Mylan is the company that makes EpiPen(R). It was one of those “inversion” companies that started in the US but is incorporated in the Netherlands to avoid taxes. Yet, the administrative offices are in Pennsylvanian in the US. It sells EpiPen(R) all over the world. In Australia a subsidiary called AlphaPharm sells the product. It’s a handy plastic syringe device that allows a person with a severe allergic reaction to grab the device and give an injection quickly.
It’s so handy that the company can sell the $1 device containing 3 cents of epinephrine for $697. That’s the price quoted by Costco. The same drug can be purchased online through Canadadrugs.com for $112.71 and through Kiwidrug.com for $122.51.
It’s not clear why other companies that package injectable drugs don’t supply prefilled syringes for this purpose — probably a very aggressive legal department or the acquisition of competing suppliers. The device is not something novel — it’s just a syringe — so it should never have received a patent.
Emergency Rooms and doctor’s offices don’t fool around with the EpiPen(R). They just purchase cheap vials of epinephrine and cheap syringes to give the dose for a few dollars. A patient could do this with a little training — it would save a lot of money. The cost of an EpiPen(R) so high the people who need the medication don’t buy it — so the few seconds a patient might take to draw up the medication in a syringe is better than no medication at all.
The Mylan company is a good example of why drug companies should be more regulated and have profits limited.
Mylan purchased the decades old EpiPen(R) rights from Merck in 2007. The consumer price in 2007 was about $60. With a major marketing effort (basically convincing patients, schools and healthcare facilities to always have the product available) the price is now about $700 accounting for about 50% of company profits. Teva Pharmaceuticals is working on a generic epinephrine injector but it probably will not be available until 2018. A startup company Windgap Medical has invented a device using powdered epinephrine but it may be many years, if ever, before the device arrives on the market — but, the device promises to extend the shelf life from 18 months (for the EpiPen) to several years.
Here are some good references about EpiPen(R) and Mylan
THE GOOD: If your brother is a doctor and you call him for medical advice that is probably good Telemedicine. The doctor clearly has your interest at heart, you can call again, the doctor will likely look up information and will probably give you some Internet links to check out. And, the doctor does not want to make you upset or interfere with the relationship you have with your actual doctor. Good idea, except doctors will not usually prescribe for a relative, or should not.
THE BAD: The same things wrong with actual provider interactions can still be wrong on video — not being given enough time to state the problem, not enough patient education, not enough of a partnership, and poor follow-up. Also, prescribing antibiotics for viral infections (the common cold) can be even a greater temptation by video.
THE UGLY: A low position of the video camera that seems to look up the doctor’s nose — yes, that’s ugly.
The most common reasons for visits to a health care provider are: cough, joint pains and skin conditions.
Evaluation of cough by telemedicine is difficult because it requires looking in the nose, ears and throat and listening to the lungs for wheezing or other sounds. This is better in person. Although, a telemedicine follow-up might be just fine.
Evaluation of joint pains is fairly easy with telemedicine. For example, back pain is usually temporary and x-rays are not advised. It’s easy to suggest ways to avoid straining the back and be encouraging. Treatment usually involves over-the-counter medications.
Evaluation of a skin condition also is fairly easy with good quality video. Diaper rash and acne are no-brainers. But, trying to separate skin cancer from a benign seborrheic keratosis is a little harder — probably best left to an office visit.
Follow-up visits for lots of things can be done by telemedicine. A follow-up visit for congestive heart failure can be done by video especially if the patient has a reliable scale at home.
Follow-up visits consume valuable office time that could and should be allotted to new or serious problems. The phone will often work just as well. Telemedicine visits can be done when office staff is not working — thus at a much lower overhead cost.
Provider-to-consultant video conferencing is a great idea. This works particularly well if the two individuals work in the same organization. If they are not in the same organization financial issues often get in the way.
A fine example of peer-to-peer video conferencing is in the UK where groups of NHS neurosurgeons at one hospital communicate with groups of NHS neurosurgeons at another hospital sharing x-ray images and and clinical details. Very difficult decisions are often better with input from colleagues — and consistency of care is improved.
Telemedicine does not solve bad-care problems. Switching bad-care in person to bad-care by video is not helpful.
Telemedicine can reduce the cost of care for simple issues that mainly need better health literacy and for follow-up of known health problems. The capacity of health care is not adequate in many countries (including the US). Telemedicine is a provider-extender and needs to be used a lot more.
According to a recent report in the BMJ medical errors are the third leading cause of death in the United States. The chart below shows where the estimated number of deaths from medical error fit into known mortality data. The article makes the remarkable observation “medical error” is not allowed as the cause of death to be recorded on death certificates. Indeed, when “medical error” is entered into the ICD 10 look up site for CMS here is the result: There are no ICD-10 Codes that match that fragment.
To be fair, the rule for death certificates is the cause of death must be the final cause. For instance, even though smoking causes heart disease which leads to a myocardial infarction (heart attack), the allowed cause of death is myocardial infarction rather than smoking, which is truly the root cause. That’s just how the system has worked for decades. So if a medical error causes a myocardial infarction the doctor must list myocardial infarction as the cause of death — in most states the qualifier “due to …” is allowed and smoking could be entered by the doctor. Interestingly, if “medical error” is listed the death would become an “accidental death” requiring review by the medical examiner (not something most physicians or families want).
251,000 deaths in the United States are caused by medical errors. This fact has been hidden, like many other underlying causes of death. The effect is that research into medical errors is lacking, the funding for research is lacking and the problem is ignored. Why should heart disease research be funded when some “cardiac” deaths are actually due to a nurse giving the wrong medication to the patient. The research really needed is to find how to prevent the medication error.
Although the graph above is bad enough, consider that the size of the bars for heart disease, cancer and COPD should all be smaller — because the real cause, in many cases, is medical error.
The number of medical errors is staggering. The errors that cause death are just the tip of the iceberg. Lots and lots of medical errors only have minor consequences. Every physician makes several errors each day. Every review of a medical chart reveals numerous errors. Care providers are astounded by this news. However, simple things like not seeing a lab report with a low blood count until the following day is an error even if nothing bad happened as a result. Of course, it would be malpractice if something bad did happen as a result.
The prevailing notion in quality improvement circles is, “don’t waste your time unless there was a bad outcome.” This notion comes from a lack of staff, and intense criticism when a provider is involved. “What do you mean there was an error, my care was excellent, nothing bad happened, you should be fired.”
Although there is a real tendency to want to blame an individual provider, both small and large errors are the result of poor clinical processes. Even errors due to provider fatigue and lack of sleep are truly process problems — a provider who worked during the night should not be working the following day. A provider sick with a cold should not be working, but so often they are.
What needs to be done:
- Just like alcoholism, the first step is to admit there is a problem.
- See medical care as a process. Strive to make sure the same problem gets the same treatment every time in every location. OR change the process.
- Stop seeing medical care as art. What work of art ever killed a person?
- Separate the compensation for medical errors from improving medical processes. Injured patients need quick compensation and medical care needs quick changes to improve. Lawsuits seem to have little impact on process of care — if lawsuits prevent errors why are we in this mess?
- Establish a non-profit foundation to advocate for reducing medical errors — something the public might be very willing to support. Sorry, Heart Association, Lung Association, Cancer Association — some money needs to go toward reducing errors. After all, if a wonderful heart medication is given to the wrong patient what good is that?
Emergency general surgery (EGS) is common in the United States. 11% of surgical admissions require emergency surgery. The statistics on EGS seem to create more questions than they answer:
- The 11% of surgerys classified as EGS are associated with 50% of all surgical deaths.
- Poor people who have EGS have a greater risk of death than average
- Rich people who have EGS have a lower risk of death than average
- Seven surgeries (removing part of the colon, removing part of the small-bowel, removing the gallbladder, operations related to peptic ulcer disease, removing abdominal adhesions, appendectomy and other operations to open the abdomen) accounted for 80% of the deaths and hospital costs related to EGS.
- The cost of ECS in the U.S. is about 7 billion dollars per year.
- EGS patients admitted by a surgeon have lower hospital costs than those admitted by a hospitalist.
- Specific quality guidelines for ECS do not exist.
One might be tempted to say the diagnosis is so complicated nothing could improve the situation for patients. However, this would be like the situation for pilots and passengers 30 years ago when major airliner accidents happened at least once a year. The quality movement swept over the airline industry which is now is rated as one of the safest of complex human endeavors. Those same measures need to be applied to EGS.
When an airplane has an emergency the crew pulls together and acts as a team. They follow a procedure practiced many times. They have simulators and tests. If an engine fails, if there is a fire, if a landing gear fails there’s a procedure to follow. Each pilot does not invent a procedure just because they are the pilot that day. Likewise, every surgeon should not invent a procedure just because they are the surgeon that day.
It would be easy to blame surgeons or the patients themselves for such dismal outcomes. But, as people in the quality improvement department say:
IT’S NOT THE PEOPLE, IT’S THE PROCESS.
The first step is to acknowledge EGS is a process. When a patient arrives in the emergency room with abdominal pain, low blood pressure, free air in the abdomen and a high white blood count there should be no barriers to evaluation an treatment.
- The goal is to have the patient in the operating room within 90 minutes from crossing the ER threshold (T).
- Blood tests and CT scan of the abdomen are done by T+ 20 minutes.
- Surgeon is in the ER to evaluate the patient by T + 30 minutes
- A decision for operation is made by T + 45 minutes.
- Pre-op antibiotics, fluids, and pressors are started as needed.
- Anesthesiologist begins care of the patient in the ER by T + 60 minutes.
- Central line is inserted, operating room is notified, ICU is notified, critical care team is notified by T+75 minutes.
- Patient is transported to the operating room. The opening incision is made by T + 90 minutes.
Such a process is obviously difficult. First, the ambulance crew can not transport a patient with an abdominal emergency to a facility unable to deal with the problem, like a small rural hospital or an urban community ER. This will require training of the ambulance crews and communication with a high level ER.
General surgeons and back-up general surgeons must be available within 30 minutes. It’s a difficult life to be immediately available — the hospital is responsible to either pay surgeons to be on-call or to hire surgeons to stay in the facility. Hospitalists are not an appropriate substitute to deal with an acute abdomen or even severe abdominal pain of uncertain cause. A helicopter ride to a higher level facility is the best solution for patients with severe abdominal pain entering a facility not capable of following the above protocol. The crazy practice of having a night-time hospitalist admit a critical surgical patient for a surgeon to see “in the morning” must come to an end.
Since the mortality rate of EGS patients is quite high the intensive care unit is the place they should go after surgery even if they seem stable in the operating room. Complications are very common so early recognition and treatment is essential. Returning to the operating room later may be needed and should not delayed. Critical care consultation should be strongly considered. Multidisciplinary rounding with critical care specialists, nurses, pharmacists, dietitians, and social workers is strongly advised. Rushing to get the patient out of the hospital to a secondary level of care is a mistake since re-admission is fairly common. The patient needs to be as stable as possible before discharge. Hospitalization for 1 – 2 weeks is not uncommon.
The difference in outcome of EGS between rich and poor is not uncommon for many things in medicine and surgery. Several factors are at play but probably the biggest is fear of big medical bills — if you can’t pay one would wait till the last moment. Second, medical literacy — always a bigger problem for lower socioeconomic groups — if you think Tums or Rolaids will fix anything you might wait too long to go for help. Finally, a negative bias toward Medicaid or “cash” patients — sometimes the finances determine whether a hospital will keep or transfer patients. At midnight many cases seem to be too “hard” and must be sent to a referral hospital which wastes valuable time.
Since prospective research is difficult and time consuming (taking years or decades) a local and national registry should be utilized. The diagnosis, the surgical approach and the outcome must be tracked to find the best combinations for the best outcome. As best practices are identified surgeons and hospitals must quickly change protocols and surgical techniques. U.S. healthcare can not stand the usual 15 years needed to implement new practices.
- Washington Post
- JAMA Surgery
- J Trauma Acute Care Surg.
- The Joint Commission
- J Trauma Acute Care Surgery
- J Trauma Acute Care Surgery
- J Am Coll Surgery
If any nurse out there has a standard order-set for EGS please share it.
One of the most frustrating problems for families and care providers is the intransigent patient. The patient who does not eat well, has poor judgement, stays at home, says they just plan to die at home, and have no intention of following family or healthcare provider advice. Like it or not, ethically and legally the patient gets to do what they want and only heartache and frustration will result from efforts to the contrary. What to do: maintain contact, don’t blame, help where possible, support, be a friend and call a social worker.
HOWEVER, the situation described might have been avoided. Might have been happier. Might be different with healthcare provider and family input at an earlier stage, by simply asking, “what do you want to happen at the end of life?” Listen carefully to the answer. Because, at that point, many people are receptive to the idea of making some plans and formalizing their wishes. Hopefully, the following documents can be completed:
- A living will or similar document.
- A financial durable power of attorney.
- A medical durable power of attorney.
- A last will and testament or a trust.
TidyForms and LegalZoom are reasonable places to get free online forms, there are probably other websites as well. Lawyers are clearly the experts here. But, for uncontested situations like severe dementia the free forms are usually adequate and a lot less expensive.
Why does this help?
- Because when the person is able to think clearly about options they can express their wishes for end-of-life care. Both family and healthcare providers will be inclined to follow the wishes of the patient knowing it truly is the patient’s desire, not just some obstructionism or retaliation against the wishes of others.
- Because management of finances and health care decisions will be assumed by someone who the patient trusts.
- And, if such documents exist the barrier to intervention is much lower. Generally no legal involvement is needed. Most healthcare providers and banks will follow the instructions of the power of attorney if the situation is logical (like the patient has a medical diagnosis of dementia).
- If a bank or care center requires documentation a person is indeed incompetent, a certification statement from two medical providers (a short statement — see below) is usually sufficient to invoke the powers of attorney without going to court. However, if contested, those signed documents go a long way to getting a favorable court ruling for the power of attorney to act as the patient’s agent.
According to Legal Zoom:
“Mental competence is defined as the ability to understand the terms of a contract and the capacity to enter into an agreement. Mental competence can be temporarily compromised, for instance, by intoxication. Permanent mental incompetence can result from severe head or brain injury, mental illness, retardation or a degenerative mental condition such as dementia. The law does not allow a principal who is mentally incompetent to designate power of attorney. A mentally incompetent principal is also prohibited from revoking a power of attorney that was properly drawn up. In fact, a durable power of attorney is designed to allow an agent to act in place of a principal who becomes incompetent, either due to illness, injury or some other reason.”
Competence is a difficult concept. That’s because competence depends on the question: competence to do what? There is a vast difference in the competence to decide what to eat and the competence to enter into a legal contract. So, a person can be competent to do lots of things but not competent to do other things — it’s not a monolithic term.
Judgment is something different. People may have poor judgment and be fully competent — if a bad decision means incompetence then we all would be in that boat at one time or another.
Mental retardation and mental illness pose huge financial and legal problems. Professional help from lawyers, psychologists, psychiatrists and social workers is essential.
Physicians statement of mental capacity — competence or incompetence. Requests for this type of evaluation are becoming more frequent as the population ages and dementia is more common. Primary care MDs should not shy away from a dementia evaluation, but there are elements that need to be addressed. A note on a prescription pad, “OK for nursing home, poor memory.” is not adequate.
It is surprising how many primary care providers base the diagnosis of dementia only on what the family reports — they never do a simple mental status exam or take the time to train a nurse to do it for them. A Mini Mental State Exam would be great — it is excellent documentation for the medical record. But, at a minimum, a check of orientation (person, place and time) is required. It’s not difficult:
- Please tell me your name.
- Where are we right now?
- Could you tell me what time it is now? [do you remember what day of the week it is today?] [what year is it?] [is it 1949, 2016 or 1975?]
Without a doubt, a person who does not know who they are can not enter into an agreement — they probably can not even sign their name! And, a person who does not know the city where they are or the correct year certainly does not have the ability to understand the terms of a contract. Those two things mean the patient is not legally competent. Those two things mean the power of attorney documents could be activated.
After an MD does an assessment which demonstrates a lack of competence the following are key elements for the statement:
[Name] has severe mental incapacity which is a permanent/temporary condition. He/she is not able to manage financial affairs or make health care decisions for himself/herself or others. In my opinion his/her power-of-attorney documents for both property and health care should now be in effect. Specifically, by reason of mental incapacity he/she is unable to do the following:
All the facts and opinions in this statement are true and correct to the best of my knowledge and belief.
[Signature of MD]
Most states require statements from two physicians. Other practitioners may be allowed to make statements about competence but the rules are variable.
Guardianship (conservatorship) is the alternative of last resort. This is an action by a court when a person can no longer make or communicate safe or sound decisions about his/her person and/or property or has become susceptible to fraud or undue influence. A judge appoints a qualified guardian — family or friends have no rights in this matter (the judge makes decisions based on the person’s best interest). The guardian does not own the assets of the ward but manages the assets and makes decisions solely for the benefit of the ward. Depending on the person’s specific competence (or lack thereof) the guardian may be directed to make decisions for the ward in these matters:
- Determine residence
- Consent to medical treatment.
- Make end-of-life decisions.
- Possess a driver’s license.
- Manage, buy, or sell property.
- Own or possess a firearm or weapon.
- Contract or file lawsuits.
Guardianship removes rights from a person and the person’s family so it is not something to be taken lightly. But, there are times when it is essential. A guardian may be a family member or friend or a public or private entity appointed by the court. They must follow the instructions from a judge and make periodic reports to the court.
When you go to an eye doctor do you walk away not really understanding what just happened? Do you know your diagnosis? Do you know what the prescription means? It should be simple but it’s not and you need to do your homework before your visit.
CAST of CHARACTERS: Ophthalmologists are MDs who do surgery and prescribe medications. Optometrists are ODs who mostly do vision tests for glasses but depending on training and State laws they may also do some of the things Ophthalmologists do. RNs, PAs and MAs assist eye doctors just as they might for any medical doctor. Opticians have a high school degree plus training to fit glasses.
Ophthalmologists may have the highest IQs of any doctor group. Ophthalmology has a reputation for a good life-style and high income. The training programs have huge numbers of applicants and only take the best and brightest. Ophthalmologists are so far from primary care they really don’t know what it is about and the reverse is also true. A high IQ does not guarantee skill at explaining eye problems.
Eye doctors are obviously visually oriented. So, one of the best questions a patient can ask is, “I don’t understand, could you draw a picture?”
The eyes alone seem to have as many things that could go wrong as the rest of the body. But. there are a five topics most people should know about:
- Glasses. What is near-sighted and far-sighted. What do the numbers on the prescription mean.
- Aging eyes. As we get older our eyes can’t adjust to see close things as well — the reason reading glasses were invented!
- Ordering glasses on the Internet works well and can save a lot of money (hundreds of dollars).
- Removal of cataracts (clouded natural lenses inside the eye) is a 20 minute painless surgery. The old lens is removed and a plastic lens inserted in it’s place. Most people need to wear glasses full or part time after the surgery.
- Diabetes is becoming very common. Diabetes hurts the eyes and may cause blindness. Good control of blood sugar is essential. Laser treatments can slow down some of the deterioration by cauterizing tiny damaged and leaking blood vessels in the retina.
The key numbers are under “Spherical”. These are the strength of the lenses needed measured in diopters. The bigger the number the stronger the lens. A positive number here means you are far-sighted and a negative number means you are near-sighted.
The cylinder is an optical adjustment needed when the natural optics of the eye are not symmetric — the shape of the cornea is not as spherical as it should be — it is a little oblong. The axis is the angle of the oblong abnormality. Any cylinder numbers mean you have this non-spherical problem called astigmatism.
The ADD is the amount of power added to the basic lens strength needed for close-up vision (the lower part of bifocals). +2.5 is typical for seeing things about 14 inches from the eyes (reading) and 1.25 is about right for seeing things about 20 inches from the eyes (computer screens).
The PD (pupilary distance) is important for centering the glasses over the eyes. The right PD is from the bridge of the nose to the center of the right pupil and the left PD is on the opposite side. In most people these are equal and only the sum is important (in this case the sum is 68).
As we get older the eyes can’t adjust well from far to near. People with normal vision may find they just need reading glasses. Near and far sighted people may need bifocals. If you have more than about 0.50 of cylinder adjustment cheap reading glasses will likely not be comfortable and prescription glasses are the solution.
GLASSES on the INTERNET
A couple of reasonable sites are zennioptical.com and 39dollarglasses.com. There are others if you search for them. It’s no big deal to adjust the frames — dipping the bows in near boiling water for 15 seconds then bending them to fit is not difficult — but do not take them to an eye shop for this — they will not help you for obvious reasons. If you have frames that fit make sure to take the measurements suggested on the website and get something similar.
Cataract surgery only takes about 20 minutes and is painless. The clouded lens is removed with a little suction blender then a rolled-up plastic lens is inserted through a needle — it opens up inside the space of the old lens.
Blindness is one of the feared complications of diabetes. It is usually do to an overgrowth of blood vessels in the retina that tend to leak protein and sometimes leak blood — both substances that damage the retina and make holes in the vision. People who keep the blood sugars in tight control tend to have less of this problem. The abnormal blood vessels can be cauterized with a very fine laser which slows down the progression of the condition.