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Pharmacy Tech 2
| Question | Answer |
|---|---|
| In the 19th century | , drugs in the United States were unregulated. ○ Some caused injury or death. Most agents contained a high content of alchol |
| To combat abuses in both formulation and labeling, in 1906 the U.S. | Congress passed the first of a series of landmark 20th century laws to regulate drugs. |
| The purpose of the Pure Food & Drug Act was to prohibit the interstate transportation or sale of | adulterated and misbranded food and drugs. |
| Adulterated | is impure by adding extraneous, improper, or inferior ingredients |
| Misbranded | to brand or label misleadingly or fraudulently. |
| Did not require drugs to be labeled, but required that drug labels not contain false information about the drugs’ | strength and purity |
| Harriscon Tax Act 1914 | Established that manufacturers, pharmacists, importer, and physicians prescribing narcotics should be Licensed and required to pay a tax. |
| Harriscon Tax Act 1914 | The law enacted in response to growing opiates and cocaine-containing medications. |
| Harriscon Tax Act 1914 | was a United States federal law, which regulated and taxed the production and distribution of opiates and cocoa products. |
| Sulfa poisoning caused the death of 107 people, primarily children. | Food, Drug, and Cosmetic (FDC) Act of 1938 Due to untested sulfanilamide concoction. ○ In response to this event, FDC was introduced. |
| Food, Drug and Cosmetic (FDC) Act of 1938 | Required only that drugs be SAFE for human consumption before marketing. |
| Food, Drug, and Cosmetic (FDC) Act of 1938 | ● Gave FDA the power to conduct inspections of manufacturing to ensure compliance. |
| Food, Drug, and Cosmetic (FDC) Act of 1938 | Act applied to interstate transactions, as well as to intrastate transactions. |
| Food, Drug, and Cosmetic (FDC) Act of 1938 | FDA required pharmaceutical manufacturers to file a new drug application (NDA) with each new drug before marketing. |
| Durham-Humphrey Amendment of 1951 States that drug containers do not have to include “adequate directions for use” as long as they include | “Caution: Federal Law Prohibits Dispensing Without Prescription.” Now, “Rx Only.” Distinguished between Legend (prescription) drugs. Over-the-counter (OTC) (non-prescription) drugs. |
| Kefauver-Harris Amendment of 1962 | In 1962 a new sleeping pill containing the drug THALIDOMIDE was found to cause severe birth defects when used during pregnancy (Europe). |
| Extended the FDC Act of 1938 to require that | ○ Drugs not only be safe for humans but also be ○ EFFECTIVE. |
| ● Requires drug manufacturers to file | Kefauver-Harris Amendment of 1962 |
| An investigational new drug application (INDA) with the FDA before initiating a clinical trial in humans. | Kefauver-Harris Amendment of 1962 |
| Once proven safe and effective, manufacturer may submit an NDA seeking approval to market the product. | Kefauver-Harris Amendment of 1962 |
| Poison Prevention Packaging Act of 1970 | ● Passed to prevent accidental childhood poisonings |
| Poison Prevention Packaging Act of 1970 | ● from prescription and nonprescription products. |
| Poison Prevention Packaging Act of 1970 | Requires most over-the-counter (OTC) and legend drugs to be packaged in child-resistant containers. |
| Poison Prevention Packaging Act of 1970 | ○ Cannot be opened by 80% of children under five. ○ Can be opened by 90% of adults. |
| Prevention and Control Act of 1970 | Commonly referred to as the Controlled Substances Act (CSA). |
| Prevention and Control Act of 1970 | Created the Drug Enforcement Administration (DEA), an arm of the Department of Justice. |
| Prevention and Control Act of 1970 | Charged with enforcement and prevention related to the abuse of controlled substances like many narcotic pain medications. |
| Comprehensive Drug Abuse Prevention and Control Act of 1970 | ● Classified drugs with potential for abuse as controlled substances. |
| Comprehensive Drug Abuse Prevention and Control Act of 1970 | Ranked controlled substances into five categories, or ● schedules. Ranging from those with great potential for abuse (Schedule I) to those with little potential (Schedule V). |
| Class I Heroin, LSD | For research only – not approved for human use |
| Class II Dispensing severely restricted | Morphine, oxycodone, meperidine |
| Class III Prescriptions can be refilled up to 5 times in 6 months | Codeine with aspirin, anabolic steroids |
| Class IV Same as for Schedule III | Benzodiazepines, meprobamate |
| Class V Some sold without prescription; must be 18 | Liquid codeine combination preps. |
| Drug Listing Act of 1972 | Gives the FDA the authority to compile a list of currently marketed drugs. |
| Drug Listing Act of 1972 | Each drug is assigned a unique and permanent product code. Known as a National Drug Code (NDC). |
| National Drug Code (NDC). | Ten characters that identify manufacturer or distributor, drug formulation, size and type of packaging. |
| The Medical Device Amendment (1976) | requires pre-market approval of safety and effectiveness of life sustaining and life supporting medical devices. |
| Orphan Drug Act of 1983 | An orphan drug is intended for use in a few patients with a rare disease or condition. ○ Developing such a drug would be prohibitively expensive, given the small market. |
| Orphan Drug Act of 1983 | encourages the development of orphan drugs by: ○ Providing tax incentives. ○ Granting manufacturers exclusive license. |
| Orphan Drug: Rituximab | Oncology |
| Orphan Drug: Ranibizumab | Ophthalmology |
| Orphan Drug: Somatropin | EPR, Metabolism |
| Orphan Drug: Lenalidomide | Oncology |
| Orphan Drug: Imatinib Mesylate | Oncology |
| Orphan Drug: Filgrastim | Hematology |
| Glatirame Acetate | MSP |
| Recombinant Factor VII (Octocog alfa) | Hematology |
| Bosentan Mohohydrate | Cardiovascular |
| Bortezomib | Oncology |
| Drug Price Competition and Patent-Term Restoration Act of 1984 | ● Also called Hatch- Waxman Act. |
| Drug Price Competition and Patent-Term Restoration Act of 1984 | Allows substation of generic drugs with the same chemical composition as brand name products. |
| Drug Price Competition and Patent-Term Restoration Act of 1984 | Once the original patent expires, any manufacturer may market a generic drug. |
| Drug Price Competition and Patent-Term Restoration Act of 1984 | Usually is less costly than the brand name. A given drug typically has several names. |
| Drug Price Competition and Patent-Term Restoration Act of 1984 | Generic name is a common name given to a drug regardless of brand name. |
| Drug Price Competition and Patent-Term Restoration Act of 1984 | One or more brand names under which the manufacturer markets a drug. |
| Prescription Drug Marketing Act of 1987 | PROHIBITS ● Re-importation of a drug into the United States. ● United States seniors getting prescription medication from Canada, Mexico, or other countries. ● Sale or trading of drug samples. |
| Omnibus Budget Reconciliation Act of 1990 (OBRA-90) | Requires states to establish standards for Drug Use Review (DUR) by the pharmacist. |
| Omnibus Budget Reconciliation Act of 1990 (OBRA-90) | Requires pharmacists to offer counseling to Medicaid patients. |
| Omnibus Budget Reconciliation Act of 1990 (OBRA-90) | Requires a manufacturers rebate to state Medicaid program between the manufacturer’s best price for a drug (typically the wholesale price) and the average billed price. |
| Health Insurance Portability and Accountability Act (HIPAA) of 1996 | Restrictions on transmission of prescription data. ● Provision of a private area for counseling. ● A training program for employees about confidentiality. |
| ● For pharmacy technicians, HIPAA means : | Must not reveal any information on any patient outside the pharmacy. ○ Violations would be grounds for immediate termination and legal action. |
| Food & Drug Administration Modernization Act | Authorizes fees to be added to a new drug application (NDA) process to accelerate the review and approval process for new drugs. |
| The FDA’s Center for Drug Evaluation & Research | Provides an Index to Drug-Specific Information with patient, consumer and healthcare professional information sheets, including FDA Alerts. |
| The FDA’s Center for Drug Evaluation & Research | ○ Alerts, such as the iPLEDGE program for Accutane(ISOTRETINOIN). |
| The FDA’s Center for Drug Evaluation & Research | Health care professionals, wholesalers, pharmacies and patients must register in the iPLEDGE program to prescribe , distribute, fill prescriptions, or use Accutane. |
| Placebo | ● Inactive substance: not real medicine administered |
| Placebo | ● Gives the impression that they’re receiving the real medicine. |
| Placebo | Used to compare against patients with the test drugs Investigational New Drug Application ( INDA) |
| Placebo | An application submitted to FDA by the manufacturer before initiating a clinical trial in humans. |
| New Drug Application ( NDA) | Once proven safe and effective, manufacturer may submit an NDA seeking approval to market the product. |
| Testing Phases | Begins in the laboratory for chemical analysis. |
| Animal testing (preclinical testing) | ● Use animals and treat them as humanly as possible. ● Test using different species. ● Only a fraction of the drugs tested on animals reach clinical trials stage. |
| Clinical trials with humans | INFORMED CONSENT is required for each patient before enrolling into clinical trials. |
| Clinical trials with humans | Requires for the patient to be told all the risks and other treatment options in a language they understand. |
| Clinical trials with humans | ● Patients should also be free to leave the trial at any time. |
| Clinical Trial Testing: Phase I | 20-100 patients. ○ Several months. ○ The main purpose is to study SAFETY. ○ Only about 25% of drugs tested in phase 1 successfully reach the market. |
| Clinical Trial Testing: Phase II | Up to several hundred patients. ○ Several months to two years. ○ The main purpose is short-term SAFETY AND EFFECTIVENESS. |
| Clinical Trial Testing: Phase III | ○ Several hundred to several thousands patients. ○ 1-4 years. ○ The main purpose is safety, dosage, and effectiveness. |
| Clinical Trial Testing: Phase IV | ○ Begs after the drug is approved. ○ Life time of the drug. ○ The main purpose is for safety |
| Patent is a right given to a manufacturer to exclusively market a new product for a specific period of time under a brand name. | ● A patent is good for 17 years. |
| Hatch-Waxman Act of 1984 | Extends patent up to 5 years to compensate for lost time in research before going to market. |
| Hatch-Waxman Act of 1984 | While the drug is under patent, a generic drug will NOT be marketed by other companies. |
| Marketed Drugs | Medical devices and biological products such as insulin and vaccines must also meet FDA testing and approval requirements. |
| The Center for Devices and Radiological Health (CDRH) | is responsible for devices. |
| The Center for Biologics Evaluation and Research (CBER) | is responsible for biological products made from living organisms. |
| Generic drugs are Pharmaceutically Equivalent is identical to the brand-name product listed in the orange book (FDA’s Approved Drugs Products publication) in terms of | ● Active ingredient. ● Dosage form. ● Route of administration and strength. |
| Therapeutically equivalent | is the body uses of the drug is the same. |
| Look Alike and Sound Alike Drugs | Federal laws require containers NOT to look like another drug, however some drugs look alike and sound alike. |
| Look Alike and Sound Alike Drugs | Safe ways to check the correct drug being dispensed is to check the NDC number on the container against the NDC number on the prescription label. |
| Tall Man Lettering | Uses a combination of lower and upper case letters to highlight the difference between look, alike, sound-alike names |
| amIODAROne | amLODIPine |
| coUMADIN | coVERSYL |
| nEURONtin | nOROXin |
| valAciclover | valGANciclovir |
| ● OTC drugs | have to be approved by the FDA . |
| ● OTC drugs | Can be used upon the judgment of the consumer without a prescription from a physician. |
| ● OTC drugs | There are over 100,000 OTC drugs in 80 therapeutic categories. |
| The manufacturer has to follow a format called drug monograph to be able to market with proper label including: | Active ingredient ● Direction for use ● Amount of content ● Warnings Expiration date |
| Behind-The-Counter BTC Medications | Medications sold without a prescription, but with RESTRICTION on their sales. |
| Behind-The-Counter BTC Medications | ● Kept behind the pharmacy counter. |
| Behind-The-Counter BTC Medications | Limitation: 3.6 grams per day and 7.5 gram per month. E.g. Pseudoephedrine and Ephedrine containing products. |
| Combat Methamphetamine Epidemic Act | Requires that cold and allergy medicine containing these ingredients be kept behind the counter. |
| Combat Methamphetamine Epidemic Act | Set daily and monthly amount restrictions. |
| Combat Methamphetamine Epidemic Act | A sales record (written or electronic) must be kept for a period of 2 years. |
| Combat Methamphetamine Epidemic Act The record should contain: | ● Drug name ● Quantity ● Name and address of purchaser ● Date and time of the sale ● Proof of ID ● Signature of the purchaser. |
| Exempt Narcotics | Sold by a pharmacist without a prescription. ○ E.g. Cough syrups that contain a small amount of codeine. |
| Exempt Narcotics | ● Only pharmacists can approve their dispensing. |
| Exempt Narcotics | urchasers have to: ○ Be at least 18 years old. ○ Provide identification |
| Exempt Narcotics | Document the sale in a bound record book (name and address of the purchaser, drug name and quantity, date, name or initial of the pharmacist.) |
| Emergency Contraceptives | Plan B |
| Plan B | ○ Has a dual marketing status (both Rx and OTC). ○ Prescription >17 years old. ○ OTC < 17 years old. |
| Plan B | Exception ○ Pharmacists in some states have authority to prescribe and dispense under protocol to patients under 17 years old. |
| Package Inset – is prescription information which comes with a document on the drug product. | Includes: ● Clinical pharmacology, ● Indications, ● Contraindications, ● Warnings, ● Adverse reaction, and ● Other related information. |
| Product Labeling | Intended for healthcare professionals who prescribe or dispense the product |
| Product Labeling | Is contained in a reference book called Physician Desk Reference ( PDR). |
| Controlled Substances | ● Drugs that have an abuse potential. |
| Controlled Substances | Enacted in 1970 by Controlled Substance Act (CSA) . |
| Controlled Substances | Five groups (or schedules) of such drugs and put a strict guideline on their distribution. |
| Controlled Substances | Requires to register with the Drug Enforcement Administration (DEA) of the Justice Department. |
| DEA Registration | Each pharmacy registers. ○ Pharmacy employees are not required to register. ○ Registration varies from 1 to 3 years in length. |
| DEA Registration ● Laws vary from state to state. | ○ some state laws are more stringent than the federal CSA. ○ the most stringent of the laws will be followed ■ If federal law is more stringent, it is followed. ■ If state law is more stringent, it is followed. |
| Drug Enforcement Administration (DEA) ● Issues licenses | ○ To medical practitioners to write prescriptions for scheduled drugs. ○ To pharmacies to order scheduled drugs from wholesalers. ○ Distributors to distribute controlled substances. |
| Drug Enforcement Administration (DEA) | Inspects medical facilities, including pharmacies |
| Drug Enforcement Administration (DEA) | Tracks narcotics from manufacturer to warehouse to pharmacy. |
| Manufacturers must label controlled drugs using the letter “C.” e.g. C-II, C-III, etc. | Record keeping: ● Schedule II – 7 years ● Others – 2 years |
| Storage | Schedule II – should be kept separately in a locked, and tamper-proof narcotic cabinet secured to the floor or wall. ● Schedule III-V can be stored on the shelf with other prescription drugs. |
| Prescriptions for Schedule II substances must be hand- signed by the prescriber except in emergencies | To minimize fraudulent use. ○ To maintain a record-tracking system. |
| An ------ of a Schedule II drug (72 hours supply) can be provided to a patient without a written prescription in most states | emergency supply |
| DEA Form 222 | ● Used to order C-I and C-II. |
| DEA Form 222 ● Must be signed by a registered person. Three copies: | ● Copy 1: Blue copy is retained by the supplier. ● Copy 2: Green copy is sent to the DEA. ● Copy 3: Brown copy is kept for your records. |
| DEA Form 222 | ● Must be kept in a separate file from other invoices. |
| DEA Form 222 | ● Note that C-III - C-V does not require federal order forms. |
| DEA Form 222 | Form has its own unique serial number. Form can be requested online. |
| DEA Numbers | ● Assigned to prescribers for controlled drugs. |
| DEA Numbers | ● Two letters and seven digits . |
| DEA Numbers | ● First letter is a code identifying the type of registrant. |
| DEA Numbers | ● Second letter is the initial of the registrant's last name. |
| DEA Numbers | ● Seventh digit is a “checksum" that is calculated. |
| DEA Numbers ● Example: AR4342793 ○ Add 1st +3rd +5th number = ___. ○ Add 2nd+4th +6th number = ___ multiply by 2 =__. ○ Then add ____+____=____. | ● The total should be a number whose last digit is the same as the last digit of the DEA number. ● AR4342793 ○ (4+4+7=15 3+2+9=14 14x2=28 then 15+28=43). |
| A prescription for a controlled substance must meet the following requirements. | ● Patient’s full name and address. ● Practitioner’s name, address, and DEA#. ● Drug name, strength, dosage form, quantity, directions, and refills. |
| A prescription for a controlled substance must meet the following requirements. | ● Must be written in ink or typewritten and signed by prescriber. ● Controlled substance must be dated on the date of issuance |
| Schedule III, IV, and V Prescriptions | ● May be verbal, written, or faxed and may be refilled if authorized by the prescriber. ● Schedule III and IV may be refilled up to 5 times within 6 months. ● Schedule V may be refilled as directed by the prescriber. |
| Food and Drug Administration (FDA) | Primary responsibility and authority is to enforce the law and create regulations to assist in providing the public with safe drug products. |
| Food and Drug Administration (FDA) | Requires all manufacturers to file applications for investigation studies and approval of new drugs. |
| Food and Drug Administration (FDA) | ● Oversees the recall of dangerous products. |
| Food and Drug Administration (FDA) | Has no legal authority over the practice of pharmacy in each state (is a responsibility of the BOARD OF PHARMACY). |
| FDA | approval process is quite thorough, but it is impossible to fully prove that a drug is safe for use. |
| The ---- has several options if it determines that a marketed drug presents a risk of illness, injury, or gross consumer deceptions. | FDA |
| Requests healthcare professionals and the public to report any adverse effects of drugs once they are marketed. | Public Safety |
| FDA seizes the drug, stops distribution, or may issue a recall of the drug. | Public Safety |
| Mediwatch | Allows any healthcare professional to report a serious adverse event that is suspected of being associated with the use of an FDA-regulated product. ○ Includes product problem, or medication error. |
| MedWatch | ● A voluntary program. |
| MedWatch | ● Designed to detect side effects not identified from research studies. |
| MedWatch | Manufacturers must file a report if an adverse drug reaction is reported. |
| MedWatch | Reports can be made. ○ Phone 1-800-FDA-0178, by mail, or online. |
| ● Adverse Effect | ○ Unintended side effect of a medication that is negative or in some way injurious to a patient’s health. |
| Removal of a drug from the market based on report . | ● Can be prescription or over-the-counter from the market. Can be from the public or healthcare professionals |
| Removal of a drug from the market based on report . | ● Adverse drug effect can be reported to the Manufacturer or to the FDA |
| Recalls Steps: ● FDA will contact the manufacturer. ● Manufactures contact wholesalers, retailers, and all consumer levels. | ● Personal phone calls are made or letters are sent to customers. ● Recalls are listed publicly. ● Listed in the weekly FDA enforcement report. |
| Types of Recalls | Class I: Serious adverse effects or death. |
| Types of Recalls | Class II: Cause temporary but reversible effects. |
| Types of Recalls | Class III: Not likely to cause adverse effects. |
| ● Vaccine Adverse Event Reporting Systems (VAERS) | ○ MedWatch does not monitor vaccines. ○ Performed by VAERS. ○ Post-marketing surveillance system operated by the FDA and the Centers for Disease Control (CDC). |
| Vaccine Adverse Event Reporting System (VAERS) | Report ○ (1-800-822-7967), online, or submitted by mail on a downloaded form. |
| JCAHO | ● Joint Commission on Accreditation of Healthcare Organizations. |
| JCAHO | ● Independent non-profit organization. |
| JCAHO | ● Establishes standards and monitors compliance |
| JCAHO | ● Monitors over 20,000 health care programs. |
| JCAHO | ● Covers hospital, health care networks, HMOs, and nursing homes. |
| ● Combat methamphetamine epidemic act (CMEA) | (CMEA) is a federal law on enacted on March 9, 2006, that places strict sales limits, storage rules, and record-keeping requirements on over-the-counter cold and allergy medications used to illegally manufacture methamphetamine. |
| Compliance | Pharmacy compliance refers to a pharmacy's ongoing commitment to follow all federal, state, and local laws, regulations, and professional standards that govern its daily operations. |
| ● Controlled substance mark | is a federal labeling requirement dictated by the Controlled Substances Act (CSA) and governed by the Drug Enforcement Administration (DEA). |
| ● Controlled substances | is any drug, medication, or chemical whose manufacture, possession, and use are strictly regulated by the government due to its potential for misuse, addiction, or harm. |
| ● Dual marketing | is a business strategy where a company sells its products or services through two different marketing channels to reach the same or different target audiences. |
| ● Exempt narcotics | Exempt narcotics refer to a specific group of Schedule V (5) controlled substances that, under federal law, can be dispensed by a pharmacist without a doctor's prescription. |
| ● Injunction | is a legal remedy in the form of a court order that compels a party to do or refrain from doing specific acts. |
| ● Legend drug | prescription medication. |
| Pharmacy liability | is the legal responsibility of pharmacists and pharmacy owners when a medication error, negligence, or breach of duty causes harm to a patient. |
| ● NDC (national drug code) | is a unique, three-segment numerical identifier assigned to all prescription and over-the-counter drug products ready for commercial distribution in the United States. |
| ● Negligence | is a fundamental legal concept in tort law that occurs when a party fails to exercise the standard of care that a reasonably prudent person would have exercised under similar circumstances, resulting in unintentional harm or injury to another. |
| Pediatric | in British English) is a medical term that means of, relating to, or specializing in the medical care, development, and illnesses of infants, children, adolescents, and young adults. |
| Pharmaceutical equivalents | are drug products that contain the identical amount of the identical active ingredient(s) in the identical dosage form and route of administration. |
| Placebo | is a substance or treatment with no active medical ingredients, designed to look exactly like a real medicine. |
| ● Product labeling | is the practice of placing text, symbols, or graphics on a product or its packaging to share essential details, ensure safety, and build brand identity. |
| Protocol | a structured, legally binding framework that authorizes pharmacists to perform clinical tasks or prescribe specific medications under defined conditions, expanding patient access to care. |
| Recall | to bring a past fact or event back into your mind, or to officially order someone or something to return. |
| ● Therapeutic equivalent | two or more drug products are expected to produce the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. |
| Amoxicillin | Controlled: No DEA schedule: Not Scheduled Refill Limits: Per prescriber's orders (no federal refill cap) Key Legal Requirements: Standard prescription drug; state pharmacy law governs refills, not DEA rules |
| Oxycodone | Controlled: Yes DEA schedule: Schedule II Refill Limits: No refills allowed. Key Legal Requirements: Standard prescription drug; state pharmacy law governs refills, not DEA rules |
| Oxycodone | Cannot be phoned in (except in emergencies, with written follow-up required within 7 days); no faxed prescriptions except in specific exceptions (e.g., hospice, LTC facilities); high abuse/dependence potential; strict recordkeeping |
| Alprazolam (Xanax) | Controlled: Yes DEA Schedule: Schedule IV Refill Limit: Up to 5 refills within 6 months from date of issue Key Legal Requirements: Can be phoned, faxed, or e-prescribed; moderate abuse potential relative to Schedule II/III |
| Codeine cough syrup (e.g., with guaifenesin) | Controlled: Yes DEA Schedule: Schedule V Refill Limits: Varies by State Key Legal Requirements: Some states require ID and signature log even without a prescription |
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