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Ok, here’s what happened: in the early 1990’s, when I began my clinical rotations, opioids were generally reserved for fractures, post-surgical pain, and cancer pain. Around that time, two things occurred: there was a movement to address undertreatment of pain by patient advocate groups, later sponsored largely by companies that provided newer opioid analgesics - specifically Purdue Pharmaceuticals w/oxycontin; and the Press-Ganey patient satisfaction surveys were introduced as a way for hospitals to be responsive to patient concerns and complaints. Patients, at least in the ED, who were hell bent on scoring opioids had only to fill out a negative PG survey to hurt a doctor who wasn’t taking their pain seriously - valid in some cases, but in other cases, a form of revenge that actually impacted careers and income for doctors.In my residency, which lasted from 1995–1999, we were told to take the patient’s complaint of pain at face value. Even today, texts state that self-report, using a visual analog scale, is the most reliable indicator of pain. So doctors, most of whom practice in good faith, tend to treat reported pain. Still, I know from personal experience that it is an uncomfortable situation for a patient to be in - I would probably have to be near death from pain before I would ask for a pain med, since I am afraid to be labeled as a “drug seeker.” That is a result of my experience personally as a physician and from listening to colleagues - it is a real song and dance between doctor and patient when it comes to prescribing pain meds. Who leads? Who follows? Etc.And there’s this: the increasing shift in medicine from a profession to a profit center for a few corporations led to cuts in staff and time pressures that shred the ability of doctors to fully evaluate and counsel patients on their pain. My ED implemented an annoying system, after getting rid of things like our stat lab and ED pharmacy - they put a red blinker on the computer to alert us when a patient had been in the waiting room—something we had no control over—for longer than 30 minutes. The message: move them in and out. Fast.Purdue Pharmaceutical should get a lot of the blame for the current crisis, as they almost single-handedly brought about this revolution in prescribing opioids for chronic non-cancer pain. They addressed the earlier fear that patients would get addicted by quoting (with the suggestion that they were quoting an actual RCT) a letter to the editor of a journal, which stated that a small sample of patients treated for pain with opioids in the author’s practice had not become addicted, therefore patients treated for pain with opioids could not become addicted. In other words, Purdue promoted anecdote as evidence and they managed, through intensive marketing, to convince the world of something that simply wasn’t true. Keep in mind, one of the three Sackler brothers who owned Purdue Pharma was an advertising genius, who had achieved a significant accomplishment a couple of decades earlier: he managed to make Valium the first “blockbuster” drug by marketing it as a benign aid to mitigate the stress of modern life, particularly for housewives.Purdue then proceeded to hire a bunch of doctors to speak to their colleagues, convincing them to try Oxycontin as a solution to troublesome patients with chronic pain. They managed to use these doctors to promote their non-evidence. Those troublesome patients, in many cases, became addicted. Some of those patients had real pain. Others had existential pain. Have you ever tried opioids? They tend to smooth out the rough edges of the moment. That might seem helpful, until you realize that a tolerance develops rapidly and dependence means eventual withdrawal.Purdue also shipped massive quantities - dumped them, really - of oxycontin into warehouses that distributed massive quantities into communities throughout the US, even after the DEA and their own executives pointed out red flags. Pill mills sprouted up all over the landscape. People spent all of their time moving from clinic to clinic, pharmacy to pharmacy - obtaining massive amounts of opioids with relative ease - and becoming, often fatally, dependent.When communities started to realize what was happening, it still took several years before they were able to shut it down - and then the drug supply dried up in terms of “legal” prescription drugs. But people were still addicted. And the Mexican cartels moved in, supplying heroin through a decentralized supply network that was efficient and profitable. And our government really failed to punish corporate malfeasance - the living Sacklers of Purdue Pharma are comfortable in their Stamford mansions, after paying trivial fines on their billion dollar drug dealing spree.There’s also this: the recovery industry is largely geared towards 12-step programs that can be cheaply run for maximum reimbursement but have less efficacy than medication assisted treatment for addicts and even alcoholics. This is the industry that fails to offer heroin addicts opioid maintenance therapy on discharge from a largely useless and overpriced stay in a residential treatment center, resulting in many unnecessary deaths, at the cost of broken families, relationships, and lives.Abstinence only programs like AA or NA “frown on” opioid maintenance therapy, yet it is the gold standard for treatment and, in terms of cost, it is much, much lower than the cost of ineffective residential treatment by untrained, non-medical personnel. I personally think these centers should be sued by families who lose their loved ones to overdose, particularly those many cases that occur shortly after discharge. Most of these centers do not provide outcome studies, something that is unacceptable in any other field of medicine. Here’s the other part of the abstinence-only paradigm: without it, the drug-testing industry, worth billions annually, would go bust.This is a societal problem—a problem of profit over people, a problem of easy money and a scheme in which too many beneficiaries can buy a place at the policy table. The recovery industry was largely behind passage of mental health parity. Ask yourself why there are more treatment facilities than mental health facilities in this country and, while you are at it, ask yourself why we spend trillions to reimburse the 17,000 plus facilities in this country while the problem gets worse and has actually lowered life expectancy in the US for the second year in a row.

'How do insurance companies use the magnitude of survival benefit (either OS or PFS) shown in cancer clinical trials to determine reimbursement?'.Estimated value of a new health technology (drug, device, vaccine, procedure) is usually assessed as a ratio called incremental cost-effectiveness ratio (ICER), the numerator the cost difference between the novelty and reference (comparator), the denominator the patient's clinical benefit, typically assessed in clinical trials by measures such as OS, overall survival, PFS, progression-free survival, and QoL, quality of life (1, 2).However, there is still no international consensus on definition of value when pricing drugs (1). This is further complicated by the fact that value may differ considerably between patient subgroups. In recent years, drug makers have also begun to increasingly exploit the ill-defined, ambiguous yet emotionally charged phrase, 'unmet need' to gain accelerated approval of anti-cancer drugs that may neither prolong survival nor improve quality of life (2, 3, 4, 5).This answer is based on what health economists and epidemiologists report about this issue. Specifically, it outlineshow two impediments are common to cost effectiveness analysis of new anti-cancer drugs regardless of country. Specifically, they’re increasingly approved based on ambiguous and incomplete data (PFS not OS), even as they're initially tested mainly on those with advanced disease (worst case scenario), a patent indication that the drug approval and valuation processes are at loggerheads.Country-specific differences notwithstanding, how the US is an outlier with exorbitantly priced new anti-cancer drugs.Two impediments common to cost effectiveness analysis of new anti-cancer drugs regardless of countryTruism to say the more information at hand, better the decision-making process and outcome. This is why it is important to note that regardless of country, cost effectiveness analysis of new cancer drugs is inherently hobbled by two main inter-linked factors (5, 6, 7).1) New anti-cancer drugs are approved based on data with a much higher degree of clinical uncertainty than that necessary to assess their cost effectiveness. After all, evidence that a new anti-cancer drug could prolong PFS by 3 months is similarly perceived as hugely beneficial by patient and regulatory agency alike. However, such a criterion is inherently ambiguous when it comes to making economic decisions.PFS does not represent a tumor-free state, a cure, and thus isn't a meaningful clinical attribute on its own. Rather, being assessed much earlier than OS on smaller sample sizes and not being influenced by cross-over (8), PFS has emerged in recent years as a surrogate for OS to satisfy increasing patient and regulator pressure for accelerated and expedient anti-cancer drug approvals even though how well PFS matches or predicts OS remains an open question for most types of cancers and stages of disease. As a 2016 medico-economic review concludes (see below from 2)'A literature review on surrogate endpoints in oncology concludes:•that intermediate endpoints tend to overestimate the medical benefit;•that they should be validated for each tumor, each stage and each type of treatment, which makes them difficult to use [3—5]. This partly explains the preference for OS by reimbursement agencies.'This review relied on conclusions drawn by 3 separate meta-analyses, meaning it's based on preponderance of evidence from multiple clinical trials (9, 10, 11). Two other meta-analyses in 2017 concluded likewise (12, 13).2) Data that lead to drug approval are generated from groups least likely to demonstrate maximal clinical benefit. Most new anti-cancer drugs are typically tested as single entities in people with late stage disease, those who've already undergone one or more rounds of other anti-cancer treatments and have often experienced tumor resistance or recurrence. Under such far from optimal circumstances, many new anti-cancer drugs show modest effect. However, if approved, such therapies would more likely be used in combination with others and in people with early stage disease. Would they be more effective under real-world circumstances remains an open question at the time their cost effectiveness is initially assessed.Note that ambiguity about drug efficacy cuts both ways. Either the new drug could turn out to be a potential blockbuster or end up merely a me-too, details that'll only emerge from PME (post-marketing evaluation) on a much larger swath of patients.Thus, cost estimates of tangible benefits of new anti-cancer drugs likely poorly estimate their true value since they have access to only worst case scenario clinical data (tested on relatively small number of patients with advanced disease), even as such data are also often only ambiguous and incomplete (PFS, not OS), a scenario akin to crossing an obstacle course blindfolded and with one arm tied behind the back.It also reveals the extent to which shoehorning outweighs scientific merit in the anti-cancer drug approval process, a criticism applicable across the board, not just in the US but also in Europe for example (4). How is it that what it takes to approve a drug has become so antithetical to what is necessary to accurately estimate its price? No clear answer on what should be a burning question for anyone since anyone could become a patient anytime.Country-specific differences notwithstanding, the US is an outlier with exorbitantly priced new anti-cancer drugsWhen inherent ambiguity about drug efficacy mixes with regulatory capture and learned helplessness of the population as has happened in the US, absurd drug price mark-ups become the name of the game. Perhaps unique among industrialized/advanced economies, the US has largely chosen employer-sponsored competing private insurance as the payment structure for healthcare. Meantime, legislation such as the 2003 Medicare Modernization Act ensured that even government insurance programs such as Medicare were deliberately hobbled from setting drug price controls. How well such approaches work in setting reasonable drug prices is reflected by the fact that despite accounting for a mere ~4% of the world's population, the US accounts for ~40% of global pharmaceutical sales (14).Analysis of drug regulation policy suggests an outsize role for cultural forces in this state of affairs. To quote a recent review (see below from 15),'...in a comparative study of drug regulation in the United States and Germany, Arthur A. Daemmrich analyzed the evolution of the medical and political settings of each country during the 20th century, highlighting points of convergence and divergence.58 Daemmrich noted that legislative changes to prescription-drug laws in the United States often occur in response to public scandals. In Germany, by contrast, changes tend to follow protracted negotiations between lawmakers and stakeholders.58 Drug regulation is highly politicized and adversarial in the United States, but much less so in Germany, where health care is widely seen as a right.'Given initial pricing for anti-cancer drugs is formulated when only inherently ambiguous data is available, the absence of a clearly defined regulatory process for setting price control on drugs in the US has artificially created an anything goes environment rife with absurd mark-ups. Let's examine the situation using a zoom-in, zoom-out approach, zoom-in to consider a couple of specific examples and zoom-out to consider international comparisons.Consider what should be a famous example, Aflibercept - Wikipedia or Zaltrap. Initially approved in 2012 for metastatic colon cancer (16), it was priced at ~$11000 per month, apparently such a preposterous mark-up that it provoked no less an entity than Memorial Sloan-Kettering to unilaterally decide it wouldn't use it. A New York Times op-ed authored by Peter B. Bach, Leonard B. Saltz, Robert E. Wittes, all from Sloan-Kettering, explained their rationale stating that available research showed that another drug, Avastin, was just as effective even as it cost ~$5000 a month (17). A month later, the drug maker Sanofi, the French pharma giant, backed down and started offering 50% discount on Zaltrap (18).As an analysis (5) points out, this example illustrates how transparency (relative cost-benefit analysis of zaltrap), choice (other equally effective options) and leverage (Sloan-Kettering size) are 3 policy levers available to negotiate down drug prices. However, they appear to be rarely used as a matter of course in US healthcare.Consider another famous example, Imatinib - Wikipedia, a drug initially developed by Novartis, the Swiss pharma giant, as a 'goodwill gesture' that unexpectedly became a blockbuster but is now selling in the US for typically 2 to 5X the cost as in many other countries as >100 US cancer specialists bemoaned in a letter to the medical journal Blood in 2013. Note also that recouping development costs plays no role in imatinib price since that was already accomplished in its first two years (2001-03) of global sales (see below from 19, emphasis mine),'Imatinib was developed as a “goodwill gesture” by Novartis and became a blockbuster, with annual revenues of ~$4.7 billion in 2012. Being one of the most successful cancer targeted therapies, imatinib may have set the pace for the rising cost of cancer drugs. Initially priced at nearly $30 000 per year when it was released in 2001, its price has now increased to $92 000 in 2012, 1 despite the fact that (1) all research costs were accounted for in the original proposed price, 5, (2) new indications were developed and FDA approved, and (3) the prevalence of the CML population continuing to take imatinib was dramatically increasing. 16 This resulted in numerous appeals by patients and advocates to lower the price of imatinib, to no avail so far.’Zooming out, comparing anti-cancer drug prices internationally, transparency, choice and leverage appear baked into reimbursement decisions in many countries, albeit to different degrees, but not in the US. See below a summary of such comparisons from a 2016 study, 20, that used proprietary data from the global health data maven, IMS Health, emphasis mine,'In the period 2004–14, global expenditures on cancer drug care rose, and cancer treatment made increasing contributions to improvements in patient survival. Internationally, however, there appears to be a wide distribution in the value obtained from cancer drug care. At the extremes, Japan achieved close to seven times as much return in health gains per dollar spent on cancer drugs as the United States did. This disparity was not only driven by economics: Although the United States consistently outspent other countries on cancer drug care in the study period, it also witnessed one of the smallest improvements in cancer-related health outcomes...the United States can do better. The country outspent all other countries in our study on cancer drugs, despite having the highest level of generic penetration in the market and normal levels of cancer drug consumption. This finding persisted even after we adjusted for population and cancer epidemiology,28,29 and it was consistent across both brand-name and generic drugs, across cancer drug classes, and over time. Growth in US cancer drug expenditures is primarily driven not by consumption—which is key to improving patient outcomes7—but by high prices for brand-name drugs. From the perspective of value, the United States accounted for 55.8 percent of total 2014 cancer drug expenditures across all countries evaluated in this study, yet it received just 12.6 percent of the global total net economic return generated in that year from oncology drug care.'Bibliography1. Panteli, Dimitra, et al. "Pharmaceutical regulation in 15 European countries." Health systems in transition 18.5 (2016): 1-118. http://eprints.lse.ac.uk/68290/7/Wouters_Pharmaceutical_regulation.pdf2. Pavlovic, Mira, et al. "Progression-free survival, overall survival and quality of life: What is their medico economic importance in oncology?." Therapie 71.6 (2016): 625-632.3. Kemp, Robert, and Vinay Prasad. "Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?." BMC medicine 15.1 (2017): 134. https://bmcmedicine.biomedcentral.com/track/pdf/10.1186/s12916-017-0902-9?site=bmcmedicine.biomedcentral.com4. Davis, Courtney, et al. "Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13." bmj 359 (2017): j4530. http://www.bmj.com/content/bmj/359/bmj.j4530.full.pdf5. Gross, Cary P., and Abbe R. Gluck. "Soaring Cost of Cancer Treatment: Moving Beyond Sticker Shock." (2017): JCO-2017. Soaring Cost of Cancer Treatment: Moving Beyond Sticker Shock6. Kleijnen, S., et al. "Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries." Annals of Oncology 27.9 (2016): 1768-1775. https://dspace.library.uu.nl/bitstream/handle/1874/331048/kleijnen.pdf?sequence=1#page=377. Taylor, David. "The reality of economics for oncologists." The Breast 33 (2017): 183-190.8. Michiels, Stefan, Everardo D. Saad, and Marc Buyse. "Progression-free survival as a surrogate for overall survival in clinical trials of targeted therapy in advanced solid tumors." Drugs 77.7 (2017): 713-719.9. Buyse, Marc, et al. "Statistical evaluation of surrogate endpoints with examples from cancer clinical trials." Biometrical Journal 58.1 (2016): 104-132. http://onlinelibrary.wiley.com/doi/10.1002/bimj.201400049/epdf10. Ciani, Oriana, et al. "Meta-analyses of randomized controlled trials show suboptimal validity of surrogate outcomes for overall survival in advanced colorectal cancer." Journal of clinical epidemiology 68.7 (2015): 833-842. http://www.jclinepi.com/article/S0895-4356(15)00113-4/pdf11. Ciani, Oriana, et al. "Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study." Bmj 346 (2013): f457. http://www.bmj.com/content/bmj/346/bmj.f457.full.pdf12. Savina, Marion, et al. "Meta-analyses evaluating surrogate endpoints for overall survival in cancer randomized trials: A critical review." Critical Reviews in Oncology/Hematology (2017). http://www.croh-online.com/article/S1040-8428(17)30218-4/pdf13. Tan, Aidan, et al. "Differences in Treatment Effect Size Between Overall Survival and Progression-Free Survival in Immunotherapy Trials: A Meta-Epidemiologic Study of Trials With Results Posted at ClinicalTrials. gov." Journal of Clinical Oncology 35.15 (2017): 1686-1694.14. Schoonveld, Mr Ed. The price of global health: drug pricing strategies to balance patient access and the funding of innovation. Gower Publishing, Ltd., 2015.15. Wouters, Olivier J., Panos G. Kanavos, and M. A. R. T. I. N. McKEE. "Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending." The Milbank Quarterly 95.3 (2017): 554-601. http://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12279/epdf16. FDA Approval for Ziv-Aflibercept17. Opinion | A Hospital Says ‘No’ to an $11,000-a-Month Cancer Drug18. Sanofi Halves Price of Drug After Sloan-Kettering Balks at Paying It19. Experts in Chronic Myeloid Leukemia. "The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts." Blood 121.22 (2013): 4439-4442. http://www.bloodjournal.org/content/bloodjournal/121/22/4439.full.pdf20. Salas-Vega, Sebastian, and Elias Mossialos. "Cancer drugs provide positive value in nine countries, but the United States lags in health gains per dollar spent." Health Affairs 35.5 (2016): 813-823. https://www.researchgate.net/profile/Elias_Mossialos/publication/301791819_Cancer_Drugs_Provide_Positive_Value_In_Nine_Countries_But_The_United_States_Lags_In_Health_Gains_Per_Dollar_Spent/links/57e410b708ae9e8425a2534a.pdfThanks for the R2A, Kyle Murao.

Errors in CommissionPrescription error. Most common medical error and one of the major cause of patient deaths in hospitals.Simple things like missing a decimal point or writing a wrong drug or illegible handwriting can prove to be fatal.Solution: electronic prescription systems, double checking of medicines by two individuals before administration, writing in bold letters, reducing work load on doctors and nurses because tired staff are prone to make more errors.Identification error.Patient is identified wrongly and prescribed the wrong treatment. This happens when patients have similar names. Sometimes, the wrong part may be operated in the same patient, especially if left and right sides are confused.Solutions: identification tags on all patients, checking not only the patient name but also other parameters like hospital number and address, proper marking of surgical site before surgery and person marking should be the person operating.Lab errors.Occurs due to sample mismatch among patients, wrong processing, technical errors in the machine and incorrect entry of results.Solutions: proper handling and labeling of samples, Accreditation of labs by national and international agencies, external quality assurance (EQUAS) program.Errors of omission.Not identifying a condition in time can lead to fatal outcomes. Solution: adequate training of staff, employing the correct individuals, continuing Medical education.Not maintaining infection control standards like hand washing, barrier nursing, excessive and prolonged use of central lines and catheters even when not needed. Solution : training and education, employing more staff.Majority of Medical errors are not reported due to fear of reprisal. A culture of self reporting without fear of punishment should be encouraged to reduce errors in patient care.Medical Errors and Preventable Deaths in U.S. Hospitals - NEJM CatalystStudy Suggests Medical Errors Now Third Leading Cause of Death in the U.S. - 05/03/2016Medical error—the third leading cause of death in the USMedical Error Self-Reporting Stifled by Fears of Retaliation“Fear of reprisals and loss of reputation” stops GPs reporting medical errors