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BHBIA

FAQ - Adverse Event Reporting

These questions are based on queries that members have sent to our ethics advisor and a summary of the responses.

Please note that this resource is simply a selection of actual queries. It does not provide comprehensive coverage of all AE reporting issues - your first port of call should always be to check the ABPI/BHBIA's Guidance notes on the collection of adverse events and product complaints from market research programmes)

This page deals only with queries relating to reporting adverse events and product complaints. For queries on other legal and ethical guidelines topics please see our Legal & Ethical Guidelines FAQ.

If you cannot find the answer to your question in the ABPI/BHBIA Guidance document or below, you can submit a new query to our Ethics Advisor. Please use the online Guidelines Query Form. (This service is only available to full BHBIA members only and you will need to log in).

Responses given are not legal advice and if a legal opinion is required this should be sought separately. The information given in the response is for information purposes only. Whilst every reasonable effort is made to ensure the information is accurate, no responsibility for its accuracy or for any consequences of relying on it is assumed by the authors.

Product complaints and special reporting situations

Q. Does the requirement to report lack of efficacy mean that – e.g. - in a patient diary study every instance where someone switches to try another product infers a lack of efficacy with the current drug?

A.

Lack of efficacy (whether expected or unexpected) only needs to be reported if these is an explicit reference to the drug not working. For example:

  • “Drug A was not very effective”
  • “Drug A did not work”
  • “Symptoms did not improve”  

Statements such as:“(switched to Drug B because) Drug B is a better product” or “(switched to Drug B because) I hoped Drug B might be more effective” do not constitute reportable events as they do not directly cite lack of efficacy for Drug A.

Q. I do not see how reporting all lack of efficacy cases will be useful – for example oncology and similar areas where late line use shows large turnover in products and low efficacy across the spectrum. Does ‘disease evolution’ correspond to a ‘lack of efficacy’ situation?

A.

All events of lack of efficacy should be collected and forwarded to the sponsor company.

Certain therapeutic areas may generate high volumes of non-clinically relevant events of lack of efficacy (e.g. oncology/ neuroscience) and the Agency should agree on the most appropriate procedures for the collection of these AE/PCs with the sponsor company. 

In addition the company researcher should discuss with the agency the appropriate level of adverse event collection for such therapy areas as it will vary from company to company depending on how the PV department view this.  

Q. The AE guidance on “use in pregnancy” now also refers to 'transmission via semen following paternal exposure' – are we required to ask men who are taking medications whether their partners are pregnant?

A.

No, researchers are not required to probe for missing information and can only report AEs based on information volunteered that meets the minimum reporting requirements.

Q. Should off-label usage be reported as an adverse event?

A.

The ABPI/BHBIA Guidance notes on the collection of adverse events and product complaints from market research programmes (April 2013) lists unapproved/off-label usage as a ‘special reporting situation’ associated with the use of a company product, that should be reported, whether or not there is an associated AE.

Q. Is under-dosing considered an AE (i.e. dosages that are not indicated in the drug label)?

A.

Under dosing may qualify as drug misuse, a medication error or off-label use and so should be forwarded.  If in doubt, the guidance is to forward.  You may also wish to contact the sponsoring company’s PV department for confirmation of the action to be taken.

Q. Do product complaints that do not involve an AE e.g. faulty packaging, need to be forwarded?

A.

Yes, product complaints that do not involve an AE such as faulty packaging, do need to be forwarded.  For full definitions of what constitutes adverse events, product complaints and special reporting situations, please see section 5 of the BHBIA and ABPI’s Guidance notes on the collection of adverse events and product complaints from market research programmes, available on the BHBIA website.

Definitions

Q. If a respondent states that he got cut by the pointy blister edge of a product, would that constitute an AE or a PC and would it have to be reported?

A.

Pointy blister edges would constitute a PC and would have to be reported.

It may also be considered as an AE (as an unfavourable and unintended change in the body), but as the reporting form is an AE/PC form it does not require the researcher filling it in to categorise it as an AE or a PC.  This can be done by the receiving PV team.

Q. Does an AE in a group of patients need to be forwarded or is it only if the AE occurs for a specific individual?

A.

AEs cited in groups of patients must be forwarded as well as those in individual patients.  It is important to ensure that the group refers to a specific group of actual patients e.g. “a few of my patients . . .” and is not a generalisation e.g. “I’ve heard some patients . . .”

Q. We seem to creating a lot of additional work for both agencies and clients by making "vague" references to groups of patients. In reality how will pharma’ companies really use these?

A.

The BHBIA does understand the concerns of members, however the guidelines clearly state that all AEs in an actual patient or patients need to be forwarded. e.g. “a few of my patients had headaches” would need to be reported. (though “patients can get headaches” would not have to be reported – as this does not refer to actual patients). 
 
We ask members to refer to the examples in the training slides for guidance, as well as discussing this with the commissioning pharma’ company’s PV department. Even AEs referring to an unspecified number of patients have a value in building a picture of the safety profile of our drugs over time. Many PV departments will use this information to identify signals of safety issues.
 
Once an AE has been identified, we can help to ensure the report is as useful as possible for PV departments by collecting as much information as we can at the end of the interview – e.g. the number of patients and other identifying characteristics, if these are available. The BHBIA does appreciate that it is not always easy in an interview situation to distinguish mentions of actual patients/groups of patients; our advice is to follow the principle of ‘if in doubt, report’
 

Q. How should we report AEs in groups of patients? What constitutes a “group” of patients?

A.

For AEs/PCs described in groups of patients with no individual identifiers, then it is acceptable to complete one form for several patients.  

A group = ‘several’ ‘a few’ i.e. an unidentified number more than 1 but must refer to actual patients seen/treated.

Q. What is the difference between a solicited and an unsolicited Adverse Event? And what is the situation regarding soliciting AEs vs reporting AEs spontaneously mentioned?

A.

Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or health care providers, or information gathering on efficacy or patient compliance.  The European Medicines Agency (EMA) state that “safety reports originating from market research (MR) programmes should be considered as solicited reports.

Unsolicited are those derived spontaneously outside organised data collection and include spontaneous reports, literature reports, other sources e.g. lay press and those from the internet or digital media.  AEs arising from the use of social media to gather MR information i.e. digital listening will be unsolicited reports whilst those cited during any other form of online market research, face to face, telephone or postal market research will be solicited reports.

However, this distinction does not make any difference to MR AE collection or reporting practices. There is no requirement for a market researcher to state whether the AE/PC is a solicited or unsolicited report.

Reporting Requirements

Q. If a market researcher identifies a generalized event (which doesn’t constitute an AE), should he go back and collect more information?

A.

A researcher is NOT required to probe for missing case criteria. The researcher should identify events based on the information cited.  However, if an AE/PC has been identified, the interviewer will go back and collect as much information as it is practical to collect at the end of the interview.

Q. Are there any differences in AE reporting requirements or specific training requirements for MR agencies performing social media listening projects?

A.

No. As with other mediums by which MR is carried out (telephone, online) MAHs conducting ‘listening’, ‘broadcasting’ and ‘engaging’ activities on company-sponsored websites have an obligation to collect and follow-up on AE/PC associated with their products.  This is the case whether public and private websites are accessed, passive and active approaches are used or company sponsored and non-company sponsored sites are used.

Q. Why are the doctor’s contact details always requested? Does anyone actually contact them? If so who does it?

A.

When first received, the information in suspected adverse reactions reports may be incomplete, even though the market researcher has obtained as much information as they can.

These reports should be followed-up as necessary to obtain supplementary detailed information significant for the scientific evaluation of the cases.  The PV team would contact the HCP wherever possible to obtain any additional information.

Q. What happens if a doctor refused to give his contact details or a patient their GPs details?

A.

If these details aren’t given or permission is not granted to pass them on (and personal data cannot be passed on without permission), the researcher should complete form without them.  

The adverse event will be processed, although PV will be unable to follow up for further information.

Q. If an AE is picked up social media and only a 'handle' or 'avatar' is available to identify the individual i.e. their real name is not available, neither is an email address or other identifier, does the AE need to be reported?

A.

It should be possible to verify the individual’s existence via (verifiable) contact details even if these are not to be used; the handle or avatar should provide a means to verify the individual exists to qualify the AE as one that should be forwarded.  So an AE should be reported if there is a handle or avatar that could be traced back, but it would be up to PV to decide whether it was followed up or not. 

Q. When our client commissions a project using online listening it entails us searching public folders i.e. Blogs, Twitter, Facebook, newspapers etc, to see what people are saying about their product. If we came across an Adverse Event would this need reporting even though the respondent has not been recruited, it is literally just a search of the web on behalf of our clients?

A.

Reporting of adverse events is a legal requirement irrespective of the source. The 2013 ABPI ‘Guidance notes on the management of adverse events and product complaints from digital media' are available on the ABPI’s website and say that:

“If a company chooses to “listen” at non-company sponsored sites, it is recommended that the listened to pages should be monitored for AEs/PCs for the period of the listening activity only.”

The BHBIA also advise that the sponsoring company’s pharmacovigilance department is consulted and that company policy is clear and taken into account.

Reporting Responsibilities

Q. We are conducting a syndicated patient study and one of our clients (a pharma company) wants us to complete an AE/PC form as soon as an AE or PC is reported and also to complete and submit a reconciliation form at the end of fieldwork even if no events were forwarded. Is this request legitimate?

A.

For syndicated studies e.g. patient diary studies, the responsibility lies with the purchasing pharma’ company to forward events to their PV department (within one business day of receiving the data, and whether individual patient records or aggregate patient data are purchased).

There is no legal responsibility for the supplier to forward AEs as the supplier is not the legal agent at the time of data collection.

However, as on this occasion, the supplier may be requested to prepare patient record data in the appropriate format for the pharma company client. It is recommended the supplier should liaise with the pharma’ company to agree the format required. This is not a regulatory requirement though.

Q. What about if the pharma’ company adds additional confidential questions to a syndicated survey?

A.

In this case the data from the confidential questions need to be treated in the same way as an ad hoc study - i.e. the agency would need to collect and forward any adverse events generated by those questions within one business day of becoming aware of them.

This is because the agency is acting as that specific pharma’ company’s agent at the time of data collection.

However, the responsibility for collecting AEs from rest of the survey (the syndicated section) remains with the pharma’ company.
 

Q. Is it the responsibility of translators to forward AEs to the client during the translation process of open-ended survey responses?

A.

If an interview is conducted in a foreign language, the local interviewer/moderator should be AE trained and so should report the AE as soon as they are aware, it should not wait till the English translation is available.  

Where translation is needed before analysis (e.g. from self-completion open questions in an online survey completed in local languages in several countries but analysed in English in the UK), it is not expected that translators would be AE trained or aware; in this instance awareness would begin with the analyst. 

All those in MR roles - e.g. coders and analysts would be expected to be AE trained, capable of identifying and forwarding AEs. 

Q. If a generic product name is cited and there are a number of brands on the market, does the AE have to be forwarded even though it’s not possible to know if company sponsoring the MR is the MAH?

A.

Yes, if only a generic name is cited and the company sponsoring the MR is one of several manufacturers and it is not possible to identify which MAH manufactured the drug mentioned, the AE should be forwarded.

Q. Our client, a full service MR agency, requires that we report to them all adverse events on any product whether or not they belong to their client (a pharma company), with all adverse events being forwarded to the client. Is this okay?

A.

The ABPI’s Guidelines for Collecting Adverse Events and Product Quality Complaints from Market Research Programmes clearly state that reporting is out of scope i.e. not required, if the marketing authorisation holder is not the commissioning company (i.e. the company sponsoring the market research).

In addition, the BHBIA would advise against collecting and forwarding adverse events associated with the products of other companies. Given this is not required by the ABPI, the MHRA or the EMA, this could make the commissioning company vulnerable to an accusation of using inappropriate means to collect competitive intelligence and consequently their agencies of unethical non-research activity.

Q. What should I do if I hear of an AE outside of the MR situation (e.g. a colleague says that have taken product X and it made them very sick) - for a product that a) My company holds the license for or b) A client company holds the License for?

A.

The ABPI/BHBIA guidelines only cover MR so advice would be to seek guidance from the company PV dept.

Q. When doing ‘3rd party’ research for another agency/researcher, we do not usually know the identity of the commissioning pharma’ company. Do we simply supply the data to the other agency in the usual way, at which point it becomes their responsibility to identify and report any AE’s/PCs to their client?

A.

All sub-contractors are obliged to use their best endeavours to forward AE’s/PCs within one business day to the commissioning pharma’ company – whether directly or indirectly, whatever the sub-contract chain.

It is essential to know the identity of the MAH in order to be able to identify AE/PCs, so all third party researchers should insist upon knowing who the sponsor/MAH is in order to be able to fulfil their AE/PC reporting responsibilities.

Q. If the UK is part of global study conducted by a US based MR agency who are not BHBIA members, the UK pharma’ companies can say they must follow the guidelines - but as non-members they are not bound by them. So how can international studies be 'policed'?

A.

It is the pharma’ company’s responsibility to ensure that Guidelines are adhered to and failure to do so risks significant findings in MHRA inspections as well as BHBIA disciplinary measures.

The BHBIA recommends that contracts and Master Service Agreements include a clause committing all parties engaged in the market research study – the commissioning company, the market research agency and any sub-contractors – to observe the Guidelines and obtain AE certification. In the absence of this it is recommended that the pharma’ company are asked to provide guidance upon their AE/PC Reporting policy and processes. 

The BHBIA strongly recommends that non-UK based agencies join the BHBIA and indeed, this is now a mandatory requirement in order to work with some UK pharma’ companies. Under the new membership scheme there are various membership and ‘certified non-membership’ categories and rates to accommodate a range of needs. 
 

Q. When a UK fieldwork agency (BHBIA member) is working on behalf of a UK based agency (non BHBIA member) who has not provided adequate means to report AE's/PCs, where does the responsibility lie in terms of ensuring adequate processes are in place to report AE's/PCs?

A.

As a BHBIA member the UK fieldwork agency has a responsibility to report AEs/PCs in accordance with the Guidelines and should make this clear to their partner agency, an agreement to forward AEs/PCs should be negotiated in accordance with the sponsoring company’s requirements. 

Ultimately, responsibility will always lie with the sponsoring pharmaceutical company to ensure that they report AEs/PCs appropriately. In the UK the MHRA will hold the pharma’ company accountable for any failures to report AEs/PCs appropriately. It is for this reason that the BHBIA recommends that contracts and Master Service Agreements include a clause committing all parties engaged in the market research study – the commissioning company, the market research agency and any sub-contractors – to observe the Guidelines. 
 

Q. We have been commissioned by a pharma’ company to conduct a global study that includes the UK. The commissioning MR department (based outside the UK) have told us that they don’t require us to collect AEs. We asked whether we should liaise with the UK affiliate about AE reporting for the UK arm of the study, but our client has asked us not to contact them. What should we do?

A.

As a BHBIA member the UK agency has a responsibility to report AEs/PCs in accordance with the Guidelines.

However, the legal responsibility for a medicine’s safety lies with the Marketing Authorisation Holder (MAH), not the agency.  Given that it is a legal requirement for a MAH to report AEs in the UK, the BHBIA/ABPI recommend that the agency reminds the global pharma’ company that they have this responsibility and keep a record of this communication. If the Global pharma’ company, still asks the agency not to report adverse events for the UK, then the agency having made the best effort to communicate the requirements, cannot be held responsible for the pharma’ company decision (and it would be up to the agency whether they still wanted to proceed with the study).

Q. We have been commissioned by a pharma’ company to conduct a global study that includes the UK. The commissioning MR department (based outside the UK) have told us that they don’t require us to collect AEs and there is no UK office – so no UK based MR or PV staff as far as we are aware. What should we do?

A.

As a BHBIA member the UK agency has a responsibility to report AEs/PCs in accordance with the Guidelines.

However, the legal responsibility for a medicine’s safety lies with the Marketing Authorisation Holder (MAH), not the agency. 

If a company sells (or is developing) a medicinal product in the UK then they must have a system/ process in place to collect adverse events, whether or not they have a UK office.  

Given that it is a legal requirement for a MAH to report AEs in the UK, the BHBIA/ABPI recommend that the agency reminds the global pharma’ company that they have this responsibility and keep a record of this communication. If the Global pharma’ company, still asks the agency not to report adverse events for the UK, then the agency having made the best effort to communicate the requirements, cannot be held responsible for the pharma’ company decision (and it would be up to the agency whether they still wanted to proceed with the study). 

Processes and Timings

Q. Companies seem to be increasingly ‘doing their own thing’, with company specific training, different reporting forms, 24 hr reporting deadlines (vs. one business day) - can anything be done about this?

A.

The BHBIA is concerned about the extra workload and the potential for confusion and possible error that could result from inter-company variation.   

We suggest that agencies should challenge the client company (MR and PV teams) on the areas of variation, for example:

  • They may be prepared to accept the BHBIA data collection form, if asked (a BHBIA survey suggested that a number of pharma’ companies accept both their own forms and the BHBIA form)
  • They may consider accepting tabulations if the benefits are explained
  • They may be understanding about a one business day reporting deadline – particularly if research takes place on a Friday night – if the practicalities are explained.

In addition, the BHBIA is highlighting the issue with PV teams through discussions with the ABPI Pharmacovigilance Expert Network (PEN).

Q. Is it okay to incorporate AE reporting consent into recruitment consent forms required for online quantitative market research or is a separate consent form needed?

A.

Yes, it is okay.  Giving potential respondents the information needed about AE reporting and seeking their consent to participate, and their consent to the use of their personal data/their doctors’ details for AE reporting should be done at recruitment and can be incorporated in to a screener.  It is important however that any consents requested are separate and clear.

Q. When are agencies required to review data for AEs, as soon as it becomes available to them or at the end of fieldwork?

A.

AEs should be reported within 1 business day of first awareness during the MR process - this could be at the end of an interview; if no interviewer is involved it could be during analysis; or if data processing is automated it could be when tables or listings are produced and checked. It is not expected that the normal MR process will be interrupted to check for AEs but that the first opportunity within the process to check for them and forward them will be taken.

There are no regulations or guidelines (EMA, MHRA or ABPI) that require market researchers to put extra steps into the MR process to identify AEs.  AEs should be forwarded within one business day of their identification within the normal MR process.  Some companies may require review specifically for AEs e.g. part way through online fieldwork. 

Q. For online MR, where data is recorded on a database during the weekend, but only seen by a researcher on the Monday, do we need to send an AER on the Monday or during the weekend?

A.

In this scenario, the AE data should be forwarded on the Monday, AEs collected through MR should be forwarded to the MAH within one business day of the reporter first becoming aware of the AE.

Q. When do AE report forms have to be filled in? i.e. should it be done as soon as the AE is mentioned?

A.

As soon as practical but it is not necessary to interrupt an interview to do it - so at the end of the interview is fine.

Q. What proportion of the AE forms sent in are incomplete to the extent that they cannot be used further?

A.

It is difficult to say what proportion of forms are incomplete.  Marketing authorisation holders (MAHs) are expected to exercise due diligence in following up the case to collect missing information.  Reports for which the information is incomplete should nevertheless be recorded within the PV system for use in on-going safety evaluation activities. 

Medical Devices

Q. When testing a prototype inhaler device would any problems that respondents encounter when handling the prototype qualify as adverse events to be forwarded?

A.

Adverse event reporting (AER) is required for potential events that have already occurred (i.e. prior to the market research fieldwork).  AER is not required for hypothetical events that are highlighted in market research i.e. events that could occur in the future outside of the market research setting.

Q. If when carrying out MR for a medical device manufacturer, and a respondent shares an AE linked to the use of a medical device manufactured by the company (e.g. misuse), should we report this as an AE (although the sponsor is not the MAH of the drug that is used within the device)?

A.

If the AE is related to use of the device it should be reported.  If the AE is related to the drug and not the device then the AE does not have to be forwarded as the device manufacturer is not the MAH for the drug (only the device). 

Q. If a company e.g. a medical device manufacturer does not have a PV department, contact or standard operating procedure for AE reporting, how should an agency report AEs?

A.

You will need to ask them how they report AE/PCs and follow their methodology.  The ABPI/BHBIA AE Guidelines state that “In relation to the collection of adverse incidents associated with medical devices, MR agencies should contact the companies they are contracted to work with in order to define the requirements for collection of medical device related reports”

Q. What is the framework relating to safety reporting outside AEs for pharmaceuticals?

A.

AEs, PCs and SRSs associated with medicinal products for human use authorised in the EU, must be reported.  A medicinal product is defined as one used to treat or prevent disease in human beings; or restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

For medical devices all AEs associated with the devices that became apparent during the MR must be collected and forwarded to the company.

In the case of both medicines and medical devices the BHBIA and ABPI’s Guidance notes on the collection of adverse events and product complaints from market research programmes apply and the operating procedure of the commissioning company (the MAH) should be followed, this is normally laid out within the project contract or master service agreement.

 

AE Disclaimers

Q. The AE disclaimer is rather long, are there any plans to develop a one liner or shorter disclaimer making recruitment and interview introductions more agile and efficient?

A.

The BHBIA in conjunction with the ABPI will examine the AE Standard Paragraphs, it is important to review the wording of consents to make them as simple to understand and as quick to deliver as possible but we’re unlikely to be able to condense it down to a one liner as there is too much that must be communicated to secure informed consent for this to be practical.

Q. Can standard disclaimers/paragraphs be provided that cover all common MR approaches and respondent types?

A.

The BHBIA has no plans to provide standard disclaimers/paragraphs for all common MR approaches and respondent types.  We will continue to distinguish between the type of wording required for HCP and non-HCPs and advise members to adjust the wording for the approach e.g. whether face to face, online or telephone.

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