DrugFactsBox™ Professional Edition excerpt as featured in 

Benefit and side effect data presented together

Informulary brings together quantified data about benefits and harms into one table,  and offers details about trial participants.  This presentation makes it easier to weigh the tradeoffs and make an informed decision about whether or not to prescribe a drug.   In contrast, the professional label divides benefits and harms into separate sections that can be many pages apart. 

Evidence-based dosing information

Mobile apps like Epocrates are designed to help doctors prescribe drugs by providing easy to navigate dosing instructions. Side effects are also provided, but in harder-to-read lists.

Informulary’s DrugFactsBox also includes basic drug and dosing information.  Whenever possible, we also alert prescribers to available evidence about specific doses.  For example, the Nuvigil DrugFactsBox shows that the 250mg dose had no additional benefit over 150mg, but it does have additional harm.  The FDA label mentions lack of additional benefit from the higher dose but not the additional harm.   Epocrates does not mention either issue - it provides only the total dosing range. 

FDA’s take 

The clinical trials that are the basis of FDA drug approval are generally short (typically lasting months) and small (typically involving less than 1,000 patients).   As a result, there may be important open questions about long-term drug benefit and safety.   We highlight these issues to help give doctors and patients a fuller picture of what is and is not known about approved drugs.  We cite the conclusions of FDA reviewers, the strength of evidence behind approval (for example, how many pivotal trials were completed, and how many were positive) and the drug's track record (for example, years on the market).   We also note whether the FDA required post marketing studies to resolve uncertainties. When available, we also collect the medical reviewer's conclusion in the "review of efficacy." This text gives the FDA reviewer's take on the benefit/harm tradeoff. 

Evidence-based alternatives

Getting people good information about drug benefits, side effects, and uncertainties is even more valuable with some context. When people look up a drug they are usually interested in  broader questions:  What are all the choices? Are there non-drug options? 

Informulary collects information on all evidence-based alternative treatment choices from professional guidelines and systematic reviews.  This is typically publicly available information from major government agencies (such as the Agency for Healthcare Research and Quality's Effective Health Care reports or the Centers for Disease Control) and major professional organizations (such as the American Heart Association).

We source our data from FDA's review of the drug's approval

We examine publicly available Food & Drug Administration approval documents – supplemented by high quality systematic reviews – to extract the most important data to highlight the benefits, harms and uncertainties of prescription drugs.  Exclusively focusing on clinical trials, we report  the facts about who was studied, with what severity of disease, and for how long.  The information in the approval documents reveal drug benefits and harms that aren’t always conveyed clearly to the general public. Our medical experts examine the extracted data and use it to make our DrugFactsBox.