mpje 2015 Flashcards
Is a pharmacist’s signature required on hardcopies or will initials suffice?
It is acceptable to either sign, initial, or utilize an electronic record identifying the verifying pharmacist.
Can a pharmacist change the date-to-fill after talking to the prescribing doctor on a CII?
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.
How are outdated CIIs destroyed?
See 21 CFR 1307.21and OAR 855-080-0105 (reverse distributor, DEA, Board approved Plan).
Can physician assistants and naturopaths prescribe CII medications?
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.
++ Does a pharmacist need to cancel a CII prescription across its face and sign?
No
What is the law for selling a controlled substance for office use? CII? CIII-V?
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.
Does post-dating the prescription for a CII by the prescriber void the prescription?
The prescription must have the date it was written on the hard copy. For more information call the DEA office at 503-721-6660.
Is a typed CII prescription with an electronically signed signature a valid prescription?
No. The prescription needs to be hand signed by the prescriber.
Is a CII perpetual inventory required in all practice settings?
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.
Does the CII annual inventory have to be separated from the CIII-V inventory?
Yes, they can be on the same report as long as listed out separately.
How long do we need to keep CII inventory records?
3 years. ***
What is required of drug outlets electronically ordering CIIs?
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.
In which cases are partial fills on CII prescriptions allowed?
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.
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?
The date dispensed, quantity dispensed each time, amount remaining after each fill and pharmacist who dispensed it.
Can a CII prescription be changed from a capsule to a tablet or liquid form of the same medication?
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 technology, 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 theoretically equivalent to the drug prescribed.
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?
Yes.
What changes can a pharmacist make to a CII prescription after speaking to the prescriber over the phone?
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).
In which situations can a faxed CII prescription serve as an original prescription?
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.
Is it legal to write/fill a CII prescription on the same page as a second prescription?
Yes, but the prescriptions must be correctly filed and cross-referenced. The original must be filed under the highest controlled prescription.
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?
Yes. Both prescriptions must be filled and dispensed/sold at the same time.
Can a prescriber write multiple prescriptions for a CII on the same day to be filled on different dates?
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)]
Can prescribers post date CII prescriptions?
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.
Does a limit exist on the quantity of CII medication that can be dispensed from a single prescription?
No, but use professional judgment.
Is it ok to fill a CII from a state that is not contiguous?
Yes, but use professional judgement and make certain the prescription is valid. ORS 689.525(1)(2)
For drug recalls on a CII, can good drug be exchanged for the recalled drug?
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.
If there is a shortage of a CII such as oxycodone, can the RPh change the drug to oxycodone/APAP after consulting the practitioner?
Yes.
Can a CII be transferred between pharmacies with interactive databases (i.e.. Walgreen’s)?
Under no circumstance can a CII be transferred.
Do you have to file CIII-V invoices separate from CII invoices?
Yes.
Is it ok if CIII-V prescriptions are filed with regular legend drugs even if there is no identifier to manually separate them?
Yes, as long as the store can run a report of all CIII-Vs dispensed that is separate from the regular legend drugs.
How many refills are allowed by law on schedule III-V medications?
A prescription written for a schedule III-V medication is good for 6 months or 5 refills whichever comes first.
Can a prescriber’s agent call in or verbally verify a CIII-V prescription?
Yes, they can verbally verify it for the pharmacist or intern.
Can a pharmacy fill an e-script for a scheduled III-V medication?
Yes, If in compliance with CFR 1306.08.
*** What schedule are pseudoephedrine, phenylpropanolamine and ephedrine in Oregon? When did they become scheduled?
Schedule III as of July 1, 2006.
Does a partial fill on a CIII-V medication constitute a refill?
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. Vicodin #90 dispensed as #30 filled 3 times constitutes 1 refill).
Can a prescriber’s agent sign a refill request or prescription for a CIII-V medication?
No.
Does the 6 month limit for refills on schedule III-V medication mean a 6 month quantity limit?
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).
Is there a limit on how much pseudoephedrine or phenylpropanolamine a pharmacist can dispense?
No, it is dictated by whatever the prescriber writes for within the DEA limitations for a CIII (i.e. 6 months or 5 refills).
Can a pharmacist ever dispense a year supply of a CIII-V?
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.
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?
No.
Can CIII-Vs be transferred in between the same chain store via the computer system more than 1 time?
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.
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)
Yes, the prescriber should be alerted of the changes to ensure that the information in the patient’s chart is correct.
Can a charitable pharmacy accept controlled substances and/or OTC drugs for donation?
No
Who can bring in drugs for donation?
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.
Is there an expiration date guideline for donated drugs?
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
** What patients qualify to receive charitable drugs?
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
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?
No.
What is a shared service contract?
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.
When a compounding pharmacy performs a quarterly audit of all bulk CII powders, does the powder need to be weighed out each time?
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.
Can pharmacies compound products for OTC sale under a retail license?
No.
Are pharmacists required to counsel on prescriptions that have been reassigned if there are no changes on them?
No, but the pharmacist may use their discretion.
Do DURs have to have a hard halt that requires a pharmacist override to proceed?
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.
Does the pharmacist need to perform a DUR on refills?
Yes.
When can an emergency medication supply be given and what quantity can be given? (non-controlled med 1120)
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.
What expiration date should be listed on the prescription label?
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.
How do pharmacies sell prescriptions purchased by the prescriber “for office use?”
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.
What regulations exist for mailing prescriptions out of state?
Check with each state that the pharmacy will be mailing to.
Can pharmacists fill prescriptions for prescribers from other states, US territories and US military bases?
Yes, if they are licensed in their own state, practicing within their scope and have a valid patient/prescriber relationship.
Who does the pharmacist contact if they feel a prescriber is overprescribing a controlled substance, unsafely prescribing or unethically prescribing?
The prescriber’s regulatory board (i.e. Board of Nursing, Oregon Medical Board).
Can a prescriber or group of prescribers have ownership positions in a retail pharmacy?
Yes, but they may not have possession of the pharmacy keys.
+++Does a drug have to be AB rated for generic substitution in Oregon?
No, it is up to the pharmacist to use their professional judgment. See ORS 689.515 (2).
Can a fee be charged to a Medication Assistance Programs (MAPs) patient?
Yes.
Can a pharmacist fill a prescription based solely on an internet questionnaire?
No, the prescriber and patient must have a valid patient/prescriber relationship which usually includes a physical exam. See 855-019-0210(2).
Can a pharmacist supervise 2 interns at the same time in a Traditional Pharmacy-practice Internship ?
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.
If only the final verification of prescriptions are being done in Oregon, does the central fill pharmacy have to be licensed in Oregon?
Yes.
***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?
No, but the PIC must be licensed in Oregon.
Which out-of-state central fill employees must be licensed in Oregon?
Pharmacists and technicians that participate in any function of the dispensing process for Oregon patients must be licensed in Oregon.
Do out of state pharmacies have to be licensed in Oregon if they fill prescriptions for Oregon patients?
Yes.
Where can a pharmacist find information about the Death with Dignity Act?
http://public.health.oregon.gov/ProviderPartnerResources/EvaluationResearch/DeathwithDignityAct/Pages/index.aspx
Can pharmacy records be stored off-site?
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.
Can a pharmacist refuse to fill a prescription?
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.
Do dental hygienists have prescribing authority?
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.
Can a pharmacist fill a hand delivered prescription that has an electronic signature on it?
No, hand delivered prescriptions must be manually signed by the prescriber or their agent.
Is it ok for a prescriber’s agent to sign a prescription for them?
It is okay for them to sign the prescriber’s name followed by their name or initials on faxed non-controlled medications only.
How can a pharmacist verify that a prescriber is allowed to prescribe Suboxone® or Subutex® for opioid addiction?
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”
Does a prescriber need the Substance Abuse and Mental Health Services Administration (SAMHSA) waiver if they are using Suboxone® to treat pain?
No.
Does Oregon law limit the initial quantity of drug dispensed for a prescription medication?
No.
Can a pharmacist combine refills on a prescription to give a greater dispensed quantity?
Yes for non-controlled non psychothreapeutic med 1120-3-4
No, unless the pharmacist has received prescriber authorization to do so.
Does the refill authorization fax have to be kept as the hardcopy when adding refills?
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).
What info has to be on a refill authorization?
Date, number of refills authorized, and name of authorizing agent.
Can a pharmacy take back prescriptions after they are dispensed to the patient?
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.
Does a technician in another state doing work on behalf of an Oregon pharmacy have to be licensed in Oregon?
Yes.
Can techs take new prescriptions off of voicemail to later be verified by a pharmacist?
No.
Can a clerk take an oral authorization from a prescriber or a prescriber’s agent for a refill?
No.
Can clerks pull drugs off of a pharmacy shelf to be used in filling a prescription?
No.
Can a technician take changes on either a prescription or refill request?
No.
When is a technician or clerk allowed to inform the patient of a change in manufacturer?
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
When can a prescription be transferred in or out of the country?
When they are coming from or going to a US military base or US territory.
If a prescription is inadvertently faxed to the wrong pharmacy, can that pharmacy fax it to the correct pharmacy?
Yes.
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?
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.
When does category 1 compounding become category 2?
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.
Can you make a compound without a prescription?
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).
Does division 45 apply to nuclear pharmacies?
No. Radiopharmaceuticals have their own guidelines and are exempt from division 45. For information on nuclear pharmacies see division 19 and 42.
If compounding a non-sterile product, do I need to comply with division 45?
Yes. Division 45 applies to sterile and non-sterile compounding, unless the compound is classified as category 1.
Does division 45 incorporate USP chapters 797 and 795 rules?
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.
What are the training requirements for compounding in division 45?
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.
Are we allowed to compound anything the doctor prescribes?
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).
Are there specific policies and procedures for the compounding pharmacy?
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.
Are there any requirements for purchasing bulk chemicals?
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.
What is the expiration date of low risk sterile preparations?
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.
What defines medium risk conditions?
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.
What is the expiration date of medium risk sterile preparations?
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.
What defines high risk conditions?
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.
What is the expiration date of high risk sterile preparations?
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.
What are the requirements of an immediate use sterile preparation?
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.
What are the requirements for same day use sterile preparations?
The compounded product must be administered within 24 hours of preparation.
What is the expiration of a multi-dose vial?
The BUD is 1 month from first usage or the manufacturer expiration date, whichever is earlier.
What equipment do I need to make a low-risk sterile preparation?
Starting January 1st, 2009 an ISO 5 or better BSC (biological safety cabinet), CAI (compounding aseptic isolator) or LAF (laminar airflow hood).
What equipment is required to make a medium-risk sterile preparation?
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.
