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WA MPJE
| Question | Answer |
|---|---|
| Sentencing for robbing a pharmacy? | additional 12 months + standard sentencing |
| What are the 3 divisions of law? | Civil, Criminal and Administrative Law |
| What is Civil Law? | disputes between individuals or corporations; contracts, agreements |
| What is Criminal Law? | violations of criminal statutes against a state |
| What is Administrative Law? | violations of law against government agencies, e.g. Dept of Health, DEA. |
| What happens if you violate administrative law? | fines or restrictions on your license (suspension, revoke) |
| What is the highest court at both the state and federal levels? | US Supreme Court and Washington State Supreme Court |
| Writ of Certiorari? | a written document of appeal issued by the US Supreme Court |
| What is the highest law of the land? | the US constitution |
| Do international treaties have precedence over state and federal laws? | YES |
| What are codes? | Codes are means to organize the many statutes and regulations into a meaningful and usable form |
| What are the two codes of Washington? | Revised Code of Washington (RCW) and Washington Administrative Code (WAC) |
| What are the two codes of Federal Law? | United States Code (USC) and Code of Federal Regulations (CFR) |
| Under the RCW code, what 3 key activities can a pharmacist do? | 1.) administer drugs and devices 2.) monitor drug therapy 3.) initiate or modify drug therapy under protocol or written guidelines authorized by another prescriber |
| When does a license expire? | every year on licensee's birthday |
| How many hours does Washington state require for license renewal? | 1.5 CEU or 15 contact hours |
| What type of topics are approved for license renewal? | legal aspects of health care; properties and actions of drugs; characteristics of disease states; or specialized pharmacy practice |
| Is license renewal required for newly graduated pharmacist? | No, they are exempt for the first license renewal. |
| Which two organizations manage CPE Monitor Program? | ACPE and NABP |
| During military service, does a pharmacist license expire? | No, it remains active as long as he/she remains in service and in good standing |
| How does reactivating a license work if reactivating within 3 years? | must pay a reactivation fee and fulfill CE requirements |
| How does reactivating a license work if reactivating after 3 years? | After 3 years and active license some other state- retake MPJE and provide evidence of active status; After 3 years and no other active license- retake MPJE for WA and 300 hrs of internship or pass a practical exam; |
| How many hours of HIV/AIDS are required for pharmacist licensure? | 7 hours |
| How much is pharmacist license fee? | original is $145 and renewal is $190 |
| What can a pharmacist intern do? | under direct supervision of a pharmacist, interns can do anything the pharmacist does except supervising techs and checking IV admixtures |
| How to become a Preceptor? | Practice in Class A pharmacy, complete commission-approved training every 5 years, have at least 1 yr of pharmacist experience, |
| One preceptor- One Intern engaged in dispensing? | A pharmacist can supervise more than one intern but only one intern can dispense at a time. |
| What is the required internship hours in WA? | 1500 hrs-- 1200 hrs from clerkship and 300 hrs from working as intern after 1st semester of 1st yr |
| What are the two pharmacy ancillary personnel? | technicians and assistants |
| How do you get Certified Pharmacy Technician (CPht)? | national exams: PTCE or ExCPT |
| Do you need CPht to become a technician? | No |
| What are the Rph: tech ratio? | 1:3 |
| Which pharmacy personal can enter Rx in computer system, retrieve drug from shelf, or stock automated drug dispensing device? | Rph, tech, intern |
| What can a pharmacy assistant do? | prepackage, label, count, pour, and put back drugs on shelf; |
| What is the ratio for Rph: assistant? | no limit |
| How is the MPJE set up? | 2 hrs; 90 questions, only 75 are used for scoring |
| How long does controlled substances records be maintained? | 2 years |
| How long does prescription records be maintained? | 2 years |
| What is the number to Poison Control? | 1-800- 222-1222 |
| Must pharmacies have the poison control number readily available? | Yes |
| What is the Ipecac syrup requirement? | Each pharmacy must maintain at least one ounce bottle of Ipecac syrup in stock at all times. |
| What are the scores given by the Commission after a pharmacy inspection? | Class A, Conditional, and unsatisfactory |
| How many hour supply must be given for emergency outpatient dispensing from institution? | 24 hr supply; cannot be for controlled substances |
| When can a physician use verbal orders? | emergency or unusual circumstances. |
| Who can accept verbal orders? | physicians, nurses or pharmacists |
| When must verbal orders be authenticated by the prescribing physician? | 48 hrs |
| What must a pharmacy label contain? | pharmacy name and address, patient's name, drug name, strength, and quantity, directions, serial prescription number, date, prescriber's name, pharmacist's initials |
| In nursing home, what is the committee that is similar to the P&T Committee for hospitals? | Pharmaceutical Services Committee |
| Can schedule III drugs be stored with other legend drugs? | No, but C-III can be stored with C-II |
| Two ways food and drugs could violate the Pure Food and Drug Act? | Adulteration and Misbranding |
| When was the FDCA created? | 1938 |
| Before FDCA was created, was there requirements such as providing safety (NDA) to FDA to get pre-market approval? | No |
| What is the Durham-Humphrey Amendment? | Created in 1951, it created what is called Legend Drugs: drugs that could not be dispensed without a prescription |
| Why are legend drugs called legend drugs? | Because they bear a "legend" on their label: "Caution: Federal Law prohibits dispensing without a prescription |
| What is the Kefauver-Harris Amendment? | 1962; established effective; GMP |
| Orphan Drug Act of 1983? | extended patent protection and giving tax relief to companies that develop drugs without significant market potential. |
| Risk Evaluation and Mitigation Strategies (REMS)? | AKA Food and Drug Administration Amendments Act; Enforced by the FDA to ensure the benefit outweighs the risk |
| Is ephedrine Rx or OTC in Washington? | Rx unless OTC combo bronchodilator <25mg of ephedrine |
| Is theophylline Rx or OTC in Washington? | Rx unless OTC combo <130mg of theophylline |
| What organization oversees biologics? | Public Health Service Act |
| Biologic manufacturers submit what type of application to FDA for new biologic testing? | Biologic License Application (BLA) |
| What is the generic equivalent to biologics called? | biosimilar or interchangeable biological products |
| What is the application for biosimilar to be marketed? | 351k |
| Poison Sales and Manufacturing Act? | requires pharmacist to maintain a poison register: date time of sale, full name and address of purchaser, kind and quantity of poison sold, purpose for use. |
| What is the process of drug development in the US? | preclinical testing (IND), Clinical Testing (phase I, II, III), NDA, post marketing (phase IV), supplemental NDA |
| What is abbreviated NDA? | a request by manufacturer to FDA to market generic versions of brand drug once patent expires. |
| What happens in Phase I clinical trial? | healthy volunteers to determine PK and PD |
| What happens in Phase II clinical trial? | patients with targeted disease to determine efficacy and dose-response |
| What happens in Phase III clinical trial? | large clinical trials with diseased patients that are double blind and placebo controlled |
| What happens in Phase IV clinical trial? | post-market surveillance looking for side effects |
| What is the FDA Food Safety Modernization Act? | Signed by President Obama that allows the FDA to recall foods |
| What are the three classes of medical devices according to the FDCA? | Class I: common simple devices needing to conform to general standard... Class II: must meet specific standards... Class III: will pose a risk of injury if not used properly, needing pre-market approval |
| What are Restricted Devices? | has the label "Caution: Federal law restricts this device to sale by or on the order of a physician" |
| Are syringes and needles restricted devices? | No |
| Can Rph sell syringes and needles without a prescription? | Yes, through the needle exchange program; customer must be at least 18 yo |
| What are the 7-point label elements required by the FDCA for OTC labeling? | 1) Name of Product... 2) Name and address of manufacturer, packager, distributor...3) Net contents...4) Active Ingredients and quantity of certain other ingredients... 5) Name of any habit forming drug... 6) Cautions and Warnings...7) Directions of Use |
| Are prescriptions required to bear the legend "Caution: Federal Law prohibits dispensing without a prescription?" | No, they just need to bear the "Rx symbol" |
| What does misbranding mean? | label is incomplete or misleading |
| How much potency is left in a drug once it reaches it's expiration date? | 95% |
| If the expiration of a drug is only shown as month and year, what day does it expire? | on the last day of the month |
| In Washington, is there a one-year limit exp date on dispensed drugs? | No; you can use the exp on the original container |
| Must sample drugs be labeled with name of prescriber and patient? | Yes |
| Is a prescription still valid if a prescriber loses his license right after writing the rx? | Yes |
| What is Expedited Partner Therapy (EPT)? | a rx for patient's partner from a physician without ever having to examine the patient's partner. e.g. Chllamydia or gonorrhea treatments. |
| In Washington, is cursive handwriting on Rx considered illegible? | Yes |
| Can pharmacist received non-complying Rx for emergencies? | Yes, as long as there is confirmation via fax, phone, or e-mail within 72 hrs. Rph must document time and day of dispensed and confirmation. |
| All legend drugs must have a seal of approval by WA State Board. What does the seal of approval look like? | a map of WA State with a mortar and pestle with text that reads "Paper Approved by the Washington State Board of Pharmacy" |
| When do legend drug prescriptions expire? | 1 year |
| When do controlled substance prescriptions expire? | 6 months |
| Is the Rx still valid if the prescriber pre-dates or post-date rx? | No |
| How do you correct a wrong date written by prescriber for controlled substance? | Rph must talk to the prescriber |
| Can pharmacist take voice messages left by prescriber? | Yes |
| According to the Joint Commission National Patient Safety Goals, what is the minimum patient identifier that must be on a prescription? | 2 |
| What are the rules for faxing an Rx? | 1. must be sent directly from prescriber to pharmacy 2. must contain date, time, and telephone, and location of fax 3. Rph must store the fax up to 2 years |
| Is a fax legal if the Rx showed "Void" or "Illegal" when faxed? | No, the fax is now illegal. Rph must follow up and convert to oral prescription |
| Usually how long is patent exclusivity for the "innovator" of the drug? | 17 years from the date the patent is filed |
| If a manufacturer wishes to add new indications, changed directions, or additional warnings, what must they file with the FDA? | Supplemental New Drug Application; this may allow for additional market exclusivity for the new claims |
| What is the generic name of a drug known as? | United Stats Adopted Name (USAN) |
| Does the generic manufacturer need to repeat Phase I, II, and III? | no, when applying for ANDA, they just need to prove bioavailability and bioequivalence |
| What is the Orange Book? | aka Approved Drug Products and Therapeutic Equivalents; published by the FDA; tells you which drugs can be therapeutically subsituted |
| What is DAW? | Dispense As Written |
| What does PRN refill mean? | the Rx can only be refilled up to one year since the date it was written. |
| How do you dispense emergency supply of an Rx? | give patient up to 72 hr supply an d contact prescriber immediately. For refills only. Does not apply to controlled substances. |
| How do you bill third parties for partial filling of meds? | Do not bill until full quantity has been dispensed. |
| How do you give a copy of a prescription to a patient? | The original must be kept in the pharmacy and a photocopy, clearly written copy, can be given to the patient; pharmacist may also hand copy the Rx but write copy on it. |
| Can an intern transfer or receive prescription transfer? | Yes |
| How do you transfer a controlled Rx? | find the original rx, write void on it, record name, address, and DEA of pharmacy, and name of Rph, date. |
| How do you receive a transfer of controlled Rx? | write pt name and address, prescriber's name and address, Transfer, original date, number of refills remaining, date of last refill, name of transferor, dates of all previous refills, name, address, and DEA number of pharmacy. Source of original Rx. |
| How many transfers can a legend Rx have? | infinite until refills run out. |
| How many transfers can a controlled Rx have? | 1 |
| Must all Rx be in child resistant containers? | Yes, unless pt, agent, or doctor signs a waiver. |
| Does a patient need to sign a waiver for child resistant containers if they are using blister cards? | Yes |
| If you are pregnant or child under 3 yo, what is the max mercury (present in thimerosol) allowed in a medication? | 0.5mcg per 0.5ml dose; exception is flu vaccines |
| True or False: Recalled Drugs are considered misbranded or adulterated and thus must not be dispensed. | True |
| What are the classes of FDA recalls? | Class I: most serious, injury or death....Class II: problems are temporary or reversible.....Class III: not likely to cause health problems |
| What are the four major categories of pharmaceutical wastes? | liquid, gaseous, radioactive, and solid waste. |
| What is WA state counterpart for OSHA? | WISHA |
| What does OSHA do? | protects workers from workplace hazards |
| Must reverse distributers be registered with the DEA? | Yes, because they handle controlled substances |
| Which federal organization governs pharmaceutical waste? | Resource Conservation and Recovery Act of 1976 (RCRA) |
| How are chemotherapy wastes regulated? | Trace Waste (Yellow bin): empty vials, syringes, iv's, gowns, gloves, zip lock bags....Bulk Waste (Black bin): not empty vials.....Spill Cleanup (Black container): spills |
| Can drugs be flushed down the toilet or sink? | No, drugs are considered dangerous waste. |
| What is Compliance Policy Guide? | followed by FDA; pharmacies would not be charged with violations of FDCA if they followed certain criteria |
| What are the criteria for compliance policy guide? | ** Rx cmpd only for individual patients **Rx did not cmpd extra in advance ** Rx not use commercial equipment ** Products were prepared from FDA approved products ** Rx did not cmpd available marketed drugs ** Rx did not promote specific drugs |
| What can compounding Rx promote and not promote? | They cannot promote a particular drug or particular class of drugs. They can promote that they offer compounding services |
| What is USP 795? | compounding of non-sterile products |
| In the absence of stability info, what is the BUD for water-containing formulations for compounded med? | 14 days fridge |
| In the absence of stability info, what is the BUD for nonaqueous liquids and solid formulations for compounded med? | 25% of time remaining on expiration of drug or 6 months |
| How do you label a compounded drug? | * name of preparation * internal ID number * BUD * initials of compounder * storage requirements |
| What is USP 797? | compounding of sterile products |
| What is the thin line that distinguish manufacturing and compounding? | distribution of compounded product by a pharmacy for RESALE is manufacturing |
| What is accomodation sales? | loaning, borrowing, or purchasing drugs to meet urgent needs of the pharmacy; it is not considered wholesale or retail sale |
| What is the percentage of total sales in 12 months for a pharmacy to not register as a wholesaler if they sold to doctors and pharmacies? | 5% |
| Can a pharmacy loan or borrow a drug that has been relabeled? | Yes, but all the required labeling must be present or it is considered misbranded. Best to loan/borrow from original container. |
| How do you borrow/loan a drug? | get a copy of the invoice; the borrower must repay with the same quantity of the same drug product |
| A pharmacy transferring a drug to another pharmacy will have to provide a pedigree for that drug except when: | *Intra-company transfer *transfers for documented medical emergency to another pharmacy *sale of min quantities to prescribers |
| What is the FDA policy on personal transport of drugs from other countries? | The FDA will not take action against individuals who bring 3 months or less supply of non-controlled drugs into the United States. The FDA will not permit transport of controlled drugs. |
| True of False: the DEA, under the Justice Dept, was created to enforce the controlled substance act? | True |
| Is self-prescribing or self-dispensing of controlled substance legal in Washington? | No but self dispensing of Schedule V is okay. |
| Is dispensing of assisted suicide drugs required by pharmacist in WA? | No |
| What is the law regarding anabolic steroids? | Prohibits physicians from prescribing and Rx from dispensing anabolic steroids, growth hormones, testosterone, HCG, or other hormones for the purpose of enhancing athletic ability |
| What is the law regarding CNS stimulants for weight control? | prohibited from prescribing or dispensing |
| What is the law regarding amphetamines and stimulants? | MD must indicate an approved indication for use |
| True of False: Employer cannot employ any person with a convicted felony involving controlled substances? | True |
| What must be included in all controlled substance prescriptions ordered by an optometrist? | notation of purpose |
| How do you validate a DEA number using the check digit? | AB1234567; first letter is level of prescribing rights, comes in A, B, or F.; 2nd letter is prescriber's last name; see p. 213 |
| How to handle loss or theft of controlled substance? | any "significant" loss or theft must be reported to DEA by phone, fax, or written message and report to local police. Rx must fill out DEA form 106 |
| What is "significant" loss of controlled substance? | It is up to the discretion of the PIC |
| How to handle insignificant loss of controlled substance? | place a record of the event, the drug, and amount; up to PIC discretion; don't need to report |
| Is breakage or spillage of a controlled substance considered loss? | No |
| How long must a Rx keep its records? | 2 years |
| How often should an Rx do it's inventory? | initial inventory when opening, or transferring ownership, then biennial thereafter. |
| In WA, what is the exp date of controlled prescriptions II, III, IV, and V? | 6 months from date written |
| Can you fax a CII rx? | yes but the fax copy must be a copy of the written rx that is signed by the prescriber |
| Can you get a telephone order for CII rx? | no |
| Authorization for emergency supply of CII? | oral order okay and give 72 hr supply, then prescriber must deliver written prescription to pharmacy within 7 days (or postmarked within 7 days); Rph writes "Authorization for Emergency Supply" on script and staple the telephoned order to the written rx. |
| What should you do if the prescriber does not deliver the written prescription for authorization for emergency supply within 7 days? | Rph must notify Board of Pharmacy and DEA |
| Can there be refills for CII? | no but partial fills are okay |
| Can a prescriber write for multiple rx for a single CII and patient? | Yes but the rxs cannot together exceed 90 day supply; each rx must have earliest date pharmacy may fill the rx. |
| How long do you have to fill partial fill of CII? | 72 hrs normally or 60 days if terminally ill/nursing home |
| What is the expiration date for CII scripts? | Federal law has no time limit but WA law states 6 months |
| What can be change or edited on a CII script after Rph consults with prescriber? | Everything but the patient's name or the drug name |
| True or False: in WA, CII may not be filed in the same file as non-scheduled II drugs. | True |
| True or False: In WA, Schedule V drugs may not be refilled more than 5 times or more than 6 months after date is written. | True |
| What is the refill limit for Schedule V drugs under federal law? | no limit |
| What is the refill limit for Schedule III-V under WA law? | may be refilled up to 6 months after date written |
| What must the transferring Rph do for controlled rx for a transfer? | 1. write void on hard copy 2. name, address, and DEA number of receiving pharmacy 3. date of transfer 4. Full name of receiving Rph 5. his/her name on the hardcopy |
| What must the receiving Rph do for controlled rx for a transfer? | 1. name, address, DEA number of transferring pharmacy 2. Rx number of the rx at the transferring pharmacy 3. full name of transferrer 4. original date written 5. date of each fill, rx #, and pharmacy 6. original refills 7. remaining refills |
| Computer records for CIII or CIV must be kept for how long? | 24 months after the last refill |
| Controlled substance records are kept for how long? | 2 years |
| What is the law regarding ephedrine, phenylpropanolamine, and pseudoephedrine (EPP)? | EPP is not accessible to general public, Photo ID must include date of birth of purchaser, and Purchaser is at least 18 yo |
| What is the buying limit of ephedrine, phenylpropanolamine, and pseudoephedrine (EPP)? | 3.6 gm within 24hr or 9gm within 30-days |
| What is the possession limit of ephedrine, phenylpropanolamine, and pseudoephedrine (EPP)? | 15gm except in home |
| What are the exceptions of having a Transaction Log for EPP? | 1. combo in liquid or gel capsules 2. prescription EPP 3. sales recorded in pharmacy profile |
| What is WRAPP? | Washington Recovery Assistance Program for Pharmacy; Helps Rph who had alcohol or substance abuse. |
| What is the possession limit on marijuana? | 15 plants; 24 ounces |
| True or False: All providers who are covered entities under HIPAA must obtain an NPI? | true |
| For what reasons can health care entities use PHI? | treatment, payment, or health care operations |
| Under WA law, how long do healthcare entities have to respond to a patient request for a copy of his/her records? | 15 days with 6 day extension (if needed) |
| Under WA law, how long do healthcare entities have to respond to a patient request for amending his/her records? | 10 days with 11 day extension (if needed) |
| True or False: disclosure of PHI to former caregivers and health care providers is currently allowed without a consent. | False; must obtain patient consent first |
| True or False: disclosure of PHI to law enforcement is currently allowed without a consent. | True but must be in writing; e.g. warrant, subpoena |
| At what age must Rph not disclose records of patients who have STD? | 14 yo; the patient must give permission regardless if the parents want the info or not. |
| At what age must Rph not disclose records of patients who have chemical dependency? | 13 yo |
| How do medical facilities notify Dept of Health about adverse events? | the event must be serious, report shall only identify facility, a root cause analysis shall be conducted |
| Providing treatment without patient consent is considered what under common law? | assault |
| In WA, what is the statute of limitations on health care negligence to file lawsuit? | 3 years from date of injury |
Created by:
taingera1