Hospital Pharmacy

Any error in the medication process (prescribing, dispensing, administering of drugs), whether there are adverse consequences or not

Medication Error

Process of resolving discrepancies between what a patient has taken in the past and what they are supposed to be taking now

Medication Reconciliation

"Devoted to eliminating death, injury, property, and economic loss due to fire, electrical, and related hazards". -Health system pharmacies are subject to fire risks due to storage of flammable materials

National Fire Protection Association (NFPA)

Federal agency responsible for conducting research and making recommendations for prevention of work-related injury and illness

National Institute for Occupational Safety and Health (NIOSH)

-Signed into law in 2010 by then President Barack Obama -Goal: to require most U.S. citizens and legal residents to have health insurance -Government's overarching goal: decrease cost of healthcare and increase quality

Patient Protection and Affordable Care Act (ACA)

-All pharmacists in the department participate in and accept responsibility for all elements of the medication use process -Pharmacist in this type of model have increased ownership/accountability/job satisfaction

Patient-Centered Integrated Model

-was established in 1936 -allowed pharmacy department and medical staff to communicate on drug use issues

Pharmacy and Therapeutics (P&T) Committee

The operational structure that defines how and where pharmacist practice: including the type of drug distribution system used, the layout and design of the department, how pharmacists spend their time, practice functions, and practice priorities.

Practice Model

-An authoritative advisory document, issued by an expert body, offering advice on the minimum requirements or optimal method for addressing an important issue or problem -Recommendation - not enforced by law -Compliance fostered through education and peer pressure

Practice Standards Definition

-Profession develops and imposes on self -Evidence based and usually surpass the minimum standards/requirements

Practice Standards/Guidelines

Errors in the Medication Use System: Wrong drug Wrong patient Wrong dose Wrong route

Prescribing

Process by which an oversight body of a health care organization having reviewed an individual health care provider's credentials and performance and found them satisfactory, authorizes that individual to perform a specific scope of patient care services within that setting

Privileging

Governmental orders having the force of law

Regulations

Their primary purpose is public protection: -FDA -CMS -DEA

Regulatory Bodies

Regulates the handling and disposal of hazardous waste pharmaceuticals discarded by healthcare organizations

Resource Conservation and Recovery Act (RCRA)

Address specific, limited situations

Rules

-Responsible for developing and enforcing regulations pertaining to environmental laws and issues -Conducts research and provides information and education on environmental issues -Works with state and local governments and businesses to protect human health and the environment

Environmental Protection Agency (EPA)

-Protect public health by assuring safety, efficacy and security of drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation -Speed innovations -Help the public get accurate information -Implements and enforces that Food Drug and Cosmetic --Act and the Drug Quality and Security Act (DQSA) -Sets labeling requirements -Sets standards for investigational drug studies and product approval -Regulates and oversees the manufacturing and marketing of drugs

Food and Drug Administration (FDA)

_________________________ is also known as the approved drug list:

Formulary

-Method whereby the medical staff, working through P&T committee, evaluates and selects medications to stock for inpatients -Framework in which medication-use policies are established and implemented -Implemented in all hospitals throughout the country

Formulary System

-Purpose: assess the progress of hospital pharmacy departments in implementing clinical pharmacy -Promoted the idea that clinical pharmacy should not be thought of separate from pharmacy practice -Mission of hospital pharmacies: fostering the appropriate use of medicines

Hilton Head Conference

A type of ADR resulting from abnormal responses to drugs that are peculiar to individuals

Idiosyncratic Reaction

-Component of National Academy of Science -Mission: "To serve as adviser to the nation to improve health."

Institute of Medicine

"everything under one roof" model

Integrated Health Systems

-All of the holes align and errors get through -If one person had done the job correctly, error would have been fixed prior to reaching patient

"Swiss cheese" model

Pharmacists have been associated with hospitals since the dawn of their existence in ____________:

1752

Supports health systems pharmacists in quality and safety through -Publishing -Education -Advocacy -Guidance documents

ASHP

Voluntary process by which the quality of care provided is assessed by an outside body on a routine basis: Who does this?

Accreditation The Joint Commission

Giving the medication to the patient

Administration

Errors in the Medication Use System: Wrong drug, dose, route, admin time, infusion rate Incorrect handling or storage Missed dose Failure to review prescribed regimen for appropriateness

Administration and Monitoring

-Professional organization for pharmacists practicing in health systems -Represent a consensus of professional judgement, expert opinion, and documented evidence -Adopted professional policy positions, statements, and guidelines -Develops standards to help pharmacists in health-systems improve medication use and enhance patient safety -The accrediting body for practice sites that conduct pharmacy residency programs and technician training programs

American Society of Health-Systems Pharmacists (ASHP)

Often imposed by an authority (e.g., federal or state government)

Laws

Med Rec: At least one source (preferably multiple) -Pharmacy profile -Medical record -Patient/caregiver interview -Patient own medications

Med Rec - Verification

Med Rec: -Make clinical decisions comparing new and old prescriptions -Discontinue unnecessary therapy -Reorder medications that were held -Document changes in medical record -Therapeutic substitution -Commonly continued medications without indication (PPIs)

Med Rec Reconciliation

Med Rec: -Communicate changes to providers -Hospital pharmacist -Community pharmacist -Surgeon -Internist -Communicate changes to patient and/or caregiver -Copy of final medication list

Med Rec Transmission

What was the first hospital?

The Pennsylvania Hospital

Evaluation to determine level of compliance with accreditation standards and goals

The Survey

Written order copied and manually or electronically entered into pharmacy or medical record

Transcribing

Errors in the Medication Use System: Illegible Misinterpretation Omission

Transcribing and Interpretation

-Advances public health by ensuring quality of medicines, food ingredients, and other health care products -Promotes safe and proper use of medications -Verify ingredients in dietary supplements -Provides standards for drugs, dietary supplements and health care products

United States Pharmacopeia (USP)

Is modifying and discontinuing the pharmacists role?

Yes

Is monitoring the pharmacists role?

Yes

Med Rec: -Correct medications -Correct dosing/frequency/route, etc.

Clarification

-Clinical vs. Distributive pharmacists -Clinical -Medical teams and nursing staff -Little/less/no distributive function? -Primary role is to assist prescribers to solve clinical problems -Distributive -Just like drug-distribution model

Clinical-Pharmacist-Centered Model

Combines clinical-pharmacist-centered and patient-centered integrated models -Majority of staff have split operational and clinical duties (patient-centered integrated) -Also has specialists assigned to specific locations or disease states (clinical-pharmacist-centered) -Large resource burden-usually only seen in large academic settings

Comprehensive Model

-Pharmacist will have more face-to-face contact with physicians, nurses, and patients -Pharmacists are in a better position to influence the entire medication process

Decentralized

Transferring drug product after review and approval of the order to the area responsible for administering the medication

Dispensing

Errors in the Medication Use System: Wrong patient or drug Error in preparation or calculation Error in drug utilization review

Dispensing and Preparation

Hospitals, accountable care organizations (ACO's), patient centered medical homes (PCMHs), long term care facilities, hospice and others

Distributional and Clinical Services

-Enforces the federal controlled substances laws and regulations -Investigates and prepares for prosecution of violators -Enforces provisions of the Controlled Substances Act

Drug Enforcement Agency (DEA)

-Pharmacist distributes drugs -Process medication orders -Reactive role -No change initiation -Not involved in the creation/development of the treatment plan -Little accountability for outcomes

Drug-Distribution Centered Model

Mission: protect the integrity of certain governmental programs as well as the health and welfare of the program's beneficiaries

Office of Inspector General (OIG)

An injury (large or small; preventable or unpreventable) that may be caused by the use or lack of intended use of a drug

Adverse Drug Event (ADE)

A drug-related problem that consists of an unexpected, unintended, undesired, or excessive response to a drug that requires some type of medical response

Adverse Drug Reaction (ADR)

A type of ADR resulting from immunologic hypersensitivities to drugs

Allergic Drug Reaction

A professional and scientific society that provides leadership, education, advocacy, and resources enabling clinical pharmacists to achieve excellence in practice and research. -ACCP practice resources are the foundation of clinical pharmacy standards

American College of Clinical Pharmacy (ACCP)

-Umbrella Organization -Provides code of ethics, information, education and advocacy

American Pharmacists Association (APhA)

-Represents consultant and senior care pharmacists -Provides resources and links to federal standards for patients residing in health-system and residential settings

American Society of Consultant Pharmacists (ASCP)

-Manages Medicare and Medicaid programs -Contracts with a private Quality Improvement Organization in each state to monitor care to beneficiaries -Quality standards must be met to serve CMS patients

CMS

"The United States' health protection agency dedicated to saving lives and protecting people from health, safety, and security threats both in the U.S. and abroad"

Centers for Disease Control and Prevention (CDC)

-Must certify institutions to participate in the federal Medicare program -Works in partnership with the state to administer Medicaid, CHIP, and HIPAA -Maintains oversight of the survey and certification of acute and continuing care providers -Develops conditions of participation (CoPs) to participate in Medicare and Medicaid

Centers for Medicare and Medicaid Services

Greater efficiency of preparation and distribution of medications

Centralized

Mission: To assure safe and healthful working conditions by offsetting and enforcing standards and by providing training, outreach, education, and assistance -Conducts periodic workplace inspections to ensure safety on the job

Occupational Safety and Health Administration (OSHA)

-Responsible for enforcing Title VI of the Civil Rights Act of 1964 and its amendments -Human relations management of protected groups -Responsible for enforcing certain provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996

Office of Civil Rights

An expected, well-known reaction resulting in little or no change in patient management

Side Effect

"principles of patient safety and quality of care that a well-run organization meets."

Standards

-Regulate pharmacy practice in each individual state -Set licensure requirements for individuals, pharmacies, and some healthcare organizations -Establish and enforce the rules and regulations of the state's pharmacy practice act -Discipline pharmacists and pharmacies -May enforce their state's Controlled Substances Act

State Boards of Pharmacy

-Independent, not-for-profit -Assess and accredits quality of health systems -Accredits nearly 21,000 health care organizations and programs in the U.S. -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."

The Joint Commission

The principle accrediting body -Independent, not-for-profit organization dedicated to improving the safety and quality of healthcare -Sets continually evolving standards -Developed National Patient Safety Goals (NPSGs)

The Joint Commission