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Guidance notes on thecollection of adverse events and product complaints frommarket research programmes

Guidance notes on thecollection of adverse events and product complaints frommarket research programmes

ABPI Pharmacovigilance Expert Network and theBritish Healthcare Business Intelligence Association(BHBIA)

Approval Status

Authors:The ABPI Pharmacovigilance Expert Network and the BHBIA

Version: 3.0

Date: 22 April 2013

Acknowledgements:We thank the many stakeholders from industry,regulators and professional organisations who provided feedback inresponse to our consultation on the 2013 revision of this guidance document.

Guidance notes on the collection of adverse events and product complaints from market research programmes

Table of contents

1. Background 1

2. Scope 1

3. Legal framework and guidance 2

4. Contractual requirements 2

5. Collection and forwarding of adverse events, product complaints and special reporting situations 25.1 Definitions 25.2 Collection and forwarding 3 5.3 Timelines for forwarding 4

6. General points to consider 46.1 Primary ad hoc market research 4

6.1.1 Research with healthcare professionals 46.1.2 Research with patients, caregivers and consumers 5

6.2 Digital media research 56.3 Syndicated studies 56.4 Longitudinal patient databases 6

7. Training 6

Annex 1: Abbreviations 7

Annex 2: Explanation of terms 8

Annex 3: Adverse event and product complaint scenarios 11

Annex 4: Standard paragraph example for use prior to a market research activity – HCP 13

Annex 5: Standard paragraph example for use during a market research interview – HCP 14

Annex 6: Standard paragraph examples for use in market research contracts 15

Annex 7: Example of an adverse event/product complaint form 16

Annex 8: Standard paragraph examples for use in market research interviews – HCP 17

Annex 9: Standard paragraph example for use prior to market research activity – patient, caregiver or consumer 18

Annex 10: Example of a market research interview standard paragraph – patient, caregiver or consumer 19

Annex 11: Standard paragraph examples for use in market research interviews– patient, caregiver or consumer 20

Annex 12: Standard paragraph example for use at start of a market research internet study containing the option for respondent free text data entry– HCP 21

Annex 13: Sample form for adverse event/product complaint report reconciliation 22

Annex 14: Revision history 23

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1. Background

Market research is used by a wide range of stakeholders to generate understanding and knowledge about amarketplace and consumer behaviour within it.

Attention to company values, legal and policy requirements are necessary for successful participation inmarket research. This is especially important because of the potential generation of safety (or quality)information which Marketing Authorisation Holders (MAHs) have an obligation to monitor, collect andmanage. These guidance notes provide suggested best practices for the monitoring and management ofadverse events (AE) and product complaints (PC) from market research; see Annex 1 for definitions.

These notes have been developed by the ABPI Pharmacovigilance Expert Network (PEN) and the BritishHealthcare Business Intelligence Association (BHBIA). They were put together as a compilation based oncurrent legislative requirements. It is up to each MAH to decide, in the context of their circumstances, howto apply these notes. The ABPI and the BHBIA reserve the right to adopt an alternative position shouldthey be called upon to discuss pharmacovigilance (PV) and market research.

This document is provided by the ABPI for information purposes only and is not intended and should notbe construed as regulatory or legal advice.

2. Scope

These guidelines apply to market research activities including, but not exclusive to:

• Market research programmes, defined by the BHBIA1 as: “generates understanding and knowledge abouta market place and consumer behaviour within it, by gaining information (data) from specific samples ofconsumers and extrapolating results to the population as a whole. Market research is scientifically-conducted research where the identity of respondents, and all personal data they give to the researchers, arekept fully confidential, and cannot be disclosed or used, for any non-research purpose. Market research isnot a commercial communication or a selling opportunity. Market research has no interest in the individualidentity of respondents. Direct action must not be taken in relation to named individuals or organisationsas a result of market research.”

• Company commissioned/supported primary market research programmes run in the United Kingdom(UK) and syndicated studies.

• Primary market research carried out in the UK, irrespective of which functional or geographical areawithin a company has initiated the study.

The commissioning company is responsible for assessing whether market research activities have apossibility of generating AE/PC. These guidelines cover all medicinal products authorised for human usein therapeutic areas for where a company has responsibilities as a UK MAH.

In relation to the collection of adverse incidents associated with medical devices, market research agenciesshould contact the companies they are contracted to work with in order to define the requirements forcollection of medical device related reports2.

The following are out of scope:

• market research activities on in-licensing opportunities or therapeutic areas where a company is notcurrently the MAH

• market research conducted in countries other than the UK

• clinical trials.

1 BHBIA Legal and ethical guidelines for healthcare market research 2012. Available at:www.bhbia.org.uk/guidelines/legalandethicalguidelines.aspx

2 Official Journal of the European Union 1993. Directive 93/42/EEC, Article 10. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

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3. Legal framework and guidance Companies and their subcontractors must comply with all applicable legislation. In Europe, the two piecesof legislation that underpin PV expectations are: Regulation 726/2004 (as amended by Regulation1235/2010) and Directive 2001/83/EC (as amended by Directive 2010/84/EU). Operational aspects,including the Commission Implementing regulation 520/2012, are detailed in the associated good vigilancepractice (GVP) guidance. GVP Module VI states3:

“A market research programme refers to the systematic collection, recording and analysis by a marketingauthorisation holder of data and findings about its medicinal products, relevant for marketing and businessdevelopment.”

“Marketing authorisation holders should have the same mechanisms in place as for all other solicitedreports (See VI.C.2.2.2) to manage that information and report valid cases of adverse reactions, which aresuspected to be related to the concerned medicinal product.”

Companies must ensure that all their activities comply with the appropriate legislative requirements forPV and with the ABPI Code of practice for the pharmaceutical industry.

The BHBIA requires all members to adhere to the BHBIA Legal and ethical guidelines for healthcare marketresearch4 as a condition of membership and this includes the responsibility to collect and report AE/PC.

4. Contractual requirementsIt is recommended that a contract is drawn up between the MAH and any contractors; any sub-contractshould meet the legal obligations for the MAH5 and any of its legally appointed agents to report AEs tothe MHRA.

Contracts between companies and market research suppliers should include wording regarding therequirements for the collection of AE/PC and subsequent follow-up. An example of standard wording isprovided in Annex 6 to assist consistency between companies.

5. Collection and forwarding of adverse events, product complaints andspecial reporting situations

There are three types of data that should be collected, adverse events (AE), product complaints (PC) andspecial reporting situations.

5.1 Definitions

• An AE is defined as: “Any untoward medical occurrence in a patient or clinical-trial subject administered amedicinal product and which does not necessarily have to have a causal relationship with this treatment.An adverse event can therefore be any unfavourable and unintended sign (eg an abnormal laboratoryfinding), symptom, or disease temporally associated with the use of a medicinal product, whether or notconsidered related to the medicinal product.”AEs include suspected adverse drug reactions, see Annex 2.

• A PC is a complaint specific to the product itself, or packaging, as opposed to its effect on the patient.Examples include damaged or missing tablets; wrong strength or colour of tablets; damaged packaging;a label that cannot be read; a liquid that should be clear but is cloudy or contains unexpected particles; abent needle; a broken syringe; a missing patient information leaflet or the identification of a potentiallycounterfeit medicine.

• See Section 5.2 for details of special reporting situations.

3 European Medicines Agency 2012. Good pharmacovigilance practices Module VI, Section VI.C.2.2.11. Available at:www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129135.pdf


5 European Medicines Agency 2012. Good pharmacovigilance practices Module I, Section 1.C.1.5. Available at:www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129132.pdf

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5.2 Collection and forwarding

All AE/PC cited in the context of any actual patient or patients should be collected and forwarded to thecompany regardless of:

• seriousness or severity of the event

• whether or not a causal relationship to the product has been established

• whether or not already reported by the patient or HCP to the MHRA

• whether or not the AE is expected in the Summary of medicinal Product Characteristics (SmPC)

• whether specific patient identifiers are present

• whether cited in individual patients or groups of patients.

All of the following special reporting situations associated with the use of a company product should bereported, whether or not there is an associated AE:

• use during pregnancy, ie drug exposure to a foetus in utero (whether the foetus is exposed via themother taking the product or transmission via semen following paternal exposure)

• exposure to a drug during breast-feeding/lactation

• overdose (whether intentional, accidental or prescribed)

• drug abuse or misuse

• medication errors (including dispensing errors, accidental exposure, maladministration, etc)

• unapproved or off-label use (ie intentional medical use of a product not in accordance with theauthorised product information) including off-label use in children or the elderly

• reports of lack of therapeutic effect, including suspected use of counterfeit/ falsified medicines/tampering. Market researchers should consult with the sponsor company to ensure appropriatecollection.

The following other safety situations should also be forwarded:

• drug-drug or drug-food interactions

• suspected transmission of an infectious agent

• occupational exposure (as a result of one’s professional or non-professional occupation).

The minimum information required for collecting and forwarding an AE/PC to a pharmaceutical companyis the name of the drug concerned and the AE/PC experienced in the context of a real patient (noidentifying patient details required).

In order for the company to fully process safety information, it is important that the following informationis collected if possible:

• reporter’s name and occupation/ title, address, telephone number, email address or other contactdetails, providing consent is obtained from the reporter to pass on their personal data, see Annex 4and/or Annex 9

• suspect drug (including, if possible dose, duration and indication of use, batch number, brand name)

• patient identifier (eg date of birth/age or age group/initials/gender) if available

• brief summary of the AE/PC.

Further examples of AE/PC scenarios can be found in Annex 3.

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5.3. Timelines for forwarding

The clock start date for expedited reporting (reporting to regulatory authorities) is the date that anyemployee of a market research supplier, or their subcontractor, first becomes aware of an AE/PC6.

Market research suppliers, or their subcontractor, should therefore report individual AE/PC reports or AEtabulations to the commissioning pharmaceutical company within one business day.

6. General points to consider

6.1 Primary ad hoc market research

6.1.1 Research with healthcare professionals

Healthcare professionals (HCPs) must be informed prior to the market research activity of therequirement to report AE/PC which arise from market research programmes. It is part of Good ClinicalPractice (GCP), as advocated by the British Medical Association and General Medical Council, to reportAE/PCs and pharmaceutical companies have statutory requirements in this regard.

All AE/PC noted during the research must be collected and forwarded to the PV department of thecommissioning pharmaceutical company within one business day of any employee of a market researchsupplier, or their subcontractors, becoming aware of the AE/PC. HCPs should be asked if they can beapproached for further information at a later date by the commissioning company’s PV department. If aHCP opts not to consent to their personal information being passed on for the purpose of conductingfollow-up on the report, this will not preclude them from participating in market research. In this case, theAE/PC report will be forwarded to the pharmaceutical company, as an anonymous report.

Examples of standard wording for informing HCPs of these obligations are provided in Annexes 4 and 5 toassist consistency.

An AE/PC reporting form should be used to capture the information that is provided. This can becompleted by the personnel responsible for conducting the research or by the HCP if the respondent is anHCP. The form is a single page containing the necessary information. There is a specific field to recordwhether or not the HCP has consented to follow-up and space to include their contact details ifappropriate consent is given. An example of a standard AE/PC reporting form is given in Annex 7.

Interviews should not be interrupted to complete the AE/PC forms. The interviewer may note downdetails of the AE/PC during the course of the interview, and should ensure that the AE/PC form iscompleted immediately after, ideally with the assistance of the reporter, see Annex 8. A record of the HCP’sassessment of causality of the event by the medicine concerned should be recorded.

If possible, further information should be collected by the interviewer on specific AE immediately after thesession has ended and recorded on the AE/PC form in the section entitled: Adverse events(s)/Productcomplaint details, etc.

In some instances and following consultation with the company, it may be possible to provide tabulationsof AE data rather than individual AE/PC reporting forms; particularly if data are reviewed in aggregate.This is irrespective of whether the study is qualitative or quantitative.

Market research suppliers must keep a record of all AE/PC sent to the commissioning company so thatreconciliation can be performed as required. Reconciliation may be facilitated by use of a form such as thatshown in Annex 13.

All PC associated with the medicines of the commissioning company that were discussed during theresearch must be collected and forwarded to the company. If possible, the lot or batch number should be recorded.

Market research suppliers should take steps to avoid sending duplicate reports.

6 European Medicines Agency 2012. Good pharmacovigilance practices Module VI, Section VI.B.7. Available at:www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129135.pdf

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Only AE/PC associated with medicines where the commissioning pharmaceutical company is the MAHneed to be collected and forwarded. The commissioning company should make available to its marketresearch suppliers a list of relevant medicines for which it holds a marketing authorisation in the UKincluding the generic and brand name.

An AE/PC must be collected in a co-promotion/co-marketing situation. Market researchers should consultwith the commissioning company to determine the process for forwarding an AE/PC to ensure all AE/PCare forwarded without duplication.

Follow-up with the HCP should be conducted by the PV department of the commissioning companywhere consent for this is given, as warranted by the nature of the AE.

Individual companies need to inform market research suppliers of the process for forwarding the AEforms to the company and supply original AE/PC reporting forms. It is recommended that companies usethe reporting form contained in Annex 7 or an alternative form with similar data elements for collection.

6.1.2 Research with patients, caregivers and consumers

In general, the guidelines given for HCPs should be followed. The guidelines differ on the following points.

1) Prior to the research, the patient, caregiver or consumer must be informed that details of AE/PCdiscussed must be collected and forwarded to the commissioning company. It must be explained thatthis is a statutory requirement for the commissioning company to follow, see Annexes 9 and 10.

The personal details of the patient must not be forwarded to the company, other than in the form of anidentifier such as age or gender.

2) If the reporter is a patient, they should be asked if they are willing to consent to provide contact detailsfor a HCP such as their doctor, so that the company can follow-up, see Annex 11. If the patient does notconsent, they may still participate in the research.

6.2 Digital media research

AE reporting requirements are the same for digital media research, including digital listening, onlinesurveys, Market Research Online Communities (MROC) or Dedicated Online Research Communities(DORC) as for any other source of market research data such as face-to-face interviews.

The start of the research process should include a question asking for permission to forward on the contactdetails of the respondent to the commissioning pharmaceutical company should an AE/PC be recorded.An example is given in Annex 10.

Should an AE/PC be uncovered in the analysis of the research, the market research supplier shouldcomplete the AE/PC report form and forward it to the company within one business day of the supplieremployee or subcontractor first becoming aware of the AE/PC.

Further information can be found in ABPI Guidance notes on the management of adverse events and productcomplaints from digital media7.

6.3 Syndicated studies

For syndicated studies, eg syndicated patient level diary studies; there is no obligation on the supplier toreport AE/PC contained within eg the diaries to MAHs.

If individual patient records, containing all relevant fields for an AE/PC, are purchased by an MAH from asyndicated patient level diary study, the MAH must process any individual AE/PC reports containedwithin these records. There is no obligation to forward AE/PC to other MAH.

If syndicated data are purchased at aggregate level, there is no obligation on the MAH to request theunderlying individual patient data.

7 ABPI 2013. ABPI Guidance notes on the management of adverse events and product complaints from digital media. Available at: www.abpi.org.uk/our-work/library/guidelines/Pages/default.aspx

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Prospective patient level diary studies conducted for an individual company are considered as ad hocresearch and follow the guidelines for primary ad hoc research.

6.4 Longitudinal patient databases

Companies access information in longitudinal patient databases for many reasons. This section applieswhen access is for market research purposes.

MAH access to a longitudinal patient database that may contain information qualifying as an AE/PC doesnot automatically convey a responsibility to purchase the database or the responsibility to assess thedatabase in its entirety for collection of individual patient safety information. When the database is used,by an MAH, data supplier, subcontractor or other analyst when acting on behalf of the MAH, there is alsono responsibility to report individual AE/PC contained within the database, for further information seeGVP VI8.

7. Training

An online electronic training programme has been developed by the BHBIA in partnership with the ABPIPEN. This is available for all market researchers (their suppliers, sub-contractors and others) to completeon the BHBIA website9.

The BHBIA recommends that the following personnel complete this training in order to be able torecognise and collect/report AEs/PCs from market research programmes:

• pharmaceutical company employees involved in market research

• employees of market research suppliers and any associated sub-contractors involved in market researchon behalf of pharmaceutical companies.

The BHBIA recommends that all pharmaceutical companies request that their market research agencies,suppliers and subcontracted employees are required to show proof of competency in the BHBIA AdverseEvent training programme prior to commissioning them to work on any market research project. TheBHBIA training is supplemented by an online competency test and certification process that needs to berenewed annually.

8 European Medicines Agency 2012. Good pharmacovigilance practices Module VI, Section VI.C.1.2.1. Available at: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129135.pdf

9 BHBIA 2012 - ABPI-approved BHBIA Adverse Event Reporting. Available at:www.bhbia.org.uk/onlinetraining/training/adverseeventreportinginmarketresearch.aspx

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Annex 1: Abbreviations

Abbreviation

ABPI Association of the British Pharmaceutical Industry

ADR Adverse Drug Reaction

AE Adverse Event

BHBIA British Healthcare Business Intelligence Association

DORC Dedicated Online Research Community

EMA European Medicines Agency

EphMRA European Pharmaceutical Market Research Association

EU European Union

GCP Good Clinical Practice

GVP Good Vigilance Practices

HCP Healthcare Professional

MAH Marketing Authorisation Holder

MHRA Medicines and Healthcare products Regulatory Agency

MR Market Research

MROC Market Research Online Community

PC Product Complaint

PV Pharmacovigilance

PEN Pharmacovigilance Expert Network

SAE Serious Adverse Event

SmPC Summary of medicinal Product Characteristics

UK United Kingdom

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Annex 2: Explanation of terms

The definitions used in this guidance are taken from the Good vigilance practice (GVP) guidance10 and the

BHBIA Legal and ethical guidelines11, where appropriate.

Term Meaning

Ad hoc research Marketing research which is designed and paid for by just one company;the research is exclusive to the commissioning company who own theresulting data.

Adverse Drug Reaction A response to a medicinal product which is noxious and unintended.Response in this context means that a causal relationship between amedicinal product and an adverse event is at least a reasonable.

Adverse reactions may arise from use of the product within or outside theterms of the marketing authorisation or from occupational exposure.

Adverse Event Any untoward medical occurrence in a patient or clinical-trial subjectadministered a medicinal product and which does not necessarily have tohave a causal relationship with this treatment. An adverse event cantherefore be any unfavourable and unintended sign (eg an abnormallaboratory finding), symptom, or disease temporally associated with theuse of a medicinal product, whether or not considered related to themedicinal product.

Commissioning Company Any pharmaceutical company funding a non-syndicated market researchactivity.

Healthcare Professional Doctor, nurse, pharmacist or any other person professionally qualified toadminister health care.

Interviewer Person who collects data from respondents for market, opinion, social,healthcare purposes.

Lack of Efficacy The apparent failure of the medicinal product or medical technology tobring about the intended beneficial effect on individuals in a definedpopulation with a given medical problem, under ideal conditions of use.

Longitudinal Patient Anonymous patient level data extracted from the healthcare records of a Databases sample of physicians and covering an extended period of time, normally

extending for a number of years.

Market Research Market research attempts to generate understanding and knowledge abouta market place and consumer behaviour within it, by gaining information(data) from specific samples of consumers and extrapolating results to thepopulation as a whole. Market research is scientifically-conducted researchwhere the identity of respondents, and all personal data they give to theresearchers, are kept fully confidential, and cannot be disclosed or used, for any non-research purpose. Market research is not a commercialcommunication or a selling opportunity. Market research has no interest inthe individual identity of respondents. Direct action must not be taken inrelation to named individuals or organisations as a result of market research.

10 European Medicines Agency 2012. Good pharmacovigilance practices Annex 1. Available at:www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129131.pdf


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Term Meaning

Market Research One of the more frequently used terms used to describe an online Online Community community created specifically for the purposes of market, social and (MROC) opinion research. Others include DORC (Dedicated Online Research

Community).

Patient Level Diary Studies Collection of patient level information by means of a diary or case reportform either left with a physician or other healthcare professional, orcaptured electronically, for them to complete following interaction withpatients. Diary studies may be primary research or purchasedretrospectively.

Primary Market Research Generates original data collected to solve the problem in hand, data iscollected directly from respondents. Primary data is derived from newand original research designed to address a specific purpose.

Product Complaint A complaint specific to the product itself, its supporting devices orpackaging, as opposed to its effect on the patient. Examples includedamaged or missing tablets; wrong strength or colour of tablets; damagedpackaging; a label that cannot be read; a liquid that should be clear but iscloudy or contains unexpected particles; a bent needle; a broken syringe; amissing patient information leaflet; or the identification of a potentiallycounterfeit medicine.

Reporter The person being interviewed/respondent who raises an AE.

Researcher Any individual, agency, organisation, department or division which carriesout or acts as a consultant on a market research project or offers theirservices so to do. The term includes any department etc which belongs tothe same organisation as that of the client.

Special Reporting All of the following situations associated with the use of a company Situations product should be forwarded, whether or not there is an associated AE:

• Use during pregnancy, i.e. drug exposure to a foetus in utero (whetherthe foetus is exposed via the mother taking the product ortransmission via semen following paternal exposure)

• Exposure to a drug during breast-feeding/lactation

• Overdose (whether intentional, accidental or prescribed)

• Drug abuse or misuse

• Medication errors (including dispensing errors, accidental exposure,maladministration, etc.)

• Unapproved or off-label use (i.e. intentional medical use of a productnot in accordance with the authorised product information) includingoff-label use in children or the elderly.

• Reports of lack of therapeutic effect or other product complaintsassociated with an adverse event, including suspected use ofcounterfeit medicine/ tampering.

The following other safety situations should also be forwarded:

• Drug-drug or drug-food interactions

• Suspected transmission of an infectious agent

• Occupational exposure (as a result of one’s professional or non-professional occupation).

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Term Meaning

Supplier Any organisation or person carrying out any survey commissioned orsupported by a pharmaceutical company. Such organisations are notrestricted to market research companies or members of the BHBIA.

Syndicated survey A market research survey where data are collected independently of anindividual company and available to purchase to a number ofpharmaceutical companies who have not influenced the original design.

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Situation Collect?

1 A respondent (current user) taking drug X for osteoarthritisin her knee indicates she discontinued use of drug X due toheadaches during the course of a market research interview.

Yes. The headaches are an AE.

2 A patient focus group is exploring which brand styleconcept to use for a diabetes portfolio. A patient in a focusgroup describes her experience of vomiting when takingdrug X. This stimulates discussion amongst the four (4)other participants who each share different AEsexperienced when taking drug X.

Yes. Report each AE expressed bya patient.

3 Company X’s drug sales aids are being tested prior to rollout in a face-to-face interview. An HCP mentions that hehas heard that patients can suffer from seizures and thatthis can be a problem.

No. Respondent does not indicatean AE for a particular patient or agroup of patients.

4 A survey is conducted to understand reasons behindprescribing habits in patients with asthma: “Please specifywhy you switched your last patient from a Drug X to Drug Y.”

1 Lack of efficacy 3

2 Rash

3 Diarrhoea

4 Care giver preference

Yes. Lack of drug effect can be anAE and a PC.

5 Market research product consumer tracker question: “TheX drug that I currently take does not work as well as it usedto.” Respondent indicates “strongly agree”.

Yes. Lack of drug effect can be AEand a PC.

6 During a face-to-face interview, respondent states: “I’veheard that drug X can cause problems related to weight gainand high cholesterol levels and I’ve taken patients off forthis reason.”

No. This is anecdotal; respondentdoes not indicate an AE for aparticular patient or a group ofpatients.

7 In an online survey, respondent states “I switched fromdrug A to drug B because drug B is a better product.”

No.

8 A patient focus group is discussing awareness of diseaserelated symptoms. A respondent indicates that “Fatigue iscommon in these types of patients”.

No. No drug is mentioned.

9 In response to the question “In the last month, whatpercentage of your patients taking Antidepressant X, haveexperienced headache?” a doctor states “50%”.

Yes. Respondent indicates an AEfor a particular group of patients.

Annex 3: Adverse event and product complaint scenarios

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Situation Collect?

10 In a usage and awareness study, respondents are asked toindicate, for a series of attributes, how they would perceivea product in comparison to other products for the sameindication. One of the attributes is “this product causesnausea” and on a five-point scale ranging from “much lessthan the other products shown” to “much more than theother products shown”, the respondent has ticked “muchmore than the other products shown”.

No. Although the respondent hasinferred that adverse events mayoccur with the product, this doesnot indicate an AE for a particularpatient or a group of patients.

EXAM

PLE

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Annex 4: Standard paragraph example for use prior to a market researchactivity – HCP

Interviewer says:

We are required to pass on to our client details of adverse events/product complaints pertaining to theirproducts that are mentioned during the course of market research. Although what you say will, of course,be treated in confidence, should you raise during the discussion an adverse event or product complaint in aspecific patient, or group of patients, we will need to report this even if it has already been reported by youdirectly to the company or the regulatory authorities using the MHRA's 'Yellow Card' system. In such asituation you will be asked whether or not you are willing to waive the confidentiality given to you underthe Market Research Codes of conduct specifically in relation to that adverse event/ product complaint.Everything else you say during the course of the interview will continue to remain confidential, and youwill still have the option to remain anonymous if you so wish. Are you happy to participate with theinterview on this basis?

EXAM

PLE

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Annex 5: Standard paragraph example for use during a market researchinterview – HCP

Interviewer says:

You are about to enter a market research interview. 'We are required to pass on to our client details ofadverse events/ product complaints pertaining to their products that are mentioned during the course ofmarket research interviews. Although this is a market research interview and what you say will, of course,be treated in confidence, should you raise during the discussion an adverse event or product complaint in aspecific patient, or group of patients, we will need to report this even if it has already been reported by youdirectly to the company or the regulatory authorities using the MHRA's 'Yellow Card' system. In such asituation you will be asked whether or not you are willing to waive the confidentiality given to you underthe Market Research Codes of conduct specifically in relation to that adverse event. Everything else yousay during the course of the interview will continue to remain confidential. Are you happy to proceed withthe interview on this basis?’

So that this is absolutely clear, I would like you to now sign the following statement:

I, the undersigned:

1. Recognise that there is an obligation for the interviewer to collect details of any adverse events about anindividual patient or groups of patients or product complaints that are mentioned during the course ofthese interviews. Although this is a market research interview, so that what is said is treated inconfidence, should an adverse event or product complaint in a specific patient or group of patients or aproduct complaint be mentioned in the discussion, the interviewer will need to collect this informationand report it to their client even if the adverse reaction or product complaint has already been reportedinto the national reporting system.

2. Agree that after the above explanation, I was given the option not to take part in this interview, if I hadany reservations.

Signed ...................................................

EXAM

PLE

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Annex 6: Standard paragraph examples for use in market researchcontracts

Article XXX – Adverse Event Reporting

1. If during the course of planning, performing or reporting on the research the CONTRACTOR isinformed of any adverse events/product complaints to any of XXXXXX’s products they should reportthe same within one business day to XXXXXX’s Drug Safety department. The CONTRACTOR mustensure that this obligation is communicated to, and complied with by, its employees and sub-contractors.

2. XXXXXX should decide whether such data is required to be added to their Drug Safety registry indiscussion with the relevant medical adviser.

3. At appropriate time intervals the CONTRACTOR must provide a summary of all adverse event/productcomplaint it has forwarded to XXXXXX to enable the reports to be reconciled.

4. Notwithstanding Article XXX (Any article related to data privacy), it must be made clear in advance toany health care professional, that if they report an adverse event then details will be forwarded toXXXXXX who may ask to contact them for further information.

5. The CONTRACTOR will ensure that all its appropriate employees and sub-contractors have undergonepharmacovigilance training to a standard acceptable by XXXXXX.

6. The CONTRACTOR should provide up to date certificates of competency for all it’s staff and any subcontracted staff working on the research to demonstrate that they have undergone and successfullypassed the required training for adverse event/ product complaint reporting in market research

7. The adverse event forms and proof of sending to the marketing authorisation holder deriving from thisAgreement shall be stored by the CONTRACTOR for a minimum of two years or for such period as maybe agreed between the parties. Before any data are destroyed they will be offered to XXXXXX forconfidential longer term storage.

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Annex 7: Example of an adverse event/product complaint form

EXAM

PLE

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Annex 8: Standard paragraph examples for use in market researchinterviews – HCP

Suggested text, should a HCP respondent raise an adverse event or product complaint:

"Doctor, [what you have just said] / [what you said earlier in the interview] is classified as an adverseevent/ product complaint. The company commissioning this market research has a legal obligation toreport this as part of their ongoing benefit risk management. I would like to spend a couple of minutes withyou now to collect the necessary details of the adverse event/product complaint, so that the company canreport this and meet their legal obligations. Are you willing to assist with the reporting of this adverseevent/product complaint?"

If yes: "Thank you. The information you provide will be sent to the company's Drug Safety department who maycontact you directly for further information. Please note that if you provide your name during the adverseevent/product complaint reporting, this will not be linked in any way to your responses given during theinterview."

Note: If respondent subsequently says no, then go to the ‘If no’ section.

If no: "Because I have become aware of this reportable adverse event/ product complaint I am obliged to reportthis to the company. I will file this report without giving any of your details, but if the Drug SafetyDepartment requires more information, may we contact you again (without identifying you to thecompany)?"

If still no: “Thank you doctor – I’ve made a note of that.”

Suggested text, if a HCP respondent provides information on a patient whilst reporting an adverseevent:

“Thank you for providing information on the patient, we would advise per the UK data protection act thatall patients are informed if an adverse event has been reported that relates to them.”

All AEs must be recorded on the faxable form and sent to the drug safety department of thecommissioning company ideally immediately and within one business day at the very latest.

EXAM

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Annex 9: Standard paragraph example for use prior to market researchactivity – patient, caregiver or consumer

Interviewer says:

Different patients sometimes respond in different ways to the same medicine, and some side effects may notbe discovered until many people have used a medicine over a period of time. For this reason, we are nowrequired to pass on to our client, who is a pharmaceutical company, details of any side effects/productcomplaints related to their own products that are mentioned during the course of market research.Although what you say will, of course, be treated in confidence, should you mention during the discussion aside effect when you, or someone you know, became ill after taking one of our client’s medicines, or aproblem you have had with one of our clients medicines we will need to report this, so that they can learnmore about the safety of their medicines.

Are you happy to proceed with the interview on this basis?

EXAM

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Annex 10: Example of a market research interview standard paragraph –patient, caregiver or consumer

Interviewer says:

Different patients sometimes respond in different ways to the same medicine, and some side effects may notbe discovered until many people have used a medicine over a period of time. For this reason, we are nowrequired to pass on to our client, who is a manufacturer of medicines, details of any side effects/productcomplaints related to their own products that are mentioned during the course of market research.

Although what you say will, of course, be treated in confidence, should you mention during the discussion aside effect/product complaint when you, or someone you know, became ill after taking one of our client’smedicines, we will need to report this, so they can learn more about the safety of their medicines.

Are you happy to proceed with the interview on this basis?

So that this is absolutely clear, I would like you to sign the following statement.

I, the undersigned:

1. Recognise that there is an obligation for the interviewer to collect details of any adverse events/productcomplaints related to their client’s products that are mentioned by me during the course of thisinterview. Although this is a market research interview, so that what is said is treated in confidence,should I mention an adverse event/product complaint during the discussion, the interviewer will needto collect this information and report it to their sponsoring client.

2. Agree that after the above explanation, I was given the option not to take part in this interview, if I hadany reservations.

Signed ...................................................

EXAM

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Annex 11: Standard paragraph examples for use in market researchinterviews – patient, caregiver or consumer

Suggested text, should a non HCP respondent raise an adverse event:

"[What you have just said] / [what you said earlier in the interview] is classified as an adverse event/problem with a medicine. The medicines manufacturer commissioning this market research needs someinformation in order to continue identifying new side effects and problems with their medicines, and waysin which the risks of known side effects can be minimised. Every report they receive contains potentiallyuseful information. I would like to spend a couple of minutes with you now to collect the necessary detailsof the adverse event, so that the manufacturer can report this to the authorities. Are you willing to assistwith the reporting of this adverse event/ problem you experienced with the medicine?"

If yes: "Thank you. The information you provide will be sent to the company's Drug Safety department (IN THEEVENT OF AN ADVERSE EVENT / PRODUCT COMPLAINT RELATED TO THE RESPONDENTTHEMSELVES THE FOLLOWING SHOULD BE ADDED: who may wish to contact your doctor forfurther information. Please note that if you provide your Doctor’s name during the adverse event/ productcomplaint reporting, this will not be linked in any way to your other responses given during the interview).Would you like to provide the name of your doctor?"

Note: If respondent subsequently says no, then go to the ‘If no’ section.

If no: "Because I have become aware of this reportable adverse event/ product complaint I am obliged to reportthis to the medicinal products manufacturer. I will file this report without giving any of your details, (INTHE EVENT OF AN ADVERSE EVENT/ PRODUCT COMPLAINT RELATED TO THERESPONDENT THEMSELVES THE FOLLOWING SHOULD BE ADDED: but if the Drug SafetyDepartment requires more information, may we contact you again to ask for permission to contact yourdoctor [without identifying you to the company])?"

If still no: “Thank you – I’ve made a note of that.”

All AEs must be recorded on the faxable form and sent to the drug safety department of thecommissioning company ideally immediately and within one business day at the very latest.

EXAM

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21


Annex 12: Standard paragraph example for use at start of a marketresearch internet study containing the option for respondent free text dataentry– HCP

The agency is required to pass on to their client, who is a pharmaceutical company, details of adverseevents related to their own product(s) that are raised during the course of market research interviews.Although this is an online market research interview and how you respond will, of course, be treated inconfidence, should you raise an adverse event/ product complaint in a specific patient or group of patients,the agency will need to report this, even if it has already been reported by you directly to the company orthe regulatory authorities using the MHRA's 'Yellow Card' system If you decide to disclose your personaldetails in association with any adverse event/ product complaint report, this information will be disclosedto the commissioning company. In such a situation you may be contacted specifically in relation to thatadverse event. Everything else you contribute during the course of the interview will continue to remainconfidential

Are you happy to proceed with the interview on this basis? Please indicate your response by selecting theappropriate option below:

I would like to proceed and give permission for my contact details to be passed on to the Drug Safetydepartment of the company if an adverse event/ product complaint is mentioned by me during the survey(PROCEED)

I would like to proceed but do not wish for my contact details to be passed on to the Drug Safetydepartment of the company if an adverse event/ product complaint is mentioned by me during the survey(PROCEED)

I don’t want to proceed and wish to end the interview here (THANK AND CLOSE)

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Annex 13: Sample form for adverse event/product complaint reportreconciliation

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Annex 14: Revision history

Version 3 amendments are as follows:

• Reorganisation of guideline structure to improve clarity.

• Updated definitions in line with 2010 pharmacovigilance legislation and BHBIA Legal and ethicalguidelines.

• Deleted Annex on types of adverse events and included as special reporting situations in Section 4and Annex 2, consistent with other ABPI pharmacovigilance guidance documents.

• Inclusion of off-label use in special reporting situations and exclusion of withdrawalreactions/rebound effects and disease progression/exacerbation of existing diseases.

• Deleted Annex on legal basis for guidance on longitudinal patient databases as this is now clarifiedin the Good vigilance practice guidance.

• Inserted a new Annex 3 with various AE/PC collection scenarios.

• Annex 12 (which was Appendix 2) has been redrafted.

Association of the British Pharmaceutical Industry7th Floor, Southside, 105 Victoria Street, London SW1E 6QT t +44 (0)870 890 4333 [email protected]

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