Pharmacy Federal Laws and Regulations

Transcription

1 Pharmacy Federal Laws and Regulations Chapter 2 1

2 Lesson 2.1 Major Federal Laws Affecting the Pharmacy Technician 1. Identify the major laws within which technicians need to work when performing nondiscretionary functions in a pharmacy. 2. Describe the implications of the Health Insurance Portability and Accountability Act (HIPAA). 2

3 Lesson 2.2 The Functions and Guidelines of the FDA and DEA 3. Define the functions of the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA). 4. Describe the FDA reporting process for adverse reactions. 3

4 Lesson 2.2 The Functions and Guidelines of the FDA and DEA (cont d) 5. Explain the necessary forms and regulations used for controlled substances. 6. List the current laws pertaining to ordering controlled stock and required record keeping. 6a. Describe the reasoning behind the DEA drug diversion act. 4

5 Lesson 2.3 Responsibilities of the Pharmacy Technician 7. List who can prescribe medications/devices. 8. Explain the difference between technicians tasks and pharmacists responsibilities. 9. Perform the function of verifying a DEA number. 5

6 Lesson 2.3 Responsibilities of the Pharmacy Technician (cont d) 10. Explain the verification process for internet pharmacies. 11. Explain the OSHA guidelines as they pertain to pharmacy. 12. Explain which law prevails among state, federal, and local laws. 6

7 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. 7

8 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. 8

9 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 control advertising of products. 9

10 Early History of the FDA (cont d) Food, Drug and Cosmetic Act prohibits misbranding and adulteration and ensures following information given to public: Ø Mandatory food labeling Ø Standards of Identity Ø Imitation foods Ø Nutritional information for special dietary foods Ø False or misleading statements about product 10

11 Amendments to the Federal Food, Drug & Cosmetic Act Durham-Humphrey Amendment (1951) made a distinction between prescription and over-the-counter drugs. This was a change/update to the law. With this amendment, the FDA had to establish the difference between RX (prescription) and OTC (over the counter) medications. All RX bulk bottles contain RX only. 11

12 Another Amendment to the Federal Food, Drug & Cosmetic Act Kefauver-Harris Drug Amendments (1962) ensured the safety and effectiveness of medications. This was another change/update to the law. FDA now requires drug companies to submit research (drug studies) proving their drug is both safe and effective before the drug can be sold. If found unsafe or not effective after it is released, FDA has the power to remove the drug from the market. 12

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14 1976 Medical Device Amendments allows FDA to: Ø FDA can now regulate and approve medical devices Ø FDA can now recall ineffective/dangerous medical devices Ø ** remember dangerous means prescription 14

15 Orphan Drug Act Orphan Drug Act 1983 created expanded research and availability of new treatments of all rare diseases. 15

16 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 16

17 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. 17

18 1914 Harrison Narcotic Act Enacted because of the excessive number of opium addicts in the United States. This act was to reduce the recreational use of opium. RX required for opium. Doctors had to register to write RX s for opium, they had to keep records that included when and why they prescribed opium for a patient. 18

19 1938 Food, Drug, and Cosmetic Act Was enacted because the earlier Food and Drug Act was not worded strictly enough & did not include cosmetics. Proves the legal status for the Food and Drug Administration (FDA) Manufacturers now must prove to the FDA that a drug is safe for use and provide directions on the label for safe use. All controlled substances were required to be labeled Warning: May be habit-forming. 19

20 1938 Food, Drug, and Cosmetic Act (cont d) Defined the exact labeling for products and defined misbranding and adulteration as being illegal Ø Misbranding = label is false or misleading Ø Adulteration = prepared or stored incorrectly Required drug companies to include package inserts and directions for safe use. Shortly after this ACT, the FDA identified certain drugs required prescriptions. The RX is born. 20

21 1951 Durham-Humphrey Amendment to the Food, Drug and Cosmetic Act This was a change/update to the Food, Drug and Cosmetic Act. Required the manufacturer s label to contain RX only or 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. 21

22 1962 Kefauver-Harris Amendments Attempts to ensure the safety and effectiveness of all new drugs. (safe and effective means it won t harm you and it works) Gives FDA authority to approve new drugs before they can be sold to patients. Drug companies must have well controlled studies that prove effectiveness. Prevented the sale of thalidomide in the United States because children were born with birth defects after usage in pregnancy. When people understood that the FDA saved the US people a huge tragedy (show picture), support for the FDA grew. Adverse drug effects must be reported to the FDA. 22

23 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. Established DEA Controlled Substance Schedules I-V. Schedule I most restrictive no medically accepted use in the US. Ø Heroin, Marijuana, Ecstasy, LSD Ø Show bulk controlled substance bottles and see pg 43 textbook. Ø Hydrocodone is now CII due to recent law change (2014)!!!! 23

24 Comprehensive Drug Abuse and Prevention Act Dr. Kapp to explain DEA Schedules - start from the bottom DEA Controlled Substance Schedule I = CI Ø No legal use/no prescriptions DEA Controlled Substance Schedule 2 = CII DEA Controlled Substance Schedule 3 = CIII DEA Controlled Substance Schedule 4 = CIV DEA Controlled Substance Schedule 5= CV Legend Drugs -> drugs that require a RX OTC drugs -> no prescription required 24

25 1970 The Poison Prevention Packaging Act (PPPA) Required all medications to be placed in containers with childproof caps or packaging. It is estimated that more than 1.4 million childhood deaths were prevented annually because of childproof caps. See page 31 BOX 2-2 Standard for child proofing is that 80% of children under 5 should not be able to open, but 90% of adults should be able to open. 25

26 Orphan Drug Act 1983 Background info It costs millions and can take over 10 years for a drug company to develop a new drug and get it approved Before this law, there was no incentive to research/develop drugs that aren t going to be widely used Only 1 in 5000 drugs make it to human testing Only 1 in 5 of those gets approved for use. 26

27 Orphan Drug Act of 1983 Drug companies won t make a ton of money on developing meds for rare diseases. Allows 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 affects 1 in every 200,000 people). US Government will give tax credits and possibly research money to companies willing to explore new treatments for rare diseases. 27

28 1987 Prescription Drug Marketing Act (PDMA) Helps to avoid counterfeit drugs and ingredients in the supply chain. Each drug has a pedigree (a record that it comes through all proper channels manufacturer to wholesaler to retailer or hospital) Limits diversion of pharmaceutical samples and prescription drugs. Diversion is the intentional misuse of a drug 28

29 1990 Omnibus Budget Reconciliation Act (OBRA 90) OBRA 90 is a law that specifically must be followed by pharmacists. The US government helps pay the medical costs for Medicare (elderly) and Medicaid (poor) patients. California s Medicaid program for the poor is called MediCAL. (Show cards) Congress made this law to address poor health care quality for the elderly. Quality improved dramatically when a pharmacist provided consultation to the patient. 29

30 OBRA 90 second slide Pharmacists must check the patient s drug profile and make sure all new drugs are compatible with what the patient is already taking. So the government decided they would require this consultation in the hopes of better health care and to ultimately save the government money because people were taking their meds correctly. In a community pharmacy there is a system that identifies new prescriptions. If the TCH does not call the pharmacist over to consult the patient, they are breaking the law. 30

31 1990 Omnibus Budget Reconciliation Act (third slide) States that a pharmacist must counsel (at the time of purchase) all Medicare and Medicaid patients who receive new prescriptions. 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, including California, adopted OBRA to apply to all new prescriptions; federal law deals only with Medicare and Medicaid. 31

32 Health Insurance Portability and Accountability Act of 1996 (HIPAA) Deals with a patient s right to privacy of their protected health information (PHI). Changes for pharmacy: Upon first visit to a pharmacy (or doctor s office) the privacy policy is provided and the patient must sign it. Keeps privileged information about a customer from being disclosed without his or her consent. This is why you must be 18 to work as a TCH. You must be held accountable for HIPAA 32

33 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. If a spouse or parent wants info, it gets tricky. 33

34 How is Information Protected via the Computer? To avoid private information being hacked, encryption is required. Encryption converts the information into a nonreadable format. So when we type a prescription and bill the insurance company, the request is encrypted. 34

35 What are the Rights of the Patient? Ask to see and get a copy of your health records. (Mail other family members over 18 - Dr. Kapp explain) Have corrections added to your health information. Receive a notice that tells you how your health information may be used and shared. (this is provided in the privacy policy given upon first visit) 35

36 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. 36

37 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: Ø File a complaint with your provider or health insurer. Ø File a complaint with the U.S. Government. 37

38 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 Have students volunteer to read each example in Box 2-3, page 34 38

39 Who can info be shared with? PHI (private health info) may be disclosed to: Ø Law Enforcement Ø Public health authorities like the BOP or CDC Ø Entities subject to FDA regulation Ø Those who have been exposed to a communicable disease Ø Employers regarding work-related illness/injury in order to comply with OSHA Ø Insurance company Ø Patient s Doctor or doctor s office Read Examples 1-3 page 35 39

40 Law Enforcement Purposes PHI may be disclosed to law enforcement, including: Ø As required by law, such as court orders Ø To identify or locate a suspect, fugitive, material witness, or missing person Ø Information about a victim Ø If criminal activity caused a victim s death Ø Take a minute to read the examples on page 35 near the bottom. 40

41 2000 Drug Addiction Treatment Act (Data 2000) Allows doctors to prescribe drugs in schedule CIII-CV for patients suffering from opioid addiction to help the patient detox. Patient must be in a treatment program and doctor must have special detox training. Review the types of medications Ø Controlled substances (DEA Schedule I-V) Ø Legend drugs = prescription (RX drugs) Ø Behind the Counter (BTC): Sudafed and Plan B Ø Over the Counter (OTC) Ø Herbals not FDA approved 41

42 2003 Medicare Modernization Act (MMA) Before this Act, Medicare (elderly) did not cover medications which could be quite expensive. MMA provides a drug discount card or prescription insurance plan. Also known as Medicare Part D. Medicare Advantage is the name of the most current program offering drug discount benefits due to low income. 42

43 2005 Combat Methamphetamine Act Bill addresses all areas of manufacturing, law enforcement, and sale of pseudoephedrine (sudafed), which is used as an ingredient in the preparation of methamphetamine. All pseudoephedrine containing products must be sold behind the counter (BTC) and only by a licensed pharmacist or technician. Sale is limited and the cash register will step you through the process. In the TV show Breaking Bad they were trying to make methamphetamine. 43

44 Drug Listing Act of 1972 Amendment to Food, Drug and Cosmetic Act Page 38 box 2-1 Amends Food, Drug and Cosmetic Act and prevents unfair or deceptive packaging and labeling. ESTABLISHES THE NATIONAL DRUG CODE NUMBER = NDC# NDC number XXXXX-YYYY-ZZ The first group of 5 numbers is assigned by the FDA. Each manufacturer has its own unique first 5 digits given to them by the FDA. 44

45 Obamacare = The Affordable Care Act (ACA) of 2010 Too many uninsured in the US. Those with insurance pay more to help cover the costs of those uninsured. US Government votes to require everyone has insurance or pay a fine each year when they pay income taxes. Hope is that if everyone is covered the costs go down for everyone. 45

46 Affordable Care Act (ACA) slide 2 Benefits Include Ø Pre-existing conditions are covered Ø You can stay on your parents insurance until age 26!! Ø Insurance cannot drop you once they spend a certain amount on you. Ø Men and women need to be charged the same amount. Women use to pay more for insurance. Ø Free annual check up (insurance cannot charge a copay) Ø California s program under the ACA is called Covered California. 46

47 ACA slide 3 Disadvantages Ø Tax penalty if you do not have coverage Ø The website to sign up was not working when promised so politically it made Obama look bad. Obamacare (ACA) is highly politicized. Many democrats and many republicans like that their kids can stay on their insurance, that pre-existing conditions are covered, and that the insurance cannot kick you off once they spend a certain amount of you. As we have seen amendments to other laws, both parties warn that they would like to add improvements to the ACA. 47

48 FDA/DEA Chapter 2.2 DEA was created under the Department of Justice. Its function is to prevent the illegal distribution and misuse of narcotics (controlled substances). The DEA issues licenses to practitioners, pharmacies, and manufacturers of controlled substances. Both agencies can work together if the drug is a controlled substance. National Drug Code (NDC) page digits

49 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. MedWatch Any medication reaction that might cause disability, hospitalization, or death should be reported. Patient s identity must be kept confidential. 49

50 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 page

51 Recalled Drugs Three classes of recalls: Ø Class 1: Products that could cause serious or even fatal harm Ø Class 2: Products found to cause a temporary health problem or a slight threat of serious harm Ø Class 3: Products that may have a minor defect or other condition that would not harm the patient As a clerk, TCH or intern you may be pulling recalled lot numbers as a regular part of your job. 51

52 Controlled Substances Are commonly known as narcotics and are addictive. Relaxants. 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. 52

53 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. 53

54 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. Five levels based on potential for abuse. C-I: strongest potential for abuse; no medicinal use in the United States (e.g., LSD, heroin) 54

55 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 NOT IN CALIFORNIA 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 (Page 43), Typical Controlled Substances. Hydrocodone is now CII!!!! 55

56 Tamper-Proof Prescriptions New scripts have up to 8 different tamper-proof security marks on them. Ø Prevents forgery and fraud. See page 45 56

57 Registration Required for Maintaining Narcotics DEA three main registration forms: Ø Form 224: needed by pharmacy to dispense controlled substances Ø Form 225: to manufacture or distribute controlled substances Ø Form 363: to run a narcotic treatment program or compound narcotics Ø **DEA 222 form is the form the pharmacy uses to order Schedule II narcotics. It is in triplicate. See picture and discuss page

58 Refilling Controlled Substances Strict guidelines C-III through C-V: can be refilled a maximum of five times within 6 months from the original order, whichever comes first. How is this different from a normal non-controlled prescription? Record must be kept with pharmacist s initials and date it was dispensed. 58

59 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 Doctors, pharmacies, and drug wholesalers all have their own DEA numbers 59

60 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 60

61 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 Schedule II should be kept separate from other nonscheduled drugs usually in a locked cabinet. Forms kept for 2 years (federal) 61

62 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 62

63 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. 63

64 Narcotic Inventory Perpetual inventory Pharmacist must validate all counts if done by a technician. Discrepancies will be investigated by DEA. 64

65 Reverse Distributor All controlled substances that are unwanted, unusable, or outdated that are returned to the distributor Ø Prevents misuse of drugs = drug diversion 65

66 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: Ø CII: no refills Ø CIII and CIV: 5 times within 6 months (120 days in California) Ø CV: no restrictions = up to a year from the date it was written. 66

67 Filling, Refilling, and Transferring Prescriptions for Controlled Drugs (cont d) Partial Filling of CII Through CV: Ø CIII, IV, and V must have remainder dispensed within 6 months. Ø CII must have remainder dispensed within 72 hours. Transfer of Controlled Drug Prescription CII Through CV: may only be transferred once. 67

68 Filling, Refilling and Transferring Prescriptions for Controlled Drugs (cont d) Some states require Schedule V drugs to be dispensed by pharmacist. (California) Controlled Substances CII Through CV may be mailed as long as contents are not identified on packaging. 68

69 Monographs/Package Inserts Can be found online. Can be found in stock bottle. Contains the following: description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, drug abuse and dependence, adverse reactions, dosage, and how supplied. See monograph on page 56/57. Boxed Warning required on monographs for meds that carry a high risk potential. Medguides describe. 69

70 Pregnancy Categories pages 58 and 59 See box 2-9 on page 59 End lecture

71 Prescription Regulations Start 2.3 Who can prescribe? FDA and DEA have no authority in determining prescribers. Prescribers are licensed by their individual state boards. (Medical Board of CA, CA State Board of Pharmacy) Standard practitioners in all 50 states are physicians, surgeons, doctors of osteopathy, dentists, podiatrists, veterinarians, and optometrists. 71

72 Who Can Receive a Prescription? Pharmacy technicians take in prescriptions, interpret them, and fill them. Technicians cannot take telephone RXs. Pharmacists give the final check, take verbal telephone orders, and transfer prescriptions to another pharmacy. 72

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74 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. This section of the book is worth reading (p.60-61) in figure 2-9 look at the prescription order versus the RX label. 74

75 Records and Labeling Requirements Regulated by state law Table 2-5 page 62 75

76 Repackaging Medication taken from bulk packages and placed into blister packs or unit-dosing devices must include: Ø Drug name Ø Strength and dosage form Ø Manufacturer and lot number Ø Expiration date 76

77 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. Pharmacies have DEA numbers as well. 77

78 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 page 63, DEA Verification Process. (This will be tested!! Final too!!) Memorize and do not forget these 6 steps. 78

79 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. 79

80 Special Prescribing Programs Programs for opioid maintenance: Ø Methadone maintenance treatment Ø Suboxone & Subutex Risk management programs for prescription drugs: Ø ipledge Program (Accutane) Ø This drug is so toxic to unborn fetuses that a pregnancy test is required before the doctor can authorize a refill. It is like a CII in the sense that no refills are allowed. It requires a new RX q time. 80

81 Pharmacy Sites Brick-and-mortar stores (community pharmacy). Mail-order pharmacies E-pharmacies (online pharmacies) Ø National Association of Boards of Pharmacies accredits them Ø Potential for illegally-ordered drugs 81

82 Occupational Safety and Health Administration (OSHA) Oversees workplace safety. 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. 82

83 The Joint Commission previously JCAHO 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. Must be accredited q 3 years. 83

84 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. 84

85 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 85

86 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. 86

87 Pharmacy Employee Requirements: Request for Waiver A pharmacy must apply for a waiver from the DEA in order to employ someone: Ø Who has been convicted of a felony related to drugs Ø Who has had DEA application for registration revoked, surrendered, or denied 87