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mpje
Maryland
| Question | Answer |
|---|---|
| How many people are on the Board of Pharmacy? How many from each practice setting? Length of term? How do they get there? | 12 - 2 from chain store, 2 from independent, 2 from acute care hospital; 1 from LTC, 1 from home infusion/home care; 2 @ large, and 2 consumer members. Appointed by governor for 4 yrs (staggered) |
| Vacancies on Board - how does one become a nominee, how many nominees | Associations submit list of nominees to Secretary and Governor. Except at large, all lists of nominees must be 3x the number of vacancies |
| What is the 2 year rule for consumer members on the board? | No substantial financial interest in any person regulated by Board within 2 yrs of appointment |
| How many votes do you need from the Board for a majority? | >= 7 |
| Does the Executive Director have voting power? | No |
| How many internship hours are needed for pharmacist licensure? School-supervised professional experience hours? | 1560; 1000 |
| Can a pharmacist renew their license after 2 years if they have not completed 30 hrs of CE credits? | Yes, if pharmacist can provide acceptable evidence of being unable to obtain require CE (sickness, familial issues, move, disaster) |
| What requirements must RPh meet if license is expired for < 2 yrs? | Renewal and reinstatement |
| What requirements must RPh meet if license is expired for > 2 yrs? | Reinstatement |
| How many hours work experience (in what length of time) does a pharm tech need before being licensed? | 160 hours in a Board-approved training program that lasts no longer than 6 months |
| What is the max penalty the Board can impose on a pharmacist as disciplinary action? | $10,000 in lieu of, or in addition to reprimand, probation, suspension and/or revocation of license. |
| Within how many business day(s) must a theft of controlled substances be reported to the field division office of the DEA in your area? | Notification is required within 1 business day. Completion/submission of DEA Form 106 is not required within 1 business day, but should be completed and submitted promptly. |
| When a pharmacist that has authority from the DEA to place electronic orders for all schedules of CDS resigns, the pharmacist's resignation must be communicated to the DEA Certification Authority within what period? | 6 hrs, b/c with electronic ordering of controlled substances, a DEA Form 222 is not needed. |
| What is the import/export law for personal medication use? | The limitation associated with the exemption from import and export requirements for personal medical use is a combined 50 dosage units and not 50 dosage units of each controlled substance. 21 CFR 1301.26 |
| What are the classes for medical devices provided by the federal FDCA? | Class 1: not subject to premarket approval; Class 2: Subject to performance standards; Class 3: Life-supporting or life-sustaining devices and require premarket approval by FDA. |
| At least how many days before introducing or delivering for introduction a dietary supplement that contains a new dietary ingredient must the manufacturer or distributor submit to the FDA information? What information? | 75 days; Information includes any citation to published articles on which basis the mfr or distributor has concluded that the dietary supplement can reasonably be expected to be safe. 21 USC 3650B |
| The FDCA prohibits the selling/purchasing/trading of a rx drug that was purchased by a hospital or other health care entity or donated or supplied at a reduced price to a charitable organization. What is NOT an exception to this prohibition? | A sale to a community pharmacy for non-emergency dispensing needs is NOT an exception. |
| What are 3 things that have to be placed on the actual CDS prescription form maintained in the pharmacy's prescription files? | 1. Physician's DEA number 2. Patient address 3. The word "void" or "transfer" on issuing or receiving, respectively, a xferred rx for a CDS |
| When must a med guide be provided to the patient? | For each dispensing - on the initial dispensing of the drug and on all refills. |
| If a 222 order form is suspected to be stolen, what should the purchaser send to the supplier? | 1. A statement regarding to the first order that it is stolen 2. A new order form |
| The initial inventory list of controlled substances should be kept for how long? | The initial inventory has to be present all the time for inspection. |
| Pharmacists that do not give out mandated med guides are guilty of what? | Misbranding |
| A pharmacy can be closed under what 3 conditions? | 1. Federal holidays 2. State emergency order 3. Religious holidays |
| For at least how long must a pharmacy keep a record of returned controlled substances to a wholesaler? | At least THREE (3) years |
| An RX prescription is written for #30, with 3 refills. When can the pharmacist refill the prescription? | - On the same day - After 2 days |
| The non-dosage form of propoxyphene is what schedule? | Schedule II. Propoxyphene (Darvon) is CIV, but the bulk non-dosage form is CII |
| What needs to be mentioned on the prescription label of a drug for a pet? | The pet's species |
| If the Board requests a print out of the prescription, then the pharmacy should be able to provide a printout of the original prescription from the computer within how long? | The pharmacy should be able to provide a print out of an original prescription/refills audit within 72 hours. If the pharmacy utilizes the central record keeping system, the pharmacy should be able to provide it within 48 hours. |
| Who has the authority to approve research based on clinical trials? | The IRB has the authority to: - approve/disapprove research - to require modifications in the research |
| What color DEA 222 form stays at the pharmacy? | Copy 1: BROWN. Stays with the supplier Copy 2: GREEN. Goes to the DEA Copy 3: BLUE. Stays at the pharmacy |
| Who decides what should be included in an emergency kit? | The pharmacist and an institutional practitioner |
| What is correct if the pharmacist is on lunch? | The pharmacy technician can perform clerical and administrative work. |
| What 4 things are true about a commercial container of controlled substances? | It must have a large enough CII or schedule letters for a person to easily see w/o taking contaner off the shelf. No need for tamper-evident package or lot# exp. date below the NDC# or drug name. |
| What must a pharmacist do on a controlled drug prescription? | Sign and date the face, verify MDs and patient's addresses, verify valid DEA #, verify name/strength/dosage form of drug are appropriate. |
| What is correct with regards to a pharmacist based vaccination program? | Pharmacist does not need a prescription to vaccinate a patient unless it is for an off-label purpose |
| If a supplier has shipped a partial order 6/12/09 and the rest of the order was shipped on 7/1/09, when should the supplier forward the copy of the DEA 222 to the DEA's office? | If the supplier filled a partial order, a copy of the DEA form should be forwarded at the end of the month of final shipment. |
| What dosage forms of PSE are regulated and restricted in limited quantity? | Only "solid oral dosage forms" like tablets, capsules, caplets, etc. are restricted according to FDA guidelines. Does not apply to elixirs, syrups |
| Drug X was d/c'ed b/c of the mfr's voluntary recall. The manufacturer received an FDA approval for a new drug Y, which is the structure analog of drug X. Can the mfr use the same NDC for drug Y, which was assigned to drug X? | Yes, only if 5 years has elapsed since the last commercial shipment of drug X |
| What is the DEA 82 Form for? | The DEA 82 form is a "Notice of Inspection of Controlled Premises" |
| Who grants the final approval for any drug's name? | Secretary of DHHS. USAN is sponsored by AMA, APhA, and USP. USAN gives the drug's name, but the final approval is given by the secretary of DHHS. |
| How long does it take the FDA to review an NDA? | The FDA takes about 6 months (180 days) to review the NDA. The FDA takes about 30 days to review the IND. |
| What federal agency can inspect without a warrant? | Only the FDA. State Boards of Pharmacy can also inspect w/o permission, but they are not a federal agency. |
| Of FARM, SOAP, and CORE, which are pharmacotherapy plans? | Only CORE: Condition, Outcome, Regimen, Evaluation. (FARM: Findings, Assessment, Resolution, Monitoring) |
| If an OTC product contains dextromethorphan, what should the pharmacist verify? | The patient's age - the patient should be 12 or older. |
| Of the following, what does not necessarily need to be mentioned on a parenteral product?: Preservative, Coloring Agent, Inert gas | Coloring agents are NEVER used in opthalmic and parenteral drugs, so not even considered. Inert gas does not need to be mentioned on the label. |
| Can naturopathic physicians order and possess controlled substances? Scientific investigators? | No; Yes |
| What are GMP protocols designed to assure? | Safety and Quality of drug products |
| A person from a neighboring state presents an rx for 100 methadone tablets. The pharmacist calls the prescribing physician and determines that the methadone was prescribed for pain associated terminal carcinoma. What should the pharmacist do? | Fill the prescription as written. Once the prescription is verified with the doctor, it can be filled as written. |
| What is the therapeutic code of the product which was reported the potential bioequivalent problems? | "AB" therapeutic code is designated if the product was reported with potential bioequivalence problems but those problems were solved by in vivo or in vitro study. |
| What is the schedule for 100 mg opium in a 100 mL solution? | Schedule V |
| Who regulates OTC products' advertisements? | The FDA regulates Rx advertisements and the FTC regulates OTC advertisements |
| FDA and IRB. CDER decides whether the clinical trials should be performed or not on human subjects (i.e. CDER decides the safety of human subjects before trials). However, it is not associated with the approval process. | |
| What can tax free alcohol be used for? | Medicinal and scientific purposes only. It can not be used for compounding purposes. |
| What does USAN base the names of new drugs on? | Chemical class and Therapeutic use |
| What are the respective classes of the following: Paregoric, Fiorinal, Tussionex | Paregoric - III (anhydrous morphine 2 mg); Fiorinal - III (Butalbital); Tussionex - III (Hydrocodone w/chlorpheniramine) |
| At what sodium level does an OTC drug not need labeling - "Do not use this product if you are on a sodium restricted diet"? | < 0.5 mg is considered sodium free. < 35 mg is very low sodium. < 140 mg is low sodium. If any dosage form contains < 140 mg, it does not need this statement. |
| What is the schedule for Tylox? | Schedule II. Tylox is a combination of oxycodone and APAP |
| Can a retail pharmacy that compounds 50 suppositories sell the stock supply to another pharmacy if requested? | No. Selling, trading, or purchasing of compounded products to other health care entities is not allowed. |
| MD - How long do prescription records need to be kept on file? | 5 years |
| MD - What are 2 things required for mailing prescriptions? | 1. Statement about temperature affect on medication effectiveness. 2. Toll-free number for contact regarding questions about meds. |
| MD - Are prescription returns allowed? | Yes, IF: packaged by mfr as unit dose or if blister packed by RPh, is single unit dose, and RPh believes integrity has or will be preserved. Note - a pharmacy technician cannot accept the return |
| MD - When can pre-printed prescriptions be used? | For non-CDS prescriptions |
| MD - What are the rules for a CIII-V transfer? | May only be transferred on a one time only basis so long as there are refills remaining |
| MD - Can price information be included on prescription advertising? | Yes, but must include total charge to consumer. No additional fees may be imposed (e.g. delivery). Note - no representations may be made as to safety or efficacy. |
| MD - What information must be recorded for CIII-V refills? (3) | - Date if Dispensing - Amount dispensed - Pharmacist's initials |
| MD - What is the age restriction for purchasing syringes? | 18 years |
| MD - Under what 2 circumstances is patient counseling not required? | - Patient is inpatient in hospital - Patient is resident of nursing home |
| MD - Can an Rx for a CII be filled if it received by fax? | Not until original is presented and reviewed by RPh. Exemptions - for immediate compounding and administration via routes other than oral route. Also for hospice and terminally ill. |
| MD - Can a CDS be eprescribed? | No; requires a wet signature. If no wet signature, pharmacist must verify verbally to dispense. |
| MD - If an RPh dispenses a CII in an emergency situation, what does the prescriber need to do? | Provide pharmacy w/written rx for emergency prescription WITHIN 7 DAYS that bears the legend, "Authorization for Emergency Dispensing" If not recv'd, contact local DEA office and DHMH |
| MD - How long after an unauthorized refill does the Rph need to notify the authorized prescriber? | Within 72 hours of dispensing. If under a state of emergency then notification must be given within 7 days. |
| MD - What are the rules for an unauthorized refill? | No more than 14 day supply, only 1 time. |
| MD - Days supply restriction for dextroamphetamine and methylphenidate? Implantable infusion pumps? CII/III? | Dextroamphetamine and methylphenidate may be filled for up to a 60 days supply if prescribed for ADHD or Narcolepsy. Rx for pumps up to 90 days supply. II/III - 30 days |
| MD - What is the monthly gram limit of PSE per recipient per month for Mail-Order Pharmacies? | 7.5g limit per recipient per month. ID of recipient must be verified before shipping. |
| MD - PSE products that contain greater than what amount need to be recorded in a logbook? | 60 mg |
| MD - What are the three features required on tamper-resistant prescriptions? | 1. A feature to prevent unauthorized copying (i.e. high security watermark, thermochromic Ink); 2. A feature to prevent erasure/modifications (Tamper resistant bg ink); 3. A feature to prevent the use of counterfeit forms |
| MD - What are the three exceptions for tamper-resistant prescriptions? | 1. Pts who are dual eligible (Medicare-Medicaid); 2. Rx paid for by a managed care entity; 3. Electronic, faxed, or verbal rx orders; 4. Emergency fills, provided that tamper-resistant rx provided w/in 72 hrs |
| MD - What is the 5% rule? | When selling or transferring a CIII-V, the pharmacy does not have to register as a distributor/wholesaler as long as the amount distributed to another registrant does not exceed 5% of the total dosages distributed and dispensed in 1 year. |
| MD - Can a CII be transferred or sold? | Yes, but a 222 Form is required. |
| What schedule are anabolic steroids? | III |
| What schedule is Lomotil? | V |
| What schedule is Robitussin AC? | V |
| What should a supplier do if they can not provide the amount requested? | May fill the order in part and forward the balance w/in 60 days. The Green 222 form should be sent to the DEA at the end of the month when the order is completed. |
| What should be done if a 222 is lost in course of transmission to supplier? | A new 222 form must be completed. The ordering entity must provide a statement that the goods ordered were never received as well as the serial number of the order form and the date of the initial order. |
| What should be done if the 222 is lost or stolen? | The ordering entity or supplier must immediately contact the DEA |
| Where should CDS records be kept? | CII - on site. CIII-V - may be kept at a central location provided at the registrant requests that it keeps invoices at a central location in writing to the DEA Special Agent in Charge. May start after 14 days of receipt of notice to the DEA |
| How often does CDS inventory need to be taken? | At least every 2 years |
| When taking inventory, is an exact count of CDS drugs required? | CII - Yes. CIII-V - Only for open containers that hold > 1000 solid dosage units. Otherwise an estimate can be made. |
| What is the DEA Form required for Pharmacy Registration? | DEA Form 224 to apply + $550. If approved, DEA will issue Form 223 to register to dispense CII-V drugs. |
| What is the DEA form for theft or significant loss of CDS? When should DEA be notified? | Form 106. MUST be submitted electronically. Must also send Form 106 to DHMH. Any theft or significant loss should be reported by telephone within 1 business day of discovery. |
| What is the days supply limit for CIV and V drugs? | IV - 180 days. V - no limit |
| How much time can lapse between refills before a legit prescription can no longer be refilled? | 180 days (6 months) |
| How long is a prescription for a CII valid for terminally ill patients and LTC Facility patients? | Prescription is valid for up to 60 days from date of issue |
| What did the Drug Treatment Act of 2000 do? | Allows qualified physicians to treat opioid dependence with buprenorphine based agents in an office-based setting |
| What is the max number of patients a physician can treat in an opioid dependence program and how? | Up to 100 patients at a given time if, after one year, qualified physician seeks a waiver of the 30 patient limit. |
| What is unique about prescriptions written by physicians authorized to run an opioid dependent program? | Must have 2 numbers - their DEA number and their "X" number" - displayed on the face of the prescription. |
| Can a physician write, "prn" refills? | No |
| Drug Importation Act of 1848 | Ordered U.S. Customs to prevent entry of foreign adulterated drugs |
| Biologics Control Act of 1902 | Designed to protect safety and purity of vaccines, serums, etc. used to treat or prevent disease in humans |
| Food and Drug Act of 1906 | Prohibited the introduction into interstate commerce of adulterated or misbranded foods and drugs. Required medications to meet the standards set by the USP and the NF |
| Food, Drug and Cosmetic Act of 1938 | Increased power of FDA to regulate food and drugs. Required mfrs to apply to FDA before a new drug could be marketed. Required new drugs to be shown as safe before marketing. |
| Durrham-Humphrey Amendment of 1951. | Previously, status of medication as Rx or OTC was determined by state low. This Amendment established legend (rX) and non-legend (OTC) drugs. Amendment classifies drugs that cannot be used safely and restricts sale to licensed practitioner. |
| Kefauver Amendment of 1962 | Substantially changed drug approval process. Must be "substantial evidence" of efficacy prior to marketing. Greatly enhanced FDA regulatory authority over drugs. Established "DESI" drug review |
| Medical Device Amendments of 1976 | Ensured safety and effectiveness of medical devices. Required mfrs to register with the FDA |
| Orphan Drug Act of 1982 | Includes diseases that affect < 200,000 ppl in the US. MFrs receive tax credits to offset research costs, granted 7 yrs of market exclusivity, separate from usual patent protection |
| Hatch-Waxman Act of 1984 | Allowed for ANDA to demonstrate bioequivalency with innovator w/o proof of safety or effectiveness. Permits brand name mfrs to seek greater patent protection. |
| Prescription Drug Marketing Act of 1987 | Banned reimportation of US mfr Rx drugs, prohibits sale or trade of sample meds, samples only dist to practitioners, strict inventory reqts for samples, states required to license wholesalers, pedigrees, banned bulk resales by hospitals |
| FDA Modernization Act of 1997 | Expedites premarketing review process for new products, ensures timely review of applications, encourages drug mfrs to study drugs in peds populations by granting patent life extensions |
| What are the requirements for patient package inserts? | Required to be given to pt or agent upon each new rx or refill. For hospitalized or LTC pts, must be provided prior to administration and every 30 days thereafter if therapy continues. |
| What is it called for failure to provide a package insert? | Misbranding |
| What products require declaration of warnings by the FDA? (7) | Mehtylsalicylate, isoproterenol inhalation, ipecac syrup (OTC sale limited to 1 oz), phenactein containing, salicylate containing, Mineral oil (use in pregnanc, bedtime only), EtOH, when used with internal analgesics and antipyretics |
| What are the types of recalls? | Class I - Reasonable probability that use of product will cause serious adverse health consequence. Class II - Exposure may cause TEMPORARY or medically reversible ADE, or probability is remote. Class III - Use not likely to cause adverse consequences |
| Who can issue recalls? What is the definition of a recall? | A recall is a VOLUNTARY action to remove product. FDA can recall medical devices, but not food or drugs. The drug mfrs recall their products. |
| MD - When should a pharmacist report his/her residence address and location of employment to the Board? | Within 30 days of any change |
| MD - What is the rule for samples in the pharmacy? | Cannot possess samples in Rx unless in hospital, where storing samples for the MD |
| MD - What is MD law regarding methadone? | May be dispensed for pain but cannot dispense as part of a rehabilitation program (maintenance), unless specific registration for that purpose |
| What is the DEA form for breakage or spillage (accidental disposal?) | DEA Form 41 |
| MD - What is a major difference between institutional and community pharmacies? | Adverse rxns must be reported to FDA in an institution, recorded in pts chart and reported to appropriate institutional committee and prescriber. Not required in community setting |
| MD - How often does inventory need to be taken for CDS in an institutional pharmacy? | At least monthly a physical count needs to be taken and compared with perpetual inventory -- at least monthly any discrepancies and reports of losses are investigated and appropriate action taken. On demand perpetual CII must be available. |
| MD - When does an emergency drug kit need to be restocked in an institution? | Within 72 hrs of notification of use or expiration (date when 1st drug in kit is going to expire) |
| If receive subpoena to release records, how much time does patient have to object? | Have 10 days to give subpoena notification to patient who can object to records unless requested by a JUDGE (court), not just by the lawyer |
| DSHEA, 1994 | Est. dietary supplement class. Major types of claims - structure/fxn, no premarket approval. health claims, need premarket approval (relationship of substance to disease/condition). drug claims, need drug regulation. |
| What is the age restriction for Plan B? | Only sold OTC to people over 17 years of age |
Created by:
battlangl99