Basic Law

Question 1

Legal Definition of the Practice of Pharmacy

Answer 1

• Interpreting prescription orders
• Compounding, dispensing, labeling, administering, and distribution of drugs and devices
• Monitoring of drug therapy and use
• Initiating or modifying drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs
  
  • Collaborative practice agreements
• Participating in drug utilization review and drug product selection
  
  • DUR, popups for allergies and interactions
• Proper and safe storing and distributing of drugs and devices and maintenance of proper records thereof
• Providing of information on legend drugs which may include, but is not limited to, the advising of therapeutic values, hazards and the uses of drugs and devices

Question 2

Pharmacy Assistant: Who

Answer 2

Registered with PQAC

Question 3

Pharmacy Assistant: What

Answer 3

• Count and label individual prescriptions
• Return used bottles to the shelf
• Often responsible for cashiering in pharmacy

Question 4

Pharmacy Assistant: May Not

Answer 4

• (Counsel)
• Pull a medication bottle from the shelf to fill a prescription

Question 5

Pharmacy Technichian: Who

Answer 5

• Registered with PQAC
• Trained to perform non-discretionary manipulative functions related to the practice of pharmacy
• Must act under the supervision of a licensed pharmacist

Question 6

Pharmacy Technician: What

Answer 6

• Enter prescriptions into Pharmacy Computer System
• Retrieve the medication to fill a prescription
• Specialized Functions IF trained
  
  • Prepare IV medications
    
    • Must be checked by pharmacist
    • Ambiguous if intern can check their work
  • Check and Stocking of auto drug distribution devices
  • Tech-check-tech for unit dose medications

Question 7

Pharmacy Technician: May Not

Answer 7

• Receive a verbal prescription other than a refill authorization
  
  • Intern/Pharmacist for changes
• Consult with the patient regarding the prescription and/or regarding any information in the patient medication record
• Consult with the prescriber regarding the patient and the patient’s prescription
• Compound the prescription, except for bulk compounding
• Some tech allowed for medication reconciliation, but have to have special training
• Interpret the data in the patient profile
• Take responsibility for the correctness of a dispensed prescription
• Provide patient information (such as counseling)
• Sign where a pharmacists signature is required
  
  • Ordering 2-2-2
  • Logbook for DEA controlled substances

Question 8

Pharmacy Intern: What

Answer 8

• “Engage in the practice of pharmacy, and the selling of items restricted to sale”
• Must act “under the direct and personal supervision of a certified preceptor or a licensed pharmacist designated by the preceptor to supervise that intern during the preceptor’s absence from that site”

Question 9

Pharmacy Intern: May Not

Answer 9

• Supervise technicians
• (Checking IVs)-can check in the med in community

Question 10

Pharmacist: Who

Answer 10

• Registered with PQAC
• “A person duly licensed by the Washington State board of pharmacy to engage in the practice of pharmacy”
• Practice and Responsibility for carrying out the duties defined as the practice of pharmacy

Question 11

Drug Order/Prescription Must Include

Answer 11

• Prescriber name and address
• Patient name
• Patient address (on rx or in profile)
• Date written
• Drug name, Strength & Quantity
• Directions for use (sig)
• Refills (if any)
• Prescribers signature
• Provision for generic substitution

Question 12

Hard Copies of Prescriptions

Answer 12

• Printed (not cursive)
• Typed
• Tamper Resistant
  
  • If patient doesn’t touch Rx, not need tamper proof prescription paper

Question 13

Allowed Transmission

Answer 13

• Hardcopy (all)
• Phone, fax, and e-prescribing

Question 14

Back Tag

Answer 14

• Sticker to put on back of prescription
• Rx numbed
• Date filled

Question 15

Valid Prescription

Answer 15

• Issued for a specific patient
• Issued by an authorized prescriber
• Was it in due course of prescriber’s practice
  
  • Scope of practice
  • Prescriber-Patient relationship
• Medical purpose

Question 16

What makes a valid prescription label

Answer 16

• Name and address of pharmacy
  
  • Phone number not required
• Prescription number
• Date dispensed
• Patient name
• Drug Name, strength and quantity
• Directions for use
• Refills
• Expiration date
• Warnings and/or precautionary statements
  
  • Federal Transfer Warning
• May include name or initials of pharmacist making final check
• May include FDA SE Warning
  
  • Call you doctor about medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Question 17

General Pharmacy Security

Answer 17

• Only pharmacists allowed to enter/secure dispensing area
• Pharmacist must be physically present if an employee in dispensing/compounding area
• Dispensing area must be enclosed if employees in other part of building while pharmacist is not present
• Pharmacies inside other establishments must be enclosed with barrier that prevents removal of items from dispensing area

Question 18

Entering Patient into Computer System

Answer 18

• Create Patient Profile
  
  • Patient’s Full Name
  • Address
  • DOB
  • Weight, if applicable
  • Gender (not legal requirement, but usually for insurance)
  • Known allergies/sensitivity
  • List of chronic conditions
  • Record or drugs dispensed by pharmacy/Other drugs patient is receiving/taking
  • Pharmacist Notes re: therapy
  • Non-child resistant cap notations

Question 19

NDC Number

Answer 19

• 1st 5 digits for manufacturer
• 2nd 4 digits for medication strength/dosage form
• 3rd 3 digits for package size

Question 20

Pharmacist Check

Answer 20

• Drug Utilization Review (initial check)
• Final prescription check
• Records must indicate pharmacist making final check (and initial check if different pharmacist than final)

Question 21

Refills

Answer 21

• Compounding or dispensing any drug pursuant to previously executed order
  
  • Use the same Rx number as previously filled prescription
• Refills are valid up to a varying time from date of original prescription
  
  • Legend Rx: one year
  • Controlled: 6 months
• Technician can take oral authorization for refills over phone
  
  • Technician name must be recorded
  • Name, initials or license of pharmacist making final check must be recorded
• Records must indicate when/if NDC changes

Question 22

Transferring Prescriptions

Answer 22

• Transfer of a prescription and its refill information from pharmacy to pharmacy may be done if the
  
  • Prescription is not expired
  • Refills remaining
• Pharmacist (or intern) to pharmacist (intern)
  
  • Over the phone
  • Fax (questions have been arising over this)
• Number of Transfers Allowed
• None for CIIs
• Once for CIII-V
• Rx or Legend: Unlimited if refills remain

Question 23

Patient Counseling

Answer 23

• OBRA 90
• Oral communication by pharmacist or intern to patient or caregiver for ensuring proper use
• Technician/Pharmacy Assistant’s Role
  
  • Not supposed to say “Is this new for you?” but rather “This is a new prescription. The pharmacist will be right over to review the medication with you.”
• Refusal for counseling needs to be documented

Question 24

Controlled Substances

Answer 24

• Medications with potential for abuse
• Drug Abuse Prevention and Control Act (1970) (Controlled Substances Act of CSA)
  
  • Established strict limits on distribution and possession of set specific drugs/substances
  • Manufacturers, distributors, dispensers and prescribers must register with DEA

Question 25

Schedule I

Answer 25

* Illicit * Drugs w/ high potential for abuse, no accepted use, lack of safety

Question 26

Schedule II

Answer 26

* Rx only * Drugs w/ high potential for abuse, accepted use, (severe physical and emotional dependency) * Narcotics: fentanyl, hydromorphone (Dilaudid), meperidine (Demerol), methadone, morphine, oxycodone (OxyContin), hydrocodone * Narcotic combos: oxycodone/APAP, hydrocodone/APAP * Stimulants: Amphetamines (Adderall), Methylphenidate (Ritalin, Concerta)

Question 27

Schedule III

Answer 27

* Rx only * Drugs w/ moderate potential for abuse, accepted use, moderate to low physical but high emotional dependence * Opiates: Codeine combos i.e. codeine/APAP (Tylenol #3) * Anabolic steroids: testosterone

Question 28

Schedule IV

Answer 28

* Rx only * Drugs w/ low potential for abuse, accepted use, limited physical and emotional dependence * Opiate: Tramadol * Depressants: phenobarbital, sleep aids (Ambien, Sonata, Lunesta) * Benzodiazepines: Diazepam (Valium), Lorazepam (Atvian), midazolam (Versed), temazepam (Restoril), triazolam (Halcion) * Stimulants: phentermine (Fastin), sibutramine (Merdia)

Question 29

Schedule V

Answer 29

* Behind Counter * Drugs with low potential for abuse, accepted use, limited physical and emotional dependence possible * Cough syrups: codeine (in certain strengths) * Diphenoxylate w/ atropine (Lomotil)

Question 30

Labeling

Answer 30

* Manufacturer container must be clearly labeled with the control classification * CII-CV

Question 31

Precursor Substances

Answer 31

* Precursor substances behind counter: pseudoephedrine, ephedrine, phenylpropanolamine * Generally must be recorded in log * OR Electronic Pseudoephedrine tracking program-NPLEX-National Precursor Log Exchange * Patient Name, address, photo ID number, type of photo ID, date of birth, date and time of sale, drug name and strength, and number of packages and tablets sold * Purchasing only for those 18 yo and older (if needs to be logged) * Exception-Precursor substances sold b/c of prescription * Limits on Quantities Sold * No more than 3.6g total in a day and 9g total in a month

Question 32

Controlled Substance Scripts

Answer 32

* In addition to the normal requirement for prescriptions for legend drugs, controlled substance prescriptions must also include: * Patient Address * Provider Address * Provider’s DEA number * Special ordering forms or ordering process to order C-2 medications for wholesalers * Inventory * C-2s can be locked or interspersed * Special Inventory Counts required * Prescriptions for C-2s must be filed separately

Question 33

DEA Number

Answer 33

* Required for HC Providers that prescribe controlled substances * Contains 2 letters followed by 7 digits * Sum of 1st, 3rd, 5th plus 2(sum of 2nd, 4th, 6th)= Last digit of DEA number

Question 34

Controlled Substance Scripts: C2

Answer 34

* Written Order Required (no fax or electronic transmission) * Refills: none * Expiration: 6 months * Exception: fax allowed for LTC or hospice patient

Question 35

Controlled Substance Scripts: C-3 through C-5

Answer 35

* Phone, fax, computer generated, and electronically transmitted orders allowed * Refills: Up to 5 * Expiration: 6 months

Question 36

Tranferring

Answer 36

* C-2’s none * C-3 and C-4: one time

Question 37

Diversion

Answer 37

* Transfer of any controlled substance from a licit to an illicit channel of distribution or use * Must have a prescription * Possession pursuant to professional practice * Federal Offense=Felony * Unlawful to obtain a controlled substance by misrepresentation, fraud, forgery, deception