HCS FINAL

-risks --- benefits -equal

"Fair Balance" -The content and presentation of a drug's most important ______ must be reasonably similar to the content and presentation of its ________ -This does NOT mean that ______ space must be given to risks and benefits in print ads, or equal time to risks and benefits in broadcast ads ---It depends on the drug's risks and the way that both the benefits and risks are presented---

Charge

What a provider attempts to bill a payer

Population Health

Health outcomes of a group of individuals (population) -Distribution of outcomes within the group (disparities) -The importance and management of non-clicicl factors (social, economic, environmental) in outcomes ---In this way, you can treat a population wile not treating specific individuals---

-disease -treamtent of disease

Health promotions -Interventions may be targeted at various levels. -By promoting health, __________ may be presented -The important point: health promotion, NOT the ________________

non-health sectors

Healthy People tries to encourage the involvement of __________________ to address determinants of health -Including: -education, housing, environment, transportation, labor, ad agriculture

-Regulation --- marketplace

The Distinction between Regulatory and Market is somewhat Arbitrary -In reality, there's almost never clean separation between regulatory and market approaches ○ ____________ shape the whole US healthcare ______________ ○ E.g., under a (regulated) global budget or when payments are pre- determined by government, a hospital must still function within a sort of market, competing with other hospitals for patients and doctors ○ E.g., Medicare Parts C & D involve choices, but are highly regulated insurance markets, with prospective government payments, and with subsidies ○ So, these categories blur and blend

5

Ten Essential Services of Public Health -Monitor health status -Diagnose and investigate -Inform, educate, and empower -Mobilize community partnerships -Develop policies and plans Enforce laws and regulations -Link people to needed services/assure care -Assure a competent workforce -Evaluate health services -Research (answer 5)

Medicalization

Impact on consumers? "____________________" -When what had been non-medical problems get re-defined as treatable illnesses -Menopause, alcoholism, ADHD, PTSD, PMS, IBS, obesity, infertility, sleep disorders -Is pharma just expanding its markets ("disease mongering")? Or raising awareness?

harm

any unintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment), that requires or prolongs hospitalization, and/or results in permanent disability or death

Food

by contrast, provides taste, aroma, nutrition

health claims

has a narrow, specific meaning at FDA and should be utilized with caution

Disparities

inequalities within a population

dietary supplement

is a product intended for ingestion (i.e., oral) that contains a "dietary ingredient" intended to add further value to the diet and therefore supplement the diet

Process

Donabedian Model the transactions between patients and providers throughout delivery of healthcare ex. Percentage of diabetes patients who receive regular eye exams? (defined as a specific frequency, e.g., annually)

Administrative systems

Structure concerns: types + examples + fixes __________________ -Problem example: poor tracking of infections -Structure change: clear assignment of responsibility for tracking

25

The average life expectancy has increased by ______ years due to public health

Drug

an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or that intends to affect a structure or function of the body

An adverse drug event (ADE)

an injury resulting from medical intervention related to a drug

drug distribution

Health insurance plans and pharmacy benefit managers (PBMs) affect ________________

investment

Pharma Industry - long considered to be a strong and profitable _________

Cost

An economist would say cost is what a provider has to spend to deliver care, the resources that go into a unit of health care service

Administrative Policies

Structure concerns: types + examples + fixes ________________ -Problem example: errors due to resident fatigue -Structure change: a new policy on work hours

0

Governmental Public Health State and Local Health Departments Retain the primary responsibility for health under the US Constitution -State (and district of Colombia) Health Departments (51) -Tribal Health Departments -Local Health Departments (2565) -Territorial Health Departments (8) (answer 0)

Checklist Manifesto

-Atul Gawande -Author of The Checklist Manifesto Also- - Surgeon and Prof at Harvard Sch of Public Health and Harvard Med School - Regular contributing writer in The New Yorker - High profile thought leader -Headed a World Health Organization committee tasked with improving global surgical care -They designed a checklist - applicable in any kind of surgery, at any hospital, anywhere in the world -Cheap & simple & beautifully effective

-knowledge --- skills -public health

-Pharmacist have valuable _____________ and ____________ -Currently providing many "__________" services

33

3 Levels of DISEASE PREVENTION: --Primary, Secondary, Tertiary-- -We can define these levels by: -Goal -Rationale -Target population -Typical intervention activities -Outcome measures (answer 33)

-name -research -NOT

1. Institutional Ad -Includes information such as: -Company _______ -Area of __________ -Does _______ mention any drug names

-RSS facilities (Receipt, Staging and Storage) -Apportionment -8 -4 -100% --- 48 -non-pharmacist

12-Hour Push Package ⪢Push-pack goes to state _________________ within 12 hours, not all the way to your town's EDS (Emergency Dispensing Sites) ⪢ _________________ = breaking up the materials at RSS into smaller packages for individual deliveries to EDS ⪢ Apportionment + delivery should happen within another _____ hours ⪢ Then, first _____ hours after delivery to EDS ---> treat emergency work force and other pre-identified strategic personnel (now= 24 hrs) ⪢ SNS guidance says EDS must treat _____% of local population within ______ hours max (from initial decision) ⪢Waivers for specific events will allow dispensing by _____________ (i.e., usual FDA rules against this may be waived)

7

5 key strategies (answer 7)

External reference pricing

A different type of reference pricing ○ ____________________________ (or international reference pricing) typically sets the reference price as a function of prices of substitute products in other countries ○ This has some market elements but this pretty heavy on the regulatory and government-imposed approach

Population

All of these are variables of what ? -Hospital or pharmacy catchment area -Student population -An employer's worker -A county, state, or country etc..

diabetes

An Hispanic Paradox: Recent immigrants have less _____________ and other health problems than those who have had longer exposure to our "toxic socioeconomic and physical environment"

-scanning -machine-readable -bed-side

Bar Codes •__________ eliminates the need to record via keyboard entry or handwriting • _______________ bar code is exceptionally accurate - Error rate of only 1 in 10 million - vs. 1 in 100 with keyboard entry - Used for groceries since 1970s • Automated ________ verification - Efficiently & consistently documents into medical record - Captures & documents near-misses - Assures compliance with policies & accreditation standards - Patients notice & have greater confidence in quality of care and caregivers

-CMS Emergency Preparedness regulations

CMS Emergency Preparedness Rule -Since 2017, health care providers and suppliers must be in compliance with new _______________________ if they wish to participate in the Medicare or Medicaid program -To ensure adequate planning and coordination for disasters

-beverage --- food -physical -smoke-free

Chronic Disease Prevention Initiatives ◍Focus on 'changing the context' to make it easier for individuals and families to make healthier choices in their daily lives. ◍ Aiming to improve accessibility, affordability and desirability of ○ Healthier _________ and ________ options ■ Particular focus on sugar-sweetened beverages (SSBs) ■ Food insecurity & better access to fresh foods ○ Active transit and leisure-time ________ activity ○ _____________ environments

56

Cost Control Techniques Organized by Market Characteristic Six characteristics of a classic economic market, helping make a market function Which of these do various cost control approaches work through? 1) Budgets exist and constrain choices 2) Buyer has good information 3) Buyer pays a price 4) Buyer decides (patient autonomy) 5) Firms (sellers, providers) seek profits 6) Multiple buyers and sellers (answer 56)

payment

DRGs: Medicare inpatient prospective payment ___________ will depend on which DRG bucket the case belongs in

SDOH (social determinants of health)

Differences in health outcomes are often due to differences in determinants Ex. -Race/ethnicity -economic/income level -educational level -geographic location For disparities, we focus a lot on __________

Institutional

Different Levels of Approaches to Emergency Planning _______________ ○ Hospitals, community pharmacies, universities, etc. - ALL of these develop individual plans to coordinate with local, state, national planners

5

Emergency Preparedness and the Medication Supply Chain -"Healthcare Ready" - a public private partnership ....We help strengthen healthcare through collaboration with public health and private sectors by addressing issues before, during, and after disasters. As the convener of industry and government, we safeguard patient health by providing solutions to critical problems. And, we provide best practices for healthcare preparedness and response."... -Rx Open" service, which maps pharmacies that are still open during disasters (answer 5)

GMP ( good manufacturing practices) -imperfect --- fraud

FDA Foreign Policy -FDA staff on the ground worldwide to ensure _______________ -Nevertheless, FDA protections are ___________ and _______ is a major concern -Imagine the many opportunities for diversion and replacement by counterfeits

MedWatch

FDA's safety information and adverse event reporting program

90%

Generics make up ______% of prescriptions dispensed

Maintain --- improve

Goal of health promotion is to enable people to _____________ or _________ their physical, mental, or social well-being

4

Goal of public health in the US: an integrated system of partnerships that includes, but is not limited to . . . (answer 4)

Health Promotion and Disease Prevention

HPDP?

-self-report -diabetes --- heart disease

Income and Education Matter -They are strongly associated with ____________ poor/fair health status -Income and the prevalence of ____________ and __________

-chronic medical condition -prescription -chronic illness

Individual Preparedness Context is --> Chronic Disease in the US -6 in 10 Americans have at least one _________________ -77-97% of Americans with chronic illness use a _______________ medication -________________ accounts for 50% of all US healthcare expenditures

7

Most Common Promotion Concerns • FDA examines ads • Also, examines what's being said at scientific meetings • Problems FDA tends to observe:• Omitting or downplaying risks • Overstating efficacy • Promotion of unapproved uses (answer 7)

8

One corporation's approach: Walgreens (answer 8)

Health Promotion

Optimize overall health (left)

Per capita

Per person. Remember, total health care spending will increase due to population growth alone

Chronically ill -Educate -reminders -physicians

Pharmacists Preparing their Community -Ensure patients have an adequate supply of medication ○ _______________ patients need 14-30 days' supply ○ ____________ patients about insurers' vacation override and emergency override policies - they may approve higher retail dispensing amounts (i.e., more units) ○ Provide early refill _____________ ○ Encourage home emergency preparedness -Work with local ___________; educate MDs on refill policies, too

-disease --- life --- heath -patient

Public Health -The science and art of preventing _________, prolonging _______, and promoting __________ and efficiency through organized community effort -Public Health sees its "_________" as the entire community, i.e., the people and the physical and social environments in which they live

12

Related issue: Product Quality Problems ◉ Problems with good manufacturing practices of dietary supplements ◎Purity ◎ Quality ◎ Strength ◎ Composition ◉ Problems with accuracy of content labeling ◎ Type of ingredients ◎ Quantity of ingredients ◎ Consistency of dosages (answer 12)

3

Rethink your drink -promoting less SSBs -making them less visible and available (answer 3)

black

Screening rate amongst white men and black men (for prostate cancer) and white women and black women (for breast cancer) were the same ---- the the death outcome was that more _________ men and women died

-local residence -cultural -Adapt

Role of community pharmacist in health promotion Knowledge, experience, ability to customize interventions to meet needs of ____________ -Address ___________ issues in educational materials -__________ educational level of materials

-Natural disasters -Disease outbreak -Man-made -Terrorist attacks

Types of Emergencies and Examples __________________ ○ Hurricanes, tornadoes ○ Floods, earthquakes, wildfires _________________ ○ Severe Acute Respiratory Syndrome (SARS) and coronavirus disease (COVID) ○ Swine Flu (H1N1) ○ Ebola _________________ ○ Radiation release ■ following Japan's tsunami ○ ______________ ■ Bomb ■ Biologic or chemical release (anthrax, sarin gas)

-bulk --- smaller containers -wholesalers --- independent

Typical Drug Distribution in US 2. Repackaging ◍ Medication sold in ________ may be re-packaged from manufacturer or wholesaler into _______________ ◍ Repackaged medications are sent to pharmacy, or to other health care institutions, or back to a wholesaler ◍ Repackaging can be done by _____________ themselves or by ____________ entities

-premium -cost-sharing -request -adherence

Typical Drug Distribution in US 7. (insured) Patient ◍ Pays insurance ___________ ◍ Pays _____________ portion of drug cost ◍ DTC ads may induce patient to __________ meds from MD ◍ Remember: drug assistance programs (financial help) ◍ Key role of ____________

Medical Errors

Yearly Preventable Hospital Deaths Caused by ___________ Exceed Those from Car Accidents, Breast Cancer, and AIDS*

-third --- nurses and physicians ○ Nurses: 2,955,200 ○ Physicians: 713,800 ○ Pharmacists: 312,500

pharmacist are the ____________ largest health profession in the country, behind __________ and _______________

Adverse Drug Reaction

unexpected, unintended, undesired, or excessive response to a medication

Phase IV

Clinical Drug Trials Phases: Studies are done after the drug or treatment has gone on the market. To gather information on effectiveness in diverse populations and side effects associated with long-term use. Not randomized or interventional, but rather, observational

Phase II

Clinical Drug Trials Phases: The drug is given to a larger group of people (several hundred) who have the target condition, to test efficacy and safety, although the studies are still too small to confirm if the drug will be beneficial on balance. Refines the questions for Phase III

Phase III

Clinical Drug Trials Phases: The drug is given to large groups of people (300-3000) to confirm its efficacy, monitor side effects, compare it to commonly used treatments, and collect additional information that will allow the drug to be used safely.

Structure

Donabedian Model the context for healthcare delivery, including buildings, staff, financing, and equipment ... and also policies ex. Does an intensive care unit (ICU) have a critical care specialist on staff at all times?

Outcomes

Donabedian Model the effects of healthcare on the health status of patients and populations ex. Percentage of diabetes patients with their blood sugar under control? (defined as A1C level in a specified range)

-5 -user fee hiring -supplement --- replace -timetables

Drug Review, FDA, and PDUFA -1992 Prescription Drug User Fee Act (PDUFA) • Note: subsequent reauthorizations happen every ___ years (1997, 2002, 2007, 2012, 2017... -"Big Pharma"/PhRMA (the industry lobbying organization) helped draft the 1992 bill • An NDA's sponsors paya "__________" for each application • That funding goes toward __________ more FDA reviewers • Meant to ____________ and not _________ existing government funding • FDA must now adhere to strict _____________ for approval to speed up the review process!

free text notes

Errors at Prescribing Stage: Free Text Notes -JAMA IM study (2016) about poor e-prescribing: two-thirds of _____________ accompanying electronic prescriptions are "inappropriate" - Some should have been in a structured field instead • E.g., drug description ,pt directions, prescribed quantity, days' supply - Others were unnecessary or incomplete

huddle

Hospital-level quality assessment: TJC - Hospital Example What system change could reduce "never events"? - Requiring a "time out" or _______ before every surgery -Everybody in the O.R. must - Introduce themselves to each other - Check the identification of patient - Review what the patient requires - Mark the surgical site on patient

Never --- Sentinel

Hospital-level quality assessment: TJC - TJC and hospital examples "______ events" or "_______ events" = devastating, preventable, unacceptable -TJC mandates performance of a "root cause analysis" after a sentinel event

-1 weeks -chronic illness --- disaster

Household Prescription Drug Stockpiles -US household medication behaviors are themselves a disaster -38% of persons with chronic medical conditions keep less than __________ supply of medications -Guidelines on "personal stock" are inconsistent -3-day, 14-day, 30-day? -Economically and socially vulnerable people are disproportionately affected by BOTH ____________ and ___________________ -Also, extra stocks may be difficult for vulnerable persons to keep and maintain

-characteristics --- receptivity -measurable --- noticeable -sharing -response --- requests

Impact on consumers? It depends on many factors, including • Patient _________ & __________ (demographics (age, education) and health status) • How ___________ and __________ are patient symptoms (Contrast: high cholesterol vs. depression) • Cost _________ (Drug price, formulary tier) • The prescriber's ___________ to patient ____________ • Will they prescribe differently because of patient request based on ad? • Or take valuable visit time to counter confusion from ad? • Visits are already short! What care gets crowded out by that discussion?

Continuous Quality Improvement (CQI)

Improving quality means making changes - a management philosophy which says: most things can be improved - emphasizes systems and processes, not the individual - recognizes both internal and external "customers" • for example, clinicians, management, patients, payers - need objective data to analyze and improve processes - CQI should become a natural part of how work is done

1

Improving quality means making changes -Measure and monitor quality: - structures, processes, and outcomes -Identify problems and errors -Analyze why problems and errors happen -Build systems (structures and processes) to prevent errors from happening again -P.D.S.A. --> Plan, Do, Study (=measure), Act (answer 1)

specialty drugs

In 2014-2015 in particular, we saw a sharp rise in spending on expensive _______________ that raised enormous concerns

-post-market surveillance -Post market evaluations

In response to such critiques ---> important reforms ---> PDUFA IV = a major reauthorization in 2007 -Allots a portion of the user fees paid to FDA to go toward FDA ______________ (i.e., pharmacovigilance, Phase IV) of drug effectiveness and safety -______________________ are performed 18 months after approval of drug, or after its use by 10,000 individuals, whichever is later

6

Individual Preparedness What do you need in your preparedness kit? -This was designed for children, who could be evacuated from school, but then staff may lack access to info files in an emergency -Make a plan with your child and memorize key names / #s. -Can also consider a backpack/duffle for any individual, in case of emergency evacuation -That is, a "go" bag -Include copies of important documents such as medical records, in a Ziploc-type bag -Emergency meds -What else? (answer 6)

-Children and Elderly need to rely on family to be their caregivers -Individual behavior, community, and workplace -You would focus on family and schools

Influences differ by age -- Policy Targeting -Why is the role of family large at the start & end of life? -What are the biggest sources of influence in your life right now? -Policies target different types of people -If you want to target health outcomes for a population of kids, where should you focus your intervention?

5

Institute for Healthcare Improvement's (IHI) -100,000 Lives Campaign The Joint Commission (TJC) -National Committee for Quality Assurance (NCQA) -HEDIS Measures Consumer Assessment of Healthcare Providers and Services (CAHPS): Patient Experience & Patient Satisfaction Pharmacy Quality #1: (URAC) Utilization Review Accreditation Commission Pharmacy Quality #2: (CPPA) Center for Pharmacy Practice Accreditation (answer 5)

-safe -effective -patient-centered -timely -efficient -equitable

Institute of Medicine (IOM) says Quality Healthcare is treatment and care that is... (6 Guiding principles for healthcare quality improvement) 1. ____________ - not adding harm 2. ____________ - backed by science 3. ______________ - respectful of and responsive to the preferences, needs, and values of individual patients 4. ___________ - no needless delays 5. __________ - not wasteful 6. ____________ - without disparities

-individual -community -state -nation -global

Levels of Health Promotions 1) ___________ —e.g., one's own education attainment, income 2) ________________ —e.g., environment, schools, safety and walkability, local availability/accessibility of essential services(groceries, primary care, etc.) 3) _________ —e.g., laws promulgated by the state legislature to improve health 4) ______________ —e.g., grant programs to improve local services, consumer protection laws 5) __________—e.g., availability of organizations that can coordinate global responses to crises (e.g., US CDC, WHO, Red Cross)

-critical pharmacy operations -stock -alternate

Managing the Effects of a Disaster on the Supply Chain -Identify in advance the essential supplies required to maintain _____________________ -Ensure adequate ______ of these are maintained -Evaluate supply logistics and identify potential _____________ sources of supplies -Ensure that institution or community pharmacy stockpiling is in accordance with state and national priorities

-before -authoritative statement -exact -prohibit --- modify -CAN -DS -DS

Mandatory notification to the FDA before making a health claim for a food label... ◉ Must be submitted 120 days ________ use of health claim ◉ Must identify an "______________" about the relationship, (ex. based on current, published, authoritative statements from certain federal scientific bodies or National Academy of Sciences ----- this is intended to expedite the process of review) ◉ Must specify _______ wording of claim that will reflect that authoritative statement ◉ FDA could decide to ________ or _______ the claim ◉ If there is no action by FDA within 120 days, then the claim _____ be made ◉ The law (FDAMA) neglected to apply same rule to ____! ◉ FDA would like to apply this rule for _____ also (ex. to require 120 days advance notice)

-DRG -CMS -Accountable Care Organizations (ACO)

Market Characteristic: Budget Constraints -Budget constraints (in these cases, on provider) • ______ (hospital prospective payment) • _______ bundled payment for hip/knee replacement --- e.g., from pre-surgery to 90 days after discharge • __________________ -rewardor penalize based on spending targets

men and black

Who has higher death rate? Men or women? Black or white?

-FDA -healthcare provider

Who says "No" to a bad ad ... ? • The __(1)___ does, but the ___(1)___ does not usually see an ad until it hits the market • _______________ can report problematic ads to FDA's Bad Ad Program

Health

a dynamic state of complete physical, mental, spiritual, and social well-being and not merely the absence of disease or infirmity*

health statements

statements regarding the product effect on health

Structure/function claims

statements that address the role of a specific substance in maintaining normal healthy structures or functions of the body

Label

what the drug company can say about the product

Public Health

what we as a society do collectively to assure the conditions in which people can be healthy*

-Claim -denied

•A ____(1)_____ is what the manufacturer says about anticipated outcomes from use of the drug •A ____(1)_____ may be __________ FDA approval if there is insufficient evidence, unacceptable risk, or disagreement about the wording of the claim (between FDA and the drug's sponsor)

Strategic National Stockpile (SNS)

⪢ a national repository of antibiotics, chemical antidotes, vaccines, antitoxins, life-support medications, intravenous administration and airway maintenance supplies, and medical/surgical items ⪢ to ensure availability and rapid, scalable deployment of critical medical assets to the site of a national emergency ⪢ for medical material preparedness and response

-ask -name --- use --- condition -brand --- generic -condition --- indication

2. Reminder Ads -A reminder to _____ your doctor about... -->May also help remind patient to take it -Calls attention to drug's ______, but NOT intended _____ or ___________ -Must identify ________ and ______ drug name -Must NOT show picture of anything suggesting _________ or ___________ Notice: no CLAIM is made about the drug

6

4. Product Claim Ads - Example 1. Brand and generic name 2. FDA approved use: allergy 3. By prescription 4. Fair balance 5. Picture not inconsistent with words - man in approved age range, adults 18+ 6. "You are encouraged to report negative side effects of prescription drugs to the FDA" 7. "Brief summary" or "major statement" is on subsequent page (not shown) 8. Ask your doctor for more info 9. Additional sources of more info (answer 6)

-placement --- promotion -point-of-purchase

"Changing the Context" for Beverages in the Retail Sector Goal: assist consumers in making healthier choices by ○ _____________ and _____________ strategies that make healthier choices the 'default' option ■ E.g., baskets of water bottles placed near register ■E.g., by default, your sandwich comes with side salad and water, instead of chips and soda ○ Providing information at _______________ that may influence purchasing decisions ■ E.g., "traffic lights" & calorie counts

-automatic

"Nudging" to promote healthy choices -Understand and capitalize on ____________ decision-making -Retailers have long appreciated this, but public policymakers are just learning -Potential intervention strategies: -Point-of-purchase food/menu labels (information plus) -Make the healthy choice the easy choice (change the default) -Choice architecture (where/how things are located) -Financial incentives -Social norms/framing (e.g., compare people with peers) -All of these strategies maintain individual choice & freedom, but increase the likelihood of the healthier behavior

-unethical -old drug -monopoly -increase

"Price Gouging" -Legal business behavior, but widely criticized as ______________ -Companies conduct market research to find a necessary & cheap _____________ -Often maneuver to ensure they have a _____________ on it -Then, ____________ up the price hugely

Rate setting

"REGULATORY" approaches to cost control? Price regulation - "_______________" = is the usual language for price regulation when talking about hospitals

-pay for performance

"REGULATORY" approaches to cost control? Softer, more indirect regulatory approaches ---> ○ Standardization of care & practice guidelines ■ Potentially paired with "_______________" (= rewards/penalties = more market approach) ■ Hope that guidelines push practice away from wasteful, low-value care ○ System transformations to efficiencies ■ Example: CMS requiring participating providers to have "meaningful use" of EHRs Likewise, hope that these innovations will improve efficiency in care

-diagnosis-related group (DRG) -Bundled -Global -price-setting

"REGULATORY" approaches to cost control? - Price regulation -Medicare's hospital _________ rates -Prospective payment per condition (i.e., per type of hospitalization) -___________ payments -Like DRG, but includes pre- and post-hospitalization care, & defines a time period -__________ budget -Examples are the VHA system in US, and UK's National Health Service -Government ____________ for drugs -In many developed countries, including Canada, the price of a given drug is the same everywhere -tend to be complicated processes - usually involving a review board, negotiations, external reference pricing -that said, all regulatory approaches involve some negotiation (or at least, stakeholder inputs, feedback and iteration) -House passed Pelosi's bill last year to negotiate prices of high cost drugs in Medicare

-patient -europe -therapeutic -one --- difference

"Regulatory" or "Market"? This is another blend of the two Reference pricing ○ __________ decides whether to pay more for expensive care (much like tiers) ○ Common system for drug pricing in ________! -Drugs are grouped into classes with identical or similar __________ effects. -Insurer pays only ______ amount (the "reference price") for any drug in class. A drug company can set a higher price, but consumer pays the ___________. -We did this already in a group discussion exercise...

Healthy People

-A US national agenda that communicates a vision for improving health and achieving health equity

Avedis Donabedian

-Physician & researcher at U Michigan -Creator of the Donabedian model:

generic

-Policies aimed at encouraging _________ entry have gotten stronger

-CPR -vaccination

-Training for pharmacists ○ Obtain complete ______ training ○ Obtain basic cardiac life support certification ○ Obtain _____________ certification ○ Participate in local emergency planning meetings -Train other health professional / Volunteer ○ National pharmacy response teams ○ State and local level teams

association --- causality

-We should be careful about distinguishing mere _________ from ____________ EX. -people with lower incomes do have poorer health -single adults do have poorer health (than married adults -people with more education do have better health -people in "nicer" neighborhoods do live longer THESE are associations -- not correlations! --impossible to disentangle the knot 9 the piling up, the clustering) of risk factors in high-risk populations, but that does not mean these aren't important factors--

-Donabedian Model -Structure --- Process --- Outcomes

-_______________ is a conceptual framework for examining health services and evaluating quality of health care (appearing in 1960s) -continues to be the dominant paradigm for assessing the quality of health care -idea that information about quality of care can be drawn from three categories: __________, ___________, and _____________

-medical injuries -medications -allergic -complications

1 in 5 Medicare patients are victims of _______________ that often aren't related to their underlying disease (2014 study), e.g., - wrong _____________ - ___________ reaction to medication - treatment leading to more _________________ of an existing medical problem "These injuries are caused by medical care or management rather than any underlying disease"

-informational technology -packaging --- labeling

2007 from IOM: Preventing Medication Errors • 1.5M preventable ADEs overall per year (~2004) • Major associated morbidity, mortality ,and costs • Half of meds used improperly • Among recommendations in the report... - Use ______________! - Improve _________ and __________!

patient engagement

2012 PDUFA Reauthorization (PDUFA V) -In 2012, user fees added for • Generic drugs - Generic Drug User Fee Authorization Act (GDUFA) • Biosimilars - Biosimilar User Fee Act (BsUFA) • Plus: more ____________ in the drug evaluation and approval process -"Patients who live with a disease have a direct stake in the outcomes of the drug review process and are in a unique position to contribute to the entire drug development enterprise, including FDA review and decision-making" -- FDA Commissioner, 2012 -Each individual patient has an experience of and perspective on their disease and therapy, and it differs from those of other patients and of their providers -Increased FDA support for patient networks, patient advisors to FDA, hearings with patients, information resources for patients and patient representatives -Added focus on patient-reportedoutcomesandpatient-centeredoutcomes* * = outcomes that patients in particular care about, like functioning and quality of life --> often "soft" outcomes & subjective judgments 15

2

2015 - American Medical Association takes a stand against DTCA -AMA says "DTCA ..." • ... drives demand for new expensive treatments • even when there are effective and less costly alternatives •even when the advertised drug may not be appropriate • and the marketing costs drive up drug prices generally • Current AMA stance: Need ban on DTCA, and better DTCA practices in the meantime • including: clear, accurate, balanced, and not until after some Phase IV experience • AMA connects this to their broader call for improved drug affordability... • Need more choices and competition in the pharmaceutical industry • Need more transparency in Rx prices and costs • Need less patient cost-sharing and fewer restrictions in insurance coverage of Rx • Drug unaffordability negatively impacts patient care • Care is compromised and delayed when drugs are unaffordable • Some patients go without necessary treatments (answer 2)

3

2016 - American Society of Health System Pharmacists also calls for DTCA ban -ASHP: "To advocate that Congress ban direct-to-consumer advertising for prescription drugs and medication-containing devices." -Noting that: • Pharmaceutical companies have increased spending on DTC advertising more rapidly than they have increased spending on research and development • DTCA advertising appears to increase drug spending and utilization • FDA regulatory oversight has not prevented the dissemination of misleading advertising by some pharmaceutical companies • "ASHP believes that medication education provided by pharmacists and other providers as part of a provider-patient relationship is a much more effective way to make patients aware of available therapies, rather than relying on direct-to- consumer advertising" -APhA has not taken a policy position (answer 3)

-brand --- generic -informative -regulated -risks -adequate provision

4. Product Claim Ads -Mentions • _______ name & ________ name • disease / condition / indication -The most _________ type -The most stringently _________ type -Companies can fulfill current requirements for product-claim type DTCA by... • Identifying the most important ______ ("brief summary" or "simplified brief summary") • "__________________" for access to more complete approved product labeling o Ask health professional for more information o Toll-free number for obtaining product labeling o Website address that provides access to package label

-employer benefits

2017 Nobel prize in Economics goes to... Research on "choice architecture" design elements, the focus of Nudge Common modern example: ___________ - If employees have to make benefit choices, don't just give them a chart comparing the options and ask employees to pick and sign up - Many won't do anything, e.g., won't sign up, won't put money away for retirement - It is better to default them to the most responsible choice for their lives, and then they can opt out if they want. - Thus, they still have freedom of choice, but you've totally nudged them in the right direction Another example: some in Congress wanted to eliminate the ACA individual insurance mandate, but set a new default: automatic enrollment into a plan - If person does nothing, they get billed for premiums, stay insured - If they feel strongly about opting out, they can actively disenroll - More freedom and higher rates of insurance vs. simply eliminating the mandate

-condition -company -name --- image

3. Help Seeking or Disease Awareness Ads -Includes medical __________ -Symptoms -Recommend seeking doctor's help -Pharmaceutical _________ name -CANNOT have drug ______ or drug _______ (the opposite of reminder ads)

99

According to FDA's definition, in the DS/FF context, a health claim has TWO essential components: ◉ a substance (whether a food, food component, or dietary ingredient) and ◉ a disease or health-related condition MUST HAV BOTH PARTS! (answer 99)

-community -Rx curriculum -disease-orientation ---- patient-centered orientation -education

American Public Health Association (APHA) Policy Statement The Role of Pharmacist in Public Health - Pharmacist is uniquely sited in the ____________ to provide public health services - We must implement more public health and population- based education in _____________ - Expand from a ___________ to a ____________ orientation with a focus on prevention - Empower community members through -_________ - Develop and mobilize community partners

-safety problems

Any possible downsides to greater speed...? • Jerry Avorn, MD, a renowned researcher at HMS/BWH and frequent pharma industry critic, warned in 2007: ---"Drugs approved just before PDUFA deadlines are far more likely than those approved at other points in the review cycle to cause ______________ after they are in widespread use"--- • Are some applications too rushed? • N Engl J Med 2007; 356:1697-1700 • Avorn further warned: • "The FDA currently lacks the authority to require companies to conduct follow-up studies of suspected safety problems. Most such studies are therefore not performed, even when they are requested." • Drug companies were not submitting further studies as promise

medication error

Any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer

-before -chain of command -theft -test

At the Community-Based Pharmacy: Disaster Plans -Minimize impact on the pharmacy itself ---> make plans _________ an emergency happens ○ Create emergency coordinating team ○ Establish ___________ and communications plan ■ Phone tree with phone numbers ○ Ensure components of pharmacy plan are coordinated with state and regional planning ○ Create a ________ and loss prevention plan (why?) ○ _____ your plan

-FDA -track

Bar Coding at the Point of Care -Bar Coding, a.k.a., - Bar Code at the Point of Care (BCPOC) - Bar Coded Medication Administration (BCMA) -Since 2004, _____ requires bar codes "on most prescription drugs and on certain OTC drugs commonly used in hospitals" -Bar code scanning of patient (wrist band), caregiver (ID), and medication itself to _____ a med from pharmacy, through caregiver, to patient -Bar codes can reduce medication errors by approximately 50-90% by assuring the "5 rights"

-investment cost

Bar Coding: Barriers to Implementation, Limitations • Up-front _________________ - Barcoding all employees and practitioners - Computer system interface & network requirements - Potential provider anxiety (docs, nurses, pharmacists, others) • burden of training • fear of technology • will it add steps to the process and increase workloads?

-bulk --- smaller -all

Bar Coding: Barriers to Implementation, Limitations • _________ meds, especially from overseas, shipped in large quantities that need to be cut into ___________ ones -Labor-intensive repackaging process if must add correct bar codes during repackaging -Potential new source of errors • Inability to bar code _____ drugs and solutions -Do complex IV solutions have the right amounts of each substance?

-wages -ingredients -manufacturing -generic -research --- development -smaller -marketing

Big Pharma is not what it used to be Your typical large pharmaceutical company of 1990 is not the large pharmaceutical company of 2015-2020 ○ Outsourcing ■to India, China, other Asian countries with lower ________ than US ■ of active pharmaceutical ____________ ■ of the drug ______________ ○ Product lines are less exciting ■ A lot of the production now is ____________ ■ Less ____________ and ___________ ■ R&D is now concentrated in __________ start-ups ○ What's left for big pharma to do in the US? ■ Coordination and _____________

-engagement --- advocacy -policies --- regulations -prevention

Boston Public Health Commission Health department for the City of Boston ◍ Mission = to protect, preserve, and promote the health and well-being of all Boston residents, particularly the most vulnerable ◍ By providing and supporting ○ accessible high quality community-based health and social services ○ community ___________ and ________ ○ development of health promoting __________ and ___________ ○ disease and injury __________ ○ emergency services ○ health promotion and health education services ◍ Example: recent multi-year CDC-funded project to foster community environments and policies that "make the healthy choice the easy choice" ◍ [CDC = US Centers for Disease Control and Prevention]

-practitioner ---- collaborate -partnership --- alone

But, public health is not just government -"...The determinants of health are beyond the ___________ of any one practitioner or discipline to manage....We must _______________ to survive, as disciplines and as professionals attempting to help our communities and each other." "It is logical to expect that there is strength in numbers and that _______________ can mobilize material and human resources and be more effective at achieving desired goals than individuals working _______."

Structure/function claim

What type of claim ? ◎ mentions only normal healthy structures or functions ◎ no need for advance notice to FDA ◎ "Ginkgo biloba promotes a healthy brain function"

self-image

CSR at CVS 2018-19 "We are passionate about beauty and the important role it plays in overall health.... - "We have an opportunity, and a responsibility, to think about the messages we send to our customers and how they impact their health... - "The CVS Beauty Mark a watermark that appears on imagery that is authentic and has NOT been materially altered..." CVS BeautyMark is a pledge to pass on a healthy __________ to the next generation

-innovation company -$2 billion -LUNG FORCE

CVS in 2014: No more tobacco products ◍transforming "from a retail pharmacy into a pharmacy ______________________ ◍ stopped selling tobacco products in >7,600 CVS/pharmacy stores ◍ thereby eliminating _______ in sales → CVS took a risk ◍ aligning with community partners and support programs to help people lead tobacco-free lives ◍ working with American Lung Association to support _______________-, raising awareness of lung cancer, the #1 cancer killer of women

-dispersed -volume -outsourcing -regulatory systems -economic fraud

Challenges presented by globalization -more _________ facilities supplying global market -increasing _________ of important products -more ____________ of manufacturing -greater complexity in supply chains -imports coming form countries with less developed ____________ -greater opportunities for __________ In COVID times: -national security concern -can we get the supplies we need for population health when manufacturing is disrupted and demands are suddenly much more intense all over the world? -Risk of EVERY NATION OUT FOR ITSELF -PPE, vaccines, therapeutics?

-Retrospective/FFS -Prospective (ex. HMO) -Diagnosis Related Groups (DRG) payments

Changing the Payment System ⪢ Private insurers & Medicare: shifted in 1980s, and beyond, from retrospective payment to prospective payment ○ Very different incentives and concerns ○ ______________: Do more & make more $$$ — concerns about overuse of care and technology ○ __________________: Do less & make more $$$ — concerns about quality of care, skimping on care ⪢ Big change in Medicare in early 1980s to a hospital prospective payment system, based on ______________________

Phase I

Clinical Drug Trials Phases: Researchers test a new drug in people, for the first time, only in a small group (20-100) of usually healthy people, to evaluate its safety, interaction with the human body, determine a safe dosage range, and identify side effects.

-patient --- pharmacist -autonomy --- dignity -honestly --- integrity -professional -values -individual --- community ---- societal -justice

Code of Ethics for Pharmacists From the American Pharmacists Association (APhA) I. A pharmacist respects the covenantal relationship between the _________ and _________ II. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner III. A pharmacist respects the _________ and _______ of each patient IV. A pharmacist acts with ______ and __________ in professional relationships V. A pharmacist maintains __________ competence VI. A pharmacist respects the ________ and abilities of colleagues and other health professionals VII. A pharmacist serves __________, __________, and _________ needs. VIII. A pharmacist seeks -_____ in the distribution of health resources

Heath Promotion

actions that are affecting one or more determinants of health

-patents -down -block -Evergreening -duplicate

DESPITE the success of the generics market in providing affordable medications... there are still concerns about too much impact of _______(1)_____ on prices, maybe too much _______(1)_____ protection out there ◍ It sometimes takes time for a price to come _________ even after patent has expired ◍ Patent-holders often try to ________ generic entries, through legal maneuvers & business -Ex. they buy out generic entries to slow the diffusion of generics ◍ "_________________": when brand-drug makers get patents on "new inventions" that are merely slight modifications of their older drugs - with little therapeutic gain, and a lot of economic gain for them ◍ Generic manufacturers try to come onto market at a lower price, but ... not too much lower, if possible ◍ Also, some more complicated medications are hard to __________, then generics just don't happen

-Regulatory -Market

DRGs: Medicare inpatient prospective payment ⪢ ______________ aspect: Government payment policy ⪢ ___________ aspect: Private hospitals responding to per-DRGbudget, making new choices based on new government policy

-US -grandfathered in -FDA

DSHEA says: older versus "new" dietary ingredients ◉ New Dietary Ingredient (NDI) ◎ An NDI is a dietary ingredient that was not sold in the _____ in a dietary supplement before 10/15/1994 (i.e., pre-DSHEA) ◎ Older ingredients were "_______________", or allowed - many are folk remedies that have been sold for centuries ◎ Companies must notify ______ before marketing a product with a NDI --->submit a safety notification 75 days before marketing ◎ But that's all - just a filed not

-CANNOT --- disease -after

Dietary Supplements are not drugs ◉ DS _________ claim to diagnose, mitigate, treat, cure, or prevent a specific ___________ ◉ But ... because they do not have the stringent approval requirements for drugs ... problems with manufacturing, safety, and health claims are generally addressed only _______ they reach the market, through legal mechanisms ◉ There have been many legal actions over recent years ◎ e.g., class action lawsuits, state investigations & prosecutions

-Violent -Transportation

Differences over time and between places suggest a big influence of social determinants -___________ mortality: shootings, stabbings (Why the spike in violent crime in the 1990s? ---> lead in gasoline (and paint), rose & fell 25 years prior) -Damages brain structure and function, most severely in kids -->reduced IQ, learning disabilities -->hyperactive/antisocial behaviors -_____________ mortality: cars -improved over time -incresing focus and safety -->seat belts, air bags, antilock breaks --> better highway design -Anti-drunk driving policies -Gun Safety? -- None really

-population -personal

Different Levels of Approaches to Emergency Planning -With disaster preparedness, we need to consider both: ○ _____________ health threat and community-level preparedness -At different levels -National, state, city, and smaller local populations ○ ______________ health, chronic disease, and personal preparedne

-Dept. of Homeland Security -Dept. of Health and Human Services (DHHS)

Different Levels of Approaches to Emergency Planning National/Federal/US ○ ____________________ has general operational responsibility ● esp. FEMA (Federal Emergency Management Agency) ○ ______________________ has medical and public health responsibility, esp. ● Centers for Disease Control and Prevention (CDC) ○ Planning, preparedness, support during disaster and recovery ● Office of the Assistant Secretary for Preparedness and Response (ASPR) ○ Coordination with other federal agencies ○ Medical countermeasures & strategic national stockpile (SNS)

-MEMA (Mass Emerg Mgmt Agency) -Mass Dept. of Public Health

Different Levels of Approaches to Emergency Planning State level - has a similar split structure to National/Federal/US ○ ________ has general responsibility ○ ________________________implements DHHS's national plans Ex: Establishing drug distribution sites, conducting disaster preparedness drills

Individual

Different Levels of Approaches to Emergency Planning ________________ - also should be prepared - home & own inventory

-increases -primary --- secondary.--- tertiary

Disease Prevention Disease prevention targets more specific populations & specificity ______________ as you go towards the RIGHT side of that continuum Often defined as 3 levels of prevention: ____________,___________ and ___________

social --- lifestyle --- environmental

Disease risk factors include many ___________, ___________, and __________ risks

-incentivize --- rare --- neglected -profitability -monopoly -unprofitable

Do we need to reform "orphan drug" policy? ◍The 1983 Orphan Drug Act (ODA) -Intended to _________ the development of drugs that will treat ________ & ____________ diseases -Defined as <200,000 people -For drugs with "no reasonable expectation" of ___________ -Provides manufacturers with an extended ___________: 7 years of exclusivity -Also: tax breaks, R&D grants, waived FDA fees, + fast track approval! ◍Supposedly has spurred a lot of novel research? ◍Though, unclear how many of those meds would be truly "________________" without these incentives ◍Many charge very high prices under market exclusivity

-safety -benefits --- risks -necessary --- fast

Drug Review, FDA, and PDUFA -FDA drug reviews try to balance... • Assuring the ________ of the product • Ensuring that known _________ out weigh known ________ • Getting ___________ meds to the public as _______ as possible • Prior to 1992, there were big concerns about too-slow approvals for submitted new drug applications • AIDSepidemic• Patients dying while awaiting the approvals of effective drugs• FDAwasunderstaffed• Slowbacklogofapplications• AIDSactivistsconductedmajorprotestactions&gotmajormediaattention

-too-slow

Drug Review, FDA, and PDUFA -Prior to 1992, there were big concerns about ________ approvals for submitted new drug applications • AIDS epidemic • Patients dying while awaiting the approvals of effective drugs • FDA was under staffed • Slow backlog of applications • AIDS activists conducted major protest actions & got major media attention

4

Emergency Dispensing Sites: Meeting the Goal ⪢ Expect arrival of SNS ("strategic national stockpile") material to your EDS ("emergency dispensing site") approximately ____ hours before doors open to general population ⪢ Prioritize/consider ○ First responders ■ Fire, police, EMS ○ Strategic personnel ■ Transport, utilities ○ Family members of above ○ Some special populations

1

Emergency Dispensing: Local Planning Team Should include: ⪢ Local public health ⪢ Emergency management directors ⪢ Various reserve teams and committees ⪢ Fire/Police ⪢ Local/Regional hospitals ⪢ Other town departments - e.g., infrastructure ⪢ Other members of community ○ volunteer organizations, teachers/school committee, city/town leadership, licensed professionals ○ "Licensed professionals"not defined, but Mass DPH has included pharmacists in development of state plans (answer 1)

-natural --- man-made -Strategic National Stockpile (SNS) -pharmacists -educating

Emergency Preparedness: Summary -___________ and _____________ disasters can significantly affect the health of the population -___________________ provides back-up supplies for widespread use in major emergencies -________________ need to be involved in planning at every stage — including individual training for themselves -Pharmacists can help limit the effects of a disaster by ___________ both patients and peers -Individuals need to be prepared for zombies, natural disasters, terrorism, contamination events, etc. -NAPLEX could include questions on this topic

costs

Economic Impact of Poor Quality Errors add to health care ______ which are wasted dollars Medication specific in: -Hospitals -Long-term care -Ambulatory care among medicare patients

2x

Education and Infant Mortality Babies born to moms who did not finish high school are almost _________ as likely to die before their first birthday as babies born to college graduates

-receive -high water mark -panic -contingency plans

Emergency Dispensing Sites - Management and operations Local Plans -Within 12 hours of SNS activation, local authorities must be ready to ___________ emergency supplies for immediate distribution of antibiotics or administration of vaccine to every member of the community -They must consider what is their "_____________" for the local population -(i.e.-->assume that schools are in session, consider college/university students, home-bound persons, undocumented immigrants, homeless, seasonal residents, travelers, prisoners, etc.) -They must plan for maximum congestion & even __________ -Major local institutions should have their own emergency _________________

-Generic injectables -switch

Errors due to shortages of generic injectables -___________________ are the most common drug type in shortage -Crucial for certain types of care in the hospital or ED -In a shortage situation, hospital must _______ meds, leading to problems •Substitutes may be inferior choices and/or may have side effects •Clinicians lack familiarity & may make more dosing errors • E.g., deaths due to confusion between morphine and hydromorphone dosing

-Medication reconciliation -Transitions

Errors in Health Care Settings: ______(1)_________ should be done at transitions in care (________ = changes in setting, service, practitioner, or level of care) -______(1)_________ = 5 steps: (1) develop a list of current medications (2) develop a list of medications to be prescribed (3) compare the medications on the two lists (4) make clinical decisions based on the comparison (5) communicate the new list to appropriate caregivers and to the patient

-structure --- process -financial incentives -harm/death -increase

Errors in healthcare Errors : -Are a result of... •Poor __________ and Poor ___________ •Perverse ________________ - practicing to the right of the flat of the curve, where too much care eventually causes harm -Can cause ____/______ -___________ costs of care -Can happen anywhere, anytime, involving anyone- Even in the "best" places, even the "best" professionals- We will err, inevitably

-errors -prevented -medication-related errors -safety

Evolution of Quality Improvement: IOM reports -One report laser focused on _______, another quality more broadly -"To err is human, but errors can be _______" -IOM: 44,000-98,000 people die in US hospitals each year as a result of medical error Most common are: _______________ -Vital need to improve patient _________! -More recent estimates, from various studies: -250,000 deaths due to medical errors per year... -400,000 deaths per year...

payment --- quality

Evolution of Quality Improvement: the ACA • The Patient Protection and Affordable Care Act (=ACA, Obamacare)- Directed DHHS (US Dept of Health and Human Services) to establish a National Quality Strategy, with three objectives, based on IHI's Triple Aim ... - better care » improve overall quality, by making health care more patient-centered, reliable, accessible, and safe. - healthy people/communities (focus on SDOH)- more affordable (to all payers - individuals, families, employers, government) • The ACA's big example = ACOs in Medicare- Linking ___________ for health care to ___________ of care, improving health, reducing costs - ACOs must meet specific targets on quality indicators to get any "shared savings" - incentives pushing away from avoidable hospitalizations, toward more person-centered approach

-formularies -medications

Examples of Roles for Pharmacists Public-health-level activities -Participating in the planning process -Creating ___________ -Developing treatment guidelines -Providing guidance on packaging, storing, administration Pharmacy-level activities -Ensuring ___________ are available when needed -Alerting patients to their role in emergency preparedness -Individual and family preparedness -Preparedness supplies

-language -understanding -clinically significant -comprehensive

FDA Recommendations forBrief Summary or Simplified Brief Summary in print DTCA -Use consumer-friendly ____________ • Avoid scientific/medical jargon • Use a "conversational tone" -Text is visually presented in a manner designed for ease of ___________ by consumers (Ex.- use "signals" such headlines, subheadings, boxes, bolding) -Provide "_______________" information on the • Most serious risks • Most common risks -Include a statement reminding consumers that the information presented is NOT _____________

-LABEL -CDER = (Center for Drug Evaluation and Research) --- CBER (Center for Biologics Evaluation and Research) -separate -main --- supplemental -slow down

FDA approval - of an NDA -Essentially, permission to market the new drug -The FDA approves the _______ -Specifically, approval comes from these 2 FDA units: ______________ and ______________ -Each indication and claim requires _____________ filing material •The __________ application, then ______________ applications •Years ago, companies would file a multi-part package, but a problem in one part could __________ the whole application •Now when filed separately, FDA can approve the main application (w/ most significant indication + claim), and not hold back that process because of a problem with a less significant indication + claim

-indications --- claims -denied

FDA approval of an NDA -Approval is for specific ______________ and ___________, as detailed in the NDA •If further indications are identified later, those must go thru FDA review •A claim may be __________ FDA approval if there is insufficient evidence, unacceptable risk, or disagreement about the wording of the claim (between FDA and the drug's sponsor) -In pharmacy practice-YOU should watchout for off-label uses and claims ---> potentially inappropriate promotion and use

-risk -adulterated -drug claim -labeling

FDA can prohibit dietary supplements that... -present "significant or unreasonable ______" -contain any "poisonous or deleterious substances" -are __________ -make a _____________ (to cure, treat, prevent...) -have untruthful __________

-FDA -scientific approach --- safeguarding

FDA's involvement, pre-NDA -Developers are not required to take ________ suggestions, though this could help in later approval process -Trials must meet federal standards regarding the ______________ and ______________ of participants

-FDA

FDA's involvement, pre-NDA -Developers may request help from _____ at any point in the process: •ex - consult FDA guidance documents & ask questions, get an IND application assessed, request guidance on Phase 3 study design (after Phase 2)

-Investigational New Drug (IND)

FDA's involvement, pre-NDA -Drug developers or clinical trial sponsors must submit an _______(1)_________ application to FDA before beginning clinical research • _________(1)_________ application includes animal study data, toxicity data, manufacturing info, study plans/protocols, relevant data on any prior human research, info about investigators

-30 -clinical trials -clinical hold

FDA's involvement, pre-NDA FDA reviews IND within ____ days and declares: Approval to begin __________, or -_____________ to delay or stop the investigation (rare)

4

For what type of product does DTCA make commercial sense? Or, educational sense? -Unique product-why? -New product, new active ingredient, new player in the market - why? (DTCA bc more expensive and they need to get info out there) -New indication for product-why?• (you want to get the product out there) -Chronic condition-why? (DTCA is rarely seen for acute conditions, such as targeted antimicrobials) -For depression, for Crohn's, for erectile dysfunction, allergies - why? (bc those are things that patients notice and they are going to respond more) -Disease affecting a large population - why? (pay for DTCA bc a lot of potential patients) • To increase awareness of an underappreciated condition • Educate people that a condition is treatable • "Restless Leg Syndrome"? "Dry eye disease"? "Low T"? • Caveat: these 3 commonly cited as examples of over-medicalization (answer 4)

-Institutional ads -Reminder ads -"See your doctor"/ "Help Seeking" ads - Product-claim ads

Four Types of DTC Ads in Print 1. _______________: visibility for company & its research • Promoting the drug company in a general way • Not very common • Seen more in business media, professional media 2. ____________ • Name of product, but no indication... 3. ____________________________ • Indication, but no mention of product • Disease-oriented, describes symptoms 4. ________________ • Indication AND the drug product

-serious conditions --- unmet needs -safety --- efficacy -clinically significant -surrogate

Four special designations to speed NDA approvals -Special designations are given to drugs that treat ___________ and fulfill an ____________ -FDA may consider these factors in making some of these special designations • Improved _______ or ________ over existing therapies • Effects on ____________ endpoints (e.g., serious disease consequences, irreversible morbidity, and death) • Effects on ___________ endpoints (e.g., intermediate endpoints, such as tumor shrinkage rather than survival) ---FDA may approve the drug even without evidence of better survival, just to get it out and available on the market fast---

-frequent -guidance -fast track -breakthrough -accelerated approval -6

Four special designations to speed NDA approvals -Sponsors qualify for more _________ meetings with FDA -May qualify for intensive FDA ____________, involving senior FDA management -These 3 special designations have the standard 10-month timeline • "____________" • "____________" • "___________________" • "Priority Review" designation has a ___ month timeline

1

From CBO's 2009 Report on Drug Marketing ---Note: big increase in pharma spending on DTCA after 1997 ---- But, still, much more is spent on promotion to health care providers than on DTCA ---- (answer 1)

-nutrition -conventional food -statements

Functional Foods ◉ Are like regular foods ◉ But ... supposedly provide health benefits beyond basic ________ ◎ Example - "oats may reduce cholesterol" ◎ Example - "cranberry juice maintains urinary tract health" ◉ Not in a separate regulatory category, not legally defined, so FDA regulates functional foods like _________________ ◎ That is, any ingredients added to basic foods must be "generally recognized as safe" (GRAS) or approved by FDA ◎ Labeling (text box on back) looks the same as a food label ◉ But... the ___________ on FFs about those extra health benefits (beyond nutrition) means FFs require some extra oversight

44

Further regulation: on Product Quality ◉ Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 ◉ Its 2007 final rule defined "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements" '◉ Final rule establishes industry-wide standards for dietary supplements, in order to encourage manufacturing that is consistent as to their identity, purity, strength, and composition ◉ cGMP Standards 1. Qualified employees 2. Manufacturing facility designed to prevent adulteration 3. Proper manufacturing processes 4. Testing of final product + quality control - potency, ingredients, adulterants/contaminants 5. Proper storage 6. Keep records of product complaints (answer 44)

-global -40% -80%

Globalization in the drug distribution chain ◍ The chain is now ________ ◍ According to FDA in March 2013 ○ ____% of drugs taken in US come from outside the US ○ ____% of active pharmaceutical ingredients (APIs) used in drugs ◍ "Like any chain, the drug supply chain is only as strong as its weakest link, and the proliferation of additional handlers, suppliers and middlemen creates new entry points through which contaminated, adulterated, and counterfeit products can infiltrate the drug supply."

-NDA -60 -STANDARD review -Priority Review -information -1 year

Goals of PDUFA's review clock • For New Drug Applications ... for New Molecular Entities and original Biological License Applications ... •The sponsor submits an _________ •1st ____ days: FDA decides whether to file the submission (i.e., NDA appears complete enough to move forward with the review process) •__________________: 90% should be completed within 10 months of filing date •So ---> the goal now is max 12 months (i.e., 60 days plus 10 months) •________________: 90% completed within 6 months of filing date •Clock will stop if FDA needs more ____________ from sponsor • So, FDA now must conduct speedy reviews, and finish within ____________

-voluntary -mandatory -detected

Growth in ADR/ADE reporting -FDA has been encouraging reporting, which partially explains the big increases -FDA Adverse Events Reporting System (FAERS) -combining: -_________ reports via MedWatch from HCPs and patients -_________ reporting from industry -Often these are very rare events that cannot be _____________ in clinical trials -No requirement to report errors -Imperfect data but incredibly important

Personnel

Structure concerns: types + examples + fixes ________________________ -Problem example: insufficient staff at retail pharmacy to counsel patients -Structure change: ratio of registered pharmacists to pharmacy technicians

-disease -regulated -petitioning -reduce -risk-reduction -NOT

Health Claims: for DS and FF ◉ Health claims relate a substance or food to a _____________ ◎ E.g., calcium & osteoporosis; sodium & hypertension ◉ Health claims allow DS and FF to put certain science-backed claims about disease prevention in labeling without being ____________ as a drug ◉ In general, health claims require _________ the FDA, then FDA evaluation ◉ Either (DS or FF) could potentially include health claims stating that an ingredient may ________ the risk of disease ◉ So, only ___________ claims are allowed, not "silver bullet" claims ◎ Not OK --> "Take Ultimate capsules and you'll never get cancer" ◎ Not OK --> "Drinking cranberry juice prevents recurrent UTIs" ◎ Might be OK? --> "May reduce the risk of..." ◉ Up to now, FDA has ______ authorized claims to treat or mitigate disease for FF or DS

26

Health People 2020 had ________ Leading Health Indicators (LHI)

haven't been released yet

Health People 2030's Leading Health Indicators (LHI) ___________________

-PBM (pharmacy benefit manager) -specialist -drugs --- co-payments -administration -formulary

Health Plans - and relationship to PBMs ◍ Examples of health plans: Harvard Pilgrim health Care, Tufts Health Plan, KaiserPermanente, Aetna, Cigna, United, BCBS ◍ Pharmacy-related insurance tasks may be "carved out" and subcontracted to a _____________ ◍ A carve-out such as a PBM is a "__________" in the insurance world ◍ Plan pays for _______ and, with PBM, defines tiered patient ___________ ◍ Plan pays the PBM for _____________ costs ◍ Plan and PBM decide what drugs go on the plan's drug __________ - balancing costs and effectiveness of meds to treat a condition ◍ The balance of incentives, rebates, & decision-making powers vary from one deal (between a plan and a PBM) to the next deal ◍ But, PBMs have been trending from more of a processing role to more real management, decision-making, and financial risk

-health -larger

Health Promotion -Optimize overall health, can reduce lifestyle/exposure risks, but mainly focus on improving ____________ in general (e.g., good nutrition, exercise, sleep) -Usually encompasses _________ populations, though we might consider subsets with particular needs such as by age or gender

-environment -community -parks -neighborhoods --- policing -obesity

Health Promotion Community level interventions -Goal and rationale -an individual's immediate ___________ can enable or inhibit healthy behaviors -Target -__________ infrastructure -Interventions -improve ______, add recreational facilities, better lighting -safe _____________ & "community ___________" -Outcomes and evaluation -_______ rates -teenage violence & mortality

-illness --- injury -imported -contaminated

Health Promotion Global level interventions -Goal and rationale -prevent _______ or _______ -Target -_____________ products, including toys, foods, medications -Intervention -bilateral trade agreements, regulations or standards for imported products; multinational agreements on good manufacturing quality standards -Outcomes and evaluation -reduced exposure to _______(1)________ products -fewer reports of defective or _______(1)________ products

-improve -budgets --- grant -pollution -bike trails -drinking water --- air

Health Promotion State & national level interventions -Goals and rationale -resource allocations or regulations can __________ community infrastructure or services Target -infrastructure or services -Interventions -_________ and ________ programs aimed at improving infrastructure -laws restricting _________ -Outcomes and evaluation -quantity/quality of public parks; ________ -____________ quality; _____ quality

-measurable objectives -Topic areas

Healthy People -A set of specific, _______________ with targets to be achieved over the decade -->Re-envisioned each decade -These objectives are organized within distinct ____________ Also: a subset of these objectives are designated as Leading Health Indicators -->especially important & monitored more frequently

-safe --- effective --- FDA -brief summary -benefits --- risks -fair balance -print -health professionals

Here are KEY POINTS to knowabout pre-1997 drug marketing in the US -Because of the 1938 Food, Drug, and Cosmetics Act (FDCA) and its subsequent amendments • Only drugs proven _____ and _______ and approved by _____ could be on the market • Advertising and promotion must include a "___________" of the FDA-approved information about the drug • Including essentially all __________ and ______ (side effects, contraindications, and effectiveness) • Doctrine of "___________" among side effects, contraindications, and effectiveness -Drug ads were • Primarily in ______ media • Primarily aimed at ___________, though DTCA was on the rise

5

History of Healthy People 1979—ASH/SG Julius Richmond establishes first national prevention agenda: Healthy People: Surgeon General's Report on Health Promotion and Disease Prevention -HP 1990—Promoting Health/Preventing Disease: Objectives for the Nation -HP 2000—Healthy People 2000: National Health Promotion and Disease Prevention Objectives -HP 2010—Healthy People 2010: Objectives for Improving Health -HP 2020 - Healthy People 2020 - launched Dec 2010 -HP 2030 - Healthy People 2030 - launched Aug 2020 (answer 5)

4

Hospital penalties in the ACA -Penalties for high rates of hospital-acquired conditions, especially infections following surgery! -And, penalties for high readmission rates! -Rationale: these problems can be reduced or prevented by following guidelines, so why should Medicare pay for them? (answer 4)

-monitors -TJC-accredited

Hospital-level quality assessment: TJC -The Joint Commission (TJC) -Accredits provider organizations: o Hospitals o Home care/hospice programs o Nursing homes/rehab centers o Behavioral healthcare and addiction service organizations o Group practices/office-based surgery practices o Laboratories -______________ aspects of structure and process, and a little bit outcomes -Hospitals must be _____________ to receive Medicare payments oThat's the main enforcement mechanism, very effective! oAnother example of how Medicare is the 800-pound gorilla in the US HCS

-quality -price transparency

Market Characteristic: Good Information -Information • Public ______ ratings - e.g.,"stars" for hospitals, physicians, Part D plans, MCOs • Practice guidelines-what experts recommend • Comparative effectiveness studies PCORI funds these - head-to-head comparisons of treatments, unlike classic RCTs which are vs. placebo • __________________ tools for patients listing charges or avg payments for different providers' services, "sunshine"

8

Market Characteristic: Multiple buyers and sellers Multiple buyers and sellers (better competition) • Internal reference pricing • Telemedicine • Antitrustenforcement-breakinguplarge provider systems • Retail clinics (often at pharmacies!!) (answer 8)

-engagement -less

Market Characteristic: Patient Autonomy Patient autonomy (buyer decides) • Patient __________ in own care & shared decision-making (between provider + pt) • These should raise the quality (value, benefit) of care • Informed and empowered patients often desire _______ care than what providers are pushing, which may reduce costs of care

-Value-based payments -quality

Market Characteristic: Price Price • Cost-sharing for patient-incentivizes patients to not overuse care • "_____________________"-payment to provider is partly based on how effective the treatment is (according to published evidence, or post-tx depending on individual pt outcome or EHR data for a whole population) • Medicare's payments to providers partly based on the __________ of their care - "pay for performance" (ACOs do this, and fyi only so does MACRA)

-penalties -high cost

Market Characteristic: Profit Seeking Profit seeking (or net revenue maximization) • __________ cut into profits • So, penalize healthcare practices that result in ___________, and the hope is that then you get more cost-effective care, e.g., •Hospital acquired infection penalties •High readmission rate penalties •Medicare now won't pay for "complications" in DRG payment to hospital if they were preventable

-adverse -quality -use

MedWatch -MedWatch used for reporting • serious _________ events • product ________ problems • product _____ errors . • therapeutic inequivalence/failure

333

MedWatch MedWatch covers a range of FDA-regulated products including drugs, medical devices, foods, cosmetics, infant formula MedWatch disseminates product safety alerts - such as product recalls - via website, email list, Twitter, RSS (answer 333)

-Affordable Care Act -coverage plans -critical information

More on CSR at CVS in 2014("corporate social responsibility") "First and foremost, we believe that building healthier communities is about improving health outcomes and providing access to quality, affordable care." ◍ Help Americans during the ___________________ health insurance marketplace enrollment period ◍ comprehensive education campaign about new ______________ ◍thousands of informational events and distributed ACA materials connecting customers to ______________

natural disasters --- terrorism

Natural Disaster vs Terrorism -Far more destruction, deaths, and costs are due to US ______________ than to ___________ -But, any of these can potentially overwhelm local ability to cope

nutrition value

Ordinary foods can claim a structure or function effect only if it is derived from ___________ ◎ example: "milk is a great source of protein & builds strong bodies" ◎ this effect does not make milk a "functional food"

2

Orphan Drugs -In the past, designated orphan drugs have included such blockbusters as Abilify, Provigik, Botox, Cialis, and Vioxx "...industry has taken advantage of the incentives to charge excessive profits and to reap windfalls far in excess of their investments in the drug" (answer 2)

-abused -Recycling -Unapproved uses -Salami Slicing

Orphan Drugs ◍Many experts believe ODA is being __________ ◍Some not-so-novel "orphan drug" development: -"_____________": find an old cheap drug that is already being used off-label for an orphan condition, buy that drug production, run a trial, get orphan status, then jack up the price hugely -"________________": get orphan approval and all the incentives that come with it, but then actually sell the drug to treat other more common conditions -"_______________": narrowly subtyping a disease or condition as finely as possible, in order to sell the drug to each disease subtype for the seven years of exclusivity ◍An important driver of high US drug expenditures today ◍Should we deny orphan drug status in such cases?

-technologies -contribute -security -trust

Other potential contributors to medication errors Health information _____________ can greatly reduce some types of errors But, computerization can also ____________ to errors Computers may induce a false sense of _________ - Beware of a naïve trust in the computer to have all the answers and catch all the mistakes, as if it is all-knowing - Health IT can give only as good as health IT gets, i.e., - "GIGO": garbage in garbage out - Clinicians still have to exercise their active judgment at all times --Conversely, there can also be too little _______ in health IT--

3

Our US Rx drug delivery system is... ...a complex and interdependent system of... -Insurance benefits/restrictions -Refill time frames -Formularies -Co-payments -Pharmaceutical benefits managers (PBMs) -'Just-in-time' delivery practices -Large burden of work on patient, physician, & pharmacist (answer 3)

-Hard -Soft

Outcomes Also sometimes called "endpoints" ________ o mortality o physiologic measurements _________ o involve more subjective assessments by clinicians or patients; e.g., o functioning o quality of life o pain

-quality -Value-based -financial -difficult -process -bonuses --- penalties

P4P: Pay for Performance -An important tool in __________ improvement? -Sometimes known as "_____________ purchasing" -_____________ incentives to providers for meeting certain performance measures - including physicians, hospitals, medical groups & other healthcare providers - usually focused on quality of care measures - but also can be cost-control performance - notice again the similarities with ACO concepts -Clinical outcomes, such as longer survival, are ______________ to measure -So, P4P usually evaluates ____________ - e.g., checking blood pressure; counseling patients to stop smoking -May include ____________ or _________ -P4P may penalize providers for poor outcomes, medical errors, increased costs -In the end, one provider's bonus is another's penalty

7

Pay for Performance (P4P) Professional societies in the US are ambivalent about P4P - Appreciate bonuses and goals of higher quality - Have concerns about... • validity of quality indicators • social determinants may influence patient outcomes more than provider care does • patient and physician autonomy and privacy • increased administrative burdens due to monitoring, reporting Highly recommended: Healthcare Triage video about P4P (6 1⁄2 min) - Includes real-world P4P initiatives - And ... studies showing P4P often has zero impact on performance! - In sum and again: it is not easy to improve quality of care - Financial incentives are not a cure-all (answer 7)

8

Pharmacists should report errors & ADEs Where to report: - ISMP.org --> see ISMP's Medication Errors Reporting Program - FDA's MedWatch Program - has a larger net of interests: • product use/medication error • serious adverse events • product quality problems • therapeutic inequivalence/failure (answer 8)

-sunshine -closely -improve

Pharmacists should report errors & ADEs Why report? - "________ is the best disinfectant" - Don't look away, look _______ - Not to place blame, but to _________ the delivery of care - To better understand underlying issues & trends through pharmaco- epidemiology

-carve out -negotiates -cost-effectiveness -distribution -pharmacies

Pharmacy Benefit Manager (PBM) ◍ E.g.: Express Scripts/Medco, CVS Caremark, OptumRx ◍ Receives "_____________" funds from health plan to cover pharmacy services ◍ _____________ prices with manufacturer (can get rebate) ◍ Develops and maintains formulary based on _________________ ◍ With plan, sets ___________ policy - mail order, vacation supply rules, cost-sharing levels, tiers ◍ Processes plan payments to ___________ (for the drug + dispensing fee) ◍ Is a middleman, does some complex tasks, may be more efficient, but also farther away from patient & patient's needs (than the insurer) ◍ Some scandals have involved not obtaining the best deals for insurers and their members, and pocketing secret rebates ◍ Too much power, too much temptation to be naughty, insufficient transparency?

accessible --- community

Pharmacy locations are very ___________ ... especially __________ pharmacist

-health -accessible -sells

Pharmacy needs strong awareness of DS/FF Consumers ask questions about DS/FF in the pharmacy... ◎ Because DS/FF are linked to _________ ◎ Because pharmacy is ___________ ◎ Because pharmacy ______ these products

dietary substances (DS)

Pharmacy needs strong awareness of DS/FF Growth in use of ________________

-periodically --- prior

Pharmacy: prepare the community -Make a poster and display in your pharmacy ________________ as well as _________ to an expected severe weather event -Have a table in the front of store for products that would be useful for consumers to purchase -Make a print-out for your own family

-modifiable -policies -dispariites

Policies and Programs Matter -Many SDOH are ____________ factors -________________ influence health outcomes and/or have influence on determinants/factors (E.g., a school breakfast program for low-income children) -Role of __________ (-E.g., what if info about that program was distributed only in English? Or, only via email? -What if child has only 1 parent working 2 jobs? -The details of a program can determine a program's effectiveness & how well it addresses disparities)

MD --- patient ---- pharmacy --- patient

Poor Communication and Patient Confusion Errors often stem from poor communication --> Between ________ and _______, or between _________ and ___________: - Failure to provide info to patient and educate patient on administration - Lack of understanding by patient - Failure to ask if patient has any problems/questions re: meds - Low adherence and taking med incorrectly - Confusion may be worse when meds are switched at the pharmacy (e.g., brand to generic, or a last-minute substitution when first drug is not covered) It is tricky and requires skills - Patient may not know what patient doesn't know - Discussion may be a burden & unwanted - Hard to know which patient really needs that discussion

-journals -sponsorship -free -US --- NZ

Prescription Drug Advertising -To health professionals • In ________ aimed at health professionals • ____________ of meetings, talks, meals • Until 2008... ubiquitous branded trinkets --> Voluntarily stopped by pharma companies • ________ samples of medications • "Detailing" (1:1 marketing of a physician by a sales rep, educating about a company's products, with the company's goal that the physician may prescribe the products more often) -Direct to consumers (DTCA) • Magazines, TV, radio, internet -Only two countries allow DTCA ! • ____ and ____ • Does our outlier status tell us anything about whether this is a good idea...?

Packaging

Preventing Administration Errors ____________ By the time an object, or an apartment, or a company hits the half-century mark, it's usually been through a redesign or two. Yet the standard-issue amber-cast pharmacy pill bottle has remained virtually unchanged since it was pressed into service after the second World War. (A child-safety cap was added in the seventies.)

-bottles --- labeling

Preventing Administration Errors Medication _________ and _____________ -Electronic and typed doesn't necessarily result in perfectly readable information... -It is a non-US example: -Mercilon is an oral contraceptive, taken once daily -How might this have been avoided?

Adverse Drug Event (ADE) -preventable

Preventing Administration Errors __________________ may include: - medication errors - adverse drug reactions - allergic reactions - overdoses -ADEs can happen anywhere (e.g., inpt, outpt) -Majority of ADEs are __________ Reducing ADEs will lead to... - safer, higher quality health care - improved health outcomes - reduced health care costs

Spending

Price × quantity. Note that this is a payer's total cost. (Unless specified as "per person spending".)

-new cases -exposure rates --- resistance -exposed --- increase -source -educate -exposure --- disease

Primary Prevention -Goal: To reduce number of _________ -Rationale: By reducing _____________ or increasing _____________, we can reduce number of new cases -Target population: Those who are most likely to be _____________ and/or could __________ their resistance -Typical activities: -Remove or reduce __________ of the risk -_______________ and make aware of disease risk -->include behavioral changes to reduce exposure -Improve general health -Outcome measure: incidence of __________; incidence of ______________ --example: Triple E (Eastern equine encephalitis) or Zika virus--

2

Process concerns -What are we doing? -Right thing, right person, right time? -Ex. what percentage of individuals with diabetes were tested for A1c level in last 6 months? -Such processes can potentially explain our notorious geographic variation in health spending and in health outcomes (answer 2)

3

Processes vs Structure : Examples -Processes = what gets done, the transactions of health care -Practice guideline oHaving or requiring them is part of structure o Following them is part of process -Bar codes? o Having or requiring = structure oUsing them = process -EHRs? oHaving them & what are their capabilities = structure oMeaningful use of them = process -Processes are easily measured & commonly measured o But... are they what we care about? o What we really want is good health o So, we also need evidence linking best practices to patient outcomes (answer 3)

55

Product Claims - Background ◉ 1990 Nutrition Labeling and Education Act (NLEA) ◎ Allowed for health claims in food labeling ◎ But these must have significant scientific agreement (SSA) ◉ 1994 Dietary Supplement Health and Education Act (DSHEA) ◎ Allowed structure/function claims in DS labeling ◎ Also allowed: claims (answer 55)

-specific disease -health claim --- drug claim

Product Claims: Two common types of claims for DS/FF Health Claim ◎ Links product to a ____________ (E.g., "This product may reduce risks of developing varicose veins" ○ A health claim like this could go on a DS/FF, if FDA says it is OK ◎ Important: distinguish between what FDA defines as a _________ (might go on a DS/FF) and a ________ (e.g., curing, treating, mitigating) ○ Drug claim example: "Helps reduce symptoms of leg pain, heaviness, and swelling in people with varicose veins"

-structures --- functions -fix --- stop

Product Claims: Two common types of claims for DS/FF Structure and Function Claim ◎ E.g., "Helps support the body in maintaining healthy circulatory function in leg veins" --> No specific diseases - just _________ or ________ of the body --> Doesn't _____ or _____ a disease - more like health promoting

-epidemics --- disease -environmental -healthy -disasters --- recovery -health services

Public Health -Prevents ___________ and the spread of _________ -Protects against _____________ hazards -Prevents injuries -Promotes and encourages ________ behaviors -Responds to ___________ and assists communities in ___________ -Assures the quality and accessibility of ___________

-education -pubic -dispensing -interprofessional

Public Health:Challenges for you to consider exploring ◍ ____________ of pharmacists ○ NU has PharmD/MPH dual degree program ◍ Growing the profession ○ Education of the __________ ○ Role of pharmacist beyond _____________ ○ Payment for broader services & recognition as providers ○ Population approach in e.g., ACOs: keeping people healthy ◍ Get involved in _____________ projects & research

NCQA - using HEDIS (including CAHPS)

Quality Assessment Relevant Entities - Health Insurance Plans Accreditation/Quality Measures - ???

URAC, CPPA

Quality Assessment Relevant Entities - Pharmacies Accreditation/Quality Measures - ???

TJC

Quality Assessment Relevant Entities -Hospitals (and other health care provider organizations) Accreditation/Quality Measures - ???

-Quality improvement -quality --- safety

Quality Improvement vs Patient Safety? - __________________ initiatives focus on ensuring patients get what they need, when they need it, in an appropriate way - __________ is a bigger / broader issue than ________

Patient safety --- harm

Quality Improvement vs Patient Safety? Patient safety is only one dimension of quality -_____________ initiatives focus on identifying and preventing __(1)___ • Note also that --> not all medical errors result in __(1)___ • And when __(1)___ does occur, it is not always the result of a medical error • But preventable __(1)___ is, by definition, a medical error

-loose -food -enhance -value --- significance

Regulation of Dietary Supplements ◉ Relatively _______ regulations apply (versus drugs) ◉ Regulated primarily under: ◎ Dietary Supplement Health and Education Act of 1994 ◎ a.k.a., DSHEA (or "dee-shay") ◉ As a special category of _______ ◉ DS are intended to _______ normal dietary intake of nutrients, or for specialized purposes such as relaxation or stimulation ◉ DS are not required to have recognized nutritional ________ or clinical ____________ ◎ That is to say... they do not have to be effective at anything! ◉ Also important: in 2007, FDA issued GMP (good manufacturing practices) standards for DS

FDA's Adverse Event Reporting System (FAERS) + CAERS

Reporting programs that track problems with drugs and DS/FF, respectively

-dissemination --- publication -delay -voluntarily

Requirements for industry: submitting ads for OPDP review -80,000 submissions per year to OPDP from drug companies! -OPDP requires submission of all promotional materials at the time of their initial __________ or ____________ -Therefore: there is a built-in _______ during which the public will see the ad -OPDP encourages companies to ____________ submit ad materials in advance, to get OPDP comments • Especially for drugs new to market (ex - ,for product launches • But,OPDP does not generally "pre-clear" promotional materials

-adherence -price -sales -doctor visits -appropriate care

Research on DTCA suggests that... -DTCA increases __________ -DTCA does not have direct effects on a particular drug's ______? -DTCA does increase _______ --> but not only for the advertised drugs • Prozac ads also increase sales of Zoloft • Encourages treatment more generally, an effect on the whole therapeutic class -DTCA increases _____________ -Patient drug requests increase chances of _______________ • Study used actors pretending to have depression • 56% not requesting drug didn't get "appropriate care"; 90% requesting drug did • But, only half of those with "appropriate care" got a drug; the rest got a mental health referral • Patient requests may signal to MD: "this is an activated patient with serious concerns"

health promotion -trusted -accessible

Role of community pharmacist in health promotion Community pharmacy is an ideal location for _________________ activities -Pharmacists are ____________ health care professionals -Most _____________ health care professional

-tertiary -secondary

Role of community pharmacist in prevention -Traditionally invited in: -___________ prevention for individuals -___________ prevention for individuals

-primary -secondary --- tertiary

Role of community pharmacist in prevention -With a dose of imagination and creativity, the role can be expanded into: -______________ prevention for individuals and populations -______________ and/or ___________ prevention for population

-profit --- society

Roles for Pharmacist -For _______ motive AND the good of ______ -Emergency preparedness kits -Set up a dedicated table and sell prep kit items ○ Periodically ○ When a storm is predicted, for example -What do you think a family needs to have to be prepared? ○ What do you have on hand now for emergencies? ○ In your apartment/dorm? That you carry around? ○ What do you typically do when you know a storm is coming?

generic

Roughly 1 in 10 chronic illness meds are _____________

-could not -adverse events -signal detection system

SAFETY CONCERNS have led to additional oversight ◉ Initially under DSHEA, FDA ______________ require a manufacturer to submit an adverse reaction report for a DS product ◉ Dietary Supplement and Nonprescription Drug Consumer Protection Act (of 2006) requires companies to report serious _____________ ◉ FDA developed a _____________ based on voluntary & mandatory reports : ◎ CFSAN Adverse Events Reporting System (CAERS, since 2003) ◎ if parallels FDA Adverse Event Reporting Systems (FAERS) for drugs

-Routine maintenance medications -adverse reaction

SNS does NOT include ⪢ _______________________, such as high blood pressure meds ⪢ Medication to treat _______________ to vaccines or emergency medications ⪢ Supplies to support the EDS Staff, such as water or sanitation supplies ---But remembermore medical materials can be purchased and supplied by SNS to states for specific situations----

-State -Governor -pre-positioned -deployment -FREE

SNS help is requested by the _______ ⪢ Commonwealth of Massachusetts formally requests assets from the SNS ○ ______(1)_______ of state, or designee, must request from DHHS ○ Mass DPH and MEMA work closely with ______(1)_______ ⪢ However, SNS materials may be ____________ without a request in anticipation of an event (e.g., for Katrina hurricane) ⪢ Federal government approves _______________ of SNS when evidence suggests that local and state assets could be overwhelmed by need Requests flow local ---> state ---> national + help flows back ⪢ ________ to areas in need

Sugar Sweetened beverages

SSBs

-new cases --- severe cases -morbidity --- mortality -exposed --- early symptoms -screening -eearly -severe

Secondary Prevention -Goal: Reduce number of __________ (especially among those who are exposed); or ... reduce number of ___________ -Rationale: By reducing number of exposures and early disease that progress to more severe disease, _________ and ______________ can be reduced -Target population: Those who have been ____________ to the disease-causing agent or have ______________ of the disease -Typical activities: • ____________ for exposure and/or disease • Post-exposure prophylaxis • __________ treatment to reduce impact of disease or reverse its course -Outcome measure: incidence of disease, prevalence of ________ disease --examples (and primary vs secondary approaches): ■ STDs/PTSD due to sexual assault; ■ environmental toxins (lead, pesticides) ■ diabetes; cancer;--

88

Some DS/FF market growth areas ◉ Seniors ◎ health promotion + disease prevention ◉ Specialty supplements ◎ prebiotics & probiotics ◎ omega-3, joint formulations ◉ Herbs and botanicals ◎ "super fruits" (noni, mangosteen, goji, açaí ...) ◎ green tea ◉ Sports enhancement/medicine ◉ Vitamins ◉ Minerals (answer 88)

-correctional

Special Populations ⪢ Provide delivery of medications to: ○ Long-term care facilities / rest homes / nursing homes ○ _________________ facilities ⪢ Organize w/ special populations leadership to pick up medications at designated EDS for: ○ Assisted living centers ○ Group homes ⪢ Essentially, local govts delegate responsibility for these populations to respective institutional staff

-NO -all -oral presentations

Specifically, it's the FDA's Office of Prescription Drug Promotion -The OPDP says "____" to bad ads -OPDP regulates _____ promotional materials • Print, TV, sales aids, patient brochures, drug websites, email alerts, webinars... -OPDP also reviews ____________ by company reps • Including sales reps, spokespeople, medical science liaisons OPDP is mainly staffed by PharmDs

-cross-training

Staffing Issues in the Pharmacy -Expect some work force reduction ○ Standard pandemic planning assumes that 30% of the population will be affected ○ Up to 40% of workforce may be affected -Solutions: ○ Develop policies for flexible work sites (tele- commuting) ○ _____________ employees to perform others' tasks ○ Identify business functions that can be outsourced

ePrescribing (in community)

Stage 1: Prescribing? Instantaneous & standardized communication between these key entities

-handwritten -scripts -call-backs --- post-visit

Stage 1: Prescribing? Potential Benefits of Connectivity for the MD ... and for Patients •Valuable informational tool w/ - Patient medication history - Drug-drug interactions - Adverse drug reactions - Clinical guidelines - Adherence monitoring - Formulary & generics information •Avoids dispensing errors from ____________ interpretation •____________ are standardized & complete •Reduces volume of ___________ and _________ interactions for physicians and their staff

-call-bakcs -computerized -satisfaction -relationship -turnaround

Stage 1: Prescribing? Potential Benefits of Physician Connectivity for the Pharmacy Provider -Reduces the volume of _____________ to physicians and patients -Provides a _____________ record of renewal requests to/from the physician office -Improved patient _____________ -Improved ___________ with physicians -Improved _____________ time

Computer physician order entry (CPOE)

Stage 1: Prescribing? ___________________________ -Major advances! -MD office computer order entry -Bedside computer order entry -SureScripts network -enabling providers to transmit new prescriptions t

-US Department of Health --- Human Services (DHHS) -Y2K -terrorist attacks --- epidemics

Strategic National Stockpile (SNS) -The SNS is managed under the ________________ and _______________ -Originally created because of concerns in advance of "______," with potential disruption of computerized systems across the US and shortages of critical medical supplies ⪢ Role has expanded over years because of _______________ in 2001 & deepening public health concerns about bioterrorism, _____________, and natural disasters

-justification -SNS inventory

Strategic National Stockpile (SNS) SNS purchasing power ○ DHHS/SNS will procure any medical, surgical, or pharmaceutical asset requested by a state with ___________ ○ Not part of the ______________, but purchased as needed in quantities necessary to meet the demand

-general -timeframe --- amount

Strategic National Stockpile (SNS) Why stockpile? ⪢ When a specific product required to treat a specific disease or condition is not available to the ________ public ⪢ When more ordinary products may not be available in the ___________ or the projected _____________ required ---For situations such as bacterial and viral disease outbreaks (including smallpox), pandemic influenza, COVID, radiation/nuclear emergencies, chemical attacks, natural disasters, explosive incidents...---

CHEMPACKs

Strategic National Stockpile (SNS) _________________ ○ SNS has "forward placed" these in 1,340+ locations throughout US, mostly at hospitals or fire stations, integrated into local hazardous material response plans ○ for quick access to nerve agent antidotes (esp. atropine inj.) in the event of a nerve agent attack or chemical accident that overwhelms local resources

-5% -95%

Strategic National Stockpile (SNS) ⪢ 12-Hour Push-Packs, ready to ship from SNS repositories ○ ~ _____% of SNS inventory ⪢ Managed inventory in SNS repositories or maintained by vendor partners ○ ~ ______% of SNS inventory

Physical facility

Structure concerns: types + examples + fixes ________________ -Problem example: contaminated steroid injections at now-closed New England Compounding Center in Framingham MA, leading to 76 meningitis deaths -Structure change: positive pressure room for compounding; sterilized equipment Administrative systems Problem example: poor tracking of infections Structure change: clear assignment of responsibility for tracking Personnel Problem example: insufficient staff at retail pharmacy to counsel patients Structure change: ratio of registered pharmacists to pharmacy technicians Computer adequacy Problem example: can't integrate & use relevant data in hospital Structure change: interconnected patient record across departments Administrative Policies Problem example: errors due to resident fatigue Structure change: a new policy on work hours

Computer adequacy

Structure concerns: types + examples + fixes __________________ -Problem example: can't integrate & use relevant data in hospital -Structure change: interconnected patient record across departments

-organs --- systems --- specific -normal -maintains -disclaimer

Structure/Function Claims - more detail for you ◉ Structure/function claim 1. is a statement describing how a product may affect the _________ or __________ of the body and it cannot mention any _________ disease 2. describes the effect on _____(1)_____ structure or _____(1)_____ function in humans ◎e.g., "calcium builds strong bones" or "ginkgo biloba promotes a healthy brain function" 3. characterizes how the product ___________ such structures or functions; ◎e.g., "fiber maintains bowel regularity" or "antioxidants maintain cell integrity" ◉ Note: if a dietary supplement label includes such a claim, it must also state in a "____________" that FDA has not evaluated the claim WHY? Because, dietary supplements often look too much like drugs, such that without a disclaimer people might assume the FDA has approved it

-workplace -infectious -family -tobacco

Ten Great US Public Health Achievements (1900-1999) -Vaccinations -Safer _____________ -Safer and healthier food -Motor vehicle safety -Control of ________ diseases -Decline in deaths from coronary heart disease and stroke -__________ planning -Recognition of _________ use as a health hazard -Healthier mothers and babies -Fluoridation of drinking water

-complications --- deaths -recovery rates -rehabilitation -long term disability

Tertiary Prevention -Goal: Reduce number of _________ & ________ -Rationale: • By reducing disease severity and increasing ________________, we can reduce the number of premature deaths or complications• -Target population: • Those who have disease and need treatment -Typical activities: • Treatment tailored to the patient • _____________ to promote recovery -Outcome measure: incidence of death and ________________ --example (blindness, amputation, other loss of function)--

-small

Testing: drills, dry runs, scenarios Actual pharmacies are too _____ and diffuse to be EDS ⪢ A high school is the usual sort of location ⪢ Assign roles ⪢ Consider set-up and signage ⪢ Distribution possibly from parents to children ⪢ Record names and basic info during distribution ⪢ Examine flows and problems during drills ⪢ Include plans for ---> the disabled, allergic reactions, weather complications

-approved -NOT -NOT -serious -frequently

The "Brief Summary" - in print ads -Brief summary generally includes • An ___________ use of the drug • Who should _____ take the drug • Circumstances under which the drug should _____ be taken • Possible ________ side effects of the drug and, if known, what can be done to lower the chance of having them • ______________ occurring, but not necessarily serious, side effects -"Fair balance" doctrine for the brief summary • Must present benefit and risk info in similar prominence, detail, depth

-label

The "Brief Summary" - in print ads Brief summary requirement -Drug ads must include "brief summary" of the ______ • Now meaning --> our modern definition of the drug "label" --- Not the physical label on container, but all the details approved by the FDA • The "label" --> A.K.A. the package insert, the prescribing information, professional labeling, direction circular, package circular • includes pharmacokinetics, dosing, effectiveness, side effects, contraindications

patients --- active

The #1 Recommendation of that IOM Report: -Allow and encourage _________ to take a more _________ role in their own medical care! - Patients should understand more about their meds - And take more responsibility for monitoring own meds - Patient = the closest person to the action - 2-way communications are essential • including discussions about errors, side effects - Patients need opportunities to consult about their medications • at various stages in care • including at the pharmacy- Improve patient information sources about meds • leaflets, internet, national helpline

health plans

The Evolution of Quality of Improvement= National Committee for Quality Assurance (NCQA) -Accreditation programs for ___(1)_______ managed care organizations, medical groups, and individual physicians. Also now: PCMHs & ACOs. -_____(1)______ seek accreditation and measure own performance with... -Health care Effectiveness Data and Information Set (HEDIS) • Structure, process, and outcome measures -Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey • Patient experience

Institute for Healthcare Improvement (IHI)

The Evolution of Quality of Improvement= -Founded by Don Berwick -(the Triple Aim guy, briefly head of CMS, MA Gov candidate, in Escape Fire...) - An independent not-for-profit in Boston, MA - NU co-op site

Hospital Standardization Program

The Evolution of Quality of Improvement= -by the American College of Surgeons because hospitals were all about surgery back then

The Joint Commission

The Evolution of Quality of Improvement= Asses the quality of hospitals

National Quality Forum

The Evolution of Quality of Improvement= Evaluates quality measures: "which ones should we use?"

American Medical Association (AMA)

The Evolution of Quality of Improvement= over time, AMA establishes uniform standards for medical education, training, and physician practice

-surveillance -guidlines -grants

The US Centers for Disease Control and Prevention (CDC) - ______________ Active and passive ○ Example: National Health and Nutrition Examination Survey (NHANES) is conducted by the CDC and monitors health and nutrition status of the US population— gets actual measurements (e.g., health conditions, environmental exposure, nutrition and dietary supplements, prescription drug information, physiological measurements, laboratory tests) -__________________, ○ Advisory Committee on Immunization Practices ○ Treatment of sexually transmitted infections -______________ to states and non-profits ○ for vaccines purchase and infrastructure -www.cdc.gov

-health --- quality --- preventing ---- controlling

The US Centers for Disease Control and Prevention (CDC) Mission: "to promote __________ and ___________ of life by _______________ and _______________ disease, injury, and disability"

Quality of Care (IOM definition)

The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge

-medicare -process -differences -easiest

The famous "Dartmouth Atlas" project -Using massive claims datasets from _________ -Rising importance of measurement, IT, analytics -Revealed large, unexpected geographical variations in _____________ of care -This implies ___________ in the quality of care -Processes of care are usually _________ to measure -->in contrast to structure and outcomes

-broadcast media/TV -brief summary -major statement -adequate provisions

Then, a watershed year for DTCA --> 1997 In 1997... - New FDA guidance opened up DTCA to _____________ -FDA acknowledges: not possible to present "____________" on TV • too lengthy --> financially prohibitive & terrible TV! -TV ads must include a "_____________", i.e., 'major risks,' -TV ads must include "______________" --> finally defined by FDA • directing viewers where to find the more complete 'brief summary' info • for example --> via a toll-free number, a health care provider, a website, or a simultaneously running print ad -Now, DTCA on TV is famous for those rapid (& often disturbing!) long lists of side effects • and those are only the "major" side effects!

-designing --- all --- harder --- easier -system --- individual -structures --- process

To Err is Human... (IOM report) - The majority of medical errors "are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them." -"Mistakes can best be prevented by _________ the health care system at _______ levels to make it safer - to make it _________ for people to do something wrong and __________ for them to do it right." -Focus on the _________, not the ________ -Improve the ____________ and ____________ of care

-distortion -more life

Too-high drug prices attract special attention and anger ◍ The market ____________ (largely caused by insurance coupled with US government's "hands-off" approach to price regulation) lead to drug prices that are often shocking ◍ People/society have especially high (limitless?) demand for ________(1)______ ◍ Setting prices for and making profit off of "________(1)______" is of course normal business behavior, from a business perspective, but it still comes across to people as especially unseemly or awful ◍ It is a public relations problem for this industry

Because that incentivizes workers to help others if families are safe

Treatment Centers - Medications ⪢ Pharmaceutical cache at each hospital ○ For staff ○ For EMS attached to the facility ○ For family of above --> WHY? ○ For inpatients ⪢ From state cache or SNS ○ IV antibiotics, vaccines ○ IV supplies ○ Oral antibiotics ○ Ventilators and suction equipment

-wholesaler -rebates -markets -drug detailers

Typical Drug Distribution in US 1. Drug Manufacturer -Ex: Pfizer, Bayer, Novartis -(Develops and produces medication) -Lots of outsourcing now of their historic pharmaceutical industry functions -Sells medications to _____________ -Negotiates ____________ with Pharmacy Benefit Manager -___________ medications to patient (via DTCA) and to physicians -Supplies their "______________" (sales force) with samples of new drugs for distribution to physicians - if physicians are willing to meet with them. Physicians may distribute these samples to patients

-bulk -repackager -sells -PBM

Typical Drug Distribution in US 3. Wholesaler (Distributor) ◍ Examples: Cardinal health, McKesson, AmerisourceBergen ◍ Purchases medications from manufacturer in ________ ◍ Sends medication bulk to ________ ◍ _________ medications to pharmacies & health care institutions ◍ Sends mail order drugs to _______

-wholesalers -repackages -patients -stocks -hospital

Typical Drug Distribution in US 4. Pharmacy (or Health Care Institution) -Purchases drugs from ___________ -_____________ some medications -Dispenses medications to _________ -____________ medications based on institutional or payer formularies, and on knowledge of recent demand -Inpatient pharmacies supply ____________ with drugs

-free -bypass -interest -marketing -prohibited

Typical Drug Distribution in US 5. Drug Samples ◍ Manufacturer provides ______ medication to physicians ○ Can _________ the wholesale and repackaging and pharmacy processes entirely ○ Used to increase _________ in new medication therapies ○a major component of spending on ______________ ◍ Physicians are ___________ from selling or trading drug samples

-Diagnoses --- monitors -Prescribe -samples

Typical Drug Distribution in US 6. Doctors and Dispensing Doctors ◍ ____________ and ___________ patients ◍ __________ medicine for patients ◍ May provide patients with free ____________ ◍ Decisions may be influenced by... -Training -Peers -Experience -Patient demands and concerns -Marketing -Drug formularies of PBM/health plan -What else?

-USP -USP Reference Standards

USP defines certain product standards ◉ Federal law recognizes ______ as the official body that sets standards for prescription drugs and dietary supplements ◎ _______________ are used to demonstrate identity, strength, purity, and quality for medicines, dietary supplements, and food ingredients ◎ For example: limits for impurities or related compounds ◎ So, you may see "USP" in on a product label where the identity and strength, etc., are described

Social determinants

Various determinants of Health: even if it may be impossible to quantify their healthcare contributions with certainty ----- ________________ are hugely important factors !

We take a lot of meds

WHY so many medication errors? Main Reason because _______________________________ Increasing numbers of Rx/year • Don't worry about these illustrative stats from a few years ago! • Just get the messaging• 17,000 unique brand/generic names • 300,000 OTC products • 500% increase over 10 years • 1999-2009: # of Rx/year increased 39% ,but population only increased 9% • 2014: 4B prescriptions filled in retail setting and $259B spent --> more opportunities for confusion and drug-drug interactions

illness

We create different interventions for people with lifestyle risks vs. advanced ____________ (think: tobacco users vs. patients with COPD)

-Identify needs and priority populations -Set your own goals -Find inspiration and practice tools -Monitor national progress -- use your own data as benchmark

What 4 things do people with Healthy People DO? 1) _______________________ -Browse objectives, learn about national goals for improving health -See how national goals align with your priorities -Consider focusing on groups affected by health disparities -Use this information to make the case for your program, secure resources, and build partnerships. 2) ______________________ -Find data related to your work -Use national data to set goals for your program -HP 2030 establishes targets for entire USA, but setting local targets contributes to our national success. 3) _____________________ -Explore critical public health topics -Learn about successful programs, policies, interventions -Look for evidence-based resources and tools your community, state, or organization can use 4)__________________ (FYI) -Check for updates on progress toward achieving national objectives -Use our data to inform your policy and program planning -See how your progress compares to national data

Price (or payment)

What a payer actually pays for a unit of care. Note that this is also the payer's unit cost.

-individual decision-making -choice

What are "MARKET" approaches to cost control? -In supposed contrast to "regulatory" ⪢ Less government top-down decision-making, mandating what you must do -instead, operating through ________________ -preserving freedom of ______________ For example: provide good information = provide transparency on prices and quality -then patients, providers, employers, payers make better decisions -examples: star ratings / provider ratings, and provider price lists by procedure

-harmful -safe -after -proactive -reactive

What are FDA's responsibilities? ◉ Under DSHEA, the FDA has the burden of proving a DS supplement is ________ or possesses a risk --->Rather than requiring that the manufacturer prove that it is ______ ◉ FDA is responsible for taking action against any unsafe DS _______ it reaches the market. ---> A reason why the MedWatch reporting system is so important! ◉ Thus, no requirement for a _________, systematic FDA review ◉ The FDA can only be _________ in the case of DS

Non-clinical determinants of health

What are all of these examples of ? -Physical environment - Employment & working conditions -Education -Social supports / social environment -Income & social status -Culture -Gender -Social services -Tax burden & its structure -Child development -Lifestyle & behaviors

-pre-market NDI notification

What are manufacturer responsibilities for NDIs? ◉Very little! ◉ That ________________________ must explain how the manufacturer/distributor concluded that their DS with an NDI is reasonably expected to be safe under the conditions of use suggested in the labeling ◉ At a minimum, FDA recommends that the manufacturer conduct a thorough search of the scientific literature and consider the evidence of safety found there, including any adverse effects associated with use

-drug --- dose -directions -information -smooth

What are some errors in Stage 5: Dispensing? -Wrong ______ and Wrong _____ -Incorrect _______ -Inadequate __________ for patient -Lack of _________ experience for patient - waiting or trying to obtain prescription conveniently - there is evidence that e-prescribing has reduced rates of Rx abandonment

-abbreviations -proprietary name

What are some methods to prevent errors in Stage 1: Prescribing? • Eliminate problematic _____________ - ISMP has a list of error-prone abbreviations, symbols, and dose designations •FDA conducts a risk evaluation when approving the _________________ in a new drug application -FDA encourages pharmacists to report problematic names (1-800-FDA-0178) •Computer physician order entry (CPOE), EHRs, & e-prescribing in the community

-re-writing -Stage 1

What are some methods to prevent errors in Stage 2: Transcribing? Transcription is ___________ -i.e., entering into the next system, usually from prescriber's orders to nurse's care planning & documentation -No surprises --> a lot like _______ methods - Ban confusing abbreviations - Avoid conflicting names - CPOE/EHR - Computer order entry with pop-up prompts for entries that don't make sense

-Bar code -sterile infusions

What are some methods to prevent errors in Stage 5 and Stage 7? Dispensing & Administration -____________ matching of product and order -"Smart" infusion pumps - calculate doses, timed delivery, connects to EHR -Assure ______________ - US Pharmacopeia (USP) guidelines for Compounding Sterile Preparations - In hospitals, enforced by The Joint Commission - Primarily affects hospitals but anywhere sterile preparations are made: physician office, outpatient clinic, home use, hospice, etc.

-changes in demographics -changes in quality

What are the two key factors affecting spending changes over time?

save one life at a time

What does medicine do?

save millions of lives at a time

What does public health do?

-FDA FTC USDA US Postal Service

What federal agency regulates the claims? ◉ Could be one or many agencies! ◉ ______ regulates product labeling (drugs and foods) ◉ _______ enforces consumer protection laws on advertising for both functional foods and dietary supplements (but not drugs) ◎ See examples 2 slides earlier: ○ açaí berry cleansers ○ POM Wonderful ◉ ________ regulates label claims for functional foods containing more than a certain percentage meat or poultry ◉ And if sent via mail --> ________ ◉ Some potential for overlap, but agencies work together

-pharmacopoeia --- formulary -food --- structure --- function -medicine -manufacturing

What is a DRUG? (FDA definition) ◉A substance recognized by an official _________ or ___________ ◉ A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease ◉ A substance (other than a ______) intended to affect the ________ or any _________ of the body A substance intended for use as a component of a ___________ but not a device, and not a component, part, or accessory of a device ◉ Biological products are included within this definition but differ in their _____________ (biological process versus chemical process)

000

What is a dietary ingredient? A "dietary ingredient" may be one, or any combination, of the following substances: -a vitamin -a mineral -an herb or other botanical -an amino acid -a dietary substance for use by people to supplement the diet by increasing the total dietary intake -a concentrate, metabolite, constituent, or extract (answer 000)

-oral -nutrients -disease -drugs

What is a dietary supplement ◉ Dietary supplements may be found in many ______ forms such as tablets, capsules, softgels, liquids, or powders ◉ DS ◎ are always labeled as dietary supplements ◎ may help ensure that you get an adequate dietary intake of essential ___________ ◎ may have other effects on the body ◎ may help you reduce your risk of ____________ However ◎DS are not represented as conventional food or as the sole item of a meal or of the diet ◎DS do not include products that are approved ______

Growth regulation

What is another "Regulatory" approach other than price regulation ?

-ourselves -automatic decisions -structuring choices

What is the best way to change behavior to improve health? Behavioral economics (e.g., "nudges"): ○ Assumes we don't always know what is best for _____________ ○ Or, if we do know, we can't always implement ■We are too busy, distracted ■Bad choices are easy, comforting, tempting ■And we don't have time, bandwidth, energy to be thinking & deciding all the time ○ We make ____________, often mindless decisions) ○ So --> let's try to maximize people's well-being by ______________

-ourselves -information

What is the best way to change behavior to improve health? Traditional economics ○ Assumes we know what is best for ____________ and act that way (i.e. rational decisions) ○ We can maximize people's well-being by providing ___________, e.g., ■ Cigarettes are bad ■ Vegetables & exercise are good ○ This is the basis for a lot of public policy

-ingredients --- amounts -contaminants -ingredients -cGMP

What the USP-Verified mark on a dietary supplement label means Independent, 3rd-party certification of product quality 1. That what's on the label is in fact in the bottle—all the listed __________ in the declared __________ 2. The supplement does not contain harmful levels of ________ 3. The supplement will break down and release ___________ in the body 4. The supplement has been made under good manufacturing practices (________)

Drug claim

What type of claim ? cures or prevents disease

Health claim

What type of claim ? ◎ always links a substance to disease ◎ must be submitted to FDA 120 days in advance, at least for FF ◎ "Substance X may reduce the risk of dementia"

-efficacy -generalizability -effectiveness -safety

Why do we need a Phase IV?? -RCTs examine ________ - in artificial clinical trial world • RCTs = randomized controlled trials = the norm in Phases I, II, III • Strict inclusion/exclusion criteria for volunteers • Limited comorbidities and other medications • Patients under care of specialists • Tight monitoring of use, nurses calling to prompt adherence • Frequent follow-ups and testing • Therefore, limited __________ -Phase IV examines ____________- in the real world • Post-market surveillance • Many thousands of users • Wide spectrum of patients and providers and behaviors • More race/ethnic representation, various ages, various co-morbidities • Other medications and drug interactions with these • Both examine ______________

-FDA -MedWatch -food -drugs

Why include DS/FF in HCS course? ◉ Pharmacists are on the front lines and can detect serious adverse events, report them to the __________ ◎ FDA's Adverse Event Reporting System (FAERS) + CAERS ○ Includes data from the "_____________" program ○ DS issues are handled separately under the "_______" arm of "FDA" ○ But, for adverse event reporting, DS is treated very similarly to ________ ◉ Potential for drug interactions

to increase awareness

Why should we include DS/FF in HCS course?

-Medicaid -high-value --- conditions -OOP max -ACA

Why so many zero-pay prescriptions?? ◍ Some are in ___________ (has many low & zero copays) ◍ Some commercial plans structure costs this way for certain ___________ medications, or for certain ___________ ◍ Some people have hit their __________________ for year (an ACA requirement now for many plans) ◍ Preventive meds are now free after _________, including generic contraceptives ◍ Even the proportion of $50+ meds has become smaller over recent years, due to patients reaching deductibles or OOP max, using coupons, and some blockbuster meds going off patent

income

_____________ is strongly linked to health status

-Cost reduction -cost control

_______________ Usually refer, respectively, to a drop in level of cost (not easy) _______________ refers to a slowdown in rate of growth Usually refer to spending (i.e., bigger/total picture)

12-Hour Push Package

_________________ ⪢Part of SNS ⪢First-line support for large-scale public health incidents, especially if the disease or agent is unknown ⪢ Each contains 50 tons of emergency medical resources: ○ Broad-spectrum oral and IV antibiotics ■ ABs already in 20-tab packs ○ IV fluids and fluid administration kits ○ Airway equipment ○ Bandages ○ Other medicines for emergency conditions ⪢Pre-packed, transport ready ⪢Rapid delivery to anywhere in US within 12 hours of federal decision to deploy them

Manages inventories

___________________ ⪢ In contrast to push-packs, these are as-needed and as- requested, especially when threat is known, and include: ○ Chemical antidotes ○ Antitoxins (e.g., Botulinum) ○ Vaccines ○ Antiviral drugs ○ Narcotic analgesics ○ Anticonvulsants ○ Chelating agents and others for radiological/nuclear events ○ Personal protective equipment ○ Ventilators ○ Other medical & surgical supplies ○ Other antibiotics ○ Additional supplies of push-pack contents

Population Health Data

________________________ are necessary to design programs for specific populations

Emergency Prescription Assistance Program (EPAP)

______________________________ -US DHHS and FEMA -For uninsured people with proof of prescription, in a disaster -Provides eligible individuals 30-day prescription assistance

Institute for Safe Medication Practices (ISMP)

_________________________________ -founded in 1990 - By pharmacist Michael Cohen - His first "medication error reports" column was inHospital Pharmacy in 1975 - MacArthur "Genius" Award ISMP's reports still hugely influential -Developed the "5 rights" --> Nonprofit org near Philadelphia devoted entirely to medication error prevention and safe medication use -ISMP.org -Detecting, collecting, reporting -Educating and advocating for safer practices

Health

a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity

Disease Prevention

reduce the occurrence and impact of specific diseases (right)

Medical errors

the failure of a planned action to be completed as intended, or the use of a wrong plan to achieve the aim