Ethics Prelim 3 Terms in this set (133) Historically, medical ethics/care has focused on: • Fiduciary responsibilities to patient • Do no harm ("Primum non nocere") • Respect for persons (Treating persons as an end in themselves, not as a mea

Ethics Prelim 3 Terms in this set (133) Historically, medical ethics/care has focused on: • Fiduciary responsibilities to patient • Do no harm ("Primum non nocere") • Respect for persons (Treating persons as an end in themselves, not as a means...) But with organ transplantation, persons undergo interventions to benefit others • Consent/authorization • Potential conflicts of interest • Using someone as a "means" History of Organ Transplant • 1954: Living kidney transplant (identical twins) • 1967: First heart transplants Drs. Christian Barnard and Norman Shumway • 1968: Uniform Anatomical Gift Act (revised in 1987, 2006) • 1970s-80s: Modern immunosuppressive era • 1981: Uniform Determination of Death Act • 1984: National Organ Transplant Act (NOTA) 1968: Uniform Anatomical Gift Act (revised in 1987, 2006) -National effort to unify states laws on donation -Sets up a regulatory framework - accepted by states -Established organ donor registries & acceptable documentation of gift -Clarified who can make donation decisions on behalf of others and whether families can override prior 1st person permission (they cannot but...) 1981: Uniform Determination of Death Act • Cardiopulmonary: Irreversible cessation of circulatory and respiratory functions, or • Neurological: Irreversible cessation of all functions of the brain, including the brain stem 1984: National Organ Transplant Act (NOTA) Established: -National waiting list and allocation program -Illegal to compensate for organs (gift, national scarce resource) -Uniform criteria for allocating different organs - grounded in patient's ability to medically benefit -Guidelines to local transplant centers (256 in US) re: wait list evaluations -Organ Procurement and Transplantation Network (OPTN) consisting of 11 regions - 58 front line organ procurement organizations Wide public support for Organ Transplant but not necessarily deep or stable • Public poorly informed about different types of donation • Assumption that the person is dead before donation occurs • Decisions predicated on knowledge of wishes/family consent • Suspicion about how organ donation decisions are made Two different forms of deceased organ donation • Donation after neurological determination of death (DNDD) -Irreversible cessation of all functions of the brain, including the brain stem" • Donation after circulatory determination of death (DCDD) -Irreversible cessation of circulatory and respiratory functions Organ Procurement Process for DNDD and DCDD (T/F): The public is more comfortable with the concept of organ donation after circulatory determination of death than after brain death while the opposite is true for many health care professionals. TRUE Ethical Concerns with DCDD • Separation of decisions re: w/w and donation • Pre-mortem interventions • Impact on other end-of-life preferences • Is pt deceased at time of organ retrieval? -"Permanent" or "irreversible" -Post-mortem interventions Dead Donor Rule • Patient must be dead before organs removed • Procurement can not cause the patient's death Challenge: Donor must be dead, but organs must be viable Living organ donation • 2014: ~ 30,000 transplants, ~6000 living donors • Who is donating? -Gender gap: 60% of living donors are female -Age gap: Living donors are often younger than recipients • Disparities in access: -More likely to receive: white, young, wealthy, privately insured, well educated Types of living donor transplants • Directed donation (most common) –Biological relative –Personal or social connection (e.g. spouse, friend) –Unrelated person who has heard about the transplant candidate’s need • Non-directed, altruistic donation –Until recently, generally not accepted (1990s) –Non-directed altruistic donations are increasing with on-line websites, social media, public appeals –Psychological motivation more complex Matching donors and recipients • Immunologically compatible donor and recipient • Paired donation (paired exchange) and chains -Two or more pairs who do not match trade donors so each candidate gets an organ -Chain initiated by a non-directed altruistic donor • Incompatible donation -Blood type or other antigens -Use specialized medical treatment before and after transplant to minimize rejection Living donation - unique ethical issues Do no harm (“premum non nocere”) Poses risk to a healthy person to improve/save the life of another person (no direct medical benefit for the donor) Respect for persons Human beings should be treated as an end in themselves and not as a means to something else. Kant What is the moral justification for living organ donation? Respect for donor autonomy But must also weigh risk to the donor: • Weighing the benefits and potential harms • Threshold of acceptable risk (autonomy vs. protection) Vetting of potential living donors Rigorous evaluation & consent process for donors -Medically and psychosocially suitable -Fully informed of the risks and benefits -Possesses decision-making capacity -Willing to donate & free from coercion -No expectation of compensation Safeguards -Psychosocial assessment -Independent donor advocate -Cooling off period (stability of preference) Concerns - Informed consent for Organ Donation • Limited long-term donor outcome data • Family members, friends may feel guilt, pressure to donate -Can donation from family members every be truly "voluntary"? Concerns - Motivations of Organ Donation • Pure altruism • Psychological and social benefits • Concerning psychological motivations • Financial or other compensation Privately brokered donations using websites and social media has made discerning motivations with unrelated directed donations more challenging (e.g.M) Overriding ethical principles of Organ Donation • Equity: individuals with similar ability to medically benefit should have similar chance of access • Distributive justice: fair distribution of benefits • Utility: maximization of net benefit to the community Current process for accessing an organ • Patient referred to a transplant center • Local transplant center performs listing assessment (medical and psychosocial eval) • If listed, patient is registered in centralized, national database • When organ becomes available, ranked list of potential recipients is created • Surgeon for top-ranked pt is contacted, decides if organ acceptable, and surgery is Ethics Prelim 3 Wait time for obtaining an organ can vary significantly • Potential recipients listed in a particular area generally considered for organs from a donor in that local area first • Transplant centers and Organ Procurement Organization can vary widely (e.g. # donors in area, # people waiting, # transplants performed, etc.) Potential inequities of Organ Transplant Waitlists • Getting on the waiting list • Strategies to decrease waiting time Getting on the waiting list • Appropriate referral for transplant eval • Variable listing practices and requirements -Psychosocial assessment -Medical assessment • Ability to pay for transplant and long-term medications -Cannot be used in organ allocation once on the wait list Psychosocial Assessment for the Waitlist • PATIENT'S KNOWLEDGE AND UNDERSTANDING –Medical illness and process of transplantation • ILLNESS MANAGEMENT –History of treatment adherence/compliance • SOCIAL SUPPORT SYSTEM LEVEL OF READINESS –Availability /functionality of social support system • PSYCHOLOGICAL AND CONGNITIVE FUNCTIONING –Psychopathology and Neurocognitive impairment • LIFESTYLE AND SUBSTANCE USE –Alcohol use, illicit substance, nicotine use Options to decrease waiting time on wait list • Choosing the transplant center • Multiple transplant center listings • Transferring waiting time • Living Donation -Public solicitation -Incompatible live donor (with desensitization) • Underground market/transplant tourism What can be done with Genetic Screening • Diagnose a condition • Actionable info about one's condition • Identify risk for conditions -Yourself -Your potential child -Your child • Curiosity (DTC testing) Genetic Screening • Single gene or gene panels: selection of specific genes based on symptoms or family hx • Exome: all protein coding genes (code for messenger RNA - proteins) ~ 1.5% of the genome • Genome: an organism’s complete set of DNA (human 3 billion base pairs) • Chromosomal microarray testing:– test for pieces of the genome that are missing or duplicated (Copy Number Variants – CNV) Ethics Prelim 3 Next generation sequencing • Allows sequencing much more quickly and cheaply • Large stretches of DNA (whole genome, exome); high volume of specimens • Commodification - Direct to consumer testing & third party data analysis • Issues re: informed consent • Incidental or secondary findings • Variants of unknown significance • Storing, managing, ownership - Logistical and privacy issues - Responsibility to recontact Genetic Testing: Validity and Utility Analytical Validity: • Can the test consistently and accurately detect whether a specific genetic variant is present or absent? Clinical Validity: • Has having a specific genetic variant been conclusively shown to increase the risk or likelihood of having a disease or eventually developing a disease? Clinical Utility: • Will use of the test provide actionable information re: diagnosis, treatment, management, or prevention and lead to improved health outcomes? Regulation of Genetic Sequencing • Food and Drug Administration (FDA) -Safety and efficacy of drugs, biological products, and medical devices • Genetic testing treated as type of medical device (diagnostic tool) -Until recently, FDA applied "enforcement discretion" to most genetic tests • FDA proposing new guidelines for -Regulating & verifying analytical and clinical validity • Frameworks to evaluate clinical utility still evolving Genetic Sequencing More than just clinical utility - Personal and social meaning • Ancestry, identity, relationships • Variations in how people deal with uncertainty • Data privacy issues • Stigmatization/discrimination General guidelines of Genetic Sequencing • Discuss Implications for family members prior to testing • Duty to inform patients of potential genetic risks to relatives and encourage direct disclosure • Primary obligation - preserve patient’s confidentiality • Disclosure w/o patient’s consent may be appropriate in rare circumstances • Legal cases may ultimately change calculation re: clinician/lab responsibility and how these issues are addressed Genetic testing in children YES • Diagnostic: (evidence of a genetic condition) where benefits include: –clarification of dx/prognosis/recurrence risk, preventive or therapeutic interventions, decisions about surveillance NO • Predictive/pre-dispositional testing for adult-onset conditions: Should be deferred unless a clinical intervention exists in childhood to prevent or mitigate harm –Concern could be psychologically harmful Ethics Prelim 3 Genetic Testing and Cancer Genetic testing is now a standard part of care for children with cancer. Provides information that is both diagnostic and pre-dispositional/predictive. American College of Medical Genetics and Genomics (ACMG)Reporting of incidental or secondary findings • List of medically actionable genes recommended to be reported as secondary findings –Known pathologic variants –Highly penetrant genetic diseases –Established interventions to prevent or significantly reduce morbidity and mortality • Option to opt-out of receiving secondary findings • List continually updated and refined Variants of Unknown Significance • Next Gen Sequencing - growing number of VUS • Deleterious difference or genetic diversity? • Costs of additional testing to clarify • Racial disparity -classification relies on background population data (mostly European) • Issues of disclosure: distress vs. right to info, may impact pt choices • Clinicians interpretations: may impact clinical care • Often resolved over time with more data - logistics and responsibility for storage and re-contacting Direct to consumer genetic testing • Variability in DTC laboratory practices/ accuracy/ interpretation • Adequacy of pretest counseling & informed consent • Potential adverse emotional, psychological, or behavioral outcomes after disclosure of results • Lack of skilled clinicians who can properly interpret results and develop a diagnostic or surveillance program • Need for referrals/follow-up testing to clarify risk • Privacy issues: who owns the data?, sold to 3rd party companies Clinical Research • Provides significant benefit to society: ensuring the safety and efficacy of medical treatment and interventions • Asks some individuals to accept a burden or risk (and no direct benefit) in order to develop knowledge that will benefit others (potential for harm and exploitation) • Most of our codes and regulations related to research involving human participants were formulated in response to significant past abuses Minimal oversight of clinical research before 19th century • During the 19th century, almost all medicine was "experimental" -Therapeutic experiments by doctors on their sick patients. (with the hope of benefiting the patient) • True medical experimentation in the late 19-early 20th century -"Auto-experiments" - Doctors conducting experiments on selves -Increasing use of vulnerable individuals/populations 1947 Nuremberg Code • Developed and used by Allies in Nuremberg Trials to convict Nazi scientists of war crimes 1964 Declaration of Helsinki • 1st international set of ethical principles for research involving human subjects. (World Medical Association) 1966 Henry Beecher NEJM Article Exposed many wrongdoings in clinical research History of Clinical Research 1947 Nuremberg Code 1964 Declaration of Helsinki 1966 Henry Beecher NEJM article 1972 Tuskegee Syphilis Study revealed 1974 National Research Act 1979 The Belmont Report 1981 DHHS - "The Common Rule" The Tuskegee syphilis study Exposed that government was targeting African Americans for Syphilis research 1974 National Research Act • Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • Charged with: -Identifying basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects -Developing guidelines to assure that research is conducted in accordance with those principles. 1979 The Belmont Report • Foundational document for the ethics of human subjects work in the US. • Three basic ethical principles surrounding conduct of research with human subjects: -Respect for persons -Beneficence -Justice (fair distribution of burdens and benefits) The "Common Rule" • 1981: Department of Health and Human Services (DHHS) issued regulations regarding research involving human subjects based on the Belmont Report • 1991: When adopted by multiple Federal Depts and agencies involved in human research, became known as the Federal Policy for the Protection of Human Subjects or “Common Rule” • 2017: The Common Rule was revised to reflect changes/ evolving trends in clinical research Common Rule describes requirements for: • Assuring compliance by research institutions • Obtaining & documenting informed consent • Institutional Review Board (IRB) policies and procedures • Additional protections for vulnerable research subjects Clinical care vs. Clinical research What makes research involving human subjects ethical? Social or scientific value of research • Is the study worth doing? Based on a socially valuable question? • Would it generate important new knowledge? • Would the knowledge gained lead to improvements in health or well-being? • Wrt a clinical trial, is there uncertainty or disagreement about the whether the new Rx is better than standard Rx? (clinical equipoise) • Will the results be disseminated? Clinical Equipoise Genuine uncertainty or conflict within the expert medical community about the comparative therapeutic merits (overall benefit or harm) of each arm of a clinical trial Scientific validity of research • Will the study be conducted in a methodologically rigorous manner? • Is the methodology proposed practical/ feasible? • Will it have sufficient statistical power to definitively test the objective? • Is the study being conducted in a sloppy or careless manner? Fair Subject Selection in research • How will subjects be recruited? Inclusion & exclusion criteria • Related only to the scientific goals of the study or do vulnerability, privilege, convenience play a part in subject selection? • Are subjects selected to minimize risk and enhance any benefits to subjects and society? • Are the individuals/groups who bear the study burdens/risks likely to benefit from and have access to the generated benefits? Favorable Risk-Benefit Ratio of research • Potential risk to individual subjects are minimized • Potential health-related benefits (not payment, access to care) to subjects are enhanced (through gen of new knowledge) • Potential benefits to individual subjects and society are proportionate to or outweigh the risks "Risk-knowledge calculus" • When risk outweighs potential benefits to individual subjects (but society benefits) e.g. Phase 1 trials, Non-inferiority trials Independent Review of research • IRBs, DSMBs, Granting agencies - provide social accountability • Review overall quality and merits of study • Is there evidence of potential bias or conflicts of interest? • Are these (intentionally or unintentionally) distorting the study design, conduct, and data analysis? Expanding potential for conflicts of interest in research • Investigator & Institutional financial interests - financial stakes in research outcomes • Public private partnerships - dissemination of data, impact of patents • Clinical care and research roles increasingly overlap in the same settings -Potential bias (clinician scientist has vested interest) -Undue influence on participants to enroll -Blurring of care vs. research Informed consent in research • Are the subjects given all the necessary information in a way they can understand it? -Purpose of study -Methods and protocol -Risks, burdens, & benefits -Alternatives to the research -Voluntary nature of participation/ability to withdraw • Do subjects understand this information and it's bearing on their own clinical situation • Are subjects making a voluntary and uncoerced decision whether to participate? Therapeutic misconception "Therapeutic misconception exists when individuals do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled in the trial may potentially benefit from the intervention under study or from other aspects of the clinical trial." For valid IC, study participants must understand: • Scientific purpose of study: to produce generalizable knowledge and to answer questions about the safety and efficacy of intervention(s) to determine whether or not they may be useful for the care of future patients. • Study Procedures: may involve procedures or tests that are otherwise not necessary for patient care. • Inherent uncertainty: often more uncertainty about the risks and benefits in studies than in clinical care • Adherence to Protocol: follows a strict protocol • Role of clinician as investigator: minimizing harm, not optimizing benefit to subject, in pursuit of new knowledge Respect for Potential and Enrolled Subjects in research • Does the study respect the privacy and confidentiality of the subjects information? • Does the study allow the subject to withdraw without penalty? • Are subjects provided with new information regarding the effect of the intervention or the subject's clinical condition as this is generated? • Is the subjects welfare carefully monitors throughout the study? • If adverse events occur are subjects provided with appropriate treatment and removed from the study if necessary? • Are subjects informed about what was learned from the study? Coverage of costs incurred - study vs. insurance vs. patient/subject, additional care needed with adverse events, randomization to approved but non-covered treatments and procedures 1999 Jesse Gelsinger • 18 yr old w/ mild form of a genetic disease called Ornithine Transcarbmylase (OTC) • Provided consent for a Phase 1 "Proof of Principle" gene therapy experiment to help severely affected newborns • An adenovirus vector carrying a normal OTC gene was injected into his liver to correct the genetic defect • The gene transfer intervention incited a violent reaction and 4 days after the injection Jesse died Changing healthcare landscape • Medical practice - Decision-making - New treatments/technologies - Changing care delivery • Healthcare organizations - Standardization/management - Competing duties and obligations - Complex systems • Healthcare commodification - Free market forces • Sociopolitical environment - Health policy - Politics Changing medical practice-technology Digital transformation of medicine • Electronic health record • Telemedicine, health-related Internet of things Ethics Prelim 3 EHR: Shapes communication & relationships • Can facilitate more efficient, coordinated, safer care (especially in acute, hospital settings) • But also changes the encounter and decreases time with pt • Shapes questions asked, prioritizes biomedical data • Professionalism issues - cut/paste, check box w/o doing exam • Reduced skill development & direct knowledge • Potential for errors/missed information & non-verbal cues Telemedicine Two-way real-time interactive communication between the patient and the physician or practitioner at [a] distant site Benefits of telemedicine • Enhanced access and quality of care in rural & underserved areas • Assessment and monitoring of remote patients • Timely care and unnecessary transfers • Patient-centered convenience • Facilitates ageing at home • Cost effective Challenges & Concerns of telemedicine • Impact on patient-clinician relationship /quality of care • Reinforce existing inequities (access to/ability to utilize) • Clinician competence/ accountability • Privacy & confidentiality issues • Follow-up & Continuity of care • Financial conflicts of interest • Impact on clinician work-load Machine Learning • Learns from data rather than being programmed with rules • Enhanced accuracy in diagnosis and prognosis Potential adverse effects of machine learning • Decreased need for clinicians in certain areas • De-skilling • Machine errors - quality of data, what's missing • "Black box" issue Positives of team care, specialization • Access to expanded expertise • Care standardization/consistency • Benefit of different perspectives/points of view • Increased efficiencies Challenges of team care, specialization • Care fragmentation & lack of continuity • Communication challenges • Disagreements among care team members • Medical and administrative hierarchies • "Bystander effect" - diffusion of responsibility • "Group think"- suppression of dissenting views Bystander effect • Tendency to be less likely to offer help in an emergency when other people are present • Diffusion of responsibility -Increases with size of group, more likely when responsibilities are not explicitly assigned -Decreases if group members are friends- however this may increase "group think" Ethics Prelim 3 Group think • Stressful environment • Shared group norms (e.g. medical culture) • Desire for conformity/loyalty to group • Isolation from outside influences (e.g. ICUs) • Suppression of dissenting viewpoints (self-or otherwise) • Ignore important information (if conflicts with collective group view) • Heightened sense of being right - can't see different points of view. Defensiveness if error occurs Hospitalists • Model arose in mid-1990s (push for more efficient care w/o sacrificing quality or patient satisfaction) • Now 50,000 hospitalists (larger than any subspecialty in internal medicine) • ~ 75% of U.S hospitals now have hospitalists • Shortened lengths of stay, decreased costs, greater care standardization (hospital- centric metrics) Hospitalists - concerns raised • Discontinuity and fragmentation of care • Longitudinal knowledge of patient • Impact on inpatient teaching • Further narrowing of clinicians' roles/knowledge base Multiple obligations/responsibilities of Healthcare organizations & care delivery networks • Health of individual patients • Health of covered populations • Financial health of organization • Ethical and efficient operations • Wellbeing of organization's employees • Responsibility to their community Healthcare organizations & care delivery networks Emphasis on: • Cost containment • Quality improvement Covered populations Use business practices to manage care: • Standardization/minimizing variance: evidence–based operational routines & rules/protocols for making clinical & Rx decisions • Redesigning clinical processes/work flow to increase efficiencies • Data driven: HCP adherence, pt outcomes and satisfaction • Incentivizing based on performance metrics: HCP, units, care sites Healthcare organizations & care delivery networks buying up physician practices • Impact on fiduciary relationship (pt vs population) • HCP - Competing duties and obligations • Challenges of working in complex systems • Invisible stakeholders at bedside (shape the options available) Complex systems • Intrinsically “hazardous”/potential for harm: nature and conduct of the work, flaws/potential for failure always present, must run continuously (cannot stop while attempting to repair) • Adaptive - continual adjustment to internal and outside forces • Emergence – ever evolving, something new is always emerging • Resilience – individuals and system must cope with inevitable failures, recover, and Ethics Prelim 3 Responses to pressure generated by conditions of complex systems • Moral distress and moral residue • Work arounds • Turfing • Bending the rules/gaming the system Moral distress and moral residue Perceived conflict between what one is expected to do and what one feels is morally right • Perception has two components - That person knows the right thing to do - That person is powerless to do the right thing or will be forced to do the wrong thing Not just an individual HCP’s issue but a patient care/safety problem & a work-place problem Work arounds • Breaking the rules and creating a "fix" to be a good worker in a flawed system • A navigational tool devised to get around some barrier perceived as a threat to getting the job done • Generally reflects pressure to adapt, perception of conflicting rules/expectations, competing demands • Problem itself is not resolved and may be obscured by the fix • Often used by HCPs with less authority (break rules or fail at your work, generally not transparent) Turfing • "Transfer responsibility for a problem from the "turf" of one professional, setting, or institution to another (for a medically inappropriate reason) as a way to get rid of the problem." • Generally requires more authority (power to "move" the problem) • Often involves pts that are difficult or drains on limited resources • A societal/organizational not a medical problem Bending the rules/gaming the system • "Done in the interest of the individual patient (or type of patient) who, in the professional's view would be treated inequitably, rendered worse off compared with others with similar needs, if otherwise well-intentioned rules were followed." • Disenfranchised patients, patients with limited access to care needs Advocacy and bending the rules Advocacy: • Public effort to work towards a more just and rational healthcare structure • Intention is to draw attention to, solve, or repudiate unjust rules, regulation, laws “Bending the rules”: • Practice is often concealed from public scrutiny; may involve deception • Involve subjective judgments of who to bend the rules for How should HCPs respond when they encounter system, organizational, and health policy factors that they perceive are undermining their professional values and fiduciary duties to patients? • Awareness - Distress, something feels wrong • Reflection –Personal moral intuitions and biases, What are the problems? –Problems of negotiating complex systems –Problems of humanity/being human –Difficulty discerning the right thing to do • Agency - self care, ethical response/action “Is there in fact something wrong with this patient’s care and if so, who or what has the power to resolve the problem?” What can one individual do? • Speak up, ask questions, listen • Bedside patient advocacy (yes!, but...) • Positive not just negative (collective) appeals to conscience • Utilize available organizational channels and supports • Change/shape organizational policies and supports • Activism, whistle blowing, civil disobedience • Recognize & reflect on accomplishments, no matter how small Organizational leadership & support essential • Identifying and addressing "foreseeable problems" • Providing opportunities for horizontal and vertical input • Processes for discussing/addressing real-time concerns • Organizational ethics: transparency, values that prioritize shared responsibilities toward patients US Healthcare system • Market approach to health care -Treated as a market commodity that can be bought/sold not as a right or a social good available to all -Above a minimal safety net, access generally determined by ability to pay (with prices responsive to market forces) -Also shaped by: • American culture - individualism, distrust of government, emphasis on technological innovation • Physicians' authority for much of 20th century over how medical care was organized and practiced • Unique among industrialized nations -Other countries adopted variations on national health plans providing access to basic medical care Health services advertising • 1847 AMA Code of Ethics: –“It is derogatory to the dignity of the profession to resort to public advertisements or private cards of handbills inviting the attention of individuals affected with particular diseases.” • 1975 Goldfarb vs. Virginia State Bar (US Supreme Court) –Professions not protected from anti-trust law • 1980: AMA v. Federal Trade Commission –AMA codes of practice violate free-trade principles –Healthcare should be treated like any other commodity –AMA subsequently lifts rules re: physician advertising & era of marketing began Ethical Issues with health service advertising Informational asymmetries/patient vulnerabilities • Difficulty assessing quality (independently evaluation of services) • Difficulty appreciating healthcare needs • Risk of harm - decisions can result in significant consequences Marketing may be misleading • Create a perception of a health need where there isn't one • Foster unrealistic expectations • Manipulate choice by presenting limited or biased information Healthcare unlike other commodities/ businesses • Organizations have shared fiduciary responsibilities to patients • Patients often don't have a choice on which services to use, can't shop around Direct to consumer advertising of pharmaceuticals background • One of only 2 industrialized countries that permit (other: New Zealand) • 1985 - FDA allowed mass-market advertising (mostly print) • 1997 - FDA redefined risk disclosure guidelines, opening door to advertising via broadcast media / internet • 2015 - FDA revised guidelines further - simpler language, greater discretion about which risks to disclose • 2016: DTCA = 6 billion dollars in US • With average amount of TV watching/day 9 drug advertisements/day; 30 hrs. of DTCA/yr Empowered patients vs. manipulation with pharmaceutical advertising Recent studies of pharmaceutical advertising • DTCA does increase patient demand, physician prescribing, less appropriate and less cost effective prescribing, and sales of the advertised drugs • No evidence that DTCA improves adherence, allows patients to obtain needed care at an earlier stage, reduces disease stigma, or provides accurate education • Many advertisements do not adhere to FDA regulations and guidelines • New concerns re: internet advertising Increasing problem with pharma shortages • # drug shortages/yr. tripled from -44% critical shortages (no alternative available) - • Multiple classes of drugs -Particularly generic sterile injectable drugs -Oncology drugs, antibiotics, anesthetic agents, cardiac meds, analgesics, etc. Multiple factors of pharma drug shortages • Shortage of core ingredients • Manufacturing problems -Low cost/narrow profit margins for generic manufacturers -Limited investment in infrastructure, maintenance and investment in facilities • Few generics manufacturers -Delays and capacity issues - more generics being made, increased demand -Little flexibility when problems occur • Product discontinuations -Few manufacturers for each generic drug -Decisions to shift to newer more profitable drugs