WA MPJE

Hospitals: WAC 246-873

040: Must have a director of pharmacy -Appropriately qualified by education, training, and experience -Each decentralized unit of a hospital pharmacy must have a pharmacist supervisor 050: Must have a 24 hour pharmacy service -Policy for after-hours nurse access: basically in the event there is no pharmacist then a nurse should be able to get meds from pharmacy 060: Plan for emergency outpatient meds- In emergency dept if no pharmacy Md and nurses can distribute meds . Oral or electronic orders must be verified by practitioner within 72 hours. Policy does not have to be in place for single dose for immediate administration. No more than a 48 hours supply of a med should be given 080: Distribution of drugs 090: Administration of drugs -Verbal orders for drugs shall be issued only in emergency or unusual circumstances and shall be accepted only by a licensed nurse, pharmacist, or physician -These verbal orders shall be recorded immediately and signed by the person receiving the order. The order will be authenticated within 48 hours 100: Investigational drugs -Basic rules about storage and distribution and administration 110: Additional responsibilities -Pharmacy staff shall participate in other activities and committees within the hospital affecting pharmaceutical services

ECFs: WAC 246-865 (Skilled Nursing Facilities)

060- Pharmaceutical services -Must have consultant pharmacist -Pharmaceutical services committee -Labeling -D/C'd drugs, returns, CSA -Labeling: unit dose, MUD, traditional prescription systems 030- Emergency Kits -Must be put together by a pharmaceutical services committee -Only for bonafide emergencies -Only accessible to licensed nurses -Pharmacy responsible for storage, security, and accountability 040- Supplemental dose kits -Each institution holding a valid WA state nursing home license, and which employs a unit dose drug distribution system may maintain a supplemental dose kit for non-emergencies -Pharmacy responsible for deciding quantities of meds, storage, accountability, etc. 070- Pass meds -When there is opportunity for a resident for an unscheduled therapeutic leave when there is not pharmacist available to dispense meds prescribed by authorized prescriber, a registered nurse or staff pharmacist may provide them with a 72 hour supply of the med to cover the residents leave -All the same requirements for dispensing med

Continuing Professional Education

15 hours (0.15 CEU) required each year to renew pharmacist license May be ACPE-accredited CE -Can use form ti request approval for a non-ACPE program -Local associations can get approval without going thru ACPE for their CE programs -Non-ACPE programs are generally not approved in other states Commission has reiterated policy to not require CE for the first renewal following graduation from pharmacy school

Pharmacy Commission Members

15 members 10 Pharmacists -Licensed in WA for 5 years, geographically representative, representing different practices 4 public members -No connection with Pharmacy 1 pharmacy techinican -Licensed by Commission -No mention of citizenship or residency 4 year term (may be reappointed once for 8 years total)

Required internship hours

1500 hours prior to licensing Earned after completing the first term in a pharmacy program 1200 hours credit given for clinical experiences during PharmD program -300 hours must be earned outside of PharmD program (probably not a thing anymore) Commission will document hours in excess of 1500 for reporting to other states with larger requirements Commission will document 1680 hours from WSU clerkships to other states

Pharmacist License

18 years of age Good moral and professional character Bachelors or Doctor of pharmacy from accredited school Met internship requirements Passed exams (Naplex/MPJE) Completion of 7 hours of HIV/AIDS education Suicide prevention CE 3 hours -RCW 43.70.422 License must be renewed subject to completion of continuing professional requirements (15 hours CE per year) and timely payment of fees No age requirement on intern license

We have a duty to report unprofessional conduct

2006 Legislature revised RCW 18.130.070: DOH to require "every license holder to report ... any conviction, determination, or finding that another license holder has committed an act which constitutes unprofessional conduct, or to report information ... which indicates that the other license holder may not be able to practice ... with reasonable skill and safety to consumers as a result of a mental or physical condition. Additional requirements were established in 2008

Loss or theft must be reported of controlled substances

A "loss" is any reduction in inventory of a controlled substance that is not due to a a lawful transfer, administration, or dispensing of the drug -Controlled substances dispensed by error to the wrong person -Controlled substances dispensed in error instead of another drug -Controlled substances dispensed pursuant to fraudulent prescriptions -Theft, burglary, damage Any "significant loss" msut be reported immediately to DEA by phone, fax, or brief written message -Loss in-transit the responsibility of the supplier -Pharmacies must report shortages from shipments they have signed for Must follow up with Form 1606 with copy to Pharmacy Commission Not significant losses should be tracked in a file kept at the pharmacy for future reference and evaluation

Schedule 2 drugs

A perpetual inventory of schedule 2 drugs must be maintained, with policies established regarding control, storage and distribution of other controlled substances

Pharmacists must take action when problems are discovered

A pharmacist has a duty to take corrective measures when confronted with a prescription containing an obvious or known error

Sales of syringes/needles in WA

A retailer may sell syringes and needles if he or she is satisfied that the device will be used for the legal use intended (RCW 70.115.050) Lawful for any person over 18 to possess sterile hypodermic syringes and needles for the purpose of reducing blood borne disease (RCW 69.50.412 (5)) Nothing in the Drug Paraphernalia Act "prohibits legal distribution of injection syringe equipment through public health and community based HIV prevention programs and pharmacies" (RCW 69.50.412 (3)) Retailers not REQUIRED to sell syringes or needles to any person (RCW 70.115.060)

Safety and Security for ADDD

AC 246-874-040 Security and safety requirements for ADDD. PIC responsible for safety and security of ADDD Secure access by biometrics or some "other secure technology" -Prevent unauthorized use Security -Track malfunction and failure to operate correctly -Downtime procedures (like disaster, power outage) -If used in assisted living facility, must be stored in secure area that locks Discharged patients shall have patient profiles removed from the ADDD as soon as possible but no later than twelve hours from notification of the discharge. When twenty-four hour pharmacy services are not available, a pharmacist shall perform retrospective drug utilization review within six hours of the pharmacy being open, except when a dispensed override medication is a one-time dose or order for discharged patients Meds stored in pt specific containers may not be returned to general stock or use

Automated Drug Dispensing Devices WAC 246-874

ADDD- automated for remote storage and distribution of medication for use in patient care -Not machines inside the pharmacy Each facility must designate a pharmacist in charge (PIC) who is responsible for oversight of the use of ADDD in the facility It is no longer required for the facility to have their plan for use of an ADDD approved by application to the Pharmacy Commission

Mid-level practitioners in WA

ARNPs -Schedules 2-5, in accordance with specialty area -May dispense up to a 72 hour supply of CSAs to own patients PAs- All schedules approved by MD Optometrist- limited list, may include 3-5 -No more than 7 days supply of CSAs -No more than 30 dosage units of 3 or 4 Single doses of Benzos for pre-procedure use Naturopaths- C3 and C4 testosterone and codeine products Pharmacists- Any schedule within scope of authorizing prescriber

OTCs Requiring CRCs

ASA APAP NSAIDs Iron preparations >250 mg elemental/pkg Diphenhydramine >66 mg/pkg Fluoride >50mg/pkg Lidocaine/dibucaine Loperamide Minoxidil Methacrylic acid Methyl salicylate Ethylene glycol NaOH, KOH, H2SO4 Drugs switched to OTC after 2001 (omeprazole, cetirizine, fexofenadine) OTC controlled substances The manufacturer is allowed to make one package size without child resistant packaging ex. Tylenol arthritis is EZ open caps

Preceptors

Actively practicing in a Class A pharmacy -likely not a thing anymore Been in active practice for at least 12 months prior to becoming a preceptor Completion of a Commission-approved preceptor training program every 5 years May supervise more than one intern during a given time period; however, two interns may not dispense concurrently under the direct supervision of the same preceptor Direct supervision- means that intern can safely work with their oversight

Compounding Facilities (WAC 246-878-040)

Adequate space and facilities, with non-sterile compounding areas separate from sterile compounding areas Bulk containers properly stored, refrigeration if needed Adequate water and cleaning supplies and equipment Facilities kept clean and sanitary

Notice of Privacy Practices (NOPP)

Advises patients that you will use their PHI for TPHCO Advises patients of their rights Advises patients that you need written permission to release PHI for other purposes Identifies Privacy Officers and how to contact Describes business associate relationships Describes state laws ad regulations Describes how you will notify of changes (posting them in pharmacy) Requires pt to acknowledge receipt of the notice Title of notice is specified in regulation- has to say the same generic thing for all forms Must post a notice in the pharmacy indicating the availability of this information Must provide NOPP to any person that requests Must track changes to NOPP

WRAPP: Involuntary Referral

After a concerned individual has intervened, an involuntary referral to WRAPP will also be kept confidential and not reported to Commission as long as participant is compliant with monitored treatment program If a drug theft is linked to the discovery of an individual's impairment, the Commission may be notified

Prescription Monitoring Program

All controlled substance prescriptions dispensed by a pharmacy or a practitioner must be entered into the WA Prescription Monitoring Program (PMP) -This does not apply to inpatient prescriptions or drugs dispensed in correctional facilities, except for controlled substances dispensed to inmates at time of release Pharmacists must obtain a valid photographic ID from the person obtaining the prescription at the time of delivery -The pharmacy must assign its own unique identification number to the pt- this is not the photo ID number. Dont need to record the photo ID number Pharmacists may access the information in the PMP for their own patients -Must pre-register with the Department to be granted electronic access --> Must notify Department if access authentication is lost/stolen -May, without pre-registration, submit a written request to Department for info on a given patient Patients may access their own information in accordance with procedures specified in WAC 246-470-040

Refills of legend drugs

All legend drugs expire after 1 year in WA Refill PRN = 1 year If Rx expired, a refill should be treated as a new Rx and given a new Rx number The full quantity of a prescription refill may be dispensed up to the last day before the Rx expires Non-CSA drugs: an emergency supply for up to 72-hours may be given (WAC 246-869-100(f)) Refills must be consistent with directions for use and patients monitored for overuse of drugs Prescribers cannot delegate refill authorization to a nurse or staff "under protocol" -NQAC has ruled out "refill protocols" for RNs

HPAC

Allows for intercompany transfer sales or transfer of drugs -May be patient specific Sites must have separate DEA Similar labeling of meds, records, administration requirements to regular hospital pharmacy Subject to inspection -Inspections infractions will be noted on hospital pharmacy inspection form

Mandatory Reporting (WAC 246-16-200 et seq.)

Must report to PQAC or other disciplinary body when you have actual information about ANOTHER licensee that he or she: -Has been convicted of or found to have committed unprofessional conduct -->Being terminated by a hospital or having privileges restricted due to unprofessional conduct requires reporting -Is unable to practice safely due to mental or physical impairment -->This could be reported to WRAPP if pt not harmed Discuss with supervisor is a good idea before reporting You must Self-Report if you: -Have been convicted or found by a hospital employer to have committed unprofessional conduct -Have information that you are unable to practice safely due to mental or physical impairment -->Can WRAPP if pt not harmed -Have been disqualified from participating in Medicare or Medicaid Contact an attorney before self-reporting

Methamphetamine Precursor OTC Sales Restrictions

Must store ephedrine, Phenylpropanolamine and pseudoephedrine products behind counter -Technically, liquids do not need to be stored behind the counter Limits set for the max amount that can be purchased OTC -Follow a combination of WA law (RCX 69.43) and Patriot Act Requires seller to maintain a log of sales showing name of purchaser, name of drug, and quantity sold, plus other specific elements Log book must be maintained for 2 years The log can be an electronic logbook ADDITION OF RESTRICTIONS ON SALES OF IODINE OR METHYLSULFONYLMETHANE Gross misdemeanor: person knowingly purchases in 30-day period or possesses any quantity of iodine in elemental form, iodine matrix, or more than 2lbs methylsulfonylmethane OTC

Licensure Examinations

NAPLEX -All 50 states now use NAPLEX -Normally, may take in your home state and transfer scores to other state at same time -->May transfer for up to 90 days after test -->575 basic fee, 75 per score transfer -250 question exam, 200 questions used for score Must complete registration in WA within 1 year after score transfer Pay close attention to security restriction

USP labeling standards for compounded products

Name of preparation Internal identification number Beyond-use date Initials of compounder Storage requirements Other items required by state law

7 Point OTC label

Name of product Name and address of manufacturer, packager, distributor Net contents Active ingredients and quantity of certain other ingredients Name of any habit forming drug Cautions and warnings Adequate directions for use

Patient Drug Use Histories

Name, address, phone number, age or DOB, gender Significant disease states Known allergies or prior drug reactions List of drugs and devices previously used by patient Pharmacist comments relevant to individual's therapy

Treatment Programs for Opioid Addiction (NTPs)

Narcotic Treatment Programs -Use methadone to maintain narcotic addicts in a controlled state free of withdrawal symptoms. -Drugs must be administered to patients at the NTP site - no prescriptions allowed. --> this rule doesnt apply for methadone used for pain -Hospitals treating may administer methadone for temporary treatment of a narcotic addict experiencing withdrawal when caring for another medical condition -Pharmacists should question methadone prescriptions prescribed for obvious maintenance doses (e.g., 1 daily). Allowed under Narcotic Addict Treatment Act of 1974 Once a patient is stable, the prescriber may allow the patient to have "carries" which is an additional dose or two. This allows the patient to have a couple of days free of clinic check ins.

Structured Professional Labeling and Prescribing Information

New rules applicable to drugs approved after 2006 or within 5 years prior, and any time the labeling is changed for an existing drug Major change is a requirement of a section called "Highlights of Prescribing Information" referring to numbered paragraphs of the main document Package inserts must follow specific format now

Legend drugs not requiring CRCs

Nitroglycerine SL SL Chewable isosorbide ≤10 mg NaF ≤110 mg/pkg Cholestyramine and colestipol powder Oral corticosteroids in doses ≤ 105 mg of prednisone equiv. Mebendazole ≤600 mg/pkg K+ supplements ≤50 mEq/dose EES granules ≤8 g/pkg, tabs ≤16 g Aerosols for inhalation Pancrelipase OCs in memory aid containers; MPG; other hormones Sucrase solutions

Patient Counseling Required- WAC 246-869-220

No "offer to counsel" -- MUST counsel Shall "directly counsel" patient -If delivered, must offer in writing to provide direct counseling and information about the drug, including how to contact the pharmacist Focus is on counseling patient Judgment used to determine amount of counseling: -Reasonable and necessary under the circumstances -Promote safe and effective administration of drug -Facilitate an appropriate therapeutic outcome for the patient All prescriptions except where medication is to be administered by a licensed health professional authorized to administer drugs Recent Commission "policy" is to counsel on all new prescriptions, and on refills when necessary Pharmacist/Intern Shall "directly counsel" patient If delivered, must offer in writing to provide direct counseling and information about the drug, including how to contact the pharmacist Delivery by mail must contain toll free number for patient to call Counseling is required on all prescriptions except where medication is to be administered by a licensed health professional authorized to administer drugs

Individual Provider Rights

No Pharmacist or physician may be compelled to participate in aid-in-dying No pharmacist or physician may be disciplined for participating in aid in dying -Institutions and clinics may prohibit employees from participating on their premises

Technician specialized functions

No longer in effect with new law IV admixture: -Techs with special training may prepare IV admixtures -Licensed pharmacist must check each parenteral drug Tech check Tech: -May check unit doses of another tech tech or intern, must have 99% accuracy -No more than 48 hour supply -The rule does not say interns can check unit dose drugs prepared by techs Automated drug dispensing devices (ADDDs) -WAC 246-872 -Techs may fill or check drugs in ADDD -Must meet special training requirements -Nursing board says nurses can fill and check ADDDs 1 utilization plan filed with commission for ancillary personnel 1 specialized function plan on file for techs to do any of the specialized functions

WA Restriction on stimulants

Non-narcotic C2 stimulants include: -Amphetamine salts and combos -Dextroamphetamine salts and combos -Phenmetrazine (Preludin) -Methylphenidate (Ritalin) Statutory and regulatory indication for these drugs: -Narcolepsy -Hyperkinesis (ADHD) -Epilepsy -Differential psychiatric diagnosis of depression -Depression refractory to other modalities -Multiple sclerosis

Shopkeepers and Itinerant Vendors

Non-pharmacies may sell OTC drugs if registered Registered to sell OTC drugs at retail Shopkeepers (eg grocery stores without pharmacy or convenience store) register via Master License application system Itinerant vendors register directly with PQAC Only sell OTCs in original manufacturer's packaging May be limited in sales of OTC EPP (Pseudoephedrine) products if found to have sold EPP in a suspicious transaction . If selling methamphetamine precursors, must maintain a log of the sale. All OTC products must be stored and maintained properly to avoid misbranding or adulteration.

Labeling

Non-prescription drugs -Date of receipt by facility -Patient's name -Manufacturer of pharmacy label -Doesnt apply to selected bulk drugs used by the facility Label changes to any label must be made by a pharmacist Drugs in containers with no/illegible labels will be destroyed

Do prescription "die" with the prescriber

Not in WA (State v Clausing) If a problem emerges with an Rx, and prescriber is dead or no longer licensed, then will need new Rx from the prescriber who resolves the issue Best practice is to encourage patient to find new prescriber

Exemptions and Waivers of CRC use

Not required for institutionalized patients Prescriber may specify non-CRC on individual prescriptions, no blanket waiver Patient or agent ma request non-CRCs on all prescriptions, blanket waiver -Pharmacist may not designate him or herself as patients agent Under Federal law, waiver may be oral or written Under WA law: MUST BE WRITTEN

Prescriptive authority NOT authorized in all states

Nurse practitioner (ARNP) -May use all drugs, all schedule appropriate for area of practice Naturopath (ND) -Generally use drugs listed in naturopathic or homeopathic pharmacopeias, products of natural origin, for treatment of human patients -CSAs include codeine and testosterone products only Optometrist (OD) -Generally use drugs for treatment of eye conditions; CSAs from a limited list Physicians Assistant- all drugs, schedules on a list of approved by supervising physician Pharmacist- all drugs, schedules approved in a protocol for his or her practice by an authorized prescriber- limited to the scope of the prescriber

Electronic Pseudoephdrine Tracking System

On 10/15/11, WA began using the National Precursor Log Exchange (NPLEx) to electronically track pseudoephedrine sales This replaces the transaction log At the time of sale, vendors will: -Enter customer ID number into system -Click on a drop-down menu to select product sold -Submit the data NPLEx will return an approval or a denial message, based on purchaser's history If a denial message is received, pharmacist will provide purchaser with information on how to go online to determine the reason for the denial -Pharmacy can select Safety Override if they feel threatened -An override generate law enforcement follow-up Purchaser's signature is captured by POS device or a manual log

Fees for pharmacist license

Original license: $200 Annual renewal fee: $265 Renewals occur on the pharmacist's birthday Late renewal penalty: $135 -Until renewal fee and late penalty fee are received by Commission, not allowed to practice pharmacy -Renewal fees may be paid up to 90 days prior to the expiration of the license

Schedule 2 Rules continued

Partial filling -Unable to supply (out of stock) must fill remainder within 72 hours and notify prescriber if remainder not refilled (can do partial fill) -Terminally--> partial filling for up to 60 days -Nursing home--> partial filling for up to 60 days -DEA has held that scheduled 2 drugs may not be dispensed in med-packs under WAC 246-869-255 in which less than the amount prescribed is dispensed- basically no partial fills in med packs CARA Comprehensive addiction and recovery plan: Can partial fill IF: 1. requested by pt or prescriber 2. not prohibited by states law 3. total dispensed in partial fillings doesnt exceed amount prescribed Label must bear "transfer warning"

Washington State Rules

Patient Medication Record Systems - WAC 246-875-020 -Ambulatory and institution slightly differ -All the "usual" -OBRA 90 adds in requirements age and telephone number Drug Use Review - WAC 246-875-040 -New and refill prescriptions must be screened Patient Counseling Required - WAC 246-869-220 Pretty much same as federal rules above: Washington requires pharmacists to: -Pharmacists must maintain and use medical records to review therapy prior to dispensing -Examine the patients medication record upon receipt of a prescription or drug order (outpatient, inpatient) to determine the possibility of: -->A clinically significant drug interaction; -->A clinically significant drug reaction; -->A clinically significant therapeutic duplication; or Improper utilization of the drug (overuse, underuse) -->Does not distinguish between new and refill orders Requires action to be taken if there is a problem

WAC 246-869-220

Patient counseling required. The purpose of this counseling requirement is to educate the public in the use of drugs and devices dispensed upon a prescription. (1) The pharmacist shall directly counsel the patient or patient's agent on the use of drugs or devices. (2) For prescriptions delivered outside of the pharmacy, the pharmacist shall offer in writing, to provide direct counseling and information about the drug, including information on how to contact the pharmacist. (3) For each patient, the pharmacist shall determine the amount of counseling that is reasonable and necessary under the circumstance to promote safe and effective administration of the medication and to facilitate an appropriate therapeutic outcome for that patient from the prescription. (4) This rule applies to all prescriptions except where a medication is to be administered by a licensed health professional authorized to administer medications

Patient access to records (Fed)

Patients may see records and may request changes in record to correct errors -Pharmacy must provide copies of records in a timely manner upon request -May charge reasonable fee for copying- proposed changes in progress -Pharmacy does not have to agree to change record, but must respond in timely manner to request -If record is not changed, pt may insert a statement in the record

Pharmacy Assistants may..

Perform all duties not reserved to pharmacists or technicians Package and label drugs for subsequent use Count, pour, and label for individual prescriptions Replace the container on the shelf, but not retrieve from shelf Must be under general supervision of a pharmacist Cannot enter new Rxs into computer system

Nuclear Pharmacies- WAC 246-903

Permit issued only to nuclear pharmacist Nuclear pharmacist must: -Meet radiation control agency (RCA) standards -Meet training or experience requirements of WAC 246-903-030 Must submit equipment list to commission and RCA prior to licensure of pharmacy

Internet Pharmacies

Pharmacies dispensing controlled substances via Internet must also be separately registered under Ryan Haight Online Pharmacy Consumer Protection Act of 2008 -Prescriptions must be based on a physical examination of patient at least once every 2 years -see text for reporting requirements

Accommodation Sales/Transfers

Pharmacies may transfer legend drugs to other pharmacies or prescribers without registering as wholesalers "to meet an urgent need" -May not exceed 5% of total sales during any previous 12 months (supplier/purchaser) -Commission has recently suggested that routine sales to physicians violate this rule Repackaging may make the transferred drug misbranded, and should not be done

WAC 246-869-010

Pharmacies' responsibilities. (1) Pharmacies have a duty to deliver lawfully prescribed drugs or devices to patients and to distribute drugs and devices approved by the U.S. Food and Drug Administration for restricted distribution by pharmacies, or provide a therapeutically equivalent drug or device in a timely manner consistent with reasonable expectations for filling the prescription, except for the following or substantially similar circumstances: (a) Prescriptions containing an obvious or known error, inadequacies in the instructions, known contraindications, or incompatible prescriptions, or prescriptions requiring action in accordance with WAC 246-875-040. (b) National or state emergencies or guidelines affecting availability, usage or supplies of drugs or devices; (c) Lack of specialized equipment or expertise needed to safely produce, store, or dispense drugs or devices, such as certain drug compounding or storage for nuclear medicine; (d) Potentially fraudulent prescriptions; or (e) Unavailability of drug or device despite good faith compliance with WAC 246-869-150. (2) Nothing in this section requires pharmacies to deliver a drug or device without payment of their usual and customary or contracted charge. (3) If despite good faith compliance with WAC 246-869-150, the lawfully prescribed drug or device is not in stock, or the prescription cannot be filled pursuant to subsection (1)(a) of this section, the pharmacy shall provide the patient or agent a timely alternative for appropriate therapy which, consistent with customary pharmacy practice, may include obtaining the drug or device. These alternatives include but are not limited to: (a) Contact the prescriber to address concerns such as those identified in subsection (1)(a) of this section or to obtain authorization to provide a therapeutically equivalent product; (b) If requested by the patient or their agent, return unfilled lawful prescriptions to the patient or agent; or (c) If requested by the patient or their agent, communicate or transmit, as permitted by law, the original prescription information to a pharmacy of the patient's choice that will fill the prescription in a timely manner. (4) Engaging in or permitting any of the following shall constitute grounds for discipline or other enforcement actions: (a) Destroy unfilled lawful prescription. (b) Refuse to return unfilled lawful prescriptions. (c) Violate a patient's privacy. (d) Discriminate against patients or their agent in a manner prohibited by state or federal laws. (e) Intimidate or harass a patient.

Remote processing of prescriptions

Pharmacist at one site reviews and approves drug for another site Commission Guidelines allow pharmacies that not owned by a common entity to enter into agreements for remote processing of orders Upon verification, ADDD will dispense filled med

Pharmacy Assistants- RCW 18.64A

Pharmacist defined in this section Interns are not defined in this section Ancillary personnel- Techs and assistants Intern cannot legally supervise ancillary personnel, this is one of the only things a pharmacist can do that an intern cannot Training programs for techs Duties of techs and assistants Limitations Disciplinary actions Pharmacy applications to use ancillary personnel Pharmacy or pharmacist responsible

Prospective DUR

Pharmacist must perform a prospective DUR unless: -Subsequent dose from previously reviewed order -Prescriber in immediate vicinity and controls drug dispensing process -System is used for emergency meds -Pharmacist retrospective review within 24 hours

Pharmacists and ancillary personnel (WAC 246-878-030)

Pharmacist responsible for inspection of drugs, equipment, and for assuring accuracy of product Must keep up to date with continuing education related to compounding Clean clothing and protective apparel Exclude persons from compounding area with lesions or other illness that could affect quality of product

Practice of Pharmacy

Pharmacist scope of practice: -Interpreting prescription order -Compounding, dispensing, labeling, administering, and distribution of drugs and devices -Monitoring of drug therapy and use -Initiating or modifying therapy in accordance with written protocols approved for practice by practitioner authorized to prescribe -Participating in DUR (required) and drug product selection -Proper and safe storage, distribution, record keeping -Providing of information on legend drugs.. therapeutic values, hazards and uses *Pharmacist cannot prescribe a device, but they can administer a device (immunizations)

Stocking the ADDD

Pharmacist, intern, or tech (under pharmacist supervision) may stock -Nurse may stock using electronic verification -Tech-check-tech under specialized functions criteria (specialized functions not a thing) Use of manufacturers original, sealed unit dose or unit-of-use packaging, in repackaged unit-dose containers or other suitable containers Patient owned meds may be stored if: -In the original bottle, properly identified -Must have policies for safe and secure handling

Application for Pharmacies

Pharmacy Commission -Must be submitted 30 days prior to a Commission meeting -One application form for all pharmacies (hospital, amb, outpt, etc.) -->For Differential hours (hours that dont match store its a part of) and ancillary personnel there is a supplemental application DEA- use form 224, online application process -A DEA license application must be completed to obtain controlled drugs -If a pharmacist is writing for control drugs under a collaborative practice agreement, you will need to apply for a personal DEA license An application must be completed if the owner changes (even if owner is a corporate officer) Relocation to another address or remodel/relocation at the current address must be approved by application

Central filling and fulfillment

Pharmacy Commission Guidelines - on web site: -"Requirements for Central Filling of Prescriptions by Washington Pharmacies and Central Prescription Filling Service Providers" Similar to rules for RMOP Must comply with DEA rules Both pharmacies involved must share electronic records Dispensing pharmacy must maintain records of all prescriptions filled by it and the central fill pharmacy Must inform patient prior to outsourcing that the prescription may be outsourced Label must have name and address of both the dispensing pharmacy and the central fill pharmacy, except where there is common ownership of both pharmacies See other requirements in text and DEA Manual

Controlled substance accountability

Pharmacy shall maintain records of all C2 with the following (for 2 years): -Date -Name of Drug -Amount -Name of pharmacist -Name of patient -Each unit that utilizes narcs must keep record too -Name of prescriber who authorized drug -Name of administer -Wastes must be witnessed -->Records of all wastes maintained by pharmacy: Quarterly summary reports shall be mailed to the DEA with copies to the state board of pharmacy--> These records are kept for 2 years -Significant losses or disappearances must be reported to state BOP, DEA and chief executive officer of the hospital and other authorities

Non-Resident Pharmacies

Pharmacy that sells or ship drugs to patients in WA Must register with WA Pharmacy Commission Registered and regulated by home state Must put 800-number on label for patients to receive consultation -Must be a toll free number Must maintain patient profiles Must provide patient information May be disciplined or fined by WA if home state doesnt investigate a complaint within 45 days -Must obey laws of their home state and WA laws

Within scope of practice

Physician- entire human body Naturopath- entire human body Dentist- head and neck Podiatrist- ankles and feet NP- specialty area PA- same as supervising physician Optometrist- eyes Ophthalmologist- same as physician Psychiatrist- same as physician Psychologist- not generally allowed to prescribe Vet- entire animal body Pharmacist- humans or animal, within scope of authorizing practitioner

Practitioners with prescriptive authority in WA

Physicians (MD, DO) Podiatrist Dentists Veterinarians Mid-level practitioners -NP -PA -Naturopath* -Optometrist* -Pharmacist* -Midwife* *- out of state prescriptions not valid in WA

Prescriptive authority in all states

Physicians (MD, DO) -All drugs, all schedules, any use in humans Podiatrists (DPM, PodD) -All drugs, all schedules, any tx of conditions of feet and ankles Dentists (DDS, DMD) -All drugs, all schedules, any tx of conditions of head and neck Veterinarians (DVM) -All drugs, all schedules, any use for treatment of diseases in non-human animals If the prescriber determines that a medication should be prescribed, they can have the prescription information communicated to the pharmacy by a designated agent.

Out of state prescriptions may be filled in WA from

Physicians (MD, DO) Podiatrists (PodD, DPM) Dentists (DDS, DPM) Veterinarians (DVM) NPs (ARNP) PAs (PA-C) When licensed in any state, territory, or British Columbia (legend drugs only from BC, US DEA number needed for controls)

Pharmacy Owner Responsibilities

Place a pharmacist in charge Pay an annual license fee (pharmacy license or facility license) -Pharmacy business owner must maintain the pharmacy license File a statement of ownership and location Maintain records of prescription and dispensing for a minimum of 2 years Maintain controlled substances (CSA) records for a minimum of 2 years Remember: If the law requires a PHARMACY to comply that means the OWNER is also responsible for making sure the business is in compliance. The owner has the license to operate the business

Definitions

Practitioner -A person duly authorized by law to prescribe drugs or devices -MD, DO, ARNP, PA, Pharmacist (w/ CTDA) Pharmacist -person duly licensed by Commission to engage in the practice of pharmacy -->Must be licensed by PQAC, even if they have a degree, they wont be a pharmacist until licensed by board Dispense -interpretation of order, and selection, measuring, compounding, labeling or packaging necessary to prepare for delivery -Counseling is not included in this Administer -direct application of a drug or device by injection, inhalation, ingestion or any others means to body of patient or research subject -Pharmacist can administer vaccines

Examples of Treatment

Processing prescriptions and dispensing drugs Maintaining and reviewing pt profile Consulting with prescribers relative to pt's care Providing emergency info necessary for the pt's care Consulting with pt or caregiver regarding the pt's meds Transferring refill info to other pharmacies

Schedule 2 rules

Products exchanged between registrants by use of DEA Form 222 for purchase and sale Power of attorney needed to order 222 forms and to sign them for the registrant Written Rx required -Date issued must be filled in (can be added with verification) -Written signature of prescriber No expiration fate on Rx under federal law -6 month expiration date in WA

Schedule 3 and 4 Rules

Products exchanged between registrants by use of invoice with address May be telephoned or Faxed May refill up to 5 times within 6 months; Rx expires after 6 months May transfer refills one time to another pharmacy if state law permits Computer records must be kept on-line for 24 months after last possible refill If use computer records, pharmacist must sign log sheet or bound book at end of each day Label must have transfer warning Technically, both date of first filling and of refilling must be on label

Schedule 5 Rules-Legend drugs

Products exchanged between registrants by use of invoice with address and DEA number May be telephoned or Faxed No refill limit or expiration date for Rx under federal law -WA: 6 months from date prescribed and no more than 5 refills -Treated the same way as schedule 3-4 May transfer refills as allowed by state law No special computer maintenance for filling records is required Ex. Lomotil, Lyrica, Guaifenesin w/ codeine Same requirements on CVs in WA as CIII and CIV, except for the computer system requirement.

Pt Info: Collection, Use, and Confidentiality: Prospective DUR

Prospective-before the fact Screen prescriptions against history prior to dispensing -Therapeutic duplication -Drug-disease CIs -DDIs -Incorrect dosage or duration of tx -Drug allergies -Clinical abuse or misuse May be manual and/or computer assisted May be "on-line"

Privacy Rule (45 CFR Parts 160, 164)

Protected health information (PHI) is that which relates to health condition (past, present, future) and identifies the patient (45 CFR § 164.501) May be used for treatment, payment, and health care operations (TPHCO) Consent not required to use information for TPHCO Notice of Privacy Practices must be provided Must obtain permission to use information for marketing, research, etc. May share data that is "de-identified" Stricter state laws must be followed Business associates must assure compliance with rules Consent from minors is subject to state law

Completed CSA Rx

Pt name Pt address Date written Drug, Quantity, Directions Physician address Physician DEA number Physician signature or name Other information required by state: -Pharmacies must have on file diagnosis for use of amphetamines -ICD10 code for opioids from episodic care prescriber WA Commission has indicated that a pharmacist may add any missing info after consultation with prescriber, may add DEA number without consultation if it is already known with certainty. (Changing the drug or the patient is not allowed)

Examples of Health Care Operations

Quality assurance within operation Quality assurance activities with external organizations Contacting providers or patients with info on treatment alternatives Medical review, legal services, auditing, and fraud and abuse detection Employee training and development -Complying with regulatory agencies and complying with HIPAA Inventory control and planning

Partial filling of Schedule 3-4

Question: Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in the actual number of dispensings being greater than the number of refills indicated on the prescription? Answer: Yes. Partial fills of Schedule III, IV, and V controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed and no dispensing occurs after six months past the date of issue

Share Pharmacy Services

RCW 18.64.570 Long-term care facilities and hospice programs—Legend drug resupply—Shared pharmacy services—Unused drugs Pharmacy may outsource for LTC or hospice program residents, if they: -Obtain approval from LTC/hospice -Provide copy of prescription or chart order to pharmacy to pharmacy providing shared pharmacy service -Supplying pharmacy retains copy of prescription, dispensing record, and notifies outsourcing pharmacy of service and quantity provided -Only transfers one fill or partial fill to another pharmacy to meet needs of patient LTC pharmacy can continue filling on subsequent fills without the need to transfer the Rx back

Pharmacist responsibilities that cannot be delegated

Receipt of a verbal Rx Consultation with the pt -WAC 246-869-220 (pt counseling is required) Consultation with Dr. Extemporaneous (no recipe) compounding of the Rx Interpretation of data in the patient record Ultimate responsibility for verification of the Rx Providing patient information as required by WAC 246-869-120 Signing of documents or registry books Professional communications with other health care professionals Decision not to dispense a drug -These responsibilities cannot be passed on to tech or assistant

Pharmacy Commission Complaint Process

Receipt of complaint (written preferred by PQAC) Case Management Team (CMT) reviews complaint -CMT consists of 3 PQAC Members -CMT may decide to investigate or to close case Investigator conducts investigation -Investigator's report provided to Reviewing Commission Member -Reviewing Commission Member may recommend: -->Closure -->Notice of Correction Statement of Charges and Proposed Settlement Opportunity for Settlement Hearing by Commission -->Clear and convincing evidence required Opportunity for Settlement Hearing by Commission -Different PQAC members than CMT -Clear and Convincing evidence required Decision by Commission -Fines -Suspension -Revocation for a specific period -Probation -Limitations on practice -Additional education, training, etc. -Stay of discipline during probation Petition for reconsideration, or appeal to Superior Court, with further appeal to Appellate Division, or possibly to Supreme Court

Records of administration: WAC 246-873-080 (9)

Records of all drugs administered to inpatients must be recorded in the patient's medical record

Telephone and Faxed Rx

Reduce oral Rx to writing FAX treated like telephoned Rx -Must show date, time, phone number, and location of fax machine on fax printout -Not printed on thermal paper Verify unclear or suspicious orders with prescriber

Drug Quality and Security Act of 2013

Reenacts § 503A -Applies to "traditional pharmacy compounders" Adds new § 503B regarding "outsourcing facilities" -Entities engaged in large volume compounding, particularly of sterile products, voluntarily --> subject to cGMPs (current Good Manufacturing Practices) -->Exempt from NDA or adequate labeling requirements -->Subject to FDA inspection -->Subject to registration and inspection fees -Must be under supervision of a licensed pharmacist

Pharmacy Commission Duties

Regulate the practice of pharmacy Examination for licensure candidates Establish qualifications for licensure of pharmacists or interns Conduct revocation or suspension hearings Regulate dispensing, distribution, wholesaling, and manufacturing of drugs and devices Regulate the practice of pharmacy "for the protection and promotion of the public health, safety, and welfare" Adopt rules for continuing professional education Do licensure for both people and facilities

Periodic physical inventories of controlled substances

Required elements: -Inventory date -Time of inventory (opening or closing) -Drug name, strength, form -Number of unite/volume -Total quantity Recommended: -Name, address, DEA number of registrant -Signature of person taking or responsible for inventory C2: actual physical count C3-5: -Estimated count for most sizes -Actual count if container had >1000 doses and has been opened

Nursing Home CSA Rules

Requirements depend on unit dose or non-UD CSA schedule must be on label of CSAs dispensed to nursing home patients Non-unit dose systems -C-II stored separately under lock -C-III stored separately from other drugs but may be stored with C-II -Bound log book for all C-II or C-III drugs -Physical counts q 24 h for C-II and weekly for C-III Unit dose - may follow above rules or develop alternative system with equivalent record keeping -C-III unit dose may be stored with other UD drugs -Discontinued unit dose drugs other than C-II may be returned to pharmacy Non Unit dose: C2s must be destroyed by the pharmacist or director of nursing plus another RN or Commission member of discontinuation. All other drugs must be destroyed within 90 days Unit dose: Only C2 drugs must have been discontinued must be destroyed onsite

Prescribing narcotics for chronic non-cancer pain

Rules for prescribers in WA went into effect in 2011 and 2012 Affects all prescribers -Medical Quality Assurance Commission rules (WAC 246-919-851) Rule does not apply to palliative, hospice, or other end of life care, nor to management of acute pain secondary to injury or surgery Require prescriber to obtain, evaluate and document the patient's health history prior to beginning treatment -Past relevant medical history -Ongoing history, including any relevant history from a pharmacist provided to practitioner (WAC 246-919-853) -Initial evaluation to include risk screening tools Requirements for prescribing narcotics to chronic non-cancer pain patients include: -Well-defined treatment plan -Obtaining of informed consent to treatment -Written agreements for treatment recommended (WAC 246-919-856) -->All chronic non-cancer patients should received prescriptions from one practitioner and one pharmacy whenever possible --> When the patient is at high risk for medication abuse, or has a history of substance abuse, or has psychiatric comorbidities, a written agreement shall be used -Periodic reviews must be conducted every 6 months unless: --> Pt has stable chronic non-cancer pain involving non-escalating daily doses of 40mg morphine equivalent doses (MED) or less, in which case annual review must be conducted (WAC 246-919-857) -The prescriber shall include the indication for the medication use on the hardcopy and require photo ID -Long acting opioids, including methadone, should only be prescribed by a prescriber who has completed at least one CME of 4 contact hours on the safe use of long-acting opioids -Episodic care practitioners (ex. ED docs) -->Prescriptions written for opioids by an episodic care provider "shall include indication for use or the International Classification of Disease (ICD) code and shall be written to require photo identification of the person picking up the prescription in order to fill (WAC 246-919-859(3)) -Mandatory consultation is required when a patient reaches or exceeds 120 mg MED (Can be done telehealth, electronic, in-person, etc.) -Prescribers are exempted if the are pain management specialists or have completed 12 Category 1 CME hours on chronic pain management with at least 2 hours devoted to long-acting opioids- Within the prior 2 years

Offer to Counsel (Fed)

Rules set by states: most require pharmacist to offer each patient a chance to discuss their drug therapy, generally must document refusal to be counseled Significant items -Name and description of medication -Dosage form, dose, route, duration of therapy -Special directions for preparation, administration, or use by patient -Common severe side effects, adverse effects, interactions, or contraindications that the patient can detect and deal with -Self-monitoring techniques -Storage and refill information -What to do if a dose is missed

Prescription Drug Samples

Samples may be distributed only to prescribers, or to hospitals at request of prescribers -Free clinics may possess and distribute No fee or charge may be imposed for distributing samples Retail pharmacies may not possess samples, unless part of a drug donation program (RCW 69.70)

Sterile products

Sterile compounding must conform with WAC 246-871 Must also conform with USP <795> and <797>

Interns

Student enrolled college of pharmacy Making timely progress towards graduation Engages in practice of pharmacy under supervision of a licensed pharmacist -Notifies Commission prior to starting at site -Preceptor oversight -May be supervised by non-preceptor RPh in the temporary absence of preceptor -Submits a final report within 30 days after finishing at site, and at least 30 days prior to taking licensure exam Pays $45 annual fee for an intern permit

Tech certification exam and CE

Techs licensed in WA after Jan 1, 2009 must have passed national certifying exam -PTCE -ExCPT Do not need to maintain CPhT status Will need to complete CE -9 hours related to pharmacy practice and directed to techs -1 hour related to law Rules relating to this statute: -WAC 246-901-030 A pharmacist must oversee the training of a tech- either in job training or technical program (thus tech training school must have pharmacist as program director)

Ancillary Personnel Duties

Techs: -Assist in performing manipulative, nondiscretionary functions (ones that do not require clinical knowledge and evaluation to make judgement, yes and no type questions) associated with the practice of pharmacy -Under supervision of a licensed pharmacist Assistants: -Antiquated definition, typing means typing on typewriter -Typing, filing, refiling, bookkeeping, pricing, stocking, delivery, nonprofessional phone inquiries, documentation of third party reimbursement -May not enter patient/prescription data into the computer system -Today, an assistant can manually bill a third party (some pharmacies hand bill Medicare part B for durable medical goods) but they cannot bill through a pharmacy software program (ex. QS1, Enterprise, PDX, etc) because that would mean that they wrote information to the computer system database.

WA Death with Dignity Act (DWDA)

Terminally ill (death expected within 6 mos) competent adult Washington residents may request a prescription they may take to end their lives in a dignified manner Must be certified by 2 physicians as terminally ill and competent -Must request a psychiatric evaluation if any question of mental incapacity Patient must make an oral and written request to the physician, then must make an oral request for the prescription, must wait 15 days from the first oral request Written request must be witnessed by two individuals, 1 of which may not be related to the patient, be entitled to share the patient's real estate, or be employed by the institution providing care 48 hours must elapse between second oral request and issuance of prescription

Closing a Pharmacy: Notification to patients

The Commission has adopted a policy encouraging pharmacies to notify patients 15 days in advance of the closing as a matter of insuring patient access: -Direct mail or newspaper ad, posting a sign near the pharmacy -Intended date of closing -Name and address of pharmacy to which prescriptions will be transferred -Instructions on how patients can arrange for transfer of their prescriptions to a pharmacy of their choice, and the last day a transfer may be initiated This is not a law but it is best practice

Unprofessional conduct

The Pharmacy Commission may discipline you for unprofessional conduct, which may include: -Conviction of a relevant crime -Misrepresentation or concealment of a material fact in obtaining a license -False, fraudulent, or misleading advertising -Incompetence, negligence, or malpractice which -->Results in injury to a patient -->Creates an unreasonable risk that a patient may be harmed -Suspension, revocation, or restriction of a license in another state -Possession, use, prescription for use, or distribution of controlled substances in any way other than for a legitimate medical use, diversion ..., violation of any drug law, or prescribing controlled substances for oneself. -Not furnishing in writing a full and complete explanation covering the matter contained in the complaint filed with the disciplinary authority -Failure to comply with an order of the Commission -Aiding or abetting an unlicensed person to practice -Violations of rules established by any health agency -Practice beyond the scope of practice -Misrepresentation or fraud in the conduct of a business or profession -Failure to adequately supervise auxiliary staff -Engaging in a profession while suffering from a contagious or infectious disease -Promotion for personal gain of any unnecessary drug, device, treatment, procedure, or service -Conviction of any gross misdemeanor or felony relating to the practice of a person's profession -Procuring, or aiding in ... a criminal abortion -Offering ... to cure or treat ... by a secret method -Willful betrayal of a practitioner-patient privilege -Violation of RCW 19.68 (anti-kickback statute) -Willful interference with a Commission investigation -Current misuse of alcohol, controlled substances, or legend drugs -Acceptance of more than a nominal gratuity from a representative of a manufacturer or vendor of medical or health-related products or services intended for patients, where a recognized conflict of interest is presented -Destroying an unfilled lawful prescription -Refusing to return unfilled lawful prescriptions to patient or agent -Violating a patient's privacy -Discrimination against patients or their agents in a manner prohibited by state or federal law Intimidation or harassment of a patient WAC 246-869-095 (revisions effective 6/1/07)

Information Required on label of dispensed legend drug (Federal Law)

The name and address of the dispenser The serial number (Rx number) Date of the prescription or of its filling The name of the prescriber If stated on the prescription, the name of the patient The directions for use and cautionary statements, if any, contained in such prescription The "side effects statement": -"Call your doctor for medical advice about side effects. You may report to FDA at 1-800-FDA-1088 Notice, Refills do not have to be on the label 21-USC 353 (b)(2); 21 CFR 209

WA vs Patriot Act Meth Precursor Provisions: Log Book

The notice of penalty is a statement within the logbook that tells purchasers that falsifying information will result in criminal penalties which include fines and prison.

Pharmacists' responsibilities in chronic non-cancer opioid treatment

The prescribing rules do not apply directly to pharmacists, nor do they modify other responsibilities The Pharmacy Commission has encouraged pharmacists to: -Learn the requirements for the five covered professional boards -Consider that "prescriptions written for 120mg MED or greater should give pause, and probably more often than not, trigger a call to the prescriber." -Only really need to do this the first time pt is on ^this big of a dose, if they stable chronic pain its cool If prescriptions are from "episodic care providers" the requirements for the ICD-10 code or diagnosis, and the requirement for obtaining photo ID, must be present- otherwise DEA could consider the prescription invalid Prescribers who designate a single pharmacy in a patient agreement should notify pharmacy- designated pharmacy will notify provider is pt obtaining from other pharmacies Pharmacists with CPAs should follow same standards as authorizing prescribers

Washington Law Requires examination of the medication record for each dispensing

This involves "interpretation of the data in a patient medication record system" which cannot be delegated by pharmacist This is part of "verification" in WAC 246-901-010(10) Requires evaluation of the patient's "utilization of the drug" Applies to the "prescription or drug order" which covers inpatient and ambulatory settings

OBRA-87 Requirements for LTC facilities

This is for Federal regulations for facilities that receive federal funds for Medicare and/or Medicaid patients Pharmacists must be involved in care of patient Development of a comprehensive care plan for each resident 42 CFR 483.25 Resident's therapy must be free of unnecessary drugs -Duplicative tx -Excessive tx -Inadequate monitoring -Inadequate indications for use -Use of drugs in presence of ADRs Comprehensive reviews of psychotropic drugs and plan to reduce use in each patient Drug Regimen Review by pharmacist every 30 days

Pharmacist to tech ratio

This may be changed with new laws Standard ratio -1:3 pharmacist:tech ratio set by commission rule for each licensed pharmacy that submits an ancillary utilization plan (1:1 in community without one) -Pharmacist supervising must be actively practicing pharmacy (not like the CEO) -Tech students/trainees count as part of this ratio Inpatient pharmacies -Ratio may include pharmacist outside central pharmacy Pharmacy services plan -May use more than 3:1 techs to pharmacists subject to commission approved plan

Utilization Plan

This may not be part of the new law Manner in which techs will be utilized -job description -task analysis -Number of positions Specialized functions -Criteria for selection of techs for specialized functions -Methods for training Assistants -Job title or function of each assistant -Delivery personnel must be assistants or techs

WA More Stringent than Federal

Time limits for access to records -WA: ASAP, with 15 day limit for initial response, 21 day maximum -HIPAA: 20 days for response, 30 day extension Time limits for amendment of records: -WA: 10 days for response, 21 days maximum -HIPAA: 60 days for response, 30 day extension

Release without permission of patient allowed by RCW 70.02.050

To a person who is reasonably believed to be providing health care to the patient and To a provider who is the successor in interest to the provider providing maintaining the information

Valid CSA Prescriptions

To be dispensed to an ultimate user (patient) -WA law allows naloxone prescriptions to be filled for a caregiver or friend of opiate user to be administered in case of accidental overdose For a legitimate medical purpose By an authorized prescriber In the due course of professional practice

Labeling: Traditional system

Traditional: individual prescription bottles labeled for patients -Same as outpatient meds except: -->Sig not required on label -->CSA schedule must be on label -->Child resistant not required (So these can go in vials but doesnt have to have sig but does have to have schedule of control med) Still includes things like name of pt, med, and amount and strength of drug, physician etc Applies to Bingo Card

Product Selection in WA

Two-line prescription blank, out of state okay to substitute unless DAW etc. is on Rx -Commission rule (WAC 246-899-050) clarifies further. If prescriber does not clearly indicate instructions, may substitute only if pharmacist: --> Has personal knowledge of rules in the other state --> Has obtained authorization from the prescriber or: Obtains current information on the rules in the the other state Indicate on oral prescriptions if DAW or substitution permitted Shall substitute unless patient requests otherwise Must use therapeutically equivalent product of identical base or salt given in same regimen May use any reliable information source to determine bioequivalence

Pharmacies- Responsible Pharmacist Manager

Unlawful to operate a pharmacy without placing a pharmacist in charge- RCW 18.64.020 Each non-licensed proprietor must appoint a responsible pharmacist manager (RPM) (essentially a PIC) -Must notify Commission when appointed -Must notify Commission when appointment is terminated Each PIC must notify Commission when appointed or appointment terminated So both owner and RPM need to notify board

Authorized Prescribers of CSAs

Up to state who can prescribe Must register with DEA and state Registration covers specific schedules for which registrant is authorized Must have registration for each location -If prescriber has 2nd office in same state, but does not store controlled substances there, does not need additional DEA number

Sexual contact with patients prohibited

WAC 246-16 Among a bunch of sex things -Cannot engage or attempt to in any kind of sex misconduct with patient or "key party" inside or outside health care setting -Prohibits attempting to engage in sexual conduct during a 2 year period after the provider-patient relationship ends

Authority of RPM

WAC 246-869-070- Responsible manager- Appointment Every portion of the establishment coming under the jurisdiction of the pharmacy laws shall be under the full and complete control (of the RPM) -Ex. Commission held an RPM responsible for inappropriate labeling on OTCs in the front section of a larger pharmacy RPM retains responsibility for ancillary personnel Basically- the pharmacy business owner cannot interfere with the practice of pharmacy- The RPM is responsible for all pharmacy operations and the space is defined as the pharmacy Every non-licensed proprietor of one or more pharmacies must place licensed pharmacist in charge

Physical standards: Adequate stock

WAC 246-869-150 Must have appropriate supplies to meet needs of patients All outdated/expired items must be pulled from stock All stock and materials must be free of adulteration, contamination or deterioration Stock is properly labeled by fed and state laws Stock must be stored in accordance with USP standards and if it is not, remove it

Adequate equipment

WAC 246-869-180 Physical standards for pharmacies—Adequate equipment. Washington is less prescriptive than most states Must have equipment needed for the types of prescriptions filled Must have other references needed for pharmacists to furnish information to patients and practitioners concerning drugs -Ex IV compounding pharmacy have Trissels Must have access to current copy of Washington laws and regulations relating to pharmacy; electronic version is permitted and on-line access satisfies this requirement

Inspections and Grades

WAC 246-869-190 Pharmacy inspections and self-inspection worksheets SELF INSPECTION: annually in March Commission inspection: -Inspector conducts exit interview with RPM or designee -Written inspection report within 14 days -Pharmacy submits plan of correction for each identified deficiency -Commission determines if plan is sufficient or not -May have to send progress report on corrections made -Pharmacy license can be suspended if patient/public risk deficiencies

Poison control

WAC 246-869-200 Must have one bottle of Syrup of Ipecac in stock at all times -Not enforceable, product not available Telephone number of nearest poison control center National Poison Center Number: 1-800-222-1222 -Connects to WA Poison Center in Seattle when dialed from anywhere in WA

Closing of a Pharmacy

WAC 246-869-250 Commission must be notified prior to closing of a pharmacy, regardless, of setting (at least 15 days prior): (also notify patients) -Intended date of closing -Names and address of persons who shall have custody of pharmacy records -Names and addresses who will acquire any of the legend drugs or CSA Within 15 days after after closing, must provide to Commission: -The pharmacy license (voided) -Written confirmation of: -->Proper transfer or destruction of legend drugs, including names and addresses of transferees -->Proper transfer of any CSAs and names and addresses of transferees -->Return of DEA registration and unused forms to DEA -->Destruction of pharmacy labels and prescription blanks -->Removal of all signs and symbols indicating the presence of a pharmacy

Assisted living services- Med Packs WAC 246-869-255

WAC 246-869-253 Prescription drug repackaging-Definitions -Unit of use: means a sufficient quantity of a drug for one normal course of therapy Unit-dose: means ordered amount of drug in an individually sealed package Med-Pack: any package prepared under immediate supervision of pharmacist When creating creating a med pack (-255): -Must be under the direct supervision of a pharmacist -Original bulk Rx container stays in pharmacy -Up to 31 day supply -Patient or agent must request non-child resistant container -Labeled with same information for each drug as for the outpatient prescription -WA Medicaid pays for compliance packaging for qualifying patients

Hospital Pharmacy Associated Clinics (HPAC) WAC 246-873A

WAC 246-873A-010: Definitions -Most of the definitions from 246-873 carry over to this one -HPAC: means a individual or multi-practitioner clinic owned, operated or under control of a parent hospital or health system- the clinic's address is identified on hospital pharmacy license WAC 246-873A-020 Hospital pharmacy associated clinic—Licensing -Current hospital pharmacy license holders- must notify commission of changes in HPAC -Adding HPAC: may add at any time, and must file pharmacy license addendum -Category 1 HPAC: Does not perform sterile or non-sterile compounding -Category 2: May sterile and non-sterile compound -Must have DEA registration to possess controlled substances Hospital pharmacy manager responsible WAC 246-873A-030 HPAC drug transfer and control WAC 246-873A-050 Hospital may dispense patient specific meds, adhering to all standards from hospital requirements Drug samples- nothing in the chapter prohibits it Controlled meds: Hospital pharmacy manager is responsible

Policies and procedures for ADDDs

WAC 246-874-030 General requirements for an ADDD Each facility must have written policies and procedures prior to use of ADDD Policies must be reviewed and an audit must be performed annually by PIC -The responsible manager may designate a Washington state credentialed health care professional acting within their scope of practices to do this review of polices and procedures. The responsible manager shall retain all professional and personal responsibility for any assisted tasks performed by personnel under his or her responsibility, as shall the pharmacy employing such personnel. As always, records must be maintained for 2 years

Accountability and Quality Assurance

WAC 246-874-050 Accountability requirements for an ADDD. Must have a mechanism for securing and accounting for wasted, discarded, expired, unused medication removal from ADDD Procedure to maintain adequate records and accountability: -System to verify accuracy of controlled substance counts -->Perpetual inventory -->Blind count for controlled substances -->Inventory count every 7 days by 2 authorized persons -->Must be stored in individually secured pockets within ADDD- cant be in a matrix or open drawer -Monitoring for discrepancies -->Discrepancy report every time count does not reflect actual inventory -->All resolved and open discrepancies must be reviewed by the responsible manager or designee within seven calendar days WAC 246-874-060 Quality assurance process requirements for ADDD. -Must have QA and performance program that monitors performance of the ADDD (more policies and procedures)

The pharmacist must contact the prescriber if needed following DUR

WAC 246-875-040 requires the pharmacist to contact the prescriber "if needed" May often resolve problems in other ways -Consulting patient to gain more information -Exercising judgement and informing prescriber

Documentation of Counseling Not Required in WA

Washington does not require documentation of counseling Washington does not require documentation when counseling is refused -It is highly recommended that the pharmacist document refusal to be counseled to protect the pharmacist/pharmacy in case of lawsuit

Use of medication record to review drug therapy for problems

Washington requires pharmacists to examine the patients medication record upon receipt of a prescription or drug order to determine possibility of: -DDI -Drug reactions -Therapeutic duplication -Improper utilization of the drug Does not distinguish between new and refill orders

Adulterated

What's in the bottle Fails to conform to compendial standards for purity, quality, strength and appropriate assays Failed to be stored under USP standards -From the Wiley Act

Minimum Necessary Data Set

When disclosing information to another covered entity the is not de-identified, must disclose only such information as is necessary for the transaction involved The requesting party must specify the requested data elements

Rxs Must be on Tamper-Resistant Pads

Written Rx's in WA state and for all Medicaid patients must be on tamper-resistant pads Does not apply to Rx's that are -Faxed -Oral -e-Prescribed If you receive a non-conforming Rx: -Validate with prescriber before dispensing -In emergency, may dispense and validate within 72 hours -Record time of dispensing and validation When receiving a transferred Rx, must ask transferring pharmacist if the original was written on a tamper-resistant pad (Medicaid) All written Rx's handed to ALL patients that are issued in WA must be on state-approved tamper-resistant paper, with a state seal in the lower right hand corner of the Rx If not written on tamper resistant paper, you can always convert it to a verbal order

Hospital Use of CSAs

Written orders rather than Rx's Outpatient pharmacies in a hospital treated like community pharmacies Schedule II requirements in WA -Perpetual inventory of C-IIs in pharmacy -Record of drugs distributed to other units -Records of administration or disposal of C-IIs, usually done in the MAR -Wastage must be witnessed -Policies maintained on destruction (see DEA form 41) -Monitoring to assure chart records are correct -Use of multiple dose vials of CSA drugs is discouraged -Physical counts of C-II or C-III drugs stored as floor stock required at each shift change Destruction Policies need to included: -A method which renders the substance unusable -Destruction completed by a pharmacist and one other licensed health professional -Completion of form 41 -Comply with Dept. of Ecology pharmaceutical waste policies

Drugs brought into hospital by patients/families

Written policy must be in place Such drugs may be administered only if properly ordered Prior to use, a pharmacist must examine them and assure they meet quality standards If not used, drugs remain sealed and are returned to patient Hospital may choose to not return certain drugs if it would be dangerous to the patient Non-returned drugs must be destroyed

Hospital or Institutional DEA numbers

Any employee of a hospital may use hospital DEA number with permission in the course of his or her duties if otherwise authorized to prescribe Remember when a resident leaves their residency, no longer a hospital employee Use hospital DEA # plus internal code; must add stamped, printed, or typed name as well as signature May be filled at community pharmacies

Community Pharmacies: Differential hours

Application must be completed Things needed for differential hours: -Pharmacy security -Drop off box or mail slot for RXs -Distinct telephone number --> Recording of phone calls if answered in main store when RPh not present -->Oral Rx's may be recorded if hours are announced by answering machine -Operating hours displayed at entrance; if in larger store, at entrance to larger store and near the pharmacy -Advertising must list operating hours

USP Guidelines General chapter <795>

Applies to non-sterile preparations Expiration dating recommended -Non-aqueous liquids and solids --> 6 months or 25% of mfr label if made from manufactured product --> Not greater than 6 months if USP or NF ingredient is source -Aqueous: 14 days, stored in cold place -All other: 30 days or intended duration of therapy Sources -USP or NF -Manufactured product with lot number, expiration date -PCCA

USP Guidelines General chapter <797>

Applies to sterile products and responsibilities of pharmacy personnel in their preparation Identifies standards for: -Low-risk, medium-risk, and high-risk sterile compounding -Verification of accuracy and sterilization -Training and evaluation in personnel aseptic skills -Environmental quality and control -Verification of automated devices for compounding parenteral nutrition therapy -Finished product release checks and tests -Storage and beyond-use dating -Quality control post-dispensing and distribution -Packaging, handling, storage and transport -Patient or caregiver training -Patient monitoring and adverse events reporting Requires a quality assurance program

REMS Requirements may include any or all of the following:

Assessments at 18 months, 3 years, and 7 years post marketing MedGuide or PPI development Communication plan to health professionals Plans: -Limit prescribing to physicians with special training -Limit dispensing to certified providers -Limit administration to certain settings -Limit distribution to patients with documentation of safe-use conditions such as lab tests -Monitoring for each patient using the drug -Enrollment of each patient in a registry REMS may apply to a drug class (Long acting opioids) or a specific drug (Tikosyn)

Definitions related to hospital pharmacy: WAC 246-873-010

Authenticated: authorized in writing in the record by means if signature containing at least first initial, last name, and title Drug administration: the act in which a single dose is given to a patient -Removing dose from previously dispensed container -Reviewing the order -Properly recording time and dose given Protocol- written set of guidelines Self-administration of drugs- patient administers his or her own meds from properly labeled containers (not same as PCA)

Complete directions for use- "UD" not allowed in WA

BC pills- " As directed on dialpak" Written schedules- "As instructed on written schedule from Dr." -Keep copy with original Rx -Estimate days' supply carefully Coumadin "Take 1 daily or as directed by physician" There are some exceptions when packaging/labeling provides the instructions

Emergency telephoned or Faxed Rx- Schedule 2

Bona fide emergency Sufficient quantity to last until written Rx can be provided Written confirming Rx must be postmarked or received at pharmacy within 7 days, if not received must notify BOP and/or DEA "Authorization for emergency supply" at top of telephoned (or Faxed) and written Rx Quantity on written confirmation must match telephoned Rx Staple written confirmation to telephoned Rx

Due Course of Practice

Bona fide patient-physician relationship Within scope of practice

Legitimate Medical Purpose

Bona fide prescriber-patient relationship Issued to treat a medical condition Not for "office use" Not fraudulent or forged Not issued solely to maintain addiction, except: -Methadone maintenance program -Office-based buprenorphine maintenance programs WA- prescriptions issued by a prescriber for his or her own use (considered unprofessional conduct) WA- may not dispense one's own prescription for controlled substances DEA has held that use must be within uses specified in package labeling Not for other statutorily specified exclusions -Anabolic steroids -Specified CNS stimulants for weight control

Side effects statement

Can be on label, but may be provided on: -On a sticker attached to package (on on label) -On preprinted vial cap -On a separate sheet of paper -In consumer medication information (ex. PIL) -In FDA-approved MedGuide containing the statement Know that it doesnt have to be on the label but can be included in the labeling

Schedule 2 faxes

Can fill a C2 from Fax if compare to original written Rx prior to dispensing Emergency supply Long term care facilities, may use as original -DEA says prescriber should have written agent agreement with RN in nursing home if RN is to act a "agent of the prescriber" to transmit orders by fax Homie infusion: injectables only, may use as original Hospice patients: may use as original -May be for a hospice patient who is being treated by the hospices at home

Pharmacist Administration of Drugs to Patients

Certification is not required to administer a prescribed drug (in scope of practice) -Certification part of prescriptive authority protocol to be able to order vaccine or other drug -Certification may be needed for payment Injectable drugs administered to pregnant women and children <3 years of age -No more than 0.5 mg of mercury per 0.5 mL dose -Flu vaccines: no more than 1 mcg of mercury per 0.5 mL dose -Use single-use vials that are preservative free whenever possible That mercury shit is referring to a preservative called thimerosal, most are preservative free anyway

Pharmacy Compounding Accreditation Board

Certification is voluntary but may be required by insurance companies for sterile compounding Evaluates compounding pharmacies compliance with 35 standards Certifies qualifying pharmacies -Non-sterile, basic -Non-sterile, complex -Sterile, low/medium -Sterile, high Labeling guidelines are extensive

Monitoring of therapy WAC 246-863-110

Collecting and reviewing patient drug histories Measuring and reviewing routine patient vital signs including, but not limited to, pulse, temperature, blood pressure, and respiration Ordering and evaluating the results of laboratory tests relating to drug therapy -blood chemistry and cell counts -drug levels in blood, urine, etc -Culture and sensitivities -when performed in accordance with policies and procedures or protocols applicable to the practice setting, -which have been developed by the pharmacist and prescribing practitioners -which include appropriate mechanisms fo reporting to the prescriber monitoring activities and results Protocols for lab tests need to be developed by pharmacist and prescribers and a copy must be in pharmacy, these protocols do not need to be filed with Commission (unlike CDTA)

Verbal Orders

Commission Rule: Verbal orders shall be issued in emergency or unusual circumstances, and countersigned within 48 hours Interpretive guideline -Allows for passive authorization: orders can be authenticated by review by other health professionals such as nurses and pharmacists Orders not subject to the passive authorization must be countersigned by the prescriber (Exclusions are specific to institution policy eg chemo) A quality assurance program must be in place Hospitals and long term care LTC facilities count in this

WRAPP: Commission Referral

Commission may refer licensee to WRAPP as an alternative to discipline Contract developed with licensee If contract completed, no disciplinary action is taken, and participation in program is kept confidential In case of discipline, WRAPP may be asked to monitor compliance

Information Required on a label of Legend Drug (WA)

Complete direction for use ("UD" not valid) Expiration date Quantity dispensed Name and strength of drug Initials of pharmacist "Warning: State or federal law prohibits transfer of this medication to any person other than the person for whom it is prescribed" Notice, Refills do not have to be on the label

Parenteral Products, Non-Hospitalized patients- WAC 246-871

Compounding must be done in Class 100 environment Must have polices and procedures- reviewed annually by PIC 040 (personnel)- there must be a pharmacist that has been trained in aseptic technique and QA (-070) Clinical services that must be offered: -Monitoring -Training -Administration (-080) Quality Assurance: -QA program reviewed annually -Errors, ADRs, Pt satisfaction, sterility -RCW 18.64.270 requires adherence to USP 795 and USP 797 when compounding products for administration to patients -USP 800 will come into play (-060) All antineoplastic medications shall be compounded within a certified Class II type A or Class II type B vertical laminar airflow hood.

Pharmacy Commission Rules: WAC 246-901: Ancillary Personnel

Consultation: -Between pharmacist and pt, agent, or provider in which pharmacist uses professional judgement to provide advice about drug therapy Verification by pharmacist -Review of order -Examination of profile -Approved order, taking into account pertinent drug and disease information to assure correctness of the drug order for a specific patient -Must generate audit trail that identifies pharmacist Immediate supervision -Visual or physical proximity to a licensed pharmacist to assure patient safety

Poison Prevention Packaging Act

Consumer Products Safety Commission to set standards for child-resistant packaging Requires child-resistant containers (CRC) on certain "household substances" Requires CRCs on all prescription drugs, except certain listed products Requires CRCs on specifically listed OTC products

National Provider Identifier- required by HIPAA

Covered providers (45 CFR 162.402-414) -Individuals: e.g., physicians, nurses, dentists, pharmacists, physical therapists -Organizations: e.g., hospitals, laboratories, ambulance companies, HMOs, pharmacies Must obtain NPI within 30 days of licensure (or update your information) Implemented on-line, National Plan & Provider Enumeration System (NPPES) Make changes to license status, address, etc., within 30 days, on-line.

Miscellaneous requirements for licensure

Criminal background checks required for providers of services to children or vulnerable adults Pharmacists required to report -child abuse or neglect -abuse of vulnerable adults Social security numbers are required to be submitted to DOH to obtain a license The pharmacists current license or photocopy must be displayed to the public in each pharmacy they working at Employer must have a copy and verify your license active If there is a restriction on license it will appear on license: This cannot be covered up. -A pharmacist with a license that has restrictions due to felony related to controlled substance violation cannot work in a pharmacy with an active DEA registration. -A pharmacist who is excluded from providing care to patients covered by a federal entity (ex. Medicare/Medicaid) cannot work in a pharmacy that bills a federal plan.

Electronic prescribing- Federal

Currently DEA does not recognize electronic signatures as valid for CSA prescriptions unless prescriber and pharmacy are using a system that is qualified under the e-prescribing rule -ScriptPro pharmacy systems are accredited and indicate on e-Rx if the prescriber's system has also been accredited Computer printed e-Rxs that are faxed are valid only if signed before faxing, according to DEA

Required Records for Pharmacies

DEA Registration Certificate Official Order Forms (222) Power of Attorney to sign order forms Initial inventory Biennial inventory records Reports of theft or loss (106) Inventory of drugs submitted to DEA for disposal (41) Records of transfers between pharmacies Inventory transaction records Must be maintained for 2 years

CSA Transfers (21 CFR § 1306.25) for controlled substances (III-V)

DEA Rule: "The transfer of original prescription information for a controlled substance listed in Schedules 3-5 for the purpose of refill dispensing is permissible between pharmacies on a one time basis only. However, pharmacies electronically sharing a real-time, online database (CVS) may transfer up to the maximum refills permitted by law and the prescriber's authorization." -Most pharmacies- one time basis means pharmacy must transfer all available refills to the other pharmacy -Shared database- may transfer any number from one refill to all available refills When transferring a controlled prescription record from your pharmacy to another, non-chain, pharmacy you must verify that you had the original prescription. This can be done through the software system, if capable, or by pulling the hardcopy.

What can be changed RPh on C2 Rx

DEA says follow state rules WA allows the following edits: -Add or change patient's address after verification -After consultation with prescriber, may changed or add -->Dosage form -->Drug strength -->Drug quantity -->Directions for use -->Issue date -Brand-generic changes -Add DEA number if known-no need to contact prescriber -May not change patient's name(other than spelling) or the controlled substance prescriber (other than brand/generic)

Other Important definitions

Deliver or delivery -Actual transfer from one person to another of a drug or a device Dispense -Interpretation of a prescription, and pursuant to that order, the proper measuring, compounding, labeling, packaging Distribute -Delivery of drug or device other than by administering or dispensing (no prescription involved) Compounding -The act of combining two or more ingredients in the preparation of a prescription (*State definition, Fed def: combining two or more active ingredients) Fed compounding -503a: traditional compounding pharmacy -503b: compounding and selling usually to hospitals -->WA does not recognize 503a and b, companies doing 503b compounding that sell to sellers must be licensed as a manufacturer wholesaler Labeling -Preparing and affixing a label to any drug or device container, all material to a patient with information Administer -the direct application of a drug or device by any means to the body of a patient or a research subject RCW 18.64.011

WRAPP: Self Referral

Details of self-referral to WRAPP are kept confidential and no notification is made to Commission as long as participant is compliant with monitored treatment program Program may require participant to voluntarily discontinue active practice during early phrase of treatment 800-446-7220

Pharmacy responsibilities in accepting an E-script

Determine that the pharmacy application has been certified to import, store and display -Information required for Rxs in 21 CFR § 1306.05(a) -Indication of signing as required in the rule -The number of refills -The prescriber's digital signature after verification Not process e-Rxs if the system is not compliant Limit access to specifically identified employees E-Rxs must be stored electronically with any required notations Fulfill pharmacists' corresponding responsibilities under CSA

Examples of Payment

Determining eligibility or coverage Preauthorization, utilization review Billing 3rd party payers, justification of charges Providing certain info to consumer reporting agencies Transmitting credit card charges Refunding charges

Drug distribution and control pt.2

Director maintains policies, with annual updates Pharmacist must see copy of order before drugs dispensed, except according to policies developed to handle emergencies Controlled substance accountability- Must have protocol in place to track and account for narcs Handling of recalls, ADRs, and error reporting- Must have protocol and process of documentation for these Labeling: -Inpatient. All drug containers in the hospital shall be labeled clearly, legibly and adequately to show the drug's name (generic and/or trade) and strength when applicable. Accessory or cautionary statements and the expiration date shall be applied to containers as appropriate. -Outpatients. Labels on medications used for outpatients, emergency room, and discharge drug orders shall meet the requirements of RCW18.64.246. Parenteral and irrigation solutions. When drugs are added to intravenous solutions, a suitable label shall be affixed to the container. As a minimum the label shall indicate name and location of the patient, name and amount of drug(s) added, appropriate dating, initials of the personnel who prepared and checked the solution. Medication orders. Drugs are to be dispensed and administered only upon orders of authorized practitioners. A pharmacist shall review the original order or direct copy thereof, prior to dispensing any drug, except for emergency use or as authorized in WAC 246-873-050

Washington revisions to Pharmacy Practice Act

Distribution of a compounded product by a pharmacy for "resale" is "manufacturing", not compounding -May be distributed for resale subject to approval by pharmacy commission (ex. shortages) Manufacturing does not include: -Office use: compounded on order of a licensed practitioner for use in practitioners professional practice for administration to patients (ex. lidocaine j tips) -Limited repackaging: Repacking of commercially available medication in "small, reasonable quantities" for office use by a practitioner -Centralized compounding: Distribution of a compounded product to other appropriately licensed entities under the ownership or control of the facility in which the compounding takes place (ex. compounding for clinics) -Delivery: Delivery of finished compounded products dispensed to "alternative delivery locations" other than patient's residence, or prescriber office, or to another licensed pharmacy to dispense to the patient (ex. CVS speciality)

Military Practitioners

Do not need to register with DEA May indicate branch of service plus their service ID number May obtain a DEA number MLPs in military must be specifically licensed in the state in which they are stationed to obtain DEA number To prescribe "off-base" need a separate DEA number

Public Health Service or Bureau of Prisons Employees

Do not need to register with DEA Use Social security number as DEA number

WAC 246-878: Good Compounding Practices

Documentation that patient and physician agree to use of a compounded product to replace a commercially available product Use of USP or NF products as first choice; otherwise pharmacist allowed to use judgment in selecting bulk sources Limit quantities compounded to need based on a history of receiving orders or to meet existing refills May sell compounded drug to a prescriber for administration to a patient (not for resale to patient) May promote compounding services, but not a specific product

Office-based narcotic maintenance programs

Drug Addiction Treatment Act of 2000 Allows office-based narcotic maintenance using buprenorphine Prescribers must obtain a DATA waiver -Are issued an additional DEA number with X as the first letter to use for these prescriptions Pharmacists may fill buprenorphine Rxs issued physicians, ARNPs and PAs with DATA waivers Pharmacists should only fill written prescriptions brought directly to them by the pt -Privacy rules are more stringent than HIPAA Only Subutex (buprehnorphine) 2 or 8 mg SL tablets, or Suboxone (buprenorphine and naloxone) 2 or 8 mg SL tablets (or their generics) may be used to fill these scripts Subutex or Suboxone may be prescribed off-label for treatment of pain, usually dosed 3-4 times a day. These drugs are Class 3 and no DATA waiver is required to prescribe these drugs for treatment of pain -Th prescription must state it is used to treat pain DATA waivers are only given to physicians, ARNPs and PAs

New Drugs (post 1938 FDCA)

Drugs may not be introduced into commerce unless: -Proven safe an effective for intended use -Inadequate labeling -Meet current Good Manufacturing Practices -Produced by a registered manufacturer

Minors Ability to Consent to Treatment in WA

Emancipated minors - 16 or over may petition court to become emancipated Minors married to a non-minor 14 or over - May consent to treatment for STDs Any age - May consent to contraceptives or pregnancy termination services 13 or over - May consent to inpatient or outpatient mental health treatment 13 or over - May consent to outpatient chemical dependency treatment

Only pharmacists, interns and techs may..

Enter a new medication order into the pharmacy computer system Retrieve the drug product to fill a prescription Stock remote dispensing devices (RNs may also do this) like Pyxis An assistant may stock the shelves, they cannot pull from the shelves

WRAPP- Washington Recovery Assistance Program for Pharmacy

Established 1983 by WSPA and WSSHP Goals: -Protect the health and safety of the public -Provide a health resource and rehabilitation support for the impaired pharmacist No fee for WRAPP services Costs of assessment and treatment borne by participant WAC 246-867-030 Reporting and freedom from liability. Basically, whether you self report or are reported by someone, everyone who is involved they are confidential- unless disciplinary action is taken- negligence, theft, etc

Federal Controlled Substances Act

Establishes a "closed system" of inventory and accounting for distribution of controlled substances 5 controlled schedules- based on likelihood of abuse Listed chemicals (precursors to controlled substances) Don't forget technically legend non-controlled substances are in schedule VI and OTC are schedule VII. There are 7 schedules, just 5 of them are controlled

Mandatory Self-Reporting

Every licensee of DOH must report to their disciplinary authority if they have conviction or whatever Consult an attorney before self-reporting

Mandatory Reporting of Unprofessional Conduct by other Licensees

Every licensee of the DOH must report to the disciplinary authority when they -Are aware that another licensee has been subject to a conviction, or found out they committed an act which constitutes as unprofessional conduct -Are aware than another licensee may not be able to practice safely as a result of a mental or physical condition -Basically, anyone licensed by DOH must report on another license holder -May report to Commission or to WRAPP

Medication Guides

FDA-developed patient labeling If required for a product or class, must dispense each time prescription is filled -Patient may request and must be supplied -Physician may authorize not dispensing MedGuide, but pharmacist not required to withhold it Where a MedGuide is required, it replaces the corresponding PIL NSAIDS the largest class requiring MedGuides Being required for most new drugs

Controlled Substances Acts

Federal Controlled substances act (CSA) -Statute in 21 USC § 801 et seq. -Regulations found in 21 CFR § 1301 et seq. -Enforced by the DEA, part of the department of Justice (headed by the Attorney General) Washington statutes -RCW 69.50- Uniform Controlled Substances Act -RCW 69.51- Controlled Substances Therapeutic Research Act -RCW 69.51A- Medical Marijuana -RCW 69.52- Imitation Controlled Substances -RCW 69.53- Use of Buildings for Unlawful Drugs Washington regulations -WAC 246-887: Regulations Implementing the CSA -WAC 246-889: Precursor Substance

What's the difference between a MedGuide and a Patient Package Insert?

Federal regulations are different for each MedGuides are required for those drugs that pose the most serious and significant public health concern- they are required to be distributed to the patients Drugs that have PPIs are generally not considered by FDA to carry the same serious and significant public health concerns as drugs with MedGuides

CSA Prescription Containers Must Bear the "Transfer Warning"

Federal: "Caution: Federal law prohibits transfer of this medication to any person other than the person for whom it was prescribed -->All CSA Rx Containers WA: "Caution State or Federal law prohibits transfer of this medication to any person other than the person for whom it was prescribed" -->All Rx containers (all drugs, not just CSA)

§503A. Pharmacy Compounding

For an identified patient Based on the unsolicited receipt of a valid prescription By a licensed pharmacist or a physician Think traditional prescription for a patient and made for them

Drug Product Selection

Generic substitution -Pharmacist responsible for choosing the product -Consider the ingredients, dose and dosage form called for -Same chemical entity -Same dosage form -Bioequivalent -Ex.: simvastatin for Zocor Therapeutic substitution -Same class -Equivalent therapeutic effect -Ex. atorvastatin for simvastatin

USP Guidelines General chapter <800>

Handling of Hazardous drugs Official Compliance Date: 12/1/19 Developed to promote safety for the patient, healthcare workers and the environment when handling HD's Responsibilities of oversight given to qualified personnel who handle HDs -Pharmacists and technicians included Must make a physical space available for HDs -Receipt and unpacking, storage, non-sterile compounding and sterile compounding of HDs OSHA requires hazard communication program -Strict training process describes how hazardous drugs should be handled, labeled and transported -SDS must be readily accessible for personnel -Personnel of reproductive capability must confirm in writing that they understand the risks of handling HDs Must train employees based on their job function -Assessed every 12 months -For new HDs and equipment they must be trained -Must document competencies Types of exposure -Dermal, mucosal absorption, inhalation, ingestion, injection EPA requires disposal of drugs to be manually sorted depending on drug category Must have a list of HDs Effects dispensing of final dosage forms, compounding (using dedicated equipment for HDs only), and administration techniques Spill control protocol requires Standard Operating Procedures (SOP) and documentation Groups of HDs determined by NIOSH: -Group 1: Antineoplastic -Group 2: Non-Antineoplastic -Group 3: Drugs that primarily pose reproductive risks to those actively trying to conceive and women who are pregnant or breast feeding --> Pharmacists responsibility to review the drugs added to the HD list

State registered domestic partners

Have the same rights as spouses

Prescribing by Pharmacists: Elements of Protocol on file with Commission

Identifications of authorizing prescriber and pharmacist who covered Time period up to 2 years Type of prescriptive authority -Types of diseases, drugs, categories, and type of authority (eg initiating or modifying) -General statement of procedures to be followed Activities required of pharmacist -Documentation of decisions made -Plan for communication or feedback to authorizing prescriber Note: Copy of CPA must be filed with Commission, but Commission does not "approve" the protocol

Disclosure to parent or guardians

If a minor is receiving mental health, STD, contraceptive, or substance abuse meds, presume they have control over record- get written permission to disclose to parents In other cases, parent or guardian must approve disclosures and may see records If parents divorced- may disclose to either parent

License Transfer

If already licensed by examination in one state, may transfer license to another state without retaking NAPLEX Many states won't allow transfer of a "transferred" license- Must maintain at least one license by examination -WA does not require this Must take WA MPJE within 2 years after transfer Keep license of the state you first became licensed in active

Faxes (DEA Rules)

If can be telephoned, it can be faxed Make sure Fax paper will be readable for 2 years or reduce to writing Pharmacist is responsible for verifying that Fax is not fraudulent -Should show originating number on fax -Fax machines are programmable -Call back prescriber at known phone to verify DEA is claiming that faxed Rxs must be signed before faxing with a wet signature DEA is claiming that faxed requests for refills by pharmacy cannot be used as the prescription and faxed back- prescriber must generate new Rx, sign it, and fax that to the pharmacy

de-identified information

If the following are removed then the remaining data by definition is de-identified info and not subject to privacy rule

Identification of ancillary personnel

If working in the pharmacy and having contact with patients; Must wear badges or tags identifying them as technicians or assistants Pharmacists are not required to wear name badges

Federal parmacists

Indian Health Service, PHS, armed forces, VA Must be licensed in at least one state or territory Do not need to be licensed in the state where stationed Cannot practice part-time outside of the installation unless licensed in that state fed pharmacists can keep active license to practice without paying fees or submitting for CA

Major sections of professional labeling

Indications and usage Dose and administration Dosage forms and strengths Contraindications Warnings and precautions ADRs DDIs Use in specific populations Drug use an dependence Overdosage Description Clinical pharmacology Nonclinical toxicology Clinical studies References How supplied, storage and handling Patient counseling information

Labeling: unit dose

Individual storage unit for each patient, clearly labeled with resident name, and labeled with physician name (RCW 18.64.570) Individual package must have the following: -Name of drug -Strength -Lot number -Expiration date -CSA schedule Pharmacy may re-use blister packed drugs that were un0used and returned to pharmacy of LTC and hospice programs

Pharmacy Commission powers

Issue subpoenas Assist law enforcement -Assist in helping law enforcement on complaints of violating legend drug act or controlled substances laws, offer educational programs to prevent diversion (WRAPP) Enter into written agreements with other state and fed agencies -Things like drug diversion, and have to work with healthcare service contractors and health care providers to assist and provide Employees of DOH, designated by Commission as enforcement officers, are vested with police powers and declare to be peace officers

DEA numbers

Issued to registered practitioners, institutions, pharmacies, etc. Format: AA1234567 2 letters plus 6-digit number plus "check digit" -->1st letter: usually "A," "B," or "F" for physicians, dentists, etc., and "M" for MLPs -->2nd letter: usually first letter of registrant's last name (may be former last name or a number) MLP: mid level practitioner (1st + 3rd + 5th) + 2 (2nd + 4th + 6th) = last digit is last digit of DEA #

Corresponding Responsibility of Pharmacist

Knew or should have known Medical vs non-medical uses Civic duty to prevent/report crime vs professional duty to treat Right to protect self from being forced to act illegally or from being put at risk of acting illegally Right to protect self from damage claims

Misbranded

Labeling/misleading Incomplete labeling Misleading/false labeling -From the Wiley Act

Prescriptions must be legible in WA

Legible means "Capable of being read and understood by the pharmacist filling the prescription or the nurse or other practitioner implementing the medication order" (RCW 69.41.010 (11)) "A prescription must be hand printed, typewritten, or electronically generated" Pharmacist cannot read script and doesnt clarify information, the pharmacist can be held liable if harm results

Additional Requirements

Limited quantities may be compounded prior to receiving a prescription Based on a history of the pharmacist receiving valid orders Within an established relationship between the pharmacist, physician, and patient

Override list

List of emergency medications which are subject to retrieval without prospective pharmacist DUR -Tailored to each facility based on needs --> Determined by PSC or P&T committee -This is the list of drugs you can take out of the machine in an emergency

RCW 18.64.580-Closed door pharmacies

Long term care pharmacies-Ratio of pharmacists to techs- Standards The commission must adopt reasonable, task-based standards regarding the ratio of pharmacists to pharmacy technicians in a closed door long-term care pharmacy If tech is performing admin tasks and not associated with immediate dispensation of drugs, they are not considered part of tech ratio

WA Authorizes to prescribe...

MD or DO- all schedules DMD, DDS- all schedules DVM- all schedules PodD,DPM- all schedules ARNPs- all schedules authorized by their state to prescribe CSAs PA-C- all schedules approved by supervising physician ^Any of the above in any state in the US British Columbia physicians, NPs, and PAs can prescribe legend drugs but not controlled unless they have a US DEA

Drug distribution and control in hospitals: WAC 246-873-080

MUSTS: -Control of all drugs throughout hospital -Monthly inspections of all areas where drugs are stored or used -Monitoring of drug therapy -Provision of drug information to patients, physicians, others -Surveillance and reporting of ADRs SHOULDS: -Obtaining and recording drug use histories and discharge planning -Preparation of all sterile products -Distribution and control of all radiopharmaceuticals -Administration of drugs -Prescribing

Physical and occupational therapists

May NOT prescribe May order and use certain legend drugs (from a wholesaler and for office use) -Topical anti-inflammatories -Topical anesthetics -Silver sulfadiazine (PT only) May administer prescribed drugs appropriate to physical or occupational therapy

Self-administration of medications (SAM)

May be done under a policy and approved protocols in a program of self-care or rehabilitation Policy must be developed by Director of pharmacy and approved by admin, medical, and nursing staffs This is not the use of a PCA In SAM, patient has control of their own meds and dosing

Therapeutic selection in WA

May do "Therapeutic Selection" based on prior authorization from prescriber -Protocol, formulary -Per-prescription basis Blanket prior authorization can be verbal, but are required to have documentation of authorization in the pharmacy Substitution using prescriptive authority protocol is not really product selection, but prescribing RCW 69.41.100

Filing CSA Rx's in WA

May do CII, CIII-CV, Legend all separate; OR C2 alone and CIII-CV/Legend together

Prohibited Products

May not compound products that are listed by FDA as having been removed from market due to lack of safety or efficacy May not compound "regularly or in an inordinate amount" products that are essentially copies of commercially available drug products May not compound products that are listed by FDA as having demonstrable difficulties in compounding Ex: -Dry powder inhalers -Metered dose inhalers -Transdermal delivery systems -Sterile products not in chapter 1206 of USP

Pt Request for Accounting of Disclosures

May request an accounting of disclosures of PHI made in the last 6 years prior to the request Do not have to account for disclosures: -Made to the pt, to carry out TPHCO, that were authorized by pt, to persons involved in pt care If provider has E records set up, then must make accounting for all disclosure for past 3 years No charge for 1st accounting within 12 month period, reasonable cost-based fee may be charged for additional responses within 12 month period

Pt Request for Confidential Communication of PHI

May request that contacting the pt be restricted to particular address, telephone, or electronic address Will acknowledge that this may restrict communication to family or caregivers -Note: WA regulation already restricts communication with family who are not obvious agents or caregivers (No sneaky aunts allowed)

Retaking failed exam in WA

May take licensure exam up to 3 times within 3 years. Ifa fail 3 times, may not retake unless have met stipulations set by the commission. This applies to NAPLEX and MPJE (RCW 18.64.020) If fail the MPJE 3 times, the stipulation is to take a qualified pharmacy law course or Commission-approved directed study or tutorial (WAC 246-863-020)

Pharmacy Quality Assurance Commission

Members appointed by the governor Executive officer hired by Commission Executive officer reports officer reports to Undersecretary of DOH for Health Systems Quality Assurance Staff are employees of DOH, Health Professions Quality Assurance Division Commission currently has own investigators within HPQA pool Inspectors and investigators are now in two different groups Licenses paid to HPQA Office

The mature minor doctrine

Minors "capable of understanding or appreciating the consequences of the medical procedure" may consent to non-emergency medical procedures based on the health care provider's evaluation of the child's: -Age, maturity, experience, general conduct as an adult, intelligence, training, economic independence, freedom from the control of parents

Consent Requirements in WA

Minors: -Emancipated minors are treated as adults -Minors married to a person who is not a minor are treated as adults -Patients with STDs or HIV must consent Abuse or neglect of a child or vulnerable adult must be reported General speaking, health care information can be shared with others who are thought to be involved in the care of the patient or potential danger by being around the patient. Providers cannot disclose information about a patients with STDs or HIV status, and some treatments for mental health.

Law Exams

Most states require some form of law exam for licensure (attestation in ID) MPJE -Used in 47 states (all except AR, CA, VA, Guam, Pueto Rico) 2.5hr computer adaptive exam- 120 questions (only 100 count, scaled passing score of 75)

Multiple Prescriptions Written on Same Date

Multiple Rxs for single substance and patient, written and signed on same day are allowed when: -No more than 90-day supply is authorized -Each Rx after the first includes instructions indicating the earliest date on which the pharmacy may fill the prescription -The prescriber concludes that this does not create an undue risk of diversion or abuse Pharmacists may not fill the Rx prior to the date indicated in the instructions This does not create a 90-day limit on amount of controlled substance that can be on a single prescription Only valid where state law allows: i.e., ok in WA, not ok in ID

WA vs Patriot Act Meth Precursor Provisions: Sales Limit

Must be at least 18 years old to purchase in WA, with valid photo ID. Limited purchasing quantities, unless patient has a prescription.

Prescriptions under DWDA

Must be for a drug the patient can ingest on their own -No injectable drugs ay be prescribed Physician may dispense drug directly to patient or with pt's permission, to a pharmacy -Must deliver Rx directly to pharmacist or by Fax Pharmacist must deliver Rx directly to physician, patient, or an agent specified in the Rx

Wholesalers

Must be licensed by Commission Pharmacies do not need to register as wholesalers in order to engage in "the sale or trade of a drug for emergency medical reasons -Transfers to another pharmacy or practitioner must not exceed 5% of total prescription sales in a 12-month period for both the supplier and purchaser Wholesaler sales of EPP are restricted: -March-October: cannot exceed 5% of prior month's total sales -Nov-Feb: cannot exceed 10% of prior months total sales

Practitioner's e-Signature

Must be verified by 2 of the following 3 forms of authentication -A biometric (fingerprint) -Knowledge factor (password) -Device separate from computer (hard token, like a fob) Rx's will be transmitted to the pharmacy as either -Digitally signed -Accompanied by digital certificate that they were digitally signed

Components and Methods

Must comply with USP or NF monographs, if they exist, and the USP Chapter on Pharmacy Compounding If no monographs exist, are made from components of approved drugs or are components that appear on a bulk ingredients list developed by FDA--> Must be manufactured in an FDA registered FDA facility PCCA is a great resource for help

Requirements for containers

Must meet USP standards for tightness, light resistance May not be reused Because 1 in 5 children can open, by design, never refer to these containers as "child-proof"

Electronic prescribing

Must meet standards for security and integrity Must be approved by Commission- approved systems listed on web site Staff must sign and adhere to security and integrity policy and procedures Must allow for communicating preferences for substitution Pharmacist responsible for accuracy, validity, and authenticity of the order Faxes no longer considered a form of electronic prescribing, but considered an image of a written prescription C2 are allowed via electronic prescribing as long as the prescriber and pharmacy are in compliance with regulation by the DEA