Pharmacy Exam 3

How can you report?

1-800-FDA-1088

Federal law requires what symbol to be placed on a manufacturer label to indicate product is a controlled substance

C

1970 Federal Food and Drug Act

1906 Federal Food and Drug Act rewritten to incorporate "False drug claims regarding their effectiveness" Manufacturers must prove the effectiveness of drugs through scientific studies

Schedule 11 drugs has how many refills?

0 refills and not transferable

2005 Combat Methamphetamine Act

Establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine. Addresses all areas of the manufacture and sale of pseudoephedrine (an ingredient used to make methamphetamine), as well as law enforcement Non-scheduled substance but is a behind-the-counter medication Strict guidelines Only a licensed pharmacist or technician may dispense, sell, or distribute this drug Max amount is 9g within a 30-day period Log book requires the following: product name, qty sold, name/address of purchaser, date and time of sales

What two agencies work together to recommend ratings for new drugs?

FDA and DEA

What is MedWatch?

FDA maintained which encourages health care professionals to report adverse effects that occur from the use of and approved drug or other medical products

What meds are required to have MedGuides accompanying them?

FDA requires MedGuides be dispensed with certain prescribed drugs Can prevent serious adverse effects, inform patient of known serious side effect, patient adherence is essential of products effectiveness

2013 Drug Quality and Security Act

Gives greater oversight of bulk pharmaceutical compounding and enhances the agency's ability to track drugs through the distribution process Gives FDA tracking system for bulk compounding supplies through distribution process. Prompted by deadly fungal meningitis outbreak of 2012 by a compounding pharmacy in Massachusetts Two separate acts: Compounding Quality Act New class of compounders to register as manufacturers with FDA; allows to sell in bulk Drug Supply Chain Security Act Related to counterfeit, falsified and substandard prescription medication. Requires FDA to create and implement a national tracking system used by manufacturers and introduce bar-coding technology to pharmaceutical products Example: counterfeit Avastatin

2010 Patient Protection and Affordable Care Act

Makes preventative care more accessible and affordable for many Americans Makes preventative care more accessible and affordable for many Americans Requires insurance companies to cover all applicants with new minimum standards, including pre-existing conditions Two important technician-related components: Electronic health records (EHR) Medication therapy management (MTM) and Medicare Part D www.hhs.gov/opa/affordable-care-act/index.html

What is perpetual inventory?

The perpetual inventory shows controlled substances received by the facility supplied to other locations returned to the pharmacy and dispensed to patients. A perpetual inventory will show the actual number of units of a drug at a particular moment and time. Perpetual inventory is done by making an initial count of all controlled substances, and then monitoring the count as drugs are dispensed by subtracting the amount taken out of stock and adding to the count all drugs received by the pharmacy and placed into stock.

1951 Durham-Humphrey Amendment

This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution:Federal law prohibits dispensing without a prescrition", requires physician supervision for the purchase of legend drugs. Also, over the counter drugs without medical supervision are required to have on the label: Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not

1983 Orphan Drug Act

This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases. The Orphan Drug Act allowed drug companies to bypass the lengthy time requirements of testing a new drug and the cost that accompanied them to provide a medication to persons who had rare disease(s) Eased restrictions (and thus costs) for development of new drugs for those with a rare disease (affecting 1 in 200,000 people) Facts: 12 - 15 years from lab to pharmacy 1 in 5000 drugs approved for human testing 1 in 5 drugs gets approved for use

1996 Health Insurance Portability Accounting Act

Title I Insurance Reform: deals with patient's right to continuance of health insurance even when changing employers or loss of employment Title II Administrative Simplification: Established electronic transaction and Code Set standards; required Health Information Privacy. Change for pharmacies: Pharmacists and technicians have direct knowledge of a patient's medical information; the patient must sign a consent form to grant others access to this information PHI = personal health information HIPAA Patient Info private

DEA form 225

To manufacture or distribute controlled substances

DEA form 363

To run a narcotic treatment program or compound narcotics

Who ultimately determines what schedule of drug is place in?

U.S. attorney general

What is USP?

United States Pharmacopeia

What should be reported?

allergic reactions adverse reactions

What is a teratogen?

any agent or factor that causes malformation of an embryo

Why are drug monographs/patient package inserts required?

because of lack of space of on drug containers. Includes: Description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, drug abuse and dependence, adverse reactions, dosage, and how supplied -Box warning or Black box warning. example: indication of other medication that cannot be taken at the same time.

what department was DEA created under?

department of justice

1987 Omnibus Budget Reconciliation Act

established extensive revisions disregarding

1987 Omnibus Budget Reconciliation Act

established extensive revisions disregarding Medicare and Medicaid conditions of participation regarding long term care facilities and pharmacy

Controlled substance records are kept for how many years?

every 2 years

1994 Dietary Supplement Health and Education Act

expanded the definition of dietary supplements and restricted the FDA's regulatory authority over them. Herbal products are dietary supplements rather than drugs. Manufacturers are allowed to make claims in regards to good health but not disease claims Guidelines set to prevent adulteration and must follow good manufacturing practices Herbal products must meet requirements and be labeled as dietary supplement labeling that identifies ingredients by name

federal vs. state law, what determines which is followed?

follow strictest law.

How can controlled substances be lent to another pharmacy?

Yes, but must meet guidelines such as Receiving pharmacy must be registered with DEA to dispense controlled substances Lending pharmacy must record that it lent the medication and receiving pharmacy must record that it received the medication If a CII is lent, it must be documented on a DEA 222 form by the lending pharmacy and must have drug information, quantity, name/address/DEA number of receiving pharmacy No more than 5% of the total number of dosage units of controlled substances can be dispensed by a pharmacy within a calendar year unless the pharmacy is registered as a distributer

Can controlled substances be mailed?

Yes. C-11 through C-V can be mailed as long as contents not identified on packaging

Risk Management programs What is the iPledge program, why is isotretinoin regulated?

ipledge Program FDA regulates isotretinoin (Accutane) because of severe adverse effects of drug Severe birth defects Increased risk of suicidality Boxed warning Restricted distribution guidelines must be followed before patient can receive medication Computer-based risk management program designed to increase awareness of dangers of isotretinoin in an effort to eliminate fetal exposure REMS = approved risk evaluation and mitigation strategies, required by FDA for approval or approved products when new safety information arises. Strategy to manage a known or potential serious risk associated with a drug.

DEA form 222

is valid 60 days after being written To order or transfer schedule 1 and 11 substances

How are C11 drugs kept stored?

locked up

How are C111-CV drugs kept stored?

locked up

what is the key on a manufacturer label to identifying if a product has been recalled?

lot number

How does a pharmacy receive a recall notice?

manufacturer

where can MedWatch be found?

online form on FDA website: fda.gov

1970 Poison Prevention Packaging Act

requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies

1990 Omnibus Budget Reconciliation Act

requires pharmacists to offer counseling to Medicaid patients regarding medications Deals specifically with practicing pharmacists Enacted because of reimbursement regulations for people who are covered by Medicaid or Medicare Requires manufacturers to provide lowest prices to any customer or Medicaid patient by rebating each state Medicaid agency the difference between its average price and lowest price Requires pharmacists to counsel (at the time of purchase) all patients who receive new prescriptions. Failure to do so may result in loss of Medicaid funds and/or fines.

What determines prescribing authority?

state boards

1990 Nutrition Labeling and Education Act

this act covers food items and their labeling; vitamins, minerals, or other nutrients are on the label and in some cases are highlighted Gives FDA authority to require nutrition labeling on most foods Vitamins, Minerals and other nutrients are on the label and some cases highlighted Requires nutrient content claims (e.g. high fiber, low fat, etc.) Health claims must meet FDA regulations Did not require restaurants to comply to same standards

How to report and adverse reaction?

www.FDA.gov under medwatch

What are MedGuides?

-required for drugs FDA has determined as posing "serious and significant concerns" -required for new and refill prescriptions -required for outpatients not under direct supervision of healthcare professional with some exceptions -every new medguide approved since 2007 has been in conjunction with a REMS Paper handouts that are available with prescription medications, dispensed by pharmacy with each fill ( New and additional refills) Medications with boxed warning also have MedGuides Address issues specific to particular drug and drug classes Contain FDA-approved information that can help patients avoid serious adverse events FDA requires MedGuides be dispensed with certain prescribed drugs Can prevent serious adverse effects, inform patient of known serious side effect, patient adherence is essential of products effectiveness

What is an amendment?

A change in the original act or law

What is NF?

National Formulary

DEA form 224

Needed by pharmacy to dispense controlled substances

What are safety data sheets?

OSHA Safety Data Sheet (SDS) must be available for all chemicals Includes information on storage requirements, handling, and what to do in case of a spill or contact with the eyes

What is the difference between opiates and opioids?

Opiates - narcotic anaglesic, derived from opium poppy. Ie. morphine and codeine Opioids - narcotic anaglesic at least part synthetic opiate. Ie. Oxycontin and dilaudid

What prescription information is submitted?

Patient information, prescriber information, pharmacy identification and prescription information - name, qty of controlled substance and date prescription was dispensed

1962 Kefauver-Harris Amendment

Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug. Burden put on manufacturers to ensure "good manufacturing practice" (GMP) and requires safety testing

1987 Prescription Drug Marketing Act

Restricts distribution of prescription drugs to legitimate commercial channels; requires drug wholesalers to be licensed by the states. Prescription Drug Marketing Act Helps prevent counterfeit drugs and ingredients from entering the supply chain Limits diversion of pharmaceutical samples and prescription drugs

1990 Anabolic Steroid Control Act

Resulted in harsher penalties for the abuse of anabolic steroids and their misuses by athletes

DEA form 510

Retail pharmacies that want to engage in whole distribution of bulk quantities of drugs containing pseudoephedrine, ephedrine or phenylpropanolamine

What is REMS?

Risk Evaluation and Mitigation Strategy. it is a strategy to manage a known or potential serious risk associated with a drug or biological product.

DEA form 106

"Report of Theft or Loss of Controlled Substances The form requests information such as the name and address of the registrant, phone number, name of the police department contacted, type of theft or loss, purchase value to registrant and nae of common carrier. "

What is an Act?

"a statutory plan passed by Congress or any legislature which is a "bill" until enacted and becomes law"

How many schedules of controlled substance are there?

5

Schedule 111-V drugs have how many refills?

5 times within 6 months and can be transfer one time

What is a reverse distributor?

Accept control substances for destruction All controlled substances that are unwanted, unusable, or outdated that are returned to the distributor Prevents drug diversion

1995 Freedom of Choice Law

Allows a member of a prescription drug plan to select any pharmacy for his/her pharmacy benefit as long as pharmacy agrees to terms & conditions

1995 Any Willing Provider Law

Allows any pharmacy to participate in prescription drug benefit plan as long as they agree to terms & conditions

1990 FDA Safe Medical Devices Act

Also known as the Humanitarian Device Exemption-Safe Medical Devices Act Encourages discovery and use of devices intended to benefit patients in the treatment/diagnosis of disease/conditions that affect fewer than 4000 individuals in the U.S. Requires that all medical devices be tracked and records maintained for durable medical equipment i.e., infusion pumps

2004 Anabolic Steroid Control Act

Amended 1990 Controlled Substances Act and replaced Anabolic Steroid definition Anabolic Steroids are scheduled III and eliminated requirement to prove muscle growth Increased number of anabolic steroid to 59 Provides requirements for registration, security, labeling, inventory, prescriptions, disposal, importation/exportation and criminal liability.

1972 Drug Listing Act

Amended the 1938 Food, Drug and Cosmetic Act Prevents unfair or deceptive packaging and labeling Provides list of all drugs made by an establishment to the FDA Each drug assigned a specific 11 digit number to identify it Specific number known as National Drug Code (NDC) 1st 5 digits identify Manufacturer Next 4 digits identify Drug Product Final 2 digits identify package size and packaging

2008 Medicaid Tamper-Resistant Prescription Act

Applies to all handwritten prescriptions for covered outpatient drugs; drugs that are transmitted from prescriber (verbally, fax, e-prescribing) are not affected by this act. It only applies whenever Medicaid pays any portion. The pharmacy may accept a faxed prescription until physicians office has a tamper-resistant prescription pad. Tamper resistant must have one or more industry recognized features to prevent : unauthorized copying, erasure/modification of information written, use of counterfeit prescription forms The pharmacy may fill the prescription for emergency purpose but must receive proper documentation from prescriber within 72 hrs. The prescription may be transferred to another pharmacy by fax/phone without the pharmacy verifying the original prescription

1967 Fair Packaging and Labeling Act

Applies to labels on consumer products; requires label to state: identity of product name & place of business manufacturer, packer, or distributor net quantity of contents (metric & U.S. customary units)

1970 Occupational Safety and Health Act

Ensures job safety and sets health standards for employees Maintains a reporting system for job-related injuries, reduces workplace hazards and audits to ensure compliance Requires use of Safety Data Sheets (SDS) Formerly called material safety data sheets (MSDS) Provided by seller of product to purchaser Important chemical information Its impact on pharmacy is to address air contaminants, flammable/combustible liquids, eye and skin protection, hazard communication standards

Which is the safest pregnancy category?

Category A - controlled studies in women show no risks to fetus

Which category is completely contraindicated in pregnant women?

Category X - controlled human studies show fetal risk outweighs any possible benefit; contraindicated in pregnant or potentially pregnant women

What are the three classes of recalls?

Class I - high probability of serious adverse effects or death Class II - possibility of temporary or medically reversible adverse health consequences Class III - low possibility of adverse health consequences

1976 Resource Conservation and Recovery Act

Environmental Protection Agency (EPA) produced federal guidelines regarding the disposal of hazardous waste. Hazardous waste includes controlled substances Flushing is no longer an acceptable method of destruction in many states

What department is the FDA under?

Department of Health and Human Services

DEA form 41

Documents disposal and destruction of scheduled drugs To destroy controlled substances

1970 Comprehensive Drug Abuse Prevention and Control Act

Established the Drug Enforcement Administration (DEA) to enforce the laws covering controlled substances and their distribution Created stair-step categories of controlled substances (Schedules I-V) 5 level stair-step schedule Higher schedule -> stricter rules Based on drug's intended medical use, the propensity of a drug to be abused, and safety and dependency concerns

What does DEA stand for?

Drug Enforcement Administration

How to order C11 medications, what forms are kept on file and for how long?

Electronics and paper filing of DEA 222 form. A copy kept on file for 2 years.

What are boxed warnings?

Encased in a bold border in manufacturer's insert Aka "Black box warning" Required on medications and products that carry a high risk potential to consumer Indicates proper use of drug to avoid or decrease possibility of a serious or even life-threatening side effects. i.e. - Antidepressants Boxed warning: increase in suicidal behavior

1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment)

Encouraged creation of both generic and new medications Streamlined process for generic drug approval Extended Patent licenses

What is the main function of FDA?

Enforce guidelines for manufacturers to ensure safety and effectiveness of medications

What is the primary role of DEA?

Enforces the nation's drug laws

1997 FDA Modernization Act

Federal Drug Legend ("Federal law prohibits the dispensing of this medication without a prescription") This is now represented by abbreviation "Rx" on label

What does FDA stands for?

Food and Drug Administration

what information is found on patient package insert?

Information also contained in the Physicians' Desk Reference (PDR) in doctor's office and Facts and Comparisons in pharmacy Includes: Description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, drug abuse and dependence, adverse reactions, dosage, and how supplied

what is MMT? What are the dispensing restrictions?

Methadone maintenance treatment (MMT) Methadone, CII, used for treating those with opiate addiction No more than 1 day's supply, must be taken at dr's office or drug treatment center

2000 Drug Addiction Treatment Act

Physicians can prescribe controlled substances to persons suffering from opioid addiction. Physicians can prescribe controlled substances to persons suffering from opioid addiction Only for maintenance or detoxification treatments Patients must be in a treatment program

2004 Isotretinoin Safety and Risk Management Act

Powerful medication used to treat acne. Brand name: Accutane Causes severe birth defects; induces spontaneous abortion; produces adverse psychiatric effects Put into place: mandatory registry of all patients, practitioners and pharmacists. Yearly evaluation Thirty day prescription allotments Blood testing during treatment and every 30 days Monthly education, testing of patients (avoiding pregnancy)

Within how many days does a prescriber need to present a prescription for an emergency telephone order for a C11?

Prescriber must present prescription to pharmacist within 7 days with "authorization for emergency dispensing" written on face of prescription

1990 Americans with Disabilities Act

Prevents discrimination against potential employees who may possess a disability Business must make "a reasonable accommodation" for the potential employee

2008 Prescription Drug Equity Law

Prohibits a prescription drug plan from requiring mail order prescription drug coverage without also providing non-mail order coverage

1906 Pure Food and Drug Act

Prohibits the sale and transport of adulterated or mislabeled food, drinks and drugs. Prohibits the mislabeling and misbranding of products. Also referred to as the Wiley Act Enacted to stop the sale of inaccurately labeled drugs Manufacturers were required to: Provide truthful information on the label before a drug was sold Prove the drug's effectiveness

2003 Medicare Modernization Act

Provides a drug discount card to those with low incomes who require assistance from a pharmacy company to obtain medications Medicare is a government managed insurance program that provides assistance to those older than 65, those younger than 65 with disabilities or those with kidney failure. Provides a drug discount card to those with low incomes who require assistance from a pharmacy company to obtain medications Provides for a voluntary prescription drug benefit to Medicare beneficiaries Adds preventive medical benefits to senior citizens Lowers the reimbursement rates for Medicare payment for durable medical equipment Medicare part D prescription plan allows beneficiaries to enroll in either regional based insurance plans or national based insurance plans

What should pharmacy staff do once they receive a recall notice?

Pull out medicines and send it back to the company to get refunds.

1914 Harrison Narcotics Act

Regulates production, Importation, Distribution, and use of Opium. In order to purchase an opium, prescription is required.

what are state prescription monitoring program?

State programs that require pharmacies to submit their controlled substance prescription to the designated state authority electronically on a periodic basis (once/twice a month or more frequently) Programs used to identify potential diversion, abuse of drugs whether by patient, prescriber or pharmacy and to identify potential patients that would benefit from drug abuse treatment programs Information provided includes: Patient information, prescriber information, pharmacy identification and prescription information - name, qty of controlled substance and date prescription was dispensed California = CURES = controlled substance utilization review and evaluation systems

What is Suboxone? what are the dispensing requirement?

Suboxone and Subutex CIII, require special consent forms to be completed by patient Used for opioid addiction Treatment supervised in a clinical setting, prescribers must meet certain criteria, if met DEA issues a special number with an X to identify as a qualified prescriber

What is the function of DEA?

Supervise and enforce laws related to use and sale of legal and illegal controlled substances.