Pharm 728 Final Flashcards
OAR Division 11
Health Professional’s Service Program
OAR Division 19
Pharmacists*
OAR Division 21
Continuing Pharmacy Eduation
OAR Division 25
Certified Pharmacy Technicians and Pharmacy technicians
OAR Division 31
Internship Regulations
OAR Division 41
Operations of Pharmacies (ambulatory and Residential Drug Outlets)
OAR Division 45
Sterile and Non-sterile compounding
OAR Division 80
Schedule of controlled substances
Notice of Proposed Rule (855-001-0000)
The Board must provide a reasonable opportunity for interested persons to be notified of the agency’s proposed action
- Includes Oregon State Pharmacist Association and Oregon Society of Health System Pharmacists
- Associated Press
Notification Deadlines
- Bulletin, at least 21 days prior
- Those requested, at least 28 days prior
- Those specified, at least 49 days prior
Duty to Cooperate (855-001-0035)
Every Licensee/Registrant shall respony fully and truthfull to inquiries/requests from the board, subject only to any applicable right or privilege.
Inspections (855-001-0040)
Board and representatives may Enter/search and premises or where records stored
Refusal is grounds for denial, suspension or revocation of registration
Duty to Report (689.455)
Unless a confidentiality Law conflict, pharmacists must report
Any Suspected violations of ORS 689; 475
Any prohibited conduct of ORS 676
Prohibited Conduct (ORS 676)
- Constitutes a criminal act against a patient or client
- Constitutes a criminal act that creates a risk of harm to a patient or client
- Conduct unbecoming a licensee or detrimental to the best interest of the public, including conduct contrary to recognized standards of ethics of the licensees profession or conduct that endangers the health, safety or welfare of a patient or client.
Oral Counseling (OAR 855)
an oral communication process between pharmacist and patient or patient’s agent that identifies patient/agent an provides professional advice regarding safety and use for purpose of assuring therapeutic appropriateness
Drug Utilization Review (OAR 855)
Evaluating Prescription Drug Order for the purpose of promoting therapeutic appropriateness:
- Over/Under utilization
- Therapeutic duplication
- Drug-disease contraindication
- drug-drug interaction
- Incorrect dosage/duration of treatment
- drug-allergy interactions
- clincal abuse/misuse
Supervision by a Pharmacist (OAR 855)
Being stationed in the same work area as the pharmacy technician or certified pharm tech/Intern and be able to control and be responsible for their actions.
Continuing Pharmacy Education Requirements
50min = 1 contact hour
10 contact hours = 1 CEU
3 CEU required every 3 yrs
(minimum 2 hrs acquired in pharm and drug law)
(minimum 2 hrs acquired in patient safety)
Certified Pharmacy Technicians must have:
- Nation Examination certification
a) PTCB test
or
b) NHA test - 10 contact hours per term
Pharmacy Technicians
Assist Pharmacist, have not completed specialized education program
Both CPhT and Pharm Techs must:
be 18
Complete a Board application and provide a valid Email address
Have no board restrictrions from any healthcare regulatory board
Difference Between:
Pharm Techs (PT)
Certified Pharm Techs (CPhT)
Certified Oregon Pharm Tech (COPht)
PT - No special skills, just recognized by board
CPhT - Passed National Exam
COPhT - Passed exam and recognized by board as having done such
Shared Pharmacy Services agreement includes:
Dispensing Drug Utilization Review Claims Adjudication Refill Authorization Compounding Therapeutic Intervention
Category Risks for Compounding 1-5
1 - Nonsterile, generally mixing two or more products (not compounding)
2 - Nonsterile, enerally compounding w/ calculations required
3 - Sterile (low risk, 3 ingredients)
4 - Sterile (medium risk, 3+ ingredients)
5 - Sterile, (High Risk, nonsterile ingredients –> sterile)
Pharmaceutical Manufacturers requirements
Transaction History
Transaction Information
Transaction Statement
What is a Suspect Product?
A product for which there is reason to believe is:
- counterfeit, diverted, stolen
- adulterated
- subject of fraudulent transaction
- otherwise unfit for distribution
Class I Wholesaler
Anywhere where Prescription Drugs
Class II Wholesaler
Anywhere Non-prescription drugs
Class III wholesaler
Drugs for Veterinary use, Devices w/o drugs, Oxygen/Other gases IV for fluid/electrolyte/calorie Medical convenience kits
FDA Approval of Condoms
prior to 1997, FDA relied upon OBP to test condoms, now mostly FDA does these tests that Oregon set standard of.
Schedule of Controlled Substances
I - No medicinal Purpose, High abuse potential (Bath Salts)
II - Medicinal Value, High abuse potential (Marijuana)
III - Medicinal Value, less abuse potential (Pseudoephedrine)
IV - Medicinal Value, lesser abuse potential (Carisoprodol)
V - No abuse potential
Prior to Pharmacist Licensure…
- Provide evidence for completing graduation requirements
- 1440 hours of school based rotational interships
- Passed NAPLEX exam (>75)
- Passed MPJE exam (>75)
- Submit completed application
NAPLEX Score Transfer
- applicant for score transfer must be graduate of a school and had a score of >75
- applicant must apply to have their score transferred
General Responsibilities of a Pharmacist include:
- Drug Utilization Review
- Counseling
- Drug Regimen Review
- Medication Therapy Management
- Collaborative drug therapy management
- Practice pursuant to State drug therapy management protocols
- Ordering intrepreting and monitoring of a laboratory test
- Oral receipt or transfer of a prescription
- final verification of work performed under their supervision
Pharmacist Practice and Duty to self Report required if…
- Convicted of a misdemeanor or a felony
- If they are arrested for a felony
Components of a Drug Utilization Review
a) Full name of the patient
b) address and telephone number
c) Gender, age/DOB
d) Chronic medical conditions/disease states
e) list of all drugs/devices
f) known allergies/ADRs
g) comments relevant to drug therapy
h) additional information
- must be kept 3 yrs
- DR prior to dispensing or preparing any prescription or refill
When is counseling required?
Who may counsel, how do you record?
- New prescription
- any changes in therapy (strength/directions etc)
- New Pharmacy
- Pharmacist or approved Intern may counsel or receive denial to counsel
- document the interaction
What is Medication Therapy Management?
Intended to optimize the therapeutic outcomes of a patient.
- enhancing appropriate medication use
- Improving medication adherence
- Increasing detection of ADRs
- Improving collaboration between practicioner and pharmacist
- Improving Outcomes
Elements of a Prescription
- Patient Information
- Drug Therapy Instructions/Protocol
- Prescriber’s authorization (signature)
Administration of Vaccines Record Keeping and Reporting requirements
- must fully document administration in patient’s permanent record
- must report to OHA alert Immunization information system within 15 days of administration.
Duties and requirements of PIC
- every pharmacy must have a PIC at one point in time.
and - must have at least 1 yr of practice
or - must have board approved PIC training course
Grounds for discipline
- Unprofessional conduct
- Repeated or gross negligence
- Impairment
- Board violation
- guilty of a felony
- guilty of OAR or ORS violation
- Fraud or misrepresentation
- practicing w/o a license
- aiding and abetting an individual engage in practice of pharmacy
- violation of provisions to ORS or rules adopted thereto
- Failure to preform duties of a pharmacist
Prescriptive Authority rule
855-019-0400
Qualified Pharmacists may prescribe hormonal contraceptives.
Prescriptive authority Training Program
Must complete ACPE for prescribing contraceptives and submit a copy of certificate of completion of training to board within 15 days of completion.
Prescriptive Authority Requirements
Must be 18, or if under 18 has evidence of previous prescription from PCP
Internship Regulations/Requirements
- Must have a Preceptor Present
- Must complete Application, including background check, fingerprints, confirmation that applicant is enrolled in a course of study
Internship Responsibilities for TPI and SRI
Traditional Pharmacy-Practice Internship (TPI)
- must have completed first year of school of pharmacy
School Based Rotational Internship (SRI)
- may not work more than 48hrs a week
- PRECEPTOR MUST BE CURRENTLY LICENSED W/ BOARD
Division 41, Operation of Pharmacies Important inclusions
- Distribution of Emergency Medication
- Central Fill Drug Outlets
- Remote processing drug outlets
- Consulting or Drugless pharmacies
- Expedited Partner Therapy
- Retail Drug Outlet for home dialysis supplies
- Remote Dispensing
- Remote Distribution Facilities
- Residential Drug Outlets
- Technician Checking Validation Program
- Hospitals w/ Pharmacies
- many many more
Oregon Pharmacy Recovery Network Mission
Pharmacists Helping Pharmacists, seek to assist colleagues overcome physical and mental impairment by chemical dependency.
Positive Alcohol Screen Criteria
Men: 15+ drinks a week
Women: 8+ drinks a week
Men/Women who have 5/4 drinks per occasion one or more times a week
BAC Levels
- 05% - judgement impaired
- 08% Driving limit
- 1% Motor Skills Clumsy
- 2% Behavior/Emotions highly affected
- 3% Confusion/Stupor/Death
Addiction Influenced by:
Genetics Psychosocial Factors (stress, motivation, perceptions) Environmental Factors (Acess, Neighborhood, etc)
Five Theories of Addiction
Genetic Vulnerability Incentive-Sensitization Reward Pathology of Learning and Memory Stress and Allostasis Pathology of Motivation and Choice
Addiction is a disorder of:
Choice Stress Memory Pleasure Genes
Addiction vs Abuse
Addiction acts as if a switch in brain that flips at some point as a result of drug use
Is there a cure to addiction disease?
No, a lifetime disease, that can be controlled
Characteristics of Impaired Health Professionals
- Massive Denial
- Higher Shame
- Feel they are Care givers, not takers
- Perceive themselves as only ones who can do their job
- Community holds them in high regard
- Have good skills to cover up their behaviors (try to look good)
Factors for High Incidence of Health Professional Abuse
Availbility Stress/Perfectionism Knowledge (superman mentality) Caretaker personality Genetics (38% w/ family history)
Pharmacist’s Abuse excuse Hooks
Self medicate to treat pain
I know more than anyone else (drug expert)
I can do this safely, docs call me w/ drug questions
Always think they can control it
Pharmacist Professional Duties:
- Do no Harm
- Warn: Patient RIsk manger
- Warn: Safety Net
- Protect Confidentiality
Continuous Quality Improvement (CQI) checkpoints
Identify RIsk
Select Best Practices
Train and Implement
Monitor, record errors, near misses and then make changes.
Avoid, Manage, Transfer
Best Practice - Take 5
1-3) Check the name 3 times
4) Check the NDC Numbers
5) Show and Tell during Counseling
Best Practice - Mark It
- Identify prescription items that cause problems
- Highlight problem with Tall man lettering, marked bottles, marked shelves etc.
Best Practice - Counseling and Patient Care
IHS prime questions
What did your doctor tell you this was for?
How did your doctor tell you to take it?
Did the doctor go over possible side-effects?
