The Pharmacy The Pharmacy Technician 4ETechnician 4E

Chapter 3Chapter 3Drug Regulation and Drug Regulation and

ControlControl

Chapter OutlineChapter Outline Drug RegulationDrug Regulation New Drug ApprovalNew Drug Approval Marketed DrugsMarketed Drugs Behind-the-counter MedicationsBehind-the-counter Medications Sample LabelsSample Labels Controlled SubstancesControlled Substances DEA formsDEA forms Public SafetyPublic Safety Law and the TechnicianLaw and the Technician

Brief History of Statutory Pharmacy LawBrief History of Statutory Pharmacy Law

In the In the 19th century,19th century, drugs in the United States were drugs in the United States were unregulated.unregulated. Medicines did not require proof that they were either Medicines did not require proof that they were either

safe or effective.safe or effective. Most agents contained a high content of alcohol.Most agents contained a high content of alcohol. Some caused injury or death. Some caused injury or death.

To combat abuses in both formulation and labeling, To combat abuses in both formulation and labeling, inin 19061906 the U.S. Congress passed the first of a series of the U.S. Congress passed the first of a series of landmark 20landmark 20thth century laws to regulate drugs. century laws to regulate drugs.

Pure Food and Drug Act of 1906Pure Food and Drug Act of 1906

The purpose of the Pure Food & Drug Act was to The purpose of the Pure Food & Drug Act was to prohibit the interstate transportation or sale of prohibit the interstate transportation or sale of adulterated adulterated and and misbrandedmisbranded food and drugs. food and drugs. AdulteratedAdulterated is impure by adding extraneous, is impure by adding extraneous,

improper, or inferior ingredients.improper, or inferior ingredients. MisbrandedMisbranded to brand or label misleadingly or to brand or label misleadingly or

fraudulently.fraudulently. Did not require drugs to be labeled, but required that Did not require drugs to be labeled, but required that

drug drug labels not contain false informationlabels not contain false information about the about the drugs’ drugs’ strength and purity.strength and purity.

Proved unenforceable and new legislation was Proved unenforceable and new legislation was required.required.

Harrison Tax Act 1914Harrison Tax Act 1914

Established that manufacturers, pharmacists, Established that manufacturers, pharmacists, importer, and physicians prescribing narcotics should importer, and physicians prescribing narcotics should be be LicensedLicensed and required to and required to pay a tax. pay a tax.

The law enacted in response to growing opiates and The law enacted in response to growing opiates and cocaine-containing medications.cocaine-containing medications.

Food, Drug, and Cosmetic (FDC) Act of Food, Drug, and Cosmetic (FDC) Act of 19381938

Sulfa poisoning Sulfa poisoning caused the death of 107caused the death of 107 people, people, primarily children.primarily children. Due to untested sulfanilamide concoction.Due to untested sulfanilamide concoction. In response to this event, FDC was introduced. In response to this event, FDC was introduced.

FDC FDC is the most important piece of legislation in is the most important piece of legislation in pharmaceutical history.pharmaceutical history.

Required only that drugs be Required only that drugs be SAFESAFE for human for human consumption before marketing.consumption before marketing.

Food, Drug, and Cosmetic (FDC) Act Food, Drug, and Cosmetic (FDC) Act of 1938of 1938

Gave FDA the Gave FDA the power to conduct inspectionspower to conduct inspections of of manufacturing plants to ensure compliance.manufacturing plants to ensure compliance.

Act applied to interstate transactions, as well as to Act applied to interstate transactions, as well as to intrastate transactions.intrastate transactions.

FDA required pharmaceutical manufacturers to file a FDA required pharmaceutical manufacturers to file a new drug application (NDA)new drug application (NDA) with each new drug with each new drug before marketing.before marketing.

Durham-Humphrey Amendment of Durham-Humphrey Amendment of 19511951

• States that drug containers do not have to include “adequate States that drug containers do not have to include “adequate directions for use” as long as they includedirections for use” as long as they include

• ““Caution: Caution: Federal Law Prohibits Dispensing Without Federal Law Prohibits Dispensing Without Prescription.” Prescription.”

• Now, Now, “Rx Only.”“Rx Only.”• Distinguished betweenDistinguished between

• Legend Legend ((prescriptionprescription)) drugs. drugs.• Over-the-counter (Over-the-counter (OTCOTC) (non-prescription) drugs.) (non-prescription) drugs.

• AuthorizedAuthorized• Verbal prescriptions. Verbal prescriptions. • Prescription refills.Prescription refills.

Kefauver-Harris Amendment of 1962Kefauver-Harris Amendment of 1962 In 1962 a new sleeping pill containing the drug In 1962 a new sleeping pill containing the drug

THALIDOMIDETHALIDOMIDE was found to cause was found to cause severe birth defects severe birth defects when used during pregnancy (Europe).when used during pregnancy (Europe).

Extended the FDC Act of 1938 to require thatExtended the FDC Act of 1938 to require that Drugs not only be Drugs not only be safe safe for humans but also be for humans but also be

EFFECTIVE.EFFECTIVE. Requires drug manufacturers to file Requires drug manufacturers to file

An investigational new drug application An investigational new drug application (INDA)(INDA) with with the FDA before initiating a clinical trial in humans.the FDA before initiating a clinical trial in humans.

Once proven safe and effective, manufacturer may Once proven safe and effective, manufacturer may submit an submit an NDANDA seeking approval to market the seeking approval to market the product.product.

Poison Prevention Packaging Act of Poison Prevention Packaging Act of 19701970

Passed Passed to prevent accidental childhood poisonings to prevent accidental childhood poisonings from prescription and nonprescription products. from prescription and nonprescription products.

Enforced by the Enforced by the Consumer Product Safety Consumer Product Safety Commission. Commission.

Requires most over-the-counter (OTC) and legend Requires most over-the-counter (OTC) and legend drugs to be packaged in drugs to be packaged in child-resistant containers.child-resistant containers. CannotCannot be opened by 80% of children under five. be opened by 80% of children under five. CanCan be opened by 90% of adults. be opened by 90% of adults.

Older patients or people with a disability may request Older patients or people with a disability may request a non-child-resistant container; other exceptions are a non-child-resistant container; other exceptions are provided for by law.provided for by law.

Comprehensive Drug Abuse Comprehensive Drug Abuse Prevention and Control Act of 1970Prevention and Control Act of 1970

Commonly referred to as the Commonly referred to as the Controlled Substances Controlled Substances Act (CSA).Act (CSA).

Created to combat and control drug abuse and to Created to combat and control drug abuse and to supersede previous federal drug abuse laws.supersede previous federal drug abuse laws.

Created the Created the Drug Enforcement Administration (DEA)Drug Enforcement Administration (DEA), , an arm of the Department of Justice. an arm of the Department of Justice. Charged with enforcement and prevention related Charged with enforcement and prevention related

to the abuse of controlled substances like many to the abuse of controlled substances like many narcotic pain medications.narcotic pain medications.

Comprehensive Drug Abuse Prevention Comprehensive Drug Abuse Prevention and Control Act of 1970and Control Act of 1970

Classified drugs with potential for abuse as Classified drugs with potential for abuse as controlled controlled substances.substances.

Ranked controlled substances into Ranked controlled substances into five categoriesfive categories, or , or schedules.schedules. Ranging from those with great potential for abuse Ranging from those with great potential for abuse

(Schedule I)(Schedule I) to those with little potential to those with little potential (Schedule (Schedule V).V).

Narcotics are highly regulated.Narcotics are highly regulated.

Comprehensive Drug Abuse Comprehensive Drug Abuse Prevention and Control Act of 1970Prevention and Control Act of 1970

ScheduleSchedule Medical UseMedical Use ExamplesExamples

II For research only – For research only – not not approved for human useapproved for human use

Heroin, LSDHeroin, LSD

IIII Dispensing severely restrictedDispensing severely restricted Morphine, oxycodone, Morphine, oxycodone, meperidinemeperidine

IIIIII Prescriptions can be refilled Prescriptions can be refilled up to up to 5 times 5 times in in 6 months6 months

Codeine with aspirin, Codeine with aspirin, anabolic steroidsanabolic steroids

IVIV Same as for Schedule IIISame as for Schedule III Benzodiazepines, Benzodiazepines, meprobamatemeprobamate

VV Some sold Some sold w/o a prescriptionw/o a prescription; ; must be must be 1818

Liquid codeine Liquid codeine combination preps.combination preps.

Drug Listing Act of 1972Drug Listing Act of 1972

Gives the FDA the authority to compile a list of currently Gives the FDA the authority to compile a list of currently marketed drugs. marketed drugs.

Each drug is assigned a unique and permanent product Each drug is assigned a unique and permanent product code code Known as a Known as a National Drug Code (NDC).National Drug Code (NDC). Ten charactersTen characters that identify manufacturer or that identify manufacturer or

distributor, drug formulation, size and type of distributor, drug formulation, size and type of packaging.packaging.

FDA requests, but does not require, that the NDC appear FDA requests, but does not require, that the NDC appear on all drug labels.on all drug labels.

19761976 Medical Device AmendmentMedical Device Amendment

The Medical Device Amendment The Medical Device Amendment requires pre-market requires pre-market approval of safety and effectiveness of life sustaining approval of safety and effectiveness of life sustaining and life supporting and life supporting medical devicesmedical devices..

Orphan Drug Act of 1983Orphan Drug Act of 1983 An An orphan drugorphan drug is intended for use in a few patients is intended for use in a few patients

with a rare disease or condition. with a rare disease or condition. Developing such a drug would be prohibitively Developing such a drug would be prohibitively

expensive, given the small market.expensive, given the small market. The Orphan Drug Act encourages the development of The Orphan Drug Act encourages the development of

orphan drugs by: orphan drugs by: Providing tax incentives. Providing tax incentives. Granting manufacturers exclusive license.Granting manufacturers exclusive license.

Over 250 orphan drugs have been approved by the Over 250 orphan drugs have been approved by the FDA.FDA.

Drug Price Competition and Drug Price Competition and Patent-Term Restoration Act of 1984Patent-Term Restoration Act of 1984

Also called Also called Hatch-Waxman Act.Hatch-Waxman Act. Allows Allows substation substation of generic drugs with the same of generic drugs with the same

chemical composition as brand name products. chemical composition as brand name products. Once the original patent expires, any manufacturer Once the original patent expires, any manufacturer

may market a generic drug.may market a generic drug. Usually is less costly than the brand name.Usually is less costly than the brand name.

A given drug typically has several names.A given drug typically has several names. Generic name Generic name is is a common name given to a drug a common name given to a drug

regardless of brand name.regardless of brand name. One or more One or more brand namesbrand names under which the under which the

manufacturer markets a drug.manufacturer markets a drug.

Prescription Drug Marketing Act of 1987Prescription Drug Marketing Act of 1987 PROHIBITSPROHIBITS

Re-importation Re-importation of a drug into the United States.of a drug into the United States. United States seniors getting prescription medication from United States seniors getting prescription medication from

Canada, Mexico, or other countries.Canada, Mexico, or other countries. PROHIBITSPROHIBITS

Sale or trading of Sale or trading of drug samples.drug samples. PROHIBITSPROHIBITS

Distribution of samplesDistribution of samples in response to prescription drug in response to prescription drug samples being illegally diverted and distributed.samples being illegally diverted and distributed.

To persons other than those licensed to prescribe them To persons other than those licensed to prescribe them except by mail or by common carrier.except by mail or by common carrier.

Omnibus Budget Reconciliation Act of Omnibus Budget Reconciliation Act of 19901990 (OBRA-90)(OBRA-90)

Requires states to establish standards for Drug Use Review Requires states to establish standards for Drug Use Review (DUR) by the pharmacist.(DUR) by the pharmacist.

Requires pharmacists to Requires pharmacists to offer counseling offer counseling toto MedicaidMedicaid patients.patients.

Requires a manufacturers Requires a manufacturers rebaterebate to state Medicaid program to state Medicaid program between the manufacturer’s best price for a drug (typically between the manufacturer’s best price for a drug (typically the wholesale price) and the average billed price.the wholesale price) and the average billed price.

Health Insurance Portability and Health Insurance Portability and Accountability Act (HIPAA) of 1996Accountability Act (HIPAA) of 1996

Defines the scope of health information that may or Defines the scope of health information that may or may not be may not be sharedshared among health care providers among health care providers without patient consent.without patient consent.

Provided for broad and stringent regulation to respect Provided for broad and stringent regulation to respect ““Patient’s right to privacy.”Patient’s right to privacy.”

Affects the confidentiality of patient medical records.Affects the confidentiality of patient medical records. Placed safeguards to protect patient confidentiality.Placed safeguards to protect patient confidentiality. Requires healthcare facilities to provide information Requires healthcare facilities to provide information

to the patient on how they protect the patient’s to the patient on how they protect the patient’s health information.health information.

Health Insurance Portability and Health Insurance Portability and Accountability Act (HIPAA) of 1996Accountability Act (HIPAA) of 1996

In pharmacy, In pharmacy, HIPAA requirements includeHIPAA requirements include: : Restrictions on transmission of prescription Restrictions on transmission of prescription

data. data. Provision of a private area for counseling. Provision of a private area for counseling. A training program for employees about A training program for employees about

confidentiality.confidentiality.

For pharmacy technicians, HIPAA meansFor pharmacy technicians, HIPAA means:: Must not reveal any information on any patient Must not reveal any information on any patient

outside the pharmacy.outside the pharmacy. Violations would be grounds for immediate Violations would be grounds for immediate

termination and legal action.termination and legal action.

Food & Drug Administration Food & Drug Administration Modernization ActModernization Act

Authorizes fees to be added to a new drug application Authorizes fees to be added to a new drug application (NDA) process to accelerate the review and approval (NDA) process to accelerate the review and approval process for new drugs.process for new drugs.

Updates the labeling on prescription medications .Updates the labeling on prescription medications . Products labeled “legend” are to be changed to read Products labeled “legend” are to be changed to read

““Only.”Only.” LEGENDLEGEND is the term that has been used to indicate is the term that has been used to indicate

whether a drug was available by prescription or whether a drug was available by prescription or over-the-counter (OTC).over-the-counter (OTC).

New labeling requirements were implemented in New labeling requirements were implemented in 2004.2004.

The FDA’s Center for Drug Evaluation & The FDA’s Center for Drug Evaluation & ResearchResearch

Provides an Index to Provides an Index to Drug-Specific Information Drug-Specific Information with with patient, consumer and healthcare professional patient, consumer and healthcare professional information sheets, including FDA Alerts. information sheets, including FDA Alerts.

Works with drug manufacturers to develop risk Works with drug manufacturers to develop risk management programs for drugs with FDA. management programs for drugs with FDA. Alerts, such as the Alerts, such as the iPLEDGE program for AccutaneiPLEDGE program for Accutane. .

Health care professionals, wholesalers, pharmacies and Health care professionals, wholesalers, pharmacies and patients patients must registermust register in the iPLEDGE program to in the iPLEDGE program to prescribe , distribute, fill prescriptions, or use Accutane.prescribe , distribute, fill prescriptions, or use Accutane.

New Drug ApprovalNew Drug Approval All new drugs All new drugs (domestic or imported) require FDA approval (domestic or imported) require FDA approval

before they can be marketed in the US.before they can be marketed in the US. Before approval, new drugs must be shown to be Before approval, new drugs must be shown to be SAFESAFE and and

EFFECTIVEEFFECTIVE and its benefits OUTWEIGH its risks.and its benefits OUTWEIGH its risks. Drug manufacturers Drug manufacturers and not the FDA is responsible for proof.and not the FDA is responsible for proof. The testing process currently takes about The testing process currently takes about 8.5 years.8.5 years. DiscoveryDiscovery: : 2-10 years.2-10 years. Preclinical testingPreclinical testing: : laboratory and animal testing.laboratory and animal testing. Phase I:Phase I: 20-80 healthy volunteers.20-80 healthy volunteers. Phase II:Phase II: 100-300 patient volunteers.100-300 patient volunteers. Phase IIIPhase III: : 1,000-5,000 patients volunteers.1,000-5,000 patients volunteers. FDA review/approval FDA review/approval Approved by FDA: 17 years.Approved by FDA: 17 years. Post-marketing testing Post-marketing testing Five year extension on Five year extension on

patent (Hatch-Waxman Act of 1984).patent (Hatch-Waxman Act of 1984).

New Drug Approval ProcessNew Drug Approval Process Placebo Placebo

Inactive substance: not real medicine administrated Inactive substance: not real medicine administrated Gives the impression that they’re receiving the real Gives the impression that they’re receiving the real

medicine.medicine. Used to compare against patients with the test drugsUsed to compare against patients with the test drugs

Investigational New Drug Application (INDA) Investigational New Drug Application (INDA) An application submitted to FDA by the manufacturer An application submitted to FDA by the manufacturer

before initiating a clinical trial in humans.before initiating a clinical trial in humans. New Drug Application (NDA) New Drug Application (NDA)

Once proven safe and effective, manufacturer may Once proven safe and effective, manufacturer may submit an submit an NDANDA seeking approval to market the seeking approval to market the product. product.

Testing PhasesTesting Phases Begins in the laboratory for chemical analysis.Begins in the laboratory for chemical analysis. Animal testing Animal testing ((preclinical testingpreclinical testing))

Use animals and treat them as humanly as possible.Use animals and treat them as humanly as possible. Test using different species.Test using different species. Only a fraction of the drugs tested on animals reach clinical Only a fraction of the drugs tested on animals reach clinical

trials stage.trials stage. Clinical trials with humansClinical trials with humans

INFORMED CONSENT INFORMED CONSENT is required for each patient before is required for each patient before enrolling into clinical trials.enrolling into clinical trials.

Requires for the patient to be Requires for the patient to be told all the risks and other told all the risks and other treatment optionstreatment options in a language they understand. in a language they understand.

Patients should also be Patients should also be free to leave the trial free to leave the trial at any time.at any time.

Clinical Trial TestingClinical Trial Testing Phase IPhase I

20-100 patients.20-100 patients. Several months.Several months. The main purpose is to study The main purpose is to study SAFETY.SAFETY. Only about 25% of drugs tested in phase 1 Only about 25% of drugs tested in phase 1

successfully reach the market.successfully reach the market. Phase IIPhase II

Up to several hundred patients.Up to several hundred patients. Several months to two years.Several months to two years. The main purpose is short-term The main purpose is short-term SAFETY AND SAFETY AND

EFFECTIVENESS.EFFECTIVENESS.

Clinical Trial Testing Cont.Clinical Trial Testing Cont. Phase IIIPhase III

Several hundred to several thousands patients.Several hundred to several thousands patients. 1-4 years.1-4 years. The main purpose is The main purpose is safety, dosage, and safety, dosage, and

effectiveness.effectiveness. Phase IVPhase IV

Begs after the drug is approved. Begs after the drug is approved. Life time of the drug.Life time of the drug. The main purpose is for safety.The main purpose is for safety.

Clinical TrialsClinical Trials Special “Treatment Status” Special “Treatment Status”

Permission given to administer drugs in patients outside the Permission given to administer drugs in patients outside the clinical trials for relief to a critically ill patient without a better clinical trials for relief to a critically ill patient without a better proven drug. proven drug.

E.g. AZT for AIDS in early 1990’s.E.g. AZT for AIDS in early 1990’s. Controlled TrialControlled Trial

Group of patients (with similar condition or disease) who are Group of patients (with similar condition or disease) who are given a placebo (or no drug) and used to compare the effect given a placebo (or no drug) and used to compare the effect of the test drug.of the test drug.

Groups are placed on controlled or treatment arm randomly.Groups are placed on controlled or treatment arm randomly. Blind Blind TrialTrial

The patient or the doctor who is treating the patient does The patient or the doctor who is treating the patient does not know which arm of the study a particular patient is on.not know which arm of the study a particular patient is on.

Marketed DrugsMarketed DrugsPatent Patent is a right given to a manufacturer to is a right given to a manufacturer to exclusively exclusively

market a new product for a specific period of time market a new product for a specific period of time under a brand name.under a brand name.

A patent is good for A patent is good for 17 years.17 years.

Hatch-Waxman Act of 1984 Hatch-Waxman Act of 1984 Extends patient up to Extends patient up to 5 years 5 years to compensate for lost to compensate for lost

time in research before going to market.time in research before going to market. While the drug is under patent, a While the drug is under patent, a generic drug generic drug will will

NOT be marketed by other companies.NOT be marketed by other companies.

Marketed DrugsMarketed Drugs Medical devices and biological products such as Medical devices and biological products such as

insulin and vaccines must also meet FDA testing and insulin and vaccines must also meet FDA testing and approval requirements. approval requirements.

The Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) (CDRH) is responsible for devices. is responsible for devices.

The Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) (CBER) is responsible for biological products made is responsible for biological products made from living organisms.from living organisms.

Marketed DrugsMarketed Drugs

Generic drugs are Pharmaceutically EquivalentGeneric drugs are Pharmaceutically Equivalent is is iidentical to the brand-name product listed in the dentical to the brand-name product listed in the orange book (FDA’s Approved Drugs Products orange book (FDA’s Approved Drugs Products publication) in terms ofpublication) in terms of

Active ingredient.Active ingredient. Dosage form.Dosage form. Route of administration and strength.Route of administration and strength.Therapeutically equivalentTherapeutically equivalent is the body uses of the drug is the body uses of the drug

is the same.is the same.

Look Alike and Sound Alike DrugsLook Alike and Sound Alike Drugs

Federal laws require containers Federal laws require containers NOT to look like NOT to look like another druganother drug, however some drugs look alike and , however some drugs look alike and sound alike.sound alike.

Safe ways to check the correct drug being dispensed Safe ways to check the correct drug being dispensed is to check the is to check the NDC number NDC number on the container against on the container against the NDC number on the prescription label.the NDC number on the prescription label.

Over-the-Counter (OTC) DrugsOver-the-Counter (OTC) Drugs OTC drugs have to be approved by the FDA .OTC drugs have to be approved by the FDA . Can be used upon the judgment of the consumer Can be used upon the judgment of the consumer without a without a

prescription prescription from a physician.from a physician. There are There are over 100,000 OTC drugs in 80 therapeutic categories.over 100,000 OTC drugs in 80 therapeutic categories. The manufacturer has to follow a format called The manufacturer has to follow a format called drug monograph drug monograph

to be able to market with proper label including:to be able to market with proper label including:• Active ingredientActive ingredient• Direction for useDirection for use• Amount of contentAmount of content• WarningsWarnings• Expiration dateExpiration date

Sample OTC Sample OTC LabelLabel

Behind-The-Counter OTC MedicationsBehind-The-Counter OTC Medications

Medications sold without a prescription, but with Medications sold without a prescription, but with RESTRICTION RESTRICTION on their sales.on their sales.

Kept behind the pharmacy counter.Kept behind the pharmacy counter. Limitation: Limitation: 3.6 grams per day and 7.5 gram per 3.6 grams per day and 7.5 gram per

month.month. E.g. Pseudoephedrine and Ephedrine E.g. Pseudoephedrine and Ephedrine containing containing

products.products.

Combat Methamphetamine Epidemic Combat Methamphetamine Epidemic ActAct

Requires that Requires that cold and allergy medicine cold and allergy medicine containing these containing these ingredients be ingredients be kept behind the counter.kept behind the counter.

Set daily and monthly amount restrictions.Set daily and monthly amount restrictions. A sales A sales record (written or electronic) record (written or electronic) must be kept for a period must be kept for a period

of 2 years.of 2 years. The record should contain: The record should contain:

Drug nameDrug name QuantityQuantity Name and address of purchaser Name and address of purchaser Date and time of the sale Date and time of the sale Proof of IDProof of ID Signature of the purchaser.Signature of the purchaser.

Exempt NarcoticsExempt Narcotics Sold by a pharmacist without a prescription.Sold by a pharmacist without a prescription.

E.g. Cough syrups that contain a small amount of E.g. Cough syrups that contain a small amount of codeine.codeine.

Only pharmacists can approve their dispensing.Only pharmacists can approve their dispensing. Purchasers have to:Purchasers have to:

Be at Be at least 18 years old.least 18 years old. ProvideProvide identification identification

Document the sale in a Document the sale in a bound record book bound record book (name (name and address of the purchaser, drug name and and address of the purchaser, drug name and quantity, date, name or initial of the pharmacist.) quantity, date, name or initial of the pharmacist.)

Emergency ContraceptivesEmergency Contraceptives

Plan B®Plan B® Has a Has a dual marketing dual marketing status (both Rx and OTC).status (both Rx and OTC). Prescription Prescription >>17 years old.17 years old. OTC < 17 years old.OTC < 17 years old.

Exception Exception Pharmacists in some states have authority to Pharmacists in some states have authority to

prescribe and dispense under protocol to patients prescribe and dispense under protocol to patients under 17 years old.under 17 years old.

Manufacturing LabelManufacturing LabelNDC number Manufacturer’s name

& addressbrand & generic names

controlled substances markLegend statement

Dispensing

Storage requirements

PT 3:3

Lot Number & Exp Date

Product LabelingProduct Labeling Package Inset Package Inset – is prescription information which – is prescription information which

comes with a document on the drug product.comes with a document on the drug product. Includes: Includes:

Clinical pharmacology, Clinical pharmacology, Indications, Indications, Contraindications, Contraindications, Warnings, Warnings, Adverse reaction, and Adverse reaction, and Other related information. Other related information.

Intended for health care professionals Intended for health care professionals who who prescribe or dispense the productprescribe or dispense the product

Is contained in a reference book called Is contained in a reference book called Physician Physician Desk Reference (PDR).Desk Reference (PDR).

National Drug Code (NDC National Drug Code (NDC Number) NDCNumber) NDC 0123401234--56785678-90-90

Identification number assigned by the manufacturer to Identification number assigned by the manufacturer to a drug product.a drug product.

Has 3 sets of numbers.Has 3 sets of numbers. 11stst five digits - manufacturer. five digits - manufacturer. 22ndnd four digits - medication strength and dosage four digits - medication strength and dosage

form.form. 33rdrd two digits - package size. two digits - package size.

Prescription BottlePrescription Bottle

A: Rx numberA: Rx number H: Number of refills remainingH: Number of refills remainingB: Prescribing physician I: Manufacturer of the drugB: Prescribing physician I: Manufacturer of the drugC: Date J: Expiration dateC: Date J: Expiration dateD: Patient NameD: Patient Name K: Direction for use K: Direction for useE: Drug Name, strength, dosage formE: Drug Name, strength, dosage formF: Pharmacy Name, Address, F: Pharmacy Name, Address, and phone numberand phone numberG: QuantityG: Quantity

AC

B

D

E

F

I

K

H

J

Controlled SubstancesControlled Substances

Drugs that have an Drugs that have an abuse potential.abuse potential. Enacted in 1970 by Enacted in 1970 by Controlled Substance Act Controlled Substance Act (CSA) .(CSA) . Five groups (or Five groups (or schedulesschedules) of such drugs and put a strict ) of such drugs and put a strict

guideline on their distribution. guideline on their distribution. Requires to register with the Requires to register with the Drug Enforcement Drug Enforcement

Administration (DEA) Administration (DEA) of the Justice Department.of the Justice Department.

DEA RegistrationDEA Registration

Each pharmacy registers.Each pharmacy registers. Pharmacy employees arePharmacy employees are not not required to register.required to register. Registration varies from 1 to 3 years in length.Registration varies from 1 to 3 years in length.

Laws vary from state to state.Laws vary from state to state. some state laws are more stringent than the some state laws are more stringent than the

federal CSA.federal CSA. the most stringent of the laws will be followedthe most stringent of the laws will be followed

If federal law is more stringent, it is followed.If federal law is more stringent, it is followed. If state law is more stringent, it is followed.If state law is more stringent, it is followed.

Drug Enforcement Administration (DEA)Drug Enforcement Administration (DEA) Issues licensesIssues licenses

To medical To medical practitionerspractitioners to write prescriptions for to write prescriptions for scheduled drugs.scheduled drugs.

To To pharmaciespharmacies to order scheduled drugs from to order scheduled drugs from wholesalers.wholesalers.

DistributorsDistributors to distribute controlled substances. to distribute controlled substances. InspectsInspects medical facilities, including pharmacies.medical facilities, including pharmacies. Tracks narcoticsTracks narcotics from manufacturer to warehouse to from manufacturer to warehouse to

pharmacy.pharmacy.

DEA RegulationsDEA Regulations Manufacturers must label controlled drugs using the letter Manufacturers must label controlled drugs using the letter

“C.” “C.” e.g. C-II, C-III, etc.e.g. C-II, C-III, etc.

Record keepingRecord keeping Schedule II – 7 yearsSchedule II – 7 years Others – 2 yearsOthers – 2 years

StorageStorage Schedule II – should be Schedule II – should be kept separately kept separately in a locked, and in a locked, and

tamper-proof narcotic cabinet tamper-proof narcotic cabinet secured secured to the floor or wall.to the floor or wall. Schedule III-V can be stored on the shelf with other Schedule III-V can be stored on the shelf with other

prescription drugs.prescription drugs.

Dispensing of Schedule II DrugsDispensing of Schedule II Drugs

Prescriptions for Schedule II substances must be Prescriptions for Schedule II substances must be hand-hand-signed signed by the prescriber except in emergencies.by the prescriber except in emergencies. To minimize fraudulent use.To minimize fraudulent use. To maintain a record-tracking system.To maintain a record-tracking system.

An An emergency supply emergency supply of a Schedule II drug (72 hours of a Schedule II drug (72 hours supply) can be provided to a patient without a written supply) can be provided to a patient without a written prescription in most states.prescription in most states.

DEA Form 222DEA Form 222 Used to order C-I and C-II.Used to order C-I and C-II. Must be signed by a registered person.Must be signed by a registered person. Three copies:Three copies:

Copy 1: Copy 1: BlueBlue copy is retained by the supplier. copy is retained by the supplier. Copy 2: Copy 2: GreenGreen copy is sent to the DEA. copy is sent to the DEA. Copy 3: Copy 3: Brown Brown copy is kept for your records.copy is kept for your records.

Must be kept in a separate file from other invoices.Must be kept in a separate file from other invoices. Note that C-III - C-V does Note that C-III - C-V does not not require federal order require federal order

forms.forms. Form has its own unique serial number. Form has its own unique serial number. Form can be requested online.Form can be requested online.

DEA Form 222DEA Form 222

PT 3:5

DEA NumbersDEA Numbers

Assigned to prescribers for controlled drugs.Assigned to prescribers for controlled drugs.

Two letters and seven digits .Two letters and seven digits .

First letter is a code identifying the type of registrant.First letter is a code identifying the type of registrant. Second letter is the initial of the registrant's last name. Second letter is the initial of the registrant's last name.

Seventh digit is a “checksum" that is calculated.Seventh digit is a “checksum" that is calculated.

DEA NumbersDEA Numbers

Example:Example: AARR43427943427933 Add 1Add 1stst +3 +3rdrd +5 +5thth number = ___. number = ___. Add 2Add 2ndnd+4+4thth +6 +6thth number = ___ multiply by 2 =__. number = ___ multiply by 2 =__. Then add ____+____=____.Then add ____+____=____.

The total should be a number whose The total should be a number whose last digitlast digit is the is the same as the last digit of the DEA number.same as the last digit of the DEA number.

AAR434279R43427933 (4+4+7=(4+4+7=15 15 3+2+9= 3+2+9=1414 14x2= 14x2=2828 then 15+28=4 then 15+28=433).).

Drug Enforcement Administration (DEA)Drug Enforcement Administration (DEA)

Branch of the U.S. Branch of the U.S. Justice DepartmentJustice Department responsible for responsible for regulating sale and use of regulating sale and use of drugs with abusedrugs with abuse potential.potential. Responsible for enforcing laws regarding both Responsible for enforcing laws regarding both

legal and illegal addictive substances.legal and illegal addictive substances. Directs most of its efforts toward illegal drug Directs most of its efforts toward illegal drug

trafficking.trafficking. Supervises legal use of narcotics and other Supervises legal use of narcotics and other

controlled substances.controlled substances.

Controlled Substance PrescriptionsControlled Substance Prescriptions

The DEA number must appear on the form and the The DEA number must appear on the form and the patient’s full name and full street address must be patient’s full name and full street address must be entered.entered.

NO REFILL NO REFILL is allowed on is allowed on Schedule IISchedule II prescriptions.prescriptions. When filling the prescription, the pharmacist draws a When filling the prescription, the pharmacist draws a

line across the prescription indicating it has been filled.line across the prescription indicating it has been filled.

Federal LawsFederal Laws

A A prescriptionprescription for a for a controlled substance controlled substance must meetmust meetthe following requirements.the following requirements. Patient’s full name and address.Patient’s full name and address. Practitioner’s name, address, and DEA#.Practitioner’s name, address, and DEA#. Drug name, strength, dosage form, quantity, Drug name, strength, dosage form, quantity,

directions, and refills.directions, and refills. Must be written in ink or typewritten and signed by Must be written in ink or typewritten and signed by

prescriber.prescriber. Controlled substance must be dated on the date of Controlled substance must be dated on the date of

issuance.issuance.

Federal LawsFederal Laws

Schedule III, IV, and V Schedule III, IV, and V PrescriptionsPrescriptions May be verbal, written, or faxed and may be refilled May be verbal, written, or faxed and may be refilled

if authorized by the prescriber.if authorized by the prescriber. Schedule III and IV may be Schedule III and IV may be refilled up to 5 times refilled up to 5 times

within 6 months.within 6 months. Schedule V may be refilled as directed by the Schedule V may be refilled as directed by the

prescriber.prescriber. Schedule II requires a written prescription by the Schedule II requires a written prescription by the

prescriber that is signed and prescriber that is signed and is not refilled.is not refilled.

Food and Drug Administration (FDA)Food and Drug Administration (FDA)

Primary responsibility and Primary responsibility and authority is to enforceauthority is to enforce the the law and create regulations to assist in providing the law and create regulations to assist in providing the public with safe drug products.public with safe drug products.

Requires all manufacturers to file applications for Requires all manufacturers to file applications for investigation studies and investigation studies and approval of new drugs.approval of new drugs.

Oversees Oversees the recallthe recall of dangerous products.of dangerous products. Has Has no legal authorityno legal authority over the practice of pharmacy over the practice of pharmacy

in each state (is a responsibility of the in each state (is a responsibility of the BOARD OF BOARD OF PHARMACYPHARMACY).).

Public SafetyPublic Safety

FDA approval process is quite thorough, but it is FDA approval process is quite thorough, but it is impossible to fully prove that a drug is safe for use. impossible to fully prove that a drug is safe for use.

The FDA has several options if it determines that a The FDA has several options if it determines that a marketed drug presents a risk of illness, injury, or gross marketed drug presents a risk of illness, injury, or gross consumer deceptions.consumer deceptions.

Requests Requests healthcare professionalshealthcare professionals and the and the publicpublic to to reportreport any adverse effects of drugs once they are any adverse effects of drugs once they are marketed.marketed.

FDA FDA seizesseizes the drug, the drug, stops stops distribution, or may distribution, or may issue a issue a recallrecall of the drug. of the drug.

MedWatchMedWatch Allows any healthcare professional to Allows any healthcare professional to report a report a

serious adverse event serious adverse event that is suspected of being that is suspected of being associated with the use of an FDA-regulated product.associated with the use of an FDA-regulated product. Includes product problem, or medication error.Includes product problem, or medication error.

A A voluntaryvoluntary program. program. Designed to detect side effects not identified from Designed to detect side effects not identified from

research studies.research studies. Manufacturers must file a report if an adverse drug Manufacturers must file a report if an adverse drug

reaction is reported. reaction is reported. Reports can be made. Reports can be made.

Phone Phone 1-800-FDA-0178, 1-800-FDA-0178, by mail, or online.by mail, or online.

Public SafetyPublic Safety

Adverse EffectAdverse Effect Unintended side effect of a medication that is Unintended side effect of a medication that is

negative or in some way injurious to a patient’s negative or in some way injurious to a patient’s health.health.

Injection Injection Court order preventing a specific action.Court order preventing a specific action.

E.g. the distribution of potentially dangerous E.g. the distribution of potentially dangerous drugs.drugs.

RecallsRecalls Removal of a drug from the market Removal of a drug from the market based on report .based on report .

Can be prescription or over-the-counter from the market. Can be prescription or over-the-counter from the market. Can be from the public or healthcare professionalsCan be from the public or healthcare professionals Adverse drug effect can be reported to the Manufacturer Adverse drug effect can be reported to the Manufacturer

or to the FDA.or to the FDA. Steps Steps

1.1. FDA will contact the manufacturer.FDA will contact the manufacturer.2.2. Manufactures contact wholesalers, retailers, and all Manufactures contact wholesalers, retailers, and all

consumer levels.consumer levels.3.3. Personal phone calls are made or letters are sent to Personal phone calls are made or letters are sent to

customers.customers.4.4. Recalls are listed publicly.Recalls are listed publicly.5.5. Listed in the weekly FDA enforcement report.Listed in the weekly FDA enforcement report.

Types of RecallsTypes of Recalls

Class I: Class I: Serious adverse effects or death.Serious adverse effects or death.

Class II: Class II: Cause temporary but reversible effects.Cause temporary but reversible effects.

Class III: Class III: Not likely to cause adverse effects.Not likely to cause adverse effects.

Vaccine Adverse Event Reporting System Vaccine Adverse Event Reporting System (VAERS)(VAERS)

Vaccine Adverse Event Reporting Systems (VAERS)Vaccine Adverse Event Reporting Systems (VAERS) MedWatch does not monitor vaccines.MedWatch does not monitor vaccines. Performed by VAERS.Performed by VAERS. Post-marketing surveillance system operated by Post-marketing surveillance system operated by

the FDA and the Centers for Disease Control the FDA and the Centers for Disease Control (CDC).(CDC).

ReportReport (1-800-822-7967), (1-800-822-7967), online, or submitted by mail on online, or submitted by mail on

a downloaded form.a downloaded form.

Law and the TechnicianLaw and the Technician

Federal laws provide foundation for the state Federal laws provide foundation for the state laws which governs pharmacy practice. laws which governs pharmacy practice.

State LawsState Laws

Responsible for Responsible for licensing licensing of all prescribers and of all prescribers and dispensers.dispensers.

Each state enacts laws governing the Each state enacts laws governing the manufacturer, manufacturer, distribution, prescription, and dispensing distribution, prescription, and dispensing of of prescription drugs.prescription drugs.

Pharmacists must comply with both federal Pharmacists must comply with both federal regulations and regulations in the state(s) in which regulations and regulations in the state(s) in which they practice.they practice.

Such regulations may reside in different departments Such regulations may reside in different departments of the state, such asof the state, such as the board of pharmacy the board of pharmacy, the , the department of healthdepartment of health, or , or consumer affairs.consumer affairs.

State Boards of PharmacyState Boards of Pharmacy

Composed of leaders from the pharmacy community Composed of leaders from the pharmacy community and the public.and the public.

Activities vary from state to state .Activities vary from state to state . Can suspend or revoke pharmacy/pharmacist Can suspend or revoke pharmacy/pharmacist

license or registration.license or registration. Provide regulations regarding the practice of Provide regulations regarding the practice of

pharmacy.pharmacy.

State Boards of Pharmacy &Legal State Boards of Pharmacy &Legal Duties of Pharmacy PersonnelDuties of Pharmacy Personnel

No statutory federal definition of the role of the pharmacy No statutory federal definition of the role of the pharmacy technician exists.technician exists. No uniform definition of role and duties of pharmacy No uniform definition of role and duties of pharmacy

technicians from state to state.technicians from state to state. Roles and duties of pharmacy technicians are changing.Roles and duties of pharmacy technicians are changing.

Requirements for pharmacy technicians vary by state.Requirements for pharmacy technicians vary by state. Some states require licensure or registration with the Some states require licensure or registration with the

board.board. Some states require passing national certification exams.Some states require passing national certification exams. Technicians duties in all states Technicians duties in all states mustmust be carried out under be carried out under

the the direct supervision direct supervision of a licensed pharmacist.of a licensed pharmacist.

Law and the TechnicianLaw and the Technician

Legal liability Legal liability means you can be prosecuted for misconduct or means you can be prosecuted for misconduct or negligence.negligence.

Misconduct Misconduct means a wrongful, improper, or unlawful conduct means a wrongful, improper, or unlawful conduct motivated by premeditated or intentional purpose.motivated by premeditated or intentional purpose.

Negligence Negligence is the most common form of misconduct.is the most common form of misconduct. Refers to failure to do something that should or must be Refers to failure to do something that should or must be

done.done. Incorrect labeling, failure to maintain patient confidentiality. Incorrect labeling, failure to maintain patient confidentiality. Failure to recognize expired drugs.Failure to recognize expired drugs. Calculation errors.Calculation errors. Dispensing wrong medication.Dispensing wrong medication. Incorrect handling of controlled substance.Incorrect handling of controlled substance. Inaccurate record keeping.Inaccurate record keeping.

Compliance Compliance is doing what is required.is doing what is required.

American Society of Health-System American Society of Health-System Pharmacists (ASHP)Pharmacists (ASHP)

One of the various professional bodies and One of the various professional bodies and associations which set and maintain pharmacy associations which set and maintain pharmacy standards.standards.

Over 30,000 members primarily practice in hospitals.Over 30,000 members primarily practice in hospitals. Serves as an accrediting organization for pharmacy Serves as an accrediting organization for pharmacy

residency and pharmacy technician training residency and pharmacy technician training programs.programs.

Drug and Professional StandardsDrug and Professional Standards

United States Pharmacopeia (USP) United States Pharmacopeia (USP) Independent scientific not-for-profit organization. Independent scientific not-for-profit organization. Sets quality standards for prescription drugs, OTC Sets quality standards for prescription drugs, OTC

drugs, and dietary supplements.drugs, and dietary supplements. United States Pharmacopeia United States Pharmacopeia

Official publication of USP.Official publication of USP. Develops authoritative, unbiased information on Develops authoritative, unbiased information on

drug use.drug use.

JACHO JACHO

Joint Commission on Accreditation of Health Care Joint Commission on Accreditation of Health Care Organizations.Organizations.

Independent Independent non-profit organization.non-profit organization. Establishes standards and monitors complianceEstablishes standards and monitors compliance Monitors Monitors over 20,000over 20,000 health care programs. health care programs. Covers hospital, health care networks, HMOs, and Covers hospital, health care networks, HMOs, and

nursing homes.nursing homes.

National Association of Boards of National Association of Boards of Pharmacy (NABP)Pharmacy (NABP)

The NABP The NABP represents all 50 state boards of pharmacy.represents all 50 state boards of pharmacy. Assists in developing, implementing, and enforcing Assists in developing, implementing, and enforcing

uniform standards. uniform standards. Develops licensing exams for pharmacists.Develops licensing exams for pharmacists.

Coordinates Coordinates reciprocation reciprocation of pharmacist licenses from of pharmacist licenses from one state to another.one state to another.

Meets regularly to discuss national trends and issues Meets regularly to discuss national trends and issues in pharmacy law. in pharmacy law.

National Association of Boards of National Association of Boards of Pharmacy (NABP)Pharmacy (NABP)

Verifies the licensure of online pharmacies. Verifies the licensure of online pharmacies. Internet VIPPSInternet VIPPS®® program program (Verified Internet Pharmacy Practice (Verified Internet Pharmacy Practice

Sites).Sites). NONO regulatory authority, unlike the FDA or DEA. regulatory authority, unlike the FDA or DEA. Coordinates issuance of “Coordinates issuance of “NCPDP Provider ID.NCPDP Provider ID.” ”

Assigned a unique number to pharmacies in the United States and Assigned a unique number to pharmacies in the United States and territories of the United States.territories of the United States.

Identifies your pharmacy to health plan claims processors and Identifies your pharmacy to health plan claims processors and third party contractors.third party contractors.

Developed the Model State Pharmacy Practice Act (MSPPA).Developed the Model State Pharmacy Practice Act (MSPPA).

OthersOthers

Basic criminal and civil laws apply to pharmacy Basic criminal and civil laws apply to pharmacy technicians. technicians.

Crimes like theft, discrimination, sexual harassment, Crimes like theft, discrimination, sexual harassment, fraud, etc. are punishable fraud, etc. are punishable just as they would be just as they would be outside of your job.outside of your job.

Terms to RememberTerms to RememberTerms to RememberTerms to Remember1.1. Adverse effectAdverse effect2.2. Combat methamphetamine Combat methamphetamine

epidemic act (CMEA)epidemic act (CMEA)3.3. ComplianceCompliance4.4. Controlled substance markControlled substance mark5.5. Controlled substancesControlled substances6.6. Dual marketingDual marketing7.7. Exempt narcotics Exempt narcotics 8.8. Injunction Injunction 9.9. Legend drug Legend drug

10.10. LiabilityLiability11.11. NDC (national drug code)NDC (national drug code)12.12. NegligenceNegligence13.13. PediatricPediatric14.14. Pharmaceutical equivalentPharmaceutical equivalent15.15. PlaceboPlacebo16.16. Product labelingProduct labeling17.17. ProtocolProtocol18.18. RecallRecall19.19. Therapeutic equivalentTherapeutic equivalent

Terms to RememberTerms to RememberTerms to RememberTerms to Remember

20. Pure Food and Drug Act of 1906 20. Pure Food and Drug Act of 1906 21. Food, Drug, and Cosmetic (FDC) Act of 1938 21. Food, Drug, and Cosmetic (FDC) Act of 1938 22. Durham-Humphrey Amendment of 1951 22. Durham-Humphrey Amendment of 1951 23. Kefauver-Harris Amendment of 1962 23. Kefauver-Harris Amendment of 1962 24. Comprehensive Drug Abuse Prevention and Control Act 24. Comprehensive Drug Abuse Prevention and Control Act

of 1970 of 1970 25. Poison Prevention Packaging Act of 1970 25. Poison Prevention Packaging Act of 1970 26. Drug Listing Act of 197226. Drug Listing Act of 197227. Orphan Drug Act of 1983 27. Orphan Drug Act of 1983 28. Drug Price Competition and Patent-Term Restoration 28. Drug Price Competition and Patent-Term Restoration

Act of 1984 Act of 1984 29. Prescription Drug Marketing Act of 1987 29. Prescription Drug Marketing Act of 1987 30. Omnibus Budget Reconciliation Act of 1990 (OBRA-90) 30. Omnibus Budget Reconciliation Act of 1990 (OBRA-90) 31. Health Insurance Portability and Accountability Act 31. Health Insurance Portability and Accountability Act

(HIPAA) of 1996(HIPAA) of 199632. Medicare Prescription Drug, Improvement, and 32. Medicare Prescription Drug, Improvement, and

Modernization Act of 2003Modernization Act of 2003