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 (can get 180d extension-longer than for interns) 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
Actually do need criminal background check!
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
-Must be done in first renewal cycle even if you just graduated
-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. For national certification: 2 hr law, 1hr pr safety
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 (law and pt safety is for national certification)
-1 hr of health equity
-$140 fee for license and renewal
-8hr of guided study in law overseen by Rph (out of state per fassetts, WAC just says for everyone so go with that)
-4 hrs HIV/AIDS training- no longer required by WA
-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
Technically techs could work remotely to do data entry (if they are under immediate supervision of Rph via real time technology)
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)
-if Rx sent electronically, record and any annotations must be kept electronically (computers can be at another l location but records must be readily retrievable at DEA registered location)
-electronic records sortable by pt name, MD name, drug, date
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 (legend and CS) transferred or destroyed (include transferee), info on CS, DEA forms returned, labels and blank Rxs destroyed, pharmacy signs/symbols removed
send name and address of who will have you records! And name and address of who will get your drugs!
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 (could double dip if new manager hired in feb-April)
-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
For change of ownership you are applying for a whole new license
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 and put in AUP
If not in AUP then would go with statutory regulations
-retail: 1:1
-hospital: 1:3
Tech check tech
A tech may check unit dose med cassettes filled by another tech or intern, no more than 48hr supply
-this can include stocking and ADDD but again only for 48hr supply
Hospital only!!!
UNIT DOSE ONLY!
Techs must show 99% accuracy
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 (State)
Submit info to meth precursor tracking:
-date/timeof purchase
-product description
-quantity sold (grams per box and #of boxes)
-purchaser name, DOB, address
-form of photo ID and ID # (UNLIKE PMP)
-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-MONO PRODUCTS IN THESE CATEGORIES DONT APPEAR TO BE EXCEMPT!, sold as Rx, sale by Chinese herbal practitioner, when recorded in pharmacy profile (seems that age requirement is not applicable here). Notice state law doesn’t specifically exempt single doses of 60 mg
-max 3.6 grams per day or 9 grams per 30 day period per customer
-max 7.5 g/ month if via mail (federal law)
-possession: max 15 grams (WA law)
-must be sold in blister packs with max 2 doses per blister (federal law)
Monitoring now replaced with NPlex
Must have technology to alert saler of violation or post a sign notifying customers of rules
Don’t forget pharmacy must annually self certify with DEA (attorney general) but registration is not required for SLCPs! (Includes training employees, and following above rules)
Note: retailer could request 180 exemption from electronic reporting use logbook if significant hardship
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
Note: vaccines can be give at a patients home!
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 (CDTA)
-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)- even if original was written by MD and they are making a change or authorizing refills
-protocol must be on file with pharmacy AND the commission
-commission doesn’t approve/deny these! Just b/w Rph and provider. They do check for all elements and file it.
-To delegate must have INDEPENDENT prescribing authority! (PAs cannot be the practitioner on this! NP can!)
-NOTE: if you are prescribing controls you will need your OWN DEA license!
-Rph can NOT prescribe medical devices (but can administer them)
-should decline to dose a poorly prescribed drug! Otherwise you are saying it’s ok to use that drug by agreeing to dose it
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)
If you refuse to fill or destroy a lawful Rx, the pharmacy AND pharmacist get in trouble
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
Note: in lecture she says labels for LTCF need schedule of drug on it, and no child resistant caps, no sig
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 (Including CS) 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 locked 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) Unit dose only!! (unlike e-kits)
-register RN or practical RN (LPN) may restock e-kit or supplemental dose kit under supervision/direction of Rph
-CNA can’t get stuff from e-kit must be licensed RN
-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 and dispense radiopharmaceuticals exclusively
-detail floor plans submitted to state radiation control agency and commission
-designate healthcare professional to access area in absence of Rph in emergencies (may obtain radiopharmaceuticals)
-non-radiopharmaceuticals must be SEPARATE from radiopharmaceutical
-CAN have an Rx for office use (big exception to rule) must say “office use only”
-must have laws and regulations
-may redistribute radiopharmaceuticals
-must submit list of equipment to commission
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
-perpetual inventory
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
-NPs may dispense up to 72hr supply of CS
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 (part of drug donation program)
-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
-recipient to give manufacturer a receipt
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 or possess drugs
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:
Animal and humane: complete training and approved by designated person
Fish and wildlife; complete training, are approved by fish and wildlife, and are biologist, vet, or wildlife officer
Note: 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
-destroy with witness unfit non-controls, and destroyed or return unwanted CS
-drug at location is stored in a locked drawer or cabinet
For field use:
-secured in locked metal box attached vehicle (inventory at beginning and end of each shift)
-must be some type of officer (humane, animal, peace) or animal control authority, sherif, county commissioner
-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
These are for pre-approved emergency medications (Distinct from after hours dispensing from ERs for Discharge meds)
-practitioner may prescribe and dispense and RN may Distribute prepackaged emergency meds to pt being discharge from ER if ANY OF THE FOLLOWING APPLY:
-no pharmacy within 15 MILES by road
-pt has no reasonable ability to reach local pharmacy (even if within 15 miles, maybe disabled or don’t have a car)
-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
IN CASES OR FULL SHELF PACKAGES! Otherwise it’s repackaging to remove single vials!
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
-everything else they must get from pharmacy
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
-Insurance claims
-child placing agency
-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 “regulated products” (precursor drugs) including PSE) and controlled substances
-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 (questionnaire, arcos, etc.) if:
-new customer AND emergent need AND due diligence 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
Note: Since the SUPPORT ACT, now ALL DEA registrants that distribute CS must report suspicious orders (via SORS)
Theft/ loss of CS
DEA form 106
-send two copies to federal authorities
-send one copy to the commission
Keep copy of 106 for 2 yrs
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)
And LTCF?
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
For LTCF all the same EXCEPT if med is given in emergency or without review RPh has 24 hours to review not 6
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 (USP) standards in STRENGTH, quality, or purity
-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
-Can’t advertise that you compound drug for certain dx state
-can’t repackage larger bottle into smaller w/o repackaged license
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 (can be PO Box, unlike PMP), 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
Note: for changing a date must speak directly with MD not and agent if it’s a CS
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 (Not true for biologic interchange)
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
Note: -must interchange biologics also unless requested otherwise by pt or cost of interchangeable isn’t less that reference
Refilling rx without new rx
-Rph can renew x1 in 6 month period for non-controlled drugs if unable to reach MD (FOR THAT PARTICULAR MED)
-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
Exceptions?
REQUIRED FOR ALL MEDICAID AS WELL AS:
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
If not on tamper resistant pad, you can fill call MD and change to verbal rx! If EMERGENCY and you cant get ahold of them you can dispense and validate within 72 hours!!
Other Exceptions:
-Rx for pt in hospital, LTCF, hospice, jail/prison and it goes directly to pharmacy and isn’t handled by the patient
What can be faxed?
-CII and pt is long term care or hospice (fax must indicate this hospice!) -(agent can send)
-SENT BY PRACTITIONER for 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 (I think faxed electronically sign for non-c2 is ok?)-No I think wet signature needed for all CS faxes per DEA
-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
-LTCF employee acting as MDs agent can submit a fax of exact image for C2
-retail can FAX c2 to central fill pharmacy
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/user 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
-need third park audit and certification
Note: HPACs and HCE are allowed to have paper records!
Note: commission does not approve these systems (licensees are responsible)
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 (technically they could if they have a US office and US DEA #)
-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 NON-CONTROLS 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 on hold rx that hasn’t been filled including C2! Would need to enter it into the computer and indicate it hasn’t been filled.- Yes this is true, would need a new Rx number
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 (or name of facility if “patient” is a facility)
-date
-exp date or BUD (should be the Rph determined exp, not when Rx exp, pts get confused)
-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
Note: if abortion drug may say prescribing and dispensing healthcare facility name instead of MD name
-“side effects statement” must be someone in the labeling or on label (FDA phone #)
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 animal then “veterinary use only”
-name of facility if applicable
-if compounded must be meet those reqs as well
Inpatient: (law just says name and strength)
-drug name (generic or trade)
-strength
-exp date (if unit dose)
-manufacturer, lot, and Rph who packaged it: if not maintained on separate record
-if compounded must meet those reqs as well
If filled at a central fill pharmacy the label must indicated retail pharmacy name and address and a unique identifier for the central fill pharmacy in
Braile, large print, and talking devices etc. are best practice standards developed but are not legal requirements for Rx labels.- EFFECTIVE JAN 2027
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!
Note: this is exp for last day you can fill entire Rx!! If rx expires tmw you can still fill the full 30 day supply!!
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 returned from ltcf or hospice
————————————————
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 (I think doesn’t meet temp indicator if signed attestation if proper storage)
-can NOt accept via drop box
-No charge made to pt! (including no dispensing fee)
-submit an attestation fir for participating
-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
-donator shall alert pharmacy of recall if they are aware of one
-for drugs requiring pt be registered with manufacturer, this rule will still apply
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 (like MRN), 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
-Notice NOT required to record the ID number
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 pet name/species, 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, individual pt, medicaid/insurance, health profession licensing agency, healthcare facility/entity
Quarterly report sent to providers for QA feedback
ADDRESS can NOT be PO Box (unlike for an address on an Rx)
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 (one prescriber and one pharmacy)
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; all need the original written date as well
Note: there is no day supply limit on a single Rx for a c2!!!
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 Rph must have it ready in 72hrs but pt may p/u after 72hrs!
- pt/MD request- remainder in 30d (no limit to amount of partial fills)
- 30 D OF ISSUED DATE
- LTCF OR terminal illness- remainder in 60 d
- 60 D OF ISSUED DATE!
-RPH Must note on Rx if pt is LTCF or terminally ill
- 60 D OF ISSUED DATE!
If cannot pay and requests I would say use 30 day rule, in fassets it says 72 hr but cites something from 2001 and in dea manual in never specifies this..
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 (sells bulk PSE for example)
-224
-225
-363
-510
Renewal forms have the suffix “a” and are no longer mailed by DEA 60 days before expiration, electronic notification sent 60, 45, 30, 15, and 5 days before exp (make sure email is up to date)
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
-hospital keep list of codes available for law enforcement and pharmacies
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
–*now make paper or electronic copy for yourself and send original to supplier. Supplier keeps original and send report to DEA via ARCOS or send a copy of 222 to DEA by end of month (or end of month in which final shipment made of partial or 60 day validity period ends)
CIII-V purchasing record reqs
Must keep receipt (invoice or packing slip which records the date and confirms order is accurate including:
-drugs and strength
-quantity
-name, address, registration # of purchaser
-# of containers sent to other persons and # 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)
-PAs do not have independent prescribing authority
-NPs do!
Rph: Canadian non controls are ok
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
-BZD single dose per Rx
-no oral drugs within 90d of ophthalmic surgery unless ophthalmologist consulted
-must note purpose on rx
-no oral steroids
-no methadone
Naturopathic dr:
-generally naturopathic or homeopathic drugs
-products of natural origins!
-CS limited to testosterone and codeine must be c3 or lower
-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
Notice out of state is ok for NP and PA
-just need to be licensed in their home state not WA
Remember: must be within scope of practice!! For a legitimate medical purpose (podiatrist must be for feet and ankles, dentist must be for head and neck)
-Rph is only one that could prescribe for both humans and animals! (Could get CDTA through a vet)
-Rph cannot prescriber off label uses in CDTA (off label can’t be delegated under CDTA)
CRNA c2-4 for anesthesia purposes according to facility protocol (no out of state)
licensed midwife:can prescribe within scope of practice if they meet license extension. *No controlled substances, and no out of state, MUST CONTAIN NOTATION OF PURPOSE
Counseling
-The PHARMACIST!!!!!!!!!!!!!!!!!!!(NOT TECHNICIAN!) 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 says Rph tailor counseling to the specific needs of pt and 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, can self prescribe non-controls
Strongly discouraged from prescribing CS or non-controls 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 (this includes pharmacists)
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 (unless just refill authorization)
-consult pt (they can do med hxs)
-consult md (clinical convo)
-counsel pt (clinical convo)
-extemporaneous compounding of an rx (bulk compounding ok w/formula)- NOT TRUE!!!
-interpret data in medical record
-substitute biological or drug product (tech can type it in but through verification Rph is the one doing product selection..)
-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
Can’t type in an Rx or change or record
Can NOT stock ADDs
-no restrictions on age or education
-ID badge NOT required
Note: app fee and renewal for licensure is $70
Must inform DOH if change of license address within 30 days
No limit to assistants as long as they are approved for use in AUP
Reporting of adverse employment actions
-If employee is terminated or restricted for unprofessional conduct or impairment employer must report within 20 days
-all licensees (includes techs, assistants, and interns) 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
Can request one time extension
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)- these are SNFs
-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 and or access automated drug dispensing device (ADDD)?
Can nursing student?
-Nurse can STOCK and RETRIEVE
-Nursing student can only retrieved!
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
-just need both to have signed agreement on this
This could be done from home or if you’re at another store and all caught up, you can jump in and help out
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
-Notice this is higher allowance than wholesalers
What percentage of drug can a pharmacy transfer to another pharmacy or practitioner?
-dollar value for prescription drug sales 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 5% total prior monthly sales (March-oct) of non-Rx drugs
-sale DNE 10% total prior monthly sales (nov-feb) of non-Rx drugs
Lower allowance than shopkeepers and itinerant vendors who’ve been restricted
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+) (unless in military or emancipated) (no need to lock it up or keep records!!)
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 including date and hour of sale, name and address, kind and quantity of poison, reason for purchase), both seller and purchaser sign the registry
-if sold outside of sellers premises, need letter of authorization
-preserve registry for 2 years
-need license to sell poisons (unless pharmacy selling an rx for a poison)
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 due to discipline
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
Rx should be reviewed and approved with 7 days!
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)- cost borne by manufacturer and wholesaler
-Allows for importation but NOT approved by FDA and interstate transportation is still illegal under federal law, I think it’s ok to produce it in WA but Iwouldn’t import it
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”
You can also change 10 mg 1/2 tab to 5 mg 1 tab
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
No CRC in LTCF
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
Notice PT and OT can order and administer certain things but can’t prescribe in WA
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 (must at least be a pharmacy assistant)
-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, herbals, homeopathic, cosmetics, emptied injector products, pet pesticides
-pharmacy can become collection site but are not required to
-submit annual report by 7/1
Other info
-covered manufacturer in or “into” WA (one that makes applicable drugs to the program) MUST participate in a take back program at all times
-retail pharmacies and wholesalers must provide list of covered manufacturers
-primary method must be physical collection site (must include a retail pharmacy, hospital or clinic with onsite pharmacy, or law enforcement agency)
-LTCF collection site can only accept drugs from residents
-signage must have toll free # and website for feedback
-operates on ongoing year round basis
-1 site per city/town and additional for each 50k residents
-underserved areas must get mail back distribution locations and periodic collection events (at least twice a year)
-program must implement system for promotion, education, and public outreach
-Upon request pharmacies must provide materials explaining use if take back programs to customers
-manufacturers bear the cost and they cannot charge people
-there must be follow up survey of residents
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
Note: possession of a counterfeit CS is a felony
You can’t be prosecuted if you called 911 for emergency OD or if you were the one who overdosed
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
-pt must be able to take the med themselves!!
-mentally competent
-18 yr+
-WA resident
-terminally ill (<6 months)
-second MD confirm competence, diagnosis and that it’s voluntary
-Note: b/w the qualified medical provider and the consultant medical provider, at least one must be a physician
-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), qualified medical provider can’t be a witness
-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 including pt agent or physician
-Recommend pt notify next of
kin
-Rx must be either brought to you by physician or Faxed! Cannot have to bring it in
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
Physical count of C2 and C3 floor stock at each shift change
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 (unless related to drug theft)
-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:
-LESSER of the ACTUAL COST FOR COPYING OR WA MAX BELOW:
-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 or HIV
-no reports to military w/o consent
-Abuse of vulnerable child or adult MUST be reported
-Generally need written consent to disclose healthcare info
-disclosures to caregivers or healthcare providers that’s previously Tx pts is NOT allowed w/o prior consent
-may be able to make some disclosures with mental health issues to help the pt
-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)
-pt has right to know about disclosures that occurred in past 6 yrs (unless they were allowed disclosures like TOP, pt request, law enforcement, pt authorized disclosure, national security, limited dataset excluding identifiers to family/employers)
-can request EHR listing of disclosures in past 3 yrs w/o above exemptions
-can’t change for first accounting of disclosures in a 12 month period but can for additional requests
-pt can provide written request for disclosures (must be signed, dated, identify type of info to be disclosed and to who and by, and have and exp date. You can charge subsequent requests for providing it and not provide until fee is paid)
-pt may revoke authorization in writing
-may disclose info to public health authorities for licensure/unprofessional conduct, if public safety
-if compulsory order the healthcare provider/pt have 14 days to seek a protective order
-can dent pt access if: could cause danger to pt or someone else, could Identify person would provided info in confidence, info was for litigation, QA, peer review, or admin purposes (in these cases pt can select other healthcare provider for which disclosure can be made to)
-keep healthcare record for at least a year after disclosure or change made upon request
-other examples when you can disclose info w/o pt consent: irb approved research, coroners office
-can request that phi isn’t disclosed to health plan if it’s been paid for out of pocket
-disclosures allowed if avoiding imminent danger (allowed but not required)
-disclosures ok upon sale of pharmacy (successor in interest)
Minors
generally guardian makes healthcare decision unless minor is:
-married to non-minor
-emancipated (petition at age 16)
-14+ with an STD
-any age seeking contraception or pregnancy termination
-13+ seeking behavioral health for mental d/o or substance use D/o
-they can get naloxone
-“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 (applies to pts 13+ yrs)
-WA protects healthcare providers from issues with divorced parents
-relatives can consent for minors if parents not available
-adult “representing” themselves as a relative is sufficient
-also could have adult with signed authorization from parents child to make healthcare decisions
-minors may give consent in Washington
-medical marijuana is an exception, need a designated provider **if under 21*
Dont disclose info for indication with age recs listed above without written consent from minor
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
can help in PREPARATION for administration of CS and non-CS where practitioner has communicated orally or written
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
LEGAL REQUIREMENTS EFFECTIVE JAN 2027
-must provide info for pts with limited English proficiency (LEP) and translation service (post sign about right to translation of complete directions for use in 10 most common languages, update every 5 years, must also mail this with mailed Rxs
-must also provide accommodations for visually/LEP impaired people upon request or OFFER it if it’s obvious that they are visually impaired or LEP
-no additional cost
-delivery of info occurrs at time of rx delivery-don’t have to provide it in person
-visually impaired material: 12 pt font label, braile label, QR code for audio, or prescription drug reader (still need to afix regular label as well)
-for LEP label must still be in English except for the complete directions for use
Not applicable for ER prepackaged discharge meds when pharmacy closed, drug sample given no more than twice in 60 days, or standing order naloxone
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 (not licensed) 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
Healthcare entity is like a free standing MD office or dental office or something like that NOT affiliated with a hospital
-72 hr supply UNLESS dispensed by Rph
-no exception made for inhalers birth control packs, etc.
Is mifepristone legal?
Yes
Retired active pharmacist license
-Dont confuse with INACTIVE
-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 substance 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, commission can rescind this authorization with 30 days notice
This is referring to gamma-butyrolactone and hydriodic acid and a bunch of other precursors
Acceptable forms of ID for PSE vs PMP
PMP
-driver license or state ID card or permit (if expired must show temporary license with exp card) for US or Canada
-US armed forces ID
-merchant marine card
-US passport or foreign passport with I-551 stamp
-Enrollment card for federally recognized Indian tribe in WA state
-state liquor control ID card for US or canada
PSE
-drivers license or state, federal or foreign ID card or permit by ANY US state or foreign government (if exp must show temp)
-US armed forces card
-Merchant marine
-US passport or foreign passport with I-551 stamp
-federally recognized tribal enrollment card
Needs: name, photo, DOB, signature, and physical description. Notice it doesn’t specify need for address! (However you still need to log the pts address even if not on the ID)
Per DEA manual also includes:
-alien registration receipt card or permanent resident card , form I-551
-employment authorization document w/photograph (form I-766)
-form I-94
-passport from Federated States of Micronesia
HPAC
Hospital pharmacy associated clinics
-category 1: no sterile or non-sterile compounding
-category 2: does sterile OR non-sterile compounding-MUST GET INSPECTED IF PARENT HOSPITAL DOSE (only areas where legend drugs are stored from parent hospital, if they order their own under own license commission doesn’t inspect)
If using CS need separate DEA registration (can’t use hospitals) but do NOT need separate pharmacy license
Hospital Notify commission 15 days before closing hpac
5% rule for CS from parent hospital to HPAC DOES apply!
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
-must keep list of officers, directors, managers, a representative and description of duties and their qualifications
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
-“key party” could include delivery driver for example
Could lose license for something not work related (conviction for sex offense)
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) also including dog handlers and researchers
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- CORRECT FDA DENIED THIS WAIVER
-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
no 222 needed
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
-This is usually for like if they don’t have something in the contracted pharmacy
-Note that if doing this to provide the first dose/fill or a partial fill to meet pts immediate needs, you do NOT need to transfer the Rx back after that fill (you are basically transferring one fill but retaining the rest)
Mandatory reporting of abuse or neglect
-pharmacists are mandatory reporters of abuse and neglect for children and vulnerable adults
-mandated when in relation to professional work
-report asap but no longer than 48 hrs
Note: must also report following conditions: animal bites, asthma, bioterrorism, domic acid poisoning, outbreak potential, novel flu strain, flu related death, foodborne or waterborne outbreaks, pesticide poisoning, serious ADRs to immunizations (for these the responsibility is with the principle healthcare provider)
Therapeutic interchange program
When filling Rx for participating state purchased health care programs:
-Rph to make therapeutic interchange if prescribed by “endorsing practitioner” unless:
-DAW (this is for drug itself not the brand vs generic)
-Refills are not permitted for interchange for: antipsych, antidepressant, anti epileptic, chemo, antiretroviral, immunosuppressive, immunomodulatory/ antiretroviral for hep C x24-48wks
-for first fill antipsych they can do limited restrictions but can’t interfere with timeliness of tx (PA completed within 24hr and must supply 72hr supply of requested drug)
-must notify provider when interchange is made
If written by non-endorsing provider will generally need to call them and have it changed (no automatic substitution)
Provider retains ability to request desired drug
Biologic product interchange
-Rph must enter specific product into EHR accessible by prescriber so they can see which product given within 5 days!!
-or they can communicate it before or after with the prescriber
-include name of product and manufacturer
-obviously don’t have to keep doing this for refills
-required to interchange unless requested not ? Or interchange isn’t cheaper
Timeframe to report theft or loss of precursor
Within 7 days after discovery report to the pharmacy quality assurance committee
Includes difference in quantity shipped vs received
Notice this is more strict that DEA manual which says written report in 15 days (although it does say verbal report at earliest practical convenience)
DEA form 107
Iodine, iodine matrix, and methylsulfonylmethane powder
Can’t have iodine or more than 2 pounds of methysulfonylmethane in powder form (prepared dosage forms, cosmetics, and beverages containing MSM are ok)
Medical marijuana
-Designated provider needed for <18, can’t consume and can be providers for only 1 person at a time
-designated provider can switch to a different pt but must wait 15 days
-terminal or debilitating Illness, includes: cancer, HIV, MS, epilepsy, spasticity, intractable pain, glaucoma, crohns, hep c w/pain/nausea, anorexia, PTSD, traumatic brain injury
-students can take on school grounds including school bus!
-card expires in 1 yr or 6 months if under 18, then need new examination
-can have a cooperative of up to 4 people (each must contribute non-monetarily)
Quantity limits for C2 and CS
-No limit in federal law
-There are refill limits and 6 months exp, but no laws regarding quantity allowed per Rx in WA
-Except for OPIOIDS THERE ARE! (7d non-operative acute, 14d operative acute and subacute)
-note: you can issue mx rx for c2 up to 90d supply with fill by dates
Note: for opioid Rxs from an episodic provider we need and ICD code on it!
5% rule for compounding, controls, and general Rxs
-compounding: interstate distribution DNE 5% of total Rxs sold
-controls: Number dosage units DNE 5% of total CS dosage units dispensed in a calendar yr
-general Rx: dollar value DNE 5% total revenue of transferor or transferee in 12 month period
What needs to be in original
Packaging?
-samples
-donations (could be opened if unit dose!)
-Drugs transferred from one pharmacy to another or to other practitioners
-PSE from itinerant vendors or shopkeepers
-dialysis dispensing
When is the only time tech can accept verbal order?
-Authorization for more refills
What can an pharmacy assistant do CS not do?
-They can count, pour, label (basically production except can’t pull drug)
-they can’t type in an Rx or type anything into pts records
-they can’t pull drug from the shelf (but they can put it back)
-Can NOT stock ADDs
-Note: they can’t pull a drug to fill an Rx, but they CAN pull a drug to prepackage medications (printing labels for smaller packages, NOT labels for an rx) on exam will say for subsequent use in a prescription
Who can stock ADD??
Other points on ADDs
Rph, interns, tech, nurses,
NOT pharmacy assistants
NOT nursing students (they can access/retrieve not stock)
Other points:
-Unit dose only! No multi dose in ADDs
-need an override list
-need secure technology to secure ADD (must track everything that happens within it)
-If ADDD in LTCF it must be stored in a locked room!!
NAPLEX
-you have 90 days after taking the test to add additional states (score transfers typically additional $75 each state)
-$100 app fee
-$475 test fee
-225 questions (200 are scored)
-prenaplex is $75 per attempt (get 2 per calendar year)
How many attempts to you get on NAPLEX or MPJE
3 attempt within 3 years
Would need to go to commission to take it 4th or 5th time (up to national limit which is 5)
Who doesn’t need to be licensed in the state they are working?
Federal pharmacists (Indian health service, Public health, armed forces, VA)
Just need to be licensed somewhere! (Most just do Idaho lmao)
Does the pharmacy need to post technician and assistant and intern licenses
-technically no law for this
-just need it for pharmacist and pharmacy (note you can cover up your address)
Can self administered meds be done at hospital ? (Inhaler or cream for example)
Yes, must be in approved policy
Labeling for non-Rx drugs in LTCF
-date the facility receives it
-patients name
-manufacturer or pharmacy label
Notes:
-Any label changes made only by an Rph (send back to pharmacy)
-this is not referring to bulk drugs used by the facility
Side effects statement
-“call you doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
-somewhere in labeling (sticker, preprinted vial cap, separate paper, PIL, medguide, on label)
Provider type initials: try below mixed up to confuse you
ARNP, DDS, DO, OD, DVM, ND, PodD, DMD, MD, CRNA
Physician: MD, DO
Podiatrist: DPM, PodD
Dentist: DDS, DMD
Vet: DVM
Nurse practitioner: ARNP
Naturopath: ND
Optometrist: OD
CRNA: nurse anesthetist (don’t mix up with CNA)
Weird Medicaid rule for prescriptions
Mandated that you have acute origin of Rx (verbal, written, fax, e-Rx) AND ask if it was written on tamper resistant pad
If transferred: you need to ask them what the origin was!!
Can Rph dispense their own CS Rx?
No
Requirements for prescribing chronic pain meds for non-cancer pain
-well defined tx plan
-written agreement: one MD and one pharmacy whenever possible
-periodic reviews every 6 months unless
-40 MME or less (non-escalating) in which case just annual
-prescriber puts indication on hardcopy and require photo ID
-Prescriber can only prescribe Long acting opioids if they complete a 4 hr CE on safe use of LA opioids
-for episodic care providers must put indication or ICD code on Rx and written to require photo ID of person picking up Rx
-also see notecard in mandatory pain consultation
-should co-prescribe naloxone or document in high risk pts.
ISO class of pec, buffed room (sec), anteroom and SCA
Pec: 5
Sec (buffer room): 7
Anteroom: 8
SCA: unclassified
Can Rph fill 12 month supply of contraceptive
If it’s written that way then yes, if written for 30d w/ 11 refills the most you can do is 90 days
Filling pt pill boxes
Rph can fill pt pill pill boxes as long as it’s for drugs that were filled at that pharmacy
Can a MD hire a pharm tech to compound without an Rph
No; they need to be supervised by Rph
When is perpetual inventory required?
-hospital for C2
-remote OUD site
-Rph not on duty
-Pharmacy ancillary personnel not physically on site
-racy free etoh
What is a chart order and Who can sign a chart order?
Chart order is for LTCF or hospice programs and only for Non-controls
MD, or their authorized agent can sign
Agent I believe is RN, MD, or Rph without need for agency relationship
Which types of LTCF can have e-kits?
Which types can have supplemental dose kits?
E-kits: nursing home and hospice
Supplemental dose kits: nursing homes
Who can sign a prescription?
Prescriber or their agent if non-controlled
CS I believe is just the prescriber
For this care I would just say that the prescriber must always sign it no matter the schedule
Things that are non-control only
-foreign rx, rx lockers/after hours dispensing, correctional facility returns, LTCF returns, changing from 30 to 90 day supply, refilling w/o new rx (and for governor emergency can’t do c2), delivering med no to pt/household, agent able to sign a chart order or rx, what MDs are allowed to self prescribe, what licensed midwife’s can prescribe
Drugs for chemical capture
-butorphanol
-diazepam
-diprenorphine
-carfentanil
-fentanyl
-ketamine
-midazolam
-tilers mine and zolazepam
Medical marijuana information
-hemp oil is legal (it’s from mature stalks of the plant)
-hemp must contain < 0.3% thc
-CBD from hemp oil is not CS but from marijuana it is
-Epidiolex (canabidiol) and CBD are not controlled substances
-marijuana is C1 in US and WA
-recreational limits: 1 oz weed, 7g concentrate/extract, 16 oz weed infused into solid form, 72 oz infused in liquid, paraphernalia
-can’t use in public
-possession >40 g is felony
-retailers can have 556 licenses
-can’t display products to public
-can’t make sales on internet
-37% tax unless medical (retailers get 10% fee for paying cash)
-paraphernalia is taxed for all
-no community gardens but can have 4 medical pts make a cooperative (up to 60 plants:15x4)
-cooperative must be 1 mile+ away from retailer, 1000ft from school and other places, 8ft fence if outside, tell WSLCB 15d before adding member and no replacement within 60d
-retailers need endorsement to sell medical marijuana and need a certified consultant who completed 20hr training and know cpr. Consultants can’t give medical advice. Put endorsement logo up. 18+ can enter with recognition card or under 18 if recognition card and w/ designated provided
-Rph medical weed database access: register w/ doh, tell doh in one business day of lost credentials, notify department and database vendor immediately if lost prescribing or dispensing of CS authority
-benefits for voluntary pt registration: up to 3x rec limits, high-thc products,
-MD, NP, PA, and naturopaths can authorize medical use
-limits for medical card holders: 3 oz weed, 21 g concentrate, 48 oz solid, 216 oz liquid (all 3x normal). Can grow 6 plants and possess 8 oz from them and md can authorize up to 15 with possession of 16oz
-non-card holders max 4 plants with possession of 6oz from them
What counts as “operations” under hipaa
-QA within pharmacy and external
-contacting MD or pt with tx alternatives or related functions
-medical review, legal services, auditing, fraud and abuse detection
-employee training
-complying with regulatory agencies
-inventory control and planning
Examples of PHI
-name, address, zip, city, dob, admission date, discharge date, age, phone, fax, email, SSN, MRN, vehicle vin, pictures
If de-identified you can use it for research
Elements of informed consent
-nature/character of tx
-anticipated results
-alternative tx including no tx
-possible risks and benefits of tx or alternative tx
Some pharm tech training program reqs
-include multicultural curriculum
-15 weeks to 24 months
-academic program: 2 quarters, 30 credits, 160 supervised practice hrs
-vocational/technical program: 800 hr (160 supervised practice)
-on the job training: 520 hrs with 12 hrs instructive education
-include 8 hr pharmacy law
-training program must renew every 5 yrs
-change to program or program director must report to commission within 30 calendar days
Expired tech license:
-<5 yrs or >5yrs but active in another state: basically pay fees
->5 yrs: need to redo all training
which animals can be euthanized?
Injured, sick, homeless, or unwanted domestic pets, or domestic or wild animals with pentobarbital only
Preuthinasia with:
-xylazine
-dexmedetomine
-metetomidine
-acetylpromazine
Notation of purpose
-sodium oxybate
-optometrist
-nurse midwife
-NP for opioids
-non-cancer chronic pain opioids
-episodic provider opioids
-phone rx
Anteroom pressure ?
ANTEROOM ALWAYS HAS POSITIVE PRESSURE!!!! ITS BUFFER ROOM THAT CHANGES!!!!
ISO of anteroom
Non-hazardous: ISO 8
Hazardous: ISO 7
