Pharmacy Technician � PTCE (Quickstudy Medical) (2018)

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Federal pharmacy laws are listed below. Indi-vidual states also have pharmacy laws. Wherethey differ, always follow the stricter law.EX:Some medications are considered acontrolled substance under state laws, butnot federal.Federal Food, Drug & CosmeticAct of 1938 (FDCA)•Effectively created the Food and DrugAdministration (FDA), giving them theresponsibility to approve all new drugsand ensure purity standards by enforcingthe rules againstadulterationandmis-branding. Adulteration includes con-tamination or failure to meet purity andquality standards. Misbranding includesfalse, inaccurate, improper, or confusinglabeling or if the product is harmful whenused according to the label directions.•The FDCA gives the FDA the power toenforcerecallsif any product is in viola-tion of these rules. These recalls mayoccur at the wholesaler, retail, or con-sumer level. There are three levels ofFDA recalls:–Class I:For risk of “serious adversehealth consequences or death.”–Class II:For risk of “temporarily ormedically reversible adverse healthconsequences” or low-probability ofserious adverse health consequences.–Class III:For products unlikely to haveadverse health consequences.Health Insurance Portability &Accountability Act of 1996(HIPAA)HIPAA is far reaching and regulates the wayhealth care personnel handle Protected HealthInformation (PHI). HIPAA defines PHI asany individually identifiable health informa-tion. Under HIPAA, pharmacies must:•Ensure the confidentiality of PHI. Thisincludes all manner of transmission,whether written, electronic, or oral (pa-tient counseling, phone calls with provid-ers, etc.). Under HIPAA, pharmacy staffmaynotdisclose any PHI to anyoneother than the patient, including spous-es and relatives unless the patient hasgiven express consent.•Train pharmacy staff on HIPAAregulations and periodically retrainor update training.•Protect against possible breaches withsecurity measures.•Dispose of PHI in accordance withHIPAA (through measures such as incin-eration or shredding).•Appoint a designated privacy officer.•Inform patients of their privacy rightsand how the pharmacy handles their in-formation.•Provide patients with their PHI recordsif requested.Most importantly, any breach must be re-ported in a timely manner to the Departmentof Health and Human Services Office forCivil Rights. If the breach affects fewerthan 500 individuals, it must be reportedwithin 60 days of the end of the calendaryear. If it affects more than 500 individuals,it must be reported within 60 days of thebreach.Occupational Safety & Health Actof 1970The Occupational Safety and Health Act of1970 created the Occupational Safety andHealth Administration (OSHA) to ensurethe safety of workers nationwide. As it re-lates to pharmacy, OSHA requires workersto be trained in safety measures, safetysheets to be available for all hazardoussubstances, and personal protective equip-ment (PPE) to be worn/utilized when ex-posure to hazardous substances is possible.Controlled Substance Act of 1970This act created formal scheduling of drugswith the potential for abuse and depen-dency ascontrolled substances. It led tothe creation of the Drug Enforcement Ad-ministration (DEA) in 1973 to help withregulatory enforcement.DEA Number CalculationsA DEA number is required to prescribecontrolled substances except for by militarypractitioners and employees in public-healthservices, prisons, and certain long-term carefacilities. Each DEA number has its ownvalidation within its digits. Each DEA num-ber consists of two letters and seven digits,enabling you to manually validate a DEAnumber. Here’s how:•Thefirst lettercorresponds to the pre-scriber’s registration type.•Thesecond letteris the first letter of theprescriber’s last name.•The 1st, 3rd, and 5th numbers are addedtogether, and the 2nd, 4th, and 6th lettersare added together and multiplied by 2.Add the two resulting figures together,and the final digit should match the 7thdigit, also known as thecheck digit.EX:Dr. JamesBryant sends in a pre-scription with a DEA number ofAB6390467.6 + 9 + 4 = 193 + 0 + 6 = 9 × 2 = 1819 + 18 = 37Since theBin the DEA number matchesthe “B” in Bryant, and the7in 37 match-es the check digit, this is a potentiallyvalid DEA number.Schedules (I-V)Controlled substances are categorized intofive differentschedules, according to theirpotential for abuse and dependency:Schedule I:No accepted medical use/highabuse potential.EX:Illegal drugs such as LSD and heroinNote:Cocaine isnotschedule I, butschedule II, although it is rarely usedmedically.Schedule II:High abuse potential. Accord-ing to the DEA, use of schedule II drugspotentially leads to “severe psychologi-cal or physical dependence.”EX:ADHD drugs such as Ritalin, Con-certa, and Adderall; opioid analgesicssuch as morphine and oxycodone; andsynthetic opioids such as fentanylSchedule III:Moderate abuse and depen-dency potential.EX:Codeine-containing products (lessthan 90 mg) and testosteroneSchedule IV:Low abuse and dependencypotential.EX:Benzodiazepines and sleep aids suchas AmbienSchedule V:Lowest abuse and depen-dency potential.EX:Codeine-containing cough syrups,Lyrica, VimpatPoison Prevention Packaging Actof 1970This act requires child safety caps on alldispensed prescriptions. Easy open capsmay be used if requested, and a record mustbe kept of the request.Drug Listing Act of 1972This act established rules for all drug man-ufacturers to supply a current drug list tothe FDA. Each drug is assigned its ownNDC (national drug code). The NDC isunique to the manufacturer and packagesize; thus, the same medication from dif-ferent manufacturers (e.g., generics) willeach have their own NDC. An NDC is usu-ally broken down into three sections.•Thefirst sectionrefers to the manufac-turer or repackager.•Thesecond sectionrefers to the specificdrug itself (including strength and form).•Thethird sectionrefers to the packagingsize.Prescription Drug Marketing Actof 1987•Requireswholesaledistributorstobelicensed.•Samples of prescription medication mayonly be given to licensed prescribers.•Exported prescription drugs may not bereimported.Omnibus Budget ReconciliationAct of 1990 (OBRA-90)OBRA was a widespread federal deficit re-duction budget bill, the pharmacy implica-tions of which initially only pertained toMedicaid recipients. However, as it was upto individual states to determine how to en-force OBRA, most expanded the act to in-clude all patients. Under OBRA, three majorrequirements are pertinent for pharmacy:•Pharmacists must offer counseling to allpatients, documenting patient refusalsfor counsel. (Undernocircumstancesshould a technician counsel patients.)•Pharmacists must perform a “prospectivedrug utilization review” (DUR) prior tofilling each prescription, which evaluatestherapy for potential problems (e.g., in-teractions, allergies, therapeutic duplica-tion, and other adverse effects).•Record-keeping mandates: Pharmaciesmust keep patient profiles of medicationsdispensed for two years on-site.Combat MethamphetamineEpidemic Act of 2005•Requires pharmacies to limit sales ofover-the-counter medications containingpseudoephedrine or ephedrine to 3.6grams per purchaser per day and no morethan 7.5 grams within a 30-day period.Products containing these ingredientsmust be kept behind the pharmacy coun-ter or in a locked cabinet and can onlybe purchased by customers over the ageof 18 with a valid photo ID.•Pharmacies must maintain a logbook ofeach regulated purchase, including thecustomer’s signature, address, productpurchased, quantity purchased, and dateand time of the sale. This logbook maybe physical or electronic and must bemaintained for a period of two years.LawsThe PTCEThe PTCE is computer based and lasts two hours. It has 90multiple-choice questions that must be answered in the firsthour and fifty minutes. The PTCB offers a “blueprint,” withan approximate percentage of questions related to specificcontent areas. However, there are several versions of thePTCE exam, and students taking the same test in the samelocation will receive different versions of the exam. Somemay contain more or less of a particular content area thananother. Once you have passed the PTCE, you are entitledto use the CPhT designation. You must recertify with thePTCB every two years and complete 20 hours of continuingeducation (CE) per two-year recertification cycle.Licensure/Registration by StateIn addition to the national certification, you may be requiredto become certified or registered with your state pharmacyboard. Each state has different requirements for pharmacytechnicians, and some do not require either national certi-fication or state registration.CertificationPHARMACYPTCEPTCE1WORLD’S #1QUICK REFERENCE GUIDEEverything you need to know about passing the PTCE

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