Read NB_ABPI PEN Complaints guidance text version

Guidance notes

on the management of adverse events and product complaints from pharmaceutical company sponsored websites

13 June 2011

Approval Status

Authors The ABPI Pharmacovigilance Expert Network

Change History N/A

Approval Date 13 June 2011

Table of Contents

1. 2. 3. 4. 5. 6. 7. 8. Introduction Scope Definitions Legal framework and guidance General points for consideration Training Social media activities Collection and follow-up of Adverse Events and Product Complaints from company sponsored sites. 1 1 2 2 3 4 5

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1.

Introduction

The ABPI Pharmacovigilance Expert Network (PEN) recognise the value of using social media to communicate externally with customers. Digital or social media channels are increasingly popular and are chosen as a means of non-product related communication. Currently social media are used by the pharmaceutical industry, advocacy groups, associations and institutions to create and raise disease and treatment awareness. In addition, pharmaceutical companies are using this medium for other purposes such as corporate awareness, responsibility, clinical trial enrolment, recruitment and patient support programmes. Despite the obvious benefits of using social media, there are regulatory and legal considerations due to the inherent nature of this channel. Caution and thoughtful attention to company values, legal and policy requirements are necessary for successful participation in the social media environment. 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 and manage. These guidance notes provide suggested best practices for the monitoring and management of adverse events (AEs) and product complaints (PCs) from social media use in company sponsored websites. These notes have been developed by the ABPI PEN and shared with the Medicines and Healthcare products Regulatory Agency (MHRA). They were put together as a compilation based on current legislative requirements. It is up to each MAH to decide, in the context of their circumstances how to apply these notes. The ABPI PEN and MHRA reserve the right to adopt an alternative position should they be called upon to discuss pharmacovigilance and social media. This document is provided by the ABPI for information purposes only and is not intended and should not be construed as regulatory or legal advice. Companies must ensure that all their activities comply with the appropriate legislative requirements for pharmacovigilance and with the ABPI Code of Practice for the Pharmaceutical Industry (see Section 4). The Prescription Medicines Code of Practice Authority (PMCPA) which administers the Code at arm's length from the ABPI has issued informal guidance about digital communications. Both are available from www.pmcpa.org.uk.

2.

Scope

These guidance notes refer to the collection and management of AEs and PCs from social media engagement for legitimate business purposes. This includes company sponsored websites (e.g. www.pharmaceuticalcompany.co.uk) and all company owned social media sites that are utilised for business campaigns. These guidance notes are applicable to all company employees engaged in external communications using social media including persons retained by way of contract with third parties

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3.

Definitions

A website is considered to be company sponsored if it is owned, paid for and controlled by the company. Control means that the company has authority over the final content. A website is considered to be non-company sponsored if the site is not owned, paid for and controlled by the company. For such a site, there must be no possibility that the pharmaceutical company has been able to exert any influence or control the final content of the site. A donation (financial or otherwise) to an organisation/website by a pharmaceutical company does not constitute sponsorship provided the pharmaceutical company does not control the final content of the site. A company may sponsor a "page" on a website/platform that they do not own (e.g. a company FacebookTM page). If the company has control over the content of the sponsored page then this is considered to be company sponsored.

4.

Legal framework and guidance

Companies must comply with all applicable legislation. In Europe, the two key pieces of legislation that underpin pharmacovigilance expectations are Regulation 726/2004 and Directive 2001/83/EC (as amended). Additional guidance documents such as Volume 9A, the MHRA Good Pharmacovigilance Practice Guide, the ABPI Code of Practice for Pharmaceutical Industry and the PMCPA guidance on digital communications should also be considered. · Notice to Applicants: Volume 9A, Part 1, Section 4.3.3: "The Marketing Authorisation Holder should regularly screen websites under their management or responsibility, for potential reports on adverse reactions. The Marketing Authorisation Holder is not expected to screen external websites for information on adverse reactions. However, if a Marketing Authorisation Holder becomes aware of an adverse reaction on any other website the Marketing Authorisation Holder should review the case and determine whether it should be reported in expedited manner. The Marketing Authorisation Holder should consider utilising their websites to facilitate adverse reaction collection, e.g. by providing adverse reaction forms for reporting or by providing appropriate contact details for direct communication". Volume 9A, Part I, Section 4.2: "The Marketing Authorisation Holder should transmit all ICSRs requiring expedited reporting promptly and no later than 15 calendar days from receipt. This applies to initial and follow-up information. The date the Marketing Authorisation Holder becomes aware of a case which fulfils the minimum information should be considered day 0".

· MHRA Good Pharmacovigilance Practice Guide: Chapter 3, Section 3.1.2 "The wealth of information available on the internet and its widespread accessibility means it is an increasingly popular way to seek and share information. "Contact Us" pages now frequently display generic company email addresses or website enquiry forms. The MAH must consider the mechanism by which incoming information is monitored to allow the identification and transfer of pharmacovigilance data to the correct person in an appropriate timeframe to meet regulatory reporting requirements". 2

· Current Challenges in Pharmacovigilance: Pragmatic Approaches: Report of CIOMS Working Group 5: Section II, d. "A procedure should be in place to ensure daily screening by a designated person(s) of the website(s) in order to identify potential safety case reports. The working group does not believe it necessary for regulators or companies routinely to "surf" the internet beyond their own sites for individual spontaneous reports". · ABPI Code of Practice for the Pharmaceutical Industry In accordance with the ABPI Code the advertising and promotion of Prescription Only Medicines (POMs) to the public is prohibited. Therefore, any promotional material about POMs directed to a UK audience which is provided on the internet must comply with all relevant requirements of the Code. Therapeutic area/disease state websites can be sponsored by companies provided that all the material available at the site complies with the Code. · The Prescription Medicines Code of Practice Authority ­ Guidance on Digital Communications Guidance on digital communications and the ABPI Code was published by the PMCPA in 20111.

5.

General points for consideration

Project management and oversight · Prior to initiation of a social media project, consultation with the following groups is strongly recommended: pharmacovigilance, legal, data protection, compliance, medical information, corporate communications, market research and other groups as required by company policies. It is recommended that the Qualified Person for Pharmacovigilance (QPPV) has oversight of any projects that have potential to generate safety information. · It is recommended that each social media project has a project owner who is also responsible for training and oversight of any activities of engaged third parties. In addition, a "digital spokesperson" should be appointed who manages the content of the site according to a defined moderation process. It is also advisable that expertise exists within the company (or via a third party) of social media platforms and that the on-line evolution of the channel (or its termination) is monitored. · It is recommended that each social media project has a project plan which includes the following: · · · · · · the objective of the project, name (and back-up) of project owner, name (and back-up) of digital spokesperson, AE/PC monitoring plan and coverage, review schedule, vendor contacts etc.

1 http://www.pmcpa.org.uk/?q=node/920

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Declaration of company involvement and responsibilities · The company's involvement in the social media site must be transparent to the users. If the site is owned by the company, this must be disclosed. In addition, it is also recommended that the company disclose the length of time it intends to sponsor the site (if known) and how it intends to screen and use any user-generated content. · Notice should be given on company sponsored sites that the company reserves the right not to publish any user-generated content especially information that would violate any applicable laws and comments which are deemed to be abusive, obscene, inflammatory, or offensive to other site users. · In accordance with Volume 9A it is advisable on any company sponsored sites to provide a mechanism for the user to report any suspected adverse drug reactions to the company e.g. providing on-line reporting forms (in situ or via hyperlinks) or by providing appropriate contact details for direct communication (e.g. phone numbers, e-mail address). In addition, it may be appropriate to provide links to regulatory authority reporting schemes (for example the MHRA Yellow Card reporting scheme). · Consideration should be given towards removing or locking company sponsored sites (inhibiting further posts) once the objectives have been reached. · If a third party vendor is involved in the social media site, it is recommended that the contract delineate the responsibilities of each party involved (especially with respect to pharmacovigilance obligations) and give rights for the MAH to audit the vendor. Data privacy · Notice should be given on company sponsored sites that user-generated information deemed to be an AE/PC will be collected by the company in order to meet legal obligations. It may also be helpful to explain why such information is beneficial for the protection of public health. It should also be noted that the company may follow-up directly with the individual who generated the AE/PC information in order to gain more information.

6.

Training

MAHs should ensure that all staff involved in the social media channel are appropriately trained for performing pharmacovigilance related activities. Individuals responsible for monitoring the sites for AEs/PCs should receive specific training on identification of AEs/PCs and other safety information relating to a MAH product, for example, pregnancy, lack of effect and overdose. In addition, staff need to be trained on who to report the information to, how and within what timeframes. All training should be documented. The above also applies to any persons retained by way of a contract with third parties.

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7.

Social media activities

Social media activities fall into three broad categories which have varying degrees of complexity and associated issues and requirements. · Listening in Monitoring social media sites allows a company to "listen to" or "see" what the public are discussing, saying or sharing about the company itself, diseases, conditions, and treatment options. This type of project is predominately performed in non-company sponsored sites, but can also take place in company sponsored sites. For example, a MAH may "listen to" usergenerated content from specific social media sites or indeed from specific users of that social media site (e.g. key health care opinion leaders or patient group representatives) for a defined period of time. In addition to "listening in" on specific sites and/or specific users companies are also utilising automated tools to detect keywords across the entire internet or specified sites. This is commonly referred to as "buzz monitoring". Whatever form the listening activity takes, the objectives and specifics of the project should be outlined in the project plan which has a project owner and has gone through the company's approval processes. The plan should also outline the management of AEs/PCs including resources to be used and training to be provided. During the listening activity, the company should declare its presence by registering on the site using the company name. This may not be practicable or possible for buzzmonitoring type activities. 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. For example, if the project plan specifies that the company will listen to user-generated content for three days, then it is expected that the company will monitor for AEs/PCs for the duration of the three days. · Giving out Many social media sites allow companies to initiate one-way communications to share important messages with the public, where interactive dialogue is not permitted or practical. This type of activity is performed in both company and non-company sponsored sites. This type of activity should only allow for one-way communication of information (i.e. from the company to the public). Therefore, it is extremely important to ensure that the site (whether company sponsored or non-company sponsored) does not allow for interactive dialogue or the creation of user-generated content. The site should therefore be checked to ensure that dialogue facilities do not exist (i.e. visitor comments/blogs). The ability of visitors to comment through other sites or platforms or technologies that are not controllable by the company, such as Google `Sidewiki'TM, do not conflict with this recommendation. If a "Contact Us" link is provided on a company sponsored site, then the company must document where the link is routed to (e.g. medical information department) and identify who will be responsible for monitoring any correspondence received and the frequency of such monitoring. It is also important to document how AEs/PCs will be managed and ensure that those monitoring the correspondence are adequately trained.

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· Engaging with Engaging, exchanging and participating in interactive communication with the public. This type of activity is performed in both company and non-company sponsored sites. For example, a company may decide to "engage" with patient groups or opinion leaders to gather insights into a particular disease state or class of treatments. The objectives and specifics of the project should be outlined in the project plan which has an owner and has gone through the company's approval processes. The plan should also outline the management of AEs/PCs including resources to be used and training to be provided. During engagement activity on a non-company sponsored site, the company must be transparent and declare its presence. For users to join a company sponsored social media site, appropriate permissions and disclaimers should be presented in advance in the terms and conditions. For example, consent should be given for the company to follow-up with a user should they report AEs/PCs. It should also be made clear that personal information may be processed on internal company databases and sent to regulators. Companies sponsoring `interactive' social media sites (or pages) must monitor the entire content of such sites on an ongoing basis including company websites where visitors may be able to leave messages or request information (refer to Contact Us paragraph above). Prepublication moderation should ensure compliance with the ABPI Code and other regulatory obligations. Monitoring should be frequent enough to ensure regulatory obligations can be met and daily monitoring for the duration of the project should be considered. Companies may wish to solicit information from interactive social media sites that they sponsor e.g. via online clinical surveys sent to site members. All information received in response to such communications should be monitored. If a company chooses to participate in engagement type activities in non-company sponsored sites, it is recommended that the site should be monitored daily for AEs/PCs only for the duration of the project. For example, if a project plan specifies that the company will engage with users of the site for a three week period, then only during this three week period is the company expected to monitor for AEs/PCs.

8.

Collection and follow-up of AEs and PCs from company sponsored sites.

Company sponsored sites used for external communication purposes can be designed to facilitate the pharmacovigilance process. For example, sites can be designed to include free text fields, provide links or access to internal/external reporting based tools which allow users to report suspected adverse drug reactions. Other components such as the "Terms and Conditions for Use" or a formal site registration process can be utilised to obtain information that enables MAHs to identify and contact users in order to validate and follow-up on safety information. A moderation process can be implemented which allows companies to define moderation activities which would include actions to be taken in response to safety information being posted. Blogging policies, netiquettes and disclaimers can also be utilised. These features and processes allow companies to have a high degree of control over how safety information generated on company sponsored sites is managed.

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MAHs conducting `listening in', `giving out' and `engaging with' activities on company sponsored websites for commercial purposes have an obligation to collect and follow-up on AEs/PCs associated with their products. Details of all AEs/PCs for the company's products (branded or generic) should be collected and documented, regardless of: · · · · · or Seriousness of the event Whether there is an identifiable reporter Whether any adverse events are listed in the product's Summary of Product Characteristics Whether a definite causal relationship or link to the product has been stated Whether the stakeholder or patient has already reported the event to the competent authority says they have reported it to the company It is also essential that the responsible person captures the date of receipt (i.e. the date that anyone from within the company or working on behalf of the company first becomes aware of the information). In order for the company to validate a case, the following information should be collected if possible: · · · · An identifiable patient A suspect drug An adverse event An identifiable reporter

Contact details should be available for the reporter to be considered as identifiable. An e-mail address would be considered acceptable. A screen name would also be acceptable if the screen name allowed for contact to be made. In addition to AEs/PCs, information should also be collected in order to comply with the requirements for reporting in special situations (as per Volume 9A) e.g. misuse, pregnancy, medication error. All AEs/PCs identified during the monitoring procedure by company employees or any individual representing or acting on the company's behalf would need to be captured and reported to the company's pharmacovigilance department within one business day of receipt. A confirmation of receipt may be issued. It is recommended that a "screen shot" should be saved and considered as source documentation. It is recommended that all cases collected are entered onto the company's pharmacovigilance database. If they do not fulfill the criteria for a valid case, they should be identified as such in the database and the company should have procedures as to how to include such non-valid cases in their signal detection activities. For company sponsored sites where users have been informed of the necessary legal requirements to collect AEs/PCs and where consent has been granted for the company to engage in further communications, attempts should be made to obtain follow-up information relating to AEs/PCs as per the usual company procedures.

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