25_Policy, Practice, and Regulatory Issues 2016
Terms in this set (73)
Who requires the hospital to develop and approve criteria for selecting medications that include indications for use, effective- ness, drug interactions, potential for errors and abuse, adverse drug events, sentinel event adviso- ries, populations served, other risks, and costs.
Joint Commission Medication Management Standard Chapter
Who requires that medical staff establish a formulary system?
Medicare & Medicaid Services (CMS) Conditions of Participation (CoP)
Name the Elements of a Drug Use Evaluation Monograph
Brand and nonproprietary names
FDA approval information, including date and
For biosimilars, interchangeability status Pharmacology and mechanism of action FDA-approved indications
Potential off-label uses
Dosage forms and strengths
Use in special populations (e.g., pediatric, geriatric,
hepatic, or renal insufficiency)
Pregnancy category and use in breastfeeding mothers Clinical trial analysis and critique
Comparison of ef cacy, safety, and cost-effectiveness Medication safety assessment and considerations Financial analysis based on use within a health system Recommendation for inclusion or exclusion
Medication use evaluation (MUE)
Performance improvement method that focuses on evalu- ating and improving medication-use processes related to prescribing, medication preparation,dispensing, administering, and monitoring
MUEs differ from DUEs in that MUEs emphasize:
improving patient outcomes using a process that identi es, resolves, and prevents medication-related problems (actual or potential)
Steps in conducting MUEs include:
(a) Establishing and implementing criteria, guidelines, treatment protocols, and standards of
care for medications and medication use policies
(b) Selecting medications for MUE on the basis of adverse medication events or risk of events,
signs of treatment failures, expense of medication, patient population or disease state
(c) Identifying data points and collecting data
(d) Evaluating adherence to criteria, guidelines, treatment protocols, and standards of care for
medications and medication use policies
(e) Interpreting and reporting MUE ndings
(f) Identifying and implementing improvement strategies in the medication-use process
Drug use review or drug use evaluation (DUE)
Process used to assess the appropriateness of drug therapy by evaluating data on drug use
in a given health care environment compared with predetermined criteria and standards
Any error occurring in the medication process (ordering, transcribing, dispensing, administering, and monitoring)
Ex: Order filled for the wrong patient
Adverse drug event
Injury resulting from medication use; may or may not result from a medication error
Ex: Hemorrhage from heparin
Adverse drug reaction
Injury not caused by medication error, non- preventable and caused by the drug at normal doses and with normal use
Ex: Allergic reaction in a person with no known allergies
Potential adverse drug event
Medication error with the potential for injury
Ex: Overdosage of a medication that was intercepted before patient administration
Preventable adverse drug event
Injury caused by medication error
Ex: Overdosage of a medication that resulted in a hospitalization
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) was in response to what report?
In 1999, the IOM released a report titled "To Err Is Human," which stated that medical errors claim as many as 98,000 lives a year. The 2004 IOM report titled "Patient Safety: Achieving a New Standard for Care" revealed the high incidence of adverse events occurring in hospitals.
It Encourages health care providers and organizations to voluntarily report and share patient safety information without fear of legal action
ii. Authorized the creation of patient safety organizations (PSOs)
(a) PSOs can be private or public entities, pro t or not-for-pro t entities, provider entities such as a health system, or other entities.
(b) PSOs provide a secure mechanism for the collection, aggregation, and analysis of data to identify and reduce risks and hazards that may occur with patient care delivery.
(c) The ACA charges PSOs to assist health systems with a high rate of risk-adjusted readmission rates to decrease readmission rates and improve transitions of care.
iii. The Agency for Healthcare Research and Quality (AHRQ) created the Patient Safety Organization Privacy Protection Center to support the implementation of the Patient Safety Act. The Privacy Protection Center provides technical assistance to PSOs to ensure that data on patient safety events submitted to the Network of Patient Safety Databases are non-identi able.
iv. Data are submitted to PSOs through Common Formats, developed by AHRQ for acute care hos- pitals and skilled nursing facilities. Common Formats provide a systematic process for reporting adverse events, near misses, and unsafe conditions, and they allow a hospital to report harm from all causes.
(a) In March 2013, CMS communicated that although the use of Common Formats is not required for CoP for Quality Assessment and Performance Improvement surveys, hospi- tals that use them will be in a better position to meet Quality Assessment and Performance Improvement requirements.
(b) CMS surveyors were also encouraged to become familiar with Common Formats.
MedWatch Form FDA 3500
For voluntary reporting is for health care professionals to report
a serious adverse event, product quality problem, or product use error with an FDA-regulated drug, biologic, medical device, or dietary supplement. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule specically permits health care professionals to dis- close protected health information (PHI) for public health purposes.
MedWatch Form FDA 3500A
For regulated industry following investigational new drug (IND) and biologic regulations and user facilities such as hospitals and nursing homes.
MedWatch Form FDA 3500B
For consumer reporting
What should not be reported to FDA MedWatch?
Vaccine-related adverse effects, veterinary medicine product adverse events, and suspected unlawful Internet sales of medical products should not be reported to MedWatch
Institute for Safe Medication Practices (ISMP)
To promote medication error prevention and initiated a voluntary practitioner error-reporting program.
i. The institute is a nonprofit PSO.
ii. Publishes four medication safety alert newsletters for acute care settings, ambulatory care settings, nurses, and medications
University HealthSystem Consortium (UHC)
An alliance of academic medical centers and affiliated hospitals.
i. It is an AHRQ-listed PSO: the UHC Performance Improvement PSO.
ii. Offers the UHC Patient Safety Net, a web-based inpatient and outpatient safety event-reporting
system that consolidates and aggregates data for speci c event types and offers best practices and policies to address common systemic areas for improvement
Vaccine Adverse Event Reporting System
Is a national postmarketing vaccine safety surveillance program managed by the Centers for Disease Control and Prevention (CDC) and the FDA for vaccine-related adverse events to be reported, analyzed, and made available to the public.
Due to National Childhood Vaccine Injury Act of 1986
National Childhood Vaccine Injury Act of 1986
Requires health care professionals and vaccine manufacturers to report to the Department of Health and Human Services (DHHS) specific adverse events that occur after the administration of routinely recommended vaccines
Occupational Safety and Health Administration (OSHA)
i. Ensures safe and healthful working conditions for employees
ii. Is part of the U.S. Department of Labor and was granted regulatory authority through the Occupational Safety and Health Act of 1970
United States Pharmacopoeia (USP)
Develops standards, enforceable by the FDA, on the identity,
strength, quality, and purity of medications and dietary supplements, including compounded products.
j. The General Chapters are as follows: Required (numbered below <1000>), Informational (numbered <1XXX), or Speci c for dietary supplements (numbered <2XXX>); the chapters pertaining to com-
pounding include the following:
i. USP 795: Pharmaceutical Compounding for Nonsterile Preparations
ii. USP 797 (being revised): Pharmaceutical Compounding for Sterile Preparations (CSPs) iii. USP 800: Hazardous Drugs: Handling in Healthcare Settings
Compounding for Nonsterile Preparations
Compounding for Sterile Preparations (CSPs)
Assign risk levels (low, medium, and high) according to requirements for the types of admixtures and preparation procedures.
If sterility testing has been performed, pharmacies can assign a beyond-use date based on the maximum chemical stability as listed in valid references. If sterility testing has not been performed, pharmacies must use beyond-use dating according to the level of risk and storage
Hazardous Drugs: Handling in Healthcare Settings
USP 797: Risk Category- Immediate Use
Room Temperature (20-25 C)
Refrigerator (2-8 C)
Freezer (</= 10 C)
USP 797: Risk Category- Low
Room Temperature (20-25 C)
Refrigerator (2-8 C)
Freezer (</= 10 C)
USP 797: Risk Category- Low with 12 hour BUD
Room Temperature (20-25 C)
</= 12 hours
Refrigerator (2-8 C)
</= 12 hours
Freezer (</= 10 C)
USP 797: Risk Category- Medium
Room Temperature (20-25 C)
Refrigerator (2-8 C)
Freezer (</= 10 C)
USP 797: Risk Category- High
Room Temperature (20-25 C)
Refrigerator (2-8 C)
Freezer (</= 10 C)
340B Drug Pricing Program
Authorized through the Medicaid Drug Rebate Program in 1990 and expanded by the ACA in 2010, allows specific categories of safety-net providers to become established
entities and procure outpatient prescription drugs at discounted prices. The 16 categories of covered entities use the discounts to expand or develop new services.
i. Eligibility is defined at the level of the health care facility and not the individual; however, the
Health Resources and Services Administration's (HRSA's) Office of Pharmacy Affairs states that only patients with an established relationship with the covered entity are eligible to receive 340B purchased drugs.
ii. Covered entities can procure drugs at 340B prices and distribute them in the following ways
(a) Procurement by the covered entity and distribution by covered entities with in-house phar-
macies or to an outpatient clinic for direct administration to patients
(b) Procurement by the covered entity but distribution to the patient from a contracted pharmacy
What are the US Senatorial committees that have jurisdiction over health-related policy?
a. Appropriations Committee writes the legislation that allocates federal funds to the many government agen-
cies, departments, and organizations on an annual basis and, in particular, funds discretionary programs.
b. Finance Committee has jurisdiction over issues that pertain to taxation and health programs under the
Social Security Act including Medicare, Medicaid, and the Children's Health Insurance Program.
c. Health, Education, Labor and Pensions (HELP) Committee, as it pertains to health, authorizes agencies,
institutes, and programs under DHHS, which includes the FDA, National Institutes of Health (NIH),
d. Committee on Veterans' Affairs oversees issues related to veterans' affairs (VA), including the VA
e. Aging Committee was initially established as a temporary committee but transitioned to a permanent,
special committee without legislative authority for matters relating to older Americans.
f. Legislation is reviewed by the committee with the most jurisdiction over the provisions in the bill. For
example, the Pharmacy and Medically Underserved Areas Enhancement Act (S 314) was referred to the Committee on Finance because it amends the Medicare program.
What are the US House of Representative committees that have jurisdiction over health-related policy?
a. Ways and Means has jurisdiction over taxation and most programs authorized by the Social Security Act, similar to the Senate Finance Committee.
b. Energy and Commerce is the oldest standing committee of the House of Representatives. It has over- sight of DHHS and is similar to the Senate HELP committee.
c. Veterans' Affairs oversees issues related to VA.
d. Legislation is sent to any committee that has jurisdiction over any of the provisions in the bill. For
example, the Pharmacy and Medically Underserved Areas Enhancement Act (HR 592) was referred to
the Energy and Commerce Subcommittee on Health and the Ways and Means Committee.
US Legislative Process
a. Legislation is drafted by a member of Congress, a congressional committee, a constituent, a state legislature, or an executive communication from the president or an administrative agency.
b. Once introduced, the bill, joint resolution, concurrent resolution, or simple resolution is generally referred to the relevant committees for consideration, markup, and approval.
c. Action, debate, and voting on legislation, which are dictated by rules, differ greatly between the Senate and the House of Representatives.
American Recovery and Reinvestment Act (ARRA) of 2009 provided a vehicle for passing the Health Information Technology for Economic and Clinical Health (HITECH) Act.
HITECH Act authorizes the U.S. DHHS to create programs to improve health care quality, safety, and ef ciency through the promotion of health information technology, including electronic health records (EHRs) and health information exchanges (HIEs). The goal of HITECH is to facilitate and expand the secure, electronic movement and use of health information among organizations according to nationally recognized standards.
i. Created the Office of the National Coordinator for Health Information Technology (ONC) to coordinate nationwide standards and implementation efforts
ii. The Standards and Certi cation Criteria Final Rule is the initial approach to adopting standards, implementing speci cations, and providing certi cation criteria to increase the interoperability, func- tionality, utility, and security of health information technology and to support its meaningful use.
iii. The Electronic Health Records Incentive Programs was issued by CMS to provide a nancial incentive to eligible professionals, eligible hospitals and critical access hospitals, and Medicare Advantage Organizations that are "meaningful users" of EHRs. ARRA 2009 speci ed three main components for "meaningful use":
(a) Use of certified EHRs in a meaningful manner (e.g., e-Prescribing)
(b) Use of certi ed EHR technology for electronic exchange of health information to improve
the quality of health care
(c) Use of certi ed EHR technology to submit clinical quality and other measures
iv. Incentive payments began in scal year 2011 and will gradually decrease until scal year 2015, when penalties are to be put into effect.
v. HITECH also affects research because it imposes new penalties for breaches in HIPAA and PHI; the Of ce for Civil Rights within DHHS will audit for compliance.
vi. An HIE is de ned as a process for exchanging health information, and an HIO (health infor- mation organization) is a model for exchanging information at local, regional (known as
RHIO [regional health information organization]), or state levels. ONC's goal for HIE is for patient information to be accessible across organizational, vendor, and geographic boundaries. Regulations related to HIE are aimed at increasing interoperability, increasing consumer and provider trust to mobilize information, and decreasing the cost and complexity of the exchange.
Three forms of HIE (Health Information Exchanges) are:
(a) Directed exchange - Ability to send and receive secure information electronically between care providers to support coordinated care
(b) Query-based exchange - Ability for providers to nd and/or request information on a patient from other providers
(c) Consumer mediated exchange - Ability for patients to aggregate and control the use of their health information among providers
Patient Protection and Affordable Care Act of 2010
i. Funding opportunities will be available for pharmacists to show their contributions as providers of medication therapy management.
ii. The patient-centered medical home model emphasizes primary care as a central role in managing
the chronic conditions of patients using a team-based care approach.
iii. Accountable care organizations (ACOs) are a set of providers associated with a de ned population of patients accountable for the quality and cost of care delivered to that population.
iv. The Independence at Home Demonstration Program promotes the interdisciplinary collaboration of clinicians to provide home-based medical care for Medicare bene ciaries.
v. The Biologics Price Competition and Innovation (BPCI) Act of 2009 is a provision in the ACA that creates an abbreviated approval pathway for follow-on biologic products, known as "biosimilars."
vi. The Physician Payments Sunshine Act (i.e., Sunshine Act) requires manufactures of drugs, medical devices, and biologicals that participate in federal health care programs to report payments and items of value given to physicians and teaching hospitals. It also requires manufacturers and group purchas- ing organizations to report physician ownership or investments.
(a) CMS authorized to implement the Sunshine Act as the Open Payments Program (b) Reports on 2013 data were released in September 2014
Safe and Secure Drug Disposal Act of 2010
Authorized the Drug Enforcement Administration (DEA) to promulgate rules for patient disposal of
unused controlled substances and controlled substance disposal by long-term care facilities
ii. The Disposal of Controlled Substances Final Rule, enacted on October 9, 2014, allows the transfer of unwanted and unused controlled substances from an ultimate user (i.e., patient) to an authorized
collector for safe, secure, and responsible disposal.
(a) Authorized collectors include manufacturers, distributors, reverse distributors, narcotic treat-
ment programs, hospitals and clinics with on-site pharmacies, and retail pharmacies, including
long-term care facilities and specialty pharmacies.
(b) Allows ultimate users to voluntarily dispose of controlled substances through take-back events,
mail-back events, and collection receptacles
(c) Regulates each element of the disposal process, including transfer, deliver, collection, return, and
recall of controlled substances
FDA Safety and Innovation Act of 2012 amends the federal Food, Drug, and Cosmetic (FD&C) Act
to revise and extend the user fee programs for prescription drugs and medical devices to establish user fee programs for generic drugs, biosimilars, and other purposes.
Amends the federal Food, Drug, and Cosmetic (FD&C) Act to revise and extend the user fee programs for prescription drugs and medical devices to establish user fee programs for generic drugs, biosimilars, and other purposes.
Addresses drug shortages and states that the manufacturer of a drug that is life supporting, life sus-
taining, or intended for use in the prevention or treatment of a debilitating disease or condition, including use in emergency medical care or during surgery, must notify the Secretary of DHHS of a permanent discontinuation in the manufacturing of the drug that may disrupt supply in the United States, together with the reasons for discontinuation, at least 6 months before the date of discontinuation
ii. Additional provisions include responding to those failing to report a shortage, expediting manufac- turer inspections, publishing a drug shortage list, authorizing hospitals to repackage drugs without registering as an establishment if distributing within a health system, and requiring the Comptroller General to conduct a study on the impact of medication shortages.
Drug Quality and Security Act of 2013
Establishes a new section (503B) in the FD&C Act to allow a compounding facility to voluntarily reg-
ister as an outsourcing facility with the FDA. The outsourcing facility must give a licensed pharma- cist direct oversight over compounded drugs. Other requirements include the following: only drugs with bulk ingredients listed as approved by the secretary can be compounded, the facility must report to the secretary every 6 months and undergo inspection by the FDA, the facility must report serious adverse events, and the facility must label products identifying them as a compounded drug.
ii. Adds a new section to the FD&C Act with product-tracing requirements ("track-and-trace")
for drug manufacturers, repackagers, wholesale distributors, and dispensers to provide trans- action details when pharmaceutical products change ownership. Entities will also need to
respond promptly in the event of a recall or an illegitimate product suspicion or investigation. Implementation of these requirements has been delayed twice, extending the compliance deadline from July 1, 2015, to March 1, 2016.
iii. Increases wholesale distributor licensure standards
Medicare Access and CHIP Reauthorization Act (MACRA) of 2015
i. Legislation repealed the sustainable growth rate (SGR) physician reimbursement methodology that threatened to reduce Medicare physician payments for more than a decade.
ii. Represents a shift in reimbursement from fee-for-service to pay-for-performance or pay-for-value
(a) Establishes the alternative payment model for physicians participating in patient-centered
medical homes, ACOs, and Medicare shared-savings programs
(b) Establishes the merit-based incentive payment system (MIPS) that reimburses on the basis of
quality, resource use, clinical practice improvement activities, and meaningful use of EHR
iii. Sunsets three existing value-based payment adjustments through the Physician Quality Reporting
System, the Value-Based Payment Modi er, and the EHR incentive program and combines them
iv. Promises to revise and replace the EHR incentive program known as meaningful use
v. Reauthorized the State Children's Health Insurance Program through scal year 2017
FDA, CMS, AHRQ, CDC, HRSA
is responsible for the safety of most foods (human and animal) and cosmetics, and it regulates
both the safety and effectiveness of human drugs, biologics (e.g., vaccines, blood products, therapeutic
proteins), medical devices, and animal drugs.
Administers Medicare, Medicaid, and the State Children's Health Insurance Program. It is
driving the Value-Based Purchasing Program, the Medicare Shared Savings Program, and the EHR Meaningful Use Incentive Program, and it develops CoP and Conditions for Coverage that health care organizations are required to meet in order to participate in Medicare and Medicaid programs.
Agency for Healthcare Research and Quality (AHRQ)
Supports research that helps people make better-informed decisions and improves the quality of health care services
Health service research provides clinical, health care system, and public policy decision-makers
evidence-based information on health outcomes, quality, cost, use, and access to improve the quality
of health care services.
Provides programs that reduce the health and economic consequences of the leading causes of death and disability. An example is Healthy People, which provides science-based national goals and objectives with 10-year targets designed to guide national health promotion and disease prevention efforts.
Improves access to health care through programs that strengthen the health care workforce, build healthy communities, and achieve health equity for people who are geographically isolated and/ or economically or medically vulnerable. HRSA houses the National Center for Health Workforce Analysis charged with estimating the supply and demand for health care workers and designating shortage criteria in order to establish Health Professional Shortage Areas or Medically Underserved Areas or Populations.
U.S. Department of Justice (DOJ)
Has jurisdiction over the DEA, which prevents, detects, and investi- gates the diversion of controlled substances and monitored chemicals.
U.S. Environmental Protection Agency
Seeks to protect human health and the environment
a. Through the Resource Conservation and Recovery Act of 1976, the U.S. Environmental Protection
Agency has jurisdiction over rules governing the disposal of solid and hazardous waste.
b. The Management Standards for Hazardous Waste Pharmaceuticals Rule proposes new regulations
for health care facilities (including pharmacies) and reverse distributors in the handling of hazardous
waste pharmaceuticals in order to improve environmental protection.
Code of Federal Regulations Title 42: Public Health
(a) Contains rules related to HHS, CMS, and the Of ce of Inspector General-Healthcare
(b) Federally quali ed health centers, organizations that receive grants for enhanced reimburse-
ment from Medicare and Medicaid for offering health care services to all patients regardless of
their ability to pay, are regulated by rules outlined in Medicare CMS regulations in Title 42.
Code of Federal Regulations Title 21: Food and Drugs
(a) Institutional Review Boards (21 CFR Part 56) contains standards for the composition, opera- tion, and responsibility of an institutional review board (IRB) that reviews and approves of studies for products regulated by the FDA.
(b) Differences exist between this regulation and that of the Common Rule for the de nitions of research, human subjects, and IRB. Both need to be considered when conducting research.
(c) IRB review is required for clinical investigations designed for submission to the FDA in support of an application or marketing permit. Exemptions from an IRB requirement are outlined in the text of this rule.
Code of Federal Regulations Title 45: Public Welfare
(a) Common Rule (45 CFR Part 46): Federal Policy for the Protection of Human Subjects (revisions proposed in 2015 with nalization planned for 2016)
• Defines research as a systematic investigation, including research, development, testing,
and evaluation, designed to develop or contribute to generalizable knowledge
• De nes a human subject as a living individual about whom an investigator obtains data
through intervention or interaction with the individual or identi able private information
• De nes an IRB in the context of the rule and is different from that of 21 CFR 56. Typical exemptions from IRB requirements include research conducted in certain educational set- tings or involving educational tests or surveys.
(b) HIPAA (45 CFR Parts 160, 162, and 164)
• Enacted through HIPAA and enforced by the DHHS Of ce for Civil Rights
• The suite of HIPAA regulations for patient privacy and security is outlined in the
Transactions and Code Set Standards, Identi er Standards, Privacy Rule, Security Rule, Enforcement Rule, and Breach Noti cation Rule.
Joint Commission Mission
"to continuously improve health care for the public, in collabora- tion with other stakeholders, by evaluating health care organizations and inspiring them to excel in provid- ing safe and effective care of the highest quality and value."
National Patient Safety Goals
To help accredited organizations address speci c areas of concern in patient safety in the areas of ambulatory health care, behavioral health care, critical access hospital, home care, hospital, laboratory, long-term care, Medicare or Medicaid long-term care, and of ce-based surgery.
Is a Joint Commission performance measurement and improvement initiative imple- mented to integrate outcomes with accountability measures in the areas of acute myocardial infarc- tion, heart failure, pneumonia, surgical care improvement project, children's asthma care, perinatal, hospital outpatient measures, venous thromboembolism, substance abuse, tobacco treatment, emer- gency department care, immunization, hospital-based inpatient psychiatric services, and stroke in its accreditation process.
i. Common standardized measures between the Joint Commission and CMS are called National Hospital Quality Measures.
ii. Accountability measures and processes that result in the greatest improvement in patient outcomes have been identi ed by the Joint Commission. These measures and processes must be of sound scienti c evidence, be in proximity between process and outcome, accurately measure the process, and minimize adverse effects without inducing unintended consequences. Measures are updated semiannually and include areas such as acute myocardial infarction, heart failure, pneumonia, sur- gical care improvement project, children's asthma care, venous thromboembolism, and stroke.
Targeted Solutions Tool
Created by the Joint Commission Center for Transforming Healthcare, provides a process for accredited hospitals to measure performance, identify barriers to excellent performance, and implement proven solutions
Process used by an on-site surveyor to evaluate a patient's medical record
as a road map to move through a health care organization to assess and evaluate its compliance with standards and systems to provide care and services. First-generation tracers follow a patient through care areas, whereas second-generation tracers focus on major organizational areas, such as high-alert medications or medication shortages.
National Committee for Quality Assurance (NCQA)
Improve the quality of health care through measurement, transparency, and accountability.
a. Accreditation programs, certi cation programs, physician recognition programs, and distinctions are directed at health plans, such as health maintenance organizations, preferred provider organizations, and consumer-directed health plans, physician networks, medical groups, and individual physicians.
b. Responsible for three key efforts to measure and improve health care quality: assessment of on-site clinical and administrative processes (around 54% of NCQA measures), through data collection for the Healthcare Effectiveness Data and Information Set (HEDIS) (around 33% of NCQA measures), and measuring member satisfaction through the Consumer Assessment of Healthcare Providers and Systems survey (around 13% of NCQA measures)
Tool that consists of more than 81 measures across five domains of care that health plans use to measure performance and focus improvement efforts.
i. Measures are developed by identifying a clinical area to evaluate. The process includes conduct-
ing an extensive literature review, developing the measure, vetting it with various stakeholders,
and performing a eld test that evaluates feasibility, reliability, and validity.
ii. Domains include effectiveness of care, access of care, experience of care, utilization and relative
resource use, and health plan descriptive information.
Comparison tool that allows users to view measure results and benchmark information that ranks health plans using the HEDIS measures
National Quality Forum
Is a nonprofit organization that aims to improve quality through a three-part
mission. (1) Build consensus on national priorities and goals for performance improvement and work in partnership to achieve them. (2) Endorse national consensus standards for measuring and publicly reporting on performance. (3) Promote the attainment of national goals through education and outreach programs.
Pharmacy Quality Alliance
a. The mission of the Pharmacy Quality Alliance is to improve the quality of medication use across
health care settings through a collaborative process in which key stakeholders agree on a strategy for
measuring and reporting performance information related to medications.
b. Develops performance measures, including proportion of days covered, gap in medication therapy, diabetes medication dosing, suboptimal treatment of hypertension in patients with diabetes, use of high-risk
medications in older adults, drug-drug interactions, and medication therapy for people with asthma
i. Laboratory and animal studies that assess safety and biologic activity in various model systems
(a) ED50 is the amount of drug that produces a speci c effect in 50% of animals tested.
(b) LD50 is the amount of drug that causes death in 50% of animals tested.
ii. Toxicologic studies completed
(a) Effects on the fetus in pregnant mice, rats, rabbits, or baboons
(b) May or may not translate into human fetal adverse effects
(c) Fetal effects in humans may occur that were not observed in animal studies. (d) Basis for pregnancy categories B, C, and some D
iii. An INDA is drafted and submitted to the FDA. It must contain a general plan of investigation, drug information (i.e., chemistry, pharmacology, toxicology, pharmacokinetics, biologic disposi- tion, laboratory and animal testing data, and existing human data), protocol, manufacturing, and control of the drug.
Phase I drug trial
i. Initial introduction of an IND into humans, typically 20-80 healthy volunteers
ii. Goal is to garner information on the pharmacokinetic and pharmacodynamic properties and safety profile of the investigational drug to design a well-controlled and robust phase II trial.
Phase II drug trial
i. Controlled clinical studies conducted in no more than several hundred subjects
ii. Goal is to evaluate the drug's effectiveness for a particular indication in patients with the disease
or condition under investigation and to determine the common short-term adverse effects and
risks associated with the drug.
Phase III drug trial
i. Involves administering the investigational drug to a range of several hundred to several thousand patient subjects in different clinical settings to con rm its safety, ef cacy, and appropriate dosage
ii. Goal is to gather necessary additional information about effectiveness and safety for evaluating the overall bene t-risk relationship of the drug and to provide an adequate basis for physician labeling.
iii. The step before the sponsor's submission of an NDA to the FDA for approval to market the drug (Box 2)
iv. Once an NDA is submitted, it is classi ed with a code that re ects both the type of drug being
submitted and its intended uses. The numbers 1-7 are used to describe the type of drug:
New molecular entity (1)
New salt of previously approved drug (2)
New formulation of previously approved drug (3)
New combination of two or more drugs (4)
Already marketed drug product (i.e., new manufacturer) (5)
New indication for currently marketed drug or switch from prescription to over the counter (6) Already marketed drug product without a previously approved NDA (7)
Phase IV drug trial
i. Also called postmarketing studies
ii. May be required by the FDA to identify additional information about the drug's risks, bene ts,
and optimal use
iii. Verify effectiveness or focus treatment on special populations
FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
(a) A code: An approved generic product considered therapeutically equivalent to other pharma-
Three criteria that must be satisfied:
☐ Must contain the same active ingredient
☐ Must be the same dosage form and route of administration
☐ Must be of identical strength or concentration
☐ Releasing mechanism
☐ Labeling (limited differences)
☐ Excipients (colors, avors, preservatives)
(b) B code: An approved generic product that is not considered therapeutically equivalent to
other pharmaceutical equivalents
Requires that a drug be prescribed and dispensed with one of the following:
(1) Medication guide or patient package inserts
(2) Communication plan to health care providers (for NDAs or biologics license applications
only, not ANDAs)
(3) Elements To Assure Safe Use (ETASU)
(4) Implementation system
ETASU may include one or more of the following:
☐ Health care providers who prescribe the drug have particular training or experience or are specially certi ed
☐ Pharmacies, practitioners, or health care settings that dispense the drug are specially certified
☐ Drug is dispensed only in certain health care settings
☐ Drug is dispensed to patients with evidence of safe use conditions such as laboratory test results
☐ Each patient using the drug is subject to monitoring
☐ Each patient using the drug is enrolled in a registry
Critical Path Initiative
a) Created in response to a signi cant decline in NDAs, biologics license applications, and
medical device applications because of the widening gap between basic science discovery
and the challenging, inef cient, and costly development of medical products
(b) Prioritizes the most pressing developmental problems and identi es areas that provide the
greatest opportunities for rapid improvement and public health bene t through three dimen- sions: safety assessment, evaluation of medical utility, and product industrialization
PHI includes information that:
i. Is created or received by a covered entity, which includes health care providers, hospitals, insur- ance companies, and business associates
ii. Pertains to the past, present, or future physical or mental health, or condition of the individual
iii. Pertains to payment for the individual's health care
iv. Pertains to the provision of health care in the past, present, or future
v. Identi es an individual or could be used to identify an individual
vi. To use or disclose PHI for research purposes, one or more of the following must be obtained:
(a) Written authorization speci cally for the use and disclosure of PHI for research purposes
involving human subjects
(b) Waiver of authorization approved by an IRB: Use of de-identi ed information or limited
data sets (limited data set [45 CFR §164.514(e)] de ned for research, public health, and
health care operations)
(c) Preparatory to research certi cations
(d) Database registration
A statement that the study involves research, an explanation of the purposes of the research, the
expected duration of the subject's participation, a description of the procedures to be followed,
and the identi cation of any procedures that are experimental
Investigational drug pharmacist's duties
a. Participating on an IRB as a voting member
b. Maintaining a working relationship with the IRB, P&T committee, principal investigators,
and the pharmacy department
c. Reviewing new and existing investigational drug study protocols
d. Meeting with investigators, study monitors, and other study personnel responsible for coordinating
the logistics of a clinical trial
e. Receiving, organizing, and maintaining the contents of study notebooks
f. Providing randomization, blinding, or control functions of a clinical trial
g. Conducting the training of IDS staff and personnel regarding investigational protocols and
study drug procedures
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