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25_Policy, Practice, and Regulatory Issues

Terms in this set (236)

how many camers does congress have?
Congress is bicameral, with two legislative chambers: the Senate and the House of Representatives
what is composition of senate?
The Senate is composed of 100 elected, voting members. Legislation and tasks are divided into 20 standing committees, 68 subcommittees, and 4 joint committees.
what is Appropriations committee?
it writes the legislation that allocates federal funds to the many government agencies, departments, and organizations on an annual basis and, in particular, funds discretionary
programs.
what is finance commitee?
it 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
what is Health, Education, Labor and Pensions (HELP) Committee?
it, as it pertains to health, authorizes agencies, institutes, and programs under the Department of Health and Human Services (DHHS), which includes the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and Centers for Disease Control and Prevention (CDC).
what is Committee on Veterans' Affairs?
it oversees issues related to veterans' affairs (VA), including the VA
health system.
what is Aging Committee?
it was initially established as a temporary committee but transitioned to a permanent, special committee without legislative authority for matters relating to older Americans.
what is legislation?
it 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) introduced in the
Senate in 2015 was referred to the Committee on Finance because it amends the Medicare program.
what is composition of house of representatives?
The House of Representatives is composed of 435 elected, voting members and six delegates from the U.S. territories or from Washington, D.C., with nonvoting privileges. Legislation and tasks are divided into
20 standing committees, 4 joint committees, and 1 select committee.
what is Appropriations Committee?
it writes the legislation that allocates federal funds to the many government agencies, departments, and organizations on an annual basis and, in particular, funds discretionary
programs.
what is Ways and Means?
it has jurisdiction over taxation and most programs authorized by the Social Security Act, similar to the Senate Finance Committee.
what is Energy and Commerce?
Energy and Commerce is the oldest standing committee of the House of Representatives. It has oversight of the DHHS and is similar to the Senate HELP committee.
what is Veterans' Affairs ?
Veterans' Affairs oversees issues related to VA.
what is legislation process?
Legislation is sent to any committee that has jurisdiction over any of the provisions in the bill. For example, the companion bill to S. 314, the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592) introduced in the House in 2015, was referred to the Subcommittees on Health in both the
Energy and Commerce and Ways and Means committees.
who drafts legislation?
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.
what are types of legislation?
bills
Joint resolutions
Concurrent resolutions
A simple resolution
where is bill introduced?
Bills are introduced into either the House or the Senate (prefixed either H.R. or S.)
what are types of bills?
Authorization bills
Appropriation bills
Companion bills
what are Authorization bills?
grant authority for a program or agency to exist or promulgate regulations.
A program must still receive an appropriation in order to receive funding
what are Appropriation bills?
designate and commit a sum of money designated for a particular purpose
by an act or bill
what are Companion bills?
such as the Pharmacy and Medically Underserved Areas Enhancement Act,
may be introduced separately or simultaneously into the House and Senate.
what are joint resolutions?
they are similar to bills. They are designated by H.J. Res. or S.J. Res. and are often used
for continuing or emergency appropriations
what are concurrent resolutions?
they are designated H.Con. Res. or S.Con. Res. They are used for internal affairs such as setting congressional hours and do not require presidential approval because they are not
laws.
what is a simple resolution?
it, designated H.Res. or S.Res., is used for internal affairs of one chamber and
does not require presidential approval.
where does legislation go after introduction?
Once introduced, the legislation is generally referred to the relevant committees for consideration, markup, and approval
what is Action, debate, and voting on legislation?
Action, debate, and voting on legislation, which are dictated by rules, differ greatly between the Senate and the House of Representatives
what is conference committee?
Because identical versions of a bill have to be approved by both chambers before they can go to the president, conference committees work to draft a compromise bill acceptable to both chambers.
what is Legislative process.
fig
what are Types of Appropriations, or Funding?
a. Entitlement spending for programs such as Medicare, Medicaid, and Social Security is automatically set
according to eligible recipients. Levels of spending can be changed only by eligibility criteria changes.
b. Discretionary spending represents annual spending levels determined by Congress; such spending is optional.
c. Continuing resolution continues funding for a program if the congressional fiscal year, ending September 30, ends without a new appropriation in place.
what is DHHS?
is the agency charged with protecting the health of Americans. Appropriations to the DHHS
represent the largest share of nondefense discretionary funding at 32% of federal monies appropriated.
what agencies are located within the DHHS?
FDA
The Centers for Medicare & Medicaid Services (CMS)
The Agency for Healthcare Research and Quality (AHRQ)
CDC
The Health Resources and Services Administration (HRSA)
what is FDA?
it 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.
what is The Centers for Medicare & Medicaid Services (CMS) ?
administers Medicare, Medicaid, and the State
Children's Health Insurance Program (CHIP). It is driving the Value-Based Purchasing (VBP) Program, the Medicare Shared Savings Program, and the EHR Meaningful Use Incentive Program, and it develops Conditions of Participation (CoP) and Conditions for Coverage (CfC) that health care organizations are required to meet in order to participate in Medicare and Medicaid programs.
what is The Agency for Healthcare Research and Quality (AHRQ)?
it supports research that helps people make better-informed decisions and improves the quality of health care services. The Public Health Service Act
of 1998 authorized AHRQ to convene the U.S. Preventive Services Task Force (USPSTF). The USPSTF is an independent panel of experts on evidenced-based practices for preventive health care who develop clinical recommendations for preventive services.
what is CDC?
it 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.
what is The Health Resources and Services Administration (HRSA)?
it 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.
what is U.S. Department of Justice (DOJ)?
Has jurisdiction over the Drug Enforcement Administration (DEA), which prevents, detects, and investigates the diversion of controlled substances and monitored chemicals
what is U.S. Environmental Protection Agency (EPA) ?
it seeks to protect human health and the environment.
a. Through the Resource Conservation and Recovery Act of 1976, the EPA 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.
who does make rules and adjudicate (enforce) them within areas of delegated authority.
Departments and agencies of the U.S. government make rules and adjudicate (enforce) them within areas of delegated authority.
who does grand DHHS the power to promulgate rules
and regulations that have the effect of substantive law?
The Administrative Procedure Act of 1946 granted agencies of the DHHS the power to promulgate rules and regulations that have the effect of substantive law
what does the federal register publish?
Proposed codification of general and permanent rules is published in the Federal Register, and the public is allowed to provide feedback within a prespecified time limit
where is final rule published ?
Final rules are published in the Code of Federal Regulations (CFR), which has 50 titles that are updated every year on a staggered basis.
what do Title 21: Food and Drugs contain?
Contains rules related to the FDA, DEA, DOJ, and Office of National Drug Control Policy
what is Pregnancy and Lactation Labeling Rule (21 FDA CFR Part 201)?
it requires changes to the content and format for drug labeling to assist in the risk-benefit assessment for medication use related
to pregnancy and lactation and includes the removal of pregnancy letter categories.
what is Institutional Review Boards (21 FDA CFR Part 56) ?
it contains standards for the composition,
operation, and responsibility of an institutional review board (IRB) that reviews and approves
of studies for products regulated by the FDA. This rule includes 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. Differences exist between this regulation
and that of the Common Rule for the definitions of research, human subjects, and IRB
(discussed later). Both need to be considered when conducting research.
what is Disposal of Controlled Substances (21 CFR DOJ DEA Parts 1300, 1301, 1304, et al.)?
it governs the secure disposal of controlled substances by DEA registrants and ultimate users.
what is Title 42: Public Health?
(a) Contains rules related to HHS, CMS, and the Office of Inspector General (OIG)-Healthcare
(b) Federally qualified health centers, organizations that receive grants for enhanced reimbursement 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.
(c) Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation
Requirements; and Changes in Provider Agreements for CMS (42 CFR DHHS CMS parts 424 and 31). This final rule expanded the definition of non-physician practitioners on hospital staffs
to include pharmacists.
what is Title 45: Public Welfare?
(a) Common Rule (45 CFR Part 46): Federal Policy for the Protection of Human Subjects (revisions
proposed in 2015 with finalization planned for 2016) protects human subjects involved in
research (discussed later). Defines an IRB in the context of the rule and is different from that of
21 CFR 56
(b) Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160, 162, and 164) protects personal health information (PHI).
(c) Enacted through HIPAA and enforced by the DHHS Office for Civil Rights
(d) The suite of HIPAA regulations for patient privacy and security is outlined in the Transactions
and Code Set Standards, Identifier Standards, Privacy Rule, Security Rule, Enforcement Rule,
and Breach Notification Rule.
what doesThe American Recovery and Reinvestment Act (ARRA) of 2009 include?
it included the Health Information Technology
for Economic and Clinical Health (HITECH) Act.
what is HITECH?
it authorizes the DHHS to create programs to improve health care quality, safety, and efficiency
through the promotion of health information technology, including electronic health records (EHRs) and health information exchanges (HIEs) to facilitate and expand the secure, electronic movement and use of health information among organizations according to nationally recognized standards
who created HITECH?
Created the Office of the National Coordinator for Health Information Technology (ONC) to coordinate nationwide standards and implementation efforts
what is The Standards and Certification Criteria Final Rule?
it is the initial approach to adopting standards,
implementing specifications, and providing certification criteria to increase the interoperability, functionality, utility, and security of health information technology and to support its meaningful use.
what is HIE?
It is defined as a process for exchanging health information through one of three forms:
Directed exchange
Query-based exchange
Consumer mediated exchange
what is Directed exchange ?
Ability to send and receive secure information electronically between care providers to support coordinated care
what is Query-based exchange?
Ability for providers to find and/or request information on a patient from other providers
what is Consumer mediated exchange?
Ability for patients to aggregate and control the use of their health information among providers
what is A health information organization (HIO) ?
it is a model for exchanging information at local, regional (known as RHIO [regional health information organization]), or state levels.
what is "Meaningful use" ?
it is part of the Electronic Health Records Incentive Programs issued by CMS to provide
a financial incentive to eligible professionals, eligible hospitals and critical access hospitals, and Medicare Advantage Organizations that are "meaningful users" of EHRs.
what are meaningful use stages?
Meaningful use consists of three stages:
(a) Stage 1 targets data capture and sharing (completed in 2014).
(b) Stage 2 targets advancement in clinical practices (through 2017).
(c) Stage 3 targets improvement in outcomes (by 2018).
what are objectives of meaningful use?
Meaningful users meet several objectives that demonstrate the use of certified EHRs in a meaningful manner (e.g., e-Prescribing), several objectives that demonstrate the use of certified EHR technology for electronic exchange of health information to improve the quality of public health and health care
(a) Opportunities for pharmacists include the provision of medication reconciliation for a minimum of 50% of patients at transitions of care, as included in the HIE objective.
(b) Each stage requires an increasing number of provider-generated prescriptions to be queried
against a drug formulary and submitted to pharmacies electronically.
what are penalties imposed by HITECH?
HITECH also imposes new penalties for breaches in HIPAA and PHI; the Office for Civil Rights within the DHHS will audit for compliance
what is The Patient Protection and Affordable Care Act of 2010 (ACA)?
it contains several provisions, ranging from
protecting consumers to improving health care quality and lowering costs to increasing access to care. As the law translates into regulation, unique opportunities exist for pharmacists to become engaged.
a. Mandates that new health plans cover USPSTF recommendations receiving a grade of A or B at no cost to patients
b. The Medicare Shared Savings Program offers providers and systems the opportunity to participate in accountable care organizations (ACOs). ACOs are a set of providers associated with a defined population of patients accountable for the quality and cost of care delivered to that population. Pharmacists may aid ACOs in achieving these quality goals.
c. Provides opportunities for pharmacists to participate in the Medicare Annual Wellness Visit
Created an optional Medicaid State Plan benefit that allows states to establish Health Homes to provide comprehensive care for Medicaid patients with chronic conditions
who and why created ACA?
Created the CMS Innovation Center to pioneer novel care delivery and payment models in which opportunities for pharmacists may exist
i. Comprehensive Primary Care (CPC) initiative explores whether reimbursable comprehensive primary care can result in better outcomes at reduced costs.
ii. Community-Based Care Transitions Program (CCTP) explores models for reducing readmissions in high-risk patients and is led by the Partnership for Patients, a nationwide partnership to reduce preventable errors in hospitals and readmissions.
iii. The Independence at Home Demonstration Program promotes the interdisciplinary collaboration of clinicians to provide home-based medical care for Medicare beneficiaries and test the effectiveness of delivering comprehensive primary care services at home and if doing so improves care for Medicare beneficiaries with multiple chronic conditions.
what is The Biologics Price Competition and Innovation (BPCI) Act of 2009?
it is a provision in the ACA that creates
an abbreviated approval pathway for follow-on biologic products, known as "biosimilars."
what is The Physician Payments Sunshine Act (i.e., Sunshine Act) ?
it authorized CMS to require manufacturers 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 purchasing organizations to report physician ownership or investments as part of the Open Payments Program.
what is The Safe and Secure Drug Disposal Act of 2010?
a. Authorized the DEA to promulgate rules for patient disposal of unused controlled substances and controlled
substance disposal by long-term care facilities
b. The Disposal of Controlled Substances Final Rule 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.
i. Authorized collectors include manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals and clinics with on-site pharmacies, and retail pharmacies, including long-term care facilities and specialty pharmacies.
ii. Allows ultimate users to voluntarily dispose of controlled substances through take-back events,
mail-back events, and collection receptacles
iii. Regulates each element of the disposal process, including transfer, deliver, collection, return, and recall of controlled substances
what is The FDA Safety and Innovation Act of 2012?
a. Amends the federal Food, Drug, and Cosmetic (FD&C) Act to reauthorize PDUFA through 2017
b. Addresses drug shortages and states that the manufacturer of a drug that is life supporting, life sustaining, 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 the 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
c. Additional provisions include responding to those failing to report a shortage, expediting manufacturer 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.
what is The Drug Quality and Security Act (DQSA) of 2013?
a. Establishes a new section (503B) in the FD&C Act to allow a compounding facility to voluntarily
register as an outsourcing facility with the FDA (Table 1).
i. The outsourcing facility must give a licensed pharmacist direct oversight over compounded drugs.
ii. 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.
b. Adds a new section (582) to the FD&C Act with product-tracing requirements ("track-and-trace") for drug manufacturers, repackagers, wholesale distributors, and dispensers to provide transaction 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.
what are Basic Comparison of the Compounding of Drug Products Under Section 503A and 503B?
table
what are FDC Act exemptions as 503A: Traditional Compounder?
• Good manufacturing practices
• Specific labeling requirements
• FDA approval before marketing
what are FDC Act exemptions as 503B: Outsourcing Facility?
• Specific labeling requirements
• FDA approval before marketing
what is Compounding practice as 503A: Traditional Compounder ?
• Compounded for identified
individual patient
• Must follow USP guidance for
compounding
what is Compounding practice as 503B: Outsourcing Facility?
• Sterile compounding
• May or may not obtain prescriptions for
individual patients
• Must follow good manufacturing practices for
compounding
what is Reporting and registration as 503A: Traditional Compounder ?
• No reporting or registration
• Must follow track-and-trace
requirements
what is Reporting and registration as 503B: Outsourcing Facility?
FDA registration required
• Reports of compounded products and bulk
ingredients every 6 months
• Exempt from track-and-trace requirements
what are fees as 503A: Traditional Compounder?
• None
what are fees as 503B: Outsourcing Facility?
• Establishment and inspection fees
what are Shipping restrictions as 503A: Traditional Compounder ?
• Under state regulations
what are Shipping restrictions as 503B: Outsourcing Facility/
none
what is Medicare Access and CHIP Reauthorization Act (MACRA) of 2015?
a. Legislation repealed the sustainable growth rate (SGR) physician reimbursement methodology that threatened to reduce Medicare physician payments for more than a decade.
b. Represents a shift in reimbursement from fee-for-service to pay-for-performance or pay-for-value
i. Establishes the alternative payment model for physicians participating in patient-centered medical homes, ACOs, and Medicare shared-savings programs
ii. 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 HER
iii. Sunsets three existing value-based payment adjustments: the EHR incentive program and the
Physician Quality Reporting System and Value-Based Payment Modifier (discussed later) and combines them into MIPS
iv. Promises to revise and replace the EHR incentive program known as meaningful use
v. Reauthorized the State Children's Health Insurance Program through fiscal year 2017. Final rule published in the Federal Register November 4, 2016. It works to broaden physician involvement in alternative payment models, to reduce administrative burden, and to ease providers into the transition.
what is Introduction of the Pharmacy and Medically Underserved Areas Enhancement Act (S. 314 and H.R. 592)?
a. The companion bills were introduced in January 2015 and were referred to committee and subcommittee shortly thereafter.
b. The bills would enable pharmacists to provide reimbursable services to eligible Medicare Part B beneficiaries residing in medically underserved communities.
c. The bipartisan bill was a result of the combined efforts of pharmacy organizations and advocates, receiving wide support in the House and Senate, with 293 co-sponsors in the House and 51 co-sponsors in the Senate.
d. After referral to committee and subcommittee, there has been no further action on this bill.
what is Title 21 of the CFR?
Most federal laws that authorize the FDA to promulgate rules are enacted by amendments to the FD&C Act, and they are organized in Title 21 of the CFR
who funds FDA?
The FDA is funded through discretionary spending every fall in Congress's appropriations bill written by the Senate and House appropriations committees, but the Senate HELP and the House Energy and Commerce committees have jurisdiction over its reauthorization.
what offices and centers effect medication use?
i. Office of the Commissioner
ii. Office of Regulatory Affairs,
iii. National Center for Toxicological Research
iv. Center for Drug Evaluation and Research (CDER)
v. Center for Biologics Evaluation and Research (CBER)
vii. Center for Food Safety and Applied Nutrition
viii. Center for Tobacco Products
ix. Center for Veterinary Medicine
what is Office of the Commissioner?
it conducts overall agency coordination; the FDA's top official, the
commissioner, requires Senate confirmation.
what is Office of Regulatory Affairs?
it regulates all inspection and enforcement activities.
what is National Center for Toxicological Research?
it supports the six product centers with scientific technology, training, and technical expertise.
what is Center for Drug Evaluation and Research (CDER)?
it regulates prescription and nonprescription drugs.
what is Center for Biologics Evaluation and Research (CBER)?
it regulates biologic products, including
vaccines, blood products, and gene therapy.
what is Center for Devices and Radiological Health?
it regulates medical devices.
what is Center for Food Safety and Applied Nutrition ?
it regulates most foods, food additives, infant formulas, dietary supplements, and cosmetics.
what is Center for Tobacco Products?
it regulates tobacco-containing products.
what is Center for Veterinary Medicine?
it regulates feed, drugs, and devices used for pets, farm animals, and other animals.
what is a clinical trial?
it is a research study of humans conducted to answer specific questions about vaccines, new therapies, or new ways of using known treatments. Clinical trials are required by the FDA to determine whether new drugs or treatments are both safe and effective.
what is An Investigational New Drug Application (INDA) ?
it is used for a new drug, a new indication, or an
off-label use that will be used in a clinical investigation's preclinical development for that new drug to be distributed across state lines before full FDA review.
what is A New Drug Application (NDA)?
it is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
what is The Abbreviated New Drug Application (ANDA) ?
it contains data that, when submitted to the FDA's
CDER, Office of Generic Drugs, allow the review and ultimate approval of a generic drug product.
what is An authorized generic drug?
it is a listed drug that is marketed, sold, or distributed directly or indirectly to the retail class of trade. Its labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code,
trade name, or trademark differs from that of the listed drug.
what is A biologics license application?
it is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and medical effects of a biologic product (monoclonal antibodies, enzymes, immunomodulators, growth factors, and cytokines) seeking approval to market in the United States.
what is The interchangeability of a biosimilar product?
it may allow it to be substituted for the legend (brand) biologic with an expectation that the same clinical outcome will occur and without the requirement of notification or intervention of a prescriber.
what is The Drug Importation Act of 1848?
Prohibited the importation of unsafe or adulterated drugs at key ports
of entry
what is The Biologics Control Act of 1902?
i. Mandated annual licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and similar products in interstate commerce
ii. Authorized Hygienic Laboratory, precursor of the NIH, to conduct regular inspections for purity
and potency
what is The Pure Food and Drug Act of 1906?
The Pure Food and Drug Act of 1906
i. Prohibited interstate commerce of adulterated or misbranded drugs
ii. Required labeling of selected dangerous and addictive substances
iii. Identified the United States Pharmacopoeia and the National Formulary (USP/NF) as official
standards for drugs
what is The FD&C Act of 1938?
i. Required that firms prove evidence of safety to the FDA before marketing
ii. Placed drug advertising under the jurisdiction of the Federal Trade Commission
iii. Recognized the USP/NF as the official compendia of drug standards
what is The Durham-Humphrey Amendment of 1951?
Amended the FD&C Act of 1938 to statutorily differentiate prescription and nonprescription drugs
what is The Kefauver-Harris Amendments of 1962?
i. Established the requirement for drug firms to demonstrate efficacy as well as safety
ii. Statutory requirement to obtain informed consent for research subjects
iii. Authorized the FDA to regulate advertising of prescription drugs and establish good manufacturing practices
what is The Comprehensive Drug Abuse Prevention and Control Act of 1970 (i.e., Controlled Substance Act) ?
it authorized the DEA and FDA to regulate the manufacture, classification (schedule), importation, possession, use, and distribution of controlled substances.
what is The Orphan Drug Act of 1983?
Established grants, federal assistance for research, and tax incentives to develop drugs targeted for a patient population of less than 200,000 or for medications with no expectation
of cost recovery.
i. Grants a period of market exclusivity to new medications (7 years) for these rare diseases (Box 1)
ii. This timeline is independent of patent life (20 years), which begins when a new molecule is invented, not when it gains approval.
what is Suboxone Orphan Drug Status Timeline?
• The first patent for Suboxone was filed in 1990.
• While being investigated under an IND, the manufacturer filed for Orphan Drug Status in 1993. The application reflected that, despite the high rates of opioid addiction, less than 200,000 patients would be using the medication
for opiate detoxification and maintenance. In addition, the application noted that market projections found no reasonable expectation that the costs of developing the drug would be recovered from sales. The drug was granted
Orphan Drug Status in 1994.
• Suboxone was FDA approved in 2002, and the market exclusivity of 7 years began.
• Market exclusivity lapsed for this product in 2009. The FDA began accepting applications for generic products.
The product patent for this formulation expired in 2010.
• The first generic formulations were brought to market in 2013.
• Controversy exists over the original estimates and approval of the product as an orphan drug.
what is The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)?
Authorized
the FDA to create an abbreviated regulatory pathway through the ANDA for generic drugs
i. Grants a period of market exclusivity to new medications (4-5 years) or new indications (3 years) from approval until the acceptance of applications for generic drugs
ii. Grants the first approved generic drug 180 days of market exclusivity before other generic drugs can be approved
iii. This timeline is independent of patent life
what is The Food and Drug Administration Act of 1988?
Officially established the FDA as an agency in the
DHHS
what is The Prescription Drug User Fee Act of 1992 (PDUFA)?
i. Requires drug, biologics, and medical device (Medical Device User Fee Amendments) manufacturers to pay fees for product applications, supplements, and other services
ii. Reauthorized every 5 years (1997, 2002, 2007, 2012, expected 2017)
what is The Dietary Supplement Health and Education Act of 1994?
Allows nutritional supplements and vitamins
to be regulated
what is The FDA Modernization Act of 1997?
i. Streamlines clinical research on drugs and devices
ii. Has exclusivity provisions for pediatric drugs
iii. Authorizes the creation of a databank (ClinicalTrials.gov) to provide easy access to information on federally and privately supported clinical trials for a wide range of diseases and conditions
iv. Provides abstracts of clinical study protocols that investigators are required to submit
1. Summary and purpose of study
2. Recruiting status
3. Criteria for patient participation
4. Location for trial and specific contact information
5. Research study design
6. Phase of trial
7. Disease or condition and drug or therapy under study
v. More than 200,000 clinical trials have been listed with locations in all 50 states and in 191 countries.
vi. Reauthorized PDUFA through 2002
what is The FDA Amendments Act (FDAAA) of 2007?
i. Statutory authority to require Risk Evaluation and Mitigation Strategies (REMS) for the safe use of medications (discussed later)
ii. Expanded the requirements for the types of drugs that must be registered on ClinicalTrials.gov; requires the submission of results for certain clinical trials
iii. Reauthorized the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.
Both were designed to encourage more research into, and more development of, treatments for
children
iv. Reauthorized PDUFA through 2012
what is The Family Smoking Prevention and Tobacco Control Act of 2009?
Gave the FDA authority to regulate tobacco products
what is The BPCI Act of 2009?
it passed as a provision within the Patient Protection and Affordable Care Act of
2010 (ACA),
i. Established a regulatory approval pathway for biosimilars
ii. Created FDA-administered periods of regulatory exclusivity for certain brand-name drugs and follow-on products
iii. Created a patent dispute resolution procedure for use by brand-name biosimilar manufacturers
what is The Reducing Prescription Drug Shortages Executive Order?
itwas signed by President Barack Obama on
October 31, 2011. It requires the FDA to:
i. Broaden the reporting of manufacturing discontinuances that may lead to shortages of drugs that are life supporting or life sustaining or that prevent debilitating disease
ii. Expedite regulatory reviews to avoid or mitigate existing or potential drug shortages. Reviews may include new drug suppliers, manufacturing sites, and manufacturing changes.
iii. Communicate to the DOJ any evidence of or behaviors by market participants that have contributed to stockpiling or exorbitant prices
what is The FDA Safety and Innovation Act of 2012?
i. Established the Biosimilar User Fee Act of 2012 to assess and collect fees for biosimilar biological
products
ii. Established the "breakthrough therapy" drug approval pathway
iii. Increased stakeholder involvement in FDA processes by providing for the establishment of a
patient-focused drug development initiative
iv. Reauthorized PDUFA through 2017
what is The 1962 Kefauver-Harris Amendments?
it included a provision requiring manufacturers of drug products to establish a drug's effectiveness by "substantial evidence."
i. It has been the FDA's position, based on the language of the statute and the legislative history of the 1962 amendments, that Congress generally intended to require at least two adequate and well-controlled trials, each convincing on its own, to establish effectiveness.
ii. In 1997 under the FDA Modernization Act, section 505(d) was amended to make it clear that the agency may consider "data from one adequate and well-controlled clinical investigation and confirmatory evidence" to constitute substantial evidence if the FDA determines that such data and evidence are sufficient to establish effectiveness.
what are preclinical studies?
i. Laboratory and animal studies that assess safety and biologic activity in various model systems
ii. Toxicologic studies completed
1. Effects on the fetus in pregnant mice, rats, rabbits, or baboons
2. May or may not translate into human fetal adverse effects
3. Fetal effects in humans may occur that were not observed in animal studies.
4. Basis for pregnancy categorization
what is an INDA?
it is drafted and submitted to the FDA. It must contain a general plan of investigation, drug
information (i.e., chemistry, pharmacology, toxicology, pharmacokinetics, biologic disposition, laboratory and animal testing data, and existing human data), protocol, manufacturing, and control of the drug.
what is 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.
what is 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.
what is 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 confirm its safety, efficacy, and appropriate dosage
ii. Goal is to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-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)
where does one submit An NDA?
it is submitted to the FDA and classified with a code that reflects both the type of drug being
submitted and its intended uses
how does one fill in an NDA?
i. The numbers 1-7 are used to describe the type of drug:
1. New molecular entity (1)
2. New salt of previously approved drug (2)
3. New formulation of previously approved drug (3)
4. New combination of two or more drugs (4)
5. Already marketed drug product (i.e., new manufacturer) (5)
6. New indication for currently marketed drug or switch from prescription to over the counter (6)
7. Already marketed drug product without a previously approved NDA (7)
ii. Letter code describes the review priority of the drug.
1. S = standard review for drug similar to currently available drugs.
2. P = priority review for drugs that represent significant advances over existing treatments.
iii. Not all phase III drugs are approved, and the FDA can impose a clinical hold at any stage.
what are Components of the New Drug Application?
Index
Nonclinical pharmacology and toxicology
Summary Human pharmacokinetics and bioavailability
Chemistry, manufacturing, and control Microbiology (for antimicrobial drugs only)
Samples, methods, and labeling Clinical data
Safety update report
Case report forms
Statistical analysis
Patent information
Case report tabulations
Patent certification
Other pertinent information
what is 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, benefits, and optimal use
iii. Verify effectiveness or focus treatment on special populations
what is generic approval?
a. A generic drug product is identical to an innovator drug product in bioequivalence and pharmaceutical equivalence. Demonstrations of bioequivalence indicate that there are no significant differences in the bioavailability (e.g., rate and extent of absorption of the active ingredient) under experimental conditions,
such as through in vivo or in vitro studies. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, defined bioequivalence statutorily as a means to approve a generic drug.
b. An ANDA must be submitted to CDER's Office of Generic Drugs.
i. ANDAs generally do not require preclinical or clinical data; rather, they must demonstrate pharmaceutical equivalence and bioequivalence.
ii. Once an ANDA is submitted to and approved by, the applicant can manufacture and market the
generic drug as a safe, effective, and low-cost option to the public.
c. Pharmaceutical equivalents share the same active ingredient, dosage form and strength, route of administration, quality, and intended use (Box 3).
what is A generic drug product?
it is identical to an innovator drug product in bioequivalence and pharmaceutical
equivalence. Demonstrations of bioequivalence indicate that there are no significant differences in the bioavailability (e.g., rate and extent of absorption of the active ingredient) under experimental conditions, such as through in vivo or in vitro studies. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, defined bioequivalence statutorily as a means to approve
a generic drug.
what is An ANDA?
it must be submitted to CDER's Office of Generic Drugs.
i. ANDAs generally do not require preclinical or clinical data; rather, they must demonstrate pharmaceutical
equivalence and bioequivalence.
ii. Once an ANDA is submitted to and approved by, the applicant can manufacture and market the
generic drug as a safe, effective, and low-cost option to the public.
what is Pharmaceutical equivalents?
they share the same active ingredient, dosage form and strength, route of administration,
quality, and intended use (Box 3).
what is Criteria for Medications to Be Pharmaceutical Equivalents?
Three criteria:
☐ Must contain the same active ingredient
☐ Must be the same dosage form and route of administration
☐ Must be of identical strength or concentration, quality, and purity
Differences allowed:
☐ Shape
☐ Releasing mechanism
☐ Labeling (limited differences)
☐ Scoring
☐ Excipients (colors, flavors, preservatives)
what are Therapeutic equivalence of generic drugs?
All approved multisource products are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). The therapeutic equivalence coding system, using A or B, helps health care providers determine whether the FDA evaluated a product to be therapeutically equivalent to other pharmaceutically equivalent products.
what is A code?
An approved generic product considered therapeutically equivalent to other pharmaceutical equivalents
what is B code?
An approved generic product that is not considered therapeutically equivalent to other
pharmaceutical equivalents
what are Therapeutic equivalents?
they can be substituted with the expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.
Assigns therapeutic equivalence code according to data submitted in an ANDA to demonstrate
bioequivalence. Products deemed by the FDA not therapeutically equivalent are rated "B."
what is criteria for Therapeutic equivalents?
(1) Pharmaceutical equivalent
(2) Therapeutic equivalence codes rated "A" by the FDA
(3) Designates a brand-name drug or a generic drug as the reference-listed drug
(4) Demonstrates bioequivalence
what is An authorized generic?
is a drug that is produced by the brand company under the NDA but marketed as a
generic. It is identical to the brand alternative in both active and inactive ingredients. The federal FD&C
Act establishes a 180-day exclusivity period after approval of an ANDA. In this period, the FDA cannot
approve other ANDAs for the same drug product.
what is challenging of drug manufacturer?
At-risk launch of a generic occurs when a generic drug manufacturer challenges the validity of the existing patent of a brand drug.
what is A biologic product?
it is a drug or vaccine that has been produced in living cells.
what is BPCI Act?
The ACA amends the PHS Act through part of the legislation known as the BPCI Act. This legislation
created an abbreviated licensure pathway for biological products found to be biosimilar or interchangeable with an FDA-approved reference biological product after 12 years of patent exclusivity.
what is A biosimilar product?
it is a biological product that is highly similar in safety and efficacy to an FDAapprovedreference biological product with only minor differences in clinically inactive components.
what is An interchangeable biological product?
it is biosimilar to an FDA-approved reference biological product
that meets additional standards. An interchangeable biological product may be substituted for
the reference product by a pharmacist without the intervention of the health care provider who
prescribed the reference product. Because this interchange is also subject to state regulation, the
statewide policy may override federal policy if it is more restrictive
what is The Biosimilar Implementation Committee, staffed by CDER, CBER, the Office of Chief Counsel,
and the Office of the Commissioner?
it has developed several guidances for industry that describe the current thinking relating to quality and scientific considerations in demonstrating biosimilarity, clinical pharmacology data required to demonstrate biosimilarity, reference product exclusivity for
biological products, and nonproprietary naming of biological products. These guidances do not
establish legally enforceable responsibilities of the FDA. As of this writing, final naming guidance
and draft interchangeability guidances are awaited.
what are Regulatory Approval Pathway Comparison for Small Molecule and Biologic Products?
table
what is a medical device?
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory that is:
i. Recognized in the official NF, or the USP, or any supplement to them
ii. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals
iii. Intended to affect the structure or any function of the body of humans or other animals that does not achieve any of its primary intended purposes through chemical action within or on the body of human beings or other animals and that does not depend on being metabolized for the achievement of any of its primary intended purposes
who regulates medical devices?
Regulated by the Center for Devices and Radiological Health
i. To be approved, a manufacturer of a class 3 (high-risk) medical device must submit a premarket approval application ensuring the device's safety and efficacy.
ii. If a medical device is essentially equivalent to an existing, legally marketed device, a 510(k) is submitted for premarket notification.
iii. An investigational device exemption allows an investigational device to be used in a clinical study to collect the safety and effectiveness data required to support a premarket approval application or a premarket notification 510(k) submission to the FDA.
what is classification of medical devices?
Classified according to the risks associated with the device:
i. Class I: Deemed low risk and therefore subject to the least regulatory control
ii. Class II: Higher-risk devices than class I that require greater regulatory controls to ensure reasonable safety and efficacy
iii. Class III: Highest-risk devices, subject to the greatest regulatory control; must be approved by the FDA before marketing
what is The FDAAA of 2007 ?
it authorized the FDA to require REMS to ensure benefits outweigh risks before or after drug approval, if necessary. Examples of drug risks and possible actions include patient education
on signs and symptoms or monitoring of laboratory values to avoid serious adverse effects, negative pregnancy tests before dispensing medications linked to serious birth defects, or administration by health care professionals in the presence of high administration-related risks
what is REMS?
authorized the FDA to require REMS to ensure benefits outweigh risks before or after drug approval, if necessary. Examples of drug risks and possible actions include patient education
on signs and symptoms or monitoring of laboratory values to avoid serious adverse effects, negative pregnancy tests before dispensing medications linked to serious birth defects, or administration by health care professionals in the presence of high administration-related risks
The FDA does not have the authority to impose penalties on pharmacies and pharmacists not in compliance with REMS requirements, but there may be legal implications such as misbranding violations or civil liability issues.
what are Risk Evaluation and Mitigation Strategies' Requirements of ETASU?
ETASU may include one or more of the following:
☐ Health care providers who prescribe the drug have particular training or experience or are specially certified
☐ 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
ETASU = Elements To Assure Safe Use.
what is Suboxone® REMS Program?
REMS elements include:
• Medication guide
• ETASU:
• Documentation of several safe use conditions by the prescriber:
• Patient meets diagnostic criteria
• Risks have been explained
• Safe storage has been reviewed
• Limited quantity prescribed at first visit
• REMS Instruction Letter to Prescribers will be mailed annually to all physicians certified to treat opioid dependence under the Drug Addiction Treatment Act of 2000 and all retail pharmacies authorized by the DEA to handle schedule 3 controlled substances by manufacturer
• Documented patient monitoring: regular visits, adherence assessments, appropriate prescribing, psychosocial support assessment, progress toward treatment goals
what is Critical Path Initiative?
i. Created in response to a significant decline in NDAs, biologics license applications, and medical
device applications because of the widening gap between basic science discovery and the challenging, inefficient, and costly development of medical products
ii. Prioritizes the most pressing developmental problems and identifies areas that provide the greatest opportunities for rapid improvement and public health benefit through three dimensions: safety assessment, evaluation of medical utility, and product industrialization
what is The Clinical Trials Transformation Initiative (CTTI)?
it is a public-private partnership that includes government agencies, industry representatives, patient advocacy groups, professional societies, investigator groups, academic institutions, and other stakeholders. It aims to improve the quality and efficiency of clinical trials.
what is The Joint Commission?
Not-for-profit, independent organization that sets standards for accrediting health care facilities through its mission "to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care
of the highest quality and value"
what is purpose of The Joint commission?
Accredits and certifies almost 21,000 health care organizations in the United States. Accreditation is reassessed every 3 years according to adherence to Hospital Standards, as assessed during on-site surveys, and quality reporting of performance indicators.
i. Standards address performance in functional areas of patient rights, patient treatment, medication safety, and infection control. National Patient Safety Goals were established to help accredited organizations address specific areas of concern in patient safety. Goals differ by health care setting and can change on the basis of recommendations from the Patient Safety Advisory Group.
what are On-site surveys?
they are unannounced and use tracer methodology to evaluate a patient's medical record as a road map through a health care organization to 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
what is Performance measurement of Joint Commission?
The ORYX is a Joint Commission initiative to integrate outcomes with
accountability in core measures: acute myocardial infarction, pneumonia, surgical care improvement
project, children's asthma care, perinatal, hospital outpatient measures, venous thromboembolism,
substance abuse, tobacco treatment, emergency department care, immunization, hospital-based
inpatient psychiatric services, and stroke in its accreditation process.
what are Included accountability measures and processes?
theyare those that result in the greatest improvement in patient outcomes as identified by the Joint Commission. These measures and processes must be of sound scientific evidence, be in proximity between process and outcome, accurately measure the process, and minimize adverse effects without inducing unintended consequences.
Measures are updated semiannually
what are National Hospital Quality Measures?
they include common standardized measures between the Joint
Commission and CMS, designed to share a single set of documentation (
what are National Hospital Quality Measure for Substance Abuse (SUB)-3?
Measure: Alcohol and Other Drug Use Disorder Treatment Provided or Offered at Discharge
Type of Measure: Process
Description: Patients who are identified with alcohol or drug use disorder who receive or refuse at discharge a prescription or FDA-approved medications for alcohol or drug use disorder OR who receive or refuse a referral for
addictions treatment out of hospitalized inpatients 18 years and older identified with an alcohol or drug use disorder
Rationale: Excessive alcohol and substance abuse negatively affects health and society. Brief interventions have
been found improve health and reduce costs
National Quality Measures contain measures not common to CMS. true or false.
true
what is The 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.
what is The National Committee for Quality Assurance (NCQA)?
Private, not-for-profit organization with a mission to improve the quality of health care through measurement, transparency, and accountability
what is NCQA responsible for?
Responsible for the development and maintenance of the Healthcare Effectiveness Data and Information Set (HEDIS)
what is HEDIS?
i. Consists of more than 83 measures across five domains of care that health plans use to measure
performance and focus improvement efforts. Domains include effectiveness of care, access of care, experience of care, utilization and relative resource use, and health plan descriptive information.
ii. Several measures are included in CMS's Quality Rating System for health plans participating in
federally facilitated marketplaces for consumers to view in 2016.
what are Voluntary accreditation programs, certification programs, physician recognition programs, and distinctions directed at?
They are directed at health plans (e.g., health maintenance organizations, preferred provider organizations, and consumer-directed health plans), physician networks, medical groups, and individual physicians.
i. Notably accredits ACOs and certifies and recognizes patient-centered medical homes (PCMHs)
ii. Assessments may include on-site clinical and administrative processes, through data collection for the HEDIS, and measuring member satisfaction through the Consumer Assessment of Healthcare Providers and Systems survey
what is The Quality Compass?
A comparison tool that allows users to view measure results and benchmark information that ranks health plans using the HEDIS measures
what is Public reporting?
"The State of Health Care Quality," which is an annual, overall assessment of the performance of the American health care system; "America's Best Health Plans" in collaboration with U.S. News & World Report; and the online Health Plan Report Card with a searchable database detailing
health plans' accreditation and performance ratings
what is The Center for Pharmacy Practice Accreditation?
Established by the American Pharmacists Association, the National Association of Boards of Pharmacy, and ASHP, offers accreditation for pharmacy practice sites on the basis of adherence to comprehensive and patient-centered medication use performance measures.
Accreditation includes community, specialty, and telehealth pharmacy practice programs.
what are Quality Improvement Efforts?
The National Quality Forum (NQF)
AHRQ
The Patient-Centered Outcomes Research Institute (PCORI)
The Pharmacy Quality Alliance (PQA)
CMS Initiatives
The Leapfrog Group
what is The National Quality Forum (NQF)?
Nonprofit organization that aims to improve quality through a three-part mission:
(a) Build consensus on national priorities and goals for performance improvement and work in
partnership to achieve them.
(1) Medicare Improvements for Patients and Providers Act of 2008: The DHHS entered into
a contract with the NQF to establish a portfolio of quality and efficiency measures for use in reporting on and improving health care quality for the federal government to determine
a return on investment in health care spending. The NQF is tasked with the formulation of
a national strategy and priorities for health care performance measurement based on evidence
related to 20 high-priority conditions identified by CMS that account for more than
95% of their costs.
(b) Endorse national consensus standards for measuring and publicly reporting on performance.
Assess evidence to support and endorse quality measures proposed by other organizations
(NCQA, American Medical Association, etc.) through a transparent, consensus-based practice
(c) Promote the attainment of national goals through education and outreach programs
what is membership to NQF?
Membership includes stakeholders from consumer organizations, public and private purchasers, physicians, nurses, accrediting and certifying bodies, supporting industries, and health care research and quality improvement organizations.
what is AHRQ?
The agency within the DHHS that supports research that helps people make more informed decisions and improves the quality of health care services through its mission to improve the quality, safety, and effectiveness of health care for all Americans
what is Health service research?
it 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.
what is The Consumer Assessment of Healthcare Providers and Systems (CAHPS) program?
it is an initiative to support and promote the assessment of consumer experiences with health care. The surveys assess the patient experience with a broad range of health care services and at multiple levels of delivery (e.g., health plans, hospitals [the Hospital Consumer Assessment of Healthcare Providers and Systems; HCAHPS] and dialysis centers) and can be used to make quality assessments for programs such as value-based purchasing.
what is available for researchers, clinicians, policy-makers,
and consumers?
Funding opportunities, toolkits, and resources are available for researchers, clinicians, policy-makers, and consumers.
what is The Patient-Centered Outcomes Research Institute (PCORI)?
Nonprofit authorized by Congress in 2010
charged with improving the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy-makers make informed health decisions through the support and funding of comparative clinical effectiveness research (CER)
what is The Pharmacy Quality Alliance (PQA)?
i. The mission of the PQA 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.
ii. Develops medication-related 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
what are CMS initiatives?
i. Hospital VBP Program was established by the ACA in 2010 and uses quality measures endorsed by NQF as well as HCAHPS to establish and apply criteria for reimbursement and incentive payments starting in 2013. Performance data are public on the Hospital Compare website.
what is Physician Quality Reporting System?
it ties quality measures to physician reimbursement and makes some data public on the Physician Compare website.
what is Health Insurance Marketplace Quality Rating System (QRS) ?
it aims to:
(a) Provide useful information to consumers using the Health Insurance Marketplace. Plans will be
required to display their QRS star ratings (5-star scale) on their website before the 2018 Open
Enrollment Period (limited pilot for 2017), and ratings will be displayed through the federally
facilitated marketplaces. These ratings incorporate quality measures such as HEDIS and PQA measures.
(b) Provide actionable information that plans can use for performance improvement
(1) Quality Bonus Payment Demonstration Project was designed to drive quality improvement
by extending bonus payments for improvements to low-performing plans.
(2) Potential opportunity for community pharmacy to improve plan ratings. EQuIPP is a performance
information management system that makes performance data available to both
health plans and pharmacy organizations.
(c) Facilitate oversight of qualified plans
what is The Leapfrog Group?
it is a voluntary program that works with employers to enable and direct purchasing
power toward health care decisions focused on safety, quality, and value. It compares hospital performance on the metrics most important to consumers and purchasers of care. A Hospital Safety Score of A, B, C, D, or F has been applied to more than 2500 hospitals on the basis of prevention of errors, accidents, injuries, and infections.
what are Basics of Formulary Management?
i. Formulary management is an ongoing process for a health care organization to establish medication use policies on drugs, therapies, and drug-related products that are evidence based and costeffective for certain patient populations.
ii. The Joint Commission Medication Management Standard Chapter requires the hospital to develop and approve criteria for selecting medications that include indications for use, effectiveness, drug interactions, potential for errors and abuse, adverse drug events, sentinel event advisories, populations served, other risks, and costs.
iii. The CMS CoP require that medical staff establish a formulary system.
iv. A pharmacy and therapeutics (P&T) committee develops consensus on medication use policies and formulary management.
v. Evidence-based evaluation of medications for inclusion on a formulary includes a drug use review or drug use evaluation (DUE) (Box 7) and will be affected by CER.
what are Elements of a Drug Use Evaluation Monograph?
Brand and nonproprietary names
FDA approval information, including date and
FDA rating
For biosimilars, interchangeability status
Pharmacology and mechanism of action
FDA-approved indications
Potential off-label uses
Dosage forms and strengths
Pharmacokinetic considerationsUse 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 efficacy, safety, and cost-effectiveness
Medication safety assessment and considerations
Financial analysis based on use within a health system
Recommendation for inclusion or exclusion
what is formulary?
A continually updated list of medications and related information, developed using the
clinical judgment of pharmacists, physicians, and other experts in the diagnosis and treatment of
disease and promotion of health within hospitals, health plans, and health care systems
what is 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
what is Medication use evaluation (MUE)?
Performance improvement method that focuses on evaluating and improving medication-use processes related to prescribing, medication preparation, dispensing, administering, and monitoring. Medication use evaluations are often also tied to cost savings.
what are Formulary management strategies?
i. Preferential use of generic drugs
ii. Formulary exclusion
iii. Formulary restrictions
what is Formulary exclusion?
Process of limiting medications from the formulary (called non-formulary or
non-preferred medications)
what is Open formulary?
Non-formulary or non-preferred medications may be covered at variable levels of cost within a health plan.
what is Closed formulary?
Non-formulary or non-preferred medications are not covered within a health
plan unless under an exception where medically appropriate
what are Formulary restrictions?
Restricting prescriptive authority to a particular service or disease state
what are Example Suboxone® (Buprenorphine/Naloxone) Sublingual Film Formulary Criteria for Use?
Health systems may wish to restrict the use of agents that are deemed high risk, high cost, or as needing special monitoring (e.g., Suboxone®)
Criteria for use may include the following:
☐ Patient inclusion: Patients meeting diagnostic criteria for opioid dependence/use disorder needing opioid agonist therapy
☐ Provider inclusion: Authorized to prescribe Suboxone® by meeting all requirements for a waiver specified by the Drug Addiction Treatment Act (DATA) 2000 as codified at 21 U.S.C. 823(g), who has experience in addiction management. Assurance of the availability of necessary treatment resources must be completed by
the physician before prescribing
☐ Considerations for use:
• Alternative first-line therapies for opioid dependence include methadone, though this agent is not available
for office-based opioid treatment
• Consider the potential for QTc prolongation in unstable cardiac disease or low potassium concentrations
• Consider the potential for drug interactions with CYP3A4 inhibitors or inducers and with central nervous system depressants
• Patients will need monitoring for several hours after administration of induction doses
• Patients should be seen weekly for the first 2 weeks of therapy and then at least monthly for the next 3 months
• Patients should be discontinued from therapy if they are found to misuse, abuse, or divert the medication; to be noncompliant with therapy; or to be unresponsive to therapy
☐ System responsibilities:
• Procedures to verify provider authorization and to restrict use to authorized prescribers must be in place
• Quantity limits may be imposed such that enough medication is dispensed to last only until the next scheduled appointment
what is Therapeutic interchange?
Authorized exchange of therapeutic alternatives in accordance with previously established and approved written guidelines, policies, or protocols within a formulary system
what is Guided-use requirements?
Include use criteria, clinical practice guidelines, and operating procedures
what are MUE?
MUEs differ from DUEs in that MUEs emphasize improving patient outcomes using a process
that identifies, 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 findings
(f) Identifying and implementing improvement strategies in the medication-use process
what is medication error?
Any error occurring in the medication process (ordering, transcribing, dispensing, administering, and monitoring)
what is example of medication error?
Order filled for the wrong patient
what is Adverse drug event?
Injury resulting from medication use or misuse; may or may not result from a medication error
what is example of Adverse drug event?
Hemorrhage from heparin
what is Preventable adverse drug event?
Injury caused by medication error
what is example of Preventable adverse
drug event?
Overdosage of a medication that resulted in
a hospitalization
what is Potential adverse drug event?
Medication error with the potential
for injury
what is example of Potential adverse drug event?
Overdosage of a medication that was
intercepted before patient administration
what is Adverse drug reaction?
Non-preventable injury caused by the drug
at normal doses and with normal use; not a
result of a medication error
what is example of Adverse drug reaction?
Allergic reaction in a person with no
known allergies
what is incidence of medication error?
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.
what was a congreessional response to report "To Err Is Human"?
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act [PSA]) and the Patient
Safety and Quality Improvement Final Rule (Patient Safety Rule) were a congressional response to these reports.
what are The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act [PSA]) and the Patient
Safety and Quality Improvement Final Rule (Patient Safety Rule) ?
It requires the AHRQ to administer a Network of Patient Safety Databases to assess national, de-identified patient safety events.
(a) Encourages health care providers and organizations to voluntarily report and share patient safety information without fear of legal action
(b) Authorized the creation of patient safety organizations (PSOs)
(1) PSOs can be private or public entities, profit or not-for-profit entities, provider entities such
as a health system, or other entities.
(2) 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.
what is the Patient Safety Organization Privacy Protection Center?
The 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-identifiable. PSOs not listed with AHRQ are not recognized under the PSA.
how is data acquired by Patient Safety Organization Privacy Protection Center?
(1) Data are submitted to PSOs through Common Formats, developed by AHRQ for acute care
hospitals 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.
(2) The NQF leads the public review and lends expert opinion regarding the Common Formats.
(3) In March 2013, CMS communicated that although the use of Common Formats is not
required for CoP for Quality Assessment and Performance Improvement surveys, hospitals
that use them will be in a better position to meet Quality Assessment and Performance
Improvement requirements.
(4) CMS surveyors were also encouraged to become familiar with Common Formats
wha is role of PSOs?
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.
what is The Institute for Safe Medication Practices?
it began in 1975 to promote medication error prevention and initiated a voluntary practitioner error-reporting program. The institute is now a
nonprofit PSO that publishes four medication safety alert newsletters for acute care settings,
ambulatory care settings, nurses, and medications.
what is Vizient, formerly known as the University HealthSystem Consortium (UHC)?
it is an alliance of academic medical centers and affiliated hospitals that is listed as an AHRQ-listed PSO under the UHC Performance Improvement PSO. Offers the UHC Patient Safety Net, a web-based inpatient and outpatient safety event-reporting system that consolidates and aggregates data for specific event types and offers best practices and policies to address common systemic areas for improvement
how are ADEs graded?
Grades of certainty criteria, including certainty/definite, probable/likely, possible, and unlikely/ doubtful, determine whether an adverse event is caused by a medication and can be assessed by tools such as the Naranjo Adverse Drug Reaction (ADR) Scale or the World Health Organization (WHO)-Uppsala Monitoring Centre (UMC) Causality Assessment
where are ADEs reported?
Adverse drug events should be reported to the U.S. Food and Drug Administration (FDA) Adverse
Event Reporting System (FAERS), a database with more than 400 million adverse event and medication error reports.
what is MedWatch Form FDA 3500 for voluntary reporting?
it 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 specifically permits health care professionals to disclose PHI for public health purposes
what is MedWatch Form FDA 3500A?
it is for regulated industry following investigational new drug (IND) and biologic regulations and user facilities such as hospitals and nursing homes.
what is MedWatch Form FDA 3500B?
it is available for consumer reporting.
who evaluates ADE?
Submitted events are evaluated by CDER and monitored by CBER
what should not be reported to Medwatch?
Vaccine-related adverse effects, veterinary medicine product adverse events, and suspected
unlawful Internet sales of medical products should not be reported to MedWatch.
what is The Vaccine Adverse Event Reporting System ?
is a national postmarketing vaccine safety surveillance program managed by the CDC and the FDA for vaccine-related adverse events to be reported, analyzed, and made available to the public. The National Childhood Vaccine Injury Act of 1986 requires health care professionals and vaccine manufacturers to report to the DHHS specific adverse events that occur after the administration of routinely recommended vaccines.
what is The FDA's Sentinel Initiative?
itwas implemented as a result of the FDAAA of 2007 to proactively monitor the safety of FDA-regulated products, such as drugs, vaccines, and medical devices. It is being implemented in stages to complement existing reporting systems, and it will have functionality to query electronic medical records, administrative and insurance claims, and registries.
what is Workplace safety?
Occupational Safety and Health Administration
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
who does develop standards, enforceable by the FDA, on the identity, strength, quality, and purity
of medications and dietary supplements, including compounded products?
The USP
who may inspect pharmacies?
Pharmacies may be subject to inspection against these standards by boards of pharmacy, the FDA,
the Joint Commission, and other entities.
what are The USP General Chapters?
The USP General Chapters are as follows: Required (numbered below <1000>), Informational
(numbered <1XXX), or Specific for dietary supplements (numbered <2XXX>); the chapters pertaining to compounding include the following:
(a) USP 795: Pharmaceutical Compounding for Nonsterile Preparations
(b) USP 797 (being revised): Pharmaceutical Compounding for Sterile Preparations (CSPs)
(1) USP 797 standards historically assign risk levels (low, medium, and high) according to
requirements for the types of admixtures and preparation procedures. The proposed revisions
limit the risk categories to category 1 and category 2, depending on a product's
beyond-use dating. Proposed revisions also introduce "in-use time," before which an ingredient used in a CSP must be used after it has been opened or punctured, or before which a
CSP must be used after it has been opened or punctured.
(2) As a result of deaths associated with microorganism contamination, CSPs have been under
scrutiny. In October 2015, CMS issued a revision to its Pharmaceutical Services CoP State
Operations Manual aligning their standards of practice for drug compounding with USP
requirements, particularly for CSPs.
(3) An area of interest for organizations is beyond-use dating and sterility for CSPs. According to USP 797, 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.
(4) In-use dating: Once opened/punctured, must be used
(c) USP 800: Hazardous Drugs: Handling in Healthcare Settings
what is USP 795?
Pharmaceutical Compounding for Nonsterile Preparations
what is USP 797?
Pharmaceutical Compounding for Sterile Preparations (CSPs)
(1) USP 797 standards historically assign risk levels (low, medium, and high) according to
requirements for the types of admixtures and preparation procedures. The proposed revisions
limit the risk categories to category 1 and category 2, depending on a product's
beyond-use dating. Proposed revisions also introduce "in-use time," before which an ingredient used in a CSP must be used after it has been opened or punctured, or before which a
CSP must be used after it has been opened or punctured.
(2) As a result of deaths associated with microorganism contamination, CSPs have been under scrutiny. In October 2015, CMS issued a revision to its Pharmaceutical Services CoP State
Operations Manual aligning their standards of practice for drug compounding with USP
requirements, particularly for CSPs.
(3) An area of interest for organizations is beyond-use dating and sterility for CSPs. According to USP 797, 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.
(4) In-use dating: Once opened/punctured, must be used
what is USP 800?
Hazardous Drugs: Handling in Healthcare Settings
How do patients get access to meds?
i. Options exist for supporting and supplementing patient access to medications. Pharmacists are a
conduit for linking patients to medication discount and prescription assistance programs.
What is the 340B drug pricing program?
The 340B Drug Pricing Program, authorized through the Medicaid Drug Rebate Program in 1990 and expanded by the ACA in 2010, allows speci c 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.
What is eligibility for the 340B drug pricing program?
Eligibility is defined at the level of the health care facility and not the individual; however, the
HRSA's Of ce of Pharmacy Affairs states that only patients with an established relationship
with the covered entity are eligible to receive 340B purchased drugs.
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