Archive for category Drug Safety
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?
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.
Hospitals are responsible to rescue patients from inappropriate treatment — especially when the need to intervene is obvious. The hospital has a board of directors responsible for the care delivered in a hospital. They hire the CEO who hires a quality manager. When bad quality management hurts or kills patients it is the hospital’s fault.
An article by Dr. Behnood Bikdeli and colleagues (JCHF. 2015;3(2):127-133) describes a huge study at 346 hospitals about treatment of patients with congestive heart failure (CHF). Here is the essence:
- CHF is life-threatening condition where the body collects too much fluid, usually due to a weak heart. The fluid gets into the lungs and causes shortness of breath.
- The treatment for CHF is to remove fluid from the body and give medications to improve heart and kidney function.
- The absolutely wrong thing to do is to give extra fluid by the veins.
- The study found about 12% of patients with CHF were treated with 1 to 2 liters of fluid in the veins during the first 2 days of hospitalization. AND, most alarming, compared to similar patients not treated this way, they were more likely to end up in intensive care or die.
- The most telling statistic is how often various hospitals let this dangerous use of intravenous fluid happen: 0% to 71%. This means some hospitals did not let it happen (0%). Some hospitals let it happen a lot (71%) — just hope your grandmother did not go to that hospital!
It is not rocket science to say fluid overload is not treated with extra fluid. This is easy to detect when the admitting diagnosis is CHF and the doctor orders say “NS IV at TKO” (translation: give salt water in the veins at a rate to make sure the veins stay open). NO NO NO the patient does not need extra fluid. This should not happen and there are lots of ways to prevent it or even rescue patients when Dr Welby writes such an order (or tries to use leaches).
- Mandate doctors use standard orders for treatment of CHF — there is plenty of latitude to customize such orders. But, IV fluid is not one of the choices without stating why.
- Educate staff that IV fluid is not required to admit a patient (an old fashioned insurance rule).
- Educate staff that IV fluid is not a cure-all. Fluid would help a dehydrated patient but not others.
- Nurses do a double check before admitting a patient from the ER with the question: does this patient have CHF and an order for IV fluids — if so, call the physician to clarify the situation or to change the order — no clarity=no admit.
- All CHF patients should be weighed daily — if the weight is going up it means more fluid is being retained — the patient needs to be rescued. Fix the problem or find someone who can, NOW.
Attention patient and family. This is easy to spot. The admitting doctor says the diagnosis is congestive heart failure but you see IV fluids being pumped into yourself or your family member. SPEAK UP! “Why is fluid treatment needed?” do not accept the answer of “everybody gets an IV”.
Attention hospital board members: do you know what your hospital is doing to prevent this obvious problem? Quality is your responsibility, you must do something besides listen to financial statements. Is your hospital the one with 0% or 71% record of treating CHF with IV fluids?
Physicians scoff at rules requiring them to use electronic records and now they must pay the penalty.
Melinda Beck reported in the Wall Street Journal 12/18/14 “Medicare to Cut Payments to Some Doctors, Hospitals”. Of the 893,851 physicians in the US, Ms. Beck reports 257,000 will be fined 1% of their Medicare fees for failure to adequately use an electronic medical record.
For example, the technically challenged doctors have failed to use electronic prescriptions, favoring instead marginally-legible hand-written prescriptions. And, they undoubtedly harmed patients by not taking advantage of allergy and interaction checks that are part of electronic prescribing.
AMA president-elect Steven J. Stack is reported as saying he was “appalled” by the government action. Every physician, obviously excluding Mr. Stack, was informed 5 years ago that fines would be imposed in 2014 by Medicare if physicians that bill Medicare fail to use electronic records in a meaningful way.
Why would a rational physician choose not to use an electronic record…?
- Because North Korea might hack the system
- Because the government told them to use an EMR (they give orders, not take them)
- Because they will be retiring soon and won’t need to learn about computers (the real reason)
- Because they will need to pay for a system to help patients
- Because young physicians want the systems, older physicians say no to all this newfangled stuff.
- Because a an electronic record might be used in court against them.
There you have it — a detailed explanation. Appalling, don’t you agree?
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.
Medication mistakes are common. A recent study by Amanda Mixon following discharge from the hospital pegs the error rate at an astounding 50%. The study focused on whether instructions given to patients at the time of discharge from the hospital matched what the patient later took at home.
The study is biased by assuming all the errors are caused by patients — not the providers. The authors point to patient problems of low health literacy and a poor facility with numbers. Illegible instructions, poor communication skills, excessive complexity of medical regimens, conflicting instructions, and giving verbal instructions to the wrong person are all provider or institutional issues.
Even a simple phone call after discharge might have cleared up patient confusion — perhaps the study would have been better with a phone call and no phone call comparison.
The article conclusion is to apply more effort to find those high risk patients. Another conclusion would be to find those high risk hospitals having difficulty telling patients what drugs to take. The study was done at a VA facility affiliated with Vanderbilt — a good place to start the search.
Hospital medication errors are very frequent. A commonly quoted figure is one error every day of a hospitalization. Meaning: wrong drug or wrong dose or wrong time or missing dose.
Consequently, it should not come as a surprise the instructions patients are given when they are sent home have frequent errors. Patients may be taking medications before they are hospitalized, so in addition to new medications those pre-existing medications need to be considered (a process called “medication reconciliation”).
You may ask: how can this be goofed up? A person has medications at home, the doctor writes a new prescription just before going home, the prescription is filled by the local pharmacy, and the prescription is taken in addition to the same medications as before. What could be more simple?
The answer is: there is plenty of room for error! What if:
- the new medication is actually a generic duplicate of a brand name home medication
- the new medication has severe interactions with a home medication
- the home medication dose is listed incorrectly
- the new medication prescription and the discharge instructions don’t match
- a new medication prescription was omitted
- a doctor outside the hospital is unaware of the new medication and prescribes something that interacts badly
- the patient get an allergic reaction to the new medication but the prescriber is not available to help
- the patient forgot to mention some of the home medications
- unnecessary brand name drugs are prescribed that are not covered under the outpatient insurance plan
- the prescriber forgot to tell the patient to stop some of the home medications that were causing symptoms prior to hospitalization
NOT SIMPLE AT ALL.
Yet, hospitals and prescribers often don’t take much time to get the medications right at discharge (there is a big push to get the patient out the door as soon as possible). Here is an actual example from 2 weeks ago:
A patient was admitted from a care center with an accurate list of medications. The admitting nurse transcribed the list into the medical record but made a mistake on one dose. The physician’s plan was to reduce the does of another medication which seemed too strong but the patient was not taking any medications by mouth at that point so no medication orders were written. A few days later the patient was ready to leave the hospital.
Unfortunately, a different physician discharged the patient rather than the one that admitted the patient. The nurse’s list of home medications was used to generate the discharge medication instructions — no new medications were ordered. But, the transcription error of the nurse was included with the instructions and the plan to reduce the dose of another medications was forgotten. Two major errors. The family actually realized the errors but the nurse the family informed forgot to call the doctor so no change to the list was made so the care center followed the flawed instructions.
So what went wrong?
- Duplicate lists of home medications were collected but the transcription error was not detected because the lists were not compared.
- The list of medications used during the hospital stay was not marked as equal to or changed from home medications.
- The planned change in home medications was not made because there was no place to put such a reminder for discharge in the hospital chart.
- The prescriber did not review the medications with the patient or family personally.
Worse yet, although errors happened there was no plan to change the system to prevent similar errors in the future.
So, as a patient or family member what can you do?
- ALWAYS bring multiple copies of an accurate list of home medications to the hospital — give a list to anyone that asks to review the medications.
- Expect the attending physician to review the discharge instructions with the patient or appropriate family member — if this does not happen immediately complain and make that expectation known. Good physicians plan ahead and sometimes do this review the day before discharge!
- Use one of the copies of the home medication list to compare to the discharge instructions. Make sure to understand ANY changes. And ask — does the new medication, if any, interact with home medications?
- Find out who to call if questions or problems with the medications arise after getting home — get a name and phone number. Often the discharging nursing unit will take the call and find the right person.
The above prescription example comes from Medical School Headquarters intended as an example of what doctors should NOT do — that is to issue handwritten prescriptions. There are just so many possibilities for error mostly coming from illegibility. Also, errors from inadequate information provided to the pharmacist and the patient.
Electronic prescribing is unquestionably the best solution. Patients should choose prescribers who use computer software to send prescriptions to the pharmacy. In fact, prescribers who don’t use computers to do this are dinosaurs soon to be extinct — perhaps it would be a good time to leave that office practice and find something more modern.
You might think electronic prescribing solves all the problems, NOT SO. Just ask any patient taking a few medications on a regular basis! Here is what they say:
- My office appointments never match when prescriptions expire –so I either have to change appointment times or hope the office will renew the prescription early — always involves a phone call and wastes my time.
- I had no idea the doctor prescribed a brand name drug instead of a generic and I got hit with an unnecessary huge bill.
- The doctor has no idea how much medications cost.
- I need 90 day prescriptions for some things and 30 day prescriptions for other things but they can’t get it straight.
- My doctor’s computer system can’t send things to my mail order pharmacy
- I have to send prescriptions to my mail order pharmacy myself — usually they are the handwritten type and sometimes the pharmacy can’t read them.
- If my doctor issues a duplicate prescription so it will last until my next visit sometimes I get more medication (and cost) than I need.
- Often generic medications are less expensive if I purchase them without involving insurance — the pharmacist sure does not tell me that!
Here are some prescription suggestions for PATIENTS:
- ALWAYS take a list of prescriptions with you to health care appointments (or just take the bottles, but there is a risk of loosing expensive medications in the process).
- Your record should include the name of the medication (brand name if appropriate) and generic name
- Dose — that means the size (mg) of the pills and number taken, or amount of liquid (ml) or strength (%) of a cream or ointment
- How often taken and whether scheduled or as needed
- Why the medication is taken
- Number of doses of medication prescribed AND exactly how many days that covers (like 30 day supply)
- When that medication will expire and need refill
- The pharmacy phone number and FAX number (the latter is very important for mail order pharmacies)
- ASK if a new medication is generic and if not if a suitable generic is available. Or, if a suitable generic in the same drug family is available.
- ASK if the medication is short term or long term. If it is long term usually ask for 90 day supply with 3 refills (if insurance will approve). And, use mail order services advised by the insurance company since they are usually less expensive.
- BEFORE leaving the prescribers presence ask if the number of refills on a new prescription will last until next appointment? And, ask for an extension of refills for older prescriptions that will expire before the next scheduled visit (otherwise you get the fun of calling the nurse for refills)
- If a specialist prescribes a medication ASK if the specialist plans on long term follow-up and providing refills — if not what communication with primary care will convey the needed prescription information. But, if the specialist plans on managing the medication expect a full review of all medications to avoid duplicate prescribing and adverse drug interactions.
Here are some prescription suggestions for PRESCRIBERS:
- Consider the cost of medications — you can’t do that if you don’t find out how much they cost, especially the brand name drugs
- Prescribe the lowest cost alternative. Before prescribing a brand name drug ask if you are sure there is a real cost benefit over an older generic. If you don’t know, find out.
- Don’t prescribe antibiotics for viral infections
- Think about refills, don’t just write some arbitrary number. Make sure the patient has enough refills and will not have to call your nurse to get them. Contrary to popular belief patients do not like to go the the pharmacy — give 90 day prescriptions where possible.
- Have a patient Internet portal to deal with medication refill issues.
- Although it’s nice to compute the number of pills a patient will need it is sometimes better for insurance reasons to say the number of days of medication is needed ( 7 days, 90 days etc.)
- To avoid duplicate prescriptions when the patients prescription will not last until the next scheduled visit the following statement is helpful “extend existing active prescription so refills last until ____ “(e.g. a year from today). Sometimes: “stop refills on current active prescription. This is a replacement so note the changes.”
- Most mail-order pharmacies will take either electronic prescriptions or faxed prescriptions — it is not rocket science to get those numbers into the electronic prescribing system — make it happen.
Finally, sloppy prescribing causes patient injuries, provider law suits, extra time, and extra costs for both the patient and the prescriber. Electronic prescriptions are a step in the right direction but they are now mostly geared for pharmacists and not the real-world problems of patients. The integration of pharmacies within care delivery systems (e.g. an ACO) is an urgent need.