State Flashcards
Board members of commission (PQAC) (pharmacy quality assistance commission)
-15 total
-10 Rph
-1 pharm tech
-4 public members
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-Rphs licensed in WA x5 yrs consecutive and immediately preceding appointment
-public member not affiliated with pharmacy
-staggered appointments so max two expire per year
-members are WA residents
Is the board a separate entity or under another organization?
Part of Washington department of health
Who chairs the board
The commission elects a chairperson and vice chairperson from its members
How long do board members serve
-1-2 terms
-each term is 4 years
-max 2 terms
How often does the board convene
-as often as necessary
-about every 8 weeks
Who can attend board meetings
-open and public to all persons
-members of public, pharmacy profession, or other interested parties
Pharmacist licensure
New
-18+ y/o, good moral and professional character, pharmacy degree, meets intern hrs, pass naplex and mpje
-bachelors or PharmD degree
-1500 intern hrs
-$400 app fee
-$530 for renewal
Transfer/ reciprocity
-licensed in another state
-bachelor or PharmD degree
-1500 intern hrs
-$465 app fee
-score transfer w/i 1 yr of exp date or mpje for license transfer
Foreign grad
-same as “new” but also has FPGEC certification
-pharmacy degree not applicable (“academic training in pharmacy”)
-intern hrs not applicable
-FPGEE and TOEFL exams in addition to naplex and mpje
Transcript required for all of the above but no drug test or background check
Note: can get temporary practice license for 180 days if just waiting on fingerprints, submit written request (must be licensed in another state), one time extension of 180 days. Can’t be PIC
Note: pharmacy license must be posted for public view in your pharmacy
CEs
-30 hrs each renewal cycle
-one time training in suicide screening by end of first full cycle
-must be 3hr long
-from doh approved list
-info on imminent harm via lethal means
-can count towards CE reqs
-2 hours of health equity every 4 yrs (1 hr per renewal cycle)
Note: suicide training and health equity can count towards 30hr req
Note: health equity and suicide don’t have to be ACPE approved but must be approved by board
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-techs: 20 hrs per cycle and 1 hour in health equity per cycle
Reinstatement process for Rph license
-pay fees
-exp <3 years: 15 CE per yr expired
-exp 3+ years: if license in other state provide active license info and take mpje. If no other license then 300 intern hrs needed then pass exams
Rph license renewal period
-every 2 years on your bday
Pharmacy intern reqs
-license required
-enrolled or graduated in pharmacy degree program or graduate from foreign school with FPGEC cert
-$90 app fee and renewal
-1500 hrs to become Rph
-preceptor required
-renewal every 2 yrs on bday (max 3 renewals- 8 yrs total)
-can get 180 day temporary practice permit if licensed in another state (can extent once for 90 days)
Pharm tech reqs
-license required
-18+ and HS diploma or GED
-20 CE per renewal period (2 hrs law and 1 hr patient safety, 1 hr of health equity)
-$140 fee for license and renewal
-8hr of guided study in law
-4 hrs HIV/AIDS training
-pharmacy tech training program
-pass national exam within 1 year of competing program
-renew every 2 yrs on bday
-ID badge NOT required
-pharm techs and trainees can administer meds (usually vaccines) under an approved AUP
-tech in training must first register as pharm assistant and complete training program within 2 yrs
If foreign grad:
-525 supervised hrs
-TOEFL if english isn’t primary language
Military personnel, spouse, or domestic partner can get temporary practice permit
Who can be in the pharmacy areas
Limited to Rph UNLESS:
-intern or ancillary person under supervision of Rph
-temporary access to legit non-pharmacy person under supervision of Rph (this may cover Rph if not in immediate pharmacy?)
-facility has policy/procedure restricting access to licensed healthcare professional and access is w/i their scope
Pharmacy size req
-“properly equipped to ensure safe, clean, sanitary conditions for proper operation, safe prep of Rxs, and safeguard product integrity”
Pharmacy security req
-Equipped with adequate security to protect equipment , records, and supply of drug, devices and other restricted sale items
-no specific reqs on alarms
Storage of prescriptions?
-separate cII
-CIII-IV in separate file or with other non controlled as allowed under federal law
Federal law: same as above, CS can be with NC if stamped with red “C” in lower right hand corner at least 1 inch high (unless electronic)
Note: basically same rules apply for other entities CS records (manufacturers, distributors, importers/exporters, narc tx programs)
Storage of CS
-All CS must be stored in substantially constructed locked cabinet
(Federal law says you can disperse throughout non controlled stock- stick with state)
Pharmacy sign req for closure
Must inform pts no later than 30 calendar days prior to closure
Signage stating:
-last day pharmacy to be open
-last day they can request rx transfer
Must notify via:
-posting a closing notice sign in conspicuous place in public are of pharmacy
-informing pts during rx pick up or delivery and including a notice w/ Rx including their right to request transfer
-posting notice in at least one local newspaper including digital format
Timeframe: Board notification for change of pharmacy ownership
-Notify board and pay fees
-any change of ownership or location must be communicate to the commission immediately
-changes include proprietorship to corporation or change if more than 50% ownership within a corporation
-After change of ownership app and fees received, purchaser can begin operations before issuance of new pharmacy license only with buyer and seller have written power of attorney agreement (agreement specifies that violations during pending app process shall be sole responsibility of the seller
Timeframe: Board notification of changes to PIC (responsible manager)
Timeframe to appoint new PIC after vacancy
-within 10 business days, reported by incoming and outgoing manager in writing!
-designate a new one within 30 calendar days
-individual PIC must also report that they have been appointed and when appointment is termites within 10 business days
-if neither inform the board then that person is held responsible for the pharmacy’s operations
Timeframe: board notification for pharmacy closure (this is correct)
-No later than 30 days prior to closing
-provide documents within 15 days after closing:
-pharmacy license
-statements containing: confirm drugs transferred or destroyed (include transferee), info on CS, DEA forms returned, labels and blank Rxs destroyed, pharmacy signs/symbols removed
Time to notify board if changes to pharmacy hours
(“notify the commission with 30 days of any changes to info provided on the application”)
Pharmacy self inspection
-Responsible manager to do annual self inspection of pharmacy on self inspection worksheets provided by commission
-complete within a month of March each year AND within 30 days of hiring new responsible pharmacy manager
-also applicable to hospital pharmacies (must also complete Hospital Pharmacies addendum)
-maintain for 2 years
Equipment required for pharmacy
-“properly equipped to ensure safe, clean, sanitary conditions for proper operation, safe prep of Rxs, and safeguard product integrity”
After hours dispensing
-Yes, filled Rxs can be picked up or returned for delivery by authorized personnel after hours if they are placed in secure delivery area outside of the drug storage space
-this secure area must be equipped with alarm or comparable monitoring system
-normally drug stored outside pharmacy accessed by licensed staff but there are some exemptions for supply chain management (must be policy in place for this and for non-controls only)
Mail order laws
-any pharmacy located outside of the state that that sends rx into the state (except in person delivery to an individual) is a non-resident pharmacy and must be licensed with the DOH
Pharmacy ownership reqs
-Original and renewal fee: $540 (can NOT be prorated) and renewal
-owner doesn’t have to be Rph but must have “responsible pharmacy manager
-must complete app, pay fee
-Inspection by commission with either no deficiencies or approved plan of correction
-Obtains CS registration from commission and registers w/ DEA if intends on having CS
After Change in ownership of a pharmacy when can buyer begin business?
-After change of ownership app and fees received, purchaser can begin operations before issuance of new pharmacy license only with buyer and seller have written power of attorney agreement (agreement specifies that violations during pending app process shall be sole responsibility of the seller
Pharmacist to tech ratio
To be determined by the responsible pharmacy manager
Tech check tech
A tech may check unit dose med cassettes filled by another tech or intern, no more than 48hr supply
Medication cassettes
No more than 48hr supply of drugs included in pt med cassette and a licensed health professionals Al must check drug before administering it to pt
USP 825
Radiopharmaceuticals
Can legend drugs be dispensed without Rx?
-authorized practitioners can administer (including CS) directly to end user without Rx (not the same as “dispensing”
Drugs that must be kept behind counter (or in locked container)
-Any detectable quantity of ephedrine, pseudoephedrine, phenylpropanolamine or their salts, isomers or salts of isomers
Requirements to sell precursor products
-Verify purchasers identity
-Ensure they are 18+ y/o
Syringes
-legal for people to possess them for purpose of reducing bloodborne illness
-on the sale the retailer should satisfy themself that the purchase is for the legal use intended (purpose is stopped spread of blood born illnesses)
So YES needle exchanges are legal and pharmacies can sell needs to anyone over the age of 18
Retails are not required to sell syringes to anyone
Pseudoephedrine
Submit info to meth precursor tracking:
-date/time of purchase
-product description
-quantity sold (grams per box and #of boxes)
-purchaser name, DOB, address
-form of photo ID and ID #
-purchaser must be 18+ (Washington law, federal doesn’t specify age minimum)
-signature
-name or initials of person conducting transaction
-if tracking system unavailable must input info w/I 72 hrs of it becoming operational
-need to provide notice of penalties for falsified information.
Restrictions don’t apply to combo products in liquid, liquid cap, or gel cap, sold as Rx, sale by Chinese herbal practitioner, when recorded in pharmacy profile
-max 3.6 grams per day or 9 grams per 30 day period per customer
-max 7.5 g/ month if via mail
-possession: max 15 grams (WA law)
-must be sold in blister packs with max 2 doses per blister
Monitoring now replaced with NPlex
Can Rph give vaccine
-yes with immunization collaborative agreement, or under Washington protocol after getting certified
-flu, pneumococcal, hep A, hep B, tetanus and Td, DT, DTP, DTaP, Hib, measles, MMR, varicella, meningococcal, and travel vaccines and any other vaccines mutually agreed upon
-need certificate of immunization training and CPR card
-must screen for contraindication (if present contact MD or refer back to MD)
-Muse use “immunization patient informed consent form” to record necessary pt and vaccine info
-may provide immunization record to pts provider, if no provider then provide it upon request
-Need to have emergency kit with BP cuff, stethoscope, tourniquet, and 2 epipens
-illegal to give vaccine with >0.5 mcg/0.5 mL mercury (in thimerosol) to pregnant or child under 3 (for flu up to 1mcg
Can Rph administer medications
An Rph exercising prescriptive authority in their practice must have a valid collaborative drug therapy agreement (CDTA)
-pharmacist must be the one to sign their own name, not name of physician on CTDA)
Collaborative Drug Practice Agreement
-valid for 2 yrs
-statement identifying practitioner authorized to prescribe and name of each Rph
-statement of type of prescriptive authority (types of dxs, drugs), training required, procedures, decision criteria of plan Rph is to follow, a statement of activities the Rph must follow when exercising prescriptive authority
-can technically include “diagnosis” if included in protocol decision criteria and Rph not practicing medicine
-pharmacist must be the one to sign their own name, not name of physician on CTDA)
-protocol must be on file with pharmacy AND the commission
Can a pharmacist refuse to fill an Rx (BC or narcotics for example)
Rph must fill RX or has the duty to facilitate (refer out including contact other pharmacy and transfer it/ return Rx) unless:
-error, inadequency on Rx, contraindications
-US or state emergency effecting availability
-lack of expertise or equipment to safely produce, store, or dispense (e.g., nuclear medicine)
-potentially fraudulent Rx
-unavailability of drug or device
-note: not required to deliver drug without being paid for it
Conscientious objection ok for:
-abortion
-physician aid in dying
-anything contrary to religious or moral beliefs
-must be consistent in how you reject rx (cant fill for one person but not another)
-must make sense (can’t refuse plan B bc you don’t believe in abortion)
-pharmacy can NOT omit drugs from stock based on owners beliefs
Note: unless rx forgery is proven or rx prove invalid you must return the rx to the patient on request! (You can make a copy for the pharmacy records of refusal)
What to do when can’t fill Rx bc drug not available?
-contact MD for alternative
-return unless Rx to pt if requested
-transfer Rx to another pharmacy if requested (ONLY IF REQUESTED)
If Rph refuses to fill they may be sanctioned for unprofessional conduct including revocation or suspension of license
Religious objection
-unclear, maybe see federal
Rph appeal
-anyone whose been disciplined, license denied, or license granted with conditions has the right to appeal the decision
Long term care facility: who can order/dispense meds
Who can administer meds?
-licensed RN, RPh, or MD may act as practitioners agent can chart an order on behalf pending signature
-they can also send an Rx to pharmacy via phone, fax, or electronic
Administer: professions that may administer drugs including student RN
Long term care: Who can access dispensing units? And medications within pharmacy staff?
Licensed healthcare professionals acting within their scope of practice, and nursing students
Labeling requirements for “prepackaged meds, unit dose meds, meds or meds sent to long term care facility”
-drug name
-strength (federal law includes # dose units if >1)
-exp
-manufacturer
-lot
-identity if Rph or provider who prepackaged med if not maintained elsewhere
Very similar to federal with above minor exemption
Reusing drug
Pharmacy may repackage and dispense unused drugs returned by long term careor hospice in per-use blister packaging
Note: can’t accept returns of CS from LTCF (they are not DEA registrants and can’t transfer CS)
Long term care facility- storage of drug
-does not directly address CS
-if drugs stored outside the pharmacy must meet following:
-drugs are under control of and monitored by pharmacy
-pharmacy makes P/P to prevent/detect unauthorized access, document drugs used, returned and wasted and regular inventory done
-access limited to healthcare pros and student RNs
-equipped for security from diversion/tampering
-facility is able to possess and store drugs
Long term care facility: emergency dispensing
-Pharmacy or Rph may provide limited quantity of drug w/o RX (limited quantity to meet immediate needs)
-specifically for nursing home or hospice programs
-E-kits need to be locked in room or container
-may also have a supplemental dose kit for non-emergency drug therapy (only for nursing homes using unit dose systems) (these are also to be locked up)
-register RN or practical RN may restock e-kit or supplemental dose kit under supervision/direction of Rph
-meds limited to those required to meet immediate needs (meds determined by committee)
-administration pursuant to valid Rx or chart order (note: obtained without rx, administered pursuant to rx/order!)
Nuclear pharmacist reqs
-proof of training/experience in handling radioactive material
-receive letter of recognition from commission
-certified by specialty board whose recognized by NRC
-4000 hrs of training/experience (only 2000 hrs can be academic training) OR
-700 hrs in structured education program
Nuclear pharmacy reqs
- adequate space
-separate from non-nuclear pharmacy
-access secured
-may be exempt from general space reqs if obtained a waiver
-detail floor plans submitted to state radiation control agency
-designate healthcare professional to access area in absence of Rph in emergencies (may obtain radiopharmaceuticals)
-CAN have an Rx for office use (big exception to rule) must say “office use only”
Nuclear pharmacy labeling reqs
Immediate OUTTER container
standard labeling in addition to:
-radiation symbol
-“caution radioactive material”
-radionucleotide and chemical form (generic name)
-activity dispensed with units (millicuries or microcuries) at calibration date and time
-volume in mL if liquid
-calibration date and time for dose
-BUD and special storage/ handling
-specific concentration of radioactivity
-pt name and identifier, and number of dosage units dispensed, for all therapeutic and blood products
Immediate container
-radiation symbol
-“caution radioactive material”
-name of nuclear pharmacy
-prescription number
-radionucleotide and chemical form (generic)
-date
-activity dispensed with units (millicuries or microcuries) at calibration date and time
-pt name and identifier, for all therapeutic and blood products
Pharmacies w/o pharmacist on-site
-Visual surveillance of full pharmacy with high quality recording for at least 30 calendar days
-Access limited and monitored
-visual and audio communication for pt counseling (clear, secure, HIPAA compliant)
-manager monthly in person inspection
-Rph capable of being onsight within 3 hrs if emergency
-must close if malfunction in surveillance or video/audio system, until repaired or Rph is on sight
Telework
-complete telemedicine training
-training includes:
-current law, liability, informed consent,
-Q&A methodology to demonstrate accrual of knowledge
-may be done electronically over internet
Or complete an alternative training and sign and retain attestation of this
Non-resident pharmacy Rph licensure reqs
-pharmacy can get a non-resident pharmacy license if they identified a manager whose license is in good standing in the jurisdiction where they are located
-this is the only exception to an Rph needing a WA license if giving meds to WA residents
-needs to submit annual report to doh
-submit copy of inspection issued within last 2 yrs
-toll free # on all labels
-includes Canadian pharmacies
Central fill pharmacy
-P/Ps manual outlining offsite pharmacy services and responsibilities of each party
-parties share real time secure database and common electronic files
-system can audit activities of central fill Rph
-Fulfillment of an Rx by central fill pharmacy is not a transfer
-must be licensed as either resident or non-resident pharmacy
Direct to user dispensing
-practitioner authorized to prescribe or administer legend drug can dispense directly to ultimate user without Rx
-includes CS
-still need to label it
Drug samples
-Mfr can distribute samples only to people authorized to prescribe or at the request of that practitioner to pharmacies of hospitals or other health entities
-so hospital pharmacies can have if practitioner requested but community pharmacies can NOT
-need written request
-cannot charge for it
-otherwise possession, or dispensing/distribution of sample by pharmacy is prohibited
-technically community pharmacy can have samples if they are donated drugs
-samples must be labeled with pt name and MD name
-Rph with CTDA can request appropriate samples since they are a practitioner
-samples for “free clinics” must be: in unopened original packaging, inspected, stored properly, and notify FDA in 5 days if significant loss or theft of samples
Correctional facilities dispensing
-Washington dept of corrections pharmacy may accept for return and REUSE of non-controlled drugs in unit dose pack or full/partial multi dose med cards
Veterinary/animal dispensing rules
-humane societies and animal control agencies may purchase/possess/administer pentobarbital
-must submit application
-undergo initial inspection
-designate one person to maintain records and drug ordering/storage
-provide list of people authorized to administer
Fish and wildlife dept may also register for CS registration and will need to identify a responsible person for managing CS and identify names of people with access (same as above)
Note: Notify commission within 10 calendar days of change in responsible person
People authorized to use these drugs need to undergo commission approved training via a vet
For pre-euthanasia sedation;
-acetylpromazine
-dexmedetomidine
-medetomidine
-xylazine
Any drugs used marked “for vet use only”
Discrepancies in record keeping report to commission in 7 calendar days and dea if CS
Designated person do inventory every 12 months
For field use:
-secured in locked metal box attached vehicle (inventory at beginning and end of each shift)
-must be some type of officer
-drug inventory completed on monthly basis
-record uses in logbook
Emergency department discharge medication when pharmacy services unavailable (providing discharge meds when pt is released after hours)
-May have P/P for providing discharge meds to pts during hrs when community pharmacy not open
-must be labeled properly
-oral or electronic chart order to be verified by MD within 72 hours
-must be labeled
-delivery of single dose for immediate administration is not subject to this regulation
Hospital dispensing from ER
-practitioner may prescribe and dispense and RN may dispense prepackaged emergency meds to pt being discharge from ER if:
-no pharmacy within 15 min by road
-pt has no reasonable ability to reach local pharmacy
-when pt needs HIV PEP
-naloxone for pt at risk of overdose
-need P/P stating only 48hr supply max can be given unless pharmacy services not available within 48 hrs (in which case 96 hrs ok)
-must have pre-approved list of eligible meds, meds prepped by pharmacy, criteria for dispensing developed, stored properly, counseling conducted
Home dialysis dispensing
Medicare approved dialysis center May provide directly to pts the following if prescribed by MD:
-heparin 1000 u/mL vials
-potassium chloride 2meq/mL
-commercially available dialysate
-NS in containers not less than 150 mL
Must have agreement with Rph to provide consultation if necessary (consultant Rph)
Dialysis program must maintain records and develop quality assurance programs
Record keeping
-Pharmacy must use electronic record keeping
-if paper records is only option then the hardcopy original rx must be kept with a card/filing procedure that contains all data on new/refill Rxs, must be organized so it’s reviewed each time an Rx is filled
-hold CS Rxs for at least two years from date record was created or received (whichever is later)
How long do CS Rxs need to be kept?
-hold CS Rxs for at least two years from date record was created or received (whichever is later)
Who can request patient records?
-patient or pt representative
-must submit written request in person
-must provide photo ID
-representative must provide proof (judicial order, if parent then proof like birth certificate), POA document
Disclosure of healthcare Info without patients authorization
-ok for treatment, operations, or payment, or if required by law
-excludes info on sexually transmitted diseases
When can you disclose info about STI
-child <14
-state/local health officer or cdc
-health facility for blood products or artificial insemination
-court order
-person potentially infected with bodily fluid
-a bunch other, fill it in later
PDMP reporting
-dispenser must submit data electronically about dispensing of CS as soon as possible but no later than one business day
-if none dispensed that day, must submit that none were dispensed within 7 days
Manufacturer or wholesaler requirement for Reporting of suspicious transactions (includes PSE)
-Report within 5 business days
-suspicious means a reasonable person may believe it’s being used for unlawful purposes based on
-amount bought
-payment methods
-past dealings with party
-cash/money order >$200
-regulated product >10% of non-Rx drugs in the order
Report must have:
-name, address, # of party making report and of receipt er
-license # of wholesaler
-unified business # of recipient
-generic name and quantity
-date
-payment method
-lot and ndc
If no reports in a month, must report this within 15d of end of month
Can skip immediate due diligence investigation as above if:
-new customer AND emergent need AND above requirements completed in 60 days of sale
For submitting a report identifying a party as a diversions risk timeframe is 30 days of refusal or order, cessation, or identification by wholesaler
Theft/ loss of CS
DEA form 106
-send two copies to federal authorities
-send one copy to the commission
Reporting of adverse event (serious reportable event)
-Facility must submit to DOH
-Notification on date and type of event and other info within 48 hrs
-Report regarding event within 45 days
-Report facility but not specific providers or pts
-RCA must be done and included in report
Reporting on license violations
-Report to DOH
-report includes:
-name, address, # or reporter and person being reported on
-ID of any patient harmed
-Brief description
-court info if applicable
-must be reported within 30 calendar days after the reporter finds out
Breach notification rule
After HIPAA breach must report to individual patient!, also secretary, and in certain circumstances to the media
When must Rph review on pt profile prior to dispensing med?
(This is more like hospital dispensing or remote, not for retail)
DUR must be down for each Rx before dispensing and delivery except if emergent medical situation or if:
-subsequent dose from previously reviewed rx
-prescriber is in immediate vicinity and controlled drug dispensing process
-accessed on override and only quantity for immediate need is removed
-24 hr pharmacy services are not available and pharmacist will review all Rxs added to pts profile with 6 hrs of facility opening
Special reqs for checking PDMP
-not specified
-just says Rph, prescriber, or licensed healthcare pro may obtain PDMP info for pt care
Federal food drug and cosmetic act
Established the FDA
Durham-Humphrey act
OTC vs Rx
Kefauver Harris Amendment
Thalidomide (I think safety and efficacy but double check)
Poison prevention packaging act
Child resistant packaging
Health insurance portability and accountability act
Privacy of identifiable health info and security of electronic PHI
Health information Technology for economic and clinical health act
Electronic health record implementation
Adulterated
-Contains any added deleterious substances, has been stored improperly, or packaged in a way allowing for deterioration
-*differs from compendia standards
-not produced under GMP
-expired
Methods used or facility controls used for, it’s manufacture, processing, packing, or holding do not conform to or are not operated in conformity with wac xxx as to safety
Misbranded
Labeling is incomplete or misleading. Includes printed/written materials accompanying drug. Also includes promotional material, advertisements, or communications to pts or healthcare professionals.
E.g., otc drug repackaged without all required labeling reqs on original bottle
Package or label bearing statement which is false or misleading or product which is falsely branded as to the stare, territory or country in which its manufactured or produced
Class 1 recall
Probable that it causes serious harm or death
-Retailers notify consumers’ physicians
-if they can identify the lot then notify physicians of all pts who got the drug
-FDA will usually issue a warning to the general public
-in hospitals: pull med, notify prescribers and dispensers, identify and notify pts
Class 2 recall
Probably will cause temporary or reversible adverse health consequence
Class 3 recall
Not likely to cause adverse health consequences
Red book
Drug pricing
Orange book
Therapeutic equivalency
Yellow book
International travel vaccine s
Green book
Animal drug products
Animal equivalent to the orange book
Pink book
Vaccine preventable diseases
Purple book
Biologics
Requirements for valid rx
Pt name, MD name, date, drug name, strength, quantity, directions, refills, generic interchange instructions, MD signature, tamper resistant pad
CS needs pt address, MD address, dosage form, MD DEA number
Notice DOB is not required
What can Rph change on Rx
-Quantity if
-package size not available
-related to dosage form
-change is to give up to total amount authorized including refills
-extends maintenance med for limited time for coordinating pt refills for med synchronization
-dosage form when in the best interest of the patient
-complete missing info if there is evidence to support this
-Rph must document changes in pt record
Rph can change also make same changes to electronic Rx
Per federal law can never change pts name, prescribed drug, or MD signature
CS:
-add/change pt address
-add MD DEA #
-Must speak to MD to change/add: DF, strength, quantity, directions, interchange, DATE
-can NOT change pt or drug
What can non-Rph change on an Rx
Not allowed unless it’s an intern
Generic interchange
-every Rx must have instruction on whether or not interchange is ok
-two signature lines at bottom
-Right: dispense as written
-left: substitution permitted
-if Rx from another state Rph may interchange unless specified not to
-verbal: specify verbally and Rph write on rx (along with manufacturer or drug dispensed)
Note: WA rx is not valid unless written on two line rx pad
Note: Rph required to interchange to generic unless out of stock or pt requests brand product and rx is not being paid for by public funds
Note: 60% of savings from substituting must be passed on the the patient
Note: exemption is that you can interchange brand (even if D.A.W is indicated) for an “authorized generic” (completely identical under same NDA)
Public notice sign about generic interchange must be displayed in the pharmacy
Refilling rx without new rx
-Rph can renew x1 in 6 month period for non-controlled drugs if unable to reach MD
-Quantity the same if for 30 day supply whichever is less
-pt requests refill
-pt has chronic medical condition
-no changes to rx
-Rph communicates renewal to MD within one business day (informing MD not obtaining permission)
Tamper resistant pads
All RXs (controls and non-controls) must be on tamper resistant pad with following:
-1+ feature to prevent copying
-1+ feature to prevent erasure or modification
-1+ feature to prevent use if counterfeit rx forms
-commission seal of approval on form (recognizes that all 3 features are present) (mirror and pestle 1.125”x1.125” in lower right corner)
Notes these 3 features also required by CMS federally
Except if out of state
What can be faxed?
-CII if sent by the practitioner to pharmacy AND pt is long term care or hospice (fax must indicate this!)
-Injectable compounded CII if sent by practitioner
-CIII, CIV, CV
-fax for allowed c2 must be copy of written rx with wet signature, not a computer generated e-signed rx
-fax may serve as emergency authorization for c2
-fax may be reference for c2 which can be filled but must compare to original upon pt arrival
-LTC employee acting as MDs agent can submit a fax of exact image for C2
Federal law is same
How should CS be prescribed
Electronically unless
-vets, long term care/hospice e-system is down, outside state, Rph and MD employed by same entity, elements required that can’t be done electronically, compounded, non-pt specific for public health emergency, research protocol, would delay care, MD waiver
Note: Rph is NOT required to verify these exceptions when getting a verbal, faxed, or written Rx and may still fill it!
Federal law doesn’t care if it’s electronic or written and also allows for verbal for CIII-V
Electronic systems for medication. Records, prescriptions, chart orders, and CS, technology reqs
-no autopopulation of identification info
-record keeping system must have real time retrieval of info regarding ordering, processing, and verification of rx
-security to protect confidentiality
-safeguards from unauthorized access, or modification to rx info or pt medical record
-functionality to document alterations of rx after dispensed including ID of who made change
-auxiliary system when automated system is down, must input info within 2 working days once system is back up
Out of state Rx
-may be dispensed if written by MD, DO, DDS (dental), DPM (podiatrist), DMD, DVM (vet), ARNP, and PA
-includes any US territory or British Columbia
-no CS from British Columbia
-out of state Rx NOT acceptable for nurse anesthetists (CRNA), optometrist (OD), naturopaths (ND), midwives, Rph, physical therapist, occupational therapists, acupuncturist
Phone Rx reqs
Patient info
-name including middle initial
-DOB
-Phone number
Prescriber
-Name
-clinic or practice name
-DEA if appropriate
-name and role of caller if not prescriber
-phone number for c/b
Drug
-name, dose, strength, directions, route, quantity, refills, notation of purpose, if generic sub is ok
-Prescribers employee can call in rx
-interns can take call but techs CANNOT unless it’s a refill!
Transferring RX
Must be done within 3 business days of request (or in a timeframe that doesn’t adversely impact pt, whichever is first)
Non-controlled
-transfer as many times as desired
-enough info exchanged to maintain auditable trail and all elements of valid rx
-if real time shared database no need to transfer rx info
-must transfer via electronic or fax unless emergent situation.
Controls
-CIII-CV refills
-one time only! (Unless shared real time database)
-communicated b/w two pharmacists (or intern)
-techs can transfer Non-controls under supervision of Rph
-techs cannot do verbal or controlled transfer; therefore techs can only transfer via fax (or electronic) under RPH supervision
Note: You CAN transfer a new rx that hasn’t been filled including C2! Would need to enter it into the computer and indicate it hasn’t been filled
What elements must be on the label
Note: these requirements cover federal law so just go with this card for labeling
-name and address of pharmacy
-rx #
-name of prescriber
-directions
-name and strength of med
-pt name
-date
-exp date or BUD
-identification of Rph who filled if not recorded in pharmacy record system
-species if not human
Note: may use trade name instead for combo products
Note: at prescribers request name and strength of med need not be shown
Outpatient- also needs:
-quantity
-#refills
-“warning federal law prohibits transfer of this drug to any person other than the person whom it was prescribed” (legend including NC) (unless blinded), unless “veterinary use only”
-name of facility if applicable
-if compounded must be meet those reqs as well
Inpatient:
-drug name (generic or trade)
-strength
-exp date
-cautionary labeling
-manufacturer, lot, and Rph who packaged it: if not maintained on separate record
-if compounded must meet those reqs as well
OTC label requirements
7 point label:
-name
-name and address if manufacturer, packager, distributor
-net contents
-active ingredients and quantity of certain other ingredients
-name of any habit forming drug
-cautions and warnings
-directions for use
Also needs “DRUG FACTS”:
-active ingredient (including amounts)
-inactive ingredients
-uses
-purpose (basically drug class “antihistamine”)
-warnings
-directions
-other info
If any above info is missing it’s misbranded
Will generally also have:
-exp date, lot, name and address of manufacturer, net quantity, what to do if overdose
Child safety cap reqs
-all legends drugs to be dispensed in child safety caps unless authorization obtained by prescriber, patient, or or representative
-Pharmacy employee can NOT be pts representative!
See also poison prevention packaging act reqs
Prescription expiration dates
(I think this is for the actual medication)
-Washington doesn’t have 1 yr exp like many other states
-instead it just says consider:
-nature of drug
-manufacturer container packaged in and manufacturer exp date
-patients container
-expected conditions drug to be exposed to
-expected length of course of therapy
-any other relevant fxs
Federal law doesn’t either!
When must Rph counsel
-Pharmacist to offer to counsel on Initial fill of new drug or change of therapy
-when Rph judges it to be necessary
Does not apply to meds administered by health professional
See other notecard for more info
When can a pharmacy take back a dispensed drug
-General pharmacies may not accept returns after it’s left the pharmacy unless:
-non controlled legend drugs maintained under custody and control of facility (can be returned and reused)
-dispensed inconsistent with prescriber’s instructions (destroy)
-return is compliant w/ WA safe med return laws pertaining to drug take back programs
-intended for destruction in compliance w/ facility P/Ps
drug normally to be destroyed unless:
-non-controlled drug and has been maintained in custody/control of institutional facility, pharmacy, or similar and (may be reused if product integrity can be assessed)
-or if they are donated drugs
-or dept of corrections
————————————————
Unit dose packages may be returned from hospitals or LTCF if: intact pack, stored correctly, under control of trained facility, labeling intact, lots/exp not mixed up
Actually can NOT accept CS returns from LTCF since they are not registered w/DEA. Unless it’s just a return from ADD (still property of pharmacy), instead they must dispose of in collection receptacle
————————————————-
Dept of corrections pharmacy can accept returns of unit dose or full or partial mx dose med cards for reuse
Donations
-Any practitioner, pharmacist, facility, manufacturer, or wholesaler may donate drugs w/o expectation of compensation
-Donated drugs should be dispensed in manner than prioritizes uninsured patients first (including insured pt but drug is not covered)
-donations accepted if:
-original sealed container or opened but single unit doses intact
-expires in greater than 6 months
-Rph accepting inspects drugs
-if donated by pt needs time temperature indicator and donor form
-can NOt accept via drop box
-No charge made to pt!
-must submit a form to department informing them of your participant and notify them when termination of participation (accepting donations) within 30 calendar days (in writing)
-donations should be separated from rest of stock and have
separate inventory
-Do NOT need a wholesaler license when donating drugs
-Drugs must come with donation form
-need policy and procedure including dealing with recalls
CS registration.
-not just with DEA but must also register with the commission (all persons or firms intending to possess or use CS)
PMP reqs
-dispenser submit info within 1 business day of dispensing (as soon as readily available)
-if no CS dispensed that day, submit this fact within 7 days
Info to submit:
-pt identifier, pt name, dob, pt address, gender and species code
-drug dispensed, quantity, day supply, refill/partial refill info
-date
-prescriber NPI and DEA, phone #
-Rx issue date
-dispenser NPI and DEA, phone #
-Rx fill date and Rx number
-source of payment (private vs type of ins, workman comp, etc.)
-when practical name of person picking up and dropping off rx based on photo ID
Non-resident pharmacy only needs to submit for pts with WA zip code
Doesn’t apply if:
-immediate one day use
-hospitals
-prisons
-vets: report only q3-6 mo and if >14d supply (need owners name but not ID#)
Others that can have access to PMP info: law enforcement officials for bona fide investigations, medical examiners, drug test sites, DOH/DSHS/HCA/DOC employees, researchers
Is CVI a thing?
Nope
How long is CS Rx valid? Legend? OTC Rx?
CII-CV: 6 months
(Notice not 30d for c2 like in mass)
Legend: 1 year
OTC Rx: 1 year
Day supply restriction for opioids
-acute non-operative: max 7 days unless justifying documentation in or record (3 day should be enough)
-acute operative: max 14 days unless justifying documentation in or record (3 day should be enough)
-subacute (6-12 weeks): max 14 days unless justifying documentation in or record
Note: can always do more with justifying documentation
Note: prescribers must check PDMP
In chronic phase written agreement plans are required if not for end of life hospice pts
Providers must provide education in safe storage and disposal and advise and provide written info on risk of dependence and overdose
Note: pharmacist is not required to check PMP
Refills:
-Refill limitations for CS
-non-controls
Controls:
CII and methadone: no refills
CIII-CV: max 5 in 6 months
Non-controls:
-can specify either # of refills or specific date if can be refills through (refill as often as needed in appropriate quantity until that date)
-PRN refills ok- authorizes refills up to one year (Rxs expire in 1 yr)
-also refills can be authorized after rx is written as md request
General info:
-refill timing and quantity must be consistent with directions!
-contact MD if early refills requested (except ophthalmic for x1 early fill if >70% expected time, md listed exact refills on Rx, and this refill doesn’t exceed this #of specified fills)
Fill by dates for CII
May provide 90 day supply worth of Rx and add fill by date indicating earliest fill date
Post dating Rxs
All Rx for CS must be dated on the day they are signed and issued
Partial filling Rx
-controls?
-non-controls?
Controls?
Yes it’s fine
-can’t exceed total quantity prescribed
-must be requested by pt or prescriber
-for non-C2 must be recorded in same way as refills
-partial fills do NOT count as refills
Non-controls and non-controls:
-yes it’s fine, issue is with billing, should bill ins until full quantity is dispensed. Could get permission to mail remainder to pt. But illegal to reuse drug that has been sold but not picked up
______________________________________
C2
- OOS- remainder in 72 h or NOTIFY MD IF CANNOT; document quantity dispensed
- 72 H OF PARTIAL FILL DATE
- pt/MD request- remainder in 30d (no limit to amount of partial fills)
- 30 D OF ISSUED DATE
- LTCF w/ terminal illness- remainder in 60 d
- 60 D OF ISSUED DATE!
Verbal orders for CS
-CIII-V is ok (federal is same)
-CII only if “emergency”
-must received Rx within 7 day (or postmarked within 7 days if by mail)
-Rph must write in Rx that it was filled on emergency basis
-C3-5 can be telephoned by agent of prescriber
Federal law is the same
Continuity of care in governor issued emergency and meds no longer available due to emergency
-may give 7 day supply for CIII-V (NO C2!!!!)
-may give 30 day supply for legend
-pt to present rx bottle indicating refills or confirmation via chart review or based on judgement when accepting a provider reconciled med list
-if no refills or exp can give amount of last quantity given or 30 day supply (whichever is smaller)
Rph must:
-document Rx as emergency rx and note where they got above info from
-inform provider asap (notice not one business day like none emergency scenario)
Note: insurance not required by law to pay
When do conduct CS inventory
-every 2 years on anniversary of registration
-within 30 days of designating a responsible manager (conducted by incoming responsible manager or designee)
-on the effective date of a med becoming a CS (if they have that med on hand)
-initial inventory upon opening pharmacy
-upon change of ownership
Note: must do perpetual inventory if it’s a pharmacy without a Rph or without ancillary personnel on-site
Who is excerpt from DEA registration
-any official of US army, navy, marine, Air Force, coast guard, Public Health Service, bureau of prisons who is authorized to prescribe, administer, or dispense but not procure CS
If prescribing instead of DEA # write branch of service and service ID # (SSN for Public Health Service employee) and name and signature of officer
DEA forms for registering with DEA for
-retail pharmacy, hospital/clinic, practitioner, teaching institution, mid level practitioner
-manufacturer, distributor, researcher, canine handler, analytical lab, importer, exporter
-narcotic tx program
-domestic chemical
-224
-225
-363
-510
Renewal forms have the suffix “a” and are mailed by DEA 60 days before expiration, if not received writhing 45 days of exp they should request forms in writing
Must renew every 36 months (3 yr)
How to validate a DEA number
First letter
-A, B, F is full practitioner (so fab!)
-M is mid level practitioner
Second letter: first letter last name
Math
-add numbers 1, 3, 5
-add numbers 2, 4, 6 and mx by 2
-add sums from step 1 and 2 together
-7th number should match last digit of sun
Note: there can be hospital DEA number with internal code number suffix for interns, residents, MLPs- these DEA codes used only when prescribing for pts of that hospital
CS records to keep
Other than Rxs
-Records of receipt and distribution
-Invoices: date, supplier, quantity, drug
222 form rules
-one item per line
-note number of lines completed on form
-list name and address of supplier (only one can be listed), supplier fill in any info about them that purchaser doesn’t know
-purchaser keeps a copy and send original to supplier
-signed only by person authorized to sign DEA application or by someone with POA
-upon receipt document on copy the date and # of containers received
-must keep all DEA forms including unaccepted ones for 2 years and keep separate from other docs
-central storage of 222 forms NOT allowed
-3 part forms no longer supplied, must make photocopy of 1 part form and submit to supplier
CIII-V purchasing record reqs
Must keep receipt (invoice or packing slip which records
-drugs
-quantity
-name, address, registration # of purchaser
-# of containers sent to other persons
# of units disposed of
Must maintain these records separate from any other records or in a way that is readily retrievable from ordinary business records
Is there a standing order for naloxone
-Yes. And naloxone nasal spray is considered OTC in WA
-no need to show proof of need
-can be used to distribute naloxone at an organization w/o physician on site
-need to provide directions for use
-no minimum age requirement
-it’s for 4 mg dose NOT high dose (5 mg)
-emergency departments can also dispense upon discharge
Prescribing/m: who can prescribe
Who can not prescribe:
-psychologist, nurse, chiropractor, midwife, physician therapist
Who can prescribe:
-physician, dentist, optometrist, podiatrist, vet, NP, PA (as approved by medical commission and same authority as sponsoring MD), naturopathic doctor, Rph (collaborative practice)
Nurse Practitioner: ICD code or diagnosis must be listed on all Rx for opioids
Optometrist:
-only C2 is hydrocodone combos
-other controls max 7 day supply
-max 30 dose units for c3-c4
-must note purpose on rx
-no oral steroids
-no methadone
Naturopathic dr:
-CS limited to testosterone and codeine
-no Botox
-no C2 and no methadone
Methadone:
-only physician or psychiatrist can prescribe for reason other than pain
Unless otherwise noted above, listed providers can rx legend through c2 including methadone for pain
-no CS from British Columbia
-out of state Rx NOT acceptable for nurse anesthetists (CRNA), optometrist (OD), naturopaths (ND), midwives, Rph, physical therapist, occupational therapists, acupuncturist
Remember: must be within scope of practice!! For a legitimate medical purpose
Counseling
-The PHARMACIST shall offer to counsel on initial fill of an Rx for a **new **or change in therapy and when professional judgement determinesthat it is necessary
-On each refill Rph to determine if additional counseling of f/u is needed (so not just counseling on new ones!), this is RPh judgement
-technician asking: “do you have Q’s for the Rph?” Is not sufficient!
-applies to discharge meds from hospitals
-does not apply to meds being administered
-patients may refuse counseling!
-no need to document offer to counsel or pts refusal
-need process for counseling when pt is not in the pharmacy
-distribution of written materials is required
WA doesn’t define counsel but under Obra 90 the following are needed:
-med name and description
-DF, dose, route, duration
-directions for prep, administration, or use
-ADRs, interactions, CI
-self monitoring
-storage and refill
-missed dose
Self prescribing
May not self prescribe controlled substances
Strongly discouraged from prescribing CS to family members but it’s not prohibited
May NOT self dispense c2-4 , but you CAN dispense CS for family member and you CAN self dispense c5
What may tech or assistant not do? (I.e., what can Rph NOT delegate?)
All delegated tasks must be performed under IMMEDIATE supervision of Rph (can use technological means to supervise)- not the same as immediately available which just means they are on the same physical premise (technology can be used here too if not on same premise)
-verbal rx
-consult pt (they can do med hxs)
-consult md
-counsel pt
-extemporaneous compounding of an rx (bulk compounding ok w/formula)
-interpret data in medical record
-substitute biological or drug product
-decide NOT to dispense
-prescription adaptation
-ultimate responsibility
Note: techs can give vaccines..
What can an intern NOT do?
Supervise others
Pharmacy assistant duties
-prepackaging and labeling
-counting, pouring, and labeling
Can NOT retrieved med from shelf, but may return med to shelf
-no restrictions on age or education
-ID badge NOT required
Note: app fee and renewal for licensure is $70
Reporting of adverse employment actions
-If employee is terminated or restricted for unprofessional conduct or impairment employer must report within 20 days
-all licensees are mandatory reporters of unprofessional or criminal conduct of other licensees (must have FIRST HAND knowledge not rumors to be required to report)
-must report impairment (WRAPP ok if no pt harmed but if pt harmed report to DOH) (based on “reasonable belief they MAY be impaired”)
-self reporting is required
How long to hold Medicaid’s documents
6 years
Shadowing a pharmacist
-in education program
-up to 3 days
-sign confidentiality agreement
Can you be a responsible pharmacy manager (RPM) aka PIC for more than one location?
Yes
Absence of Rph
-Rph must have immediate direct access to pharmacy (on premises and maintains contact with pharmacy- can use technology for
Real time Communication if not on same premise)
-must be accessible for pt counseling
-if Rph is readily available but not within direct and immediate access, the pharmacy can continue dispensing and with non-discretionary actions that don’t require counseling
Rx drug price advertising
-pharmacy may advertise drug prices
-advertisement must be for informational purposes only and include brand and generic name as well as strength
-cannot advertise prices of controlled substances
-CS may not be physically displayed to the public
-don’t imply that you are selling the brand if it’s the generic that you are selling
-upon pt request you must disclose cost of a rx drug
Poison control number readily available?
Pharmacies are no longer required to have poison control number readily available
Commission pharmacy inspection
-regularly inspects or based on pt complaint
-commission provides written report within 10 business days
-pharmacy response with plan of action within 10 business days
-commission responds with if plan is adequate within 10 business days
Does pharmacy have to post an inspection certificate?
Do they have to post pharmacy license ?
(In public view)
-No
-yes
24 hr pharmacy services required in hospital
-if Rph not available 24hr, all orders must be reviewed within 6 hrs of opening
-if Rph not present after hrs a designated RN may enter pharmacy for drug (only one per shift)
How often must hospital pharmacy policies and procedures be updated?
Annually
Verbal orders in hospital
-only in emergency or unusual circumstances
-accepted only by MD, RN, or Rph
-48hr authentication by MD rule has been removed (refer to federal for this)
Points on extended care facilities (type of LTCF)
-must provide timely delivery of drug (own pharmacy or contract w/ outside)
-pts may choose own pharmacy
-pharmaceutical services committee (like P&T
-label reqs same as for LTCF
-OTC can stay in original bottle w/ pts name on it
-no returns unless NC and remain in custody of facility
-discontinued sealed unit legend and c3-5 can be sent back to pharmacy
-discontinued c2 destroyed within 30 days (2 witnesses rph/rn)
-can have e-kits same rules as “LTCF” (NOT used to provide starter doses!)
-supplemental dose kits (for starter doses or when dose changes)
Can an RN stock an automated drug dispensing device (ADDD)?
Can nursing student access ADDD?
-Yes
-Yes
Remote medication order processing
-pharmacies can have agreements to process for remote processing:
-receive, interpret, clarify orders
-data entry, transferring
-regimen review, interpret clinical data
-interventions and provide drug info
-doesn’t include dispensing
Shopkeepers and itinerant vendors
-Stores that want to sell OTC drugs that aren’t licensed as pharmacy, don’t have a pharmacy, or hours are different from pharmacy within must register as shopkeepers.
-door to door salesman register as itinerant vendors
-must sell in manufacturer original package
-PSE products may only be purchased from wholesaler or manufacturer, if they sell suspiciously they’ll be subject to the following: (wholesaler rules)
-sale DNE 10% total prior monthly sales of non-Rx drugs March-oct and DNE 20% nov-feb
What percentage of drug can a pharmacy transfer to another pharmacy or practitioner?
-dollar value shall not exceed 5% of revenue of total drug sale of either transferor or transferee during any consecutive 12 month period
-should be during shortage or emergency need, NOT routine!
-must be in ORIGINAL PACKAGING! No repackaging or it’s misbranding
-if bought at 340b price you can only sell to another 340b eligible otherwise you can only loan it with loan repaid with drug
Wholesaler PSE rules
-sale DNE 10% total prior monthly sales (March-oct) of non-Rx drugs
-sale DNE 20% total prior monthly sales (nov-feb) of non-Rx drugs
Can only sell to pharmacy, shopkeeper, itinerant vendor, practitioner authorized to prescribe that drug, or traditional Chinese herbal practitioner
Restricted OTC
-certain C5 (update with ch 5)
-PSE
-plan B and other are OTC but Ella and Ella one are Rx only
-dextromethorphan must be 18+ to buy (ID or must look 25+)
In Washington the following are Rx only:
-ephedrine containing products (bronkaid or primatene)
-unless it’s 25 mg or less and combined with other drugs OR if it’s ma Huang in natural form (also 25 mg max)
Caustic poison act
Misbranding if caustic poisons don’t have:
-substance name
-name and address of manufacturer
-24+ pt font “POISON” in contrasting colors
-directions for tx of injury
Must be labeled like this if retailed, not if sold to pharmacies, scientists, arts, etc.
Also: retailers must maintain a register and record sales of arsenic, cyanide, strychnine (need to verify photo ID and record info include reason for purchase)
CLIA waiver
For pharmacists and other health care professionals performing point of care based lab tests must obtain CLIA waiver
CLIA sets a bunch of rules for lab testing (point of care want to be exempt from these rules)
Exceptions to not selling mercury
-prescribed thermometer
-electronic thermometer with mercury battery
-thermometer used to calibrate other devices
-devices sold to hospitals or hospital controlled healthcare system
Transfer caution label
Federal law requires for CS but Washington requires for all legend drugs
Source with most current drug labeling
Dailymed
Patient information leaflets (PILs)
-Supplementary Info sheets supplied by pharmacies
-Washington requires written info to be supplied with Rxs delivered outside the confines of the pharmacy (I think this means mail order)
Prescriber dispensing
-must be labeled (can omit drug name and directions at their discretion)
-sample packages need to have name if prescriber and patient
-nurses and MAs cannot dispense on behalf of prescriber
-exception: RN employed by public health program can dispense meds for reproductive care and prevention/Tx of communicable dx pursuant to standing order
-prescribers cannot dispense FOR other prescribers
Rx issues from prescriber that died or lost their license
If no issues with the Rx it’s valid as long as it’s not expired
Prescriptions considered invalid
-prescriptions that have been sold to the pt
-most internet prescriptions (based on questionnaire; no examination of the pt)
Expedited partner therapy
Ok under WA law, must:
-not charge ins for partners med
-ask about partners conditions and allergies and advise they ask their Md before taking if so
-prepare separate container for partners med and label w/ partners name if know or pts name followed by “partner”
-separate rx number
Can you prescribe steroids for weight lifting
No
Growth hormone/ somatropins dispensing rules
-needs to be got approved condition: GH deficiency leading to short stature, Turner’s syndrome, idiopathic short stature, SHOX deficiency m, failure to catch up ht after small for gestational birth, GH deficiency or wasting syndrome w/ AIDS
Pharmacy’s have right to know indication before dispensing
Note this is an exception bc normally drugs can be allowed for off label
Use (just can’t be advertised for it)
Amygdaloid (Laetrile, vit b-17)
-WA allows intrastate production (must be tested for purity/potency)
-Allows for importation but NOT approved by FDA and interstate transportation is still illegal under federal law
Dispensing Rx for off label use
Pharmacists are allow but not required
Cursive prescriptions
Legally “illegible”- Rph liable if damages occur and he didn’t verify- so call to verify and indicate this on rx
“As directed”
-previously prohibited but not anymore , but Rph must ensure pt know how to use med
-avoid if possible and be more specific when able “use according to written sheet provided by MD”
What happens when Rx is faxed and says “void”?
-it’s invalid, need to get new rx or verbal
-if it says “copy/fax” that’s fine
When is therapeutic substitution allowed?
-if pharmacy received prior authorization to do so by physician or group of physicians (could be blanket or for individual pt)
-under CDTA
-via formulary substitution in hospital per established protocol
Can prescribers agent provide authorization for refills?
-No! Remember they can relay authorization for an Rx or refill but cannot independently authorize when Md is on vacation or something
Can you change rx with refills to a large quantity? (Ex 30d w 2 refills to 90d)
Yes for non-controls but this is NOT required
-pt should tolerate initial fill of 30 days first
-must notify prescriber
-can’t do it if prescriber says “no change to quantity” in writing or verbally
-insurance may not pay
-Use judgement and be safe
Can you use different tablet strengths to make a different dose?
Yes
If mx strengths use must indicate “to be taken w/ other strength”
Rx copy
You can make a copy of an rx must must stamp/notate it with “copy”
Packaging reqs (aside from child resistant caps)
-Tight sealed from air and water
-opaque
Can a Rph administer drugs
Yes, by any route (pursuant to an order)
Who can administer meds
-anyone who can prescribe them
-Rph
-pharm tech under Rph supervision with proper training and on acillarty utilization plan
-RN and LPNs
-Student RN
-RN tech (no chemo, blood, IV med, CS)
-RN assistant can give insulin
-medical assistants-
-certified: (no C2, no chemo, no experimental, no central line)
-registered: as determined by supervisor
-phlebotomist: no
-HD tech: when delegated by practitioner
-midwives (CPM): baby stuff
-occupational and physical therapist: drug used for Theo practice
-resp therapist: resp meds
Blah blah blah list goes on
Can you fill an Rx for epipen autoimjector for an “authorized entity”?
Yes
Who can deliver an rx to a pt?
Delivery of CS rules
-pharmacy employees
-common carriers
-couriers or taxicabs
-USPS
-not volunteers!
CS: must be delivered to ultimate user or member of their household! (Ex cannot deliver to relative at different address, or cannot send to pts MD)
Note: non-controls can be delivered wherever the pt wants
Can you sewer drugs in Washington?
No
Washington drug take back program (“safe medication return”)
-Operated by MED-Project
-for rx and otc drugs
-can NOT take back: C1, exposed sharps (med devices ok), vitamin/minerals/supplements,
non-OTC drug products
-pharmacy can become collection site but are not required to
-submit annual report by 7/1
Written hazardous drug control program
-written inventory of HD
-hazard assessment for each drug
-policies and procedures
-annual review and update
-consider input from employees
-adequate facilities (ventilated cabinets)
Usp 800 highlights that I don’t know as well
-environment sampling SHOULD be done q6 months
-personnel training annually
-review SOPs annually
-receive HD in neutral or negative pressure
-gloves worn for unpacking HD
-No antineoplastics in automated counting machines, but can be put in automated dispensing cabinets
-should use CSTD for compounding and must use for administration
-prime iv with non-HD
-sodium hypochlorite for deactivation
-detergent or peroxide (RTU) for cleaning
-70% isopropyl for disinfecting
Penalty for unlawful possession of CS
Misdemeanor
Unwitting possession is not a crime
4 reqs for valid CS Rx
- Issued to individual pt
- Authorized practitioner
- Due course of prescribers practice (bona fide MD-Pt relationship within scope of practice)
- In good faith for legitimate medical purpose
Physician aid in dying
-mentally competent
-18 yr+
-WA resident
-terminally ill (<6 months)
-written and oral request followed by a second oral request 7 days later (at this time MD gives pt chance to rescind request)
-written request witnessed by 2 ppl (one must not be related, inheriting anything, or employed by institution giving care)
-48 hrs after second request can give rx (IDK if this is still a thing)
-Rph send copy of dispensing record to doh within 30 days
-changed from MD to “qualified medical provider (MD, PA, NP)
-Rx can be electronic
-Rph can dispense to person designated by pt
Prohibited used of CS
-can’t use steroids or GH for wt lifting
-can’t use stimulants for wt control (includes phenmetrazine)
-sodium oxybate- must put indication on rx (cataplexy or daytime sleepiness in pts >7 w/ narcolepsy
-limited indications for stimulants (Rph is entitled to know): narcolepsy, hyperkinesia (adhd), drug induced brain dysfunction m, epilepsy, differential diagnostic psych eval or depression, refractory depression, MS, binge eating d/o
-optometrist must include “notation of purpose” on rx
-nurse practitioner must put diagnosis or ICD code on opioid Rxs
How long should computer records be kept on file for C3 and C4?
24 months after last possible refills (so 2.5 years worth of data on refillable prescriptions)
Pain management consultation
Mandatory if 120+ MME/ day
Unless:
-pt following taper sch
-temporary escalation for acute pain
-pain and function stable with non-escalating dosage
-if prescriber is exempt bc
-they are pain specialist
-12 CME in chronic pain and OUD within last 4 yrs
-3+ yrs exp in chronic pain and 30% of current practice is direct supervision of pain management care
CS in hospitals
-perpetual inventory for C2 in pharmacy area
-records of drugs dispensed to other units
-records of administration of drug
-wastage must be witnessed by 2 ppl
-policies for destruction made and sent to DEA and commission: renders drug unrecoverable, done by by Rph one other, quarterly summary send to DEA and commission, ecology rules
-multi dose vials for CS discouraged
-CS records kept for 2 yrs
LTCF md “agent”
Can’t call them prescriber “agent” if not directly employed by MD, so would need a formal agent agreement in order to do things on their behalf
Can be revoked at any time
Should send copy to pharmacies that will received Rxs
Nurse or pharmacist at the facility may serve as an agent WITHOUT a formal agreement!
NPlex
-National precursor log exchange
-Replaced log book for PSE (small retailers may request exemption, max 180 days and can request additional exemptions 30 d before exp. Must show reason and anticipated duration.)
-enter ID#
-drop down menu for product sold
-tells if sale is compliant or recommends denial
-has safety override function (must immediately call law enforcement when able)
Random rules about OUD
-Insurance plans must offer at least one med for OUD w/o need for PA
-pregnant women must be educated about risk v benefit of the med to the baby
-new pharmacy credential to allow remote dispensing sites for OUD meds
Washington recovery assistance program for pharmacy (WRAPP)
-recovery program for substance abuse
-can be self referred, involuntary referral, or referred by commission
-commission doesn’t have to be alerted if you’re compliant
-may be instead of discipline if referred by commission
-licensees are required to report on other licensees for suspected impairment (may report to commission or WRAPP
Note: failure to comply with substance use program reqs- program must report to
Commission within 7 calendar days! Individual must also report on themselves within 7 calendar days (even if program already reported on them!)
Basic requirements for or information collection, use, quality assurance, and confidentiality (under both federal and state law)
-maintain or records (electronic)
-conduct prospective DUR
-act on DUR findings
-provide info to pts needed for appropriate use of meds
-assure confidentiality
-engage in quality improvement activists
How long to maintain patient records
2 years
Timeframe for response to pr request for access or corrections to their records
Charges?
Access, initial response:
-15 days
-one time extension of 6 days (21d total)
Corrections:
-10 days
-one time extension of 11 days (21d total)
Note: these WA timelines are stricter than HIPAA so use these instead of HIPAA!
Charges:
-max $1.24/page x first 30 pgs then max $0.94/pg beyond 30 pgs
-max $28 clerical fee
-can charge for basic office visit if personally changing the records
WA HIPAA things
-WA more strict than HIPAA in following ways
-Limits to respond to pt requests
-consent by minors
-consent by pts w/ STDs of HIV
-no reports to military w/o consent
-Abuse of vulnerable child or adult MUST be reported
-disclosures to caregivers or healthcare providers that’s previously Tx pts is NOT allowed w/o prior consent
-Rph obtain from each pt names of individuals to whom oral or written disclosures are permitted and record this in pts record
-can disclose for law enforcement but not simply a police officers request (need court order or something or if identifying suspect, fugitive, witness, missing person)
NOTE: civil subpoena is NOT the same as a court order, will required pt consent!
-state registered domestic partners have same rights as spouses or family member (one must be 62+, otherwise marriage is only option)
Minors
generally guardian makes healthcare decision unless minor is:
-married to non-minor
-emancipated
-14+ with an STD
-any age seeking contraception or pregnancy termination
-13+ seeking behavioral health for mental d/o or substance use D/o
-“Mature minor” (judgement) can consent to non-emergency procedures
-minor controls disclosure of PHI for things in which they have consented!!! (Disclosure for other this controlled by guardian)
-insurers and pharmacies must not disclose info about “sensitive conditions” (gender, sex, SUD, violence, mental health) to plan enrollee, only to pt themself
-WA protects healthcare providers from issues with divorced parents
-relatives can consent for minors if parents not available
-minors may give consent in Washington
WA law opioid refusal informing
Prescribers must inform pts their right to refuse and opioid Rx or order
Duty to warn (of dangers associated with prescription)
Falls on prescriber not the pharmacist
Assisted living facility medication assistance by non-practitioner
-Updated rule saying non-practitioners can help meds (basically administering meds)
-can not be IV (can hand insulin syringe to pt)
-can help with “self-administration” if pt can’t do it themselves
-pt must be cognitively aware
Closure of manufacturing or wholesaling facility
-must report to customer and commission no later than 30 calendar days before closure
-by 15 days after closing: return license, confirm all drugs transferred appropriately, provide inventory, give info on transferee of drugs, confirm dea reg and 222s returned, signs removed
Accessible prescription Information
-must provide info for pts with limited English proficiency (LEP) and translation service (post sign about right to translation in 10 most common languages)
-must also provide accommodations for visually impaired people
Compounding semaglutide
-it’s okay when it’s in shortage! Bc you can compound a commercially available product when it’s on shortage or unavailable
-must not use salt for as it’s not FDA approved
Remote dispensing sites for OUD meds, where technology is used to dispense medications
-a pharmacy can extend its license to register a remote dispensing site for OUD tx
-each site must be separately registered with the commission
-pharmacy to control and monitor meds, maintain security, document returns and waste, keep perpetual inventory, ensure only supplying pharmacy is stocking meds there
Max amount a healthcare entity can dispense to a pt
-72 hr supply UNLESS dispensed by Rph
-no exception made for inhalers birth control packs, etc.
Is mifepristone legal?
Yes
Retired active pharmacist license
-Allows retired Rph to practice on and intermittent or emergent basis
-can work max 90 days per year
-need to do CEs
-renew every 2 yrs
Pharmacy owned lockers
-for Rx pick up of filled Rxs
-ok for non-controls
-don’t need to be separately register if within pharmacy space
Reports of precursor receipt
Any manufacturer, wholesaler, or retailer who receives precursor drugs from outside Washington must submit report of such to commission within 14 days
May request to do monthly reports if regularly done
Acceptable forms of ID for PSE
-driver license or permit (if expired must show temporary license with exp card)
-US armed forces ID
-merchant marine card
-ID issued by foreign federal or state gov
-US passport or foreign passport with I-551 stamp
-Enrollment card for federally recognized Indian tribe in WA state
Needs: name, photo, DOB, signature, and physical description. Notice it doesn’t specify need for address!
HPAC
Hospital pharmacy associated clinics
-category 1: no sterile or non-sterile compounding
-category 2: does sterile or non-sterile compounding
If using CS need separate DEA registration (can’t use hospitals)
Some state wholesaler intricacies
-wholesalers outside of WA must get WA license as well as copy of inspection by resident state or third party within last 2 yrs (renew every 2 yrs too), copy of resident and other state licenses
-if wholesaler sellling drugs to another country need letters from countries consulate saying recipient is authorized to get drug
-each location must be registered if operations occur at more than one location
-facilities must have quarantine location for bad drug
-adequate lighting outside
-must be equipped with alarm system (notice unlike pharmacies where it’s only specified for secure location outside of pharmacy for after hours)
-separate storage for CS and non-controls
-maintain records for: source of drugs, identify and quantity, dates or receipt and distribution
-wholesalers do NOT need to be licensed pharmacists
Sexual misconduct points
-Can not discuss the possibility of dating etc after professional relationship ends, or ending the professional relationship so you can date
-no sexual contact for a period of 2 yrs after professional relationship ends
-emergency situations can be exemption
-can Tx if the relationship is pre-existing and no e/o potential for exploiting the pt
Ancillary utilization plan
Must submit plan AUP to commission and maintain a copy in pharmacy outlining how ancillary personnel can be utilized
When does Washington state CS registration and pharmacy license expire? (Including hospital pharmacies)
When do healthcare entity credentials expire?
Every year in June first
Healthcare entity: October 1st each year
Timeframe for commission action against licensees
-license revocations, fines, and things like that go into effect 28 days after written notice is given (could be later or sooner if commission thinks you’re a threat to the public)
-can issue “stop service” and issue must be corrected within 24 hrs or the stop service is issued and then commission must inspect within 5 business days so you can fix issue and resume
-if “effective immediately” action is taken (bc commission thinks you’re a threat) you are entitled to a show cause hearing within 14 days of making the request (must request hearing within 28 days of receipt of notice), must show immediate jeopardy for the immediate suspension, if so full hearing must be done within 90 days of request
Cost reporting to prescribers
-must have process for reporting cost of Rxs prescribed by individual prescribers on quarterly basis
-idea is to increase awareness of healthcare costs to prescribers don’t prescriber unnecessary things
WA out of country purchasing of drugs
-maybe disregard, I don’t think that this waiver was ever approved, just requested
-waiver to license and purchase from Canadian, Irish, United Kingdom, and other non-domestic wholesalers
-for cost savings
-can’t be temperature sensitive drugs
-must be for consumers without insurance coverage (they need the price relief the most)
Provision of drugs to ambulance or aid services
-Hospital operated pharmacy can do this
-hospital located in same or adjacent county
-Medical program director requested based on agreed upon protocol
-drugs must be relevant to ambulance practice
-Provision of drugs is not contingent on ambulance taking pts to that hospital
Can a pharmacy outsource shared pharmacy services to another pharmacy for orders/Rxs from a LTCF or hospice?
-Yes if they get permission from LTCF or hospice to do so
-Note that if doing this to provide the first dose or a partial fill to meet pts immediate needs, you do NOT need to transfer the prescription
