Law Review

A patient comes to your pharmacy asking whether they could obtain naloxone due to concern that a close friend may be at risk of overdosing. Is it legal for the friend to possess naloxone even if he is at no risk of overdose himself? How can he obtain this medication?

(RCW 69.41.095) - Any person or entity may possess, store, deliver, distribute, or administer an opioid overdose medication pursuant to a prescription or order. - A prescriber (or a practitioner under a standing order, protocol, CDTA) can prescribe, dispense, distribute to 1) a person at risk of overdose, 2) to a first responder, family member, or any person or entity in a position to assist a person at risk of an opioid overdose

From an FDA standpoint, what is the difference between a 503a and 503b facility?

503A facilities are pharmacies licensed by a state and engaged in good-faith practice of pharmacy and compounding to the following standards - Receipt of a prescription for an individual patient - Limited quantities may be prepared in advance of a prescription - Components comply with USP or NF monographs and must be manufactured in and FDA registered facility - Not include prohibited products 503b facilities are Outsourcing Facilities that - Do not need to have a prescription - Are registered with the FDA - Cannot be a wholesaler - Comply with Good Manufacturing Process regulations and pay an annual fee - Are the only source for "office use" compounded products - Does sterile compounding (but can also offer non-sterile in addition)

Would the paperwork be different for a CS transfer if the medication was a CIII-CV medication instead of CII?

No 222 forms are required. Just use an invoice with the address and DEA number of each registrant.

When does a parent have legal control over a child's records? What are the exceptions?

In most cases, parents have control over a child's PHI Exceptions: Emancipated Minors or Minors that fall under "Mature Minor Doctrine" STD Tx for > 14yo Birth Control/Abortion at any age 13+ outpatient mental health treatment 13+ outpatient substance abuse treatment

When is it appropriate to fill an out of state Rx?

Out of state Rx are ok for these prescribers: MD, DO, DMD, DDS, DPM, PodD, DVM, ARNP, PA, PA-C. Others are not allowed. - In general, should follow the rule of the state in which it came from. Substitution should be done based on the laws from where the Rx is from.

The patient's provider orders a PRN albuterol HFA. As these are not stocked on the wards, the patient's nurse calls to request one. What is required to be on the label prior to providing the albuterol HFA to the nurse?

Patient name, drug name, drug strength, expiration date, and accessory or caution statements as appropriate (WAC 246-873-080, section 5a)

Assume that this is a prescription for a patient's chronic pain. Is it legal for the prescription to be written and filled for a 90 day supply of medication? If so and the insurance only covers a 30 day supply, can the single 90 day prescription be split to allow for 3 fills of 30?

(21 CFR 1306.12 and 1306.14) - There are no Federal (DEA) restrictions on how many days supply a single CII prescription is written for, so a single Rx can be a 90-day supply. - C-II Partial fill laws would not support the splitting to 3 fills of thirty. - The prescriber should issue three 30-day prescriptions, each dated with a do-not-fill date

Since there is no pharmacy service in the evening, is the emergency department allowed to dispense drugs to patients?

(RCW 70.41.480) (WAC 246-873-060) - Only if the patients being discharged have no reasonable access to community pharmacy or hospital outpatient pharmacy - Policies and procedures must be in place as to what types of medications can be dispensed and how they are pre-packaged. - No more than a 48 hour supply unless community or hospital pharmacy services will not be available within 48 hours, in which a 96 hour supply is the max. - The practitioner must counsel the patient on the medication - The medication must be pre-packaged by the pharmacy with specific labeling (Name, address, phone of hospital, name of drug, strength, cautionary information, expiration date, directions for use) - The order must be kept available for future review by the pharmacist

You are a new employee at a long-term care pharmacy and just got a request from a new facility for an emergency kit. What is an emergency kit? Describe how the emergency kit functions.

(WAC 246-865-030) - These are medications supplied to a SNF or Hospice Program (not other settings) for emergency administration by authorized people of the facility pursuant to a valid prescription. - The idea is if there is an urgent medical need, the facility can have immediate access to these medications without needing the pharmacy to send it. - What's in it is determined by the pharmacy and the facility's pharmaceutical services committee

What is the difference between an LTC emergency kit and a supplemental dose kit for unit dose systems?

(WAC 246-865-040) a. A supplemental dose kit is for non-emergency drug therapy in SNF settings only. This is to be used in a unit dose system.

How do controlled substances need to be stored in a long-term care facility? Does this change based on the schedule of the drug?

(WAC 246-865-060) - All meds must be stored away from unauthorized access - CII must be stored separate from other drugs and must have a separate key and lock from other meds. - CIII drugs must be stored away from other drugs but may be stored on separate shelf, drawer, or compartment with CII drugs.

You recently moved to a new town and found a job in a pharmacy that has a large front-end area selling gifts, OTC medications and beauty products. Currently, the hours for the entire store are the same, but the owner has told you that she wants to keep the rest of the store open at times when the pharmacy is not. What documents are required to allow the store to be open hours that the pharmacy is not? What signage is required?

(WAC 246-869-020) - A differential hours application must be submitted at least 30 days prior to commencing, and the PQAC must inspect the pharmacy and approve the application. - A sign showing pharmacy hours must be present at the entrance to the establishment AND must be displayed at the pharmacy.

Can medications be returned to a pharmacy? When is it allowed?

(WAC 246-869-130) - In general, not allowed once left premises - Drugs that were legally dispensed in unit dose forms or in sealed vials/ampules where the RPh can determine whether entry was made + whether met storage requirements. Nothing that was handled by a patient can be returned. - Hospitals and LTC Facilities can do return/reuse of unit dose pkg or medication dose cards which the RPh can determine whether entry to the pkg was made or not. Meets: Drug stored in proper conditions, drug never come into possession of the patient, packaging is not altered/defaced so that identity of drug/potency/lot/exp retrievable - Ctrl substances shall not be returned except for destruction per DEA

What medications from long term care facilities are allowed to be returned to the dispensing pharmacy to be reused?

(WAC 246-869-130) - Any medications that are in a patient specific container cannot be returned. - Yes under specific circumstances: unit dose or modified unit dose, LTC or hospice program

The patient wants to obtain non-child resistant caps for this medication. What are the different ways that a patient can obtain non child-resistant caps?

(WAC 246-869-230) - Prescriber authorizes it on the prescription for that fill - Patient or patient's agent requests it in writing on the back of the prescription, a permanent record, or on the medication record. The indication of non-CRC must be put on the pt record

You are a new employee at a rural hospital in Washington. You realize that the hospital does not have 24-hour inpatient or outpatient pharmacy services. You are wondering what the rules and regulations are regarding this. In the absence of a pharmacist, who is allowed to access the pharmacy to obtain medications?

(WAC 246-873-050) - A single designated registered nurse may obtain drugs from the pharmacy. There must be policies and procedures. - The stock container and order must be available for inspection by the pharmacist.

Does a pharmacist have to provide prospective drug review (Pro-DUR) for all drug orders before they can be administered even if the pharmacy is closed?

(WAC 246-874-040) - In general, a pharmacist must perform a prospective drug review for a drug order with exceptions when the pharmacy is open. - If the inpatient pharmacy is closed, but there is remote order entry/verification, they should provide verification of orders. - If none of the above, the pharmacy must provide a RETROSPECTIVE drug review within 6 hours of the pharmacy opening.

What PPE is necessary for administration of hazardous drugs to patients? What type of equipment is necessary?

- 2 pairs of chemotherapy gloves, chemotherapy gowns are needed if using injectable HD - Closed system transfer devices are necessary for injectable products

You are a generous staff member and are willing to borrow hydromorphone 4mg tablets from a nearby pharmacy in the same chain. What documentation does the pharmacy need per law to transfer the medication? How should the DEA 222 forms be utilized?

- A DEA 222 form or electronic equivalent must be submitted. Triplicate DEA 222 forms still exist but are being phased out by Oct 31, 2021. - The original form is filled out by you (purchaser) and you make a copy for your records - The original form is given to the other pharmacy (supplier), who fulfills the order and keeps the original form on file - The purchaser annotates on the copy the amount of product received and date it was received - The supplier fills out the amount of product supplied and the date it was supplied. - The supplier sends a copy of the 222 form to the DEA either by mail or email. For the old triplicate forms, the process is similar, but the forms are as follows: - Form 1 (Brown) - Goes to supplier - Form 2 (Green) - Goes to DEA - Form 3 (Blue) - Goes to purchaser

What is required in an order to be considered legal to be dispensed from an ADDD?

- A chart order requires: patient's full name, date, drug name, strength and form, directions, and signature - can be electronically sent as well, or phoned by agent of prescriber

Valid transfers of medications from one to another, assuming the pharmacy is not registered as a wholesaler or manufacturer

- A community pharmacy transferring their entire stock of Truvada to another pharmacy in the same chain. - A hospital pharmacy transferring a significant portion of Truvada to one of its HIV clinics registered as an HPAC - A community pharmacy transferring their entire inventory of medication to another due to the pharmacy permanently closing - A community pharmacy may NOT transfer their entire stock of Truvada to a local HIV clinic for their use WAC 246-879-010 - Intracompany transfers of medications are valid between pharmacies of the same chain or hospital is allowed. An HPAC is a hospital pharmacy associated clinic, which is registered under the hospital pharmacy license. The hospital can store and move drugs to that clinic since it is under the hospital pharmacy's ownership and responsibility.

You are a pharmacist inspector from the PQAC and have been tasked to inspect different types of facilities. What is true about the pharmacy self inspections?

- A self-inspection must be done annually using the worksheet (completed in the month of March) - Every change of responsible manager - Extra addendums are required for: Hospital, Long Term Care, Nuclear Pharmacy, Nonsterile compounding, Sterile Compounding.

A prescriber calls your pharmacy asking about the new Washington State opioid prescribing requirements. What is the difference between acute pain, subacute pain, and chronic pain per WA law? How many days of opioids are able to be prescribed based off of these descriptions? (WAC 246-817-906)

- Acute pain is the normal pain due to procedures, disease, or trauma. Considered to be < 6wk in duration. 7 Days unless clinically documented. - Subacute pain is pain that lasts 6-12 weeks in duration and is continuation of acute pain. 14 days unless clinically documented. - Chronic pain is pain that lasts past the acute healing or disease. May or may not be associated with current pathologic process. No limit of prescriptions, but needs a written agreement.

Controlled substance inventory

- All controlled substances must be counted - Exact count for all CII and then any other CIII-V only need estimated count, unless container has > 1000 tablets/capsules - Inventory must be done either prior to open of business or after it closes for the day - C-II records must be separated from C-III to C-V records - Inventories do not get submitted to the DEA. They must be kept on file for 2 years

What kind of recordkeeping is necessary? Do all meds used from the LTC emergency kit need to be used with an order from a provider?

- All meds used from E-Kit must be used via a valid order from prescriber. DEA also notes that controlled substances must be issued via a valid prescription. E-Kit items don't need to have orders reviewed by pharmacy prior to use. - List of contents must be posted on/near the kit - Current contents, records documenting receipt and removal of drugs must be maintained and open for inspection.

How does CSOS (controlled substance ordering system) ordering work? Does the pharmacy still have to fill out DEA 222 forms if ordering via CSOS?

- Allows for electronic ordering of controlled substances, especially CII drugs. A CSOS certificate is what the pharmacy must obtain, and this will allow for digital signing of controlled substance orders. - The DEA registrant (CSOS Coordinator) and powers of attorney with CSOS Power of Attorneys can order via CSOS - Do not need 222 forms, though having backup forms is a good idea in case CSOS certificate expires, or the computer fails.

You are now inspecting Wellness Hospital Pharmacy and its associated Hospital Pharmacy Associated Clinic (HPAC), Live Long Clinic. What is true about HPACs?

- Any healthcare professional is able to dispense medications that they are allowed to prescribe. Note that these medications must be labeled just like the medications from a pharmacy. - Medications supplied by the hospital pharmacy are under their responsibility. Medications can be ordered by a facility or healthcare provider under their scope of practice from a wholesaler. - HPAC need to be listed under the hospital pharmacy license to be considered an HPAC - HPACs do need to do a physical inventory of C-II and C-III drugs at every nurse shift change if there is no ADDD, just like a hospital setting.

You drop a bottle of Adderall 10 mg pills and a significant amount spills. Do any DEA forms need to be filled out?

- Breakage and spillage is not considered a "loss". Ideally the damaged drug should be sent back via a DEA registered reverse distributor. A DEA 41 form should be kept on file, not sent to DEA, and the method of destruction must be witnessed by a secondary authorized employee. (See Section V of DEA RPh Manual, Part D "Breakage and Spillage" section - If sending the CII to the reverse distributor, a DEA 222 form should be sent by the reverse distributor to you. Follow DEA 222 form directions as if you were the supplier.

What are the components that can be changed on a CII prescription? What cannot be changed?

- CANNOT change Pt name, the drug name (other than brand/generic), prescriber signature - Can change almost anything else.

What are the illnesses that a prescriber can authorize marijuana for?

- Cancer, Epilepsy, HIV, PTSD, Chronic Renal Failure needing HD, Crohn's Disease, Glaucoma, Hepatitis C, Intractable Pain, MS, Spasticity Disorder, Traumatic Brain Injury, a disease that results in nausea, vomiting, wasting, appetite loss, cramping, seizures, muscle spasms, or spasticity. Note there is no "other" category.

Which patients are exempt from the WA opioid prescribing laws?

- Cancer, palliative, hospice care - Inpatient hospital treatment - Procedural premedications

In the community pharmacy setting, when is FDA med guide required to be dispensed along with the product?

- For drugs that FDA requires a med guide - Must be given each time the medication is dispensed, when there is a change in the information on the med guide, and when pt requests - If dispensed to a clinic, only the first time it is dispensed does it need to be given to patient

Your compounding pharmacy, which also does sterile compounding, is working to ensure compliance to USP 800. What classes of drugs do USP 800 refer to? What resource lists those drugs?

- Hazardous drugs from the NIOSH list. - Drugs can be excluded if a risk assessment is performed and the drug is a final dosage form of an HD product and doesn't require further manipulation.

How should PPE, hazardous waste, and hazardous drugs be disposed?

- Hazardous waste must be kept separate from regular waste - All outer PPE must be discarded in a yellow trace chemotherapy waste container - Trace waste (empty vials, empty bags, etc) will be discarded in a yellow trace chemotherapy waste container. - Bulk waste (with visible amount of antineoplastic) must be thrown away in a black container, which should be reverse-distributed to be disposed by a waste facility.

Are faxed prescriptions for CII prescriptions legal? In what circumstances?

- In general no. - Faxes may be used for LTC facilities, hospice patients, and home IV products and use it as the hard copy. These must have a wet signature and are not electronically signed - Alternatively a faxed copy can be utilized for an "emergency supply" assuming the prescriber delivers a written Rx to the pharmacy within 7 days

When do controlled substance inventories need to be completed? How long do these files need to be available for inspection? Would this change if you worked in hospital or long-term care pharmacy?

- Initial Inventory (even if 0) | Biennial Inventory (every 2 years) | When a controlled substance is newly controlled or rescheduled | When business closes or is transferred - 2 years - No changes in total inventory requirements, but note in hospital CII must have perpetual inventory, CII and CIII drugs must be counted at change of shift

What are the requirements for a pharmacist to work in a nuclear pharmacy?

- Licensed as a pharmacist in WA - Completed a 6 month on the job training program under supervision of a licensed nuclear pharmacist or completed a nuclear pharmacy training program in a college of pharmacy. - Has a certification from PQAC that the person is a nuclear pharmacist

Naloxone and pain specialist consultation re opioid laws.

- Mandatory Pain specialist consultation when > 120 MED, Naloxone must be considered and discussed at 50+ MED - Exceptions: (246-919-935) Pt is tapering, pt needs acute pain Tx, Pt's pain and function is documented as stable and is not escalating. - Physician exempted when (246-919-940) - MD is a Pain management specialist | Minimum 3y experience in chronic pain mgt and at least 30% of current practice is direct provision of pain mgt | Physician completed minimum of 12 CE hours on chronic pain mgt within previous 4 years, and at least 2h in substance use disorders | Physician is pain management physician in a multidisciplinary chronic pain treatment center

Is a pharmacy legally allowed to sell marijuana products?

- No, federal law prohibits dispensing of cannabis, which is schedule I - CBD or Hemp products with THC < 0.3% are exempt - Dispensaries are only allowed to sell cannabis products and paraphernalia. Nothing else. Not even a Tee shirt - There are FDA approved THC and CBD derivative products that can be prescribed for certain indications

What is nuclear pharmacy? What type of products does nuclear pharmacy produce? Describe the general tasks that a nuclear pharmacist is involved with.

- Nuclear pharmacy is a specialty of pharmacy that makes radiopharmaceuticals to deliver radiation doses. These can either be used for diagnosis or therapy. - Nuclear pharmacists do things like regular pharmacists

What are the OBRA-90's counseling requirements and how do they differ from WA requirements?

- OBRA-90 is a MEDICAID requirement, with an OFFER to counsel. Sets specific items that pharmacist should be prepared to discuss with patients. - WA requires counseling the patient or the patient's agent for all prescriptions, though the RPh shall determine the amount necessary and reasonable (246-869-220)

You decide to give the patient a partial fill of the CII medication. Describe how partial filling is allowed for CII medications.

- Original federal law, the pharmacy can partially fill, and the remainder must be FILLED within 72 hours or not at all. If the remainder can't be filled, it is voided and the prescriber notified. - If patient is terminally ill or in a nursing home, may partially fill for up to 60 days from date written. - Comprehensive Addiction and Recovery Act (CARA Law) allows partial fill of a CII drug by the patient or prescriber (has to be initiated by them). The remaining portions may be filled no later than than 30 days after the date in which the Rx is written.

The pharmacy has a new staff member who is not very familiar with medication disposal. He recalls hearing of P-listed and U-listed drugs but is not sure what those are. Name a few examples of each kind and how they should be handled differently.

- P-Listed: Epinephrine, Nicotine, Warfarin > 0.3%, Phentermine, Physostigmine, Arsenic - U-Listed: Cyclophosphamide, Daunorubicin, Melphalan, Warfarin < 0.3% - P and U listed wastes must be segregated and labeled. - P listed bottles are not empty until washed 3 times. The solution and any wiping materials all go into P listed disposal. - U-Listed containers are considered empty if less than 3% weight remains

You are inspecting a pharmaceutical wholesaler. As an inspector, you know that a wholesaler can sell medications to who?

- Pharmacies - Practitioners (like physicians) - Other Wholesalers - Shopkeepers WAC 246-879 A wholesaler may sell to any entity that is legally allowed to possess or prescribe medications. A wholesaler may not sell to individual patients. A practitioner generally gets their medications for office use directly from a wholesaler. A shopkeeper is a retail outlet, like a grocery store without a pharmacy.

Can prescriptions be dropped off when the pharmacy is closed? Can calls be made to the pharmacy when it is closed?

- Prescriptions can be dropped off but must be dropped off in a "mail slot" or "drop box" - The pharmacy must have a separate line from the rest of the establishment unless all calls are recorded for the pharmacist review. - Prescriptions can be called in on a recording device. This phone number must either be of a different phone number than the rest of the establishment OR all phone calls made on that phone must be saved and played back to the pharmacist.

When the pharmacy commission hears a case and decides on sanctions, what are sanctions that the pharmacy commission can discipline the pharmacist?

- Sanctions: Fine, Suspension, Revocation, Probation, Limiting Practice (such as can't be a preceptor), Needing CE or re-education - The commission CANNOT do things like: Incarcerate, enforce contracts or payment of contracts.

Can all pharmacy staff work with hazardous materials? What kind of training is required and does this need to be recertified?

- Staff must be trained and have documentation of training and recertification every 12 months - They also must be retrained when a new process, new hazardous drug, or new equipment is used.

Can the prescriber write a prescription for marijuana for a pt w/ a terminal illness? What is the process?

- Technically no. There is a distinction between a prescription and an authorization for marijuana. Patients can be "authorized" by a provider. - Patients can get an authorization if they are a resident of WA, have a treatment plan, have a qualifying condition, and the prescriber fills out an authorization form with a specific type of tamper proof paper. - Authorization allows the patient to possess more cannabis, grow it. Patients can further go and register to get a medical marijuana card that allows for more liberties including purchasing high THC items, have it tax free, and have arrest protection.

How should a pharmacist counsel if the patient is not present and a family member picks of the medication?

- The law states that the patient or the patient's agent should be counseled on the medication. The family member counts as the patient's agent. Counsel the agent. - If Rx is delivered, then there must be in writing information how to contact the pharmacy for direct counseling and information about the drug. Do this if you have any inclination that the person picking up for patient is not fit to be the agent of the patient.

Prior to completing the setup of the PCA, the patient is in severe pain and the provider orders a one-time dose of hydromorphone 1mg. There are pre-filled 2 mL syringes containing hydromorphone 1mg/mL in the PARU ADDD. What must occur after the order is placed for the patient's nurse to be able remove the dose from the ADDD? Since the dose requires the nurse to only use half of the volume of the prefilled syringe, what must the nurse do with the remainder of the syringe after administering the dose?

- The nurse must wait for the order to be verified by a pharmacist in order for a prompt to administer it to be viewable, for a drug label barcode to be scannable, and for the drug to show up in the list of a patient's active medications to allow for removal from and ADDD. [WAC 246-873-080, Section 6] - Once the order is verified, the nurse must access the ADDD via fingerprint, "dispense" the drug from the ADDD using the patient's active list, scan the barcode of both the drug and the patient's ID wristband, then administer only 1mL of the syringe to accurately dose. - The remainder of the syringe must be destroyed using a locked discard container in the ADDD. The nurse must access the ADDD via fingerprint, indicate a partial dose was given for the correct patient, and have a second nurse witness the remaining dose and it's destruction by documenting their fingerprint as well. [WAC 246-873-080, Section 7d]

Due to the COVID-19 situation, the prescriber is unable to provide a written or electronic prescription for this patient with excruciating pain. The prescriber would like to call for an emergency C-II prescription. What are the legal requirements to allow this to happen?

- The pharmacist must write on the verbal prescription "Order for an Emergency Supply" and the written prescription must be marked as the authorization for an emergency supply. - A written prescription for the emergency supply must be delivered to the pharmacy within 7 days. If not received by then, the pharmacy must notify the PQAC and DEA

You are opening a new community pharmacy and need to ensure that you have the right paperwork to order and obtain controlled substances. Which forms do you need to submit to obtain certification to order controlled substances?

- The pharmacy needs to submit a DEA 224 - The pharmacy must also register with the PQAC to get authority to possess and dispense controlled substances

What if this were a controlled substance or a CII? Pharmacy selling to veterinarian for use in their hospital due to a temporary shortage.

- The practitioner must have a DEA number and otherwise legally be able to possess and administer controlled substances - Otherwise follows similar rules and 5% rule, but the DEA 5% rule is not the gross dollar value but instead the total number of dosage units of all controlled substances it distributes within the year. Pharmacies that exceed the DEA 5% rule must register with the DEA to be a controlled substance distributer. - If a CII is transferred, a 222 form should be used as if it was transferred between pharmacies.

What labeling is required on nuclear pharmacy products? (WAC 246-903-020)

- The product must be shipped in a double container, with an inside "immediate container" and an outside "immediate outer container" - The immediate container must have: Standard Radiation Symbol, "Caution-Radioactive Material", Name of the nuclear pharmacy, Prescription number, Name of radiopharmaceutical, Date, The amount of radioactive material in millicuries or microcuries - The immediate outer container must have: Standard Radiation Symbol, "Caution-Radioactive Material", Name of radiopharmaceutical, Amount of radioactive material contained in millicuries or microcuries, volume in milliliters if a liquid, the requested calibration time for the amount of radioactivity contained, expiration data, concentration of radioactivity.

In the inpatient setting, when are medication guides required to be given to the patient?

- When patient requests - When REMS requires it - Package insert for estrogens and OC are required at first dispensing/use and every 30 days in hospital settings

In what settings do a patient not have to be counseled? Can patients decline counseling?

- When patients are administered medications. - Patients may decline medication counseling, but not to a technician. They must decline to the pharmacist - Note: With any treatment that is administered, a patient must provide informed consent. They may not have to be educated by a pharmacist about the medication, but they still should be educated about the benefits and risks of treatment by the provider

After many years of operation, the pharmacy decides to close. When must the PQAC be notified of closing and what information must be provided to them? What about with the DEA?

15 days prior to closing, notify PQAC: - Date of closing - Who will have custody of pharmacy records - Who will have custody of all legend drugs Notify the public/patients: - Date of closing - The pharmacy who will have the prescription records of the patient after closing - How patients can transfer prescriptions to another pharmacy and the last day that this transfer can be done Within 15 days after closing the PQAC needs to get pharmacy License and a written confirmation of: - Where the pharmacy's legend drugs were transferred or if they were destroyed - For controlled substances a list of names and addresses to where they were transferred including QTY and Date of each item. - Confirmation of DEA registration and DEA forms returned to DEA - Confirmation that all pharmacy labels and blank prescriptions were destroyed - Confirmation that all signs and symbols of the pharmacy have been removed To the DEA, need to return the DEA registration and 222 forms. Also will need to give location of where all controlled substances are destroyed or transferred out.

How much time does WA law provide for the pt record to be prepared and released?

15 days under WA law is the right answer, 6 day extension once if needed. 10 days is for a patient request of correction to records 30 days is federal HIPAA law limits, which WA is stricter

What is the pharmacist to pharmacy technician ratio in a community pharmacy?

1:1 without a technician utilization plan. As of late 2019, Revised WAC 246-901-130, the ratio is determined by the pharmacy manager. This ratio must be specified and placed in the AUP

What type of personal protection is necessary for a person to work with hazardous drugs?

2 pairs Powder Free Chemotherapy gloves, Disposable Long-sleeved Gowns that close in the back, Shoe covers, hair covers, sleeve covers, face/eye protection if not using properly vented C-PECs

If you work in a mail order pharmacy or deliver the medication, how should counseling legally be provided?

A delivered prescription must have in writing information on how to contact the pharmacy for direct counseling and information about the drug.

You are working in an inpatient pharmacy and receive an order for bupivacaine/hydromorphone for epidural patient-controlled analgesia (PCA). The patient is currently in surgery, but will need the PCA once out of surgery and in the post-anesthesia recovery unit (PARU). The final product requires 2.5mg of hydromorphone. The automated drug dispensing device (ADDD) in the pharmacy contains 1 mL ampules of hydromorphone 10mg/mL. How do you remove the hydromorphone from the ADDD in the pharmacy in a way that maintains a documented trail of how much you are using and where it is going?

Access the ADDD using your fingerprint. To maintain a documented trail of where the hydromorphone is going, you first need to ensure that the drug you are removing from the ADDD in the pharmacy is associated with the ADDD in the PARU. The ADDD will prompt you to count the total amount of drug in the compartment and then indicate the amount of drug you are removing. Make sure that the vial you remove is not expired!

If you put spilled Adderall pills back in the bottle and then later dispensed them, is the prescription adulterated, misbranded, or neither?

Adulterated, the pills are bad. Assuming the bottle is labeled correctly it's not misbranded.

If the Rx were written by a prescriber located in British Columbia, Canada, how would this differ?

BC Canada is fine for the same prescribers above, but note no controlled substances unless they're registered with DEA in the US

What is the role of a long-term care pharmacy consultant? What are activities that a pharmacy consultant should complete with a long-term care facility?

Be on the pharmaceutical services committee which creates and maintains the P&P for safe medication use Review of patient medication records at LTC, review of medication administration processes, drug information, and coordination of staff training

How often do controlled substances at a long term care facility need to be counted by staff? Assume the LTCF does not have an ADDD.

C-II drugs must be counted every 24 hours and C-III drugs every week

What tasks are a pharmacy assistant allowed to perform?

Calling a patients insurance to troubleshoot rejections They can help locate an item but they cannot help with clinical judgment

A med is not in stock at your pharmacy but is at a central fill pharmacy. Which of these delivery situations is allowed?

Central fill pharmacies are only allowed to deliver to the dispensing pharmacy. Home pharmacy can deliver drug to the patient, an agent of the patient, or the patient's home, not the prescriber. The prescriber would technically not be considered the agent of the patient. Other learning points: Controlled substances must be delivered to the "ultimate user", not to a relative who doesn't live with the patient, or doctor's office. Compounded prescriptions can be delivered to locations other than a patient's home when requested, or to the prescriber, or to another pharmacy.

Say the patient fills the prescription once but wishes to transfer the remainder of the prescription back to his or her home state. Is this allowable?

Depends on home state's rules. For WA, controlled substance medications can only be transferred once (unless share a common record system) and must have an audit trail. Void must be written on the original hard copy, the name address and DEA# of the receiving pharmacy, date of transfer, name of receiving and transferring pharmacist must be put on there.

What is the pharmacist to technician ratio in other settings?

Determined by the pharmacist in charge. There used to be a ratio of 1 RPH : 3 TECH but it was removed via WAC 246-901- 130

All of the other drugs in the patient's bag are normally stocked by the hospital. What should be done with the patient's drugs?

Drugs from outside the hospital which are not used during the patient's hospitalization shall be packaged and sealed, if stored in the hospital, and returned to the patient at time of discharge or given to the patient's family (WAC 246-873-090)

May Advair Diskus be substituted w/ Fluticasone/Salmeterol Diskus 250/50 mcg? What about Dulera 200/5 mcg inhaler?

Fluticasone/Salmeterol is the generic of Advair and should be substituted under generic substitution laws. Substituting for Dulera is a THERAPEUTIC INTERCHANGE. Therapeutic interchange is not automatically allowed under law unless it falls under one of these conditions. These are the ok conditions: 1. CDTA (technically prescribing another med, not a therapeutic substitution) 2. If written on the Rx allowing substitution 3. A "prior authorization log" with documentation in the pharmacy records, aka a written agreement for that prescriber and his meds. 4. If the prescriber is an endorsing practitioner within the WA Therapeutic Interchange Program.

What needs to be done to a resident's medications when he or she is discharged from LTC? What documentation is necessary?

Meds can be released to the patient with the authorization of the prescriber. Need to document who it was released to, what, how many. If medications are not released to the patient, they must be destroyed or returned. Schedule II drugs must be destroyed within 30 days by either Director of nursing services, RN designee, Pharmacist, + RN employee of facility as witness OR by PQAC. Schedule III-V drugs must be destroyed within 90 days. Non-scheduled drugs must be destroyed as well.

If the pharmacy mis-filled the med and dispensed Percocet 5/325 instead of Norco, the drug adulterated, misbranded, both, or neither?

Misbranded, there's nothing physically wrong with the Percocet, it's just not labeled correctly. Adulteration would be if the medication was expired, broken, or otherwise altered.

What is the pharmacist to assistant ratio in a community pharmacy?

No limit as long as you have a utilization plan

While the PCA is in the process of being compounded, another order is placed for the same PCA for a different patient, who is located in the Surgical Intensive Care Unit. Can you direct the IV technician to use the same hydromorphone ampule you already provided to compound this new PCA since it has more than enough drug remaining?

No, for 2 reasons. First, the law discourages the use of multiple dose vials of controlled substances [WAC 246-873-080, Section 7g]. But more importantly, this would not allow for proper tracking of the controlled substance. A unique vial must be used for each different location such that the final compounded products will be correctly associated with the ADDDs in the patients' respective locations.

While you are working with the patient on finding drug donation sites, your manager notifies you of a recall. Per the 2013 Drug Quality and Security Act (DSCSA), is your pharmacy required to send a transaction history, transaction information, and transaction statement to the reverse distributor upon returning the med?

No, returning medications to a reverse distributor by a pharmacy is exempt from these requirements The DSCSA requires that every time a medication changes hands from one supplier to another, that a drug pedigree (via transaction history, transaction information, transaction statement) is provided to keep track of where the medication came from and to ensure if a recall happens, that it is trackable. There are certain exceptions for pharmacies. If the pharmacy sells to a patient or does an accommodation sale to a prescriber (selling small amount for emergency purpose) or sends it back to a reverse distributor, these requirements are waived. Another way to remember this is whether the pharmacy's transfer of medication would be considered wholesaling. Any wholesaling would need these transaction details submitted.

Valid use of PHI w/o consent from the parent?

PHI can be used without consent for: -Treatment, Payment, Healthcare Operations - Pharmacy/Health Care providers for treatment, Third parties for payment/audits. But these are the minimum needed to provide the service. -To anyone if need to avoid or minimize imminent danger to the health or safety of the patient -Law enforcement under a warrant or subpoena. -An individual who has signed authorization from the child's parent to make healthcare decisions for the child, or an adult representing to be a relative responsible for the healthcare of the child, or a relative caregiver who has a signed and dated declaration. -Research requires consent.

PMP (Prescription Monitoring Program)

PMP reporting involves all controlled substances CII-V Dispensing must be reported within 1 business day to the PMP A practitioner that legally dispenses a controlled med directly to pt w/o pharmacy involvement is NOT exempt from reporting to PMP A practitioner that administers a single dose of CS to a pt prior to a procedure is exempt from reporting to PMP

What if a controlled substance is present in the patient's drug bag?

Pharmacy must ensure the bag is stored in a locked location and that the quantity of controlled substances is accounted for through written documentation. Example: the patient signs a form while witnessing the sealing of their medications into a bag and then they are returned the sealed bag upon discharge, where they sign again that they receive it. The hospital keeps a log book of patient bags that contain controlled substances and does a bag count every 96 hours.

If you instead were to dispense the medication to the owner of a pet, what would have to be on the prescription to be considered valid?

Prescription requirements are the same for an animal vs humans. Important that prescriptions are written for the patient - aka the animal, not the owner. The owner's information should be present in case the prescription needs to be reported to the prescription monitoring program.

The prescription was written for 1 inhaler with 5 refills. Assuming 1 inhaler lasts 1 month, the patient wanted to get a 3-month supply of inhalers rather than just 1 at a time. Is this possible? If so, what must be done to ensure proper documentation? (RCW 18.64.520)

Pt needs to complete at least a 30 day supply of the drug unless this Rx was previously dispensed as a 90 day supply. Not allowed to exceed total units/refills. Prescriber approval is not required but the prescriber must be notified.

A veterinarian at an animal hospital wishes to obtain a gabapentin oral solution bottle from your pharmacy for use in their hospital due to a temporary shortage. She wants to make sure that she does this correctly and lawfully. What is a valid way of getting the veterinarian the product?

Sell it directly to the practitioner and document that it's an emergency medical reason. - This must be limited quantity for an "emergency medical reason" (WAC 246-879-010) - The best way is to sell the medication to the practitioner (not through a prescription, as writing a prescription in this case is fraudulent). The pharmacy can sell to a practitioner and will not need to register as a wholesaler as long as < 5% gross dollar value of total sales is to practitioners within the year (5% rule). Also the practitioner should not have more than 5% of their sales from a given pharmacy.

A parent of a 16-year-old child is asking for a copy of the child's pharmacy dispensing records to be mailed to her home. What are the minimum required set of records for a pharmacy to keep about a patient?

State law: Allergies, Medical Conditions Patient full name AND Address Complete prescription records including serial number and all components of Rx Dates of each dispensing Authorization for easy open caps OBRA-90: A reasonable effort to get... Date of birth Gender Phone Number Other medications or devices the patient is taking or using

Who has access to the LTC emergency kit and does the emergency kit have to be stored in specific environments?

The emergency kit must be locked up

Who in the pharmacy is allowed to order schedule II controlled substances?

The individual who signed the original 222 form or people who have a power of attorney. The power of attorney doesn't have to be a pharmacist. (ie. the owner of the pharmacy who is a registrant with the DEA, a pharmacist who has power of attorney, a technician who has power of attorney)

What must be included on a PCA label?

The label must include a patient name, patient location, name and strength of all drug additives, name and strength of solution, date (and time if appropriate) of administration, and date the final product was made [WAC 246-873-080, Sections 5c and 7a-b]. Note, that while administration instructions (e.g. infusion rate) are also required by hospital policy, they are not required by law.

If there is positive pressure between room B and A (higher in B) what is the minimum ISO specification of room A per USP 797 guidelines?

There are two important details. Room B must always be at least ISO 7. Room A can be either ISO 7 or 8 (a minimum of ISO 8), but the important detail is whether air is flowing into room B from room A (room B is a negative pressure room) or whether air is flowing out from room B into room A (room B is a positive pressure room). In this case, we have a positive pressure room with air flowing out of room B into room A. Therefore room A can be ISO 8 because the "less clean" ISO 8 air is not contaminating Room B's air. If the situation were switched, where room A had higher pressure than B, air would flow into room B. If your "less clean" ISO 8 air flowed into room B, you would be contaminating the ISO 7 air inside that room. Therefore room A would need ISO 7 air so that it wouldn't be considered contaminating Room B's air. Primary Engineering Control (PEC - The hood, biologic safety cabinet, where the compounding is happening): ISO 5 Buffer Room (room in which the PEC is located): ISO 7 Ante Room: ISO 7 or 8 depending on if positive or negative pressure Note Antineoplastics need to be in certified Class 2 A or B vertical laminar flow Biological Safety Cabinet along with PPE to protect employees from accidental exposure

What is the difference between compounding and manufacturing?

WAC 246-878-010 - "Compounding" shall be the act of combining two or more ingredients in the preparation of a prescription. - "Manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance or device or the packaging or repackaging of such substance or device, or the labeling or relabeling of the commercial container of such substance or device, but does not include the activities of a practitioner who, as an incident to his or her administration or dispensing such substance or device in the course of his or her professional practice, prepares, compounds, packages, or labels such substance or device. An important component is whether there is a patient, prescriber, pharmacy relationship. Having a prescription is important in this determination.

Can a fee be charged for the preparation of PHI records?

Yes fees can be charged for the preparation and for the copying. You don't have to know the values.

How can a PCA be delivered to the floors?

You cannot send controlled substances to the floor via the pneumatic tube system because it breaks the documented chain of custody. This chain is maintained by having a technician deliver the medication to the ADDD on the receiving floor (signing in using fingerprint). The pt's nurse must remove the drug from the ADDD via the pat's profile on the floor to keep the chain intact prior to admin [WAC 246-873-080, Section 7].

When the nurse comes to the inpatient pharmacy to retrieve the albuterol HFA, the central technician is busy and accidentally labels a levalbuterol HFA which is then provided to the nurse. This is discovered prior to administration to the patient because the bar code on the drug doesn't scan. Is pharmacy required by law to do anything to document this medication error?

Yes! While the exact series of steps is not spelled out in the law, the requirement to report and record it is there. Within hospitals specifically, there is a requirement to establish a pharmacy quality assurance program to formally take steps towards preventing medication errors (WAC 246-873-110). WAC 246-865-060: There shall be procedures established for the reporting and recording of medication errors and adverse drug reactions

You are working in the general medicine satellite pharmacy at your hospital and receive a call from a medical resident. She informs you that she has a patient who was admitted with shortness of breath secondary to a drug resistant Mycobacterium Avium Complex lung infection. This patient has been using clofazimine prescribed by the infectious disease clinic for this purpose through a special FDA investigational drug access program. The hospital does not have a supply of clofazimine as it is not commercially available, but the patient has his supply in a large bag of medications he brought from home. Is it legal to use this supply of clofazimine to treat the patient in the hospital?

Yes, but the medication must have a written order and the medication must be physically examined by a pharmacist to assure acceptable quality prior to administration by a nurse. Yes, hospitals are required to develop written policies and procedures for the administration of drugs brought into the hospital by or for patients (WAC 246-873-090). Requires (1) a written order by a practitioner, and (2) the drug should be identified and examined by a pharmacist to ensure acceptable quality for use in the hospital

A physician calls asking if you can compound a supply of a given medication so her patients can come to you without having to wait to get the compounded medication. She says that she typically has 1-2 patients a day, but wants to be sure you have enough on hand for an entire weeks' worth at a time. Is it legal to compound medications before you receive a prescription from a patient?

Yes, in limited quantities: - To meet a reasonable need (FDA guidance and WAC 246-878-020) - Not more than a 30-day supply on hand - Determined by historical dispensing records from the previous year

Are pharmacists required to complete specialized training to prepare sterile compounds to patients?

Yes, pharmacists need training via residency, CE or on-the-job training in sterile facility. PIC responsible for continuing ed for all staff.

Is it legal to have one pharmacist supervise 3 technicians and an assistant at one time?

Yes, provided a utilization plan is available

Per WA law, can a ND prescribe Advair? What are prescribing limits for an ND?

Yes. ND cannot prescribe Botulinum Toxin, cannot treat malignancies unless in collaboration with MD/DO, and have limited controlled substance prescribing (Only CIII-V of testosterone and codeine products only)

Once compounding is complete, the technician provides you with the compounded drug product, a partially used bupivacaine singleuse vial an empty hydromorphone ampule, and a syringe with leftover hydromorphone. You perform the final check and confirm the correct amount of hydromorphone is remaining in the left-over syringe (while accounting for some overfill of the original ampule). What do you have to do with the remaining hydromorphone?

You must properly dispose of the remaining hydromorphone by documenting the left-over dose and the reason it is left-over. Another licensed healthcare provider (pharmacist or tech) must witness by observing the amount remaining, watching you dispose of it into a special locked receptacle, and then marking themselves as a witness in the ADDD using their fingerprint. [WAC 246-873-080, Section 7e]

During one of your inspections, the inspector asks you for your master formulation record and compounding formula/log. What are these documents and how long should they be retained?

a. A master formulation record is like a recipe that describes how to make the compound. It contains ingredients, steps, storage, and quality assurance procedures. Per the USP 795 Self-inspection sheet, it should contain: i. Assigned name, strength, dosage of preparation ii. Calculations iii. Description of ingredients and quantities iv. Compatibility/Stability Information + References v. Equipment needed to prepare the preparation vi. Mixing Instructions vii. Container used to dispense, Packaging, Storage Requirements viii. Description of final preparation ix. Quality control procedures and expected results b. A compounding formula or log is the record of the compounding each time the product is made from the master formulation record. Per the self-inspection worksheet, it should contain i. The name, dose, and strength of the product ii. Reference to the master formula record iii. Names, quantities, source, lot, exp of all components iv. Name of person who prepared product, did the quality control, and did final check v. Date of preparation vi. Assigned number or prescription number vii. Beyond use date viii. Duplicate Rx label ix. Description of final preparation x. Quality Control Results xi. Documentation of any quality control issues or adverse reactions c. The master formulation record must be kept as long as that product is being made and for 2 years afterwards. The compounding logs must be kept for at least 2 years (just like prescriptions)

Which of these are requirements for WA registered nuclear pharmacies?

a. A self-inspection form with nuclear pharmacy addendum must be completed annually b. The pharmacy must complete a non-sterile and sterile compounding self-inspection addendum c. The PIC must be a registered nuclear pharmacist d. Nuclear pharmacies must keep patient records including chronic medical conditions and allergies Nuclear pharmacies have to complete all the normal self-inspection documents. They all also do sterile and non-sterile compounding, so they must complete those addendums. Nuclear pharmacies are pharmacies, so they need to keep patient records.

What is part of a Quality Assurance (QA) program for sterile compounding?

a. Ability to track medication errors b. Ability to track patient satisfaction c. Ability to justify beyond use dating (expiration date) for all sterile products "Patient satisfaction" is a required component, and takes many forms, including tracking adverse effects, feedback from patient about the quality of the product, and of any other patient related components related to the prescription.

You begin working at a Long-Term Care Pharmacy which provides service to a LTC facility via an automated drug dispensing device (ADDD). To familiarize yourself with how to use it and how it fits into the facility, you decide to review the policy and procedure manual.

a. Discharged patients must be removed from the system within 12 hours of discharge b. Pharmacists, pharmacy interns, pharmacy technicians, or RN or LPN can replenish an ADDD c. A perpetual inventory must be done, but also an inventory of each controlled medication must be done at each replenishment and at minimum once every 7 days if not done sooner than that. d. Each individual ADDD must be registered with the PQAC Other security features that are important: - Biometrics or some similar secure technology - Patients must be removed from the system within 12 hours of discharge - Employees must be removed upon notice of termination - Access is limited to WA credentialed HCP within their scope - Replenishment only via RPh, intern or tech (supervised) or state licensed RN/LPN with eVerification - ADDD located within a secure area in the facility

A drug utilization review needs to be done on all orders prior to withdrawal from an ADDD except:

a. For a previously reviewed order b. When the provider is nearby and controls the dispensing process c. For an override when the pharmacy is closed, but reviewed within 6 hours of opening

When can a medication be returned to the ADDD for reuse?

a. Non-Controlled medications can be returned to unsecured bins if "adequate controls" are in place b. Medications in patient specific containers may not be returned to general use stock locations c. System must be in place to track all returned and destroyed medications at the facility

The patient hears that there are some drug donation programs in the state. What is true regarding drug donations for the purpose of dispensing to another patient?

a. Pharmacy must be a participating site b. Medications need to be in original sealed/tamper-evident packaging OR single unit doses that are intact c. Expiration date must be > 6 months from the donation date to be re-dispensed d. Donated medications ideally have a Time Temperature Indicator (TTI) to identify if they are adulterated. e. RPh must use his or her best judgment to determine whether the medication was stored in proper conditions and is not adulterated. f. Controlled substances are not allowed to be donated Note that donated drugs must be given to patients at no charge. The meds may not be billed through insurance.

You work at a compounding pharmacy that provides sterile compounding services to patients (non-institutional). The PQAC inspector arrives for a regular pharmacy inspection. What documents will be required to show during inspection? Specifically, what documents are required for sterile compounding?

a. Policy and procedures manual documenting i. Personnel training and competencies ii. Building and facility standards iii. Environmental monitoring and cleaning/disinfecting iv. Equipment v. Standard Operating Procedures (SOP) and Master Formula and records vi. Testing and BUD vii. QA program b. Self-Inspection addendum for Sterile Compounding

Can technicians prepare sterile compounds? if so, are there any additional requirements for training and/or documentation that would allow this?

a. Technicians require training and supervision by the pharmacist on duty. Training description must be written down in P&P manual. i. Specialized function AUP must be approved by PQAC. b. Assistants are not allowed to prepare compounds

The owner has a friend who has a pharmacy in Oregon near the border to Washington. What does that pharmacy need to do to serve patients in Washington?

a. The pharmacy must hold a non-resident pharmacy license for WA b. The pharmacy must submit a current inspection report at licensing and at every renewal Non-resident license. Requires to have a TOLL FREE number for patients to contact. Not necessary to be in WA. They must follow the same counseling and medication record requirements as WA. As of Jun 2019, they must also submit an inspection report showing they meet equivalent standards to WA. Not all pharmacy staff are required to be licensed in WA

What are the components of the WA death with dignity laws?

a. There do need to be 2 independent physicians certifying the patient's terminal condition. A psychiatrist may be required if one of the physicians feels the patient has impaired judgment or has a psychiatric disorder. b. Only pharmacists may be involved in the dispensing of the medication c. The prescriber must be an MD or DO d. The pharmacy must submit a report of the dispensing to the DOH within 30 days e. The patient must make at least 2 verbal requests and one written request, with verbal requests separated by at least 15 days

Situations that require patients' positive informed consent:

a. When a pharmacist initiates a blood pressure medication via CDTA b. When a pharmacist administers a shingles vaccine after being asked for one by a patient c. When a pharmacist enrolls a patient into his research study Patients must consent to any care that is provided. If the pharmacist is initiating or changing therapy (such as via CDTA or protocol), the patient must have consented to the therapy. Facts that are important to disclose are - Nature of the treatment proposed and administered - Anticipated results of treatment - Alternatives to the proposed treatment - Risks, complications, benefits to the treatment, alternatives, and non-treatment Another setting that is necessary for informed consent is research and in use of investigational new drugs

Say this was a different patient, and he is a terminal patient with a qualifying condition. Could he legally get a family member to purchase, possess, or administer the product to him?

a. Yes, if they are the "designated provider", 21 years of age or older, or is the parent or guardian of a patient older than 18 b. This is a person who has signed onto the authorization and is entered into the database as a designated provider. c. Note a designated provider can only be a designated provider to 1 patient at a time, and one patient can only have one designated provider at a time.

You have been worried about one of your staff, who has been coming to work impaired and are concerned that the impairment may lead to patient harm. What is TRUE regarding reporting and participation in the WRAPP program?

https://www.wsparx.org/page/WRAPP - - All licensees with personal knowledge must report. This includes everyone from a pharmacist to an assistant. - Self-reporting is also required. - Participation is confidential unless the PQAC refers the person to WRAPP or if drug theft or another crime is linked to the impairment - Non-pharmacy healthcare workers have their own versions and a general recovery program for healthcare professionals in general