“You see, but you do not observe. The disctinction is clear.”
Sherlock Holmes complaining to Dr Watson in A scandal in Bohemia.
”Ready, next!” Old Mrs A enters. She is slightly demented, does not sleep very well, and has a failing heart, but insists on living on her own. Her medical conditions have so far been reasonably managed, and her daughter comes by every day to check that she has taken all her medicines. Mrs A now complains about a dry cough and not being able to sleep and some dizziness on arising The symptoms started after the latest change of drug regimen, since a cardiologist had stopped her digoxin thinking that it might be contributing to, or causing, her dementia. She was now taking candesartan. Could this be an adverse drug reaction? Probably yes, but you are not sure, particularly since candesartan is not supposed to have the same effects as the ACE inhibitors; and the thought of filling in yet another form – not to mention finding the wretched thing in the first place – fills you with dread. Your main concern now is how to help your patient. Should you reduce the dose of her beta-blocker, or change the candesartan? Will you wait and see what happens after the reduction of the beta-blocker which you decided on? Do you have the time for yet another appointment with Mrs A?
A decision is made, Mrs A leaves and you now have 10 minutes to eat your lunch before the next patient arrives. Why should you spend your time reporting a mere suspicion when instead you could have your quick lunch in peace?
The answer is – because it matters! Only by communicating our observations can others learn, and therapy be improved. One astute observation can change the world; as in the case of a Dr McBride in Australia who in the early 60s noticed an unexpected increase in babies born with phocomelia. His letter to the Lancet where he proposed that the common denominator, and possible cause of these malformations, was the drug – thalidomide - that the mothers had taken during pregnancy, was the start of what we today call pharmacovigilance.
Contrary to what some might believe, pharmacovigilance must not be a bureaucratic exercise; it is all the activities needed to find out if we in real life get the results from drugs that we were hoping for when they were approved for use.
So where does the needed evidence come from? Randomised controlled clinical trials give us a good picture, at the best, of a drug’s efficacy – the probability that it will achieve a desired outcome – but only very incomplete information of its potential to cause unintended harm. Other kinds of good epidemiological studies provide evidence, but rarely the first hypotheses about things going wrong. Today, 50 years after the thalidomide disaster, we still rely on the observational powers and diagnostic ability of clinicians to identify and report possible adverse effects of medicines occurring in clinical real-life use. But we also need to make much better use of patients’ knowledge about their own diseases and their observations on what works or does not work for them.
Discuss with your patients what their expectations and needs are, and how they view the benefits and possible risks with the different treatment alternative available to them. A rheumatic pianist may accept less than optimal pain control, but not a reduction in dexterity, whereas another patient may prefer maximum pain control at the expense of maintained mobility. Some patients are prepared to accept much more in terms of risk than others, provided that the benefits that they hope for can be attained. An example is the elderly lady who, when told by her doctor about the imminent withdrawal due to an increased risk of cardiac arrhythmia of the drug she had successfully been using for her urinary incontinence: “ my dear young man, I’d rather die tomorrow from a heart attack, than live another year wetting myself”.
Is it not time for a real dialogue between all those who could transform pharmacovigilance from a system for exchange of data between regulatory agencies and pharmaceutical companies to an integrated part of healthcare, with results that directly benefit healthcare professionals and patients?
Doctors need to raise their voices and request that appropriate training, time and resources be made available which will aid their ability to identify adverse effects of medicines – be it reactions related to the inherent characteristics of the drug, or effects related to their use. Drug-drug interactions, suspected antibiotic resistance, or lack of effect/unexpected effects due to substandard medicines or counterfeit medicines – all causes of patient harm need to be recognized and dealt with as promptly as possible.
Systems that facilitate adverse reaction reporting – and feedback! - need to be implemented. Where electronic patient record systems are in use, a possibility to mark up and electronically submit a report should be built into the system as a default. Double entry of data is not only a waste of time, it is also a source of possible error, and an insult to hard working clinicians who need to spend more, not less, time with their patients.
Request that the regional and national pharmacovigilance system has a feed-back mechanism, not only to acknowledge the receipt of your report, but which also will give you information back from existing knowledge sources that is relevant to you and which will enable you to make better treatment decisions.
Demand that the suppliers of prescription support systems integrate relevant data sources and display the information in a way that is helpful to you! Instead of a complete list of every adverse reaction ever reported to a particular drug, would it not be much better to be provided with a targeted risk assessment based on existing intelligence from the treatment of patients with diseases and characteristics similar to the person sitting in front of you. This is not science fiction – the IT solutions to support such features exist today – but resources must be made available towards the implementation of more sophisticated decision support tools. This requires not only money, but also a political will to invest in systems which will not be immediately cost-effective, but which have the potential of long-term gain, both in terms of cost reductions and, more importantly, for patient safety.
Talk to the administrators and decision makers! Remind them that adverse reactions cost large amounts of money and cause considerable morbidity and mortality . Tell them that the best way to get good quality data and to reduce the much talked about problem with under-reporting of adverse drug effects is to give you the means by which you can, and will, contribute to patient safety in your area, in your country, and ultimately, in the world.
- Council of Europe: Creation of a better medication safety culture in Europe: Building up safe medication practices. Expert Group on Safe Medication Practices (P-SP-PH/SAFE) (2006)