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Pharmacy Federal Laws and Regulations

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1 Pharmacy Federal Laws and Regulations
Chapter 2

2 Introduction Practice of pharmacy is governed by series of laws, regulations, and rules enforced by federal, state, local government; institutions and pharmacy management. Technicians need to understand these laws for passing the PTCB Certification Exam and for employment.

3 FDA History FDA history is important with respect to pharmacy.
FDA is under the direction of the department of Health and Human Services. Main function is to enforce guidelines for manufacturers to ensure the 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 1902 Biologics Act.

4 Early History of the FDA
Investigated the adulteration and misbranding of agriculture goods used for food and drugs. Ability to regulate and enforce was limited. In the 1930s, the FDA gained the right to inspect factories and the control advertising of products. It took a horrendous event to pass new standards enforceable by the FDA. In 1937 a Tennessee drug company advertized a new sulfanilamide elixir specifically aimed toward children. The toxic solvent went untested (per the current laws) and over 100 people, mostly children, died. It turned out the solvent was similar to antifreeze, which is deadly to humans.

5 Early History of the FDA (cont’d)
Food, Drug and Cosmetic Act prohibits misbranding and adulteration and ensures following information given to public: Mandatory food labeling Standards of Identity Imitation foods Nutritional information for special dietary foods False or misleading statements about product

6 Early History of the FDA (cont’d)
Durham-Humphrey Amendment made a distinction between prescription and over-the-counter drugs. Kefauver-Harris Drug Amendments ensured the safety and effectiveness of medications.

7 Early History of the FDA (cont’d)
1976 Medical Device Amendments allows FDA to: Regulate and approve devices Recall ineffective/dangerous devices Orphan Drug Act created expanded research and availability of new treatments.

8 Description of Laws Act: “A statutory plan passed by Congress or any legislature which is a ‘bill’ until enacted and becomes law” Amendment: A change in the original act or law

9 1906 Federal Food and Drug Act
Enacted to stop the sale of inaccurately labeled drugs. Manufacturers were required to put truthful information on the label before selling their drug. Manufacturers had to prove their drug’s effectiveness. Why do you think that a major federal law about drugs wasn’t 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. What are the dangers of inaccurate labels? Anyone taking a drug could be harmed by inaccurate or incomplete information about its ingredients, intended uses, strength, recommended dosing (too little can be as bad as too much), side effects, contraindications, or method of storage.

10 1914 Harrison Narcotic Act Enacted because of the excessive number of opium addicts in the United States. People could no longer obtain opium without a prescription. Records must be kept about prescriptions. Restrictions are in place for importation and distribution. What countries were the main poppy producers in the early twentieth century? What about today? India, Turkey, and China in twentieth century; today, many countries in Southwest and Southeast Asia and Latin America How is opium ingested? Opium can be eaten or smoked, but today, it is usually processed into heroin (or morphine). Mrs. Winslow’s Soothing syrup’s main ingredient was morphine and killed many children due to overdosing. Morphine or dosing is not located any where on the label.

11 1938 Food, Drug, and Cosmetic Act
Was enacted because the earlier Food and Drug Act was not worded strictly enough and did not include cosmetics. Required drug companies to include directions to the consumer regarding use and package inserts on drugs. All controlled substances were required to be labeled “Warning: May be habit-forming”. Why are cosmetics included in a law about 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.

12 1938 Food, Drug, and Cosmetic Act (cont’d)
Defined the exact labeling for products and defined misbranding and adulteration as being illegal Proves the legal status for the Food and Drug Administration (FDA)

13 1951 Durham-Humphrey Amendment
Required the labeling “Caution: Federal law prohibits dispensing without a prescription.” Made certain drugs require a doctor’s order and supervision. Made the initial distinction between legend drugs (by prescription only), over-the-counter (OTC) medications, and non-legend 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 the doctors.

14 1962 Kefauver-Harris Amendments
Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market. Burden put on manufacturing companies to have good manufacturing practices (GMP). Prevented the sale of thalidomide in the United States because children were born with birth defects after usage in pregnancy. Do you know of any drugs that were 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 COX-2 NSAIDs were recalled in 2004 after studies showed an increased risk for 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.

15 1970 Comprehensive Drug Abuse Prevention and Control Act
The Drug Enforcement Agency (DEA) was formed to enforce the laws concerning controlled substances and their distribution. Created a stair-step schedule of controlled substances. What does a controlled substance’s schedule rating mean? Higher schedules, or categories, have stricter rules than lower schedules.

16 1970 The Poison Prevention Packaging Act
Required all medications to be placed in containers with childproof caps or packaging.

17 Tylenol Poisoning 1982 Tylenol Extra Strength capsules were emptied and replaced with powdered cyanide. Seven people were killed. Case was never solved. Johnson and Johnson ordered public to immediately stop using TES and medication was pulled of store shelves. JJ started using the plastic covers “DO NOT USE IF TAMPERED WITH.” JJ also developed the “caplet” to help relieve concerns.

18 Orphan Drug Act of 1983 The Orphan Drug Act allowed drug companies to bypass the lengthy time requirements of testing a new drug and the cost that accompanied them to provide a medication to persons who had rare disease(s) (disease that affected 1 in every 200,000 people). It takes 12 to 15 years for a drug to make it from the experimental lab to the pharmacy. Only 1 in 5000 drugs that make it to preclinical testing are approved for human testing. From there, one in five drugs gets approved for use.

19 1987 Prescription Drug Marketing Act
Helps to avoid counterfeit drugs and ingredients in the supply chain. Limits diversion of pharmaceutical samples and prescription drugs.

20 1990 Omnibus Budget Reconciliation Act (OBRA 90)
OBRA 90 deals specifically with practicing pharmacists. Enacted because of reimbursement regulations for people who are covered under Medicaid or Medicare insurance. States that a pharmacist must counsel (at the time of purchase) all patients who receive new prescriptions. Why does OBRA 90 apply only to prescriptions for patients with Medicare and Medicaid? OBRA 90 is a federal law that deals with reimbursement procedures for Medicare and Medicaid, which are federally funded programs.

21 1990 Omnibus Budget Reconciliation Act (cont’d)
All patients must be given information on the drug that they are taking, its name, when to take it, how long to take it, and any side effects or possible interactions. Many states adopted OBRA to apply to all new prescriptions; federal law deals only with Medicare and Medicaid. Some states have chosen to use the OBRA 90 reimbursement rules for all types of insurance, but the counseling rules apply to all prescriptions in all states (unless, of course, a state has a stricter law).

22 Health Insurance Portability and Accountability Act of 1996 (HIPAA)
HIPAA deals with patient’s right to continuance of health insurance even when changing employers Changes for pharmacy: technician has direct knowledge of patient’s medical information on a daily basis, so patients sign a consent form to grant access to this information. Each part of HIPAA had a different deadline for compliance. Some deadlines were as recent as 2008. HIPAA regulations often use the acronym PHI, which stands for “personal health information.”

23 Patient Confidentiality
Keeps 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.

24 What Information is Protected?
All individually identifiable health information is protected. Pertains to information in any form or media.

25 What Does this Mean for the Pharmacy?
The physician can call and request information on his/her patient. The patient’s health insurance company can request information. Information can be shared with patients about their own coverage or medications.

26 How is Information Protected via the Computer?
Encryption converts the information into a nonreadable format. Must be approved by the National Institute of Standards and Technologies.

27 What are the Rights of the Patient?
Ask to see and get a copy of your health records. Have corrections added to your health information. Receive a notice that tells you how your health information may be used and shared. Elaine being difficult Elaine mentions that she was “difficult” in 1992 so she missed HIPAA by 4 years.

28 What are the Rights of the Patient? (cont’d)
Decide if you want to give your permission before your health information can be used or shared for certain purposes, such as for marketing. Get a report on when and why your health information was shared for certain purposes.

29 What are the Rights of the Patient? (cont’d)
If you believe your rights are being denied or your health information isn’t being protected, you can: File a complaint with your provider or health insurer. File a complaint with the U.S. Government.

30 Examples of what a Technician cannot Do
Give out any personal or medical information pertaining to the patient to any entity not covered under HIPPA Share any information with any family member or friend, coworker, manager, or any entity not covered under HIPAA Box 2-3

31 Examples of what is not Covered under the HIPAA Patient Rights
If you work for a health plan or covered healthcare provider, the Privacy Rule does not apply to your employment records. news cast

32 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 in order to comply with OSHA News cast of a person intentionally spreading a sexual disease.

33 Law Enforcement Purposes
PHI may be disclosed to law enforcement, including: As required by law, such as court orders To identify or locate a suspect, fugitive, material witness, or missing person Information about a victim If criminal activity caused a victim’s death Dental records, replacement surgeries, any identifying marks

34 2000 Drug Addiction Treatment Act (Data 2000)
Physicians can prescribe controlled substances to persons suffering from opioid addiction. For the purpose of maintenance or detoxification treatments. Methadone on the brain Methadone is the most common

35 2003 Medicare Modernization Act (MMA)
MMA provides a drug discount card to those with low incomes who require pharmacy company assistance for obtaining medications.

36 2005 Combat Meth Act Bill addresses all areas of manufacturing, law enforcement, and sale of pseudoephedrine, which is used as an ingredient in the preparation of methamphetamine. Strict guidelines: only a licensed pharmacist or technician may dispense, sell, or distribute this drug. Nplex The state of Oregon now requires a prescription for pseudoephedrine.

37 FDA/DEA DEA was created under the Department of Justice.
Its function is to prevent the illegal distribution and misuse of narcotics. The DEA issues licenses to practitioners, pharmacies, and manufacturers of controlled substances.

38 FDA Reporting Process and Adverse Reactions
There is toll-free number (1-800-FDA-1088) for reporting any defect found in OTC medications and any other drug problems. Any medication reaction that might cause disability, hospitalization, or death should be reported. Patient’s identity must be kept confidential. Drug manufacturers, importers, and distributors are required to report adverse events and product problems, but reporting by healthcare workers and consumers is voluntary. However, employers and states might have different rules that you should be aware of. What are the reporting rules in your state?

39 FDA Reporting Process and Adverse Reactions (cont’d)
MedWatch: program under the FDA that allows consumers and healthcare professionals to report any discrepancies in medication or adverse reactions to medications. See Figure 2-3. Where can you find the information you need to submit a report to the FDA? The forms can be found online, in the 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.

40 Recalled Drugs Three classes of recalls:
Class 1: Products that could cause serious or even fatal harm Class 2: Products found to cause a temporary health problem or a slight threat of serious harm Class 3: Products that may have a minor defect or other condition that would not harm the patient

41 Controlled Substances
Are 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. 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).

42 Controlled Substances (cont’d)
Opioids, such as codeine and morphine, are substances created from opium. Each type of narcotic is assigned a rating that depends on its addiction and abuse potential. Who decides what rating to give a controlled substance? Although the FDA and DEA do work together to recommend ratings for new drugs, the U.S. Attorney General ultimately determines under which schedule to place a drug.

43 Ratings of Scheduled (Controlled) Substances
Letter “C,” meaning controlled substances, is used in addition to Roman numerals to indicate the addictiveness or abuse potential of narcotics. Are five levels based on potential for abuse. C-I: strongest potential for abuse; no medicinal use in the United States (e.g., LSD, heroin) Why might a drug be labeled under two different schedules? Different doses of the same drug might have different dependency potentials.

44 Ratings of Schedules (Controlled) Substances (cont’d)
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 Attorney General decides under which schedule to place a drug Refer to Table 2-2, Typical Controlled Substances. 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.

45 Tamper-Proof Prescriptions
New scripts have up to 8 different tamper-proof security marks on them. Prevents forgery and fraud. Different types of prescription security

46 Registration Required for Maintaining Narcotics
DEA—three 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

47 Refilling Controlled Substances
Strict guidelines C-III through C-V: can be refilled a maximum of five times or within 6 months from the original order, whichever comes first. Record must be kept with pharmacist’s initials and date it was dispensed.

48 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.

49 Ordering Controlled Substances (cont’d)
Top and middle copy with carbon paper: returned to distributor or wholesaler Filing electronically is also possible but not for CI or CII Pharmacy retains bottom copy Invoice and form retained for 7 years

50 Ordering Controlled Substances (cont’d)
C-III, C-IV, C-V: ordered on normal invoice forms but must be filed and retained for DEA or BOP inspection Should be kept separate from other nonscheduled drugs Forms kept for 2 years

51 Ordering Controlled Substances (cont’d)
Receipt of controlled substances: pharmacist compares copy of Form 222 to invoice Both copies signed for accuracy Errors: forms become invalid; cannot be erased or thrown away 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.

52 Record Keeping Three Methods of Filing Controlled Substances and Legend Drugs (Table 2-4) System Drawer 1 Drawer II Drawer III 1 C-II C-III All other separate through C-V prescriptions 2 C-II C-III–C-V* and separate all legend drugs 3 C-II All other through C-V* prescriptions *If any C-III, C-IV, or C-V controlled drugs are kept with noncontrolled drugs (System 2) or mixed with C-II drugs (System 3), they must be stamped with a red “C” for easy identification. All records must be kept on site for no less than 2 years. Many states, however, have longer requirements for keeping records; remember the strictest law is the one that must be followed. When taking inventory, you must have exact counts of C-II controlled substances at all times. The final count can be inventoried only by a licensed pharmacist.

53 Narcotic Inventory Perpetual inventory
Pharmacist must validate all counts if done by a technician. Discrepancies will be investigated by DEA. Perpetual inventory is done through identifying an initial count of all controlled substances and 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.

54 Reverse Distributor All controlled substances that are unwanted, unusable, or outdated that are returned to the distributor Prevents drug diversion

55 Filling, Refilling, and Transferring Prescriptions for Controlled Drugs
Original Fill of CII Through CV: written, oral, or fax Emergency CII Original Fill: oral order only in emergency situations Refills of CII Through CV: CII: no refills CIII and CIV: 5 times within 6 months CV: no restrictions

56 Filling, Refilling, and Transferring Prescriptions for Controlled Drugs (cont’d)
Partial Filling of CII Through CV: CIII, IV, and V must have remainder dispensed within 6 months. CII must have remainder dispensed within 72 hours. Transfer of Controlled Drug Prescription CII Through CV: may only be transferred once.

57 Filling, Refilling and Transferring Prescriptions for Controlled Drugs (cont’d)
Some states require Schedule V drugs to be dispensed by pharmacist. Controlled Substances CII Through CV may be mailed as long as contents are not identified on packaging.

58 Monographs/Package Inserts
Contained in the Physicians’ Desk Reference (PDR) in doctor’s office and Facts and Comparisons in pharmacy Contains the following: description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, drug abuse and dependence, adverse reactions, dosage, and how supplied Monographs are more than just package inserts or instructions for use; they’re a written chemical “recipe” for a drug that the USP uses to standardize products made by various manufacturers. Monographs are officially published in the Code of Federal Regulations (CFR).

59 Prescription Regulations
Who can prescribe? FDA and DEA have no authority in determining 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.

60 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.

61 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 required because of adverse effects or possibility of teratogenicity on an unborn fetus. 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. Currently, Accutane is a widely used teratogenic medicine. Women taking this antiacne prescription must use two forms of birth control.

62 Records and Labeling Requirements
Regulated by state law Table 2-5

63 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

64 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. Prescribers must renew their registrations every 3 years.

65 DEA Verification (cont’d)
First two characters are letters: A or B followed by first letter of prescriber’s last name. Next seven digits are composed of numbers added together. Refer to Box 2-12, DEA Verification Process. Prescribers who change their last names can apply for a DEA number change. However, they are not required to by federal law. A physician’s DEA number usually begins with A or B, but the DEA number for a mid-level practitioner (MLP) begins with M. MLPs include nurse practitioners, physician assistants, and nurse midwives, among others. DEA numbers for researchers start with R.

66 Non-Child-Resistant Caps
Medications are required to be packaged in containers that are exceptionally hard for children to open. Adults can request no childproof caps. Pharmacy keeps information on patient’s record and might require a signed release form. Why might an adult request a non-childproof cap? Arthritis and low vision are two reasons why some adults might have trouble opening a childproof container.

67 Special Prescribing Programs
Programs for opioid maintenance: Methadone maintenance treatment Suboxone & Subutex Risk management programs for prescription drugs: iPledge Program

68 Pharmacy Sites Brick-and-mortar stores Mail-order pharmacies
E-pharmacies National Association of Boards of Pharmacies accredits them Potential for illegally-ordered drugs

69 Occupational Safety and Health Administration
Materials Safety Data Sheets must be available for all chemicals. Includes information on storage requirements, handling, and what to do in case of a spill or contact with eyes.

70 The Joint Commission Mission is to improve the safety and quality of care via accreditation of healthcare 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.

71 State Laws Each state has its own set of laws that must be followed by all employees in the pharmacy. States have laws that differ from federal law. The strictest law is the one that must be followed. States and employers often have stronger regulations than the minimum federal requirements.

72 Liabilities Tort: causing injury to a person intentionally or because of negligence Negligence: an action taken without the forethought that should have been taken by a reasonable person; a mistake Does negligence include deliberate errors? No. Negligence refers only to unintended mistakes, but carelessness can still have legal consequences.

73 Liabilities (cont’d) Intentional mistake: penalty ranges from criminal charges to awarding of damages Negligent mistake: affect employment and can result in punitive damages Be aware of rights and responsibilities. What should you do if you made a negligent mistake that caused someone harm? Make notes about what happened while your memory is fresh. Get a copy of your employer’s rules and regulations that relate to the mistake, and a copy of your employer’s legal policy. Contact an attorney if a criminal investigation or lawsuit seems likely.

74 Pharmacy Employee Requirements: Request for Waiver
A pharmacy must apply for a waiver from the DEA in order to employ someone: Who has been convicted of a felony related to drugs Who has had DEA application for registration revoked, surrendered, or denied


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