Regulatory Compliance ALL IN ONE

To Err Is Human: Building a Safer Health System

A report by the Institute of Medicine estimating that 44,000 to 98,000 people die each year as a result of medical errors.

Institute for Safe Medication Practices (ISMP)

A nonprofit organization dedicated to medication safety, providing education, resources, and advocacy to prevent medication errors.

Just Culture

Culture within healthcare that encourages open discussion about medical errors without fear of punishment, aimed at identifying learning opportunities and system improvements.

Medical Error

Preventable adverse effect of medical care resulting from a failure to complete a planned action as intended, or the use of an incorrect plan.

Process Errors

Office Administration - Charting, Appointment, Filing System errors

Investigation - Lav, Diagnostic Imaging errors

Communication - with patients, nonmedical providers, healthcare team

Workforce management - coverage, mandated overtime, lack of required breaks

Unused med returned to wrong place

override med use safeguard

lack of double checking

incorrect storage

failure to pay attention to label

dispensing machines filled with wrong product

different meds mixed in same drawer

Knowledge/skill errors

Executing clinical task - falure to follow standard practice, lack of experience

Diagnostic - delay in diagnosis; wrong diagnosis due to misinterpretation or results

Wrong Treatment - influenced by pt preference, decision made by provider

Incorrect - directions, dosage form, medication, patient, preparation, prescriber, quantity, refills; strength, substitution

Expired/deteriorated product

Clinicla review error

Administration event (vaccine)

Risk factors for errors

Excessive task demand - nonstreamlined process, inconsistent workload

Extra organizational factors - LASA, complex insurance

failure to comply with procedures - lack of time or understanding

intraorganizational factors - customer service, breaks, quality of work life, policies

interpersonal factors - conflict, communication

lack of knowledge - nonspecialist in specialist area, new grad with no shadowing, no training

patent counseling issues - counseling, health care literacy, wrong info provided

personal characteristics - age, deficits, health, stress

environment - lighting, noise, interruptions

MedWatch

FDA reporting system for adverse events, product defects, and safety issues related to drugs and medical devices.

Vaccine Adverse Event Reporting System (VAERS)

managed by CDC and FDA to collect and analyze data on adverse events following vaccinations. Patient can voluntarily report events, and healthcare providers are required to report certain events.

Voluntary Reporting

Least labor intensive method for collecting data on adverse events, allowing healthcare professionals and patients to report incidents without mandatory requirements. Many errors not reported due to lack of awareness or incentive.

Direct Reporting

Uses trained observers to watch real time administration of what is going on.

Chart Review

A method of collecting data on adverse events by systematically reviewing patient charts and records to identify incidents that may not have been reported.

ADE Trigger tool

A systematic approach to identifying adverse drug events (ADEs) by using specific criteria or triggers in patient records that signal potential incidents.

The JCAHO Sentinel Event Reporting System

System established by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to collect and analyze data on sentinel events, which are unexpected occurrences involving death or serious physical or psychological injury.

Patient Safety and Quality Improvement Act of 2005

Patient Safety Act. authorized the creation of a nationwide network of PSOs to improve safety and quality by providing a venue for health care institutions to voluntarily report information related to errors.

Root Cause Analysis (RCA)

A method aimed at identifying the true root cause(s) of an adverse event, focusing on systems of care rather than individual actions.

Retrospective Process

The 5 Whys

Uses the general rule that if you have not asked “Why?” at least 5 times, you have not gotten to the actual root cause.

Ishikawa diagrams

Uses a diagram that resembles a fishbone with the categories of people, materials, methods, environment, and equipment as branches on the diagram and then fills in the “bones” with the appropriate details

Causal Mapping

Uses a cause-and-effect diagram through a mapping approach so one can visualize relationships

5 Rules of Causation

• Clearly shows the cause-and-effect relationship

• Uses specific and accurate descriptors for what occurred, rather than negative or vague words

• Human errors must have a preceding cause

• Violations of procedure are not root causes, they must have a preceding cause

• Failure to act is only causal when there is a duty to act

Failure Mode Effect Analysis (FMEA)

A prospective analysis to examine ways in which processes or products might fail, allowing for the identification of potential harm before implementation.

each step of the process is outlined, the team brainstorms all the ways in which the process could fail and defines the effect of each potential failure to the end user (often the patient). An estimation (on a 10-point scale) is made of the likelihood of the failure, the severity of the potential failure, and the probability that the failure will be detected

Criticality index

a measure of how likely a task or activity is to be on the critical path of a project or network

USP Chapter 797

Sterile Preparations

USP Chapter 825

Radiopharmaceuticals–Preparation, Compounding, Dispensing, and Repackaging

USP Chapter 795

Nonsterile Preparations

High-Alert Medications

Drugs that pose a heightened risk of causing significant patient harm when used in error.

Anticoagulants, Chemotherapy, Insulins, Opioids, Digoxin, contraindicated in pregnancy, sedatives in children, sulfas, pediatric liquid, phenytoin, epidural, -olols, -erines, parenteral nutrition, NaCl >0.9%

Internal Reporting Systems

Frameworks within organizations for reporting medical errors, including voluntary reporting, direct observation, and chart review.

Error-Prone Abbreviations

Abbreviations and symbols which have been misinterpreted and involved in harmful medication errors, such as cc for cubic centimeters.

cc - mistaken for units

U or u - mistaken for 0 or 4

Versions of SC or SQ - mistaken for 5 every or sublingual

hs - mistaken for half strength

versions of QD - mistaken for QID

HCT - mistaken for HCTZ

lack of a leading 0 before a decimal can be taken as 5 instead of 0.5

trailing 0 after a decimal - can be taken as 10 instead of 1

tbsp ot Tbsp - mistaken for tsp

Adverse Drug Event (ADE)

An injury resulting from the use of a medication.

Patient Safety Organization (PSO)

Organizations authorized by Congress to provide a venue for healthcare institutions to voluntarily report and analyze patient safety data.

Culpability in Medical Errors

Determining accountability for errors based on assessments regarding the nature of the action, intent, and adherence to procedures.

1. Were the actions as intended?

2. Was the person under the influence of unauthorized substances?

3. Did he or she knowingly violate a safe operating procedure? If so, was the procedure available, workable, intelligible, and correct? This gets at those procedures that staff feel make no sense and are not value-added in their workflow. This may indicate a component of system-induced error

4. Do they pass the substitution test? If others would have made the same decision, they are less likely to be culpable. If not, were there deficiencies in training or experience?

5. Does the individual have a history of unsafe acts? If not, the individual is less likely to be culpable.

ISMP Best Practices

Guidelines provided by the Institute for Safe Medication Practices to improve patient safety and reduce medication errors.

• Collecting and analyzing reports of medication-related hazardous conditions, near-misses, errors, and other adverse drug events

• Disseminating medication safety information, risk-reduction tools, and error-prevention strategies

• Educating the health care community and consumers about safe medication practices

• Collaborating with other PSOs, educational institutions, governmental agencies, and other health care stakeholders

• Advocating for the adoption of safe medication standards by accrediting bodies, manufacturers, policy makers, regulatory agencies, and standards-setting organizations

• Conducting research to provide evidence-based safe medication practices.

Safety Event Analysis

The process of reviewing and analyzing medical errors to prevent recurrence and improve systems.

Sentinel Event

patient safety event that reaches a patient and results in death, permanent harm, or severe temporary harm and intervention required to sustain life. These events signal the need for immediate investigation and intervention.

Medication Errors

Mistakes that occur in the prescribing, dispensing, or administration of medication.

Look-Alike/Sound-Alike Drugs (LASA)

Medications that can easily be confused due to similar names or packaging, which can lead to errors.

• Using both the brand and generic names on prescriptions and labels

• Including the purpose of the medication on prescriptions

• Configuring computer selection screens to prevent look-alike names from appearing consecutively

• Changing the appearance of look-alike product names to draw attention to their dissimilarities.

Overriding Medication-Use Safeguards

Actions that eliminate safety checks intended to prevent medication errors.

Accreditation

A formal process by which an authorized body assesses and recognizes an organization, program, group, or individual as complying with requirements.

Administrative agency

A government entity or an entity created by a statute that administers a legal framework which governs the implementation and delivery of a public program.

Administrative Code

All regulations made by administrative agencies of a jurisdiction brought together in 1 unit

Administrative law

Statutes, rules, regulations, orders, and decisions that determine how regulatory bodies operate and the scope of their authority

Certificant (licensee)

An individual who has met the requirements set by a certifying body to obtain a certification or license in a specific profession or field, demonstrating their qualifications and competency.

Certification

Procedure by which an authorized body evaluates and recognizes an individual, institution, or educational program as meeting predetermined requirements.

Certification Body

Agency awarding certification

Code of Conduct

Set of guidelines for professional behavior and ethical standards that individuals or organizations are expected to follow.

Competence

Demonstrated ability to apply knowledge or skills, and where relevant, demonstrated personal attributes as defined in certification requirements

Compliance

Conforming to the guidelines on which accreditation was based.

Credentialing

Process of assessing and validating qualifications of a practitioner to provide services.

Governance

Combination of processes and structures implemented by a board to inform, direct, manage, and monitor the activities of the organization

Interim License

A temporary authorization granted to a practitioner to provide services while fulfilling specific requirements for full licensure.

Jurisdiction

Legal right by which an adjudicative body exercises its authority to receive evidence, apply the law, control its processes, make decisions, and declare judgments.

Law

Rules, standards, and principles enacted by a political authority and interpreted by the courts that guide a defined jurisdiction

License

Recognition of competence to practice a given occupation or profession conveyed to an individual or entity by a regulatory body.

Monitoring compliance

Oversight carried out by accreditation bodies to ensure continuing compliance with accreditation standards.

Out of Compliance

Failure of an accredited organization to meet agreed accreditation standards

Practitioner

A professional who has met the necessary qualifications and holds a license to provide specific services in their field.

Probation (restriction)

Order that allows an individual to begin or continue to practice subject to certain conditions.

Promagulate

To formally announce or make known regulations or policies.

Recertification

Requirement for periodic reevaluation of activities designed to provide assurance that the knowledge and skills of the practitioner are current

Reciprocity

An agreement between states or countries to recognize each other's licenses or certifications, allowing practitioners to operate in multiple jurisdictions without requalification.

Regulation

Statement issued by an administrative agency that sets standards, directs conduct, and has the force of a law.

Renewal

The process by which a professional license or certification is extended for a specified period, often requiring proof of ongoing education or practice.

Revocation

Removing the license to prohibit the practice of a profession.

Sanction

A penalty imposed by a regulatory body for non-compliance with laws or standards.

Scope of practice

The range of activities and responsibilities that a licensed professional is authorized to perform within their profession, determined by law or regulation.

Standard of Practice

Rules, requirements, responsibilities, and conditions that describe the minimal level of expected performance of a profession

Statute

A law that governs conduct within its scope

Unfair/deceptive practices

Actions that mislead or deceive consumers, violating regulatory standards and ethical guidelines.

Violation (professional misconduct)

A breach of professional conduct or ethical standards that undermines the integrity of the profession.

The Joint Commission (TJC)

The nation's oldest accrediting body for health care organizations, focused on organizational-wide patient safety.

Food and Drug Administration (FDA)

Responsible for ensuring the safety, efficacy, and security of food, drugs, biologic products, medical devices, and cosmetics.

Drug Enforcement Administration (DEA)

Established to enforce the Controlled Substances Act and regulate the use of controlled substances.

National Committee for Quality Assurance (NCQA)

Focuses on patient-centered care in the evaluation of specialty pharmacies.

Pharmacy Quality Alliance (PQA)

A nonprofit dedicated to improving medication safety, adherence, and appropriate use.

TJC Tracers

A method used by The Joint Commission to assess the quality of care and services provided in healthcare organizations by following a patient's journey through the healthcare system.

Individual

System

Program Specific

PQA Measures

measures a health plan’s performance and quality improvement by examining adherence, appropriate medication use, medication safety, and medication management services.

Adherence — PQA looks at health plan and pharmacy

Appropriate Medication Use

Medication Management Services — PQA looks at health plan and pharmacy

Medication Safety

American Society of Health-System Pharmacists (ASHP)

A professional organization representing pharmacists who practice in hospitals, health systems, and other direct patient care settings. Focuses on education, advocacy, and the advancement of pharmacy practice.

ASHP Key Standards

Practice Management

Patient Care Services

Quality Improvement

National Association of Boards of Pharmacy (NABP)

A professional organization that assists in the regulation of pharmacy practice and ensures the protection of public health by supporting the state boards of pharmacy.

State Boards of Pharmacy

Regulatory agencies that oversee the licensure and practice of pharmacy within individual states, ensuring compliance with relevant laws and standards.

Compounding

The combination, mixing, or alteration of drug ingredients to create medications tailored to individual patient needs when a manufactured drug is not available.

503A pharmacy

A traditional compounding pharmacy that compounds in response to individual prescriptions rather than in bulk.

State BOP remains primary oversight

503A Requirements

• Compounding be conducted for an identified individual patient

• Drugs compounded in advance of receiving prescriptions were compounded only in limited quantities

• Drugs were distributed pursuant to a valid patient-specific prescription

• Compounding must take place by a licensed pharmacist in a state licensed pharmacy, federal facility, or by a licensed physician.

• not compound drug products that are kept for office use by hospitals, clinics, or health care practitioners.

• Act removed wording regarding the prohibition on advertising of compounded products and restored the practice to 503A pharmacies after several pharmacies challenged this provision in court.

503B Compounding Facility

A facility that compounds medications in bulk for office use and is subject to more stringent regulations than 503A pharmacies, including compliance with Current Good Manufacturing Practice (cGMP) standards.

FDA Oversees

503B Requirements

Register with the Secretary of the US Department of Health and Human Services (HHS); Submit biannual reports identifying drugs compounded and adverse event reports; Be subject to FDA inspections; Pay all applicable establishment and reinspection fees; Not compound drugs made from bulk drug substances (ie, active pharmaceutical ingredients) unless the FDA has determined there is a clinical need to compound with the substance and places it on the 503B bulks list, or the drug compounded from the bulk drug substance appears on the FDA’s drug shortage list; Not compound drugs that have been removed from the market; Not compound drugs that are a copy of an approved drug; Not compound drugs that appear on the FDA’s list of drugs that present demonstrable difficulties for compounding unless compounding is done in accordance with all applicable conditions identified on the list; If a drug is subject to a Risk Evaluation and Mitigation Strategy (REMS), the pharmacy must demonstrate a plan to use controls comparable to the controls applicable under the relevant REMS to ensure safety of drugs with considerable adverse effects.

503B Labeling Requirements

• The statement “this is a compounded drug” (or comparable statement)

• Identifying information of the pharmacy

• Lot or batch number

• Drug name

• Dosage form

• Strength

• Quantity

• Date compounded

• Expiration date

• Storage and handling instructions

• National Drug Code (NDC, if available)

• “Not for resale” statement

• “Office Use Only” statement (if applicable)

• List of active and inactive ingredients.

Food and Drug Administration Modernization Act 1997 (FDAMA)

addressed the changing nature of compounding pharmacies by creating a “safe harbor” exempting pharmacies from the more stringent FDA regulations. This “safe harbor” required that compounders refrain from advertising their product and abide by requirements designed to increase drug safety.

Compounding Quality Act (CQA)

established regulations for compounding pharmacies after contaminated products caused health issues.

Established 503A Pharmacies and 503B Outsourcing Facilities.

Current Good Manufacturing Practices (CGMP)

regulate the proper design, monitoring, and control of manufacturing processes and facilities to assure the identity, strength, quality, and purity of drug products

United States Pharmacopeia (USP)

issues standards that apply to compounding by developing references for the identity, quality, purity, strength, packaging, and labeling for ingredients used in compounded preparations.

USP General Chapters

establish procedures, methods, and practices utilized by practitioners to help ensure the quality of compounded preparations

USP Compounded Drug Monographs (CPMs)

contain formulations and quality standards for specific preparations

USP Monographs for Bulk Drug Substances and other ingredients

provide standards for identity, quality, purity, strength, packaging, and labeling for bulk substances and other ingredients that may be used in compounded preparations

Space

sufficient counter space, a sink with purified water, and limited traffic flow is ideal for nonsterile drug compounding. Personnel should not perform other activities besides nonsterile compounding in this space while compounding activities are in process. Required to have a controlled atmosphere with approved lighting temperature, humidity, and ventilation. Materials used in the construction of a compounding area should be as nonporous and seamless as possible to limit microbial contamination and facilitate cleaning and disinfecting procedures.

Equipment

may use disposable or dedicated equipment to reduce the chance of bioburden (ie, the number of bacteria living on a surface that has not been sterilized) and cross-contamination. Pharmacy staff must inspect equipment prior to use and, if appropriate, verify it for accuracy as recommended by the manufacturer or at least every 12 months, whichever is more frequent. After compounding, the equipment must be cleaned to prevent cross-contamination of the next preparation.

Storage

must monitor conditions in storage areas. temperature must be monitored each day and documented in a temperature log at least once daily or stored in the continuous temperature recording device. When it is known that a product has been exposed to temperatures either below or above the storage temperature limits, it must be determined (eg, by consulting literature or analytical testing) whether the product is expected to retain its integrity or quality. If this cannot be determined, the product must be discarded.

Nonsterile Cleaning & Sanitizing

Walls Storage Shelving - Every 3 months, after spills, and when surface contamination is known/suspected.

Floors - Daily, after spills, and when surface contamination is known/suspected.

Work Surfaces - At the beginning and end of each shift, after spills, when surface contamination (eg, splashes) is known/suspected, and between compounding with different components.

Ceilings - When visibly soiled and when surface contamination is known/suspected.

PEC and equipment inside the PEC

Clean & Disinfect - Daily and when surface contamination is known or suspected

Sporicidal - Monthly

Removable work tray of the PEC

Clean and Disinfect Worksurface of the tray daily. All surfaces of the area and under the tray monthly.

Sporicidal - work surface of the tray monthly; all surfaces and the area underneath the work tray monthly

Floors; Work surfaces outside the PEC; Passthroughs'

Sterile Compounding Clean, Disinfect daily Sporicidal Monthly