When thalidomide was launched as a sedative in the middle of last century, it was lauded as a “wonder drug” for insomnia, coughs, colds and headaches. Not only that, but it was discovered to be an effective antiemetic which had an inhibitory effect on morning sickness. Within a few years the horrible truth became clear that infants were being born with deformities resulting from an adverse drug reaction (ADR).
An outcome of this discovery was a commitment from government regulators and pharmaceutical manufacturers to institute tests and clinical trials for safety during pregnancy. Additionally, postmarketing surveillance is now an industry standard process following the launch of any medicine.
Primarily through health care professionals, adverse event reports (AERs) are submitted to medicine and healthcare regulators on a territory by territory basis.
However during the mid-1990s, the Internet provided a new platform for health information discussion which was outside of the traditional healthcare system context. It became apparent that spontaneous reportable adverse events might occur on any number of different websites, making the job of monitoring much more complex.
In 2001 the World Health Organization Collaborating Centre for International Drug Monitoring (a.k.a Uppsala Monitoring Centre) launched the Vigibase Online project, now known as VigiFlow.
The impact of online conversation
Since the turn of the millennium, the Internet has had exponential and explosive growth in all countries and cultures of the world; meaning that the sheer number of opportunities for conversations online has also resulted in the potential for an increasing amount of spontaneous adverse event reports that could overwhelm reporting infrastructures and pharmacovigilance teams.
A few years ago now, research from a US-centric perspective attempted to quantify the actual number of reportable adverse events which may occur for any given number of ‘mentions’ of a brand of product; to determine a generalized golden rule for understanding the potential risk of high reportable adverse events through emerging channels such as social media.
However, in an international context, this idealized ‘golden ratio’ for reportable adverse events online does not have much meaning.
The Uppsala Monitoring Centre succinctly reinforces this point in their guidelines to pharmaceutical companies entitled “Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre”;
“…there are differences between countries (and even regions within countries) in the occurrence of adverse drug reactions and other drug-related problems. This may be because of differences in:
- drug production
- distribution and use (e.g. indications, dose, availability)
- genetics, diet, traditions of the people
- pharmaceutical quality and composition (excipients) of locally produced pharmaceutical products
- the use of non-orthodox drugs (e.g. herbal remedies) which may pose special toxicological problems, when used alone or in combination with other drugs”
New research into Reportable Adverse Events online
Creation Healthcare has therefore undertaken speculative research to better understand reportable adverse events online in an international context. The primary hypothesis which Creation Healthcare will prove or disprove when complete, is as follows;
“There is no generalized ratio of reportable adverse events versus product mentions in Internet-based conversations. The quantity of reportable adverse events varies by therapy area, channel, and language”
The focus of this piece of research is centered on three questions;
- What kind of social media conversations are likely to result in reportable adverse events?
- Are there variations in the prevalence of reportable adverse events online by therapeutic area, platform, country or language?
- How can pharmaceutical companies choose the most effective digital engagement strategy to suit their approach to handling reportable adverse events?
A presentation of the highlights of this research will be revealed at the [intlink id=”london-28-september-2010-digipharm” type=”page”]DigiPharm Europe conference in London on Wednesday 29th September 2010[/intlink].
Subsequently a comprehensive report will outline how the number of online reportable adverse events for one therapy area in particular (cardiovascular prescription medicine) also varies by brand name, generic name, active ingredient name, and identifying the breakdown of the number of ‘mentions’ which relate to online sales of medicine (with and without prescription). These will be compared with the top-selling medicine in nine other therapies areas.
Unsurprisingly, there are great variations in the numbers of ‘mentions’ of both brands (excluding generic names) and active ingredients throughout the international landscape. Looking at the top-selling heart medicine, during a one-week period from the 4th July 2010 to the 10th July 2010, the differences can be seen as pins of varying sizes on the global map;
Also comparing the top ten therapy areas, according to sales of prescription medicine, it is again apparent that the number of mentions during this same study week varies considerably. Brands (excluding generic names) and active ingredients in the area of Diabetes Type II are the most prevalent;
When looking more closely at a single area (cardiovascular and heart medicines), a great proportion of the mentions of brand names, active ingredients, and generic names is in relation to the sales of medicine online – often without prescription.
Consider this breakdown where the top 5 heart medicines by sales volume are monitored for their brand name (excluding generic names) and active ingredients compared with results which mention side effects, results with terminology associated with selling drugs, and results which contain personal pronouns or evidence of conversation rather than general medical information;
Approximately 50% of the results appear to mention a side effect however it is not until investigating further within this category that the true extent of potentially reportable adverse events can be determined. Looking only at the results with a mention of a side effect, and a mention of a brand name or ingredient; it becomes apparent that approximately 50% are producing results which are specifically about selling medicines online. Many of these contain words like ‘without prescription’ or ‘no prescription’; an alarming fact in itself although not a primary focus for this research.
Clearly there is an increasing amount of content on the Internet, and in the case of medicines a great proportion is from illegitimate suppliers of products online. Much of the content is produced for the purpose of medical education and information and there are naturally a number of results which contain reportable adverse events with an identifiable person associated with the event.
What is also apparent is that these types of results do seem to vary by brand name, active ingredient name, and generic name; they also vary by country, language, and therapy area.
The process for reporting has become somewhat more complicated in an online environment where there are no traditional country borders, and where people converse freely in their own preferred language with others who are located in other parts of the world; each theoretically regulated by separate frameworks and systems.
Creation Healthcare will be presenting more detailed findings at the [intlink id=”london-28-september-2010-digipharm” type=”page”]DigiPharm Europe conference[/intlink] including an overview of the regulatory differences and the actual number of reports that were made in various territories. Be sure to come and hear the latest, and we certainly hope to see you there. If you cannot make it, please do [intlink id=”contact” type=”page”]contact us to arrange a meeting[/intlink] where we can discuss these findings in confidence.