Ch 7: Requirements of the Pharmacy Area O State Laws Require Adequate Equipment and a Proper Environment for a Pharmacy to be Licensed O Proper location O Proper size O Must meet ADA requirements O Environmental conditions O Storage O Sterile compounding (if desired) O Hazardous waste storage/disposal
20132015 Requirements of the Pharmacy Area (contd) O Security O Reference materials O Proper equipment O licensure 2013-2015 Ch 8: How do we get a new
drug? O Research O Investigation O Marketing 2013-2015 The New Drug Approval Process O Put in place to protect the public O Steps insure that requirements of drug laws are met
O Safety O Effectiveness O FDA is responsible for approval 2013-2015 Mechanisms Involved O The New Drug Application (NDA) O The Investigational New Drug Review (INDA)
2013-2015 The New Drug Application (NDA) O Used since the 1938 FDCA O Must prove both safety & effectiveness O Includes screening by several committees O Medical O Pharmacology O Chemistry O Statistical O Contains 4 Phases
2013-2015 Phase 1 O Tests the maximum tolerated dose O Not designed to test efficacy O Uses a small subject group O Usually takes place at a single research facility 2013-2015
Phase 2 O Determines the Effectiveness vs. Disease O Uses volunteers from the affected drug group O Usually several hundred subjects involved 2013-2015 Phase 3 O Uses several thousand subjects
O Multiple testing centers across the U.S. O Double-Blind Testing used O Neither the subject or the investigator know which is the active drug and which is placebo O Last phase before FDA consideration 2013-2015
Phase 4 O Occurs AFTER FDA Approval and the drug is marketed O It is the responsibility of the practitioners using the drug to report adverse effects to the FDA O Many drugs have been removed from the market after negative Phase 4 reports. 2013-2015 The Approval Process
2013-2015 20132015 Drug Approval Facts O Average time to market runs 12 to 16 years O For every 5,000 drugs entering pre-clinical trials: O 5 will enter Phase 1 trials O 1 will gain FDA Approval
2013-2015 Investigational New Drug Review (IND) O NOT an application for drug approval O IS an application for an exemption to the federal law prohibiting the interstate shipment of unapproved drug products O Usually occurs before NDA trials occur
2013-2015 Drug Patents O Authority for patents comes from the U.S. Constitution O NOT the right to make a product O IS the right to forbid another from manufacturing the same product or importing it from another country O Period of 20 years, but begins from the time of application Way before approval 2013-2015
Ch 9: The Chemical Name O A description of the physical structure of the drug molecule O Gives information on: O How the molecule can be synthesized O How the molecule will react with other chemical compounds O How a drug will be metabolized O What actions the drug may have in the body 2013-2015
The Generic Name O The name used for FDA approval on the NDA O Assigned by the manufacturer O Can give a clue as to the drugs actions O ie.) Suffixes -olol, -opril, -itidine, etc. O Used in communication between practitioners, in professional journals, and
in research 2013-2015 The Trade name O Used to build brand loyalty O Trademark O May also give a clue as to the advantages of a product O ie.) Lithobid - twice daily dosing O May have more than one trade name for
a generic entity O ie.) Zestril vs. Prinivil 2013-2015 The NDC Number O Used to identify the manufacturer, drug entity, and package size 00000-0000-00 00000-xxxx-xx
Manufacturer xxxxx-0000-xx xxxxx-xxxx-00 Drug Entity Package 2013-2015 Other Methods O Abbreviations - STUDY YOUR LIST
O Mnemonic O Used in computer systems O No dependable commonality between systems 2013-2015 Ch 10: Legal Classifications of Medicinal Products OOver the Counter OLegend OControlled Substances OSchedule Listed Chemical
Products 2013-2015 Over the Counter O Determined to be safe for use without direct medical supervision O Must have complete instructions for use and warnings about misuse on every package 2013-2015
Legend O Deemed too dangerous to use without direct medical supervision O Requires a prescription O Stock bottles must bear the legend warning 2013-2015 Legend Warning
2013-2015 Controlled Substances O Legend drugs which have a high potential for abuse even with medical supervision O Special limitations on the prescription O Regulated by the 1970 Controlled Substances Act 2013-2015
The Closed System of the Controlled Substances Act O Every facet of a drugs manufacture, distribution, and use is tracked O A clear paper trail is generated O Requires licensing of practitioners who will handle controlled substances O The DEA Number 2013-2015
The DEA Number O Unique identifying number for each person or entity who will have control over controlled substances O Issued by the Federal DEA O Who needs a DEA number? O Any practitioner who is registered by the State to prescribe, manufacture, or have possession of controlled substances O The State determines who needs, or can
receive, a DEA number 2013-2015 The DEA Number is Self Verifying O All the information needed to check the validity of the number, is contained within the number itself O All DEA numbers start with a letter O All DEA numbers have the first initial of the practitioners last name as their 2nd digit O Then Seven Numbers
2013-2015 To Verify a DEA Number Example: AA0242622 O Add the 1st, 3rd, and 5th numbers 0 + 4 + 6 = 10 O Add the 2nd, 4th, and 6th numbers then double the sum
2 + 2 + 2 = 6 x 2 = 12 O Add the two answers together 10 + 12 = 22 O The resulting sum should have a digit that matches the last digit of the DEA number 2013-2015 The Schedules O Schedule I O Schedule II
O Schedule III O Schedule IV O Schedule V Know common drugs in each schedule! 2013-2015 Bottle Labeling for Controls A large letter C and the number of the schedule to which the
product belongs 2013-2015 The Warning Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed **Must appear on every controlled substance prescription dispensed 2013-2015 SLCP Classification
O Schedule Listed Chemical Products (SLCP) O Created by The Combat Methamphetamine Epidemic Act of 2005 (CMEA) O Pseudoephedrine O Requirements for keeping SLCPs behind the pharmacy counter O MUST be dispensed by a licensed pharmacist O Quantity limits O Must be at least 18 years old 2013-2015
Ch 11: Routes of Administration O Route of Administration = How a Drug Enters the Body O Parenteral vs. Enteral O Common Routes of Administration O Know what each route is, and its abbreviation! 2013-2015 Parenteral vs. Enteral
O Enteral Administration occurs any time the drug is introduced at any point along the tube which runs from the mouth to the anus O Parenteral Administration covers any other entry besides topical. O Topical Administration occurs when the drug is applied to the outside surface of the body. Absorption into the body may, or may not take place. 2013-2015
Common Routes of Administration O PO - By mouth O NG - Naso-Gastic O SL - Sublingual O BUCCAL - between the cheek & gum O IV bolus volume of fluid delivered over a short period of time O IV drip volume of fluid delivered over a long period of time O IV piggyback - small volume of fluid
delivered thru the tubing of another IV 2013-2015 Routes (contd) O IM - Intra-muscular O SC (SQ, subcut) - Subcutaneous O IC - Intracardiac O Transdermal - Through the skin
O Topical - Applied externally Memorize these abbreviations! 2013-2015 Dosage Forms OSolids OLiquids OSemi-Solids 2013-2015 Solid Dosage Forms
OTablets O O O O Compressed Enteric Coated Sustained Release Sublingual / Buccal OCapsules
O May also be sustained release O Good choice for bad tasting medications 2013-2015 Liquid Dosage Forms OSolution O drug is dissolved in diluent OSuspension O small particles are suspended in a liquid
OSyrup O sweetened vehicle OElixir O vehicle contains a high percentage of alcohol OExtract O drug is the oil or active portion of a plant
OTincture O alcohol based dosage form used externally 2013-2015 Semi-Solid Dosage Forms O Cream O Actually an Emulsion. Active ingredients are dissolved in oil droplets and suspended in water. O May be broken excess heat or cold
O Lotion O A thinner emulsion than a cream O Ointment O generally petrolatum based O wont absorb into skin like emulsions O more potent on a gram per gram basis 2013-2015 Ch 12: Patient Confidentiality O Every patient has the right to expect
confidentiality O We must protect patient information and be aware of any unintended transfer of information O Elevators O Corridors O Lunch Room O Telephone Conversations O Never allow yourself to be overheard when speaking about patient specific information
2013-2015 The HIPAA Law O Health Insurance Portability and Accountability Act of 1996 O Took effect in 2003 O Formalized confidentiality policies O Affects health care providers, health insurance companies, and health care payment companies 2013-2015
The HIPAA Law O Administered by the US Department of Health and Human Services O Enforced by the Office of Civil Rights O Controls access to a patients Protected Health Information (PHI) 2013-2015 The Notice of Privacy Practices
O Must be given to every patient or their guardian O Explains how the pharmacy will use their PHI O Explains the patients rights regarding their own PHI O Best to have the patient sign a log to prove they received the Notice 2013-2015 Release of PHI Under the HIPAA Law:
O We MUST release PHI when: O the patient requests their own information O the HHS Office of Civil Rights requests PHI O We MAY release PHI when it involves: O the patients treatment O the payment for treatment O the day to day operation of the pharmacy O These reasons MUST be listed on the Notice of Privacy Practices
2013-2015 HIPAA Exemptions O The HIPAA Law specifically exempts three organizations from its restrictions: O law enforcement agencies O Food & Drug Administration O workers compensation claims 2013-2015
Patient Rights on PHI O Patients have the right to: O restrict the release of their PHI O amend their PHI O request an accounting of who has viewed their PHI O request confidential communications 2013-2015 Management of HIPAA O Each pharmacy organization must appoint
a HIPAA Compliance Officer who is the final judge on all HIPAA decisions O All HIPAA documentation must be retained for 6 years O HIPPA affects various practice settings O Technicians may encounter problems 2013-2015 The HITECH Act O Updates HIPPA
O Takes into account the increase use of computers and transmission of electronic devices O Greatly increases punishment for unauthorized release of PHI O Important provisions: O Strengthens electronic security of PHI O Allows online access to PHI by patient O Allows online submission of PHI forms O Regulates the patient notification of PHI breaches O Clarifies the definitions of who may access PHI and under what circumstances
2013-2015 The HITECH Act (cont.) O Understand that: O Penalties, including criminal and financial, may now be leveled against any individual member of the pharmacy team that is held responsible! O Updated HIPPA requirements are contained
in a table in Chapter 12 20132015 Reasons Not to Use a Drug O Any lack of confidence in the product O Inappropriate storage conditions O Questionable source O Different appearance than normal O Many counterfeit drugs O Verify any changes in product labeling or
appearance O Questionable equivalence 2013-2015 Reasons to Contact a Prescriber O Any time there is a question about clarity, intent, or safety O Contact the prescriber BEFORE you fill the order!
2013-2015 Reasons to Refuse a Prescription O When a legitimate medical reason for the prescription does not exist O When the pharmacist determines the filling of the order will be harmful to the patient and the problem can not be resolved with the prescriber
O When the sole reason for the prescription is to support a drug addiction O The DEA has stated that this is not a valid reason for a prescription O Except a licensed drug addiction treatment center 2013-2015 Illegitimate and Fraudulent
Prescriptions O It is important that we are aware of attempts to illegally obtain prescription drugs O Always bring questionable prescriptions to the pharmacists attention O A prescription may not be legitimate if: O Being prescribed for an indication that is not approved O One particular provider writing abnormally high numbers of prescriptions or quantities O Large number of individuals dropping off prescriptions in someone elses name
O Large increases in controlled substance orders being generated by your pharmacy 2013-2015 Illegitimate and Fraudulent Prescriptions O Indications that a prescription may be forged: O Looks too good O Quantities, directions, or dosages that vary from the norms
O Photocopied prescription blanks O Different colored ink used on the same prescription blank O Erasures or changes on the prescriptions 20132015 Drug Use in Pregnancy O Know the categories that are safe, and unsafe, for use in pregnancy O The FDA assigns pregnancy categories to medications according to their known risks O Study Chart in Chapter 12
2013-2015 Ch 13: The OBRA Law O Omnibus Budget Reconciliation Act (1990) O The purpose of OBRA was to capture potential cost savings in the Medicaid drug program How? Get pharmacists involved in drug therapy
2013-2015 How OBRA Saves Money O Retrospective Drug Utilization Review O Education of Practitioners O Prospective Drug Utilization Review O Patient Counseling O Rebates from Manufacturers 2013-2015 Retrospective DUR
O Happens AFTER the drug is dispensed O Identify inappropriate use of drugs O Watches prescribing habits of practitioners O Generates FUTURE savings O Solves FUTURE problems 2013-2015 Education of Practitioners O OBRA makes the State Board of Pharmacy responsible for educating practitioners
about the findings of the retrospective DURs O Keeps practitioners current with recommended prescribing method 2013-2015 Prospective DUR O Occurs BEFORE the drug is dispensed O Done by the pharmacist who dispenses the medication
O Only step which catches problems BEFORE they occur O Phases of the prospective DUR O The error can be corrected BEFORE the patient receives the medication 2013-2015 Prospective DUR Review O Drug duplication?
O Drug / Disease contraindication? O Drug / Drug interaction? O Incorrect dosing or duration? O Drug allergies? O Clinical abuse or misuse? 2013-2015 Patient Counseling O OBRA mandates we offer to counsel EVERY Medicaid patient O Most states have expanded OBRA to include
every patient O Notice, we offer, but the patient can refuse O If the patient accepts counseling, the PHARMACIST must provide it 2013-2015 Patient Counseling Should Include O Medication name & description O Dosage route & duration
O Special directions or precautions O Common side effects O Therapeutic contraindications O Required self monitoring O Proper storage O Refill information O Missed dose information 2013-2015 Questions? 2013-2015
Assignments Due Next Week O Class Two Homework Worksheet O Study Drug Flash Cards # 21 40 NEXT WEEK IS OUR FIRST SECTION TEST! Covers Chapters 1 thru 13 NO MATH QUESTIONS 2013-2015
