Pages 1-50 in DS book Flashcards
Definitions, Pharmacy practice act, Some general pharmacy laws/rules
Abandoned application
applicant fails to complete all application components within 30 days after being notified by the Board of an incomplete application
Abandoned application (terminal distributor/wholesaler)
90 days to demonstrate compliance of all laws once completed application submitted
Access to drug stock
physical access AND influence over handling of Rx drugs including purchases, inventories,, issuance of medical order, etc. Does NOT include janitorial, IT, or other staff with limited, supervised access
Drug
Use in diagnosis, cure, treatment, or prevention of disease in humans or animals. Also if intended to affect the structure or any function of the body of humans/animals.
Temporary Removal of Drugs from a TDD (3 things)
1.) licensed HCP to prescribe can temporarily remove Rx drugs to treat current/prospective patients. Return in 24 hrs.
2.) Person authorized to dispense/furnish naloxone must return within 24hrs to TDD
3.) Remov non-controlled Rx drugs/immunizations from TDD for current/prospective pts. Return in 24 hrs
Faxed prescriptions when sending to pharmacy (4 things)
1.) Can be traditional prescription form, but regardless must ALWAYS be manually signed by prescriber. Same goes for faxed refill authorizations
2.) If agent of prescriber sends fax, their full name must be included
3.) Faxed Rx must have all Rx requirements AND ID # of fascimile machine used to transmit prescription, full name of prescriber or agent if applicable
4.) OG prescription will be in patient chart at physician’s office
Computer to fax prescriptions (illegal except 2 exceptions)
1.) Rx computer to fax prescriptions operates in CLOSED system
2.) Temporary telecommunication outage for NON-CONTROLLED only
Readily Retrievable
Within 3 business days for records to be produced for review
Refuse to Grant or Renew
Deny original or continued licensure for a period of at least 24 months
Terminal distributor
Pharmacy that sells (dispenses) drug at retail; includes labratories
Virtual wholesaler Distributor (4 things)
Must be licensed as wholesaler distributor with virtual wholesaler classification
Registered as business entity with state/local
Operate out of a location zoned for commercial use
CANNOT operate out of a residence/personal dwelling
Occasional sale
Wholesale of a commercially available Rx drug to another TDD or person exempted from being a terminal distributor (vet, dentist, physician, etc.) Must follow 5% rule unless they have wholesalers license
- Does not apply to intracompany sales between pharmacies under common ownership or control or among hospitals/healthcare entities under common control
Personal supervision (direct)
RPh shall be physically present in pharmacy or in area where practice of pharmacy is occurring to provide personal review and approval of all professional activities
Federal legend
All Rx drugs must have “Federal Law Prohibits Dispensing Without a Prescription” or “Rx only” on stock bottle
Minimum standards of a pharmacy (11 items; 1 specifically for institutional pharmacies)
Library, equipment, stock of drugs, prescription containers, space and fixtures, pharmacy hours posted, personnel and staffing, “Catch all” additional minimum standards req. for specialized pharmacy, internet access, employee name tag WITH job title and specify tech registration status. Institutional pharmacies must have quality assurance program as well
4 websites/items a pharmacy must be able to access via internet
Board’s website, LA Writer Ohio laws and rules, The code of laws of the USA, and The Code of Federal Regulations
4 items the quality assurance program in an institutional setting must monitor/evaluate
1.) Quality and appropriateness of patient care
2.) Pursue opportunities to improve patient care
3.) Prevention/Detection of drug diversion
4.) Resolve Identified problems
10 items that involve the practice of pharmacy in Ohio
1.) Interpreting prescriptions
2.) Dispensing drugs and drug therapy related devices
3.) Compounding drugs
4.) Counseling individuals with regard to drug therapy, recommending drug therapy related devices, and assisting in selection of drugs/appliances for tx of common diseases
5.) Performing drug regimen reviews with patients
6.) Performing DURs with providers authorized to prescribe drugs when RPh determines an individual with an Rx has a drug regimen that warrants discussion
7.) Advising individual and healthcare professionals treating individual with regard to their drug therapy
8.) Acting pursuant to consult agreement with authorized prescriber(s)
9.) Engaging in the administration of immunizations
10.) Engaging in administration of drugs (LAIs)
Drugs Returned to Stock in Pharmacy. When can you do it?
If drug has been dispensed, but not picked up or delivered, never left prescription department, and/or never left control of delivery agent
Requirements for Drugs Returned to Stock in pharmacy (7 conditions must be met)
1.) Exp date on container (OG manufacturers exp. date OR 1-year from date Rx was dispensed, whichever is less)
2.) Must be kept in Rx bottle it was dispensed with OG patient label on it. Do NOT return to manufacturer bottle. Should not remove label UNLESS: a.) adding/modifying the existing label, adding new label over existing label (same exp. date), if prescription label was placed on OG manufacturer sealed packaging (exp/lot # must be readable)
3.) When dispensing drug to different patient from one that was returned to stock, new container must be used
4.) Store properly
5.) If drug recall, must remove unless pharmacy can determine the exact lot # of the drug in the prescription bottle that was returned.
6.) Cannot return if any sign of tampering/adulteration
7.) Can transfer/sell to intracompany if under common control
NOTE: does NOT apply to inpatients
Two requirements if returning drugs to stock after delivery agent came back with it
1.) Had to be dispensed in tamper evident container/package prior to leaving pharmacy
2.) Be in manufacturer’s original tamper evident packaging
Consult agreements (5 entities can be in a CA with RPH)
1.) Physician
2.) PA if authorized by at least one supervising physician
3.) Certified Nurse Practitioner
4.) Certified Nurse Midwife
5.) Clinical Nurse Specialists
(3-5) if authorized by collaborating physician
NO OTHER PROVIDERS CAN BE IN A CA
3 requirements for entering a CA
1.) Physician has ongoing physician-patient relationship with each patient whose drug therapy is being managed
2.) Diagnosis for which patient has been prescribed drug therapy is within the scope of practice of physician’s practice
3.) Pharmacist has training/experience related to the particular diagnosis for which drug therapy is prescribed
6 things that a pharmacist is authorized to do in a CA
1.) Change duration of treatment for current therapy
2.) Adjust strength, dose, dosage form, frequency, administration, or route of admin.
3.) Discontinue use of drug
4.) Administer drug if drug is included in CA
5.) Add drug to patient’s therapy
6.) Order lab tests related to managing patient drug therapy and if specified within practice protocols, evaluate results related to drug therapy being managed. CANNOT DIAGNOSE!!!!
Who can terminate a CA? (3 people)
Pharmacist, physician, or patient/individual who gave consent for patient
How long is a CA good for?
2 years, then can be renewed
What are the 4 things that must be in writing for a CA?
1.) Diagnoses/diseases being managed and if they are primary/co-morbid diseases
2.) Description of drugs or drug categories the agreement involves
3.) Description of procedures, decision criteria and plan for RPH to follow
4.) Description of how RPH is to comply with records of each action taken and at what regular intervals this will take place
Consent required for CA (4 items); RPH must tell patient these things
1.) Pharmacist may be utilized in management of patient’s care
2.) Patient has right to participate or withdraw from CA
3.) Consent may be part of patient’s initial consent to treatment
4.) Managing RPH means Rph managing patient’s drug therapy pursuant to a CA
7 acceptable communication methods between RPH and provider for CA (Same methods can be used for Written Notice (confirmation of delivery)
1.) Electronic mail that confirms delivery
2.) Interoperable electronic medical records system
3.) Fax that confirms delivery
4.) Electronic prescribing system
5.) Electronic pharmacy record system
6.) Documented verbal communication
7.) Any other method of documented notification as outlined in the CA
If the RPH in a CA is an agent of the prescriber they must do 3 things when issuing prescriptions
1.) Include required information of consulting prescriber
2.) Telephone # where managing pharmacist can be contacted during business hours
3.) All positive ID on the prescription including manual signature shall be of the pharmacist on behalf of the prescriber
If a pharmacist is able to prescribe controlled substances, when do they need to check OARRS and how far back do they need to go?
1.) when changing controlled substance dose, strength, dosage form, route or frequency OR if adding a controlled substance to their therapy
Must go back 1 year in OARRS each time checked
What healthcare professionals that are authorized to prescribe drugs DO NOT need to follow the laws regulating practice of pharmacy when supplying drugs to their patients? (6 of them)
Physicians, podiatrists, vets, dentists, NPs, optometrists
When healthcare professionals dispense drugs from their office do they need to be labeled/packaged according to pharmacy regulations?
Yes and records of purchase/dispensing must be maintained as well
Emergency dispensing, not including C-II’s, conditions that must be met in order to comply with law for emergency dispenses (8 main items)
1.) Pharmacy has record of a prescription for the drug in the name of the patient with either no refills left or the refills have expired
2.) RPh unable to contact prescriber for refill authorization
3.) RPh judgement says the drug is essential to sustain life, continues therapy for a chronic condition, or failure to dispense drug could result in harm to patient
4.) Cannot exceed 30 day supply if on consistent drug therapy, but able to do two additional 7 day supplies in 12-month period
5.) Record dispensing/notify physician within 72 hours of dispensing
6.) Must keep records for one year after sale or dispensing
7.) RPh MUST create new Rx document for the emergency refill
8.) Pharmacy MUST have a record of the prescription (can use real-time database to access patient records if not at that specific pharmacy)
4 things must be kept on record when doing emergency dispensing
1.) Name and address of patient
2.) Name and address of individual receiving drug (If different than patient)
3.) Amount dispensed
4.) Original Rx #
Must keep these records for one year after dispense
If a co-pay or deductible is waived who is responsible, individual RPh or business?
The business or TDD is responsible, NOT individual
If the cost of an Rx is cheaper cash than with co-pay do you have to say anything?
Yes, must always charge the lower amount so if cash price is lower than co-pay/co-insurance than patient must be informed of cost-savings
