admin exam 2 Flashcards
Risk
Anything that threatens the ability of a person or organization to accomplish its mission
Some degree of probability that exposure to a hazard will lead to a negative outcome or consequence such as loss, damage, injury, or death
Risk in community pharmacy
Exposure to hazard
Negative outcome
Risk Management
The application of knowledge and experience to manage the occurrence of a potentially bad incident
Enterprise risk management: Involves using knowledge and experience to manage risks within a business or organizational environment
Risk Management
Not just the responsibility of the pharmacy manager
Pharmacists and pharmacy staff need to be aware of and directly involved in risk management strategies
Areas of risk in pharmacy
Historically have been
- Fire
- Theft
- Negligence related to prescription filling errors
- Injury on premises
- Competition
Speculative risk
Involves a chance of gain or benefit as well as loss
Speculative risks are not insurable
Examples
- Investments
- Operating/purchasing a pharmacy
- Small business ownership
Why do we care about what is insurable?
Pure risk
Risk in which there is only the opportunity of sustaining loss
There is no opportunity for gain
Pure risks are accidental, unanticipated, unavoidable
Include illness, death, fire, flood and accidents, medication errors
Insurance is designed to assist people in managing their exposure to these unanticipated or accidental risks
In order for pure risks to be insurable the loss must
Be measurable in dollar figures
Have a defined time and place
Be accidental for the insured
The probability of the event must be accurately calculated based on a similar cohort
The insured must have an insurable interest
The insurance costs must be reasonably priced
The risk management process
5 steps suggested in the text
- Establish the context
- Identify and analyze risks
- Evaluate and prioritize the risks
- Select and implement an appropriate risk management strategy
- Monitor decisions and update the risk management program
Establish the context
What are the goals of the risk management process?
What are the potential vulnerabilities of the business?
Do employees or patients risk injuries?
How might the reputation of the pharmacy/hospital suffer if a patient is injured due to a pharmacy error?
Can risk be avoided by not providing certain services or products?
Identify and analyze risks
Pharmacy managers should analyze the operation
Risks result from
- Activities inherent in the pharmacy practice operation
- Issues with physical facilities (exercise: name them)
- Issues with protected health information
Evaluate and prioritize the risks
Every risk cannot be addressed at one time so prioritization of risk is necessary
Some risks are common yet have a high degree of loss (shoplifting, rejected prescription claims)
Some risks are uncommon and have a very high degree of potential loss (fire, flood, patient harm from a dispensing error)
Select and implement an appropriate risk management strategy
Involves development of specific policies and procedures to avoid risk as well as to manage incidents where risk occurs
In the community setting what would these P & P include
In the hospital setting what would these P & P include
Monitor decisions and update the risk management program
Pharmacy managers must monitor compliance with current prevention strategies as well as develop new strategies (P & P ) to address changes in services
Pharmacy managers must monitor occurrences including reporting and follow-up
What is appropriate follow up to occurrences
Techniques to manage risks
Although risk is inherent in pharmacy practice different types of risk require different techniques to manage them including
Risk avoidance
Risk prevention
Risk absorption/retention
Risk sharing or transfer
Risk avoidance
This sounds like an obvious approach
Is impractical in the pharmacy business
Impossible to avoid the risks associated with drug distribution/prescription dispensing
There may be goods and/or services where the risk outweighs the benefit of providing them
- (ex: sterile compounding in community pharmacy)
Risk prevention
The most effective technique to manage risks
A goal of all pharmacists, regardless of the practice setting
A primary goal of all pharmacy managers
Involves taking steps to minimize the likelihood of its occurrence
Involves development of policies and procedures, standard work to prevent errors and improve patient safety
Risk absorption/retention
Pharmacies absorb some risk regardless of the practice setting
Community pharmacies absorb losses from shrinkage (shoplifting, employee theft, unsalable products) though they implement many strategies to prevent them
Hospital pharmacies absorb losses from expired compounded medications, unsalable products, billing errors though they implement many strategies to prevent them
Risk sharing or transfer
Another technique in risk management is to transfer the risk to another party
Pharmacies and pharmacists share risk with insurance companies
Insurance companies share risks by entering capitated agreements with providers (paying them a set amount per member per time period regardless of the actual amount spent on healthcare services)
Types of insurance for a pharmacy
Property insurance
Liability or casualty insurance
Business owner’s policy
Individual professional liability insurance
Umbrella or excess liability
Worker’s compensation
Emerging risks in modern pharmacy practice
OBRA 90
HIPAA
Others?
Risk with information management/technology
Strategic risk: Information technology systems must be compatible with the pharmacy’s goals.
- Pharmacies must constantly make choices between investing in technology and other types of resources
- Successful implementation of information technology projects is difficult and requires many financial and human resources
- Systems must integrate and interface with others within and outside the organization
Risk with information management/technology
Performance risk: the degree of uncertainty inherent in the procurement and application of information technology that may keep the system from meeting both its technical and operation goals
Operational risk: risk of loss resulting from inadequate or failed internal processes including people, systems and external events. Includes internal fraud, external fraud, system failures and the human-automation tradeoff
Risk with information management/technology
Psychosocial risk: the moral and legal issues related to the interaction of information technology and the safety and health hazards that technology poses to employees in the workplace. Includes repetitive-motion injuries.
Risks, Risk Management Techniques and Specific Strategies
Computer system malfunction/ avoidance/upgrade or replace system
Customer theft/ reduction/ install security cameras, utilize security tags, sequester high risk items
Forged prescriptions for controlled substances/ elimination/ do not stock controlled substances, avoidance/ implement policies and procedures for prescription verification of validity
Risks, Risk Management Techniques and Specific Strategies
Medication errors/ reduction/ utilize bar-coding systems, double checks on high risk medications
Misreading orders or prescriptions/ avoidance/ use CPOE or electronic transmission of prescriptions
HIPAA violations/ reduction/ designate a private patient counseling area
The managers’ role in risk management
Serve as liaison between upper management and pharmacy staff to promote quality and reduce risk in all aspects of pharmacy operations
To discuss risks, their occurrences and outcomes of the occurrences with pharmacy staff
To encourage reporting of near-misses and error data
Communication
The risks of not taking risks
What would they be?
- Not staying current with technology
- Not staying current with MTM and other patient-focused programs
- Not providing the goods and services that your customers want
Compliance with Regulations and Regulatory Bodies
The legal and regulatory environment that is external to a pharmacy practice organization can exert significant influence on both the organization and its members
Patients put their trust in their pharmacists
State and federal laws provide layers of protection to shield the public from pharmacy practice that can cause harm
Standards for pharmacists’ performance
Standard: something established by authority, custom, or general consent as a model or example
Standard applies to any definite rule, principle or measure established by authority
Standards for a pharmacist’s conduct and the operation of a pharmacy are derived from laws and from professional standards and values
Standards for pharmacists’ performance
Violation of these standards may result in litigation if a patient is harmed and may affect the licensure status of both the pharmacist, the manager and the pharmacy
In the most severe cases violation of these standards can result in civil liability and criminal prosecution
OBRA 90
Omnibus Budget Reconciliation Act of 1990
Requires proper patient records (What is included in this patient record?)
Requires prospective drug review (What is included in this review?)
Requires the offer of patient counseling (What is included in the counseling?)
Why is it important for the pharmacy manager to monitor compliance?
HIPAA
Health Insurance Portability and Accountability Act of 1996
The pharmacy manager must know
- Who is covered by the privacy rule
- What information is protected
- What the covered entity must do to protect information
- That appropriate documentation is maintained
HIPAA
The pharmacy manager must ensure and is responsible for
- Employee training
- Notice of privacy practices
- Definition of business associates including contracts
- Patient authorizations for release of PHI
- Ensuring that PHI is appropriately maintained and released
Civil law and liability concerns
Negligence is the key to the outcome of any lawsuit
Negligence: failure to do something that a reasonable and prudent person would do or doing something that a reasonable and prudent person would not do
How can you prevent this from happening?
Civil law and liability concerns
Background
Investigations into medication errors tend to focus on the front end or active end of the error (the front-line practitioner or pharmacist)
Human nature results in the desire to place blame on an individual when an error occurs
Effective approaches to medication error investigations focus on the latent end or blunt end factors (factors that contribute to errors at the organizational or system level) Systems issues
Latent failures
Weaknesses in organizational structure
May include faulty information management, lack of appropriate training and decisions made by upper management
May result from incomplete information such as missing allergy or diagnosis information, unclear communication of a drug order, lack of an independent double check system, lack of computer warnings, ambiguous drug references, drug storage issues and sound-alike/look-alike drugs
Latent failures
Properties of the medication use process or system
Categorized by the key element of the system in which they occur
- Patient information
- Drug information
- Communication of drug information
- Drug packaging, labeling and nomenclature
- Drug device acquisition and use
- Drug storage, stock and distribution
- Environmental factors
- Staff competency and education
- Patient education
- Quality processes and risk management
The ordering process
Errors occur due to
- Illegible handwriting
- Look-alike drug names
- Sound-alike names
- Ambiguous orders
- Abbreviations
What can be done to avoid these?
Illegible handwriting
Clarify prescriptions/orders
Ask for the indication or purpose of the medication
Institute double-check systems
Utilize electronic submission of prescriptions
CPOE
Sound-alike/Look-alike drugs
Clarify orders
Read back orders
Store medications separately
Discourage verbal orders
Require complete directions, strength, route of administration and indication for use
Tall man lettering
Ambiguous orders
Clarify the order including dosage form and route of administration
Avoid leading and trailing zeros
Avoid unnecessary decimal points
Use the metric system exclusively
Selecting medications
What is in place to prevent selecting the wrong medication (wrong drug or strength?)
When utilizing automated dispensing technology where can medication errors occur?
Confirmation bias: the phenomenon that when choosing an item, people see what they are looking for and once they think they have found it, they stop looking any further
Abbreviations
The ISMP has developed a list of unsafe abbreviations that should be avoided 100% of the time
The Joint Commission has instituted this list and monitors for the use of unsafe abbreviations during compliance visits
How does this list and avoidance of the unsafe abbreviations get instituted in the outpatient/community setting?
Sterile admixture preparation
The process has great potential for errors
- Patients are often more acutely ill
- Mediations delivered directly to the blood stream
- Most IV admixtures are clear, colorless, and water-based so they all look alike
- Greater chance of dosage miscalculations and incorrect measurement
Minimizing errors in the sterile admixture preparation process
Use commercially available unit-dose products whenever possible
Standardize concentrations and doses
Standardize preparation processes including labeling
Institute double-check systems for high-risk medications (What are high-risk medications?)
Utilize automated compounding equipment whenever possible
Pre-printed order forms
Utilized in hospitals to standardize work
What would be the advantages?
- Standard concentrations
- Standard monitoring practices
- Standard information for providers
- Decreases opportunity for errors in the prescribing process
Patient counseling and education
The pharmacist/patient interaction can often prevent a dispensing error
Important factors that play a role in preventing medication errors include
- Direct patient education
- Health care literacy
- Patient compliance
Error prevention through reporting and monitoring systems
A responsibility of the manager and pharmacy staff
Systems approach
What factors inhibit the reporting of medication errors?
- Inconsistent definition of errors
- A punitive approach
- Mandatory reporting systems
- Failure to improve systems
- Lack of feedback
- Complex reporting processes
- Concern for personal liability
- Low priority associated with reporting
Medication error reduction strategies
From highest power or impact to lowest
- Fail safes and constraints
- Forcing functions
- Automation and computerization
- Standardization
- Redundancies
- Reminders and checklists
- Rules and policies
- Education and information
- Suggestions to be more careful or vigilant
Medication error analysis
Analysis of pharmacy specific or medication specific errors having the potential to cause patient harm
Analysis of organizational aggregate data
Analysis of near misses (often not done)
Analysis of errors that have occurred in other organizations (often not done)
Must be shared with staff at all levels
Steps in the Development of a Business Plan
Identify an action plan
Assess critical risks and opportunities
Establish an exit plan
on the exam:
Risk
Hospital (mostly)
community
Business planning
Remediation
Value added services
Defining the Business or Program
Conduct a preliminary evaluation/explore the business concept
- Conduct a literature search
- Obtain published systematic literature reviews
- Search the internet
- Consider the size and receptivity of potential customers
- Consider potential revenue
- Seek the advise of others
Conduct Market Research and Analysis
Market = customers of the program
May be described geographically
Consider the demographics of the regional population
Consider that customers are not always patient. They may be physicians or other health care providers.
