The%20Pharmacy%20Technician%204E

1
The Pharmacy Technician 4E

• Chapter 3
• Drug Regulation and Control

2
Chapter Outline

• Drug Regulation
• New Drug Approval
• Marketed Drugs
• Behind-the-counter Medications
• Sample Labels
• Controlled Substances
• DEA forms
• Public Safety
• Law and the Technician

3
Brief History of Statutory Pharmacy Law

• In the 19th century, drugs in the United States
  were unregulated.
• Medicines did not require proof that they were
  either safe or effective.
• Most agents contained a high content of alcohol.
• Some caused injury or death.
• 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.

4
Pure Food and Drug Act of 1906

• 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.
• Proved unenforceable and new legislation was
  required.

5
Harrison Tax Act 1914

• Established that manufacturers, pharmacists,
  importer, and physicians prescribing narcotics
  should be Licensed and required to pay a tax.
• The law enacted in response to growing opiates
  and cocaine-containing medications.

6
Food, Drug, and Cosmetic (FDC) Act of 1938

• Sulfa poisoning caused the death of 107 people,
  primarily children.
• Due to untested sulfanilamide concoction.
• In response to this event, FDC was introduced.
• FDC is the most important piece of legislation in
  pharmaceutical history.
• Required only that drugs be SAFE for human
  consumption before marketing.

7
Food, Drug, and Cosmetic (FDC) Act of 1938

• Gave FDA the power to conduct inspections of
  manufacturing plants to ensure compliance.
• Act applied to interstate transactions, as well
  as to intrastate transactions.
• FDA required pharmaceutical manufacturers to file
  a new drug application (NDA) with each new drug
  before marketing.

8
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.
• Authorized
• Verbal prescriptions.
• Prescription refills.

9
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
• An investigational new drug application (INDA)
  with the FDA before initiating a clinical trial
  in humans.
• Once proven safe and effective, manufacturer may
  submit an NDA seeking approval to market the
  product.

10
Poison Prevention Packaging Act of 1970

• Passed to prevent accidental childhood poisonings
  from prescription and nonprescription products.
• Enforced by the Consumer Product Safety
  Commission.
• Requires most over-the-counter (OTC) and legend
  drugs to be packaged in child-resistant
  containers.
• Cannot be opened by 80 of children under five.
• Can be opened by 90 of adults.
• Older patients or people with a disability may
  request a non-child-resistant container other
  exceptions are provided for by law.

11
Comprehensive Drug Abuse Prevention and Control
Act of 1970

• Commonly referred to as the Controlled Substances
  Act (CSA).
• Created to combat and control drug abuse and to
  supersede previous federal drug abuse laws.
• Created the Drug Enforcement Administration
  (DEA), an arm of the Department of Justice.
• Charged with enforcement and prevention related
  to the abuse of controlled substances like many
  narcotic pain medications.

12
Comprehensive Drug Abuse Prevention and Control
Act of 1970

• Classified drugs with potential for abuse as
  controlled substances.
• 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).
• Narcotics are highly regulated.

13
Comprehensive Drug Abuse Prevention and Control
Act of 1970
Schedule Medical Use Examples
I For research only not approved for human use Heroin, LSD
II Dispensing severely restricted Morphine, oxycodone, meperidine
III Prescriptions can be refilled up to 5 times in 6 months Codeine with aspirin, anabolic steroids
IV Same as for Schedule III Benzodiazepines, meprobamate
V Some sold w/o a prescription must be 18 Liquid codeine combination preps.
14
Drug Listing Act of 1972

• Gives the FDA the authority to compile a list of
  currently marketed drugs.
• Each drug is assigned a unique and permanent
  product code
• Known as a National Drug Code (NDC).
• Ten characters that identify manufacturer or
  distributor, drug formulation, size and type of
  packaging.
• FDA requests, but does not require, that the NDC
  appear on all drug labels.

15
1976 Medical Device Amendment

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

16
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.
• The Orphan Drug Act encourages the development of
  orphan drugs by
• Providing tax incentives.
• Granting manufacturers exclusive license.
• Over 250 orphan drugs have been approved by the
  FDA.

17
Drug Price Competition and Patent-Term
Restoration Act of 1984

• Also called Hatch-Waxman Act.
• Allows substation of generic drugs with the same
  chemical composition as brand name products.
• Once the original patent expires, any
  manufacturer may market a generic drug.
• Usually is less costly than the brand name.
• A given drug typically has several names.
• Generic name is a common name given to a drug
  regardless of brand name.
• One or more brand names under which the
  manufacturer markets a drug.

18
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.
• PROHIBITS
• Sale or trading of drug samples.
• PROHIBITS
• Distribution of samples in response to
  prescription drug samples being illegally
  diverted and distributed.
• To persons other than those licensed to prescribe
  them except by mail or by common carrier.

19
Omnibus Budget Reconciliation Act of 1990
(OBRA-90)

• Requires states to establish standards for Drug
  Use Review (DUR) by the pharmacist.
• Requires pharmacists to offer counseling to
  Medicaid patients.
• Requires a manufacturers rebate to state Medicaid
  program between the manufacturers best price for
  a drug (typically the wholesale price) and the
  average billed price.

20
Health Insurance Portability and Accountability
Act (HIPAA) of 1996

• Defines the scope of health information that may
  or may not be shared among health care providers
  without patient consent.
• Provided for broad and stringent regulation to
  respect Patients right to privacy.
• Affects the confidentiality of patient medical
  records.
• Placed safeguards to protect patient
  confidentiality.
• Requires healthcare facilities to provide
  information to the patient on how they protect
  the patients health information.

21
Health Insurance Portability and Accountability
Act (HIPAA) of 1996

• In pharmacy, HIPAA requirements include
• 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.

22
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.
• Updates the labeling on prescription medications
  .
• Products labeled legend are to be changed to
  read Only.
• LEGEND is the term that has been used to indicate
  whether a drug was available by prescription or
  over-the-counter (OTC).
• New labeling requirements were implemented in
  2004.

23
The FDAs Center for Drug Evaluation Research

• Provides an Index to Drug-Specific Information
  with patient, consumer and healthcare
  professional information sheets, including FDA
  Alerts.
• Works with drug manufacturers to develop risk
  management programs for drugs with FDA.
• Alerts, such as the iPLEDGE program for Accutane.
  
• Health care professionals, wholesalers,
  pharmacies and patients must register in the
  iPLEDGE program to prescribe , distribute, fill
  prescriptions, or use Accutane.

24
New Drug Approval

• All new drugs (domestic or imported) require FDA
  approval before they can be marketed in the US.
• Before approval, new drugs must be shown to be
  SAFE and EFFECTIVE and its benefits OUTWEIGH its
  risks.
• Drug manufacturers and not the FDA is responsible
  for proof.
• The testing process currently takes about 8.5
  years.
• Discovery 2-10 years.
• Preclinical testing laboratory and animal
  testing.
• Phase I 20-80 healthy volunteers.
• Phase II 100-300 patient volunteers.
• Phase III 1,000-5,000 patients volunteers.
• FDA review/approval Approved by FDA 17 years.
• Post-marketing testing Five year extension on
  patent (Hatch-Waxman Act of 1984).

25
New Drug Approval Process

• Placebo
• Inactive substance not real medicine
  administrated
• Gives the impression that theyre receiving the
  real medicine.
• Used to compare against patients with the test
  drugs
• Investigational New Drug Application (INDA)
• 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.

26
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.
• Requires for the patient to be told all the risks
  and other treatment options in a language they
  understand.
• Patients should also be free to leave the trial
  at any time.

27
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.
• Phase II
• Up to several hundred patients.
• Several months to two years.
• The main purpose is short-term SAFETY AND
  EFFECTIVENESS.

28
Clinical Trial Testing Cont.

• Phase III
• Several hundred to several thousands patients.
• 1-4 years.
• The main purpose is safety, dosage, and
  effectiveness.
• Phase IV
• Begs after the drug is approved.
• Life time of the drug.
• The main purpose is for safety.

29
Clinical Trials

• Special Treatment Status
• Permission given to administer drugs in patients
  outside the clinical trials for relief to a
  critically ill patient without a better proven
  drug.
• E.g. AZT for AIDS in early 1990s.
• Controlled Trial
• Group of patients (with similar condition or
  disease) who are given a placebo (or no drug) and
  used to compare the effect of the test drug.
• Groups are placed on controlled or treatment arm
  randomly.
• Blind Trial
• The patient or the doctor who is treating the
  patient does not know which arm of the study a
  particular patient is on.

30
Marketed Drugs

• 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 patient up to 5 years to compensate for
  lost time in research before going to market.
• While the drug is under patent, a generic drug
  will NOT be marketed by other companies.

31
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.

32
Marketed Drugs

• Generic drugs are Pharmaceutically Equivalent is
  identical to the brand-name product listed in the
  orange book (FDAs 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.

33
Look Alike and Sound Alike Drugs

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

34
Over-the-Counter (OTC) Drugs

• OTC drugs have to be approved by the FDA .
• Can be used upon the judgment of the consumer
  without a prescription from a physician.
• 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

35
Sample OTC Label
36
Behind-The-Counter OTC Medications

• Medications sold without a prescription, but with
  RESTRICTION on their sales.
• Kept behind the pharmacy counter.
• Limitation 3.6 grams per day and 7.5 gram per
  month.
• E.g. Pseudoephedrine and Ephedrine containing
  products.

37
Combat Methamphetamine Epidemic Act

• Requires that cold and allergy medicine
  containing these ingredients be kept behind the
  counter.
• Set daily and monthly amount restrictions.
• A sales record (written or electronic) must be
  kept for a period of 2 years.
• 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.

38
Exempt Narcotics

• Sold by a pharmacist without a prescription.
• E.g. Cough syrups that contain a small amount of
  codeine.
• Only pharmacists can approve their dispensing.
• Purchasers have to
• Be at least 18 years old.
• Provide identification
• 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.)

39
Emergency Contraceptives

• Plan B
• Has a dual marketing status (both Rx and OTC).
• OTC gt17 years old.
• Prescription lt 17 years old.
• Exception
• Pharmacists in some states have authority to
  prescribe and dispense under protocol to patients
  under 17 years old.

40
Manufacturing Label
NDC number
Manufacturers name address
brand generic names
Dispensing Storage requirements
Lot Number Exp Date
Legend statement
controlled substances mark
PT 33
41
Product Labeling

• 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.
• Intended for health care professionals who
  prescribe or dispense the product
• Is contained in a reference book called Physician
  Desk Reference (PDR).

42
National Drug Code (NDC Number) NDC 01234-5678-90

• Identification number assigned by the
  manufacturer to a drug product.
• Has 3 sets of numbers.
• 1st five digits - manufacturer.
• 2nd four digits - medication strength and
  dosage form.
• 3rd two digits - package size.

43
Prescription Bottle
44
F
A
C
D
K
E
H
I
J
B

• A Rx number H Number of refills remaining
• B Prescribing physician
  I Manufacturer of the drug
• C Date
  J Expiration date
• D Patient Name K Direction for
  use
• E Drug Name, strength, dosage form
• F Pharmacy Name, Address,
• and phone number
• G Quantity

45
Controlled Substances

• Drugs that have an abuse potential.
• Enacted in 1970 by Controlled Substance Act (CSA)
  .
• Five groups (or schedules) of such drugs and put
  a strict guideline on their distribution.
• Requires to register with the Drug Enforcement
  Administration (DEA) of the Justice Department.

46
DEA Registration

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

47
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.
• Inspects medical facilities, including
  pharmacies.
• Tracks narcotics from manufacturer to warehouse
  to pharmacy.

48
DEA Regulations

• 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.

49
Dispensing of Schedule II 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 emergency supply of a Schedule II drug (72
  hours supply) can be provided to a patient
  without a written prescription in most states.

50
DEA Form 222

• Used to order C-I and C-II.
• 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.
• Must be kept in a separate file from other
  invoices.
• Note that C-III - C-V does not require federal
  order forms.
• Form has its own unique serial number.
• Form can be requested online.

51
DEA Form 222
PT 35
52
DEA Numbers

• Assigned to prescribers for controlled drugs.
• Two letters and seven digits .
• First letter is a code identifying the type of
  registrant.
• Second letter is the initial of the registrant's
  last name.
• Seventh digit is a checksum" that is calculated.

53
DEA Numbers

• Example AR4342793
• Add 1st 3rd 5th number ___.
• Add 2nd4th 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
• (44715 32914 14x228 then 152843).

54
Drug Enforcement Administration (DEA)

• Branch of the U.S. Justice Department responsible
  for regulating sale and use of drugs with abuse
  potential.
• Responsible for enforcing laws regarding both
  legal and illegal addictive substances.
• Directs most of its efforts toward illegal drug
  trafficking.
• Supervises legal use of narcotics and other
  controlled substances.

55
Controlled Substance Prescriptions

• The DEA number must appear on the form and the
  patients full name and full street address must
  be entered.
• NO REFILL is allowed on Schedule II
  prescriptions.
• When filling the prescription, the pharmacist
  draws a line across the prescription indicating
  it has been filled.

56
Federal Laws

• A prescription for a controlled substance must
  meet
• the following requirements.
• Patients full name and address.
• Practitioners name, address, and DEA.
• Drug name, strength, dosage form, quantity,
  directions, and refills.
• Must be written in ink or typewritten and signed
  by prescriber.
• Controlled substance must be dated on the date of
  issuance.

57
Federal Laws

• 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.
• Schedule II requires a written prescription by
  the prescriber that is signed and is not refilled.

58
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.
• Requires all manufacturers to file applications
  for investigation studies and approval of new
  drugs.
• Oversees the recall of dangerous products.
• Has no legal authority over the practice of
  pharmacy in each state (is a responsibility of
  the BOARD OF PHARMACY).

59
Public Safety

• FDA approval process is quite thorough, but it is
  impossible to fully prove that a drug is safe for
  use.
• The FDA has several options if it determines that
  a marketed drug presents a risk of illness,
  injury, or gross consumer deceptions.
• Requests healthcare professionals and the public
  to report any adverse effects of drugs once they
  are marketed.
• FDA seizes the drug, stops distribution, or may
  issue a recall of the drug.

60
MedWatch

• 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.
• A voluntary program.
• Designed to detect side effects not identified
  from research studies.
• Manufacturers must file a report if an adverse
  drug reaction is reported.
• Reports can be made.
• Phone 1-800-FDA-0178, by mail, or online.

61
Public Safety

• Adverse Effect
• Unintended side effect of a medication that is
  negative or in some way injurious to a patients
  health.
• Injection
• Court order preventing a specific action.
• E.g. the distribution of potentially dangerous
  drugs.

62
Recalls

• 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
• Adverse drug effect can be reported to the
  Manufacturer or to the FDA.
• 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.

63
Types of Recalls

• Class I
• Serious adverse effects or death.
• Class II
• Cause temporary but reversible effects.
• Class III
• Not likely to cause adverse effects.

64
Vaccine Adverse Event Reporting System (VAERS)

• 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).
• Report
• (1-800-822-7967), online, or submitted by mail on
  a downloaded form.

65
Law and the Technician

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

66
State Laws

• Responsible for licensing of all prescribers and
  dispensers.
• Each state enacts laws governing the
  manufacturer, distribution, prescription, and
  dispensing of prescription drugs.
• Pharmacists must comply with both federal
  regulations and regulations in the state(s) in
  which they practice.
• Such regulations may reside in different
  departments of the state, such as the board of
  pharmacy, the department of health, or consumer
  affairs.

67
State Boards of Pharmacy

• Composed of leaders from the pharmacy community
  and the public.
• Activities vary from state to state .
• Can suspend or revoke pharmacy/pharmacist license
  or registration.
• Provide regulations regarding the practice of
  pharmacy.

68
State Boards of Pharmacy Legal Duties of
Pharmacy Personnel

• No statutory federal definition of the role of
  the pharmacy technician exists.
• No uniform definition of role and duties of
  pharmacy technicians from state to state.
• Roles and duties of pharmacy technicians are
  changing.
• Requirements for pharmacy technicians vary by
  state.
• Some states require licensure or registration
  with the board.
• Some states require passing national
  certification exams.
• Technicians duties in all states must be carried
  out under the direct supervision of a licensed
  pharmacist.

69
Law and the Technician

• Legal liability means you can be prosecuted for
  misconduct or negligence.
• Misconduct means a wrongful, improper, or
  unlawful conduct motivated by premeditated or
  intentional purpose.
• Negligence is the most common form of misconduct.
• Refers to failure to do something that should or
  must be done.
• Incorrect labeling, failure to maintain patient
  confidentiality.
• Failure to recognize expired drugs.
• Calculation errors.
• Dispensing wrong medication.
• Incorrect handling of controlled substance.
• Inaccurate record keeping.
• Compliance is doing what is required.

70
American Society of Health-System Pharmacists
(ASHP)

• One of the various professional bodies and
  associations which set and maintain pharmacy
  standards.
• Over 30,000 members primarily practice in
  hospitals.
• Serves as an accrediting organization for
  pharmacy residency and pharmacy technician
  training programs.

71
Drug and Professional Standards

• United States Pharmacopeia (USP)
• Independent scientific not-for-profit
  organization.
• Sets quality standards for prescription drugs,
  OTC drugs, and dietary supplements.
• United States Pharmacopeia
• Official publication of USP.
• Develops authoritative, unbiased information on
  drug use.

72
JCAHO

• Joint Commission on Accreditation of Health Care
  Organizations.
• Independent non-profit organization.
• Establishes standards and monitors compliance
• Monitors over 20,000 health care programs.
• Covers hospital, health care networks, HMOs, and
  nursing homes.

73
National Association of Boards of Pharmacy (NABP)

• The NABP represents all 50 state boards of
  pharmacy.
• Assists in developing, implementing, and
  enforcing uniform standards.
• Develops licensing exams for pharmacists.
• Coordinates reciprocation of pharmacist licenses
  from one state to another.
• Meets regularly to discuss national trends and
  issues in pharmacy law.

74
National Association of Boards of Pharmacy (NABP)

• Verifies the licensure of online pharmacies.
• Internet VIPPS program (Verified Internet
  Pharmacy Practice Sites).
• NO regulatory authority, unlike the FDA or DEA.
• Coordinates issuance of NCPDP Provider ID.
• Assigned a unique number to pharmacies in the
  United States and territories of the United
  States.
• Identifies your pharmacy to health plan claims
  processors and third party contractors.
• Developed the Model State Pharmacy Practice Act
  (MSPPA).

75
Others

• Basic criminal and civil laws apply to pharmacy
  technicians.
• Crimes like theft, discrimination, sexual
  harassment, fraud, etc. are punishable just as
  they would be outside of your job.

76
Terms to Remember

• Adverse effect
• Combat methamphetamine epidemic act (CMEA)
• Compliance
• Controlled substance mark
• Controlled substances
• Dual marketing
• Exempt narcotics
• Injunction
• Legend drug

• Liability
• NDC (national drug code)
• Negligence
• Pediatric
• Pharmaceutical equivalent
• Placebo
• Product labeling
• Protocol
• Recall
• Therapeutic equivalent

77
Terms to Remember

• 20. Pure Food and Drug Act of 1906
• 21. Food, Drug, and Cosmetic (FDC) Act of 1938
• 22. Durham-Humphrey Amendment of 1951
• 23. Kefauver-Harris Amendment of 1962
• 24. Comprehensive Drug Abuse Prevention and
  Control Act of 1970
• 25. Poison Prevention Packaging Act of 1970
• 26. Drug Listing Act of 1972
• 27. Orphan Drug Act of 1983
• 28. Drug Price Competition and Patent-Term
  Restoration Act of 1984
• 29. Prescription Drug Marketing Act of 1987
• 30. Omnibus Budget Reconciliation Act of 1990
  (OBRA-90)
• 31. Health Insurance Portability and
  Accountability Act (HIPAA) of 1996
• 32. Medicare Prescription Drug, Improvement, and
  Modernization Act of 2003