by Rose Rohloff
"The use of cardiovascular medications can have a variety of neuropsychiatric consequences." Therefore, the following highlights are good review for anyone prescribed a CV drug, especially for the elderly, those with other conditions such as liver or kidney insufficiency, and/or also being prescribed psychiatric medications.
Angiotensin-converting enzyme inhibitors
"Bottom line: ACE inhibitors and angiotensin II receptor antagonists are associated with low rates of neuropsychiatrie side effects, though mood symptoms, psychosis, and delirium have been reported."
Beta-adrenergic blocking agents or Beta (β)-Blockers
"Bottom line: β-Blockers as a class are not clearly associated with depression; there is the most evidence for a propranolol-depression link, but even this relationship is equivocal. In contrast, β-blockers are associated with increased rates of fatigue."
Calcium channel blockers (CCBs)
"Bottom line: CCBs may be associated with fatigue in some patients, but otherwise cause few neuropsychiatrie symptoms."
"Bottom line: Diuretics most often cause neuropsychiatrie symptoms indirectly, through electrolyte abnormalities (thiazides) or vitamin deficiencies (loop diuretics). Acetazolamide is associated with fatigue and with delirium in renal failure."
Doctors should always monitor electrolyte levels (sodium/Na and potassium/K+) of their patients taking diuretics.
Centrally acting agents - Antiadrenergic agent
"Bottom line: Clonidine is consistently associated with fatigue and sedation; delirium is infrequently associated with its use. (Clonidine) is also commonly used to reduce symptoms of opiate withdrawal.
Bottom line: Methyldopa is clearly associated with fatigue and sedation. In contrast to early studies linking methyldopa with depression, later reviews and studies have found this association to be relatively weak. Other neuropsychiatrie symptoms are uncommon.
Bottom line: Reserpine is associated with both sedation and daytime fatigue. Incidence of depression may be elevated among patients taking reserpine. However, other (generally more recent) reports question this association."
"Bottom line: Fatigue is the most common neuropsychiatrie side effect associated with -adrenergic antagonists; other neuropsychiatrie side effects are infrequent."
"Bottom line: Vasodilators are generally associated with low rates of neuropsychiatrie consequences. Hydralazine is a leading cause of drug-induced lupus, but this syndrome affects the central nervous system much less commonly than the idiopathic form of the disorder."
"Bottom line: Most Class I Antiarrthymic agents have been associated with psychosis and delirium in case reports. The syndrome of cinchonism associated with quinidine may include sensory changes along with delirium, and procainamide is a cause of drug-induced lupus.
Bottom line: Class III Amiodarone is associated with thyroid abnormalities in 15% of patients, and untreated thyroid dysregulation can lead to a variety of mood, cognitive, and psychotic symptoms. In contrast, direct neuropsychiatrie effects of amiodarone are uncommon.
Bottom line: Digoxin is associated with delirium and other cognitive effects, especially in toxicity. Visual changes and hallucinations may also occur with digoxin use, even at normal serum levels."
Conclusion by Author
"... numerous cardiovascular medications can have neuropsychiatrie side effects, ranging from mood symptoms to cognitive effects to psychosis, and though a given agent may not consistently cause neuropsychiatrie symptoms in the general population, idiosyncratic reactions are possible." More specific studies are needed for, "clinicians ... to make fully-informed prescribing decisions for their patients."
Patients and their families know the cognitive baseline of individuals being prescribed medications, and therefore, should always monitor for any neuropsych impact seen if CV drugs are used, on an individual basis for what is safe per person. Any and all side effects should be know, along with contradictions to other drugs, for all medication being taken.
* Dr Huffman is a professor of psychiatry at Harvard Medical School and the director of the Cardiac Psychiatry Research Program in the Massachusetts General Hospital (MGH) Division of Psychiatry and Medicine. He also serves as the associate chief for clinical services in the Department of Psychiatry at MGH.
What should you be aware of regarding Vancomycin?
by Rose Rohloff
proliferation of the intestines (often after antibiotic use); and some hospitals are using as the standard protocol for elderly in the emergency room, for asymptomatic pneumonia, and other infections.
Clinicians (nurses, doctors, physician assistants, etc.) are supposed to do comprehensive history and physicals (H&Ps) before using any drugs or treatments. And, it is important to know underlying conditions before using Vanco, because it can raise glucose levels, especially in diabetics, and/or cause kidney (renal) insufficiency, especially in elderly.
The following use case is regarding an admitted primary care doctor as the patient.
"I don't know what the average "lay person" does when they don't have all this information, and without a medical person to look out for them."
"This article is exactly why they stopped Vanco when he had his MRSA infection. His kidneys were starting to get compromised, so they immediately stopped it and started him on a different antibiotic, Daptomycin, which worked just as well and had less side effects for his kidneys and diabetes. Thankfully they caught it very early because of the blood tests they were doing to see what was happening. The new antibiotic was infused only once a day as opposed to twice a day Vanco, and there weren't all the extra blood draws to make sure the kidneys and glucose were doing okay. God is really in control and watching out for us, because the medical field doesn't always do that, even with a fellow medical person."
Vanco and high glucose/hyperglycemia
Vanco and kidney (renal) failure
Changes in vancomycin use in renal failure Stefaan J Vandecasteele 1, An S De Vriese pub in 2010
Abstract A progressive increase in vancomycin resistance with consequent treatment failure has been observed in staphylococci. Therefore, new dosing guidelines advocating much higher vancomycin doses have been issued. Target trough levels of 15-20 microg/ml are proposed. Whether and how these targets can be achieved in patients with chronic kidney disease or those on dialysis are still under evaluation. The higher vancomycin doses to achieve these treatment targets carry a substantial risk for nephrotoxicity. This risk is incremental with higher trough levels and longer duration of vancomycin use. Critically ill patients, patients receiving concomitant nephrotoxic agents, and patients with already compromised renal function are particularly at risk for vancomycin-induced nephrotoxicity.
Elderly patients are more prone to vancomycin toxicity with IV administration due to age-related changes in renal function, the volume of distribution, and accumulation. These patients need to be carefully monitored and require a more conservative dosage regimen. NIH 2022
Acute kidney injury during daptomycin versus vancomycin treatment in cardiovascular critically ill
Conclusions: Daptomycin appears to be safer than vancomycin in terms of AKI risk in ICU patients treated for cardiovascular procedure-related infection. Daptomycin could be considered as a first line treatment to prevent AKI in high-risk patients. NIH 2019
by Rose Rohloff
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.
The 1974 Research Act was created in entirety from the Belmont report, and put into place to prevent the Government, it agencies or representatives, military and private companies, from violating an individual's freedom: by forcing, tricking or coercing persons for research, testing and administration of unknown injections/materials, and experimental procedures. This law was enacted after a century long track record of precedence including, and not limited to, the following:
Demonstrated lack of Respect for Persons and their protections in violation of 1974 law.
1- Autonomous agents, individuals capable of deliberation about personal goals and of acting under the direction of such deliberation. The Government and companies have to give weight to autonomous persons' considered opinions and choices, and cannot obstruct their actions and judgments, nor deny individual freedom to act on considered judgments, and cannot withhold information necessary to make a considered judgment. Necessary information includes - but not limited to - all medical opinions by established, industry experts, health status, the necessary assessments, labs, with close monitoring of physical lab and test follow ups of each and every autonomous persons as part of clinical research and testing, along with full documentation of testing, efficacy, use of chimera for research and testing, any and all conceivable side effects, and interactions of conditions.
2- persons with diminished autonomy are entitled to added protections.
Violators to the law have been marketing to the most vulnerable, including the immature and the incapacitated who were in need of extra, added protections, even to the point of excluding them from any injections or procedures which may harm them; violating added safety precautions for children, elderly, or those with diminished capacity.
Informed consent - must include full disclosure of ALL contents to be injected, any and ALL possible side effects (which can be several pages long), how those persons are individually to be closely monitored, safety guidelines, and above all the right to say no before or at any time, and full reporting of all individuals regarding their safety monitoring/labs/assessments, and any and all side effects. By promoting COVID shots all still under clinical trial/research, and coercing with careers/jobs, inability to travel, etc. in order to take the shots, this law is being violated through: lack of informed consent, lack of protections of autonomous persons, and/or illegally acting as IRSB board members marketing to those not autonomous and capable of self-determination, with higher standards of protection to be invoked, and assuming the role for their safety.
The maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others.
An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.
Undue influence also includes offers of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable as in the case of targeting children, persons with limited capacity, and elderly with elements of mental defect, or instilling fear.
Short term morbidity and mortality cases from the shots are well reported and known, such as death, myocarditis along with spontaneous cardiac arrest with no warning, debilitating neurological conditions, etc. And, there is no means yet to determine mid and long term effects because Phase I trials have not been competed, let alone Phase II and III - which is vital information in order to determine informed consent.
Injustice has been performed with companies and government representatives, by involving vulnerable subjects, including the young, those unable to fully comprehend with all necessary information, and scaring parents with compromised capacity for free consent. In addition to lack of individual, tightly scheduled, continual monitoring and follow ups, autopsies of all persons involved in this trial participation should be conducted for reporting by the pharmaceuticals companies for any and all persons who received the shots, as well as labs determining efficacy and detriments (as examples, antigen creation, D-dimer, Pulse Cardiac and Troponin Tests) for all those who were coerced or unduly influenced to participate in research.
This law was created to protect people from government abuse through experimentation. The government cannot arbitrarily dismiss components, create resolutions or stipulations to supersede the law, as to invalidate its protection of individuals from them, including, but not limited to Health and Human Services (HHS) Center for Disease Control (CDC), Food and Drug Administration (FDA), National Institute for Health (NIH), etc. and pharmaceutical companies, etc.
Persons have been illegally acting as members of, or bypassing, IRSB safety review and monitoring of each and every person receiving injections, with open undue influence and coercion, to participate in Covid injections. Coercion has been especially directed to the diminished autonomous, children and elderly, through TV ads, library recordings, verbal encouragement, schools or other public venues acting as government agents, and/or clinical researcher recruiting participants, and/or illegally as untrained IRSB member who is not following up to ensure safety of the people they recruited, coerced or used undue influence.
Overall lack of informed consent has become too often common practice across the healthcare industry, including people being given consent forms hours or minutes prior to surgery; no alternative treatments or lifestyle-nutrition changes prior to medications begin prescribed, and undue influence to intubate or perform surgery on patients in lieu of alternative treatments.
by Rose Rohloff
An India folklore, regarding lack of awareness, demonstrates the current myopic view of various specialists, who look at isolated symptoms without comprehensive assessments, resulting in poor or lack of diagnosing of real issues to address in patients. The industry push to eliminate primary care, teaching people they don’t need a primary doctor, or using primary care doctors as simple pass-through without diagnosing, handing off to multiple other doctors, has resulted in the loss of care coordination, overdosing multiple medications with contraindications/side effects, with increased conditions because multiple doctors only look at their individual view.
The following version of the blind men and the elephant story is from Peacecorp.gov, and is analogous to the existing healthcare system of specialists.
Long ago, old blind men were curious about the many stories they heard about elephants. The men were led to one for each person to independently touch the animal.
All body systems impact each other, designed to function as a whole, for a well orchestrated, compensatory mechanism. By only looking at individual symptoms of isolated systems, patient’s underlying conditions are not addressed for health, and can often be fulminated and/or obscured by medications. And, the reason primary care doctors are imperative for knowing the whole patient, knowing how to diagnose and treat many conditions. Primary doctors should only pass their patients to specialists for complicated, complex conditions, while always following their patient and maintaining all coordination with any other doctors.
by Rose Rohloff
Calm intelligence, professionalism, logic and sense. Nine (9) doctors interviewed https://www.bitchute.com/video/2JPy7qZiXvNr/ regarding Covid, Hydroxychloroquine (HCQ) and masks.
With perpetual reporting of the COVID-19 virus, there has been a lot of panic reaction from the public, fostered by the media, as well as from local clinical staff. These reactions have brought existing issues in the healthcare system to the forefront, that we can address go forward, especially for discernment to champion better quality of care. The following two use case examples happened last week, which demonstrate panic reactions from clinicians, the need for good primary care, and the need to address care standards, especially in crisis, with sense at the delivery level.
An immune suppressed mother has three children, one being a 10 yr. old daughter who woke with a 102 temperature and a sore throat. The mother is not reactionary, having good instinct regarding when her children are fighting off bugs, building up their immune systems. She phoned the pediatrician to ask for testing if it is strep or a virus. The pediatrician stated they only test for COVID-19 if someone is hospitalized, and they would not do a strep test, “Don’t bring your child in”, and then the pediatrician went on a rant about social distancing, “This virus will not end …” (with no reported cases in the area) etc. and simply ordered Amoxicillin.
I don't want to give my daughter an antibiotic if she doesn't need it, and especially if it is a virus, let alone the Corona virus." Removing all emotion from the situation with her, we discussed getting zinc in EZC Pak from the CVS a mile away, that she could pick up via their drive through, along with foods high in Vitamin A to boost her daughter's immune system. I also called the local Urgent Care center explaining the situation: a mother immunosuppressed, her daughter is in the EMR system, she just wants a strep swab to avoid unnecessary antibiotics, to please have a nurse do the swab through the car window when she drives up - avoiding any cross contamination issues. They stated no problem.
The same week, a second mother of four small children, one being a seven year old who was having sore joints and some blood in her urine. The doctors in Green Bay did a wonderful job of a full, very detailed history and then exam with targeted tests, quickly diagnosing Rheumatic Fever. Her and her other three, healthy children were instructed to do proactive strep testing since they all had close exposure with the daughter. "The center made us feel like lepers. Instead of simply coming out to the car to meet us, they brought us to an empty lobby with a nurse who came out in a full hazmat suit to do simple strep swabs. The nurse freaked out when my son simply cleared is throat, creating anxiety, complaining, "He just coughed."
The clinicians throughout both cases should have been calming, simply asking good questions, and then only ordering the correct test before ordering medication. And, in both cases, clinicians could have had the tests quickly, avoiding the waste of hazmat gear, not frightening healthy family members as well as not exposing them to potential germs in the health facilities - avoiding cross contamination issues.
What we need to focus heavily on:
One point stood out regarding their focus that is so often missing in health systems: seeing 'clean' patients first, and then seeing contagious patients grouped together, ensuring avoidance of cross contamination, and minimizing the volume of masks, gowns or hazmat suits used.
Hopefully, many good things will come from this virus experience to positively shake up our healthcare system, including basic sense procedures, with the importance to rebuild and focus on great primary care again. Another glaring issue to address is the role of clinicians as cool, calm professionals, removing emotion when instructing with full information, with clearly explained options for informed consent and decision-making for delivery of quality care.
by Rose Rohloff
A Wall Street Journal (WSJ) article https://lnkd.in/e9awgQT 1/24/2020 posted wrote:
"Nearly 150 years ago, a German physician analyzed a million temperatures from 25,000 patients and concluded that normal human body temperature is 98.6 degrees Fahrenheit. That standard has been published in numerous medical texts and helped generations of parents judge the gravity of a child’s illness. But at least two dozen modern studies have concluded the number is too high. Or was it?
In a new study, researchers from Stanford University argue that Wunderlich’s number was correct at the time but is no longer accurate because the human body has changed. Today, they say, the average normal human-body temperature is closer to 97.5 degrees Fahrenheit."
Championing your own health is about understanding your healthy baselines. Just as individuals have a variable "healthy" baseline for their blood pressure and heart rate, why would an individual not have an individualized, normal baseline for their temperature? And, temperatures are now measured using different methods:
forehead-ear-mouth-rectal, producing deviations based upon how the temperature is obtained. It is important to understand, compare what mechanism was used to take the temperature.
Is your normal 98 degrees, while another may run 97 degrees? Is the person normally running 97 degrees now have a temp of 99 along with malaise, dehydration because they are fighting a virus or bacteria? Assessment/vital sign numbers provide more information for clinicians (Doctor, PA, Nurse, etc.) when provided in context of associations, trends, baselines and influencing factors.
It is known taking medications will impact various lab values. For example, Diuretics e.g. Lasix (Furosemide), can cause low potassium levels. There is an interesting article in Medscape, Which Drugs Interact With Lab Tests? Jun 18, 2019., addressing the fact that certain medications can also interact with the actual processing of certain lab tests causing inaccurate results.
A recent view of the prescribing information for 1368 prescription drugs found that 134 (9.8%) included information about a specific lab test interaction, 31 (2.3%) stated that the drug did not interfere with lab tests, and four stated that there was no available information. ...
Patients, families and caregivers need to be aware of what name, class, internal action, as well as all other medication interactions for every medication, vitamin and supplements being taken.
As Dr. Scott shares as insightful, it is also important before getting lab values done to understand if any medications being taken will impact labs to be processed and cause false results.
Why have $MM/$BB EMRs?
A 40-year old mother went to the doctor after treating herself holistically for some laryngitis, stuffy nose, congested sinus, with continued symptoms after five days. After an exam, the doctor stated, “I am not going to give you antibiotics. You do not have a fever; your lungs sound clear. It looks like a little virus with severe allergies. I recommend an antihistamine.” The patient told him, “Thank you for not putting me on antibiotics when they are not needed, that makes me happy.” He responded, “I am glad you are glad.”
This story is sadly too often the new normal, numerous instances of patients and their caregivers stating issues of diagnosing with medication prescription, or misdiagnosis; the doctor or nurse having no idea of pre-existing conditions or a full list of medications currently being taken, a lack of care coordination or care planning because the time was not taken to simply read the chart (whether written or electronic), and ensuring a comprehensive history followed by the necessary physical assessment.
No physician or nurse should walk in to care for a patient without first having read the patient’s record, knowing all current information, the last visit/healthcare encounter, chronic conditions/comorbidities, and all medications; then, asking for updates of changes. Unfortunately, even without having to decipher poor handwriting, being able to read clean typed text, clinicians are not simply reading the basics of information they should before doing any diagnosis, planning and care, or prescribing of medications.
A popular trend in houses is the use of marble and granite as counter tops. A leading surface expert, Linda Lybert President of Healthcare Surface Consulting stated, “Granite and Marble are like large sponges you cannot wring out.” The photo displayed shows the build up of E. coli bacteria in the pores of stone. According to Ms. Lybert, even when sealed, the porousness is reduced, but not eliminated. And, bleach is not able to eliminate once they reside in the crevices.
As the elderly begin to lose their mobility and agility, it is important to maintain clean surfaces in bathrooms and bedrooms, along with the most important surface being the skin. Diligent hand washing and bathing is important throughout the day to avoid cross contamination from the loved one you are caring for, as well as to them. The other surface area to be conscientious of is bedding. When excrement accidents occur, it is important to wash bedding with very hot water to not only clean them, but also kill the microbes.
Clostridium difficile (commonly known as C-diff) "is in the community and found in outpatient settings. There are significant risk factors in patients who are immunosuppressant, individuals who have been on antibiotic therapy, and the elderly population." C-diff is a secondary, very dangerous and potentially deadly infection after antibiotic use. [read article] It is important to those in the community to have appropriate antibiotic prescriptions and use, especially avoiding unnecessary broad spectrum antibiotic use which targets the "good" bacteria you need internally (and not on external surfaces) to kill off C-diff.
The Push For Value-Based Care
by Rose Rohloff
But, what is value? Is society conditioned to accept low quality as value, because a lower standard has become the norm?
Value is a relative term based upon personal perception, and oftentimes great marketing. True value is based upon insightful knowledge of what entails quality along with the cost of delivering goods and services. Value-based care is the new buzz for basing reimbursement in the healthcare industry. But again, what is value care: personal perception, marketing, cost?
The primary issue with such score deviations is determining if poor marks are isolated instances (one offs); or, if the variance of only highest and lowest reflect the knowledge of reviewers. Are the high ratings from non-healthcare persons based on perception of the veneer friendliness and scheduling, with one star comments based on specific quality requirements, care competency posted by those with healthcare insight/experience?
As a 35+ year healthcare veteran, an answer was determined accompanying a Medicare patient ‘John’, in his mid-80s who experiences early stage dementia, to the office for a post-op visit for a leg stint placement.
Upon arriving, another elderly patient (80s) was sitting outside, unattended in wheelchair, hot sun, 100 degree weather, no water. When asked why he was there, he stated, “I can’t stand the freezing air conditioning inside while waiting for a ride.” After walking John into the lobby, the gentlemen clearly seen through the glass door was pointed out to the receptionist stating that he was left in hot sun, no water, unattended. The receptionist stated, “It is his choice to stay out there.” I then stated, “Get someone to check on him, give him water, put him in the shade and check when his ride is supposed to arrive and monitor him if it is delayed or bring him inside.”
One person escorted us back to exam room. She did not introduce herself or her title. She proceeded to take the blood pressure with no other vital signs (unknown if a secretary, an aide, a nurse or tech).
She then asked the patient, “How much do you weigh?” He gave a number. As patient champion I responded, “He doesn’t know, he has not weighed himself. You need to weigh him yourself.” She responded, “We don’t have a scale.” She then left. I followed her witnessing her documenting the incorrect data.
I reiterated he has dementia with no idea how much he weighs. She replied, “It doesn’t matter anyways, we just need to put something in the record.” She was reflecting an 11 pound weight loss from previous recording. It is unclear if they performed the previous weighing, if it was done just prior to surgery to determine proper anesthesia delivery for his surgery.
Another woman in scrubs entered the exam room without introducing herself or her title, asking John to remove his shoes and socks. (The scheduled appointment was with the PA so the patient assumed her identity.)
She asked him if his wound was healed and he replied, “Yes.” She documented something in the chart without ever assessing his wound for healing or determining if there was infection.
She bent down and felt his feet with her whole hands stating they feel warm, and then asked if he had numbness in his feet. John responded, “Yes.”
Having worked as a registered nurse (RN) in cardiovascular and neuro intensive care units (ICUs), I know she never did pedal (foot) pulse checks x4 comparing both feet. She never assessed location of numbness, or if chronic/intermittent, positional with sitting/, standing, walking, etc.
The family had asked if aspirin could be stopped as the patient has experienced nose bleeds in the past. The staff person responded yes and since there was 90% blockage of the previous stint, it was cleaned out and continue Plavix. There was no establishment of lab work as part of care plan determining effectiveness of the medications, especially since the previous stint occluded.
"1,750 or so stent patients are also prescribed Plavix to prevent clots from forming around the stent, but of that group, approximately 500 (29%) carry a genetic variation that prevents them from converting Plavix into its active form. This gene-related lack of response stands to be "especially severe" in about 50 (3%) of those patients, who won't derive any benefit from Plavix - 2010 Vanderbilt Medical Center
Perceived value based on quality versus true value and cost
The care competency and quality as true value-based care during the visit includes:
- lack of basic cleanliness standards with severe cross contamination practices
- no introduction of name or title of any staff member
- fraudulent documentation in the electronic medical record (EMR)
- no assessment performed during a specific post operative visit (a family member could have taken the BP and said his feet felt warm.)
- lack of care planning and evaluation of medication regime
- unnecessary secondary office visit charging for follow up
- another elderly patient left unattended in the hot sun
If the U.S. healthcare system wants to achieve true value-based care, we need an educated population, higher accountability of staff standards with the ability to send evaluations direct to payers based on specific facts and not emotion, and surveys must include care competency reviews versus only veneer questions of politeness, room appearances, and on time scheduling.
As the dark side of IVF slowly comes into focus, even more transparency is needed
by Pamela Mahoney Tsigdinos, July 27, 2018
Population Health: has the focus on big data, populations & large systems caused the loss of individuals?
Kyle Reyes, CEO, The Silent Partner Marketing
The solution is bringing analysis down to the most base level of management with front line analysis, to coincide with first-hand observation, the voice of the patient & their caregivers/champions, and reducing the ever growing administrative overhead. Bigger is not better for addressing health and care of populations, when the focus is shifted upward with large systems where individuals are lost: Especially when the individual issues are indicative of the core problems that need to be addressed for quality care delivery.
The need for P&P Reviews
This week, reports were released in the media that US homes need Narcan to aid in opioid overdose epidemic, surgeon general advises
The general public needs to be aware: Naloxone has been reported to foster increased abuse of drugs by allowing revival of overdosing for continuing to take more drugs. Naloxone is the generic of Narcan. Just as EpiPen is only the delivery system and not the generic drug Epinephrine, It is important to know the difference between the brand name versus the generic drug name.
The danger of advising the untrained public to distribute emergency medicine
Many clinicians, let alone the general public, are not specifically trained in the proper dosage and treatment with Naloxone for the various forms and dosages of opioids and heroin.
FDA Advisory Committee on the Most Appropriate Dose or Doses of Naloxone to Reverse the Effects of Life-threatening Opioid Overdose ... Sept 2016
"The effectiveness of naloxone, and thus the exposure required, will depend on the opioid dose, the potency of the opioid in binding receptors, the lipophilicity of the opioid in crossing into the CNS system and the elimination half-life of the opioid, together with patient factors (7, 26). Appendix  and [2a] includes further information on naloxone pharmacology. The complex pharmacology of appropriate dosing is further compounded as often the fentanyl involved is illicitly manufactured without normal procedures or controls and may be introduced surreptitiously into heroin or prescription painkillers. Reports from the field confirm the need for additional naloxone doses to reverse opioid overdoses including those involving more potent fast onset synthetic opioids."
Narcan (Naloxone HCL) Use in Opiod Overdose: A Perspective
An important point for the general public who is not used to or trained in emergency medicine, this “rescue” drug is only the first step in the opioid crisis ... not the end all and be all of treatment. I would like to respond to this “advisory report” from the Surgeon General as a pharmacist, an Emeritus Professor, Pharmacy Practice from a College of Pharmacy, former President/Chair of the Michigan Pharmacist Association (MPA) and Fellow of this Association; and lastly as a chronic pain patient.
I have used opioids now for chronic pain management after a car accident almost twenty-years ago. I will admit, I was taken aback by my family physician about a month ago being given a prescription for Narcan (generic name Naloxone) as a “precautionary measure” for my chronic opioid use. The form I was prescribed is a nasal formulation vs. the oral/injection form. When I took it to a pharmacy to be filled, I had to undergo “special counseling” by a pharmacist (even with my credentials) which consisted of a video on proper use and a warning that after use, 911 had to be called and I was to be taken to the emergency room for follow-up. This is the proper follow-up when someone is prescribed any rescue medication for a drug reaction. The Naloxone is only to be given when a known opioid (i.e. codeine and it’s derivatives; Fentanyl, Meperidine, etc...) is given or taken in life-threatening incidences. I was instructed, "Were you aware that Naloxone has two elimination half-lives because this drug has an active metabolite; and, were you aware that Naloxone and Naltrexone are different agents, but are easily confused."
I believe giving someone this agent for overdose situations is giving a false sense of security that nothing else needs to be done. Nasal Naloxone is like putting a bandage on a cut artery. You may stop the blood flow at the moment, but the wound will continue to bleed if the wound isn’t sutured properly. Without appropriate emergency room follow up of an opioid overdose the person may die from that overdose.
Many opioids vary in dose, strength, predictability and most of all drug half-life. Knowing the half-life of drugs is essential to know how long the drug is going to last in your body. Drug half-life’s, drug absorption, distribution and elimination is well covered in Colleges of Pharmacy in courses such as pharmacology, pharmacokinetics and pharmacotherapeutics. Pharmacists do not know the pharmacokinetics on every drug substance out there by memory, and we are called the drug experts. Physicians do not have nearly as much education on medications as pharmacists, yet they are the first line of treating drug overdoses in emergency situations along with the nurses, Physician Assistants and Nurse Practitioners.
The general public is being provided a false sense of security by the media to carry this drug in their homes to address the opioid crisis. The public needs to be AWARE there is more to treating an opioid overdose than just squirting this agent up their nose.
Joan M. Rider-Becker, BS, PharmD, FMPA
Retired, Emeritus Professor, Pharmacy Practice Ferris State University College of Pharmacy
B.S. Pharmacy-Ferris State University College of Pharmacy-1987
Pharmacy Practice Residency-Bronson Hospital Kalamazoo, MI-1987-1988
Doctor of Pharmacy (PharmD), University of Michigan-College of Pharmacy Ann Arbor, MI 1990
by Rose Rohloff
Another common practice over the past decade is the prescription of broad spectrum antibiotics for non-life threatening conditions. Broad spectrum antibiotics are for use in life threatening conditions/sepsis when there is no time to wait for a culture, or the inability to do a culture. Broad spectrum antibiotics target the necessary bacteria needed in the adult intestinal tracts; and so, the standard practice has become the second prescribing for probiotics; the requiring of multiple medications to be taken. Additionally, numerous reports over the last 10 years have shown the continued misuse of antibiotics (e.g. CDC Grand Rounds) causing antibiotic resistance, with the need for more and more antibiotics to be created and used.
What has caused the layering of medications
Consumer engagement is needed with all medications being prescribed to be fully empowered, to understand: 1) the need for prescriptions, why and when appropriate, 2) the side effects of medications to determine alternatives versus adding on more medications, and 3) to eliminate the misuse of medications without the continued layering of additional drugs. Antibiotics should only be used when the body, given time, cannot fight a severe bacterial infection. And, antibiotics should only be given out after a culture is performed to eliminate a virus as the cause, or to target the specific bacteria. Broad spectrum antibiotics should only be used with life threatening-septic issues while waiting for a culture, or there is not the ability to perform a culture.
A middle aged male was recently experiencing severe abdominal pain, subsequently prescribed three (3) medications in two (2) weeks from three (3) different sources (an Emergency Room, a primary care doctor, a Gastroenterologist). There was no diagnosis, no care coordination within an established plan of care, no thorough instruction in the medications, with the last prescription based on a guessed misdiagnosis which worsened his pain. One prescription was a steroid with the patient being instructed to take as he needed it; the second was an offering by the office secretary blindly asking if he wanted an Epipen when he called to actually speak with the physician for worsening abdominal pain, swelling and to discuss his lab work.
The common standard operating procedure (SOP) in medicine has become symptom and write a prescription, another symptom and write another prescription, etc. This SOP has lent to the opioid crisis, antibiotic resistance, as well as many other drugs being dispensed routinely with side effects causing secondary prescriptions for the side effects of the existing medications being taken.
Several variables cause the use of this SOP beginning with the lack to get a full, detailed history - taking time to speak with patients - to establish a diagnosis and then plan of care, determining if simple steps are first needed such as icing and therapy for pain before opioids, or to remove foods and medications isolating side effects or allergies. Last week, I attended the HIMSS conference, the largest healthcare conference in the country, with attendees from around the world. One executive stated, "I just returned from Finland where they have an effective health system, because people live healthy, and the doctors appropriately tell their patients NO when seeking a simple, quick fix of a drug that is not needed."
Reasons for the mainstream SOP?
I think there are always multiple reasons for issues within healthcare. The symptom=prescription issue can be: Doctors are processing patients through with 'factory-care', Physicians receiving kickbacks from pharmaceutical companies; The lack of proper clinical training; Protocols blindly being followed without individual evaluation (e.g. Vanderbilt University study on Plavix standard for all Cardiac Cath Patients); as well as the alliance of public policy and pharma, direct consumer marketing without proper education.
A healthcare executive summarized the situation well last week when stating to me, "I ultimately make the decision for my own care, with the advice of the physician. It is the doctor's role to diagnosis, and then we discuss all options, along with a plan of care, coordinated with speaking with all other involved physicians." It is important for consumers to understand the need to champion their own care working with physicians, determining what options should be used before medications (diet and some of the old fashioned home remedies still hold true), addressing underlying issues versus only symptoms, and removing or changing medications to eliminate side effects when there are alternatives. Questions to have answered:
An example of direct consumer marketing lacking in education: In 2016, there was broad publication when the company Mylan raised the prices of the Epipen after State Law was passed to stock it in every school. Many individuals and groups were upset because there is not a generic offering. With proper information, the public would be educated that Epipen is the patented delivery system, not the drug epinephrine. The generic already existed in the form of a $15-$18 sterile needle. It is also necessary to establish where and when is it appropriate to stock epinephrine, not specifically the Epipen.
Why are you prescribing this medication, what is it specifically doing in my system?
What are non-medication alternatives, what are other medication alternatives?
How long should I take this, what is the outcome? How does it interact with my other medications?
What should be monitored for an outcome, side effects?
The media writes about the desire for transparency with many in the public demanding posted costs for healthcare; however, the public fails to understand - healthcare is not the same as other businesses. First, in business production & marketing creates increased sales volume. Whereas, in healthcare volume is driven by need, and the primary goal of providers should be getting, keeping people healthy, in effect driving away their business. Second, the highest percent of revenue for hospitals comes from the government agency Health and Human Services (HHS), especially the Medicare division. Below is the formula for calculating inpatient payment. So unlike businesses, utilities, or other services, healthcare costs, prices and payments are not simple amounts to readily comprehend. Healthcare information has been publicly available, now is the time to educate consumers in the population of how to find and understand it to champion their care.
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