DRUG REACTIONS AND
"Last year, nearly 4 billion prescriptions were filled in retail U.S. pharmacies. These are staggering numbers. Yet, despite the steady upward trend of prescriptions filled per year, (about 300 million more annually) are we any healthier? I would certainly argue this is not the case. In fact, the World Health Report of 2000 ranked the United States number 37 in overall healthcare. Despite numerous policy changes and enormous increases in healthcare spending, it isn’t looking more promising at the time being." United States Tops 4 Billion Annual Prescriptions: Is Our Health Improving? by Chris Sovey from the October 5, 2012 Healthy Consumer. That number is now at least 4.28 billion.
Stop and do the math. That adds up to over 13 prescriptions per year for every man, woman, and child in the United States. That means that for every person who makes zero trips to the drug store, someone is making twenty-six. It's not difficult to understand why there is a pharmacy franchise on every corner, or why ADR's are a catastrophic problem for our nation.
But honestly, I don't want to spend an inordinate time on Adverse Events, Drug Reactions, Drug Side Effects, or whatever you want to call them. If you want to, you can go online and make your head swim with the absolutely freaky numbers (HERE are some statistics for you). What I am actually more interested in today's post is the under-reporting of these ADR's. What do I mean by "under-reporting"? Follow along as I show you another of the medical community's dirty little secrets.
- The February 1997 issue of the British Journal of Pharmacology (Under-Reporting of Adverse Drug Reactions in General Practice) sheds some light on this by revealing some frankly shocking statistics, after following over 80 GP's for only three days. Here are some 'cherry picked' sentences from this study's abstract. "The average number of ADRs observed per day per GP was 1.99 which indicates that, as a whole, GPs might be expected to report only 1 out of every 24 ADRs to the pharmacovigilance centre. Under-reporting was lowest for serious and unlabelled effects and for drugs marketed recently. Adverse effects due to drugs are part of GPs routine activities." Wow! GP's deal, on average, with two ADR's per day, which does make ADR's a "routine" activity. Notice that only about 4% were reported.
- Three years later in Y2K, a position-paper released by the World Health Organization (Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre) revealed that less than 10% of the doctors are reporting ADR's. "Under-reporting is a common phenomenon in all countries. Correcting for under-reporting is difficult, however, because its extent is unknown and very variable. Even at established centres the reported proportion of serious reactions may not be more than 10%. Several of the countries participating for many years in the WHO Drug Monitoring Programme receive 200 or more adverse reactions per million inhabitants annually from about 10% of physicians. In many other countries, however, the reporting rates are much lower." In other words, all of the data on ADR's --- even in the "developed" countries --- seems to be coming from the few physicians who actually report.
- We see the same principle in play with CHILDHOOD VACCINATIONS. Barbara Loe Fisher of the National Vaccine Information Center (NVIC) stated that, "Former FDA Commissioner David Kessler estimated in a 1993 article published in the Journal of the American Medical Association (JAMA) that less than one percent of doctors report injuries and deaths following the administration of prescription drugs". Fisher went on to say that this estimate, "may be even lower for vaccines. In one study that our organization conducted in New York in 1994, only 1 doctor in 40 ever reported to VAERS [the Vaccine Adverse Event Reporting System]."
- Is this only an "American" problem? Nope. The September 2006 issue of the Canadian medical journal BCMJ (the British Colombian Medical Journal) carried the study, Drug Safety: Side Effects and Mistakes or Adverse Reactions and Deadly Errors?. In it, authors Carleton and Smith concluded that, "Adverse drug events are a leading cause of preventable patient harm. Patients can suffer from an adverse reaction to a drug, an improper dose, or a lack of drug treatment. Adverse drug reactions rank as one of the top causes of death and illness in the developed world and have huge socioeconomic significance. It is estimated that as few as 5% of all adverse drug reactions are reported to appropriate agencies. Children are particularly vulnerable. Medication errors are estimated to account for more than 5% of hospital admissions." Many experts would argue that the stat given in the last sentence above is far too low.
- In a 2006 meta-analysis of 37 peer-reviewed studies on the topic that was published in the medical journal Drug Safety, authors Lorna Hazell and Saad Shakir (Under-Reporting of Adverse Drug Reactions: A Systematic Review) concluded that, "The median under-reporting rate across the 37 studies was 94%. There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs".
- Three years later the same journal published a review of 45 papers on the same topic (Determinants of Under-Reporting of Adverse Drug Reactions: A Systematic Review) but asking the question "why?". In other words, why are the rates of ADR's so high? After saying that, "A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation," they reveal why reporting wasn't happening (these are in the order listed). "medical specialty [doctors under-report more than those who work with them, such as nurses, techs, etc.], ignorance, diffidence, indifference, insecurity, complacency, lethargy, lack of time, lack of interest."
- A 2010 issue of the peer-reviewed scientific journal Postgraduate Medicine (Improving the Reporting of Adverse Drug Reactions in the Hospital Setting) started their paper (written by two medical doctors, a pharmacist, and an MBA), with some interesting facts on who is and who isn't reporting. "The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest." "Voluntary" is nice. I certainly wish the IRS would allow me to "voluntarily" pay my taxes. What voluntary reporting of ADR's does in healthcare, however, is completely skew what we oxymoronically refer to today as "EVIDENCE-BASED MEDICINE".
AND JUST THIS YEAR -- 2014 -- WE LEARNED THESE TIDBITS
- In a story that was published just one short month ago by Rachel Lutz in the Pharmacy Times (Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training), we see that these educational efforts still aren't paying off as she reveals, "A lack of training on pharmacovigilance likely leads pharmacists to underreport adverse drug reactions (ADRs), according to a recent analysis.
- But do educational efforts work in reducing ADR's? Maybe they do in some countries, but listen to these conclusions of a study published in one of this year's issues of ISRN Pharmacology (Effect of Educational Intervention on Adverse Drug Reporting by Physicians: A Cross-Sectional Study). After looking at CME efforts (Continuing Medical Education) to educate practicing Indian physicians about the need to report any ADR's, and then comparing the educated physicians to docs that did not undergo CME, they concluded that, "The most important revelation of this study was that although adequate knowledge and the right attitude about adverse drug reaction reporting were instigated in the doctors after the educational intervention, the practice was still neglectful in both groups." In plain English, this means that the educational efforts of the past two decades don't seem to be making a lot of difference.
- Just a few months ago, the Saudi Pharmaceutical Journal (Knowledge and Awareness of Adverse Drug Reactions and Pharmacovigilance Practices Among Healthcare Professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia) wrote that, "Adverse Drug Reactions (ADRs) are scantly reported with poor contribution by healthcare professionals worldwide and in particular in developing countries." So; how did their country (our "ally" in the war on terror --- a country that is by any measure "developed") stack up? "Most hospitals had follow-up documentation systems, but did not include ADRs reporting. There was no distinct pharmacovigilance system in place. Our study has demonstrated a lack of knowledge and awareness of pharmacovigilance and ADRs reporting among healthcare professionals in hospitals. The poor knowledge of ADRs reporting emphasized the urgent need to implement the appropriate strategies to improve the awareness of pharmacovigilance practices and ADRs reporting."
Here's the deal. I could have gone on and on and on and on. In fact, I could have written a book. The bottom line is that drugs are never as safe as you've been led to believe by YOUR DOCTOR, a TV COMMERCIAL, or Aunt Ethel, who claims that the reason she has lived to be 103 years old is because of those wonderful YELLOW PILLS she's been washing down with scotch for the last 45 years. Unfortunately, I see lots (when I say "lots" here, I mean LOTS) of people who have been seriously messed up by our nation's CULTURE OF DRUGS. Could be Antibiotics (HERE is an example). It's frequently STATINS or the drugs people take for DEPRESSION. And I dare not leave out the shots we give our children that cause all sorts of neurological problems, including vast amounts of AUTISM. The truth is, it could be anything. If you think I am over-exaggerating, re-read the bullet points above --- or better yet, take a moment to read the "trust us" slip of paper that comes with every prescription you purchase.
What's my advice to you? Get serious about your health and your weight. If you are trusting your doctor to keep you healthy, one one of these days you are in for a rude awakening. Start today doing whatever it takes to get off as many drugs as you possibly can (as always, seek your doctor's permission before doing so). Isn't it time to make the decision to get healthy? After all, you owe it to yourself (HERE).
Good stuff? If you think so, take two seconds to share it with someone you care about -- particularly if they think drugs are great. While you're at it, take just a second to help us reach more people by liking us on FACEBOOK.