Patient safety/QA

what are LASA Drugs?

lookalike-soundalike drugs.

What is Tall-Man Lettering?

the practice of using capital letters on part of a drug or medicine name to help differentiate it from a similarly sounding/looking drug or medicine.

What are Leading and Trailing Zeros for?

They are used to prevent dosage errors.

what strategies can be used to minimize risk of medication errores?

Bar codes

NDC codes

Identification of LASA medicines

Tall-Man lettering

Leading and trailing zeros

ISMP error-prone abbreviations

Spacing Doses and Units

Drug Name and Dose Running Together

Avoiding Abbreviated Drug Names

What did the Omnibus Budget Reconciliation Act (OBRA) do?

introduced drug utilization reviews, DURs, and mandated each state to offer medical counseling to patients.

What do DURS do?

ensures that medicines prescribed to that patient in the past were correct.

what are the three kinds of DURS?

prospective, concurrent, retrospective

What do prospective durs do?

attempt to identify potential errors before those errors can take place - based on the history of that medicine and the patient.

what errors do prospective DURS look for?

Drug-drug interactions

Drug-disease interactions

Changes in drug dosage over time

Overuse or underuse of the medicine

what do concurrent durs do?

occur at the same time that the medicine is being dispensed to identify problems during the dispensing process.

what kind of problems do concurrent durs find?

Identification of drug-drug interactions

Inappropriate dosage changes

Potential for drug-disease interactions

Abuse of medicines

what do retrospective durs do?

examine the impact of medicines after they have been dispensed to the patient.

what do durs analyze?

Indications: suitable for medicine, no contraindications

Drug selection: drugs appropriate for the clinical scenario

Dosing: dose and treatment duration

Interactions: drug-drug; drug-food; and drug-disease interactions

Medicine preparation: procedures for preparing the medicine.

Administration: administration steps, quantity distributed

Counselling: guidance given to the patient on how to safely take the drug

Monitoring: for ongoing clinical data collection

Results: data collection on the effects the drug has had on the patient

what is a patient information leaflet (PIL)?

a document insert that answers many of the basic questions about a drug – including:

Trade and generic name of the drug

Indications of the drug

Basic mechanism of action

Clinical pharmacology

Side effects – including rare adverse effects

Warnings

Dosage forms

Contraindications

Routes of administration

Dosing times

The FDA mandates that patient information leaflets are included in:

ALL prescribed meds.

what prescriptions require medication guides?

prescriptions for which there are specific risks, and these risks must be outlined for patients to read

Information on MedGuides includes:

Risks involved in taking the medicine

Possible side effects

Mechanisms to avoid adverse reactions

Other additional information, where relevant to the medicine

Isotretinoin

NSAIDs

Antidepressants

Fentanyl

Metformin

Amphetamine-based drugs

Immunosuppressant drugs

are all drugs that:

require medication guides.

What is medwatch (1993)?

he FDA’s reporting system for an adverse reaction.

Does medwatch cover vaccines?

no, the Vaccine Adverse Event Reporting System (VAERS) does.

Does medwatch cover adverse effects from veterinary medicines?

no

What is medwatch advantageous?

it can detect unexpected reactions to a medicine. In turn, the FDA can issue an alert notice – informing healthcare professionals and the public to the dangers of a given medicine. This may lead to produce recalls or withdrawals. Changes to future labelling may also be introduced.

What is The Beers’ List?

an important list of medicines that should be prescribed with added caution in older patients.

What are the four key objectives with Beers’ criteria?

Deprescribing medicines that are no longer necessary or are harmful.

Reducing polypharmacy as much as practicable.

Reduce the incidence of drug-drug and drug-disease interactions.

Increase the risk:benefit ratio of the medicine to the patient.

What are Sentinel events?

unexpected occurrences that result in serious harm or risk to a patient, including physical or psychological injury, or even death.

Why are sentinel events important?

They signal a need for immediate investigation and response to understand the underlying causes and prevent recurrence and they highlight critical safety issues within healthcare systems, including pharmacy operations, where medication safety plays a pivotal role.

What are the key features of a sentinel event?

unexpected nature, serious harm or risk, triggers for immediate action.

what are examples of medication errors?

wrong drug, wrong dose, and/or wrong route.

Medication Errors

Adverse Drug Events (ADEs)

Failure to Monitor

Labeling and Packaging Errors

Omissions in Therapy

are all:

causes of sentinel events.

Patient Harm: immediate and long-term health impacts.

Trust and Reputation: loss of patient trust and damage to the reputation of the pharmacy or institution.

Regulatory Actions: investigations by regulatory bodies (e.g., Joint Commission.), fines, or legal consequences.

Operational Implications: potential disruption in workflow, increased workload due to corrective actions, and financial costs.

are all:

consequences of sentinel events.

Immediate Action

Investigation

Implementation of Preventive Measures

Continuous Monitoring

are all:

responses to sentinel events

what is a root cause analysis (RCA)?

a systematic process used to investigate and understand the underlying causes (root cause) of adverse events, such as medication errors or sentinel events

why are root cause analyzes important?

it helps improve patient safety by addressing systemic issues rather than focusing solely on individual mistakes.

Questions asked during an RCA include:

Why did the sentinel event take place?

What factors created the circumstances for the sentinel event to occur?

Who was involved – and why were they involved?

Were all standard operation procedures (SOPs) complied with?

What was the most important causative failure that led to the event?

What preventative measures were introduced at the time to ensure no repeat of the event?

Will these preventative measures be sufficient, or are further measures required?

How will the results of these strategies be measured? How frequently will this measuring take place and who will implement and monitor these measures?

what are some challenges with RCAs?

Complexity of Healthcare Systems: Pinpointing a single root cause in such a dynamic environment is challenging

Bias and Subjectivity

Insufficient Resources: time, staff, money for a thorough investigation

Lack of Standardization: inconsistent methods from different institutions

Overemphasis on Proximate Causes

Challenges in Implementing Solutions

Difficulty in Measuring Effectiveness

Communication and Collaboration Barriers

Time Pressure

Fear of Legal or Regulatory Consequences

Polypharmacy

refers to the concurrent use of multiple medicines at the same time (at least taking 5 or more medicines at the same time).

Polypharmacy most impacts

older patients

This process of polypharmacy is sometimes referred to as the

prescription cascade

prescription cascade

where the side effect of a medicine is assumed to be a new clinical problem that requires an additional medicine

polypharmacy risks

Medication error

Drug-disease interactions

Loss of compliance by the patient

Patient compliance

refers to the degree to which a patient follows medical advice.

compliance is also referred to as

adherence

he more medicines that a patient must take, the more likely it becomes that their compliance will

reduce

• A _____ should exist to increase the probability of the highest possible compliance.

positive prescriber-patient relationship

Patients who face a____may also reduce compliance.

high cost of medicines

Concordance

refers to the relationship between the prescriber and the patient – where both parties come together to make decisions about how treatment should progress.

Placebo

refers to the belief a patient has that the medicine they take will have a positive outcome.

nocebo effect

patients have negative expectations of a drug

Airway equipment including bag valve masks, oral and nasal airways, oxygen masks and nasal cannulas, Magill forceps.

IV access equipment (or intraosseous): angiocaths, IV tubing and IV fluid. If the facility elects to utilize intraosseous access for emergency medications, then a drill and needles must be included.

Medications utilized in the treatment of cardiac arrest including epinephrine and amiodarone.

Medications utilized to treat cardiac dysrhythmias including adenosine, cardiazem, a beta blocker (usually Lopressor®), and atropine.

Monitor equipment with a defibrillator or an AED.

Medications to treat allergic reactions such as EpiPens®, Solu-medrol® and Benadryl®.

Aspirin 81mg PO

Nitroglycerin spray or 0.4mg tablets

are all:

located in crash carts

At least monthly, crash carts must be properly maintained – including:

Checking expiration dates on the first day of each month.

Removing and replacing expired medicines.

Expiration date for defibrillation pads on the AED or defibrillator must be checked.

Battery charge on the AED/monitor must be checked and documented.

auxiliary labels

cautionary labels added to a dispensed medicine to provide extra information to the patient on the safe administration, use, and storage of their medicines

Auxiliary labels do not:

refer to the dose the patient has been prescribed.

tell the patient what medicines to take, the dose, or at what time to take their medicine.

Quality control (QC)

refers to a set of activities and procedures that ensure a product or service meets certain minimum quality standards.

Quality assurance (QA)

s the process of managing quality, to ensure that defects do not occur in the production process. involves all the team – who ensure that they are doing the right thing to prevent error.

Quality control involves:

a small team testing the quality of a product

quality assurance involves:

the entire team ensuring they are doing what they should be doing to prevent any errors from occurring in the first place.

Quality assurance is __ whereas quality control is ___

mangement, inspection

Quality assurance is __ whereas quality control is ___

proactive, reactive

Quality assurance is __ whereas quality control is ___

a process, a product

Quality assurance __ whereas quality control ___

analyzes the process, analyzes defects

Quality assurance happens __ whereas quality control happens ___

during development, after the product is made

HEPA filters are designed to remove

99.97% of particles less than 0.3 microns in size

That laminar flow hoods should be turned on for at least

30 mins before use

recall

a voluntary action taken by a company to remove a defective product from the market.

The FDA is responsible for:

Overseeing and monitor the company’s strategy in the recall process.

To review the suitability of the recall.

To classify the kind of recall that it falls under.

recall Class I:

A dangerous or defective product that could cause serious health problems or death

recall class II

A product that might cause a temporary health problem or pose slight threat of a serious nature

recall class III

A products that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.

enforcement report

Each week, the FDA issues an this which lists all recalls up to that date

Code blue indicates:

a medical emergency such as cardiac or respiratory arrest

Code red indicates:

fire or smoke in the hospital

Code black typically means:

there is a bomb threat to the facility

Common reasons for activating Code Blue include:

cardiac arrest – such as from a heart attack or abnormal heart rhythm.

respiratory arrest – in cases where patients stop breathing.

confusion – including if the patient is showing signs of a stroke.

sudden and severe drop in blood pressure (hypotension)

Continuous quality improvement (CQI):

is a management system that attempts to understand the service process; to identify target problems; and to establish measurable inputs that improve quality over time.

The purpose of the sharps’ container is to:

safely house needles and other sharp medical instruments until disposal

Sharps containers can be easily identified because:

they are red and contain a biohazard symbol

The “Do Not Use” list is provided by:

the Joint Commission (JC)

The purpose of the Do Not Use list is to:

eliminate possible confusion – an essential part of the process of quality assurance in retail and hospital pharmacies.

The “Do Not Use” list complies:

a series of pharmacy abbreviations that should be avoided.

The “one-handed scoop technique” is the recommended technique used to:

recap needles

The “one-handed scoop technique” involves

placing the needle cap on the counter in the direction needed.

Scooping up the cap with the needle end.

tightening the cap, using the same hand (keeping free hand out of the way)

Both pairs of disposable chemotherapy gloves worn when handling hazardous drugs must be changed:

every 30 mins

Chemotherapy gloves must be disposed of in:

hazardous waste containers

it is recommended that chemotherapy drugs should always be

counted on separate trays

The purpose of inventory management is

to ensure that there are always sufficient levels of required medicines within the pharmacy.

A formulary is:

the approved list of drugs and medicines to be used, purchased, and stocked in a pharmacy setting.

the reorder point:

a point, once reached, triggers the purchase of additional stock to ensure that medicine levels do not fall too low.

non-formulary medicines:

drugs that do not have a defined location in the pharmacy and may necessitate a manual tracking system.

The quantity of drug ordered is determined by the:

PAR level – periodic automatic replenishment.

what is the PAR level – periodic automatic replenishment

used to calculate the quantity of drug to be ordered, and it is based on minimum and maximum permitted stock levels.

What are the three major subtypes of inventory management system?

computerized, manual, and JIT

advantages of Computerized inventory management systems

highly effective systems

provide additional data and reports, such as medicine turnover rates and maintaining perpetual inventories.

Orders may be configured automatically or manually

which management system is more time consuming, increase the risk of medication error, and must be forensically updated to ensure that medicines needed arrive on time?

Manual inventory management systems

which management system operates on the principle that medicine arrives to the pharmacy when it is needed which keeps available stock levels to a minimum, is unsuitable for an entire pharmacy inventory to function, is an effective management system for inventory that has a routine turnover rate in the pharmacy – that is to say, for drugs which are consistently dispensed on a regular and more predictable basis.

just in time (JIT) inventory management systems

purchase order:

a form that details the content of the medicine order.

Every purchase order contains the following entry fields:

Purchase order number (PO #).

Date of the medicine order.

Name of the pharmacy or facility.

Medicine ordered.

Quantity of medicine ordered.

Cost.

Shipping address.

Terms of payment.

invoice

the bill of sale for all medicines delivered to the pharmacy – detailing the cost and the products purchased.

Direct purchasing

refers to the purchase of medicines direct from the drug manufacturer

Typically, direct purchasing is used when:

buying specialist medicines – such as vaccines, orphan drugs (drugs used to treat rare diseases), or drugs with special storage requirements.

Prime vendor purchasing

refers to the purchase of medicines through a middleman, such as a wholesaler.