[vc_row][vc_column][mpc_textblock content_width=”100″ font_preset=”preset_0″ margin_divider=”true” margin_css=”margin-top:20px;margin-bottom:20px;”]Patients Discuss and Debate the Medical Outcomes from Generic Formulations[/mpc_textblock][vc_row_inner][vc_column_inner][mpc_image image=”12451″ image_size=”large” force_fullwidth=”true” image_opacity=”100″ image_inner_border_gap=”0″ effect=”none” image_hover_opacity=”100″][/vc_column_inner][/vc_row_inner][mpc_textblock content_width=”100″ font_preset=”preset_2″ margin_divider=”true” margin_css=”margin-top:20px;margin-bottom:20px;”]By Jeff Terkowitz
When mature products face the introduction of generics, patients are often considering, or asked to consider, switching their medications. At that transition, there is a high need for Real World Data documenting patient experiences. What happens to medical outcomes when patients switch medications? Where does a business get the Real World Evidence (RWE) about patient experience that is so needed during any transition from an exclusive formulation to the availability of competitive generics?
A logical place to start is with the patient consumers. After all, individual patients are the first to notice if they have a different health experience when they transition from a protected formulation to a generic that is supposed to provide equivalent health outcomes.
Inspire members discuss medication transitions, openly and frequently. In fact, over 21,700 posts use the term “generic” in the content of the discussion. They often want to know if a generic is available, who has tried it, and what happened. For example, in a post titled, “Has anyone tried generic [medication name]?”, the member initiating the thread recounted a dramatic difference in drug performance: “I was recently changed to the newly released generic version of [medication name}. Within 6 weeks my [test result] has gone from 0.7 to > 6 ???”
Another member said, “Has anyone been switched to generic form of [medication name]? I’ve just started my 2nd month on generic and my [test result] increased 600%. Waiting for scan results now.”
Granted, in this context, the members’ statements are informal. But they are an unprompted, real-world, timely report of responses to a medication change. Moreover, they document an atypical experience outside of the clinical trial, at a time when a generic is being released into a much larger population. Are there other unusual responses? What are they?
In another example, a member wrote a post titled “Generic for [medication name]”:”Has anyone else noticed any problems with the new generic? Sore throat, wheezing, tickle cough, etc. Probably not the meds, but started as soon as the switch was made.”
Of the seven replies, one member described having similar side effects when changing to the generic:
“I …had a terrible reaction to [the generic formulation]. Caused me to have breathing problems and the ones you mentioned you are having. Thankfully I was able [to] go back to the name brand [medication name] and no longer having issues.”
That response appeared one day after the initial post. The usual method of gathering feedback on medications is through providers reporting ADRs to the FDA, a slow and formal cumulative post-release pharmacovigilance process. What about reactions patients don’t consider important enough to describe to a doctor, but will talk about online? Could online patient and caregiver conversations on social health networks be a more immediate resource for obtaining RWE? In advance of clinical confirmation, is it possible to observe post-approval medical outcomes — not just ADRs — in advance of clinical confirmation?
Initial results are promising. In 2018, Inspire partnered with the Stanford University School of Medicine to learn if potentially life saving information on ADRs and other side effects from treatment were hidden in the advice, support, and helping discussions among thousands of patients and caregivers on Inspire.
After performing natural-language analysis of 8 million public posts, the team discovered that some patients receiving the chemotherapy drug erlotinib (Tarceva) reported hypohidrosis – the inability to sweat – a condition that can lead to heat exhaustion, heat stroke, or even death. This ADR had never been reported in the medical literature but Inspire members had been discussing it for over 11 years.
The team also found Inspire members discussed ADRs among themselves much earlier than reported in the medical literature– an average of 7 months before any of these side effects had been reported. These results were published in JAMA Oncology.1 The case study can be found here.
The implication of the study and of the posts on Inspire about generic formulations is that people discuss medical outcomes in social media in advance of any kind of formal reporting, and not just adverse effects; they provide timely feedback on all of their experiences with transitioning to generic formulations. In the case of the Stanford study, the analysis was performed with proven statistical tools and with appropriate respect for patient privacy: Only posts labeled “public” were analyzed. Social media analysis will not substitute for clinical studies and ADR reporting; however, it can be used to identify potential areas of further study for medical outcomes, and for more subtle side effects, long before the traditional process detects them.
Given that the law requires that the generic and proprietary formulations perform equivalently in terms of health outcomes, other experiences recounted on Inspire are less dramatic than the ones quoted above. However, another post mentioned a recurring topic: patients being unaware that their insurance plan allowed the pharmacy to substitute a generic automatically. “I just (got) my first 45 day prescription of the generic version from (provider)… It simply says “generic [medication name].” I only noticed the difference because the price was reduced.”
Other common concerns were members asking their community if the generic was providing an equivalent in health benefit, either in symptom control or in having a similar profile of side effects; others describe situations in which the insurer will cover the generic but not the proprietary formula, with varying outcomes and degrees of satisfaction.
For companies in need of RWE about drug transitions and health outcomes, the data is available through Inspire’s online patient and caregiver community, where real patients regularly discuss their medications; the evidence comes from the skillful analysis Inspire research staff applies to the data.[/mpc_textblock][/vc_column][/vc_row][vc_row css=”.vc_custom_1483606399832{padding-top: 20px !important;padding-bottom: 20px !important;}”][vc_column][vc_row_inner css=”.vc_custom_1496685033252{padding-bottom: 40px !important;}”][vc_column_inner width=”2/3″][mpc_textblock content_width=”100″ font_preset=”preset_2″ margin_divider=”true” margin_css=”margin-top:20px;margin-bottom:20px;”]Download this case study, “Health Economics and Outcomes Research (HEOR) with Advanced Cancer Patients”[/mpc_textblock][mpc_button preset=”preset_1″ block=”true” url=”url:https%3A%2F%2Finspireresearch.com%2Fresource%2Fhealth-economics-and-outcomes-research-heor-with-patients%2F|title:Health%20Economics%20and%20Outcomes%20Research%20(HEOR)%20with%20Advanced%20Cancer%20Patients||” font_preset=”preset_1″ font_color=”#ffffff” font_transform=”none” font_align=”center” title=”Download this case study” icon=”fa fa-angle-right” icon_color=”#ffffff” icon_size=”14″ icon_effect=”stay-left” icon_gap=”20″ background_color=”#084a8e” border_css=”border-radius:2px;” padding_divider=”true” padding_css=”padding-top:10px;padding-right:20px;padding-bottom:10px;padding-left:20px;” margin_divider=”true” margin_css=”margin-top:30px;” hover_font_color=”#ffffff” hover_icon_color=”#ffffff” hover_background_color=”#116eba”][/vc_column_inner][vc_column_inner width=”1/3″][mpc_image image=”12435″ image_link=”url:https%3A%2F%2Finspireresearch.com%2Fresource%2Fhealth-economics-and-outcomes-research-heor-with-patients%2F|title:Health%20Economics%20and%20Outcomes%20Research%20(HEOR)%20with%20Advanced%20Cancer%20Patients||” image_size=”large” image_opacity=”100″ image_inner_border_gap=”0″ effect=”none” image_hover_opacity=”100″][/vc_column_inner][vc_column_inner width=”1/3″][/vc_column_inner][/vc_row_inner][flipbook-shelf ids=”humanizing_the_brand_experience, insights_from_engaged_patients, expert_by_experience_2016, expert_by_experience_2015, expert_by_experience_2014, case_studies_using_multimodal_research, case_study_prostate_cancer_consumer_support_group_survey, case_study_sleep_disorders_private_research_community”][mpc_callout layout=”style_8″ title_font_preset=”preset_5″ content_width=”100″ content_font_preset=”preset_2″ icon_disable=”true” background_color=”#e8e8e8″ border_css=”border-width:5px;border-color:#d3d3d3;border-style:solid;” padding_css=”padding:15px;” mpc_button__preset=”preset_1″ mpc_button__block=”true” mpc_button__url=”url:%2Fresources|||” mpc_button__font_preset=”preset_1″ mpc_button__font_color=”#ffffff” mpc_button__font_transform=”none” mpc_button__font_align=”center” mpc_button__title=”Learn More” mpc_button__icon=”fa fa-angle-right” mpc_button__icon_color=”#ffffff” mpc_button__icon_size=”14″ mpc_button__icon_effect=”stay-left” mpc_button__icon_gap=”20″ mpc_button__background_color=”#47aff3″ mpc_button__border_css=”border-radius:2px;” mpc_button__padding_divider=”true” mpc_button__padding_css=”padding-top:10px;padding-right:20px;padding-bottom:10px;padding-left:20px;” mpc_button__margin_divider=”true” mpc_button__margin_css=”margin-top:10px;” mpc_button__hover_font_color=”#ffffff” mpc_button__hover_icon_color=”#ffffff” mpc_button__hover_background_color=”#116eba”]Inspire offers a trusted community to patients and caregivers. Our goal with this blog, this website and our content is to provide the life science industry access to the true, authentic patient voice. In so doing, we support faithful operationalization of patient-centricity. Take a look at our case studies, eBooks and news outlet coverage.[/mpc_callout][/vc_column][/vc_row][vc_row][vc_column][mpc_textblock content_width=”100″]References:
1 Ransohoff, Julia D., et al. “Detecting Chemotherapeutic Skin Adverse Reactions in
Social Health Networks Using Deep Learning.” JAMA Oncology, Vol. 4, no. 4, 2018, p. 581.,
doi:10.1001/jamaoncol.2017.5688.
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