COVID-19 impact on PharmacoVigilance activities
Most of the companies must have been undergoing rough phase during this COVID-19 pandemic situation. This situation shall be overcome by adapting new technologies and also by continuously testing the functionalities of these new technologies. Majority of the companies have been increasingly following Business continuous activities by implementing robust Business continuous plans (BCP).
In general, Pharma companies use multiple storage devices like electronic storage devices, Share drive devices in their daily routines of PharmacoVigilance (PV) activities.
It is evident that robust BCP and Disaster recovery (DR) testing shall surely support companies during any kind of natural calamities including COVID-19 situation.
I would like to summarise that below supporting functionalities of Pharmacovigilance activities shall be considered and tested frequently for facing any kind of situation like this.
1. Business Continuous Plan (BCP) testing
2. Disaster Recovery (DR) testing
3. Back-up and Recovery testing
4. Periodic testing of Storage platforms like Share drives and any electronic storage
5. Electronic Archival systems testing
During the current pandemic the reporting of adverse events related to the widespread use of medicinal products for the treatment or prevention of the pathogen causing the pandemic may increase. At the same time, there is a risk that during a pandemic work forces in industry may be reduced due to high employee absenteeism.
Companies can implement certain Change management practices that are deviating from the routine way of working inview of COVID-19 situation. Companies can adapt few work around practices for continuing their PV activities and document through change control and change management processes.
ICSR expedited reporting: MAHs may have understandable difficulties complying with the relevant deadlines. Hence those MAHs which are for justified reasons relating to the pandemic unable to continue standard reporting operations, they should temporarily – until the pandemic is resolved – prioritise the reporting obligations as follows:
Clinical trials: safety reporting shall be continued by contacting patients through phone; monitoring shall be managed virtually with remote monitoring. Refer Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
Follow-up (FU) management: It can be continued as usual while doing follow-up management with patients; May be it is of difficult for HCPs currently due to COVID-19 situation either to contact patients or they themselves giving relevant follow-up detauls to any PV units. Note: Certain National competent authorities (NCAs) announced these workarounds to companies performing FU management.
MedDRA coding: MSSO adding new COVID-19 terms to MedDRA and updated MedDRA version 23.0 that is initially released on 1st March 2020. These recommended practices described the validity and coding of ICSRs. These recommendations are relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection. During this transition until it is implemented on 4th May 2020, MSSO recommended few practices on coding of Covid-19 MedDRA terms (Reaction or event term, Indication and Lab tests).
Current guidance: GVP Module VI Chapter VI.C.6.2.3.4., the indication for which the suspected medicinal product was administered should not be included in the ICH-E2B section ‘Reactions/Events’ unless aggravation of the medical condition occurs.
Interim guidance until implementation of MedDRA version 23.0: If a patient experiences an aggravation or exacerbation of their condition, then, because there is no single term for aggravation of COVID-19 infection, two reactions should be entered in accordance with MedDRA term selection:
Coronavirus infection and Condition aggravated.
Lack of therapeutic efficacy with potential life threatening events: This Covid-19 situation seems to be a prime example for ICSRs in the products which has LOE for treating or preventing Covid-19 infections. Hence ICSRs reported with LOE for treating Covid-19 are required for expedited reporting. Refer "Detailed guidance on ICSRs in the context of COVID-19".
Electronic signatures: It is difficult to sign (hand written) and scan those documents during COVID-19 situation like this. It is not advisable when a lock down situation and also no such facilities are available outside too.
Authorities also started approving Marketing Authoristaions (MAs) in timely manner by approving MAs with digital electronic signatures. It might be high time for companies who have not yet implemented electronic signatures in routine PV activities. It shall be ensured to have a validated electronic signatures in place to authenticate and validated signatures similar to hand written signatures. Refer REGULATION (EU) No 910/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC.
Product Information updates (SmPC and Package leaflet): Due to this Covid-19 pandemic crisis, it may be difficult for MAHs to provide and update different national language texts. Hence the CMDh has agreed to apply the labelling and packaging flexibilities to certain crucial medicines for use in COVID-19 patients only. It is possible for MAHs to notify the relevant national competent authorities in advance and should also provide a link to a website where the product information in the relevant official language may be obtained. Refer "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC"
To summarise all critical PV activities shall be continued without fail irrespective of any crisis. If any non-compliance is estimated or expected, it is always better to raise a deviation or implement change management practices to implement certain workarounds.
Most of the companies must have been undergoing rough phase during this COVID-19 pandemic situation. This situation shall be overcome by adapting new technologies and also by continuously testing the functionalities of these new technologies. Majority of the companies have been increasingly following Business continuous activities by implementing robust Business continuous plans (BCP).
In general, Pharma companies use multiple storage devices like electronic storage devices, Share drive devices in their daily routines of PharmacoVigilance (PV) activities.
It is evident that robust BCP and Disaster recovery (DR) testing shall surely support companies during any kind of natural calamities including COVID-19 situation.
I would like to summarise that below supporting functionalities of Pharmacovigilance activities shall be considered and tested frequently for facing any kind of situation like this.
1. Business Continuous Plan (BCP) testing
2. Disaster Recovery (DR) testing
3. Back-up and Recovery testing
4. Periodic testing of Storage platforms like Share drives and any electronic storage
5. Electronic Archival systems testing
During the current pandemic the reporting of adverse events related to the widespread use of medicinal products for the treatment or prevention of the pathogen causing the pandemic may increase. At the same time, there is a risk that during a pandemic work forces in industry may be reduced due to high employee absenteeism.
Companies can implement certain Change management practices that are deviating from the routine way of working inview of COVID-19 situation. Companies can adapt few work around practices for continuing their PV activities and document through change control and change management processes.
ICSR expedited reporting: MAHs may have understandable difficulties complying with the relevant deadlines. Hence those MAHs which are for justified reasons relating to the pandemic unable to continue standard reporting operations, they should temporarily – until the pandemic is resolved – prioritise the reporting obligations as follows:
- Submission of serious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic;
- Submission of other serious ICSRs;
- Submission of non-serious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic;
- Submission of other non-serious ICSRs.
Clinical trials: safety reporting shall be continued by contacting patients through phone; monitoring shall be managed virtually with remote monitoring. Refer Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
Follow-up (FU) management: It can be continued as usual while doing follow-up management with patients; May be it is of difficult for HCPs currently due to COVID-19 situation either to contact patients or they themselves giving relevant follow-up detauls to any PV units. Note: Certain National competent authorities (NCAs) announced these workarounds to companies performing FU management.
MedDRA coding: MSSO adding new COVID-19 terms to MedDRA and updated MedDRA version 23.0 that is initially released on 1st March 2020. These recommended practices described the validity and coding of ICSRs. These recommendations are relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection. During this transition until it is implemented on 4th May 2020, MSSO recommended few practices on coding of Covid-19 MedDRA terms (Reaction or event term, Indication and Lab tests).
Current guidance: GVP Module VI Chapter VI.C.6.2.3.4., the indication for which the suspected medicinal product was administered should not be included in the ICH-E2B section ‘Reactions/Events’ unless aggravation of the medical condition occurs.
Interim guidance until implementation of MedDRA version 23.0: If a patient experiences an aggravation or exacerbation of their condition, then, because there is no single term for aggravation of COVID-19 infection, two reactions should be entered in accordance with MedDRA term selection:
Coronavirus infection and Condition aggravated.
Lack of therapeutic efficacy with potential life threatening events: This Covid-19 situation seems to be a prime example for ICSRs in the products which has LOE for treating or preventing Covid-19 infections. Hence ICSRs reported with LOE for treating Covid-19 are required for expedited reporting. Refer "Detailed guidance on ICSRs in the context of COVID-19".
Electronic signatures: It is difficult to sign (hand written) and scan those documents during COVID-19 situation like this. It is not advisable when a lock down situation and also no such facilities are available outside too.
Authorities also started approving Marketing Authoristaions (MAs) in timely manner by approving MAs with digital electronic signatures. It might be high time for companies who have not yet implemented electronic signatures in routine PV activities. It shall be ensured to have a validated electronic signatures in place to authenticate and validated signatures similar to hand written signatures. Refer REGULATION (EU) No 910/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC.
Product Information updates (SmPC and Package leaflet): Due to this Covid-19 pandemic crisis, it may be difficult for MAHs to provide and update different national language texts. Hence the CMDh has agreed to apply the labelling and packaging flexibilities to certain crucial medicines for use in COVID-19 patients only. It is possible for MAHs to notify the relevant national competent authorities in advance and should also provide a link to a website where the product information in the relevant official language may be obtained. Refer "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC"
To summarise all critical PV activities shall be continued without fail irrespective of any crisis. If any non-compliance is estimated or expected, it is always better to raise a deviation or implement change management practices to implement certain workarounds.
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