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sun123
First Group
| Question | Answer |
|---|---|
| ATF-11 | Pharmacy needs to purchase 95% Ethanol |
| ATF-1447 | For pharmacy requiring greater quantities of tax free alcohol. |
| DEA 106 | Report theft (also report to local police) / Immediately, when DEA 106 form is sent in with police report, also send to board. |
| DEA 222 | Ordering and recording the amount received. 1st (brown) and 2nd (green) copy to supplier. Purchaser keeps 3rd (blue) copy - recording the amounts received on each line and the dates received. |
| DEA 222 Partial Fills | Order can be partially filled with the remaining quantity shipped within 60 days. No longer valid after 60 days from when executed by purchaser. |
| DEA Second Copy | Supplier sends 2nd copy of form to DEA by end of month. If supplier can’t fill all or part of order within specified time, can ENDORSE to supplier 2 but must put name and address of supplier 2 on back of form and supplier 1 cannot fill any part of order. |
| DEA 222a | To requisition DEA Form 222 |
| DEA 224 | New Application for Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner.n |
| DEA 224A | Renewal for Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner. |
| DEA 225 | New Application for Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter |
| DEA 363 | New Application for Narcotic Treatment Programs |
| DEA 363A | Rebewal for Narcotic Treatment Programs |
| DEA 41 | Destruction of controlled substances |
| DEA 510 | New Application for Domestic Chemical |
| FDA-2632 | NTP: Application for Approval of Use of Narcotic Drugs in a Narcotic Addiction Treatment Program completed and signed by the program sponsor. |
| FDA-2633 | Medical Responsibility Statement, completed and signed by each physician licensed by law to administer or dispense narcotic drugs at the primary dispensing location of this program. |
| FDA-2636 | Application for hospital to use Methadone for NTP |
| New Drug | After June 25, 1938 subject to 1906 FDA Require NDA (generics via ANDA - show bioequivalence Must be proven SAFE & EFFECTIVE |
| FDA Kefauver-Harris Amendments 1962 | Drugs approved from 1938-1962 to be SAFE & EFFECTIVE. (Due to Thaladomide flipper babies.) Prescription and OTC drug advertising regulated by this. |
| Ryan Haight | ONLINE PHARMACY: Face to face; DEA Endorsement; Enhanced penalties for CIII-V; Prohibits advertising illegal sales; Internet pharmacies must post information on their websites; State Cause of Action: Attorney General of each state can shut down sit |
| Waxman-Hatch Amendment: “Drug Price Competition and Patent-Term Restoration Act of 1984”. | Give 5 additional years to the already established 17 years patent exclusivity. Gave extra 6 months to companies for peds. Gave faster drug approval to generic companies (don’t have to wait for patent to expire to do research). |
| Duram-Humphrey Amendment 1951 | Made two classes: Legend (Rx) “Caution: Federal law prohibits dispensing without a prescription.” OTC “adequate directions for use” on manufacturer’s label. |
| How often is controlled substance inventory done? | It must be done yearly. CII inventory must be separate from CIII-V. |
| What does Institutional Practitioner mean? | Does not include pharmacy. It refers to a hospital or other entity (other than the individual) license, registered or otherwise permitted to dispense controlled substance in the course of professional practice. |
| Can CIIs be partially filled? | NO, unless hospice, terminally ill, LTC or community care: 60 days |
| When can a faxed CII count as the original? | LTC; Hospice; Community based care; Pain infusion |
| What is necessary for a CII emergency supply? | LTF can call emergency 72 H supply. Prescriber must sign, mail or FAX within 7 days. Prescriber must right “Authorization for Emergency Dispensing” on face. |
| What schedule are: Amphetamine, Methamphetamine, Codeine, Marijuana (in OR), Meperidine | CII |
| How long do records prescription records have to be kept in Oregon? | Records kept 3 years |
| Can CIIs be postdated? | NO. No postdating but different dates can be written for up to 90 days. |
| What schedule are these? Pseudoephedrine, Phenylpropanolamine, Ephedrine Fiorinal, Benzphetamine, Marinol Tussionex Suspension, Tylenol+Codeine Tablets | CIII |
| What are CIII amount limitations? | <15 Hycodone </= 90 Codeine |
| What schedule are these: Propoxyphene, BDZ, Meprobamate, Ambien, Soma, Fioricet? | CIV |
| What does USAN stand for? | United States Adopted Name: Designates non proprietary names |
| What did the FDCA 1938 of do? | gave FDA authority to oversee safety of food, drugs and cosmetics. Grandfathered drug: any drug prior to 1938. DCMTP. Drug and device are mutually exclusive. Class 1 device: “General Controls” |
| What is NDC? | National Drug Code: Not required on any manufacturer/unit dose/prescription labels. Can be reassigned after 5 years from the last commercial shipment of a drug by manufacturer. |
| What is the CFR? | Code of Federal Regulations: Requires manufacturers to imprint solid oral dosage forms (Rx or OTC) with code that identifies manufacturer and drug product. |
| What do homeopathic medications need to identify them? | Only have to ID manufacturer or nature of drug (NOT INGREDIENTS). |
| What is the Rx Drug Marketing Act (PDMA) 1987: Dingle? | It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It's designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. 'Samples'too. |
| What is Phase I? | Small group of health volunteers, looking for toicology, pharmacokinetic and pharmacologic properties AND assessing safety. |
| What is Phase II? | >/= 100 People with disease/condition to determine effectiveness, adequate dosage, relative safety and AEs. |
| What is Phase III? | Like HRA: Final testing. Large group of people from several geographical locations. Examining effectiveness as compared to a control. Led by clinicians at these remote sites. |
| What is Phase IV? | Post marketing surveillance. Health professionals should report any problems with drug. Manufacturer must submit yearly reports. |
| Type P New Drug FDA therapeutic Class | P=Priority reviewed faster because of significant advantages. |
| Type S New Drug FDA | S=Standard. Similar to other drugs on the market. |
| Type 1 New Drug FDA | New molecular structure. |
| Type 6 New Drug FDA | New therapeutic indication for a drug. |
| Type AA | Potential use for HIV/AIDS = Fast tracked accordingly. |
| Type E | For life threatening - Priority usually given. |
| Type N | Non-Prescription |
| Type V Orphan Drug | Orphan Drug <200,000 people in the US. |
| Orphan Drug Act 1983 | To reduce cost of orphan drugs. Rare disease affects <200,000 people in USA (in general). |
| Which nurses can write prescriptions in Oregon? | Nurse Practitioner Nurse Practitioner Midwife Nurse Specialist |
| Can an optometrist prescribe CIIs? | NO, Only CIII-CVs. |
| What is a 'reverse distributor? | A wholesaler who will take back controlled substances and destroy them. This does not apply to a company's own product. |
| Can a prescriber's agent sign a refill request or prescription for a CIII-V medication? | NO. MD Must do this himself. |
| How long should I keep my CE Certificates in Oregon? | 3 Years for 'pain' and 1 year for regular. |
| How long does the Oregon Board of Pharmacy require prescription records and other records to be kept? | 3 Years unless prescripions are electronically scanned in a reproducible image, then 120 days for noncontrolled and 3 years for controlled. |
| Who enforces HIPPA | Office for Civil Rights |
| What are the restrictions for Iodine dispensing. | < 2.2% no restrictions >2.2 is restricted |
| What is ISMP? | Institute of Safe Medication Practices which is dedicated to medication error prevention. |
| In a HOSPITAL, how often does a perpetual CII inventory have to be reconciled? | Monthly |
| Can a pharmacist combine refills on a prescription to give a greater than dispensed quantity? | NO, unless the pharmacist has received authorization from the prescriber to do so. |
| DEA 225A | Renewal Application for Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter |
| Who enforces drug recall? | Not enforced, rather a voluntary action by the pharmaceutical manufacturer. |
| What records for controlled substances can be maintained at a central location rather than the registered location? | After written notification by the registrant to the DEA, 1) Financial and 2) Shipping records can be maintained at a central location. |
| What is NDC? How many digits does a specific product have? | National Drug Code. 10 or 11 digits. |
| What is the major objective of an IND approval? | To protect the 1) Rights and 2) safety of the people of which the drug will be tested. |
| In the absence of stability data, in regards to expiration dating or beyond-use dating, what guidelines can a pharmacist follow for non-aqueous liquids and solids? | 25% of time remaining on the commercial product or a maximum of 6 months (whichever is less). |
| In the absence of stability data, in regards to expiration dating or beyond-use dating, what guidelines can a pharmacist follow for aqueous liquids made from solids obtained from manufactured drug products? | 14 days when stored at a cold temperature. |
| In the absence of stability data, in regards to expiration dating or beyond-use dating, what guidelines can a pharmacist follow for all others? | The time duration of therapy (not lasting more than 30 days). |
| What is DME (Durable Medical Equipment)? | Equipment that can 1) Stand repeated use; 2) Primarily used for medical purpose; 3) appropriate for use in a home (i.e. wheelchairs, oxygen tanks). |
| What amendment required safety and efficacy studies on medical devices including diagnostics and laboratory products prior to the marketing of the devices? | Medical Device Amendment of 1976 (MDA) |
| HIPPA Penalty for civil violation? | $100 per offence with a cap at $25,000.00 in a calendar year. |
| HIPPA Penalty for knowingly obtaining or disclosing protected health information? | $50,000.00 and 1 year imprisonment. |
| HIPPA Penalty for obtaining protected health information under false pretenses? | $100,000.00 and 5 years in imprisonment. |
| HIPPA Penalty for obtaining or disclosing protected health information with intent to sell, transfer or use information for personal gain or malicious harm. | $250,000.00 and 10 years imprisonment. |
| What should happen when a marketed drug product exhibits problems? | the drug manufacturer is encouraged to issue a drug recall notice. |
| What drug schedule is Phenobarbital in? | CIV |
| What is LAAM? | Levacetylmethadol (LAAM) synthetic opioid similar to the structure of methadone. Indicated for 2nd line tx for opioid dependence if pts fail to respond to methadone or buprenorphine. |
| What is 'tamper-evident' packaging? | Packaging designed to prevent foreign materials from getting into the final product. |
| Who is responsible for the Medicated and Medicare programs? | CMS (Centers for Medicare & Medicated Services |
| Can a drug product be exempt from demonstrating therapeutic equivalence? | Yes, but only under the grandfather clause. |
| How many compliance offers are there in Oregon? | 6 |
| What is the makeup of the Oregon State Board? | 5 practicing pharmacists and 2 public members. |
| How long is the NAPBLEX score transferable? | 1 Year. |
| What state agency is responsible for issuing a license to a wholesale distributor? How often does it have to be renewed? | Board of Pharmacy; 1 year |
| What is VAWD? | Verified Accredited Wholesale Distributors: A program designed to protect the public from counterfeit drugs entering the US drug supply. |
| Does Oregon recognize VAWD? | No. |
| What is the formula for Duke's Magic Mouthwash? | 1) Nystatin Suspension 100,000U/ml, 30 ml or Nystatin Powder 3M units 2) Hydrocortisone 60mg; 3) qs Diphenhydramine Syrup to 240ml. |
| Can a Nurse Specialist prescribe? | Yes |
| What does the Americans with Disabilities Act (ADA) of 1990 apply to? | 1) Companies employing 15 or more people; 2) Companies receiving or not receiving federal financial assistance; 3) Replaced the word 'handicapped' with 'disabled'. |
| What is HPUS? | Homeopathic Pharmacopeia of the United States. Published by a private organization. |
| How often does a DEA registration have to be renewed for a manufacturer? | Annually |
| How often does a DEA registration have to be renewed for a distributor? | Annually |
| How often does a DEA registration have to be renewed for a Dispenser? | 3 Years |
| How often does a DEA registration have to be renewed for a Prescriber? | 3 Years |
| What jurisdiction does enforcing PPPA fall into? | CSPS (Consumer Product Safety Commission) |
| What must be identified on each commercial oral capsule, as an imprint? | The company name; drug and strength of the drug. |
| What schedule is Benzphetamine? | CIII |
| What schedule is Marinol (Drobinal)? | CIII |
| What schedule is Carisprodol (SOMA) | CIV |
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sun123
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