Still, you take the medication as prescribed. At first
you imagine your body may adjust or the pills
will come to understand you. It is no use.From Virginia Chase Sutton: Lithium and the Absence of Desire.
Patient engagement
Patient engagement is one of the mantras of current healthcare improvement efforts. Medical students and junior doctors likely think they are doing it better than their elders ever did. They are after all taught communication skills, where an earlier generation wasn’t. In fact, they are taught that they are being taught communication skills. They are taught how to communicate bad news. They are not taught how to hear awkward or bad news.
The younger generation are almost certainly worse than former generations of doctors at listening for or actually hearing “the treatment you put me on doctor has made me worse”.
Patients and doctors are caught in Stockholm Syndrome
There are two ways in which doctors have a problem when it comes to adverse events. One is that it is now clear that ever better communications skills, in the sense of friendliness and superficial approachability, will increase the likelihood of trapping patients in a Stockholm syndrome so that they are unable to report adverse events to their doctor.
Doctors, caught in their own Stockholm syndrome, and faced with an industry that is friendlier than and understands them better than ever before, are themselves ever less likely to report adverse events to companies and their unwillingness to report makes it ever harder for them the pick up on hints their patients may offer. There are no training modules within medicine that teach medical students or junior doctors about Stockholm syndrome. There are no courses showing medical students or junior doctors how industry markets to them by encouraging them to stick to the practice of evidence based medicine.
Against this background, treatment related adverse events have become the fourth or perhaps the third depending on the study you go by or even the leading cause of death if we extrapolate from hospital settings to what might be happening in community settings.
The situation has echoes of the joke about the Black Man thrown out of a Church in the American South in the 1960s. Sitting in the dust he asks God how many hundred years will it take till he and his kin gain entrance. A voice from Heaven says My son, I’ve been trying to get in there for 2000 years.
The dilemma faced by patients
This is where the rubber hits the road when it comes to engagement. Part of the problem is doctors are inured to the legal, financial and political implications of what they do. We make a virtue of being value neutral when it comes to treating men injured in combat or women with an incomplete abortion. But now when Churches are scared of pharma (see Fn 1), there is a greater need than ever for the kind of moral courage it once took to stand up to governments and treat enemy combatants or to stand up to churches and treat women, we seem to have lost that kind of courage.
Aside from the loss of courage, we miss how political the simple things we do can be and how our position overwhelms basic humanity.
Take Sylvia for instance who has just been put on doxycycline and become suicidal. She has a real dilemma. Let’s say she works in the mental health field. Does she report this problem to her doctor? The first problem is even if she does work in the system, for her like others entering his consulting room, she is rather like a mouse confronting a cat. He may smile and swish his tail, but still…
It’s like a prisoner confronting a warden. Caught in the zeitgeist, warders like junior doctors are no doubt trained in communication skills these days. They may chat about football results but all the power is on one side. If Sylvia goes to her doctor and he enters into her medical notes that she has been suicidal, this might compromise her future employment prospects. If she wants to work with children in the future, her medical records will be scrutinized and if this comes to light her job prospects may be gone – perhaps without her ever knowing why.
If she tries to engage her doctor on the possibility that this is an adverse event, we find out what patient engagement really means. She is the person who has been through the experience. She may be pretty confident in her judgement. The problem came on after she started the drug and cleared once it stopped.
But he has never seen this before – or perhaps seen but never noticed it before, or had it mentioned to him but never registered it before. And he has 12 years of medical training and many more years of practice. He may look at the datasheet on doxycycline, perhaps even check out some internet sources. He will not find anyone saying doxycycline causes suicide – unless he stumbles onto the RxISK site.
This is a moment of great drama. Sylvia will feel every minute of it, but her doctor will likely not be aware of anything. Unless he enters into the medical record, a clear statement that this might be an adverse event, Sylvia is at risk of legal, financial, insurance and other consequences of an entry that designates her as suicidal – i.e. she has a medical condition- rather than as the victim of a treatment related event.
He will be scared to take her side. He may not think he’s scared. This is the lack of fear that walks on by because others have looked at the issue and if drug companies, regulators and other doctors have not found that doxycycline causes suicide who am I to engage with this unclean woman. Unclean –anything as strange as suicidality will make someone as unclean as any Samaritan woman might have once seemed.
What does Sylvia do next?
The first message is this. Any Sylvia or Sylvain bringing an adverse event to their doctor should do so in the form of a RxISK report. You should hand in the RxISK report first before trying to talk about it. If you talk first and your doctor dismisses you, it will then be difficult to bring the RxISK report up.
But presenting a RxISK report and perhaps indicating this has been sent to the regulator – FDA, HealthCanada, MHRA, EMA, TGA, CARM – puts the interaction on an entirely different footing. Your doctor is now faced with the fact that there is a record of a possible adverse event and if he pays no heed to it and things go wrong he is in a less secure position than he would be in if he records that you became suicidal rather than you had an adverse event.
The more standing up for yourself like this feels like violence or disruptive, the more you are getting to grips with the violence that the system is doing to you. The more awkward it feels, the more you are testing whether lip service to patient engagement is just another way to trick patients into doing as they are told – unless of course your doctor proposes engagement.
If he doesn’t propose, how it works out in practice is that smiling sweetly he will double Sylvia’s dose or recommend something else. Smiling equally sweetly, she will say “of course”, will leave and will not take it.
Patient non-compliance is the drapetomania of the 21st century (Fn 2).
We have a Dream that one day people will rise up and live out the true meaning of this creed: “we hold these truths to be self-evident: that all men are created equal”.
Engagement is traditionally the first step to an enduring relationship
Does our relationship with our doctor amount to anything? Is it worth fighting for? If worth fighting for, getting a RxISK report on the record offers a Rosa Parks refusal to give up our seat on the bus moment. Everyone who takes a report to a doctor can help establish whether the affable person they are dealing with is in fact able to engage with them. If a doctor is unwilling to accept a RxISK report and put it on their record, your life may not be safe in their hands.
It would be fatal to overlook the urgency of the moment. RxISK repeatedly gets asked whether we know a doctor who lives in someone’s area who takes treatment induced problems seriously. Getting doctors to accept and complete RxISK reports would help all of us generate a HeatMap showing where the eligible doctors are. If we can seize the moment, the others will die out.
Footnotes
- I have recently been disinvited from a Catholic Church linked meeting on psychotropic drugs and children apparently for using an analogy between child abuse in the Church and pharmacotherapy abuse in clinical care.
- Drapetomania was the DSM (-1) name given to the illness that caused slaves to run away from their masters.
Lindy says
This is an important article and one I hope will be widely read by the medical profession. In 1996 I took a break from taking Prozac. At that stage I experienced a lessening of dystonic symptoms and rang my neurologist to say I thought Prozac was the cause of my movement issues, which I’d been experiencing since 2003, when I began taking SSRIs.
The neurologist very soothingly asked me what else was going on in my life at the time. I told him I’d moved into a new home and had a border collie pup. He then went on to very kindly point out that the dystonia had improved because I was enjoying life. There was never any investigation into whether the SSRIs might actually be causing the dystonia.
It was another 13 years, by which time I had degenerated to the point where the dystonia was generalised, I had developed dyskinesia, could not speak a coherent sentence and both Achilles tendons had been permanently damaged by repeated micro tearing due to muscle rigidity, before I did my own research and found that yes, the SSRI/SNRI meds were likely to be the cause of my issues. Despite the neurologist noting my phone call and suggestion of the potential cause in a letter to my GP and the local hospital, doctors continued to prescribe that form of medication for me. One noted, three weeks after I switched to Cipramil: “Her dystonia is worse, but she is doing well at work and walking three kilometres a day”. He then went on to note that I’d been admitted to ED that week with a racing, arrythmic heart. No one picked up on that original comment, or stopped to think about the direct correlation between the SSRIs/SNRIs and my worsening movement disorder. Every time a new one was introduced, I got worse within days. Over the years, I raised the possibility time and time again. Each time I was “patted on the head” and told I just had to get used to it. At one stage, I was referred to the local hospital to work with a physiotherapist, who said: “My job is to prepare you for life in a wheelchair.” I stayed long enough to learn to walk down stairs safely and then I fled, never to return. A wheelchair was not on the agenda and to this day, despite everything, I’ve avoided it. If I’d had lesser mental strength, was more prone to suggestibility, if I’d believed that that was where I was headed, I have no doubt I’d have succumbed to using one.
What I’ve learned is this: Most doctors at the front line – the humble GPs – care a great deal about their patients and, on the whole, listen. There was no hint of SSRIs causing movement disorders in their prescriber “bible”, MIMS. MIMS is basically an advertising brochure. The hard core information is held on-line. In New Zealand’s case, the in-depth information can be found on the Medsafe website. It is the specialists, the psychiatrists, who are the most knowledgeable, yet most do not listen to, or act on, their patients’ concerns (especially to people with mental health disorders, including anxiety/depression). Sadly, predjudice is still rife, even in a world where these disorders are endemic and they occur across the full spectrum of society. I’ve learned that it is not wise to speak up for oneself, to challenge a specialist. When the diagnosis was finally made, my successive GPs (and I contacted all of them purely as an educative process in the hope what happened to me never happened to any other of their patients), were genuinely mortified and apologetic. Those poor folk simply didn’t realise – at the time – that these meds could cause movement disorders. They were busy and the information was not at hand. Bar one, the psychiatrists I’d seen and contacted to let them know – even though I was not confrontational – shut me down the moment I told them what I was calling about. They did not want to know. The one who did was of a younger generation of doctors, not at all patriarchal and willing to listen. He invited me to speak at peer review, warning me that as my condition was rare I would meet with disbelief and that everything I said might be challenged. I took along photos of my sons and granddaughter, some artwork I’d done and my QANTAS award for journalism. Before the meeting got underway, I made it clear I was not a number or file, I was a Mum of two, a grandmother, a would-be artist and a dedicated writer. An hour and a half later, I emerged from that room having been challenged, challenged and challenged again. But I had won them over. The general consensus was that I should never trial any drug with a serotonergic action again, that I was a genuine case of treatment injury. Within a fortnight, two more cases of SSRI-induced movement disorder were diagnosed within our region. The doctors in my local practice and hospital are more alert to potential problems with medication, even if those problems seem improbable or outlandish. They listen, they research.
I guess what I’m saying is: “Doctors, please listen. Our lives, our careers, families, homes and general well-being are dependent on you listening.” And to people who have been injured or lost a loved one to SSRI-induced suicide: “Use your experiences to educate.”
That doesn’t mean telling people to stop their meds, that they’re dangerous and they shouldn’t be on them. It means encouraging people to watch for changes of personality, or changes in the way their bodies move. If there are issues, get the patient back to their doctor and go along to support what they are saying. Ask for a double appointment, it costs more but gives you time to properly air your concerns and gives the doctor time to work things through in his or her head.
Lastly, find a doctor who “works” for you, someone whose personality and professional ability/ethics make you comfortable. Last year, needing to find a new doc, I went to the local chemist and asked if he knew of a doctor who was pharmacologically savvy, open-minded, prepared to listen and had a well-entrenched sense of humour. He did and I made an appointment to check him out. After a quarter of an hour consult, we decided we could work together as doctor and patient.
Many thousands of people take medications without incident, sadly some of us get permanently injured or die. These things are largely preventable if we act in time, if someone listens. Finding that someone just needs a bit of lateral thinking. A pharmacist is a good start when it comes to a GP. If it’s specialist care you’re after, ask your GP: “If you had a family member with this problem, who would you take them to?” You’ll inevitably get a good result.
gill says
I have to say I was amazed when I discovered it isn’t an automatic thing for a doctor to enter into his records an adverse effect to a patients’ prescribed drug.
Am I missing something? (I am not a medical professional -)
When you are admitted to hospital, one of the questions always asked is ‘are you allergic to any drugs such as Penicillin etc.’
If that needs to go on your medical record as an adverse effect then why can’t it be accepted that a record needs to be made for other drugs?
I agree- with everything mentioned above- GPs need to treat Rxisk reports as a normal consideration in their everyday administrative procedures.
gill says
Just a very quick comment- re. medical records.
On admittance to hospital one of the questions the nursing staff always ask you is ‘are you allergic to any thing , like Penicillin, for example’
If they can record this treatment related effect on your hospital records surely it should follow with every other drug ? This practice should be followed by GPs also.
I have been amazed that doctors do not see it as normal administrative procedure to note down a possible adverse effect caused by a drug. I have always been under the impression they did until Rxisk.org was brought to my attention.
As I have said previously, I feel Rxisk should become an automatic consideration by Doctors
and they should accept reports from patients as a matter of course- as is mentioned above.
annie says
As we all know, the huge lists of side effects, from many of the drugs in the Rxisk database, are inadequate for the patient or prescriber to respond to in the accompanying literature.
The only possible Safety Net for the patient, and the blinkered doctor, is an additional insert in all medication packets.
Headed, Rxisk.
Rxisk – Safety Data
Important information for all patients and prescribers.
1. Drug Title
2. Interaction with other drugs
3. Rxisk factors and side effects
4. Withdrawal protocols
Do not see your doctor.
See your Rxisk Datasheet.
Solved; one simple solution.
The engagement with the doctor, is then divorce.
Put it in the box and the dream comes true for Rxisk and suddenly the suicides will stop, the aggression and violence with stop, the human race with not be dependant on drugs to live wholesome lives and life will go on as it did before without this thirty year history of strangulation by pharma….it can be done.
gill says
Doctors/GPs collecting data in their surgeries re. treatment related adverse effects would be a fairly simple admin. operation. (I am aware their time is precious and quite often up to their eyes in admin work – I worked in the NHS along side Doctors and Nurses for a few years on a medical ward)
Each individuals’ computer record could have a box to be ticked if a Rxisk report is completed –
a doctor need not be committing himself to saying an adverse effect is definitely linked to a drug- just that there is a possibility- (GPs seemingly sensitive about labelling a drug as being the cause of a side effect although, as I pointed out previously -they don’t seem to worry about someone saying they are allergic to Penicillin)
Quarterly or six monthly collation of their patients’ information for that period could be done via the computer – and printed off. (Spread sheets or programing)
This data would then show what drugs had been reported, the type of side effect and any other information that would be considered significant.
This data could then be sent to the appropriate body for research etc.
This would also mean a patient has a surgery record of anything that has caused/is causing concern.
Voila>
gill says
In addition to the above – I would like to mention that I have found another person who happens to be a member of the National Rheumatoid Society- who was in fact, like myself, taken off Enbrel following a psychotic episode and placed on another drug-
It is highly unlikely that this will ever be recorded or reported other than through her own GP and consultant- whereas if the system I mentioned above or something similar was in place at her Doctors’ surgery- both my own episode and hers would be shown in a National Data Base-
Doctors really need to be logging into Rxisk- wake up call please.
Lindy says
Annie, Gill, the points you make are valid. I only recently discovered that despite reporting my own rare reaction to SSRI/SNRI meds to the Centre for Adverse Reactions Monitoring, no one had recorded it. It’s only since I presented CARM with my RxISK report and that of a specialist that I now have a CARM file number as proof that my case has been accepted as genuine. I agree that we need accurate consumer information in every packet of medication. But here in New Zealand, virtually no medication comes with a data sheet. However, you can ask the pharmacist to print one – important if a patient is prescribed a medication they haven’t used before.
My notes at hospital and GP level are clearly marked: “Adverse reaction to SSRI medication/ Serotonin syndrome, tardive dyskinesia, tardive dystonia.” Nonetheless, it’s vital that patients and their families remain vigilant. My sister experiences anaphylaxis, a potentially fatal reaction to suxamethonium, which is given as part of general anaesthesia. Two years ago, she developed a twisted bowel as the result of an appendectomy gone wrong and required urgent surgery. We had spent the hours leading up to her going to theatre recounting, reiterating to nurses and doctors alike that she must not be given this drug. It was written in her notes, which were red stickered as a warning. I don’t know what made me go with her as far as the ante room outside theatre that night, maybe little more than thinking that, as she was on morphine, she might not be able to speak for herself. A few minutes after arriving, the theatre registrar came out, opened Nick’s file and sad: “You don’t have any allergies do you?” I was aghast. I couldn’t believe it. I told her about Nicky’s reaction and, to her credit, the registrar immediately ordered that all sux be removed from the theatre in case it was administered by mistake. It was only when she closed the file and placed it on the bed that I realised what had happened. There were two files there and one was not Nick’s. We too, need to educate ourselves and assume responsibility for our health. Mistakes happen.
gill says
Re. medical records -If someone has actually been suicidal and come out of it- one would hope there is some sort of rehabilitation programme in place to help people back into employment eventually- and they are not left dangling for cats to play with?
gill says
Hello Lindy – ( sorry -I forwarded my last comment before your comments appeared above)
I agree with you completely, comprehension of medical records is always open to human error as in your own potentially highly charged situation above- and we all need to be able to challenge and sometimes question what is being done. (Unfortunately-Some people will never be able to do this depending on their own personal circumstances)
With regards to ‘Patient Engagement’ and ‘Doctors being afraid of acknowledging a drug’s possible adverse effect’-
their order of consideration should be ,the patient first and foremost, and they shouldn’t be worrying about what drug companies and regulators are thinking.
With regards to a Doctor’s concern that other Doctors may disagree with their recording a possible adverse effect of a drug and what they would think about them- if there was a system in place like I mentioned above- it would give a National overview of what was happening with patients and drugs, matching up at surgery to surgery level.
(Hail Rxisk Reports)
A Doctor would only be handing over the fact that there have been possible adverse effects-
with his own patients-stating facts and he would never have to converse with other Doctors about them if he didn’t want to. A lot of valuable data would not be lost and at least the poor patient would have something on record.
It seems strange to me that my hospital record could flag up an adverse reaction to a drug ,(this in turn could save my life)- yet my own GP may never acknowledge it at all?
(PS – I am going to try to make sure both my records are up to date- as you have Lindy)
Lindy says
Gill, I obviously don’t know where in the world you are, but if you’re in the UK my understanding is that patients can log an adverse event under their own steam. I think it’s a Yellow Card?
You’re right when you say that one doctor may not support the views of another when it comes to adverse events. It comes down to matters of opinion and whether the doctors you have seen are up-to-date with their pharmacology. Equally, as mentioned in my rather lengthy initial response, many are left in the dark until the post-marketing data is released by Big Pharma and even then it takes time for the message to get through, unless the MHRA or FDA distributes a “Dear Doctor” letter to all prescribers highlighting new and more serious adverse events.
Ihas taken a great deal of fight to get my case acknowledged. The primary reason for that was that I had reacted to a 17-year succession of SSRI antidepressants. At the time I was diagnosed, Pfizer Wyeth had not released the post-marketing data on Effexor-XR as a cause of movement disorders. It took another year for that to emerge and be accepted. Only then was my case deemed solid by our Accident Compensation Corporation.
I’m a little puzzled. I would have thought you would have a unique patient number linked to a nationwide computer network recording your GP and hospital notes. Having said that, I don’t think we’ve got quite that far in NZ.
gill says
Hi Lindy- yes I guess I am not sure where in the world I am sometimes either! (lol)
I am resident in the UK and am aware of the yellow card and I have reported my own adverse event to Rxisk.
We do have a unique patient number per person- but hospital and GP records don’t necessarily match up .
I think the point I was trying to make is – at present the majority of patients only tell their Doctors/ Consultants about adverse events and it doesn’t appear to go any further than that..
If that Doctor doesn’t make a note of it on their record, the information is lost and the patient hasn’t had it acknowledged. Symptoms may be treated but they haven’t been linked to the drug the patient is experiencing problems with. (Unless the patient turns up with a Rxisk report or Yellow Card and I suspect 9 times out of ten they don’t))
As far as I am aware, there is no way at present for data to be collected from Surgeries/consultants re. adverse events. It is not an automatic thing for a Doctor to consider reporting an adverse event linked to a drug, There could be two people in Scotland and three people down in Cornwall who have all experienced the same adverse event on the same drug and n’er the twain shall meet and no one will ever know about them, because they did not use Rxisk / yellow card.
If it was common practice for a Doctor to acknowledge a patients’ adverse event and record it administratively then handing it to a National Data Bank- it would help greatly in the recovery of the patient (personal morale) and would also provide valuable statistics as to what could be happening with certain drugs.
I guess if every Doctor could agree to asking a patient to complete a Rxisk report it would make life simpler?
Nothing exists like Rxisk – but if Doctors or their patients don’t use it, a lot of valuable information is lost and it just remains within the confines of a patient/doctor conversation.
(I think a lot of the anger that builds up in people after there adverse event is due to feeling they haven’t been believed when they say a drug has done something obnoxious to them.)
Thank you Lindy-hope you are having more sunshine than we are in NZ.
Rock ‘n’ Roll Rxisk>>.
Lindy says
Hi Gill, Sadly, it is FREEZING. I have family in the UK, so I know you’ve been cold and short on sunshine. New Zealand (especially the South Island) is awash with rain. RxISK needs legs, for all GPs to know about it. You’re right in that GPS often don’t report because they’re simply too busy. I hope that David and co have a database of all GPs that they can deploy to distribute information/encourage GPs to get patients to report adverse and other, more positive events.