Archive for category drug side effects
Many patients take too many medications which leads to unnecessary side effects, drug interactions and high cost. Yet physicians sometimes fight just to get patients to take necessary medications. Two examples:
- Provider: How many medications are you taking?
Patient: Including vitamins I think fifteen.
Provider: What? I only have two medications on my list.
Patient: I restarted all the medications I was taking before you hospitalized me plus all the new prescriptions from when I left the hospital and I added some vitamins.
- Patient: I stopped that medication because I thought it was causing my hair to fall out.
Provider: Your heart medication does not cause hair to fall out. And, even if it did you could die without it.
The medications you take should be reviewed at each visit so you and the provider consider which are truly needed and why. The provider who gives the patient a prescription is responsible to make sure there is no interaction or duplication with ongoing treatment. Yes, that means cardiologists and dentists also. A proactive patient should simply ask, “Is that new medication compatible with all of my existing medications and does it replace one of the existing medications?”
The highest risk situation for evaluation of medications happens when alternate providers become involved. Like a hospital doctor, an ER doctor or a specialist. They tend to add medications without fully considering the existing medications, often thinking the primary provider will resolve any drug issues — too bad when a fill-in primary provider steps into the mix.
An article in the Washington Post January 28, 2017 by Dr. Ranit Mishori advises the following questions for providers and patients to consider together about medications:
● What is this medication, and why am I taking it?
● Are there non-pharmacologic options to treat this condition?
● How long do I need to be on it?
● What are the benefits of continuing to take it?
● What are the possible harms of using that medication?
● Do any of my medications interact with any another?
● Can I lower the doses of any of these medications?
● Which of my medications are more likely to be nonbeneficial considering my age, my other medical conditions and my life expectancy?
● Are there any medications I can get off completely?
New drugs need to be compared to something. And, at a very minimum that something is the placebo, a sugar pill. When you see an advertisement claiming some product is 80% better, a reasonable person would ask, “better than what?”
A comparison group is hugely important in all of science. One of the biggest flaws in all research is not picking an appropriate control or comparison which makes the research worthless.
Erik Vance of the Washington Post reported on 12/2/16: “People susceptible to the placebo effect may be keeping us from getting new drugs.” The idea is many drugs can’t be proven to be better than a placebo. The FDA prevents those poor drug companies from marketing those drugs and making tons of money.
So here is the anti-scientific conclusion Mr. Vance reported: only use people that are unaffected by placebos in the control group. Sadly, that would exclude most conscious human beings. The control group would be strange people that could feel the tiny effects of the drug and ignore any psychological impact of taking a pill. And, voilà drug approved. A drug that most people would find no better than eating a sugar cube could be marketed at $800 per pill. And, advertisements could fool most practicing physicians into prescribing it.
This idea is totally nuts. The FDA would be within its authority to only allow the drug to be prescribed to that small group of strange people, not the whole world. Assuming the FDA was reasonably competent the idea and the huge profits should go down the drain.
Do you want to take a medicine that fails to work as well as a sugar pill? Probably not. Expect good science. Demand honest comparison with placebos.
Elderly patients are taking too many drugs. And, in most cases the drugs can be stopped. This surprising idea was highlighted by Dr. Ezekiel J. Emanuel in his New York Times article 11/22/15. He backed up his statements with a study from 2010 (JAMA). The figures that follow are from that study.
The first figure is the logic diagram for stopping medications in elderly patients who have several chronic diseases. The second figure is the list of medications that were stopped in the study. Only 2% of the stopped medications eventually had to be restarted. The cost savings alone is huge and the reduction in the risk of side effects is likewise tremendous. “Less is more”.
Health care providers often prescribe drugs intended for younger healthier patients to older sicker patients. Often the drug testing originally done to approve drugs excludes older sicker patients due to the risks of side effects. A drug might add many years of life to a 50 year old but that’s not likely for an 80 year old with multiple problems. In fact, over medicating elderly patients may hasten death — this has been proven in many studies.
Dr Ezekiel suggests asking the following questions to the health care providers who prescribe medications, tests or treatments to elderly patients (or perhaps any patients):
- What difference will it make?
- How much improvement is expected?
- How likely and severe are the side effects?
Evaluate the answers carefully, if the answers are: small difference, not much improvement, and fairly likely side effects then perhaps that drug, test or treatment is not needed.
Dr. Emanuel favors the advice of teaching hospital doctors like him, but it’s just not practical or necessary for patients to get a university consultation. Stopping medications is not rocket science. As the graphic says, it may be better for many elderly patients to get “hugs not drugs“.
A story in Pro-Publica (7/12/15) and reproduced in the Washington Post highlights the problems with anticoagulants when given in nursing homes. The graphic at the left shows the magnitude of the problem — lots of patients in nursing homes get these drugs. The next graphic shows data from North Carolina pinpointing the main culprit: WARFARIN.
What is going on? Well, warfarin is a tricky drug because it changes the body’s system to make the blood clot. Some people tend to clot too much (and get clots in the brain, a stroke, and some people get clots in the lungs, a pulmonary embolus). Those people are at risk of death from too much blood clotting. So, health care providers prescribe an anticoagulant to make the blood clot less easily. Unfortunately, this creates a state where people bleed easily. It is indeed a situation “between a rock and a hard place“.
Warfarin is one of the most common of the drugs for this purpose. It has the advantage of an existing antidote and it is inexpensive. But, it requires frequent blood testing to keep the anticoagulant effects in a reasonably safe range. Providers must order the tests and must change the dose according to the results.
Thrombin inhibitors are a new class of anticoagulants which have the same bleeding risks and are expensive. Their claim to fame is that blood testing is not needed. They also have the disturbing quality of not having an antidote if bleeding starts. Taking all this into consideration, most providers choose the older drug warfarin.
The reasons for excessive bleeding in nursing homes are:
- Prescribers (not the nursing home staff) fail to order blood testing when they should and fail to adjust the medication as they should.
- Prescribers fail to stop anticoagulants when the risk of falling exceeds the risk of blood clotting.
- Pharmacists for nursing home patients are not as connected to their patients as they should be — usually the pharmacist is the safety net for bad prescribing — sadly, they are out of the loop.
- RNs in nursing homes have the training to catch medication errors but function as administrators and are not on the front line of care. Thus, like pharmacists they are not performing the safety net function they might in hospitals or doctor’s offices.
- Elderly patients are the most prone to adverse drug events — for them, if a side effect is possible they will likely experience it. It there is a risk of bleeding they probably will.
What should be done:
- State certification organizations should develop guidelines that require nursing homes and their prescribers to have a protocol for anticoagulation management — not every prescriber can be allowed to invent their own method — that’s the mess we have already!
- Nursing homes should use electronic means to track anticoagulants and the adherence to prescribing protocols. This is not rocket science, those protocols (evidence based guidelines) and computer programs already exist! So, USE THEM.
- Proactive patients and families should ask about the protocol that will be followed for warfarin in the nursing home — if there is no protocol SPEAK UP — show them a copy of this blog.
Switching from a brand name medication to an available generic medication is safe, easy and will likely save you a lot of money. Thanks to the work of the FDA, generic medications in the United States are quite safe. Patients in the US take more generics than in other countries.
When a patient starts a new brand-name drug (e.g. Lipitor) there is a risk of a side effect or allergy to the active ingredient. But, when a patient switches to a generic medication (e.g. atorvastatin) the patient already knows the active ingredient agrees with them so the chance of a reaction is as close to zero as medical science can make it.
Prescribers are well aware that some generic medications may come in different forms (tablets or capsules) and different strengths — this is not a problem, the prescription just has to be adjusted to match what the patient needs. Most care providers are quite willing to make the change to help lower the cost of treatment — patients tend to take medications they can afford!
The Wall Street Journal had a story today based on the opinion of a “pharmacist-economist” who has been a lead author on only one paper in the past 20 years and who thinks tablets and capsules of the same medication are distinct entities (yes, but it makes no practical difference). The WSJ is clearly interested how the switch to generics affects the economics for big pharma — it would not be good and the stocks could go down — such a disaster. However, if you have stock in a brand-name company you could use your stock dividends to pay for the drug.
The new bio-similar drugs and even some old drugs (like warfarin) may have a slightly different effect that depends on some minor manufacturing quirk. Prescribers are well aware of these peculiar drugs and can easily make adjustments and do tests as needed. Fortunately, small manufacturing differences for the vast majority of drugs is a distinction without a difference for the patient.
This principle needs to be considered in everyday terms. The table salt at restaurants may come from separate and distinct sources — it really makes no difference to the customer — salt is salt! Marketing departments want you the think a generic is like coal and a brand-name is like diamond — intellectual garbage.
Too much treatment is dangerous just like too little treatment. Treating blood pressure too early or too aggressively increases the risk of death. Treating elderly patients with diabetes with too much medicine increases episodes of low blood sugar that damage the brain and leads to broken bones from falling.
In 2014 the national guidelines for blood pressure treatment were changed to allow a higher blood pressure. Similarly, a recent study found increased mortality for elderly patients treated too strongly for diabetes.
This is not rocket science. Imagine a blood pressure medication that could lower the blood pressure to any level. Knowing that zero blood pressure means you are dead, it stands to reason there is a point where treating blood pressure goes from helpful to dangerous. Same for blood sugar.
Sometimes this problem is called “treating the test“. In essence prescribers just look at the numbers and write a prescription, but ignore symptoms of weakness or spells of altered consciousness. Hypertension and diabetes are good examples but this happens with lots of other conditions.
Examples of over-treatment include treating a sore throat with antibiotics, treating mild asthma with oral steroids, or treating an elevated lyme serology test with antibiotics. It takes time to make a correct diagnosis and time to explain treatment to patients — some health care providers simply don’t take the time to do either.
Most drugs have a “therapeutic window“. As long as the window is open the patient gets benefit. But, the window closes due to side effects and advanced age.
If a person is over 80 or in poor health excessive medical treatment is a substantial risk. In this group even the thought of a low cholesterol diet is foolhardy. It’s all about risks and benefits.
Highly educated and experienced cardiologists just can’t get it right: the correct dose of aspirin after a heart attack is 81 mg (called low-dose), NOT 325 mg (called high-dose). The current prescribing error rate is 60.9% as published by the American Heart Association in 2014.
Personal communication with several cardiologists elicits the comment: the higher dose is needed because of the risk of another heart attack — and “in my experience” it just works better. It’s hard to believe this clinical error in this age of quality assurance. The problem is BLEEDING not heart attacks! The stomach BLEEDS due to aspirin and the higher the dose the higher the risk of BLEEDING.
Just imagine the risk and strain for a recent heart attack victim who vomits blood, needs a transfusion and must undergo a stomach scope — some patients die. From a cardiology standpoint: “they died from something unrelated to the heart attack” — great thinking.
Cardiologists completely and totally get it wrong when they simultaneously prescribe high dose aspirin and the anticoagulant warfarin — the ghastly mistake happens 40% of the time.
The chemical reaction of “acetylation” is caused by aspirin within small blood cells called platelets. Acetylation of platelets is responsible for the favorable heart effects of aspirin. It has been known for at least 30 years that 81 mg of aspirin completely acetylates every platelet a person has — more aspirin does no more. According to the 2012 TRITON-TIMI trial:
“We observed no difference between patients taking a high dose versus a low of aspirin as it relates to cardiovascular death, heart attack, stroke or stent thrombosis,” according to Payal Kohli, MD involved in the study and quoted in Science Daily.
Hospital quality improvement programs need the “guts” to just say NO. 325 mg is not correct. Cardiologists are the sweetheart doctors making millions of dollars for hospitals — it should not matter, JUST SAY NO.
It’s almost impossible for even the most proactive patient to question the great doctor that just saved their life. So, hospital quality assurance has an even greater responsibility than usual. The prescribing error needs to be corrected — hospital pharmacists and quality improvement departments need to be strongly involved — this error has gone on far too long.
When you question people given a placebo (containing no medication) 25% will feel better (placebo effect) and 45% will think they have a side-effect (nocebo effect). The remaining 30% notice nothing. What a delema for doctors! Some people feel better without medication, some feel worse with medication and some don’t think the medication is working either way!
The answer is not to over-think the problem. Patient’s should become informed about the medications they take — know the top 3 side effects. And, if something definitely unusual (and bothersome) happens shortly after taking a new medication run down the side-effect list and check with your health care provider. If a side effect you have is really on the list a response from the health care provider: “I’ve never seen that” is just not helpful.
Many medications have side effects that people just must live with. Like strong blood pressure medications that cause a slight dizziness on standing. Or an anti-allergy medication that causes a dry mouth. Some people expect to feel better with blood pressure medication — not so — a lower blood pressure is the desired effect, not any “feeling”.
Nancy Morden MD MPH with others from the Dartmouth Institute for Health Policy and Clinical Practice published a nice “Perspective” in NEJM 3694;4:299-302. The essence of the article is the observation that published goals of treatment which don’t specify how to reach the goal lead to prescribers” jumping the gun” with strong expensive medications rather than a prudent step by step approach.
A good example from the article is controlling blood pressure. Guidelines state the desired blood pressure goal is less than 140/90. Prescribers tend to skip dietary management, skip lowering the salt intake, skip reducing alcohol consumption and jump right to strong blood pressure medications (with the attendant drug allergies, risks and costs).
Another criticism is stopping a medication too soon. The example is beta-blocker medication after a heart attack. It is not enough just to start the medication. The medication must be continued indefinitely. Too often the medication is stopped because the reason for starting it is forgotten.
Here are the areas the authors found problematic:
- Blood pressure control
- Cholesterol management
- Diabetes control
- Clot prevention for occlusive vascular disease
- Lipid control for coronary artery disease
- Long term beta-blocker after heart attack
- Avoidance of antibiotics for acute bronchitis
- Drug use generally in the elderly
From the patient standpoint: if a health care provider says you have some condition or diagnosis make sure to ask for a step-wise approach to treatment. In other words, ask for simple or less expensive things to be tried first. Then insist on follow-up to see if the first steps work. If the simple things work, you win. Make sure to research the diagnosis on the internet to exhaust the simple and low cost alternatives. Later, if the simple things are not enough move on to the next step.
There are obviously situations where a slow cautious approach is not correct. If you are having a heart attack or a stroke or a blood clot it’s too late to do simple things.
Make sure to understand how long a medication might be needed — if it is “until something better is found” then stick to it and make sure the providers give a good reason for stopping (particularly if you change providers).
Bill(*) had a really bad headache and died before he could call 911. He died of a complication of warfarin which he was taking to prevent blood clots. Instead, the best intentions to prevent a stroke lead to uncontrolled bleeding in the brain, high pressure inside the skull and death.
Warfarin and other anticoagulants are necessary medications but also dangerous medications. People take the medications because the risk of blood clots, for them, is higher than the risk of anticoagulation. The last thing a patient wants is for drug management errors to tip balance so the risk of the medication is too high.
So, what are the expectations of people who take warfarin? What do they expect of their providers? What do the providers expect of them?
- Patients expect providers to follow drug guidelines to the letter
- Providers expect patients to follow instructions and learn about warfarin
- Patients want to be in the loop — meaning the risks are high so they want to be in a position to make sure the necessary communication happens and dose adjustments make sense.
- Providers need to be able to contact patients and expect positive feedback — “message received, will change dose to ___ as directed”
- Patients expect a consistent process no matter the day of the week or which provider is on call.
- Above all, patients expect adequate prevention and minimum risk.
Here are several marks of quality warfarin management:
- The same day of drawing lab (INR) the patient is informed 1) the result 2) the change in dose and 3) the date of the next lab. Finger-stick methods with quick results allow some offices to provide instructions before the patient leaves the office.
- The patient is asked to keep a record of results and instructions. And, to “read back” the instructions. Thus the provider knows the patient got the right message.
- The patients have the phone number to call for any evidence of abnormal bruising or bleeding. They should expect to get lab tested or go to the emergency room.
- There is no impediment to getting the warfarin prescription refilled when needed.
- Providers use computer applications or paper tables to select the correct warfarin dose. Only if there are unusual problems do they deviate from established guidelines.
- If the INR is out of range the dose is changed and the INR is rechecked within a week — even if the patient was on a monthly lab routine.
- The day the INR is checked patients do not take the usual warfarin dose until the results are available.
- Providers never say “just keep taking the same dose unless we call you”. That is a recipe for disaster if a lab test is lost or sent to the wrong provider.
- The lab the patient uses is open 7 days a week.
- Providers instruct patients to follow a consistent diet so the amount of vitamin K in the diet is fairly constant. A sudden drop in vitamin K intake causes the INR to rise and bleeding risk to increase.
Back to the case of Bill. He forgot to get his INR checked on Friday and nobody called him to check why. He knew the lab was not open on the weekend. The nosebleed was unusual but not too bothersome — besides, his doctor was not on call and he did not know who to call. He took a slight fall and bumped his head – he didn’t think small head injuries were risky. He had a good memory but sometimes forgot how many warfarin pills to take on Saturday so he took 2. Wrong, wrong and wrong. The outcome might be better if the medical process was better and if patient education was better.
(*) Bill’s case is not real but such deaths have been reported. It is true warfarin is related to rat poison.