question

Is a pharmacist's signature required on hardcopies or will initials suffice?

answer

It is acceptable to either sign, initial, or utilize an electronic record identifying the verifying pharmacist.

question

Can a pharmacist change the date-to-fill after talking to the prescribing doctor on a CII?

answer

The date-to-fill is part of the directions written on the script therefore it would be allowed to change after speaking with the prescribing doctor.

question

How are outdated CIIs destroyed?

answer

Reverse distributor DEA Form 41

question

Can physician assistants and naturopaths prescribe CII medications?

answer

Yes, check the formulary at http://www.oregon.gov/OBNE/rules/850-060-0226.pdf. PAs may if they hold a current DEA registration for CII medication.

question

Does a pharmacist need to cancel a CII prescription across its face and sign?

answer

No

question

What is the law for selling a controlled substance for office use? CII? CIII-V?

answer

A prescription cannot be written to provide medical offices medications. If the office wants CII medications a DEA 222 form must be used to transfer the CII stock. For all other medications, an invoice must be utilized.

question

Does post-dating the prescription for a CII by the prescriber void the prescription?

answer

The prescription must have the date it was written on the hard copy. For more information call the DEA office at 503-721-6660.

question

Is a typed CII prescription with an electronically signed signature a valid prescription?

answer

No. The prescription needs to be hand signed by the prescriber.

question

Is a CII perpetual inventory required in all practice settings?

answer

No, it has been required in hospitals for a long time (monthly reconciliation). A quarterly reconciliation is required for retail pharmacies but not a perpetual inventory.

question

Does the CII annual inventory have to be separated from the CIII-V inventory?

answer

Yes, they can be on the same report as long as listed out separately.

question

How long do we need to keep CII inventory records?

answer

3 years.

question

What is required of drug outlets electronically ordering CIIs?

answer

The pharmacist must be able to retrieve the electronic DEA 222 from their ordering system for review by Board inspectors. This electronic form must contain the date and quantity of each controlled substance received.

question

In which cases are partial fills on CII prescriptions allowed?

answer

Partial fills are allowed on CII prescriptions when: 1)The pharmacist is unable to fill the entire amount and the remaining balance is dispensed within 72 hours. If the remainder is not filled within that timeframe, then the remainder is lost and the prescriber should be notified of the actual quantity filled. 2)For patients that are residing in a long term care facility or community based care facility or diagnosed with a terminal illness in which scripts are good for 60 days from the date the prescription was written.

question

What information must be documented on the original hardcopy or electronic record (a single screen) each time you partial fill a CII for hospice/terminally ill patients, long term care or community based care patients?

answer

The date dispensed, quantity dispensed each time, amount remaining after each fill and pharmacist who dispensed it.

question

Can a CII prescription be changed from a capsule to a tablet or liquid form of the same medication?

answer

Yes, if you contact the prescriber and they authorize the change. If the prescriber is not reasonably available for consultation and the prescribed drug does not utilize a unique delivery system technoloy, an oral tablet, capsule or liquid form of the prescribed drug so long as the form dispensed or administered has the same strength, dose and dose schedule, and is therapuetically equivalent to the drug prescribed. Per

question

If a CII medication is written with only the first or last name of patient, can a pharmacist call the prescriber to clarify it and then fill the prescription?

answer

Yes.

question

What changes can a pharmacist make to a CII prescription after speaking to the prescriber over the phone?

answer

A pharmacist CAN change the drug strength, dosage form, drug quantity, and the directions. Changes that cannot be made are the patient's name, controlled substance prescribed, and the addition of a prescriber's signature (the prescription must be hand signed).

question

In which situations can a faxed CII prescription serve as an original prescription?

answer

A faxed prescription can serve as an original for patients in a long term care facility , community based care, enrolled in hospice, or receiving home infusion/IV pain management therapy. The prescription must be manually signed by the prescriber prior to faxing.

question

Is it legal to write/fill a CII prescription on the same page as a second prescription?

answer

Yes, but the prescriptions must be correctly filed and cross-referenced. The original must be filed under the highest controlled prescription.

question

If a prescriber writes for a quantity of a CII that is greater than the amount the patient's insurance will pay for, can the prescription be split into two prescriptions, one for insurance and one for cash?

answer

Yes. Both prescriptions must be filled and dispensed/sold at the same time.

question

Can a prescriber write multiple prescriptions for a CII on the same day to be filled on different dates?

answer

Yes, as long as the total quantity does not exceed a 90 day supply and each subsequent prescription states the earliest date it can be filled and the practitioner provides written instructions on each written prescription. [CFR 1306.12(b((ii)]

question

Can prescribers post date CII prescriptions?

answer

No, the prescription must have the date that the prescription is actually written and a fill date can be designated in the instructions to the pharmacist.

question

Does a limit exist on the quantity of CII medication that can be dispensed from a single prescription?

answer

No, but use professional judgment.

question

Is it ok to fill a CII from a state that is not contiguous?

answer

Yes, but use professional judgement and make certain the prescription is valid. ORS 689.525(1)(2)

question

For drug recalls on a CII, can good drug be exchanged for the recalled drug?

answer

Yes, it can be exchanged without a new prescription, but you need to document on the hardcopy what was taken back and the quantity replaced.

question

If there is a shortage of a CII such as oxycodone, can the RPh change the drug to oxycodone/APAP after consulting the practitioner?

answer

Yes.

question

Can a CII be transferred between pharmacies with interactive databases (i.e.. Walgreen's)?

answer

Under no circumstance can a CII be transferred.

question

Do you have to file CIII-V invoices separate from CII invoices?

answer

Yes.

question

Is it ok if CIII-V prescriptions are filed with regular legend drugs even if there is no identifier to manually separate them?

answer

Yes, as long as the store can run a report of all CIII-Vs dispensed that is separate from the regular legend drugs.

question

How many refills are allowed by law on schedule III-V medications?

answer

A prescription written for a schedule III-V medication is good for 6 months or 5 refills whichever comes first.

question

Can a prescriber's agent call in or verbally verify a CIII-V prescription?

answer

Yes, they can verbally verify it for the pharmacist or intern.

question

Can a pharmacy fill an e-script for a scheduled III-V medication?

answer

Yes, If in compliance with CFR 1306.08.

question

What schedule are pseudoephedrine, phenylpropanolamine and ephedrine in Oregon? When did they become scheduled?

answer

Schedule III as of July 1, 2006.

question

Does a partial fill on a CIII-V medication constitute a refill?

answer

Partial fills are allowed on CIII-V medications and do not constitute a refill. The partial dispensing may not exceed the total amount authorized in the prescription order (i.e. #90 dispensed as #30 filled 3 times constitutes 1 refill).

question

Can a prescriber's agent sign a refill request or prescription for a CIII-V medication?

answer

No.

question

Does the 6 month limit for refills on schedule III-V medication mean a 6 month quantity limit?

answer

No, the prescription is valid for 6 months from the date it is written and can have up to 5 refills. After 6 months the script is no longer valid and any unused refills are void. The rules do not apply to quantity dispensed. (It is legal to dispense a prescribed quantity that exceeds a 6 month supply).

question

Is there a limit on how much pseudoephedrine or phenylpropanolamine a pharmacist can dispense?

answer

No, it is dictated by whatever the prescriber writes for within the DEA limitations for a CIII (i.e. 6 months or 5 refills).

question

Can a pharmacist ever dispense a year supply of a CIII-V?

answer

Yes, it depends on how the prescriber wrote the prescription (i.e. if the prescriber wrote for "#365 1 tab daily", the pharmacy could fill the whole prescription at one time for the full quantity). Use professional judgment and fill in context.

question

Can a technician take a phoned in refill okay for a drug classified as a CIII, CIV or CV that has no changes of any kind?

answer

No.

question

Can CIII-Vs be transferred in between the same chain store via the computer system more than 1 time?

answer

Only if they share a real time database where each fill at each location can be seen in real time. This is not considered to be a transferred prescription.

question

Does the pharmacist need to notify the prescriber if a sig is changed due to a substitution of medication strength? (i.e. Zoloft 100mg 1/2 tab daily vs. Zoloft 50mg 1 tab daily)

answer

Yes, the prescriber should be alerted of the changes to ensure that the information in the patient's chart is correct.

question

Can a charitable pharmacy accept controlled substances and/or OTC drugs for donation?

answer

No

question

Who can bring in drugs for donation?

answer

Anyone, but donated drug must meet the criteria laid out in the rules and the pharmacist may always use their discretion as to whether or not the drug is safe and appropriate for re-dispensing.

question

Is there an expiration date guideline for donated drugs?

answer

Yes, a charitable pharmacy may not distribute a donated drug that bears an expiration date that is less than nine months from the date it was donated

question

What patients qualify to receive charitable drugs?

answer

A patient who has a valid prescription for the drug, is a resident of Oregon and is underinsured or does not have adequate health insurance for the prescription requested or a patient enrolled in a program of public assistance as defined in ORS 411.010

question

Will prescription drugs that were dispensed in a standard prescription vial, to an individual patient who manages their own medications, be accepted for re-dispensing?

answer

No.

question

What is a shared service contract?

answer

A contract that allows an Oregon pharmacy to compound for another Oregon pharmacy or prescriber without being licensed as a manufacturer. The pharmacy or prescriber can dispense the compound to their patients or use it for office use. The Oregon pharmacy must only do a limited amount of compounding sales to have this kind of contract.

question

When a compounding pharmacy performs a quarterly audit of all bulk CII powders, does the powder need to be weighed out each time?

answer

It would be acceptable if the pharmacy initially weighs the active powder and the empty container and then tracks the descending weight of the container for each quarterly audit.

question

Can pharmacies compound products for OTC sale under a retail license?

answer

No.

question

Are pharmacists required to counsel on prescriptions that have been reassigned if there are no changes on them?

answer

No, but the pharmacist may use their discretion.

question

Do DURs have to have a hard halt that requires a pharmacist override to proceed?

answer

No, this is preferable, but a system that documents which pharmacist performs each function (i.e. DUR vs. verification) and ensures DURs are performed is acceptable.

question

Does the pharmacist need to perform a DUR on refills?

answer

Yes.

question

When can an emergency medication supply be given and what quantity can be given?

answer

Up to a 72 hour emergency supply can be given on non-controlled medications that the patient is currently taking, when no refills remain and while awaiting the prescriber's authorization.

question

What expiration date should be listed on the prescription label?

answer

The pharmacist should use their professional judgment. Although 12 months is often the standard of practice, the manufacturer's expiration date or a date less than a year may be used if appropriate.

question

How do pharmacies sell prescriptions purchased by the prescriber "for office use?"

answer

Prescriptions "for office use" must be sold on invoice. A file should be kept of all invoices separate from wholesaler invoices. CIIs must be transferred by a DEA 222 form initiated by the purchasing practitioner. Prescriptions are patient specific, sales to prescribers must be sold on an invoice and not be processed as a prescription.

question

What regulations exist for mailing prescriptions out of state?

answer

Check with each state that the pharmacy will be mailing to.

question

Can pharmacists fill prescriptions for prescribers from other states, US territories and US military bases?

answer

Yes, if they are licensed in their own state, practicing within their scope and have a valid patient/prescriber relationship.

question

Who does the pharmacist contact if they feel a prescriber is overprescribing a controlled substance, unsafely prescribing or unethically prescribing?

answer

The prescriber's regulatory board (i.e. Board of Nursing, Oregon Medical Board).

question

Can a prescriber or group of prescribers have ownership positions in a retail pharmacy?

answer

Yes, but they may not have possession of the pharmacy keys.

question

Does a drug have to be AB rated for generic substitution in Oregon?

answer

No, it is up to the pharmacist to use their professional judgment. See ORS 689.515 (2).

question

Can a fee be charged to a Medication Assistance Programs (MAPs) patient?

answer

Yes.

question

Can a pharmacist fill a prescription based solely on an internet questionnaire?

answer

No, the prescriber and patient must have a valid patient/prescriber relationship which usually includes a physical exam. See 855-019-0210(2).

question

Can a pharmacist supervise 2 interns at the same time in a Traditional Pharmacy-practice Internship ?

answer

No, in a Traditional Pharmacy-practice Internship the ratio is one intern to each pharmacist or pharmacist preceptor regardless if one of the interns is a school based placement. A traditional internship is characterized by an intern working outside a school based program and is volunteering or being compensated for their time. A School-Based Internship is characterized by not recieving compensation but recieving credit towards a degree.

question

If only the final verification of prescriptions are being done in Oregon, does the central fill pharmacy have to be licensed in Oregon?

answer

Yes.

question

Do out of state pharmacists and technicians have to be licensed in Oregon if they are working for a mail order pharmacy that sends prescriptions to Oregon patients?

answer

No, but the PIC must be licensed in Oregon.

question

Which out-of-state central fill employees must be licensed in Oregon?

answer

Pharmacists and technicians that participate in any function of the dispensing process for Oregon patients must be licensed in Oregon.

question

Do out of state pharmacies have to be licensed in Oregon if they fill prescriptions for Oregon patients?

answer

Yes.

question

Where can a pharmacist find information about the Death with Dignity Act?

answer

http://public.health.oregon.gov/ProviderPartnerResources/EvaluationResearch/DeathwithDignityAct/Pages/index.aspx

question

Can pharmacy records be stored off-site?

answer

Records must be stored onsite for at least one year and may be stored in a secured off-site location if retrievable within three business days for at least 2 more years for a total of 3 years. Records and documentation may be written, electronic or a combination of the two.

question

Can a pharmacist refuse to fill a prescription?

answer

Yes, but pharmacists should use professional judgment including awareness of the position papers that the Board has regarding moral and ethical objections and pain management. The pharmacist cannot be a barrier to access.

question

Do dental hygienists have prescribing authority?

answer

Yes, but it is very limited. Under the supervision of a dentist they may prescribe fluoride, fluoride + varnish, antimicrobial rinses. Also, they may prescribe NSAIDS if they have received further training.

question

Can a pharmacist fill a hand delivered prescription that has an electronic signature on it?

answer

No, hand delivered prescriptions must be manually signed by the prescriber or their agent.

question

Is it ok for a prescriber's agent to sign a prescription for them?

answer

It is okay for them to sign the prescriber's name followed by their name or initials on faxed non-controlled medications only.

question

How can a pharmacist verify that a prescriber is allowed to prescribe Suboxone® or Subutex® for opioid addiction?

answer

Pharmacists receiving a prescription for Suboxone® or another approved narcotic to treat opioid addiction should verify that the prescriber has been granted a waiver. The following can be used to verify that the prescriber is approved to prescribe Suboxone® or Subutex® for opioid addiction:1) Check the prescriber's Drug Enforcement Administration (DEA) number; physicians granted a waiver under DATA 2000 are issued a special DEA number that always begins with "X"; as of July 2005, physicians are required to include this special DEA number on all prescriptions for Suboxone® or Subutex®;2) Check the Substance Abuse and Mental Health Services Administration (SAMHSA) physician locator at: http://www.samhsa.gov/;3) Call SAMHSA at 1-866/287-2728 (physicians can elect not to be listed on the Web site); or4) Call the prescriber and ask to have the DEA registration certificate faxed to you.

question

Does a prescriber need the Substance Abuse and Mental Health Services Administration (SAMHSA) waiver if they are using Suboxone® to treat pain?

answer

No.

question

Does Oregon law limit the initial quantity of drug dispensed for a prescription medication?

answer

No.

question

Can a pharmacist combine refills on a prescription to give a greater dispensed quantity?

answer

Yes, only on non-controls

question

Does the refill authorization fax have to be kept as the hardcopy when adding refills?

answer

Yes, unless the computer system can add refills to the unchanged prescription and the system does not create a new prescription number (documentation of authorizing agent and authorization source must still be retrievable in this situation).

question

What info has to be on a refill authorization?

answer

Date, number of refills authorized, and name of authorizing agent.

question

Can a pharmacy take back prescriptions after they are dispensed to the patient?

answer

If an error is made on a scheduled medication or if it is a nonscheduled medication, the pharmacy may take it back for destruction only.

question

Does a technician in another state doing work on behalf of an Oregon pharmacy have to be licensed in Oregon?

answer

Yes.

question

Can techs take new prescriptions off of voicemail to later be verified by a pharmacist?

answer

No.

question

Can a clerk take an oral authorization from a prescriber or a prescriber's agent for a refill?

answer

No.

question

Can clerks pull drugs off of a pharmacy shelf to be used in filling a prescription?

answer

No.

question

Can a technician take changes on either a prescription or refill request?

answer

No.

question

When is a technician or clerk allowed to inform the patient of a change in manufacturer?

answer

A technician or clerk may inform the patient of a change in manufacturer on a prescription, that doesn't otherwise require counseling from the pharmacist, if the following criteria are met: 1) the pharmacy must have a policy and procedure in place, the technicians and clerks must be trained properly and the training must be documented, 2) the technician or clerk must inform the patient that the pharmacist has changed the manufacturer and that the medication may look different, 3) the technician or clerk must point out the product identification label (PIL) and tell the patient that the PIL should match the contents of the prescription container, and 4) the technician or clerk must then offer the patient an opportunity to speak with the pharmacist.

question

When can a prescription be transferred in or out of the country?

answer

When they are coming from or going to a US military base or US territory.

question

If a prescription is inadvertently faxed to the wrong pharmacy, can that pharmacy fax it to the correct pharmacy?

answer

Yes.

question

Do I need to follow the rules set forth in division 45 if I do simple compounding (like magic mouthwash or mixing 2 creams) in my retail pharmacy?

answer

No. Simple and infrequent compounding using non-sterile commercial components to fill a single prescription for a non-sterile product is classified as Category 1 compounding. The Board states that Category 1 compounding is not considered compounding for all intensive purposes.

question

When does category 1 compounding become category 2?

answer

When the compounding becomes complex (multiple ingredients, etc...), requires complex calculations, a scale is needed to weigh ingredients, if it requires alterations of the original dosing form (making capsules, etc...), or changes in the route of administration (making suppositories, etc...). Any of these requirements would result in a compound that is no longer classified as category 1.

question

Can you make a compound without a prescription?

answer

You may compound a reasonable amount of drug product without a prescription, but you must be anticipating prescriptions for what you are compounding or you must be distributing the product under the Shared Pharmacy Services agreement (as defined in OAR 855-006-0005).

question

Does division 45 apply to nuclear pharmacies?

answer

No. Radiopharmaceuticals have their own guidelines and are exempt from division 45. For information on nuclear pharmacies see division 19 and 42.

question

If compounding a non-sterile product, do I need to comply with division 45?

answer

Yes. Division 45 applies to sterile and non-sterile compounding, unless the compound is classified as category 1.

question

Does division 45 incorporate USP chapters 797 and 795 rules?

answer

No. The Board doesn't require strict application or adherence to all USP 795/797 guide-lines. It is expected that appropriate guidelines be followed based on individual settings.

question

What are the training requirements for compounding in division 45?

answer

The PIC is responsible for training, testing, and assessing all employees involved in sterile and non-sterile compounding. The PIC must also implement policies and procedures for employees to follow that are reviewed at least annually. This includes a verification procedure for pharmacists to determine correct drug, dose, form, calculations, and label. For low to medium risk compounding retesting aseptic skills must occur at least annually and retesting for high risk compounding must occur at least semi-annually. Records must be kept to demonstrate training and testing.

question

Are we allowed to compound anything the doctor prescribes?

answer

No. You may not compound products that are commercially available, unless the Board has given prior approval to compound a commercially available product that is temporarily in short supply/unavailable. For parenteral products a commercially available product may be compounded if there are multiple companies that provide the mixture (ex. KCl premixed IV bags) or if the premix IV admixture is commercially available as well as the premixed IV bags (ex. Using a commercially available vial of medication to make an IV bag, even though there is a commercially available premixed IV bag).

question

Are there specific policies and procedures for the compounding pharmacy?

answer

If a pharmacy participates in compounding, the PIC must ensure that there are policies and procedures that provide at least the following: an organized index, product formula information, log book, conditions and surveillance of the compounding environment, compounding procedures and requirements, training requirements for all staff, cleaning, QA plan with a BUD (Beyond Use Date/expiration date), product labeling, shipping and delivery procedures, pharmacist final verification, and safety procedures. IV admixtures made for a specific patient does not need to comply with the worksheet or log book requirements if it can still be tracked for recall purposes. The pharmacy must keep records on site and organized for 3 years.

question

Are there any requirements for purchasing bulk chemicals?

answer

Bulk chemicals need to be purchased from an outlet registered by the Board. The bulk chemicals must also have a certificate of analysis and labeling that shows the date obtained and the BUD. The BUD cannot be greater then 5 years from opening, unless tested to extend the BUD by no more then 1 year.

question

What is the expiration date of low risk sterile preparations?

answer

Without sterile testing; at room temperature the BUD can be up to 48 hrs, under refrigeration the BUD is up to 14 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.

question

What defines medium risk conditions?

answer

These conditions meet the same conditions as low risk conditions and include 1 or more of the following; multiple sterile products are combined, will be administered to multiple patients, will give to one patient multiple times, requires complex aseptic manipulations, and a long duration to compound.

question

What is the expiration date of medium risk sterile preparations?

answer

Without sterile testing; at room temperature the BUD can be up to 30 hrs, under refrigeration the BUD is up to 9 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.

question

What defines high risk conditions?

answer

CSPs are classified as high risk for any of the following reasons: compounded from non-sterile ingredients (manufactured products intended for other routes of administration) or a non-sterile device is used before terminal sterilization. If exposure to an environment that does not meet ISO 5 for greater than 1 hour and the product lacked effective antimicrobial preservatives. If the non-sterile procedures (mixing or weighing) occurred in an environment that does not meet ISO 7 or personnel is improperly gloved or gowned. If water containing preparations are stored for more then 6 hours.

question

What is the expiration date of high risk sterile preparations?

answer

Without sterile testing; at room temperature the BUD can be up to 24 hrs, under refrigeration the BUD is up to 3 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.

question

What are the requirements of an immediate use sterile preparation?

answer

It is classified as a low risk compound provided: It doesn't contain hazardous material, the compound has less then 3 sterile ingredients, involves simple manipulations, is completed in one sitting, and will be administered within the hour. They can be prepared in the following conditions; must use aseptic manipulation, use sterile ingredients and devices, but does not need to meet ISO 5 conditions and does not need to wear gloves or gown.

question

What are the requirements for same day use sterile preparations?

answer

The compounded product must be administered within 24 hours of preparation. The compound may be classified as low or medium risk classification if it is prepared using sterile ingredients and devices and has ISO 5 or better environment. Other environmental requirements are a mixing cabinet with restricted air flow, a partitioned area around the cabinet ("buffer zone") that is clearly identified and the area is cleaned daily with low particle counts and free of cardboard boxes/clutter. Preparations must be completed in 1 sitting, may not exceed 8 CSPs per batch, use gloves, appropriate gown and mask with hair and shoe covers, and single dose ampoules are not reused.

question

What is the expiration of a multi-dose vial?

answer

The BUD is 1 month from first usage or the manufacturer expiration date, whichever is earlier.

question

What equipment do I need to make a low-risk sterile preparation?

answer

Starting January 1st, 2009 an ISO 5 or better BSC (biological safety cabinet), CAI (compounding aseptic isolator) or LAF (laminar airflow hood).

question

What equipment is required to make a medium-risk sterile preparation?

answer

Starting January 1st, 2009 an ISO 5 or better BSC, CAI or LAF can be used. A BSC or LAF can be used in an ISO 7 or better buffered room that is attached to an anterior room with ISO 8 or better. CAI's may be used in an ISO 8 or better environment. These areas must have positive air flow pressure.

question

What equipment is required for high-risk sterile preparations?

answer

Starting January 1st, 2009 it will require the same standards as medium-risk sterile preparations (see above).

question

Are there requirements on how frequently the compounding room must be cleaned?

answer

All work surfaces and floors must be cleaned at least daily in ISO 7 and 8 areas. All other surfaces in these areas (shelving, walls, ceilings) must be cleaned monthly. The cleaning solution should be a high-level disinfectant or you may alternate regularly between medium-level disinfectants. These areas must be checked and certified by a qualified person at least every 6 months and when alterations have been made to the area.

question

What needs to be documented on the formula worksheets?

answer

All documents of preparation, verification and dispensing/transfer must be kept for 3 years and contain the following information; Drug name and strength, quantity made, date prepared, pharmacy unique lot number, ingredients, manufacturer lot numbers with their expiration dates, BUD, verification and the name of the verifying pharmacist, names of all technicians involved, copy of the label used for the compounded product (or a system to identify batches of prescriptions), mixing instructions, physical evidence of the proper weight of each drug used, and certification of completion of any additional testing that may be required.

question

Are there specific requirements for using hazardous drug materials?

answer

You are required to follow state and federal laws, there are no additional stipulations specified in division 45. Contact the EPA (www.epa.gov/) and OSHA (www.osha.gov/) for further information.

question

What does CSP stand for?

answer

Compounded Sterile Preparation. It incorporates anything compounded in an IV room (prepared sterile products under manufacturers' guidelines in an environment with possible exposure to contamination) or preparing with non-sterile components and devices that must be sterilized before administration.

question

What additional policies and procedures are required for sterile compounding?

answer

You must follow the requirements described in question 10, but also ensure an appropriate BUD with end product testing and random sampling of the environment and CSPs when it's appropriate. The PIC needs to have a QA plan in writing with records requiring the cleaning, testing and calibration of all equipment.

question

Do I need to perform random end product testing?

answer

It depends, if you are mixing high risk CSPs or wish to extend the BUD, you would be required to perform end product testing. The BUD must not exceed USP 797 guidelines unless quality is verified by end product testing.

question

What needs to be on the label of sterile parenteral products?

answer

The labeling requirements include all of the regular items (patient name, etc...), but also require the following: Rate of infusion, BUD, storage requirements, ingredients information (name, quantity and concentration of all ingredients including primary solution), and initial of pharmacist who verified it.

question

Can I reassign a parenteral admixture to another patient?

answer

Yes, as long as it has been stored properly and the BUD has not lapsed.

question

What defines low risk conditions?

answer

An ISO Class 5 environment or better, no more than three commercially manufactured sterile products placed in 1 container, and limited manipulations

question

When a prescriber writes a new prescription for a controlled substance but requires the destruction of a previously prescribed controlled substance prior to the new medication being dispensed how does a pharmacist go about fulfilling the request?

answer

A pharmacist cannot accept the return of a controlled substance. A pharmacist can witness the patient destroying the medication (adding controlled substance to kitty litter or coffee grounds inside water water bottle then throwing it away) and document that the medication was destroyed prior to the new medication being dispensed.

question

Does a residential care facility need to report the disposal of controlled substances that were prescribed for residents to the DEA or the Oregon Board of Pharmacy?

answer

No.

question

Who will take back controlled substances for destruction?

answer

Reverse distributors. There is a list of them on the Oregon Board of Pharmacy website under Forms- click on "controlled substance destruction firms".

question

What should a pharmacy do with broken controlled substance tablets?

answer

Keep a dual or joint destruction log and document what was destroyed, date of destruction and who witnessed it.

question

Does the DEA allow the return or destruction of controlled substances to the pharmacy after dispensing?

answer

No, except in the case of errors. See 21 CFR 1307.21.

question

What are the requirements for filing controlled substance prescriptions?

answer

Separate C-II prescriptions from others. C-III-C-V can be filed separate or with legend prescriptions

question

When a pharmacy has a change in PIC and is required to do a controlled substance inventory can they make it the annual inventory as well?

answer

Yes, but the next controlled substance inventory must be within 365 days.

question

How often does a complete controlled substance inventory have to be done?

answer

Annually (within 365 days) and with each change in PIC.

question

Can the controlled substance count be corrected on inventory?

answer

Yes, if diversion is suspected then the pharmacist must investigate and report it to the Board. The working copy should be kept so corrections made are documented and gives a clear picture of what occured.

question

What are the most common drugs left off the controlled substance annual inventory in pharmacies?

answer

Pseudoephedrine products (esp. Zyrtec-D), phenylpropanolamine products and ephedrine products.

question

Can someone other than the PIC perform the annual controlled substance inventory? Can it be done without the PIC being present (i.e. on vacation)?

answer

Yes to both, but the PIC is responsible for its accuracy.

question

Do pharmacies applying for a DEA license have to apply for an Oregon controlled substance license first?

answer

Yes, they must apply for both a DEA license and an Oregon controlled substance license. The DEA will not release the DEA license until the Oregon Board of Pharmacy has issued the Oregon controlled substance license.

question

What is required on the DEA 222 form when controlled substances are checked in?

answer

The date and quantity of medication received is required to be recorded on each line (including initials of the person checking in the controlled substances) of the DEA 222 form. All of the previous requirements for a DEA 222 can be applied to electronic/CSOS 222s.

question

Is ID required for picking up controlled substances from the pharmacy?

answer

No, but the pharmacy can choose to require it.

question

Do colleges/ research facilities that have an FDA research license also have to have a DEA license to possess controlled substances? Do they need a license from the Oregon Board of Pharmacy?

answer

Yes, they need a DEA license. The Oregon Board of Pharmacy may waive the requirement for registration with the State of Oregon.

question

Is there an age requirement to pick up a controlled substance?

answer

No.

question

What is required to be on the hardcopy of a controlled substance prescription?

answer

A prescriber's name, address, DEA number, and the patient's name and address must be on the hardcopy of a controlled substance prescription. These may be printed on the dispensing label placed on the back of the prescription. The CII prescriptions must also be hand signed by the prescriber. The pharmacist does not need to cancel the prescription across its face.

question

What is required to be on an escript of a controlled substance prescription?

answer

A prescriber's name, address, DEA number, and the patient's name and address must be on the esccript of a controlled substance. These may be printed on the dispensing label and placed on the back of the prescription. The scheduled prescriptions must contain a digital signiture with authentification of the prescriber defined in 21 CFR 1311. (10-45) and recipients of digitally signed controlled prescriptions are to follow the requirements for validating scheduled prescriptions under 21 CFR 1311. (50-100).

question

How long are CII prescriptions good for? CIII-V? Regular legend medications?

answer

CII- A CII prescription has no expiration date. It is up to the professional judgement of the pharmacist to determine if the prescription is in proper context and is still needed by the patient. CIII-V- 6 months or 5 refills whichever is sooner. All regular legend prescriptions- up to 1 year based on how the refills are written.

question

What schedule is methamphetamine?

answer

It is a CII if it is in the form of an FDA approved product and is prescribed for a currently accepted medical use. Street use methamphetamine would be considered a schedule I drug.

question

If a controlled substance prescription was inadvertently transferred to the wrong pharmacy, can it be transferred to the correct pharmacy?

answer

Yes.

question

Why do Canadian pharmacies sell prescription medications for so much less to US patients? Is it legal to fill Canadian prescriptions in the US? Is it legal to have a US prescription filled by a Canadian pharmacy?

answer

Canada has a governing body similar to the US FDA; however, their governing body only requires them to sell "FDA" approved drugs to Canadian patients. This means that Canadian pharmacies can import drugs that are nonstandarized and unapproved from other countries to sell at reduced prices to nonCanadian patients (aka Americans). It is not legal to fill a Canadian prescription in the US. There are no Canadian pharmacies licensed with the Oregon Board of Pharmacy, so they cannot legally ship prescription medications into Oregon.

question

How many CE hours will you get for attending a Board meeting?

answer

4 Hours per day or 2 hour for a half day of law CE.

question

How many CE hours will you get for attending a PIC class?

answer

3 hours. 1 of law CE, 1 in pt safety, and 1 in other

question

Where can a pharmacist or technician go for free CE?

answer

Online at PowerPak or CECity or simply Google "Pharmacy CE" for additional opportunities.

question

How long should I keep my CE certificates?

answer

3 years for pain CE and at least 1 year for regular CE. It is encouraged to keep all CE records for 3 years.

question

What are the requirements for biennial continuing education for pharmacists?

answer

30 hours per 2 years, at least 2 hours must be earned in the area of drug law and effective from July 1, 2015, at least 2 hour must be earned in the area of patient safety or medication error reduction

question

What is the Health Professional 's Service Program?

answer

It is the impaired health professional program established by the Oregon Health Authority in July 2010. The Board may refer Pharmacists to this program if they believe that a Pharmacist has been impaired by alcohol, has a substance abuse disorder or dependency, or has a mental-health disorder.

question

How should a hospice nurse dispose of narcotics in the home after a patient passes away?

answer

Joint destruction with documentation. Refer to the Department of Environmental Quality (DEQ) for eco-appropriate ways.

question

How should medications safely be disposed of?

answer

Contact the Department of Environmental Quality (DEQ) or crush med, put in milk jug, dissolve in water, add clumping agent such as kitty litter and put lid on it to throw it away. Never throw medication away in its original container.

question

If a pharmacy employee is convicted of a drug related felony, is there anything a drug outlet needs for that employee to work for them?

answer

The pharmacy employee may work in the pharmacy only if the drug outlet obtains a waiver from the DEA that allows access to controlled substances.

question

Will there be discipline if a notice of noncompliance is received?

answer

In most instances there will be.

question

What is the lowest form of discipline that does not give probation or fines, but is reportable to clearinghouses?

answer

A reprimand.

question

What quantity of CII medication can be dispensed to get a hospice patient through an emergency period when the pharmacist is unable to contact the prescriber?

answer

Whatever quantity is needed to get the patient through the emergency period, after obtaining an emergency verbal prescription from the prescriber.

question

What is Expedited Partner Therapy (EPT)?

answer

It is treating all sexual partners for certain sexually transmitted diseases, even when the treating practitioner has not examined those partners. OAR 855-041-04000

question

Is an EPT prescription valid if the name of the patient it is intended for is not on the prescription?

answer

Yes

question

Can a practitioner write an EPT prescription for any antibiotic or any sexually transmitted disease?

answer

No. It must be one of the drugs and diseases listed on the established DHS protocols.

question

How long is an EPT prescription good for? Can it be refilled?

answer

30 days from the date written with no refills.

question

Can a pharmacist fill an EPT prescription for the patient without their name on it?

answer

Yes. The pharmacist is not required to obtain an EPT patient's or partner's name, address or demographics.

question

Is a pharmacist expected to do a DUR or give counseling for EPT prescriptions?

answer

Yes. The pharmacist must at least make an effort to obtain the patient and partners drug allergies and concomitant drugs. Also, written information about the drug must be given with each prescription.

question

How long does the Oregon Board of Pharmacy require prescription records and other records to be kept?

answer

3 years (unless prescriptions are electronically scanned in and a reproducible image is available, then 120 days for all noncontrolled prescriptions and 3 years for all controlled substance prescriptions). The DEA requires prescription hardcopies of controlled substances to be kept for two years. Pharmacies may want to keep records longer (i.e. 7 years +) for Medicare requirements/audits etc.

question

Regarding HIPPA, can pharmacy benefit manager (PBM) billing info be e-mailed to someone's home address in order to work on billing from home?

answer

Probably not since it wouldn't be secure, however, BOP does not regulate the HIPAA rules. Contact HIPAA at phone: 503-947-5255 or website: www.oregon.gov/DHS/admin/hipaa/index.shtml .

question

If a prescriber requests a patient's pharmacy records, can a pharmacist provide them and not violate HIPAA?

answer

Yes, as long as the request is within the normal course of business, because both the prescriber and the pharmacist are part of the healthcare team caring for the patient.

question

If the Oregon Board of Pharmacy requests information about a patient or other co-workers, can the pharmacist or technician provide this information and not violate HIPAA?

answer

Yes, the Oregon Board of Pharmacy is grouped into a category with other enforcement/ regulatory agencies who are exempt from HIPAA. These privileges are given so that the Oregon Board of Pharmacy can complete investigations.

question

Who enforces HIPAA?

answer

The Office of Civil Rights. http://www/hhs/gov/ocr/privacy/

question

How can someone feel reasonably confident that a particular internet pharmacy is legitimate?

answer

The website should have a VIPPS (Verified Internet Provider Practice Site) symbol on it which means that the National Association of Boards of Pharmacy has inspected them and determined that they are a legitimate internet pharmacy provider.

question

Does a unit-of-use product (i.e. inhaler, ointment) require a product identification label?

answer

No.

question

When does a correctional facility have to be licensed with the Oregon Board of Pharmacy?

answer

If they have non-patient specific stock medications, they must be licensed with the Board. If they are just "storing" patient specific meds, they do not have to be licensed with the Board.

question

Do I have to pay for certified copies of my license?

answer

You can request up to 2 certified copies free of charge at the time of your license renewal. Additional copies or copies at other times of the year will cost $5.00 each page of two.

question

When do out of state pharmacists need to be licensed by the Oregon Board of Pharmacy?

answer

Beginning April 1st 2009, any pharmacist in a state outside of Oregon that engages in the practice of pharmacy for patient specific activities such as MTM, MRR, collaborative therapy, therapeutic interchanges must be licensed by the OBOP.

question

Who should a potential counterfeit medication be reported to?

answer

The FDA

question

Who should a severe medication adverse event be reported to?

answer

Medwatch

question

What should someone do if their regular medication looks different (i.e. different color or shape)?

answer

Verify that the medication matches the description product identification label (PIL). And contact the pharmacy/pharmacist to ensure the medication is correct if different from the PIL or if they have additional questions.

question

What does the law say about prescribers writing prescriptions for medications, including controlled drugs, for family members?

answer

There are no laws prohibiting prescribers from writing prescriptions for controlled substances for family members unless the prescriber's license prohibits it. The prescriber's licensing board should be notified of excessive use.

question

Can pharmacists order and/or authorize lab tests?

answer

Yes.

question

Does a distributor of blood bags need to be licensed by the Oregon Board of Pharmacy?

answer

The Oregon Board of Pharmacy does not regulate blood products, even with the anticoagulant in it.

question

What are the restrictions on dispensing Iodine or iodides?

answer

There is no restriction on tincture of Iodine or iodides if it is under the allowable 2.2% of elemental iodine. Anything over 2.2% is restricted.

question

What is ISMP?

answer

The Institute of Safe Medication Practices which is dedicated to medication error prevention.

question

Can non-veterinarians write prescriptions for animals?

answer

No, non-veterinarians writing prescriptions for animals is beyond their scope of practice.

question

What schedule does marijuana fall into and can it be used legally for medical use in Oregon?

answer

It is a Schedule II: however, the Oregon Board of Pharmacy does not regulate the medical use. That falls under the Department of Health and the Oregon Medical Marijuana Program (971-673-1234)

question

What is the NABP clearinghouse?

answer

The place that the National Association of Boards of Pharmacy uses to check whether or not there are past, current or pending actions on a licensee in all states that they have practiced in (i.e. the Oregon Board of Pharmacy will find out information from the NABP regarding disciplinary action for pharmacists that want to reciprocate from other states).

question

What does it mean to "depot" drugs?

answer

A pharmacy can store a prescription from another licensed prescription drug outlet in their pharmacy for a patient to pick up (i.e. usually occurs in remote locations). Prescriptions can also be "depoted" at the prescriber's office (NOT the prescriber's home), the hospital or medical care facility in which the patient is receiving care, the patient's workplace, an alternate residence designated by the patient, the

question

Is Tramadol (Ultram) a controlled substance in OR?

answer

Yes it is a Control IV

question

What is a prescriber's scope of practice?

answer

An MD or DO can write prescriptions for anything other than veterinary medications. Other prescribers must prescribe within the limits of their practice (i.e. a dentist could not prescribe an eye drop).

question

Is my pharmacy required to have a separate counseling area?

answer

Not necessarily, but it is the responsibility of the pharmacist or intern to provide a counseling environment that is confidential and maintains patient confidentiality.

question

How do I obtain a copy of the OBOP quarterly newsletter?

answer

The Oregon Board of Pharmacy's official Newsletter can be subscribed to by sending an e-mail to the National Association of Boards of Pharmacy, with only the word "Subscribe" in the subject heading to: [email protected].

question

If I don't have a computer, will I still be held accountable for the information the Board Newsletter contains?

answer

Yes, it is the Board's primary form of communication to all licensees.

question

What is the Strategic National Stockpile (SNS)?

answer

It is the US Government stockpile of antiviral drugs and other drugs and medical supplies that can be made available to a state in an emergency.

question

When is it okay for a pharmacist to dispense a drug refill without a valid prescription?

answer

When there is a declared emergency or the patient and pharmacist are in an area engaged in disaster assistance. The following criteria must also be met: a) In the pharmacist's professional judgment, the drug is essential to the maintenance of the patient's health or the continuation of therapy; and (b) The pharmacist provides no more than a 30-day supply; and (c) The pharmacist records all relevant information and indicates that it is an Emergency Prescription; and (d) The pharmacist informs the patient or the patient's agent that the drug

question

When can a pharmacist dispense a new or modified drug therapy?

answer

A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may, after consultation with any authorized prescriber, initiate or modify any drug therapy, and dispense an amount of the drug to meet the patient's health needs until that patient can be seen by a health-care practitioner, provided that: (a) The pharmacist acts in accordance with currently accepted standards of care; and (b) In the pharmacist's professional judgment, the drug

question

If a prescriber dies or retires and surrenders their license, are the prescription refills still valid?

answer

Since there is no longer a patient/ prescriber relationship the refills become invalid. A pharmacist should use good professional judgment and encourage the patient to seek a new care provider. A general rule would be one to two month supply.

question

Who is responsible for pharmacy security?

answer

The PIC and the pharmacists on duty are responsible for adequate protection against theft and diversion. They are also responsible for supervising all pharmacy personnel (ensuring that they are working within their scope of practice) and making sure the pharmacy is compliant with all state and federal laws (only a pharmacist can have a key/access to the pharmacy when closed). If a violation does occur or drugs are

question

How long does a pharmacist, technician or intern convicted of misdemeanor or a felony or arrested for a felony have to report the information to the Board?

answer

10 days

question

How long does a pharmacist, technician or intern have to report a change in employment or resident address to the Board?

answer

15 days

question

How long does a pharmacist, technician or intern have to report misconduct of a licensee to our Board or another regulatory Board if applicable (i.e. RN misconduct reported to Nursing Board)?

answer

It should be reported without undue delay and not later than 10 days after learning of the misconduct.

question

When must a pharmacist or technician report an arrest for a misdemeanor?

answer

If not convicted, arrests for misdemeanors must be reported to the Board upon renewal of license. If convicted, within 10 days

question

Can you transfer a prescription to Canada?

answer

No

question

At what age may a pharmacist administer a vaccination to a patient per current protocol?

answer

The patient must be at least 7 years old and it must be in accordance with the protocol determined by the Oregon Health Authority. The pharmacist may also vaccinate a patient outside of the State protocol if instructed to administer a vaccine pursuant to a valid prescription

question

Who must a pharmacist report vaccine-related adverse events to?

answer

To the Vaccine Adverse Event Reporting System (VAERS) and to the patient's PCP

question

Does the immunizing pharmacist have to notify the patient's PCP after giving an immunization?

answer

No, but they must ensure that required information is reported to the OHA ALERT immunization system

question

How long does a pharmacist have to report to the required immunization information to the OHA ALERT immunization system?

answer

15 days- this replaces the former requirement to notify the patient's PCP

question

Does a pharmacy need to track how drugs are accounted for and wasted in an Automated Distribution Cabinet (ADC)?

answer

Yes, there must be a policy and procedure for this and a QA plan to track it.

question

Can ADC's be stocked with CII's?

answer

Yes.

question

Is it okay for the list of the drugs contained in the code cart to be located solely on the top of the tray located within the code cart?

answer

No, the list must be affixed to the exterior of the code cart.

question

What is a CPO?

answer

The Chief Pharmacy Officer (CPO) is the pharmacist who supervises the pharmacy operations in the hospital. They may be the PIC if there is only one pharmacy in the hospital or they may manage several PICs if it is a health system with multiple pharmacies.

question

Can emergency rooms dispense more than a 24 hour supply of medication to ER patients? Can they do so at times when the regular hospital pharmacy is open?

answer

Yes, enough medication may be dispensed to the ER patient to get them through the emergency period as defined by the facilities policies and procedures. The amount may not exceed a 48 hour suppy except for unit-of-use packaging or full courses of therapy as determined by the RPh's professional judgement. The emergency supply can be dispensed at any time of the day from the emergency room prepacks.

question

How often does a perpetual CII inventory have to be reconciled in the hospital?

answer

Monthly.

question

Can IVs be prepared in batches with the use of a log documenting the date prepared, technician preparing, pharmacist checking, drug, amount compounded, expiration date, and the commercial product used?

answer

Yes, IV's may be batched, but a pharmacist's initials must be on final IV label for each one.

question

Under what circumstances may a patient use a drug brought to the hospital from home?

answer

If, in the pharmacist's professional judgment, withholding the drug would be detrimental to the patient's health. The practitioner or pharmacist must first identify it, assure that it is in a labeled container and it must be pursuant to a practitioner's order.

question

Who can repackage and label from bulk to unit of use?

answer

A pharmacist or technician can do so; however, a pharmacist must verify, initial and keep a log for verification purposes.

question

In rural areas, is it ok for retail pharmacies to supply drug inventory to a local hospital's drug room without the pharmacies having an IP license?

answer

Yes, they would sell it to the hospital on invoice and use a DEA 222 form to transfer CIIs. Also, the hospital's drug room pharmacist consultant must be doing QA and monitoring activities.

question

How many registered nurses per shift may have access to the night cabinet?

answer

One- and they must be designated in writing and receive proper training prior to getting access to the cabinet.

question

How often do perpetual inventory sheets, sign out sheets or other dose-by-dose documentation of CII's need to be randomly sampled?

answer

At least quarterly.

question

How long do pharmacy records have to be stored onsite and retained?

answer

They must be stored on site for at least 1 year and retained for 3 years. After the first year, records may be stored at a secure, off-site location if retrievable within 3 business days.

question

Does a secondary storage area such as a cath. Lab attached to the main hospital by a sky bridge require a separate license?

answer

No However, a secondary storage area in a separate location (i.e. not attached to the hospital) must be registered as a drug room.

question

Can CII's be stored in the robot if there is adequate security to limit access to designated employees?

answer

No, but CIII - CV's can be stocked in it.

question

Who may stock the robot?

answer

pharmacy technician, certified pharmacy technician, intern or pharmacist

question

What is the difference between a remote storage area and a secondary storage area?

answer

A remote storage area is a patient care area which is under the control of the hospital's central pharmacy, but is not located in the same building (i.e. cath. lab that is across the sky bridge). A secondary storage area is an area in the hospital, supplied by the central pharmacy, that may include facilities such as a drug room, a distribution cabinet or a hospital department/nursing unit.

question

What is a TPI?

answer

It is a Traditional Pharmacy-practice Internship in which the intern may not function as such until they have satisfactorily completed their first academic year in pharmacy school. TPIs may receive monetary compensation for their work.

question

What is an SRI?

answer

It is a School-based Rotational Internship in which the intern receives school credit rather than getting paid. They may not work more than 48 hours per week in SRIs.

question

Can an intern perform a DUR?

answer

Yes, if the intern feels comfortable with their knowledge base and has the pharmacists' permission (the pharmacist and intern are responsible for the actions of the intern). Pharmacists and interns are the only employees that may perform/pass/enter through a computer DUR. A technician may not clear or pass any halt due to a DUR, even if the next screen provides the DUR information in detail.

question

Can 2 TPI's work under the same preceptor and get intern hours for it?

answer

No, only one TPI would be able to claim the intern hours. The other student could work doing only technician/clerk functions and would not receive any intern hours for the time worked. See FAQ regarding Community and Interns

question

Is an intern responsible for reporting unprofessional conduct to another licensee's professional regulatory board?

answer

Yes, and this information should be reported to the appropriate professional regulatory board within 10 days of learning of it.

question

Can interns that have graduated from pharmacy school and hold a pharmacy degree, but are not yet licensed as pharmacists use the title PharmD?

answer

Yes, because PharmD is an academic term, but they cannot be called pharmacists (RPh) or perform the duties of a pharmacist until they have passed all exams, hold a pharmacy degree and are licensed by a Board of Pharmacy.

question

How long is my intern license good for?

answer

New licenses are valid until the last day of November following the second anniversary of issue unless automatically terminated. Renewed license are good for 2 years unless automatically terminated.

question

How could my intern license be automatically terminated?

answer

a) Licensure to practice pharmacy is granted in any state; or (b) The licensee, other than a foreign pharmacy graduate or an applicant for licensure by reciprocity, fails to maintain enrollment or active registration in a pharmacy degree program for a period greater than one year; or

question

How long do I have to surrender my intern license if it is automatically terminated?

answer

30 days

question

When is an intern eligible to take the MPJE and NAPLEX?

answer

After the Board is notified by the school that your degree, with not less than 1440 hours of SRI, has been conferred.

question

How long is preceptor license good for?

answer

Up to two years and it expires on June 30 of odd numbered years, concurrent with licensure as a pharmacist.

question

Does my preceptor have to supervise all of my intern hours?

answer

No. The preceptor just needs to supervise the majority of the interns hours. Another pharmacist can supervise the intern while the preceptor is not there (i.e. vacation, days off etc.).

question

Does a preceptor have to keep documentation tracking a TPI's intern hours?

answer

No the intern is responsible for documenting the hours they plan to claim. However, it is a good standard of practice for all preceptors to check the hours their intern has documented for accuracy.

question

How many interns can a preceptor supervise for direct patient care?

answer

TPI- 1 intern, SRI- up to 2 interns

question

Is there ever a time where a preceptor can supervise more 2 interns at a time?

answer

Yes, a preceptor may supervise up to 10 interns for public health outreach programs that do not involve direct patient care. The preceptor should use professional judgment to determine if and when this is appropriate.

question

If an intern is arrested for a misdemeanor, when must they report the information to the Board?

answer

If not convicted, an intern must report the arrest when either renewing their intern license or applying for a new application to practice pharmacy. If convicted, within 10 days

question

Can an intern provide immunizations?

answer

Yes, if the intern is trained to do so (immunization qualified and current CPR certification) and comfortable providing the service. The pharmacist supervising must also be immunization qualified through training accredited by the CDC, ACPE or similar health authority approved by the Board and have current CPR certification.

question

Does DEA recognize a LTC nurse as an agent of the practitioner for CIII through CV drugs?

answer

No

question

What is the expiration date for "salad packs"?

answer

60 days from the date they were filled.

question

What is the expiration date for bubble packs with 1 chemical entity in each bubble?

answer

1 year or the manufacturer's dating if sooner.

question

Do product identification label requirements need to be followed for bubble packs and "salad packs"? (855-041-0065)

answer

Yes.

question

Can medications used in a hospice setting be used as house supply if the resident has left or expired?

answer

No.

question

When do long term care pharmacies have to assist in the establishment and supervision of the policies & procedures for the safe storage, distribution, administration & disposition of drugs, for professional advice/medication counseling of patients and/or caregivers, and documenting the quality assurance activities?

answer

If they are: 1) the primary provider for the long term care facility or 2) they are a contracted pharmacist consultant for the long term care facility or community based care facility or 3) they are accepting medication back for redispensing or 4) they are supplying an emergency drug kit to the long term care or community based care facility, they must comply with these rules. If they are a secondary provider for a long term care facility, they must confirm that the primary provider or consultant is doing these things for them and their patients or the secondary provider must do this for their own patients.

question

When can bubble packed long term care medications be returned and re-dispensed?

answer

When all of the following criteria are met: 1) the drug is in an unopened tamper-evident unit, 2) the drugs or devices have remained at all times in control of a person trained and knowledgeable in the storage and administration of drugs in long term care facilities or supervised living groups using the services of a consultant pharmacist, and 3) the drug or device has not been adulterated or misbranded and has been stored under conditions meeting United States Pharmacopeia standards. Medications must be credited to the patient account prior to repackaging to be use for another patient.

question

Can medications that are "salad packed" (2 different chemical entities in each bubble) be returned and re-dispensed?

answer

No, they can be returned for destruction only, provided that the salad pack contains no controlled substances.

question

Can controlled substances be returned to the pharmacy?

answer

No, they must be destroyed at the site.

question

Can a retail pharmacy accept the return of controlled substances from a jail or long term care facility?

answer

No, controlled substances must be destroyed on site.

question

If medications are sent out to the long term care facility or community based care home, but never reach the patient, can the medication be returned to the pharmacy and reused?

answer

Yes, as long as no more than 1 chemical entity is in each bubble.

question

What circumstances only require the PIC to be licensed in the state of Oregon?

answer

Out of state pharmacies that only mail prescriptions directly to patients are only required to have the PIC (or similar position) licensed with Oregon and does not require other employee pharmacists to be licensed.

question

When can I retake the NAPLEX or MPJE if I fail to get a score of 75 or greater?

answer

You must wait at least 91 days to retake the NAPLEX and at least 30 days to retake the MPJE.

question

How do I transfer my NAPLEX score?

answer

You must request a score transfer from the NABP (National Association of Boards of Pharmacy) BEFORE taking the exam, be a graduate of a school/college of pharmacy approved by the board of pharmacy, and provide documentation (Oregon score transfer application, passport photograph, copy of birth certificate, and evidence of pharmacy school graduation).

question

What are the requirements of a pharmacist if he wishes to reciprocate to Oregon?

answer

You must have an active license in good standing with the state you wish to reciprocate from, have passed the NAPLEX (score 75 or greater) and have a pharmacy degree from a school or college approved by the Board. You are required to have worked for a period of at least one year (with a minimum of 2000 hours) in the state of current licensure or met the internship requirements of Oregon within a year of application. You are also required to pass the MPJE with a score of 75 or greater. A pharmacist with their first professional degree outside of the United States is ineligible for reciprocity and must follow the requirements set forth in OAR 855-019-0150.

question

Can a licensed pharmacist in another state practice as an intern in Oregon?

answer

No, unless the pharmacist is requesting to reciprocate to Oregon and requires additional work experience hours. Even then, they still must apply for and receive an Oregon intern license from the Board before working as an intern in Oregon. More work experience is required if they haven't worked for at least 1 year (with a minimum of 1440 hrs) or completed the required internship hours (completed 1440 hrs within 1 year prior to application). Note: hours completed outside of the United States can not be used toward the required 1440 hrs.

question

What can an out of state licensed pharmacist do in Oregon while awaiting reciprocity approval?

answer

The Pharmacist is able to perform the duties of a clerk and if they obtain a technician license they may perform the duties of a technician, but they MUST obtain a technician license through the Board. They may not perform any activities reserved for a licensed pharmacist (Counsel, DUR, MTM, verification, etc...).

question

When I reinstate my license do I need to pay the licensing fees for all of the years I was not licensed?

answer

You must pay the licensing and late fees for all the years the license has been lapsed and have all CE requirements met for the lapsed years. If the time lapsed is greater then 1 year, you must also take and pass the MPJE. However, if you are a retired pharmacist that was licensed for at least 20 years (or if you had your license revoked by the Board) you are only required to pay for the current annual licensing fee, pass the MPJE, and have CE for all years since retirement.

question

What are some reasons that would cause the Board of pharmacy to suspend a license?

answer

The Board can revoke, suspend, or restrict a pharmacist, intern, or technician license for various reasons, such as; unprofessional conduct, violating a pharmacy or drug law, a felony, engaging in fraud, inability to perform your job, or being negligent. A partial list of reasons can be seen in OAR 855-019-0310.

question

If my license is revoked, suspended or restricted by the Board can I ever get it reinstated?

answer

Potentially, but the Board must find that the public interest will be protected if you are reinstated. You must prove this by giving various documentation and presentations showing how the current situation has changed since revocation. A complete list of requirements is listed in OAR 855-019-0320. It is important to note that for every case, even if all Board recommendations were satisfied, the Board must determine that the petitioner is not a threat to public interests if a license is reinstated.

question

Are there any specific requirements to be a PIC?

answer

You must have at least 1 year experience as a pharmacist or complete the PIC training course approved by the Board within 30 days of becoming a PIC. You must also notify the Board within 15 days of becoming a PIC or resigning as the PIC. You can not be a PIC of more than 2 pharmacies, unless there is written approval from the board.

question

As the PIC what am I responsible for?

answer

The PIC is responsible for the full operation of the pharmacy. Some specific requirements are listed that the PIC must personally complete, while other requirements the PIC is responsible for may be delegated to qualified employees. A list of these requirements can be seen in OAR 855-019-0300.

question

Is it required to maintain a perpetual inventory of controlled substances?

answer

It depends. It is required for C-II medications in hospital pharmacies (with a monthly inventory reconciliation), but a quarterly inventory reconciliation of all C-II's must be done in retail pharmacies.Note: The annual controlled substances inventory is still required. It must be taken on one day before opening or after closing and occur no later than every 365 days.

question

What are the procedures that only a pharmacist is allowed to do?

answer

Only a pharmacist can do the final verification on prescriptions. A pharmacist or a pharmacy intern (with the supervision and final approval of the pharmacist) may review laboratory tests (monitor, interpret, and/or order these tests), perform distinct pharmacist services (such as CDTM, DRR, or MTM), or execute other tasks that require professional pharmacist judgment.[Note: counseling, immunizations, DUR, and receiving oral prescriptions can all be done by a pharmacist or intern.

question

Do I need to perform a DUR for prescription refills?

answer

Yes. A pharmacist or intern must perform a DUR prior to dispensing or preparing all prescriptions and orders even if the computer does not prompt them to do so.

question

Do I need to document my counseling interactions?

answer

Yes, a pharmacist or an intern must personally document that counseling was accepted or declined after the interaction. A patient's electronic signature for insurance purposes is not sufficient. A decline to be counseled on a prescription that is new or changed must be directly to a pharmacist or intern. Under NO circumstances may any customers' refusal be accepted by a clerk or technician. For hospital discharge prescriptions, the pharmacist must ensure the patient receives adequate counseling.

question

Can I write a prescription based on CDTM?

answer

Yes, a pharmacist can transcribe a prescription based on CDTM between identified pharmacist(s) (practitioner authorized) and practitioner(s), with filed documentation of the pharmacists' activities and decisions/plan. The CDTM must be specific enough that any pharmacist would develop the same prescription; this should be accomplished by following the requirements laid out in OAR 855-019-0260.

question

Can I fill an internet prescription?

answer

No. Oregon pharmacists are only able to fill valid prescriptions developed from a legitimate patient-practitioner relationship. Online questionnaires are NOT considered a valid and adequate patient-practitioner relationship.

question

Can I fill a prescription for a controlled substance if it was received electronically?

answer

Yes, per new federal regulations a pharmacist may fill a prescription for a controlled substance if it was recieved electronically. See CFR 1306.08 for further details and guidance.

question

Do I need to print non-controlled electronic prescriptions or can I store them electronically?

answer

Yes, you can store them electronically if they are non-controlled. OAR 855-041-0060 (1)(a) An "original prescription" is a prescription maintained in the same physical manner in which a pharmacy first receives the prescription.

question

Can I administer immunizations to children?

answer

You can administer vaccines to patients that are age 7 or older based on the State protocol. You may adminsiter a vaccine outside the State protocol with a valid prescripton to adminster the vaccine.

question

Are there any other requirements to administer immunizations besides being immunization and CPR certified?

answer

There are protocols that must be followed in order to administer immunizations. A list of these requirements is found in OAR 855-019-0280 and should be studied and implemented before administering vaccines.

question

When do I have to do the Pain Management CE?

answer

A pharmacist must complete 7 hours of pain and management CE within 24 months of their first license renewal

question

When was the DEA established?

answer

1973

question

What is the CMEA?

answer

Combat methamphetamine epidemic act where each pharmacy must be self certified to sell ephedrine or pseudoephedrine

question

What does SLCPS mean?

answer

Scheduled listed contained products that contain ephedrine, pseudoephedrine, or phenylpropanolamine

question

What does a valid RX entail?

answer

Drug name, strength, dosage form, quantity, sig, and # of refills. Must be manually signed by prescriber

question

How to distinguish practitioner type DEA?

answer

DEA #s starting with M indicate midlevel practitioner DEA#s starting with B or F occur for high level practioner

question

Do federal government practitioners need a DEA number?

answer

No, they can write under their facility DEA #

question

What is the five percent rule when it comes to controls?

answer

A pharmacy can distribute control substances to another pharmacy without registering as a distributor if the amount does not exceed 5% of the calendar year.

question

When does a pharmacist need to renew their license?

answer

Biennually after the first license before June 30th.

question

What is the DEA Form 222?

answer

Form to order CIIs First page goes to distributor Second page goes to DEA Third page stays with purchaser

question

What is the DEA Form 224?

answer

Form to register to dispense control substances

question

What is the DEA form 224a?

answer

Renewal form for dispensing control substances Needs to be renewed every 3 years

question

What is the DEA form 224b?

answer

Renewal form for dispensing control substances for RETAIL outlets Needs to be renewed every 3 years

question

What is the DEA form 223?

answer

Duplicate copy of the Registration Certificate to dispense control substances

question

What is DEA form 106?

answer

Form to report theft or loss. Must be sent to DEA within 24 hours

question

What is DEA form 363?

answer

Form for prescribing controls for addiction such as methadone (Dolophine) and buprenorphine (Subutex, Suboxone)

question

What is DEA form 510?

answer

Form to register for chemical distributor

question

What is DEA form 41?

answer

Drugs surrendered or disposed (spilled drugs) From distributor to DEA

question

How many forms are in one DEA form 222? How many books may one pharmacy have at one time?

answer

Each DEA Form 222 has 7 forms. A pharmacy can have 6 books at one time. A total of 42 forms.

question

What is the punishment for unlawful manufacturing or distributing of C-Is?

answer

Class A felony

question

What is the punishment for unlawful manufacturing or distributing of C-IIs?

answer

Class B felony

question

What is the punishment for unlawful manufacturing or distributing of C-IIIs?

answer

Class C felony

question

What is the punishment for unlawful manufacturing or distributing of C-IVs?

answer

Class B misdemeanor

question

What is the punishment for unlawful manufacturing or distributing of C-Vs?

answer

Class C misdemeanor

question

What is the punishment for unlawful possession of C-Is?

answer

Class B felony

question

What is the punishment for unlawful possession of C-IIs?

answer

Class C felony

question

What is the punishment for unlawful possession of C-IIIs?

answer

Class A misdemeanor

question

What is the punishment for unlawful possession of C-IVs?

answer

Class C misdemeanor

question

What is the punishment for unlawful manufacturing or distributing of hydrocodone?

answer

Class B felony

question

What is the punishment for unlawful possession of hydrocodone?

answer

Class A misdemeanor

question

What is the punishment for unlawful manufacturing or distributing of oxycodone?

answer

Class A felony

question

What is the punishment for unlawful possession of oxycodone?

answer

Class C felony

question

How many members of the state board of pharmacy are there?

answer

9 members 5 pharmacists 2 techs 2 non-pharmacy related civilians

question

How long is each term of the members of the state board of pharmacy?

answer

Four years. No more than 3 terms end each year.

question

How many times a year must the BOP meet?

answer

Meet at least once every three months to transact its business

question

When do drug outlets need to register with the State board of pharmacy?

answer

annually

question

Can you fill a prescription from an out of state prescriber?

answer

Yes, but must verify with prescriber first to ensure the RX is valid

question

What is the Ryan Haight Act?

answer

Ryan Haight Online Pharmacy Consumer Protection act of 2008 is a law that states that online pharmacies cannot distribute control substances. Exempt are manufacturers or distributors who do not dispense controls. An online pharmacy who wishes to dispense controls must register with the DEA and apply for a modification of registration

question

How much SCLPs can be distributed per CMEA?

answer

No more than 3.6grams/ day can be purchased per individual No more than 9grams/month can be purchased per individual No more than 7.5grams/month can be imported by US postal service

question

How many days does a pharmacy must tell the BOP of a temporary change in pharmacy?

answer

3 days

question

What is the training time for nuclear pharmacists?

answer

6 months

question

How long must birth control records be kept?

answer

prescriptions must be kept for 3 years and questionnaires kept for 5 years

question

When does a pharmacist have to renew their license?

answer

Before June 30 biennially

question

When is the PIC self inspection form due?

answer

Before Feb 1 annually

question

When is the pharmacy registration due?

answer

Before March 31 annually

question

An RPh may write and fill an epinephrine prescription to be used by a trainee to treat an anaphylactic reaction. What are the rules for that?

answer

A trainee must complete a training program approved by OHA, must have a Statement of Completion, and Authorize to Obtain epinephrine. An RPh can generate and dispense an epi pen for not more than one child and one adult.

question

How many times can a trainee obtain epinephrine?

answer

Up to 4 times within 3 years of initial training

question

An RPh may write and fill a naloxone prescription to be used by a trainee to treat opioid overdose. What are the rules for that?

answer

A trainee must complete a training program approved by OHA, must have a Statement of completion, and Authorize to obtain Naloxone. An RPh can generate and dispense up to two unit-of-doses of naloxone.

question

How many times can a trainee obtain naloxone?

answer

Up to 6 times within 3 years of initial training

question

Do secondary drug storages within the hospital require separate registrations with the BOP?

answer

No

question

Do drug rooms (secondary storages located in a separate location from the hospital) require separate registrations with the BOP?

answer

Yes

question

How many people can have access to the night cabinet?

answer

Only one registered nurse

question

When must a hospital RPh verify a medication dispensed by the ER?

answer

within 24 hours or if the pharmacy is closed within the first day the pharmacy is open, but not to exceed 72 hours.

question

Are C-IIs allowed in robotic distribution systems?

answer

NO

question

What is a SPDO?

answer

Supervising physician dispensing outlet They must register with BOP annually before March 31

question

Do SPDOs need to retain a pharmacist licensed in OR?

answer

Yes

question

Personnel involved in high risk compounding must be retested in aseptic manipulative skills how many times a year?

answer

Semi-annually

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