working in a pharmaceutical advertising agency, you hear a lot of acronyms tossed around. ISI means "important safety information". PPI means "patient prescribing information". one term that's used a lot is CHC - "clear health communication". clear health communication basically means that the safety, efficacy, and warnings about a drug must be communicated to the public and to HCP (that's another one - "health care providers") in a way that is clearly understood by the average person.
the level of understanding is a bit lower for consumers; on average, drug companies assume the average consumer can read at a 5th grade level. consumer facing materials are often stripped down to share the basic information about a drug. the level of understanding is a bit higher for HCPs; on average, drug companies assume that health care professionals can read at an 8th grade level. HCP materials usually go into more robust detail about the chemical structure, proper administration and expected adverse effects associated with a drug.
the overarching regulator of both consumer facing and HCP materials is the FDA. for both groups, the FDA enforces the rules stipulating that drug companies create informative materials that clearly communicate the safety, efficacy and adverse effects of any drug. if drug companies fail to do this, they can face hefty fines and damages.
if this preamble hasn't already given you a headache, imagine that you've gone to see your doctor because you suffer massive migraines.
your doctor prescribes a new anti-migraine medication that is administered intravenously, and assigns his assistant to complete your treatment. your doctor has read the ISI and the PPI on this drug and realizes, "OK, this drug has to be administrered as a drip or intramuscular injection," but he gets called away by something urgent and forgets to tell this to his medical assistant, (for the sake of argument) a 20-year old girl fresh out of Stanford Medical Assistant Vocational Training school who has no idea what an ISI is but knows that the office is running behind schedule and, in a well intentioned, proactive attempt at time management, administers the anti-migraine as an IV push rather than as an IV drip. imagine that this administration is wrong, and because of it you lose the arm the anti-migraine drug was injected into.
unfortunately, the above scenario is real: diana levine, a vermont-based musician, recently developed gangrene and lost her arm due to the improper administration of phenergan, a wyeth anti-nausea/ anti-migraine drug. since they can't order wyeth to give her her arm back, a jury ordered wyeth to pay levine almost $7 million in punitive damages. wyeth appealed the judgement, saying the drug label (or all the ISI and PPI information that apparently nobody read) was in full compliance with FDA regulations. last week, the supreme court ruled 6-3 in favor of upholding the lower court's decision, stating that the federal compliance of the drug label does not bar lawsuits under state law claiming inadequate warning of the potential health risks.
