Law/Ethics 1 Flashcards

Question

Pharmacist may dispense naloxone in accordance with a protocol without a prescription for __

Answer 1

anyone who is at risk of experiencing an opioid related overdose or to the family member of a person at risk

Answer 2

summon emergency services when an overdose occurs

Answer 3

patient refuses documentation of training within 12 months

Answer 4

False, all employees must be trained

Answer 5

naloxone is available except in a shortage

Answer 6

COmplete an ACPE accredited training course on tobacco cessation Screening procedure recommended by the CDC Refer high risk to PCP Implement follow-up Must refer patient to Ohio tobacco quit line

Answer 7

Within 10 days of the arrest

Answer 8

18 or older

Answer 9

biennially

Answer 10

A person who is engaged in the sale of dangerous drugs at retail A person who has possession, custody, or control of dangerous drugs for any purpose other than for that person's own use and consumption

Answer 11

Pharmacies Hospitals Nursing homes Laboratories

Answer 12

Wholesalers Manufacturers Outsourcing facilities 3rd party logistic providers Repackagers

Answer 13

A compounded dangerous drug if it exceeds the assigned beyond use date Is not stored or dispensed properly Quality is wrong Contains other substances

Answer 14

Prescriptions must occur in the course of the person's professional practice MD, DO, Doctor of Podiatry CNP PA Veterinarian Pharmacist

Answer 15

APRNs PAs RPhs

Answer 16

must be affiliated with a collaborating physician

Answer 17

Must prescribe under a collaborative practice agreement or a physician driven protocol

Answer 18

Scope of practice should be assessed by the dispensing pharmacist Used to determine if a prescription is within the scope of the prescriber

Answer 19

A non-resident prescriber whose license is in good standing is authorized to write prescriptions in another state that may be filled in Ohio

Answer 20

Shall be responsible for the practice of the profession of pharmacy Responsible for compliance with all state and federal laws Only pharmacists may be listed as the responsible person for TDs Supervision of drugs, adequate safeguards, security and control of drugs, and maintaining all drug records Cannot have a disciplinary action on their license

Answer 21

No, unless granted by the board

Answer 22

Also responsible for the development implementation supervision and coordination of all services provided by the pharmacy

Answer 23

Only a physician may be the responsible person Responsible person must be physically present on site a sufficient amount of time to provide adequate supervision

Answer 24

A physician or nurse practitioner may be the responsible person Must possess a waiver to furnish buprenorphine Must be on site min of 15 hours per week or 50% of total hours facility is open, whichever is less

Answer 25

Must have a responsible person at all times Must notify the board within 10 days if there is a change in responsible person Complete inventory of controlled substances taken by new responsible person

Answer 26

Detailed procedures exist for the sale or transfer of a pharmacy or TDD and also for the closing of a pharmacy or other TDD

Answer 27

Destruction must make the substance non-retrievable Records of controlled substance destruction must be maintained for a minimum of three years

Answer 28

Positive identification cannot rely solely on a private personal identifier such as a password the following are acceptable: Manual signature Barcode Biometrics Board approved system of randomly generated personal questions

Answer 29

When significant loss of any dangerous drug or controlled substance occurs TDD must notify the board by phone If theft or loss is a controlled substance, must use federal DEA report form and filed to the state board within 30 days Must also notify the board law enforcement and DEA for any theft or loss of DEA form 222

Answer 30

An authorized board agent may, without notice, carry out an on-site inspection or investigation The license must submit, within 30 days, a written notice stating corrective actions taken or dispute of the observed violation

Answer 31

Before purchasing drugs at wholesale: A TDD is required to verify that a seller is licensed to sell dangerous drugs Queries must be documented at least annually

Answer 32

If a TDD is selling drugs to another entity they must check the board's online roster to determine if the purchaser is licensed as a distributor or terminal distributor There are exemptions

Answer 33

To prevent their use, adulterated drugs shall be stored in a separate secure area apart from other drugs May not be stored longer than one year from the date of adulteration or expiration Disposal of controlled vs non-controlled substances have different rules

Answer 34

All category III terminal distributor licensees must complete a controlled substance inventory at least once yearly Responsible person is responsible for completing and maintaining the inventory Inventory records must be maintained for three years

Answer 35

Applies to sales over the internet at retail into, out of, or within, Ohio Must be properly licensed in Ohio Must follow Ohio laws as well as federal laws Applies to vet pharmacies as well

Answer 36

TD shall not employ in a position which allows access to controlled substances any person who has been convicted of a felony relating to controlled substances or has had an application for DEA registration denied revoked or surrendered

Answer 37

Made by a prescriber, or a prescriber's agent Agent must provide first and last name May be left on a voicemail

Answer 38

Signed by a prescriber in the same manner as the prescriber would sign a check or legal document May be transmitted by fax but must include certain items including the word void or faxed on the face of the original

Answer 39

Must contain full name of prescriber and prescriber's agent Controlled substance prescriptions only if complies with code of federal regulations 21 CFR 1311

Answer 40

A licensed professional authorized to prescribe drugs may temporarily remove drugs from a licensed TDD in order to treat patients Maintain control and direct supervision over the drugs at all times Drugs must be returned within 24 hours Storage temps and conditions must be adhered to

Answer 41

TDDs shall provide effective controls and procedures The board evaluates the overall security of a TDD

Answer 42

No drug that has been dispensed and has left the physical premises of the TDD shall be returned There are exceptions

Answer 43

Meets the following requirements: -Holds a TDD -Is exempt form federal taxes -Is not a hospital

Answer 44

May work in certain capacities in charitable pharmacies, are not required to be registered or certified technicians Must be written policies regarding support personnel Permitted to sort non-controlled drugs under supervision of a licensed pharmacist Not permitted to label, package, repackage, or dispense

Answer 45

Must be an original manufacturers container, it is clearly marked as a sample Prior to transfer must be stored under proper conditions to prevent adulteration Marked with expiration date and lot number Not expired Not a controlled substance

Answer 46

Must have a valid prescription Shall comply with all other rules related to dispensing Pharmacy is responsible for determining the eligibility requirements for a patient to receive a sample drug Must be free of charge Must be clearly marked as sample when dispensed

Answer 47

Program authorized to accept prescription drugs donated, or given for the purpose of being dispensed to individuals, who are residents of Ohio and meet eligibility standards Repository programs may be outpatient pharmacies, hospitals, or nonprofit clinics Must notify the board within 30 days of establishing or discontinuing a program This rule commonly applies to patients who are in LTC facilities who have drugs discontinued or those who pass away

Answer 48

Eligibility requirements: Resident of Ohio, Uninsured, or underinsured Donation and recipient forms must be completed Pharmacy may charge a handling fee, not to exceed $20, to cover restocking and dispensing costs Donated drugs must never have been possessed by the patient

Answer 49

Any person outside of Ohio that ships, mails, or delivers dangerous drugs at retail into Ohio Non-resident TDD's must maintain an Ohio license and must comply with all requirements This does not include drugs shipped into the state for destruction or disposal Must have a responsible person with an Ohio pharmacist license

Answer 50

Must maintain all records of drugs dispensed in the state of Ohio for a minimum of three years Must meet labeling requirements for any prescription dispensed in Ohio

Answer 51

The address of the originating pharmacy must be on the label If the central fill and the originating pharmacy are not owned by the same company, the name of the central fill pharmacy must also be shared with the patient The central fill pharmacy and the originating pharmacy must have access to common electronic files as part of a real time online database Must have a written quality assurance program

Answer 52

A non-resident pharmacy must follow the laws of Ohio unless they can demonstrate that following Ohio law causes them to violate the laws in the state in which they are located

Answer 53

Non-resident pharmacies must offer to counsel on every prescription dispensed By telephone or in writing on a separate document Must include a number where a pharmacist can be reached Must be no cost to the patient Must have sufficient telephone service to provide access to incoming callers

Answer 54

Non-resident TDDs shall permit authorized BOP agents to enter and inspect their premises and delivery vehicles The TDD shall be responsible for all costs incurred by the board of pharmacy agent in conducting the inspection In lieu of an inspection the TDD may submit: -Inspection reports from anoteher state licensing agency -Documentation from the NABPs verified pharmacy program (VIPP)

Answer 55

Must comply with USP 797 and 800 compounding regulations Compounded drug must appear prominently on the label May only be patient specific if for human use May be non-patient specific if for animal use An Ohio licensed pharmacist must be on the TDD as the responsible person Product quality issues must be reported to the state board within 72 hours of discovery

Answer 56

Drugs must be stored in a securely locked substantially constructed cabinet or safe This should be placed in an area that's not readily accessible It shall remain locked and secured when not in use The combination or access code must be changed if an employee who knows the code has been terminated If it's locked with a key, the key must be kept inaccessible to anyone other than the prescriber or pharmacist

Answer 57

Must keep a record of all dangerous drugs received, administered, personally furnished, disposed of, sold, or transferred Administration records for non controlled drugs must contain the identification of the healthcare professional administering the drug, For controlled drugs it must include positive identification

Answer 58

One or more pharmacists may enter into a consult agreement with one or more physicians if all the following are met: -Each physician has an ongoing physician patient relationship -The diagnosis is within the scope of practice of the physician -Each pharmacist has training and experience related to the diagnosis

Answer 59

Physician assistants Certified nurse practitioners Clinical nurse specialists Certified nurse midwifes -all must be authorized by their collaborating position

Answer 60

Manage drug therapy -Starting or stopping medications -CHanging doses/dosage forms/routes -Ordering labs -Administer drugs covered under the agreement Does not authorize the pharmacist to make a diagnosis

Answer 61

Can be terminated at any time by the pharmacist, prescriber, or patient If any of the 3 parties terminates the agreement, the other 2 parties must be notified in writing Terminations must be recorded in the medical record

Answer 62

Must be in writing and must include: -Diagnosis being managed -Description of the drugs or drug categories involved -Description of the procedures, decision criteria, and plan the RPh is to follow -Description of compliance with record keeping -All prescribing, administering, and dispensing must include positive identification Must be communicated to each patient The RPh must maintain a record of each action taken for each patient under the agreement Communication shall take place "at regular intervals" specified by the physician The pharmacy or medical board may adopt additional rules and can include categories of drugs or disease states for which they may not appy

Answer 63

A pharmacist acting in accordance with a consult agreement regarding a physicians change in a drug for a patient whose drug therapy the pharmacist is managing is not liable for damages in a tort or other civil action for injury or loss allegedly rising from the change The reverse is also true unless the physician specifically authorized the change

Answer 64

Pharmacists must have training and experience related to the particular diagnosis for which drug therapy is prescribed Must be an Ohio licensed pharmacist in good standing, and who meets the training and experience criteria -Privileging and credentialing, board certification, CE and other training -Must be a process to verify pharmacists meet the criteria

Answer 65

Consent shall be obtained from each individual patient participating in a consult agreement - inpatients are an exception The consent must communicate the following: -A pharmacist may be utilized in the management of patient care -The patient has the right to withdraw from the agreement -Consent may be obtained as part of the patient's initial consent to treatment

Answer 66

Controlled substances may be ordered/managed under a consult agreement Pharmacists must maintain a valid controlled substance prescriber registration in Ohio Must maintain a DEA number Must pull an OARRS report prior to managing therapy

Answer 67

May not delegate drug therapy management to anyone else not listed in the agreement -May delegate the administration of drugs to a licensed healthcare professional in accordance with their scope of practice Rules of consult agreements do not apply to therapy management by formulary Pharmacists must meet with patients under an outpatient consult agreement at least once yearly

Answer 68

Review patient's history Conduct an initial consultation with the patient Order and evaluate tests Prescribe medication, evaluating any contraindications Document in the medical record Prescriptive authority shall not exceed what is specified in the consult agreement

Answer 69

May administer controlled substance narcotics under consult agreement for the maintenance or detoxification of opioid addiction

Answer 70

Agreement must be signed by the primary physician (medical director) or designee AND the responsible person on the terminal distributor license or an individual pharmacist All amendments must be signed and dated by the primary physician and the pharmacist listed

Answer 71

Consult agreements must contain a quality assurance mechanism Ensure pharmacists are only acting within scope authorized by the agreement A description of the CQI program

Answer 72

Is a distinct group of services that is intended to optimize the therapeutic outcomes of a patient MTM can be an independent service provided by a pharmacist or pharmacy intern or can be in conjunction with dispensing

Answer 73

Enhancing appropriate medication use Improving medication adherence Increasing detection of adverse drug events Improving collaboration between prescriber and pharmacist Improving outcomes Completing a Comprehensive Medication Review (CMR) is often a core component of MTM

Answer 74

An Ohio licensed pharmacist An Ohio licensed intern under the supervision a pharmacist A pharmacist or pharmacy intern practicing in another state in accordance with that state laws and rules

Answer 75

MTM should meet individual patient needs and may include the following: -Conducting a patient health status assessment -Developing a medication treatment plan for monitoring and evaluating response to therapy and monitoring the safety and effectiveness of medication therapy -Performing a medication review to identify, prevent, or resolve medication related problems -Providing education and training to a patient -Documenting the delivery of care -Providing services to enhance adherence