The "Failure to diagnose factor"...whether relevant to a death or not...is a sure way for a physician to lose a malpractice lawsuit. Complete autopsies almost always find something worth knowing that was unexpected. So, beginning in the late 1970s, the medical malpractice climate had become so threatening that non-teaching-hospital inpatient autopsies essentially came to a halt. But, note Dr. Minarcik's Sept. 2014 article, HERE. Since about 2010, most hospitals have compensated by searching for safer and improved processes & performance with the OPPE/FPPE metrics to track physicians. There is another huge underlying factor which I will go into, below (about overdoses).
Especially following the joining of Dr. John Carter with our group (1984), we began to identify coroner-ordered, autopsy-discerned deaths or findings that could help the living.
- SIDS cases: In the latter 1980s, Dr. Carter began to address the cause of sudden infant death syndrome. In short, intrigued by a British physician's theory that most cases were due to accidental suffication, he arranged her visit and had speaking sessions by her over S. C. Within several years, the number of SIDS cases had decreased dramatically.
- Has possible heart symptoms: Some years back, Dr. Carter detected a pattern of patients dying of heart disease after their primary doctor had set up an appointment for them with a cardiologist. On advising our hospital leadership of this, the Lexington Medical Center Urgent Care sites began to refer any such case straight to the hospital ER; and these sorts of deaths have dropped dramatically.
- Has no doctor: This is the most risky status in our experience. Having noted this risky situation in our cases for years, Dr. Carter rightly & formally suggested the need for public warnings of this risk (53% of our 101 natural death autopsies in 2013 were of patients without a doctor and 6 of the 101 had had health problems and refused to see their doctor or get a doctor!).
- Gun control: This became a hot issue when President Obama became president & there was the Trayvon Martin case (2012) in Florida and the Michael Brown case in Ferguson, Missouri (2014). The danger of public outcry distorting & impeding investigations is illustrated in the 20 minute episode of Forensic Files, "Just Deserts". Our experience suggested that most of our cases were NOT due to (1) ordinary citizens impulsively killing or (2) police killing. I presume (hope) that shooting details are being logged properly into the national FBI crime statistics database. The conversations fell flat and never got to the point of including ER data. But, Dr. Shaw has posted some interesting data, HERE. In 2012, out of 16 million police arrests in the USA, there were only 420 persons that police shot (42% of those shot were white). Also, the Officer Down Memorial Page now exists on the internet, HERE.
- Lexington's Quality and Patient Safety Program: As part of a national initiative, hospital's monitor their physicians' outcomes in patient treatment. It is a completely "inside" program. But, in 2011, Dr. Shaw arranged for certain coroner autopsy cases to be funnelled into this OPPE/FPPE program with remarkably positive effect.
- ***Single-medication & Polypharmacy overdose deaths: In late 2012, Dr. Shaw noticed the prevelance of polypharmacy deaths in his series of apparent natural manner of death autopsies. Coroner & Medical Examiner autopies are ONLY performed in the USA in death cases that were unexpected. Using de-identified case details and after discussing medication use and availability with elderly relatives, friends, and kin, it appeared to him that the "able-bodied" public has a deaf ear toward TV, radio, and print advice and warnings about medication dangers. Dr. Shaw's fear is that the polypharmacy death rate in the elderly, not-as-able-bodied population is MUCH higher due to mix-ups and forgetfulness of when doses were last taken! The CDC estimates that prescrition narcotics drugs cause more USA deaths per year than heroin & cocain combined (a JAMA June 2015 report notes that just opioid overdose deaths of 16,000 cases per year exceeds combined OD deaths from cocaine and heroine4)! And, using 2007 data, the CDC estimates the cost to the US economy to be $55.7 billion per year (just treatment costs and the trauma from impairment wrecks and accidents. S. C. DHEC reports the following accidental S. C. meds deaths: 276 deaths in 2010; 222, in 2011; & 225 in 2012.
Here are some online warnings from agencies who may be aware (but having John Q. Public aware is a whole different matter). In January 2012, the CDC published (Grand Rounds) that there is a nationwide epidemic of prescription drug overdoses. The FDA will apparently take some reports of a single medication adverse effect at Medwatch; but there are medical literature charges that such data at FDA never result in proper cautions getting to physicians and other health care providers. The federal FDA does not track or review such multi-drug deaths, and I have been told that the FDA will only accept on-line a single agent death if the batch number of the medication is known. But, since things can change in time, here is a web page about prescription safety & links for reporting your adverse event, HERE. And, HERE is one review of at least the "pain meds" part of the national epidemic.
THE ELDERLY: This age group is often beclouded by polypharmacy...which includes the above. BUT, nothing much is likely to be reported because "they are old and expected to die soon". In addition5 to the above, this population had as many as 33,000 serious USA hospital admissions 2007-2009 just because of serious adverse effects from just one type of anti-coagulant ("blood thinner"). Insulin and other medications taken to deal with diabetes lead to large numbers of adverse effects.
BUT, there is a HUGE impediment to a common sense approach to pain management: federal law makes it a complete pain in the process by taking a stiffling position on the pharmacy releasing just a partial amount of what the patient's prescription allows (and let them return for more if they really need more; that law HERE). Dr. Shaw suspects 2012 had around 40 polypharmacy OD cases, and there is some preliminary thought that about 20 had some features of the Serotonin Syndrome; reflecting rapid national warnings from other sources about that syndrom, we had no definite such cases in 2013.
Adverse event medical device reporting: The FDA has reporting mechanisms that seem to me to be intimidatingly bureaucratic, HERE.
As I understand it, this sort of institutional reporting to the FDA would be done through the Risk Management Department.
Other: desiring to launch this page now (July 2014), I will have to add the 6 or so other issues Dr. Carter discerned for us from autopsy data later.
Obesity: We are analyzing 2014 data in light of Obesity Hypoventilation Syndrome (OHS) wherein severely obese (BMI greater than 35) persons have Pickwickian Syndrome like impaired ventilation resulting in chronically low pO2 & high pCO2 (often associated with sleep apnea) resulting in chronic hypoventilation, respiratory acidosis, pulmonary congestion, and right heart failure. Things are even worse when there is overlap with COPD. Untreated OHS is reported to have an 18 month mortality rate of 23% (vs. 9% for obesity only)2 and a 50 month mortality rate of 46%3!!!
- S. C. Governor's Prescription Drug Abuse Council: This group hopes to have recommendations by the end of 2014 for the 2015 legislative session. They indicate 225 such deaths in S. C. in 2011. Based on our data for just one county in 2013, I think this problem is drastically under-detected, under-reported and therefore underestimated. The Bureau of Drug Control (BDC) is an agency in S. C. that uses a team of S. C. licensed pharmacists commissioned as law enforcement officers to investigate (usually set to get calls from prescribing practitioners but also might take calls from others, main number 803-896-0636 or use any contact e-mail listed here).
- ISMP: this (Dr. Mike Cohen) excellent, non-profit agency reports drug deaths at home, HERE
- H-CUP: hospitalizations triggered by pain medicine overuse, HERE.
- SAMHSA/DAWN: because of the speed with which ERs (EDs) have to operate, I think this study likely significantly under-assigns rates of adverse drug effects, HERE.
- WHO: world deaths due to alcohol report: a News.Mic web site analyis HERE; WHO anouncement, HERE.
- Dr. Lynn Webster's (of Utah) personal campaign, the over-prescription aspect:
- Feb 2013 5 minute YouTube commentary, HERE.
- October 2013 10 minute YouTube commentary, HERE.
- 2012 3 minute YouTube commentary, HERE.
- Adverse drug effects: As an appendage to the above concerns found in the autopsies we do, (1) HERE is an online calculator to warn of potential adverse interactions; and, following is a beginning listing of alledged, serious medication effects:
- Alzheimer’s risk increased: benzodiazepines (anti-anxiety), HERE.
- Toward more safety: On 6 October 2014, another common class of pain killer was reclassified by the federal DEA onto a schedule which does not allow prescribers to phone in the prescription, HERE.
ADDITIONAL HUGE, UNDERLYING HUMAN NATURE FACTORS: Probably in early 1962 (while deciding which major to choose for my starting year at The Citadel), I interviewed hometown Dr. Ralph Dunn for whom my nurse mother had long been an employee. Cutting to the chase...as we discussed how medicine has a lot of scientific basis, he told me part of a profound truth: (1) "Patients aren't able to pay for medical advice. They feel cheated if they pay you money and walk out with empty hands. You have to give them something concrete...pill samples, a prescription slip, a shot, or some other treatment. You can't just talk. If you don't, you will not make enough income to stay in business." PROFOUND insight! ...(2) Now, I would add the other part: people want an instant "fix" for whatever ails them. They are extremely eager to believe advertizements...especially if it suggests benefit from a secret treatment or a treatment that "most doctors want to suppress". Years ago, some patients even fell for arthritis advice to soak in tubs of cow manure! (3) Most patients are afraid to question...much less resist or refuse...the doctor's advice ("doctor's orders"). (4) Lastly, the federalization of USA health care (Medicare, Medicaid, and Obamacare [the ACA]) has forced the system into worse "helter-skelter medicine". Patients & caregivers MUST remember that they "buy" services from medical practitioners and have the right to decline suggestions or "orders" or request alternative directions based on many personal reasons. With careful thought, you may even go so far as to "fire" your provider and contract with another care giving provider.
- Duane Graveline, M. D., M. P. H., page 97, Correspondence, "Statin Drugs", JAPS, Winter 2014, vol. 19, number 4. HERE.
- Nowbar S, et. al., "Obesity-associated hypoventilation in hospitalized patients: prevalence, effects, and outcome", Am J Med. 2004 Jan 1;116(1):1-7, HERE.
- Our group's Dr. John Carter, memo dated 14 April 2015.
- Daniel Saal, M. D., PhD., "A Piece of my Mind: Rewriting the Script", JAMA 313(23):2323-2324, 16 June 2015.
- "How 'the most dangerous drug in America' is making its way through nursing homes", HERE, 13 July 2015.
(page launched, July 2014; latest adjustment or addition 13 July 2015)