Use of Social Media by Pharmaceutical Medical Information Teams

Transcription

1 A White Paper Presented By ArisGlobal Use of Social Media by Pharmaceutical Medical Information Teams Ome Ogbru, PharmD, Medical Information SME

2 What is Social Media? The Merriam-Webster Dictionary defines social media as forms of electronic communication (as Web sites for social networking and microblogging) through which users create online communities to share information, ideas, personal messages, and other content (as videos). Social media websites are really platforms for communication, networking, and ultimately building relationships. Social media enables us to connect, share, learn, and discover resources. The fundamentals of impactful social media interactions include the following: Great or compelling content Two way conversation Building relationships Building trust Listening Providing value Should Pharmaceutical Medical Information Teams Consider Social Media? The simple answer is Yes at a minimum, social media-based communication should be carefully considered. Pharmaceutical medical information (MI) teams provide support to healthcare professionals (HCPs), and consumers to increase their knowledge about a company s product so they can make the best decision for their patient s health or their own health, respectively. Essentially, pharmaceutical MI teams are centers of knowledge, health educators, and a source for credible and accurate information about a company s products. 2

3 The fundamentals of social media mentioned above are already embedded in medical information practice. Medical information practice involves providing credible and useful content, listening, trust, bilateral conversation, and providing value to healthcare professionals and consumers. These are the fundamentals of a great relationship. Although it is underappreciated, medical information teams actually build relationships with patients and HCPs. From the medical information perspective, social media is a channel for engaging and participating in health conversations that are already naturally occurring on social media platforms. Social media is for building relationships, listening to health care professionals and consumers, and ultimately sharing valuable information that supports safe and effective use of the company s products to improve health. If MI teams appropriately engage consumers and healthcare providers through social media the likely outcomes could be the following: A. Better educated consumers and HCPs B. Quicker awareness of new scientific data C. Better support provided to both HCPs and consumers D. Improved relationship between companies and the community E. Improved health literacy (and hopefully health outcomes) F. Increased intelligence and insights for product life cycle planning G. Increased value provided by medical information teams FDA Guidance on Pharmaceutical Industry Use of Social Media and the Internet for Product Promotion Thus far the Food and Drug Administration (FDA) has published 3 documents about product promotion on social media and the Internet by pharmaceutical and medical device companies. These draft guidelines clarified their thinking and approach to evaluating content shared on Internet and social media platforms. There are no specific guidelines for medical information teams. MI teams should base their practice and approach to social media and Internet on the FDA draft guidelines. It is encouraging that the FDA favors pharmaceutical and device manufacturers educating consumers and providers using the Internet and social media. The FDA recognizes that product manufacturers have additional information that is valuable to the public. However, such interactions should not be an excuse for off-label promotion or violation of any aspect of product promotion regulations. The FDA states that when companies adhere to its draft guidance their communication will not be considered as evidence of promoting their products inappropriately and such communications are not expected to comply with the disclosure requirements for promotional labeling and advertising. This is a critical distinction. The first FDA draft guidance addressed how pharmaceutical companies should respond to off-label inquiries, including inquiries originating from digital platforms. Here are some of the main points from this draft guidance: 1. FDA acknowledges that firms are capable of responding to requests about their products in a truthful, non-misleading, and accurate manner. 3

4 2. Requests must be unsolicited. 3. Only respond to questions about their product and not a competitor s product. 4. Public response to unsolicited requests for off-label information should be limited to providing the company s contact information for their medical or scientific team and should not include any off-label information. 5. Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments. [Note: this empowers medical information teams.] 6. Responses should be scientific in nature. 7. Companies should keep records of the off-label request, contact information for the requester, the response provided, and any follow up information. The second FDA draft guidance for industry addressed how pharmaceutical and device companies provide benefit and risk information on Internet and social media platforms with character space limitations (e.g., Twitter). Microblogs like Twitter pose a challenge because there is limited space to add fair and balance statements and responses. The main suggestions from the FDA are: 1. Manufacturers should carefully consider whether a character-space limited platform is a useful tool based on the complexity and risk profile of their product. 2. Each message or tweet should be accurate and non-misleading and reveal material facts. 3. Benefit information should also include risk information in the same message or tweet. 4. A direct hyperlink to a page that is devoted exclusively to risk information about the product should be included in each post. The FDA provided this hypothetical example of a product tweet: NoFocus (rememberine HCl) for mild to moderate memory loss-may cause seizures in patients with a seizure disorder The third FDA draft guidance is about how companies should address misinformation about their products on the Internet and social media websites. MI teams should study this guidance carefully because correcting product misinformation is a logical expansion of MI services and a way to add more value to the organization while improving the safe and effective use of pharmaceuticals and devices. Whether it is consumer user generated content (UGC), or comes from another company, misinformation about products should be identified and appropriately addressed. The major points of this draft guidance for industry are as follows: 1. The FDA recognizes it may benefit public health for pharmaceutical and device companies to correct misinformation about their products. However, this should not be used as an opportunity to promote the product outside of regulatory requirements. 2. Manufacturers are not responsible for third-party UGC about their products when the UGC is not produced by, or on behalf of, or prompted by the firm even if the firm owns or operates the platform where the content is posted. 4

5 3. Firms may choose to correct or not correct misinformation. However, they cannot cherry pick what information they choose to correct on any particular post. If a posting contains both erroneous positive and negative information, firms should address both. 4. When companies voluntarily address misinformation in a truthful and non-misleading manner and as outlined in the draft guidance, the FDA will not object if the accurate content provided does not meet regulatory requirements regarding labeling or advertising. 5. The response should be accurate, specific to the misinformation, non-promotional, and consistent with product labeling. 6. Firms do not have to correct misinformation on every page of a website. 7. Companies are not required to submit corrective information to the FDA if the draft guidance is followed. 8. Companies should keep records that include the content of the misinformation, where it was published, the date published, the corrective information, and date it was provided. FDA Guidance on Pharmaceutical Industry Use of Social Media and the Internet for Product Promotion We conducted a survey to learn more about how MI teams are using social media and their perspectives about this topic. We sent a survey to MI leaders and team members in the ArisGlobal database and also used social media platforms to disseminate the survey to additional medical information professionals. We received 27 responses representing 21 pharmaceutical companies. Large, midsize, and small pharmaceutical companies were represented in the survey. Most of the participants had over 5 years of experience in medical information and 56% had over 10 years of experience. The majority of participants (66%) had director-level titles or higher. Sixty-seven percent of participants did not believe that social media platforms (e.g., Twitter, Facebook, and LinkedIn) provide an opportunity for MI teams to engage providers and patients. Individual comments in this section included: (1) We do not engage in social media as a company policy due to lack of regulatory transparency. (2) We get adverse events received through social media. (3) Social media lacks the coziness and the direct discussion platform that is mostly needed in peer-to-peer discussions between providers and patients. (4) Too much liability risk. (5) Since the use of media platforms is increasing, it is a mode of providing information on safety of product and its management, and as a method of submitting medical inquiries. Do social media platforms (Twitter, Facebook, LinkedIn etc.) provide an opportunity for MI teams to engage providers and patients?. 5

6 None of the companies have a dedicated MI social media channel or plan to launch one within the next year. Five MI teams worked with other groups such as marketing or communications to monitor social media and respond appropriately. Twelve companies (48%) had no plans to use social media while 32% do not use social media but plan to in the future. Which statement best describes how MI is using social media at your company? Amongst Facebook, LinkedIn, and Twitter, Facebook was selected by more recipients as an appropriate social network for MI to use. The most common response to this question was other and many respondents who chose other suggested that none of the 3 social networks were appropriate for MI. YouTube, blogs, and websites were suggested as alternatives to Facebook, LinkedIn, and Twitter. Legal and regulatory concerns were the most common barrier identified for lack of MI using social media, followed by concerns about receiving adverse events (and obligations associated with them). Lack of resources was the third reason for MI teams not using social media. What barriers prevent MI from participating in social media? 6

7 We also asked whether there was value in MI proactively communicating on-label information through social media or any other channel. Thirty-two percent of participants felt that this is the role of marketing while an equal number thought there is value in MI being more proactive. Thirty-two percent felt that being proactive is too risky or that MI teams may be perceived as promotional and will no longer be able to answer off-label questions. Our survey confirms that many pharmaceutical medical information teams have not embraced social media as a channel for providing medical information. It is encouraging that 32% of the companies who responded are developing social media strategies. Regulatory concerns and liability risk were cited as reasons for not participating in social media. With the recent FDA social media guidance there is more clarity on how companies can use social media in a compliant manner. Liability can be minimized by selecting the right kind of social media engagement, what is shared, and having strict internal social media processes. Concern about receiving adverse events through social media channels was also mentioned. Pharmaceutical companies treat adverse events received from social media channels as they would adverse event reports received from other channels (i.e., ). Most companies provide the contact information of their medical information or safety department to the patient or healthcare provider. Social networks differ considerably in how members interact and how content is shared. Respondents to our survey preferred Facebook over Twitter and LinkedIn for pharmaceutical medical information engagement. Blogs, websites, and YouTube were also suggested. Most likely, the choice of social media platform would depend on the type of interaction or the content that is being shared. Niche healthcare social networks may also be useful for engaging the healthcare community. Ways for Medical Information Teams to Leverage Social Media FDA guidance for the industry on using social media to promote their products provided clarity on their position. Some may conclude that social media is not a viable option for pharmaceutical companies to engage consumers and providers because of the requirement for fair and balanced posting in social media communications. There is some merit to this view point since no pharmaceutical company enjoys scaring consumers about the side effects of their product. A closer look suggests that there is plenty of opportunity and multiple ways for industry to positively engage consumers and providers and remain within FDA social media guidelines. The first step is switching from a mindset of product promotion to one of listening, educating, building trust, increasing health literacy, and improving health outcomes. Educating, engaging, and fostering dialogue does not always mean tweeting about a company s product. For example, tweeting about new published cholesterol guidelines does not require fair balance since a particular product was not mentioned. Company social media posts can also include facts about a disease with a link to a company blog or publication for more details. Correcting misinformation on social media platforms and other websites about a company s product is valuable to the public and to the pharmaceutical company. When there is a need to share information about a company s product, the appropriate social media platform for the type of information being shared should be used and FDA guidelines should be observed. One area where pharmaceutical companies can provide value is helping providers and patients find financial resources to help with the cost of care. Social media platforms can be used to promote product coupons, financial assistance programs, or share information about reimbursement or government assistance. 7

8 Here are some ways that medical information teams can use social media to improve health literacy and provide more value to patients and healthcare professionals: 1. Correct misinformation about the company s products. 2. Share useful, unbiased resources where patients and providers can learn. 3. Share the medical information department s contact information with those seeking more information. 4. Share interesting facts and tips about managing a condition with links for more information. 5. Manage a medical information blog and post answers to frequent on-label questions received through medical information. 6. Raise awareness about new publications or changes in labeling. 7. Develop and share rich media content that teaches how to use a product. 8. Conduct virtual journal clubs with healthcare professionals. 9. Connect patients with specialists and healthcare providers with other experts. conclusion Although social media has been around for many years, pharmaceutical companies are experimenting with how to leverage this channel. Recently, the FDA published guidelines that clarify how pharmaceutical companies can use social media channels without violating FDA rules. These guidelines clarified some of the questions surrounding pharmaceutical companies using social media. Several pharmaceutical companies have blogs and social media channels managed by marketing teams and/or communications teams. Social media could be an exciting and effective channel for medical information teams to engage consumers and providers. Our survey confirmed that many medical information teams are not using social media channels. Two thirds of participants did not see social media as a useful channel for medical information, however, a third of survey participants are developing their social media channel. The other two thirds may want to review FDA draft guidelines and review the potential benefit of using social media to engage consumer and HCPs. The benefits of social media engagement may significantly outweigh perceived risks. References Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (FDA Draft Guidance) ( FDA Draft Guidance December 2011) Guidance for Industry Internet/Social Media Platforms with Character Space Limitations Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (FDA Draft Guidance June 2014) Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (FDA Draft Guidance June 2014) 8

9 About the Author Dr. Ogbru is a Medical Information Subject Matter Expert at Aris Global. He is also the founder of RxEconsult, a professional healthcare network for sharing healthcare knowledge. Over the last 13 years Dr. Ogbru has held several roles in the pharmaceutical industry, including Director of Global Medical Information and Communication. He has also served as a consultant for WebMD. Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from Dr. Ogbru has written several journal articles and book chapters. In 1997, he shared an award from the American Journal of Pain management for Outstanding Contribution to the Interdisciplinary Pain Management Literature. He is passionate about medical information, online health information, and use of social media to increase health literacy. About ArisGlobal ArisGlobal is the leading provider of integrated solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality and compliance for medical inquiries. Life science companies using ArisGlobal s solutions can better build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world ArisGlobal LLC. All rights reserved. aginquirer, agtracker, agresponder, agbiblio, and the ArisGlobal logo are trademarks or registered trademarks of ArisGlobal in the US Patent and Trademark Office and other jurisdictions. Other marks may be trademarks or registered trademarks of their respective owners and are acknowledged as such. The information you see, hear or read on the pages within this presentation, as well as the presentation s form and substance, are subject to copyright protection. In no event, may you use, distribute, copy, reproduce, modify, distort, or transmit the information or any of its elements, such as text, images or concepts, without the prior written permission of ArisGlobal. Trademarks, service marks, and logos (collectively the trademarks ) displayed on the pages within this booklet, are the property of their respective owner. No license or right pertaining to any of these trademarks shall be granted without the written permission of ArisGlobal, LLC (and any of its global offices and/or affiliates). ArisGlobal reserves the right to legally enforce any infringement of its intellectual property, copyright and trademark rights 9