1. Pharmacy Law, Ethics, and Regulatory Agencies
Chapter 2

2. Lesson 2.1
Federal Laws Affecting the Pharmacy Technician and Functions of the FDA and DEA
List the history of federal drug laws in chronological order.
Describe the implications of the Health Insurance Portability and Accountability Act (HIPAA).
Explain how the Patient Protection and Affordable Care Act (ACA) and the Drug Quality and Security Act (DQSA) have changed health care.
Define the functions of the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA).
Describe the process for reporting any problems with a drug or any adverse reactions to the FDA.
Explain the three classes of drug recalls defined by the FDA.

3. History of the FDA History of the FDA is important in pharmacy
FDA is under the direction of the Department of Health and Human Services
FDA’s main function: Enforce guidelines for manufacturers to ensure safety and effectiveness of medications
What does FDA stand for? (Food and Drug Administration)
The FDA was a small, unimportant agency until 1901, when deaths caused by contaminated vaccines led to public outrage and the Biologics Act of 1902.

4. 1906 ‒ Pure Food and Drug 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
Why do you think a major federal law about drugs hadn’t been written earlier? (The technology needed to make drugs of standard purity, composition, and strength wasn’t developed until the nineteenth century, so there wasn’t any way to enforce such laws.)

5. 1914 ‒ Harrison Narcotics Act
Enacted to curb recreational use of opium
No longer available without a prescription
Records required for prescriptions
Importation and distribution were restricted
What countries were the main poppy producers in the early twentieth century? What about today? (India, Turkey, and China in the twentieth century; today, many countries in Southwest and Southeast Asia and Latin America.)
How is opium “taken”? (Opium can be eaten or smoked, but today it is usually processed into heroin or morphine.)

6. 1938 ‒ Food, Drug, and Cosmetic Act
Enacted because the 1906 law was not worded strictly enough and did not include cosmetics
Required drug companies to include directions to the consumer regarding use of a drug, and also package inserts
All addictive substances had to be labeled: “Warning: May be habit forming”
Why are cosmetics included in a law concerning food and drugs? (It is important for cosmetics to be accurately labeled and tested for purity and safety because even though they are used externally, they might cause a rash, be absorbed through the skin, or enter the bloodstream in another way.)

7. 1938 ‒ Food, Drug, and Cosmetic Act
Defined the exact labeling for products and defined misbranding and adulteration as illegal
Requires the following:
Mandatory food labeling
Standards of identity
Information on imitation foods
Nutritional information for special dietary foods
Provided the legal status for the Food and Drug Administration (FDA)
Up to this point, the FDA did not have legal power to enforce regulations.
Misbranding involved false or exaggerated claims on labels. Adulteration meant mishandling of food or drugs (for example, inclusion of impurities or harmful ingredients) that could result in injury or death for consumers.

8. 1951 ‒ Durham-Humphrey Amendment
Required label on prescription drugs: “Caution: Federal law prohibits dispensing without a prescription.”
Required a doctor’s order and supervision for certain drugs
Made the initial distinction between legend drugs (by prescription only) and OTC medications that do not require a doctor's order (non-prescription drugs)
How did this law change the role of the pharmacist? (The authority to prescribe medicine was placed fully in the hands of doctors, so pharmacists had to rely more fully on them.)
Until 1951 there were was no distinction between prescription and OTC medications.

9. 1962 ‒ Kefauver-Harris Amendments
Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market
Burden put on manufacturers to ensure “good manufacturing practice” (GMP)
Prevented the sale of thalidomide in the United States; children in Europe were born with birth defects after mothers used drug during pregnancy
Do you know of any drugs sold in the United States that were recalled? (Phenylpropanolamine [PPA] was a common ingredient in cold medicines and weight-loss products until 2000; it increased the risk of stroke. Vioxx and other cyclooxygenase-2 [COX-2] nonsteroidal antiinflammatory drugs [NSAIDs] were recalled in 2004 after studies showed an increased risk for gastrointestinal [GI] bleeding and cardiovascular problems. Elixir Sulfanilamide is perhaps the most deadly drug to have been sold in the United States. The manufacturer did not test the liquid form of the drug, which turned out to be equivalent to antifreeze. In 1937, more than 100 people died of kidney failure while taking it.)
The Kefauver-Harris Amendments required manufacturers to prove the safety of a drug and to provide substantial evidence of its effectiveness for the intended purpose.

10. 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)
What does a controlled substance’s schedule category mean? (Drugs in schedules with a lower number [for example, Schedule II] are more tightly restricted than are drugs in schedules with a higher number [such as Schedule V].)
The FDA created the schedule system to identify controlled drugs by their potential for abuse. Schedule I includes drugs with no medically accepted use in the United States. Schedule II drugs have the most potential for abuse, and Schedule V drugs, the least. “Schedule” drugs require special handling and documentation and come under specific licensing and prescribing regulations.
In 1972, the Drug Listing Act established the National Drug Code (NDC), a special numbering system created to identify a medication as a unique product. Technicians use these numbers today as a safety check and in bar coding software.

11. 1970 ‒ Poison Prevention Packaging Act
Required all medications to be placed in containers with childproof caps or packaging
Includes both OTC and legend drugs
Exceptions include:
Physician request for non-childproof cap
Certain legend medications
Hospitalized patients or patient request
Did you know that database programs have a special field for adding to a patient’s profile his or her request for special caps? (Answers will vary.)

12. 1983 ‒ Orphan Drug Act and 1987 ‒ Prescription Drug Marketing Act
Orphan Drug Act: Eased restrictions (and thus costs) for development of new drugs for those with a rare disease (affecting 1 in 200,000 people)
Prescription Drug Marketing Act
Helps prevent counterfeit drugs and ingredients from entering the supply chain
Limits diversion of pharmaceutical samples and prescription drugs
It takes 12 to 15 years for a drug to make it from the experimental lab to the pharmacy.
The Orphan Drug Act was designed to allow companies with medications intended for special and small populations to reach the market earlier than normal for approval.
Only 1 in 5000 drugs that reach preclinical testing is approved for human testing; of these, 1 in 5 drugs is approved for use.

13. 1990 ‒ Omnibus Budget Reconciliation Act (OBRA ’90)
Deals specifically with practicing pharmacists
Enacted because of reimbursement regulations for people who are covered by Medicaid or Medicare
Requires pharmacists to counsel (at the time of purchase) all patients who receive new prescriptions
Why does OBRA ’90 apply only to prescriptions for patients with Medicare or Medicaid? (OBRA ’90 is a federal law that deals with reimbursement procedures for Medicare and Medicaid, which are federally funded programs.)

14. 1996 ‒ Health Insurance Portability and Accountability Act (HIPAA)
Deals with patient’s right to continuance of health insurance even when changing employers
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
Each part of HIPAA had a different deadline for compliance.
HIPAA regulations often use the acronym PHI, which stands for protected health information.

15. Patient Confidentiality
Prevents privileged information about a customer from being disclosed without his or her consent
Changes have been made throughout all medical facilities and medical information centers that limit access to patient information
All individually identifiable health information is protected
Pertains to information in any form or media
Technicians play a crucial role in protecting a patient’s records. How do you think you can do this in a retail or community setting? What about talking on the phone in front of a waiting customer? Discussing what a customer is picking up in front of others? Asking for identifying information? (Answers will vary.)

16. Public Health Activities
PHI may be disclosed to:
Public health authorities
Entities subject to FDA regulation
Those who have been exposed to a communicable disease
Employers regarding work-related illness/injury to comply with OSHA
Some exceptions exist if the matter is one of public safety. Always check with the pharmacist if you are unsure of what to disclose and to whom.

17. Law Enforcement Purposes
PHI may be disclosed to law enforcement officials:
As required by law (for example, court orders)
To identify or locate a suspect, fugitive, material witness, or missing person
To provide information about a victim
If criminal activity caused a victim’s death
Some exceptions exist if public safety may be at stake. Always check with the pharmacist to clarify what can be disclosed and to whom.

18. 2000 ‒ Drug Addiction Treatment Act (DATA 2000)
Physicians can prescribe controlled substances to persons suffering from opioid addiction
Only for maintenance or detoxification treatments
Have you ever heard of a methadone treatment center? (Answers will vary. These are clinics that provide treatment for those suffering from opioid addiction.)

19. 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 federal agency, and Medicare Part D pertains to the prescription program, which technicians will be involved in.

20. 2005 ‒ Combat Meth Act
Addresses all areas of the manufacture and sale of pseudoephedrine (an ingredient used to make methamphetamine), as well as law enforcement
Strict guidelines
Only a licensed pharmacist or technician may dispense, sell, or distribute this drug2005 ‒ Combat Meth Act
The state of Oregon now requires a prescription for pseudoephedrine.

21. 2010 ‒ ACA and 2013 ‒ Drug Quality and Security Act
Patient Protection and Affordable Care Act (ACA): Two important technician-related components:
Electronic health records (EHR)
Medication therapy management (MTM)
Drug Quality and Security Act (DQSA)
FDA tracking system for bulk compounding supplies
Implementation of the ACA will be an ongoing process because its components take effect over the course of several years.
The technician is an integral part of the team approach, and EHRs, as well as MTM, will be required for patient safety.
Technicians doing data entry or charting are responsible for ensuring that the most accurate record of medications is kept for the patient and his or her caregivers.
The DQSA was enacted after scares with compounded products to require manufacturers to use a tracking system.

22. Functions of the FDA and DEA
Enforces guidelines for manufacturers to ensure safety and effectiveness of medications
Anything that contains any avoidable, poisonous, or harmful substance is considered unsafe
DEA
Prevents illegal distribution and misuse of controlled substances
Issues licenses and enforces the nation’s drug laws
The Food, Drug, and Cosmetic Act established standards that pro­hibit misbranding, adulteration, and misleading labeling of any products before they are provided to consumers.
How many packaging standards are there under the Food, Drug, and Cosmetic Act? (There are 5, and they can be found on p. 31.)
The DEA issues licenses to practitio­ners, pharmacies, and manufacturers of controlled substances.

23. FDA Reporting Process and Adverse Reactions
1-800-FDA-1088: Toll-free number for reporting any defect in OTC medications and any other drug problems
Should report: Any medication reaction that might cause disability, hospitalization, or death
Patient’s identity must be kept confidential
Drug manufacturers, importers, and distributors are required to report adverse events and product problems, but reporting by health care workers and consumers is voluntary. However, employers and states might have different rules, and technicians should know them.
What are the reporting rules in your state? (Answers will vary.)

24. FDA Reporting Process and Adverse Reactions
MedWatch: FDA program that allows consumers and health care professionals to report any discrepancies or adverse reactions to medications
Figure 2-3 (pp ) shows Form FDA 3500B, MedWatch Consumer Voluntary Reporting.
Where can you find the information you need to submit a report to the FDA? (The forms can be found online, in the Physician’s Desk Reference [PDR], or in Facts and Comparisons. Information about the drug and what happened should be obtained from the product’s package and package insert and from the people who were affected.)

25. Recalled Drugs Three classes of recalls:
Class 1: Products that could cause serious harm or prove fatal
Class 2: Products found to cause a temporary health problem or pose a slight threat of serious harm
Class 3: Products that may have a minor defect or other condition that would not harm the patient
These recalls come to the pharmacy via or mail. As a technician, you may be required to pull the affected products from the shelf and, in some cases, notify patients to return their items for replacement. The affected products are identified by their NDC number.

26. Lesson 2.2
Controlled Substances, Drug Warnings, Prescribing Medications, and Pharmacy Guidelines
Describe the proper handling of controlled substances.
Explain the necessary forms and regulations used for controlled substances.
List the basic information contained in a drug monograph.
Explain the purpose of boxed warnings and MedGuides.
List and explain the five pregnancy categories established by the FDA.
List who can prescribe medications and medical devices.
Describe prescription orders and prescription labels.
Perform the function of verifying a DEA number.

27. Lesson 2.2
Controlled Substances, Drug Warnings, Prescribing Medications, and Pharmacy Guidelines
Explain the purpose of risk management programs for prescription drugs.
Explain the verification process for Internet pharmacies.
Explain the Occupational Safety and Health Administration (OSHA) guidelines as they pertain to pharmacy.
Explain the purpose of the Joint Commission.
Explain why pharmacy technicians must be knowledgeable about the law when performing nondiscretionary duties.
Discuss the differences between morals and ethics.

28. Controlled Substances
Commonly known as narcotics and are addictive
Narcotics are derived from opium or opium-like substances
Opium comes from the poppy seed plant and has analgesic effects and also affects mood and behavior
Opioids, such as codeine and morphine, are substances created from opium
Each type of narcotic is assigned a rating that depends on its addictive and abuse potential
In the language of federal regulation, the word narcotics refers to all controlled substances, whether or not the chemical or drug has the characteristics of a true narcotic (an addictive drug that dulls the senses).
Who decides what rating to give a controlled substance? (Although the FDA and DEA work together to recommend ratings for new drugs, the U.S. Attorney General ultimately determines under which schedule to place a drug.)

29. Ratings of Scheduled (Controlled) Substances
Five levels based on potential for abuse:
C-I: Strongest potential for abuse; no medicinal use in the United States (for example, LSD, heroin)
C-II, C-III, C-IV, C-V: All medicinal narcotic drugs
C-V: Kept OTC in some states because of low potential abuse
C-II: Must be locked up because of high potential abuse
U.S. Attorney General assigns the schedule for a drug
The letter “C,” meaning controlled substance, is used in addition to Roman numerals to indicate the addictiveness or abuse potential of narcotics.
Why might a drug be labeled under two different schedules? (Different doses of the same drug might have different dependency potentials.)
What are exempt controlled substances? (Schedule V medications are exempt from some regulations pertaining to higher-rated drugs because, although they contain narcotic substances, they have a very low potential for abuse.)
Although federal law states that C-V medications may be sold without a prescription, many states impose stricter laws that require prescriptions or registration of purchases.
Refer to Table 2-2 (p. 37) for information on typical controlled substances.

30. Tamper-Proof Prescriptions
New scripts have up to eight different tamper-proof security marks on them
Prevents forgery and fraud
If these prescriptions are copied, they may have “VOID" across the entire page to identify this special paper.

31. Registration Required for Maintaining Narcotics
DEA has four main registration forms:
Form 224: Needed by pharmacy to dispense controlled substances
Form 225: To manufacture or distribute controlled substances
Form 363: To run a narcotic treatment program or compound narcotics
Form 41: Returns to reverse distributor
The DEA requires extensive record keeping for controlled drugs, and technicians must know how to prepare these forms.

32. Refilling Controlled Substances
Strict guidelines
Drugs rated C-III through C-V can be refilled a maximum of five times or within 6 months of the original order, whichever comes first
Record must be kept with pharmacist’s initials and date drug was dispensed
Drugs rated C-II cannot be refilled. It is important for technicians to know drugs’ schedules and the refill guidelines for those schedules.

33. Ordering Controlled Substances
Pharmacy obtains C-II substances from a distributor
Form 222 must be filled out by the receiving pharmacy in pen, typewriter, or indelible pencil
Top copy and middle copy with carbon paper are sent to the supplier or manufacturer
The DEA even limits the number of order forms a pharmacy can have on hand at a time, and a DEA number is needed to reorder forms.

34. Ordering Controlled Substances
Top and middle copies with carbon paper are returned to distributor or wholesaler
Filing electronically is also possible (but not for C-I or C-II drugs)
Pharmacy retains bottom copy
Invoice and form are retained for 7 years
Once the scheduled drugs have been received, the invoice forms for Schedules III through V must be kept for no less than 2 years.

35. Ordering Controlled Substances
Drugs rated C-III, C-IV, or C-V
Ordered on normal invoice forms but must be filed and retained for DEA or board of pharmacy (BOP) inspection
Should be kept separate from other nonscheduled drugs
Forms kept for 2 years
Even with such strict regulation and documentation, thousands of incidents exist of controlled substances being stolen, lost in transit, or pilfered by employees each year.
For example, in 2002 a half million doses of OxyContin were reported lost or stolen.

36. Record Keeping Three methods of filing controlled substances
In some states, the BOP may require a specific method
Controlled substances must be logged out of pharmacy stock before being issued
Double-check the remaining stock
Refer to Table 2-3 (p. 40) for more information on the three methods of filing controlled substances and legend drugs.
Levels are first counted; the amount of each drug must be correct. Then the technician or pharmacist subtracts the amount taken.

37. Narcotic Inventory Perpetual inventory
Pharmacist must validate all counts done by a technician
Discrepancies are investigated by DEA
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.

38. Reverse Distributor
All controlled substances that are unwanted, unusable, or outdated that are returned to the distributor
Prevents drug diversion
Any controlled substances that are unwanted, outdated, or unusable can be returned to an approved company for destruction. This is a way to prevent drug diversion and ensure proper destruction of these medications.

39. Filling, Refilling, and Transferring Prescriptions for Controlled Drugs
Original fill of C-II through C-V: Written, oral, or fax
Emergency C-II original fill: Oral order only in emergency situations
Refills of C-II through C-V:
C-II: No refills
C-III and C-IV: 5 times within 6 months
C-V: No restrictions
Pharmacists are ultimately responsible for deciding on the need for and documentation of emergency fills; however, as a technician, you will be involved in record keeping and the filing of these documents.

40. Partial Filling of C-II Through C-V
C-III, C-IV, and C-V: Must have remainder dispensed within 6 months
C-II: Must have remainder dispensed within 72 hours
Transfer of prescriptions C-II through C-V: May be transferred only once
Some states require Schedule V drugs to be dispensed by a pharmacist
Controlled substances C-II through C-V may be mailed as long as contents are not identified on packaging
Always sign documentation in pen and complete carefully because this is a permanent record.
Schedule II drugs cannot be transferred because they can only be filled once.

41. Monographs/Package Inserts
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
Boxed warning (also called Black Box Warning)
MedGuides: Printouts required for certain medications
Monographs are more than just package inserts or instructions for use; they’re a written chemical “recipe” for a drug that the U.S. Pharmacopeia (USP) uses to standardize products made by various manufacturers.
Monographs are officially published in the Code of Federal Regulations (CFR).
A Black Box Warning indicates a high risk potential for consumers and is required on certain medications per the FDA. MedGuides are paper handouts required for medications that could cause serious adverse reactions. For a list of medications that require a Black Box Warning, see

42. Pregnancy Categories
FDA established five categories to identify a drug’s potential harm to a fetus or pregnant woman
Category X: Not to be used during pregnancy
Category A: No evidence of harm based on studies
Categories B-D: Various levels of risk
See Box 2-9 (p. 48) for a full explanation of the pregnancy categories.
Where would you find this information? (The PDR has a section. You will also be warned in a Drug Utilization Review if performing data entry.)

43. Prescription Regulations
Who can prescribe?
FDA and DEA have no authority to determine prescribers
Prescribers are licensed by their individual state boards
Standard practitioners in all 50 states are physicians, surgeons, doctors of osteopathy, dentists, podiatrists, veterinarians, and optometrists
In some states, which other professionals can write prescriptions? (Nurse practitioners and physician assistants are permitted to prescribe some medications and devices in some states.)

44. Who Can Receive a Prescription?
Pharmacy technicians take in prescriptions, interpret them, and fill them
Technicians cannot take phone orders
Pharmacists give the final check, take verbal telephone orders, and transfer prescriptions to another pharmacy
Most states prohibit pharmacy technicians from taking phone orders for legend drugs.

45. Prescription Labels
The information on a prescription label differs from a prescription order
Two necessary components are pharmacy information and patient information
Special labeling sometimes is required because of adverse effects or the possibility of teratogenicity to an unborn fetus
Labels include: Name, address, and phone number of the pharmacy; name of prescriber and date prescription was filled; prescription number and cautions
Teratogenic means “monster making,” in reference to the severe birth defects that such drugs can cause if taken by a pregnant woman.
Thalidomide was a teratogenic drug.

46. Repackaging
Medication taken from bulk packages and placed into blister packs or unit-dosing devices must include:
Drug name
Strength and dosage form
Manufacturer and lot number
Expiration date
All information must be logged into a binder or a system in which such information can be retrieved easily.

47. DEA Verification
All prescribers must be registered with the DEA to write prescriptions for controlled substances
Prescribers are given a nine-character identification code, which is different for each prescriber
First two characters are letters: A or B, followed by the first letter of the prescriber’s last name
Next seven digits are composed of numbers added together
Prescribers must renew their registrations every 3 years.
Refer to Procedure 2-1 (p. 52) for more information on the verification process for a prescriber’s DEA number.

48. Special Prescribing Programs
Programs for opioid maintenance:
Methadone maintenance treatment (MMT)
Suboxone and Subutex
Risk management programs for prescription drugs:
iPledge Program
Methadone is a Schedule II drug used in the treatment of opioid dependence.
The FDA’s iPledge program is a computer-based risk management program designed to increase awareness of the dangers of isotretinoin in an effort to eliminate fetal exposure to the drug. Restricted distribution guide­lines must be followed before a patient can receive a prescription for isotretinoin.

49. Pharmacy Sites Brick and mortar stores Mail-order pharmacies
E-pharmacies
National Association of Boards of Pharmacies (NABP) verifies these sites but does not regulate them
Potential for illegally ordered drugs
Voluntary accreditation: Through Verified Internet Pharmacy Practice Sites (VIPPS)
For an Internet pharmacy to be approved, the FDA has implemented a program to ensure credibility; this program is still voluntary.
An e-pharmacy’s VIPPS status can be checked. The websites are regulated by the state in which the pharmacy is physically located and by federal guidelines.

50. Occupational Safety and Health Administration (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
Technicians should always be aware of storage and safety requirements for products such as compounding materials.
In all workplaces, including pharmacies, all chemicals must have an SDS on file in an SDS binder, or the SDS must be available electronically through a database.

51. The Joint Commission
Mission is to improve the safety and quality of care via accreditation of health care organizations
Areas of concern:
How look-alike, sound-alike drugs are identified
How communication, allergy notification, conflicting prescriptions, verbal orders, and other areas that may create an avenue for errors are handled
Accreditation is voluntary, but commitment to excellence and patient safety are both excellent reasons to go through the process and adhere to the standards.

52. Legal Standards State law: Differs by state Liabilities
Negligence or tort
Mistakes are made for many reasons
Consider purchasing malpractice insurance
Laws change regularly
All pharmacy personnel should become familiar with the laws by obtaining the regulations booklet from their state board of pharmacy.
The word negligence may describe an action taken without the forethought that should have been applied by a reasonable person of similar competency; a mistake was made.

53. Ethics and Morals
Morals: A person’s beliefs concerning right and wrong
Ethics: A set of values used in a profession
Refer to Box 2-13 (p. 56) for the pharmacy technician’s code of ethics.

54. Questions?