Presentation on theme: "Angela Singh, PharmD Assistant Professor of Pharmacy FAMU COPPS IPPE I"— Presentation transcript:
1 Angela Singh, PharmD Assistant Professor of Pharmacy FAMU COPPS IPPE I Retail Pharmacy LawsAngela Singh, PharmDAssistant Professor of PharmacyFAMU COPPSIPPE I
2 Federal Laws Food, Drug and Cosmetic Act (FDCA) Controlled Substance Act (CSA)Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)Health Insurance Portability and Accountability Act ( HIPAA)Combat Meth Act; Public Law
3 Food Drug & Cosmetic Act (FDCA) 1938 Brought about by the elixir of sulfanilamide incident.Drugs marketed before 1938 were exempt.Requires that product manufacturers prove their product is safe and effective for use under conditions set forth.Prohibits the introduction of misbranded or adulterated foods, drugs or devices, including cosmetics.
4 Food, Drug & Cosmetic Act cont. Legal PrescribersRequirements for Prescription LabelRequirement for Prescription Refills
5 Controlled Substances The Attorney General for the US designates a drug as a controlled substance.Criteria to evaluate and classify a substance as a controlled substance.Actual or relative potential for abuseScientific evidence of its pharmacological effects.Its history and current patterns of abuseThe scope, duration, and significance of abuseExtent of risk to public healthLiability of psychological or physiological dependence.Chemical similarity to another controlled substances.
6 CSAMain federal law regulating the manufacture, distribution and dispensing of controlled substance.Enforced and regulated by DEAFDA retains authority to regulate some habit-forming drugs.Five SchedulesSchedule I substances with the highest abuse potential may not be marketed in the US.
7 Classification of Controlled Substances Schedule I: Drugs with no accepted medical use in the US; high potential for abuse and lack of accepted safety for use under medical supervision.Schedule II: Drugs with acceptable medical use but a high potential for abuse including severe psychological and physical dependence.Schedule III: Drugs with acceptable medical use and less potential for abuse, low to moderate potential for physical dependence, but high potential for psychological abuse
8 Classification of Controlled Substances Schedule IV: Drugs with acceptable medical use and less potential for abuse than schedule III drugs and a limited potential for psychological and physical dependence.Schedule V: Drugs with acceptable medical use and less potential for abuse than the Schedule IV drugs; limited potential for psychological and physical dependence.
9 Prescription Requirements Full name and address of the patientName, strength and quantity of medicationDirections for useDate of issuanceActual signature of the prescriberFull name, address and the DEA number of the prescriber. DEA number should be identified before the drug is dispensed.
10 Determining the Validity of a DEA Number Dr. Byron Brown's DEA number is: ABThis is how you would validate the above DEA number; 1. Add the 1st, 3rd, and 5th digits = 32. Add the 2nd, 4th, and 6th digits = 63. Multiply the result of the previous step by x 6 = 124. Add the results of the 1st and 3rd steps = 155. The DEA number is valid if the last digit of the result in the previous step is the same as the last digit of the DEA number. Also, the second letter of the DEA number has to be the first letter of the doctor's last name. Finally, the first letter of the DEA number has to be an A or a B. Since all of these conditions were met, this DEA number is valid
11 Omnibus Budget Reconciliation Act (OBRA) ‘90 Requires comprehensive drug review and an offer to counsel by a pharmacist for patients or their caregivers.Eight areas must be covered:Name and description of the medicationRoute of administrationDosageDosage FormSpecial directions and precautions for preparation, administration and use by the patient.Common side effectsDrug interactionsSelf-monitoring therapy and storage.
12 HIPAACreates uniform standards for electronic health care transactions (EDI), establishes security protections for data that is electronically stored and transmitted (Security), and sets forth privacy rights for individuals regarding their personally identifiable health information (Privacy).
13 HIPAALimits the ways that health plans, pharmacies, hospitals and other entities can use patients’ personal medical information.Protects medical records and other individually identifiable health information, whether it be on paper, in computers or communicated orally.
14 HIPAA: Patient Protectors Access to Medical RecordsNotice of Privacy PracticesLimits on Use of Personal Medical InformationProhibition on MarketingStronger State LawsConfidential CommunicationsComplaints
15 HIPAA: Health Plans & Providers Written Privacy ProcedureEmployee Training and Privacy OfficerPublic ResponsibilitiesEquivalent Requirements for Government
16 HIPAA: Civil and Criminal Penalties For civil violations monetary penalties of $100 per violation, up to $25,000 per year for requirement or prohibition violated.Criminal penalties apply for certain violations, such as knowingly obtaining health information in violation of the law.Criminal penalties range from $50,000 to $100,000 dollars in penalties and 1-10 years in prison.
17 Combat Meth Act Effective September 30,2006 Requires that products containing pseudoephedrine, ephedrine, and phenylpropanolamine to be placed behind the counter or in a locked cabinet.Customer may not exceed:3.6 grams on daily purchase9.0 grams on 30-day purchase
18 Combat Meth Act: Logbook Purchasers must present a photo ID AND sign a log book.Exception for purchases of 60 mg or less of pseudoephedrine.Logbook must contain the following:The product nameThe quantity soldName and address of purchaserDates and times of sales
19 Questions???????????????? firstname.lastname@example.org 599-3369 #345 New Pharmacy Bldg.