Basic Law Flashcards
Legal Definition of the Practice of Pharmacy
- 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
Pharmacy Assistant: Who
Registered with PQAC
Pharmacy Assistant: What
- Count and label individual prescriptions
- Return used bottles to the shelf
- Often responsible for cashiering in pharmacy
Pharmacy Assistant: May Not
- (Counsel)
- Pull a medication bottle from the shelf to fill a prescription
Pharmacy Technichian: Who
- 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
Pharmacy Technician: What
- 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
- Prepare IV medications
Pharmacy Technician: May Not
- 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
Pharmacy Intern: What
- “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”
Pharmacy Intern: May Not
- Supervise technicians
- (Checking IVs)-can check in the med in community
Pharmacist: Who
- 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
Drug Order/Prescription Must Include
- 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
Hard Copies of Prescriptions
- Printed (not cursive)
- Typed
- Tamper Resistant
- If patient doesn’t touch Rx, not need tamper proof prescription paper
Allowed Transmission
- Hardcopy (all)
- Phone, fax, and e-prescribing
Back Tag
- Sticker to put on back of prescription
- Rx numbed
- Date filled
Valid Prescription
- 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
What makes a valid prescription label
- 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
General Pharmacy Security
- 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
Entering Patient into Computer System
- 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
NDC Number
- 1st 5 digits for manufacturer
- 2nd 4 digits for medication strength/dosage form
- 3rd 3 digits for package size
Pharmacist Check
- Drug Utilization Review (initial check)
- Final prescription check
- Records must indicate pharmacist making final check (and initial check if different pharmacist than final)
Refills
- 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
Transferring Prescriptions
- 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
Patient Counseling
- 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
Controlled Substances
- 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
Schedule I
- Illicit
- Drugs w/ high potential for abuse, no accepted use, lack of safety
Schedule II
- 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)
Schedule III
- 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
Schedule IV
- 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)
Schedule V
- 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)
Labeling
- Manufacturer container must be clearly labeled with the control classification
- CII-CV
Precursor Substances
- 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
Controlled Substance Scripts
- 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
DEA Number
- 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
Controlled Substance Scripts: C2
- Written Order Required (no fax or electronic transmission)
- Refills: none
- Expiration: 6 months
- Exception: fax allowed for LTC or hospice patient
Controlled Substance Scripts: C-3 through C-5
- Phone, fax, computer generated, and electronically transmitted orders allowed
- Refills: Up to 5
- Expiration: 6 months
Tranferring
- C-2’s none
- C-3 and C-4: one time
Diversion
- 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