teaching methods employed effective?
- Suggestions for improvement
| Documenting the training|| |
The golden rule is to document every training. All training records should be signed and dated by the trainer and the trainee. In case of self training, 'self' should be written in space for trainer. In case where training was conducted via web or telephone, a scan of the training record form should be printed and filed. It is a good practice to prepare an individual file for training records for each individual. This file should contain, apart from training records and certificates, individual training calendar, curriculum vitae and job description, assessment results for various trainings, feedback forms (if individual is a trainer), slides, handouts, etc.
| Challenges|| |
Managing trainings can be challenging. Pharmacovigilance is a relatively new subject in many countries, and not many academic courses are designed to cover all aspects. Therefore, it becomes essential for any organization to ensure proper trainings for all pharmacovigilance employees. Some of the challenges likely to be faced, especially by a multinational organization are:
1. Employees located at different geographies
This would require frequent travel by the trainer or the trainee. These can also be managed by conducting web based training or through video conference keeping in mind the time difference between the two places. Another option is to have a trainer at the remote location itself, if the training requirements at that location are high in terms of number of trainees and number of trainings.
Another challenge expected due to geographical spread of the department is of language barrier, though English is now an acceptable language for pharmacovigilance related communications, internationally.
Some monetary investments would be required. Examples include, external trainers and courses, procuring software for web based trainings, national/international travel, etc. These may require justification and prior approval from the higher management.
Lack of infrastructure like slow internet connections, room to accommodate large number of trainees, lack of equipment to conduct video/web based trainings, can be a challenge in some cases.
4. Lack of appropriate trainers
A trainer is expected to know the subject matter well, have adequate experience, have good communication skills and expected to clarify any doubts arising during the conduct of training. Finding such a trainer or trainers can be an uphill task. Lack of a good trainer is generally overcome by outsourcing the training activity to a third party.
| Conclusion|| |
Having a well trained staff is highly essential for any pharmaceutical company or a CRO. Effective and efficient management of the training needs can be carried out by carefully planning and identifying the employee's needs and matching them to the company's objectives. With proper planning and execution, the company can manage all its pharmacovigilance related compliance needs effectively and efficiently. A far sighted approach to training is to have a training department as a mandatory function of the pharmacovigilance department. This function should be given as high an importance, as one would accord to the Quality Assurance unit as these are the two important pillars of a successful pharmacovigilance department. An effective approach to ensure that training does get the due importance it rightly deserves, the authors recommend that the training deliverables should be every employee's 'Key Result Area' and a 'true measure' of the effectiveness of the training system would be 'No observations' in relation to training deliverables in any systems audit or inspection.
| References|| |
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|2.||US FDA (March 2001). Draft Guidance for Industry - Postmarketing Safety Reporting for Human Drug and Biologi-cal Products Including Vaccines, Available via http://www.fda.gov/Biologics Blood Vaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vac-cines/ucm074850.htm. Accessed 25 Nov 2009 |
|3.||Medicines and Healthcare products Regulatory Agency (MHRA), Good Pharmacovigilance Practice Guide, Cambridge, Pharmaceutical Press, 2009, pp 101-103 |
|4.||US FDA Code of Federal Regulations, Title 21, Part 314.80. http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/none CFRSearch.cfm. Accessed 25 Nov 2009 |
|5.||US FDA Code of Federal Regulations, Title 21, Part 11. http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/none CFRSearch.cfm. Accessed 25 Nov 2009 |
|6.||ICH E2C - Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, http://www.ich.org/cache/none compo/276-254-1.html. Accessed 25 Nov 2009 |
|7.||ICH E2D - Post-Approval Safety Data Management: Defini-tions and Standards for Expedited Reporting, http://www.ich.org/none cache/compo/276-254-1.html. Accessed 25 Nov 2009 |
[Table 1], [Table 2]