Presentation Transcript

1. Pharmtech chapter 1 part B

2. Faxed Rx’s for Schedule III, IV and V drugs can serve as the original EXCEPT: 1. A sched. II substance compounded for parenteral use. 2. Sched. II substance for LTCF 3. For hospice patients
3. All Rx’s are monitored by FDA and states as your write them and they are presented to pharmacies Every Rx one writes is tracked and filed permanently with the state and Washington attributed to your DEA no.
4. Transferring Rx’s Rx’s can be transferred among online linked pharmacies for refilling purposes. Transfer must be between two licensed DEA pharmacies The original Rx must be VOIDED On reverse side of the original RX the new pharmacies DEA no. is written with its name and address along with the date of the transfer
5. Receiving pharmacists must write “transfer” on the face of the Rx Date of the original Rx must be recorded Along with the date of dispensing No. of refills must be recorded Name and address of original pharmacy and pharmacist who sent the Rx is recorded Along with the DEA no.
6. Child Resistant Containers Authorized by the Poison Prevention Act of 1970 Applies to Rx’s and OTC meds. It must be resistant to 80 % of children under 5 yrs old but can be opened by 90% of adults.
7. Exceptions to Child resistant container law Single time dispensing of product as requested by doctor Requested by the patient Package must be labeled “This package for homes with no kids” For institutions as long as staff dispensing meds. Certain harmless meds like antibiotics, cortisone, BCPs can be exempt
8. OSHA Affects use of flammable materials and air contaminants and used of Material Safety Data Sheets provided by sellers with chemicals.
9. NDC codes All meds have an 11 digit National Drug Code assigned First five digits identify the manufacturer, next four identify the drug product itself, last two digits identify the packaging
10. Orphan Drugs Drugs which treat diseases of which there are fewer than 200,000 cases in the world. Law for orphan drugs encourages their manufacture by tax incentivizing and exclusive licensing for eliminate competitors
11. OBRA Omnibus Reconciliation Act protects LTCF patients from overuse of antipsychotics, too many medications used, required to taper off dosing when antipsychotics used, drug holidays to determine if drugs really needed, drugs must be locked, etc. Lowest prices must be applied to Medicaid pts.
12. Dietary Supplement Act Herbal meds are considered dietary supplements and not drugs. These manufacturers can advertise health benefits but NOT disease treatments for them. They also must identify all contents and meet purity standards Adulteration is barred by law
13. HIPAA Privacy of Rx information Rx records confidential Protect name of patient receiving any meds
14. Special drugs Law that specifically raises penalties for athletes using anabolic steroids AND A law that specifically controls the use of Accutane (Isotretinoin) since it was found to cause birth defects, induce spontaneous abortions, suicides. Can only be used by registered pharmacists and doctors who educate their pts. about its risks IN WRITING about pregnancy risks and females must be tested monthly for pregnancy. Used for acne.
15. Medicare Drug benefit Act 2003 Medicare PART D Medicare pays for certain drugs, voluntary part of Medicare, also covers DME
16. Methamphetamine Laws The sale of certain OTC meds with ephedrine, methamphetamines of any kind, pseudoephedrines, etc. is restricted as to quantity and any excesses require name of purchaser and address. Discourages crystal meth lab operations!
17. USP 797 Assures all pharmaceuticals are prepared sterilely Especially geared towards compounding pharmacies USP is a quality standard like UL is for electrical products Clean room standards and gowning standards are determined by it
18. DEA Enforces compliance with the Controlled Substances Act. Puts drugs in their proper schedule, registers pharmacies, issues DEA permits and forms 222 and 41 to monitor destruction of meds. DEA under the DOJ.
19. FDA Assures purity and efficacy of all meds. Issues recalls when necessary for misbranding or adulteration. It also regulates package inserts with pt. information of how to use drugs and risks and side effects and dosing. Reviews all new drug applications.
20. TJC (the joint commission) Addresses patient safety and quality of care, mostly in hospitals but also in pharmacies. Inspects all healthcare facilities, pharmacies, LTCF’s, etc. Accreditation by TJC is VOLUNTARY! But it’s necessary if you want to be Medicare provider to get reimbursed.
21. State Boards of Pharmacy Regulatory agency in each state that oversees pharmacy operations in that state. Can discipline pharmacies and pharmacists who don’t comply with the law and PHARMTECHS
22. USP U.S. Pharmacopeia, sets standards for all Rx and OTC medications nationally as well as for foods and dietary supplements like vitamins.
23. The Orange Book Determines the equivalency of two different drugs which have the active ingredient in the same strength and dosage. This book determines if a drug may be substituted since it says they are equivalent.
24. Epidemiology Science that deals with the incidence, spread and control of a disease in a population. Risk factors include; 1. age, gender, genetic factors, immune system, race
25. Signs and symptoms Signs: what a pt. complains of (subjective) Symptoms; what a dr. sees. (objective)
26. Drug Interactions Drug-drug type: Addition type: two drugs taken at once cause effect that’s equal to the sum of the indiv.drugs Potentiation: one drug increases/prolongs effect of another drug Antagonism: one works against another Synergism: same as potentiation basically
27. Certain diseases affect the absorption and effect of certain meds Certain foods affect the absorption and effect of other drugs Size of patient affects drug dosage, liver, kidneys, detoxify drugs so their health is key to drug administration Age of patient a major factor in dosing pts.
28. Books American hospital Formulary Drug Book: uses of drugs, interactions, pharmacokinetics and dosages. Red Book: Price guide reference for drugs, guides to manufacturers, insurance payment fees, etc. For the business of pharmacy Goodman and Gilmans; only a textbook of pharmacology and drug classes and kinetics and metabolism
29. Orange Book: FDA book of approved drugs and therapeutic dosing. Merck Index: outlines the chemical formulas for drugs. Physician’s Desk Reference (PDR): all the product inserts from the manufacturers with the dosages and descriptions of all drugs. US Pharmacopia: official guide to all drugs and standards of each for purity and quality.
30. USP also describes approved uses for drugs and regulations to store and dispense them.