Regulation of pharmacy practice

Biosimilar and biologics

A biosimilar is a biological product that has highly similar structure and function to reference product and has no significant difference in safety and effectiveness from reference product Biosimilar to filgrastim (Neupogen) is filgrastim-sndz (Zarxio) Biosimilar to infliximab (Remicade) is infliximab-dyyb (Inflectra) No interchangeable biologics to date Purple Book = Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations = lists reference products, biosimilar products and interchangeable products

Glucose screening

ADA guidelines recommend testing for diabetes and prediabetes using A1C, FPG or 2-hour plasma glucose after a 75-g OGTT. OGTT not practical in community pharmacy. FPG less expensive and and can be used but requires patient to fast 8+ hours. A1C does not require fasting and provides accurate long-term blood glucose reading but more expensive Screening can be ordered to all adults ≥45 and is adults of any age who are overweight or obese (BMI ≥ 25 for general population, ≥23 in Asian Americans) with ≥1 risk factor.

Advanced practice pharmacist

APh license enables pharmacists to provide clinical services in various settings. Similar to a clinical pharmacist in a hospital or ambulatory care setting. APh can do the following: Perform patient assessments Order and interpret drug therapy-related tests in coordination with PCP or diagnosing provider Refer patients to other healthcare providers Participate in evaluation and management of diseases and health conditions in collaboration with other healthcare providers Initiate, adjust and discontinue drug therapy pursuant to order by patient's trying prescriber and in accordance with established protocols. If initiating or adjusting controlled substance, APh must be registered with DEA To be an APh, pharmacist must meet two of the three following requirements: Earn certification in relevant area of practice e.g. ambulatory care, critical care, oncology pharmacy or pharmacotherapy Complete postgraduate residency program Have provided clinical services to patients for 1 year and at least 1500 hours under a CPA or protocol with physician, an APh, a pharmacist practicing collaborative drug therapy management or within a health system

Medication utilization evaluiation

ASHP defines medication utilization evaluation (MUE) as performance improvement method that focuses on evaluating and improving medication-use processes with the goal of optimal patient outcomes - improve the use of drugs to increase health benefit for patients. Can be conducted for a specific drug, drug class, disease state, or process such as prescribing, dispensing or administration Can be used when drug is especially toxic, used in a group at high risk of ADRs (pediatrics), if medication is being considered for addition to or removal from formulary, identify poor and/or costly prescribing habits. Purpose include determine optimal medication therapy, preventing medication-related problems, evaluating efficacy of a medication and improving patient safety

PRN refillsq

Acceptable for non-controlled but cannot be refilled past 1 year from issue date. But number of refills depends on day supply the prescription is written for

Retinoid MedGuides

Acitretin (Soriatane) Isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)

PIC

Adequate authority to make sure pharmacy is compliant with federal and state law Has strict liability for violation of law in the pharmacy even if he or she did not have actual knowledge of the violation Can supervise up to 2 pharmacies as long as they are within 50 driving miles of each other. Any change of PIC is reported by pharmacy and departing PIC to the board in writing within 30 days. Cannot be a designated representative-in-charge (DRIC) for a wholesaler or vet food-animal drug retailer at the same time PIC must complete biennial self-assessment form for their pharmacy before July 1st of each odd-numbered year. Additional self-assessment form must be completed within 30 days if new permit is issued, when pharmacy has new PIC, and when pharmacy moves to new location. Each self-assessment form will be kept in pharmacy for 3 years.

Others MedGuides

Alendronate and other BPPs MABs Quinolones Etanercept (Enbrel) Erythropoietin stimulating agents (Procrit, Epogen, Aranesp) Bupropion (Zyban) Fentanyl (Duragesic, Fentora) Pimecrolimus (Elidel) Raloxifene (Evista) Tacrolimus (Protopic, Prograf, Astagraft) Tamoxifen (Soltamax) Teriparatide (Forteo) Testosterone (Androgel) Varenicline (Chantix) Warfarin (Coumadin, Jantoven)_

Aux labels

Alerts patients to key warnings, dietary requirements, and storage requirements. Should be evidenced-based and written in simple language

Antiarrhythmics MedGuides

Amiodarone (Cordarone, Pacerone)

LABA that need MedGuides

Arfomoterol (Brovana) Formoterol (Foradil, Perforomist) Formoterol/budesonide (Symbicort) Salmeterol (Serevent Diskus) Salmeterol/fluticasone (Advair Diskus, Advair HFA)

Antipsychotic MedGuides

Aripiprazole (Abilify) Olanzapine (Relprevv injection) Quetiapine (Seroquel)

Translation

At request of patient or representative, pharmacist must provide translated directions for use which must be printed on prescription container, label, or supplemental document. If translated directions for use appear on prescription container or label, English version of directions also need to appear on container or label whenever possible and can appear on other areas of the label outside of the patient centered area. If English cannot be placed on the label or the container, it should be provided on a supplemental document. Pharmacist can use translations made available by the board and pharmacist not required to provide translated directions for use beyond languages that the board has made available in translated form

ADHD MedGuides

Atomoxetine (Strattera) Dexmethylphenidate (Focalin) Dextroamphetamine (Dexedrine) Dextroamphetamine/amphetamine (Adderall) Lisdexamfetamine (Vyvanse) Methylphenidate (Concerta, Daytrana, Metadate CD, Methylin, Ritalin)

Cholesterol screening

Available at most community pharmacies. CardioChek = cholesterol measuring device that meets National Cholesterol Education Program (NCEP) standards for accuracy Wipe away the first drop of blood with gauze and use the second drop of blood. Position capillary tube/pipette slightly tilted upward to avoid gaps and air bubbles. Repeat as needed to fill capillary tube/pipette. Insert plunger into capillary tube (no assembly needed for capillary pipette). Place capillary tube over test strip application window. Hold it slightly above blood application window making sure to avoid touching surface of the strip. Gently press plunger down or squeeze bulb of capillary pipette to move blood onto test strip. Results appear in 2 minutes

Body fat analysis (BMI and waist circumference)

BMI formula: Kg/m^2 (Pounds * 703)/inches^2 Normal BMI: 18.5 - 24.9 kg/m^2 Waist circumference used with BMI. If most of the fat is around the waist, there is high risk which is defined for adults as a waist size > 40 inches for males or > 35 inches for females

Blood pressure assessment

BP that remains high for a long period of time (HTN) can lead to severe consequences, include HF, stroke and kidney failure. Low BP (hypotension) may not be a serious issue as long as patient feels fine, but orthostatic hypotension is dangerous because of subsequent dizziness and risk of falls. Sudden drops in BP due to low or high body temp, infection, dehydration, bleeding or allergic reaction are serious. To measure accurately: Ask about recent tobacco, alcohol and caffeine which can increase BP. Wait at least 30 minutes before having BP taken Measure after using restroom to empty bladder and rested for 5 minutes in a chair that supports the back with the feet resting on the floor Sit and refrain from talking during measurement Arm being used to measure BP should be resting on table or armchair same level as the heart At initial visit, take two readings (one in each arm) 1-2 minutes apart and record average. At next visits, use arm with the higher pressure In elderly or if dizziness or lightheadedness is present, measure for orthostatic hypotension while patient is standing 1-2 minutes after the sitting measurement. Orthostatic hypotension present if SBP decreases at least 20 mmHg or if DBP decreases at least 10 mmHg Sphygmomanometer technique: Proper cuff size Wrap it snuggle around arm with marker on cuff placed over brachial artery. Lower part of cuff should be above elbow. 2 fingers should fit snugly under cuff Place diaphragm or bell over brachial artery under cuff Pump bulb until pressure is 30 mmHh above estimated SBP

Antidepressants that require MedGuides

Bupropion (Wellbutrin) Citalopram (Celexa) Doxepin (Sinequan) Duloxetine (Cymbalta) Escitalopram (Lexapro) Fluoxetine (Prozac) Imipramine Mirtazapine (Remeron) Nortriptyline (Pamelor) Paroxetine (Paxil) Sertraline (Zoloft) Trazodone (Desyrel) Venlafaxine (Effexor)

Manufacturers offering discounts of a branded drug

CBOP wants the patient to get the med they need at the lowest cost possible. Manufacturers are prohibited in CA from offering drug discount for the purpose of pushing a more costly branded drug on the patient. The exception: manufacturer can offer the drug at a discounted price if the price is less than the cost of the generic equivalent. Manufacturers can also provide the drug for free to certain patients - low income, cannot afford the drug

Written prescriptions for Medi-Cal outpatient drugs

CMS has required that all written, non-electronic prescriptions must be on tamper-resistant pads for all Medi-Cal outpatient drugs (including OTC, non-controlled, and controlled) to be reimbursable by the federal government. Tamper-resistant pad must meet three requirements: Prevent unauthorized copying of a completed or blank prescription form - e.g. word void appears when prescription is photocopied; forms watermarks Prevent erasure or modification of information written on prescription by provider - e.g. quantity check off boxes so prescriber can indicate quantity by checking applicable box; check boxes must be printed on form so prescriber can indicate number of refills ordered; preprinted text "Rx is void if more than ____ Rxs on paper" on prescription paper

Medication error reporting

California requires all pharmacies to have a quality assurance (QA) program to document, assess and prevent medication errors. There must be a readily-retrievable P&P for QA program so pharmacy staff knows what to do when med error happens Investigation of med error must begin within 2 business days from date the error was discovered; otherwise, the sequence of events leading up to even will be forgotten. Assessment should be conducted with root cause analysis (RCA) to discover causes in the system that led to error with the goal of designing changes to avoid future repeats. The QA review should be immediately retrievable in the pharmacy and cannot be stored off site. Must be kept in the pharmacy for at least 1 year. Record must contain the following: Date, location and participants in QA review Pertinent data and other info related to med error Findings and determinations Recommended changes to policy, procedure, systems or processes to avoid repeat of med error Pharmacist must inform patient that med error occurred and should inform patient of any steps that can be taken to avoid further injury (e.g. using another agent to lessen effects of drug taken in error). Pharmacist must inform prescriber that med error occurred.

Expiration datres

Can be expiration date on manufacturer's container or 1 year from the date the drug is dispensed. Monographs for some preparations state how labeled expiration date must be determined e.g. BUD for reconstituted Augmentin = 10 days. If container does not have expiration date, it is misbranded, treated as expired, and should not be dispensed

Pharmacists furnishing naloxone pursuant to board protocol

Can bill Medi-Cal, Medicare B, and private insurance Offered to those who request it and opioid users at the highest risk for overdose. Highest risk criteria includes: History of prior overdose If total opioid amount taken in a day is ≥ 50 morphine milligram equivalent (MME) Concurrent BZD use Recent period of opioid abstinence Chronic illness that affects lung, liver, or kidney Pharmacists furnishing naloxone according to protocol must follow these steps: Complete 1 hour of CE on naloxone use or equivalent curriculum-based training program Ask if recipient uses opioids or knows someone who does Ask if recipient has a known naloxone hypersensitivity Patient counseling cannot be waived - train the recipient in opioid overdose prevention, recognition, response and administration of naloxone Provide board-approved fact sheet. Must notify PCP that naloxone was furnished with patient's permission Keep records of furnishing naloxone for 3 years

Converting a 30-day supply into a 90-day supply

Can convert 30-day supply to 90-day supply for non-controlled, non-psychiatric drug if: Patient completed initial 30-day supply with no negative effects or patient previously received same med with a 90-day supply Total quantity dispensed (including refills) does not exceed the amount authorized on prescription Pharmacist notifies prescriber of increase in number of day supply dispensed Cannot dispense greater supply if: Prescriber indicates "no change to quantity" or words of similar meaning The prescriber indicates that dispensing initial amount is medically necessary

Dispensing epinephrine auto injectors

Can dispense EpiPen to pre-hospital emergency medical care person, lay rescuer or authorized entity for first aid purposes. Physician provides written order that species quantity of EpiPen to be dispensed to those described above. Each EpiPen should be dispensed with manufacturer's product info sheet and labeled with the following: Name of person to whom prescription was issued The designation "Section 1797.197a responder" and "First Aid Purposes Only" Dosage, use and expiration date Pharmacy can also provide auto-injectors for a school district or charter school based on a physician/surgeon written order

Furnishing PrEP

Can furnish at least a 30-day supply up to a 60-day supply of TDF 300mg/emtricitabine 200mg once daily to patients who meet the following criteria: Negative HIV test within last 7 days. If recent HIV test unavailable, pharmacist must order HIV test and ensure negative result before furnishing. Positive tests should be referred No s/sx of acute HIV infection (fever, fatigue, sore throat, rash) Does not take any meds contraindicated with PrEP regimen Pharmacist needs to counsel which cannot be waived by patient. May educate about side effects, safety during pregnancy and breastfeeding, adherence to regimen, importance of timely testing and treatment Pharmacist must notify patient that all future prescriptions of PrEP must be supplied by PCP. Pharmacist can only furnish 60 day supply every 2 years. If patient does not have PCP or patient refuses consent, patient must be provided with list of healthcare providers that can be contacted for follow up

Prescriptions from another state

Can furnish drug or device from written or oral order form prescriber licensed in a state other than California if out of state prescriber has a license equivalent to that required of a California prescriber

Pharmacies furnishing naloxone to schools pursuant to a prescription

Can furnish naloxone to a school district, county office of education or charter school pursuant to a prescription.

Furnishing self-administered hormonal contraceptives

Can furnish pills, patch, ring, and injection (Depo-SubQ Provera) Must have complete at least 1 hour of CE, application of the United States Medical Eligibility Criteria (USMEC) for contraceptive use, and other CDC guidance on contraception. Equivalent curriculum-based training program completed on or after 2014 in accredited CA school of pharmacy also sufficient to participate in this protocol. Protocol required pharmacist to complete these steps: Ask patient to complete self-screening form; patient will need to complete self-screening form initially and annually or whenever patient indicates a major health change. May be prohibited based on responses e.g. h/o breast cancer, heart disease, DVT, or tobacco use. Form includes questions that can identify use of drugs that could decrease contraceptive efficacy (epilepsy drugs - enzyme inducers). Measure and record patient's seated BP if combined (estrogen and progestin) hormonal contraceptives are requested or recommended Ensure patient is trained in administration and received counseling including dose, effectiveness, potential side effects, safety concerns, importance of receiving preventative health screenings and lack of protection against STIs Provide patient with 3 fact sheets: -birth control guide -patient product information (PPI) -administration fact sheet for specific formulation Refer to their PCP or to nearby clinic for f/u. Notify PCP of any drugs/devices furnished. If no PCP, provide patient with written record of drugs/device provided If self-administered hormonal contraceptive services not immediately available or pharmacist declines based on conscience clause, must refer patient to another pharmacist or facility to get product. State mandatory reporting laws must be follow if sexual abuse is suspected Keep records for 3 years

Peer review and self eval

Can include standard objective criteria and position-specific criteria

Bone density screening

Can offer ultrasound densitometer that measures bone density in heel. Provides the T score. Gold standard is dual-energy X-ray absorptiometry (DEXA) scan. If it is determine that the patient has low bone density, patient should be referred for physician consult and DEXA. Have patient sit, remove shoe and sock from foot that will be tested. Apply gel to machine and bare heel if necessary. Place patient's heel in machine, membranes will fill with warm water and surround heel and ankle. Results appear in 1 minute. Wipe off gel and clean membranes

Intern pharmacist

Can perform almost all functions of a pharmacist at discretion of and under supervision of a pharmacist. Intern pharmacist cannot have a key to pharmacy. All prescriptions filled by intern pharmacist must be checked by pharmacist before dispensing. Pharmacist can supervise 2 interns at a time. Intern pharmacist may not perform discretionary duties nor act as a pharmacist; can only act as a technician when no pharmacist is present.

Standard order sets

Can promote best practice, decrease med errors, improve workflow, improve patient outcomes and standardize patient care. Standard order sets reduce the need to call prescribers for clarification about an order. Only beneficial when developed carefully and are implemented at the facility; should be evidence-based, should not include non-formulary meds, drugs withdrawn from market or equipment no longer available. Baseline tests and frequency of monitoring must be defined and when emergency treatment (such as use of reversal agents with anticoagulants) is required.

Nuclear pharmacy

Compound and dispense radioactive drugs for diagnostics or treatment. Pharmacist qualified in radioactive drug management must be in the pharmacy whenever radioactive drugs are being provided to medical staff. All personnel involved in furnishing radioactive drugs are under the immediate and direct supervision of qualified nuclear pharmacist. Pharmacies that compound nuclear drugs must have a sterile compounding permit from BOP

Furnishing prescription NRT

Can recommend OTC product including patch and gum. Can also furnish prescription NRT including inhaler and nasal spray by following these steps: Complete minimum 2 hours CE or equivalent curriculum-based training program completed within last 2 years at accredited CA school of pharmacy Completes ongoing CE focused on smoking cessation every 2 years Reviews patient's current tobacco use and past quit attempts Asks the patient a series of screening questions: -are you pregnant or plan to become pregnant? (If yes, do not furnish and refer to appropriate healthcare provider -have you had a heart attack within last 2 weeks? (If yes, furnish with caution and refer to appropriate healthcare provider) -do you have history of heart palpitation, irregular heartbeats, or have you been diagnosed with serious arrhythmias? (If yes, furnish with caution and refer to appropriate healthcare provider) -do you currently experience frequent chest pain or have you been diagnosed with unstable angina? (If yes furnish with caution and refer) -do you have any history of allergic rhinitis? (If yes, avoid nasal spray) -have you been diagnosed with temporal mandibular joint (TMJ) dysfunction? (If yes, avoid gum) Counsels patients on therapy and refers for further smoking cessation support Notifies PCP of drugs or devices provided or enters info in a shared patient record system. If no PCP, pharmacist provides written record of what they received and advises patient to consult PCP of their choice. Records of furnishing NRT kept for 3 years

Tablet splitting

Can save patients money and health plans can also save money because manufacturers sometimes charge the same price for higher and lower doses of same drug Easiest tabs to split are the scored meds. Patients should use commercially available devices (pill cutters/splitters) specifically designed to split tablets. There are some tabs that crumble easily and others that are coated to protect GI lining or to prevent drug from degrading in the stomach. Patients with manual dexterity problems (arthritis, Parkinson's), visual impairment or cognitive impairment are not good candidates for tablet splitting. Do not advise patients to split very small tabs, asymmetrical tabs, NTI drugs, capsules, EC tabs, film-coated tabs, or ER tabs. Pharmacist and patient should determine whether splitting tablet is appropriate.

Prescriptions from foreign countries

Cannot fill a prescription from another country but DC and the US territories are treated the same as US states for filling prescriptions

NSAIDs that need medguides

Celecoxib (Celebrexa) Diclofenac (Voltaren, Flector, Cambia) Diclofenac/misoprostol (Arthotec) Etodolac Indomethacin (Indocin) Ketorolac (SPRIX) Meloxicam (Mobic) Nabumetone Naproxen (Anaprox) Oxaprozin (Daypro)

Telepharmacies serve a need in undeserved, rural areas

Considered underserved location if no pharmacy within 10 miles. Remote dispensing sites permitted to operate to meet the needs of local residents Remote/telepharmacy site managed by a supervising pharmacy that owns the remote pharmacy. The supervising pharmacy is licensed, but not the remote site. The remote site is considered to be a satellite location of the primary, supervising site. The pharmacist supervises all activities in the remote pharmacy (e.g. DUR, filling, counseling) with technology, such as audio-visual equipment Requirements for telepharmacy: Counseling for each prescription must be done remotely and is required Single pharmacist off site can supervise 2 techs working at the remote site Responsible tech will have the key to remote site; drugs stored at the remote site, including controlled substances, and the PIC at the supervising site retains responsibility. The supervising pharmacy and the remote site must be within 150 miles of each other Controlled substance must be stored separately. All management of controlled substances such as pulling them from separate area, filling, and dispensing must be captured on video. Video recordings must be kept at least 120 days A pharmacist from supervising pharmacy must travel to remote pharmacy and conduct inspection of facility at least once-monthly Pharmacist is not located in the remote site; techs carry out the work but they are still permitted to do only non-discretionary tasks. Tech cannot accept new prescriptions, compound meds (requires direct supervision) or perform other discretionary tasks Tech can be trained to order and accept drug deliveries of controlled substances. Controlled must be stored in secure location and separate location from other drugs at all times. Must be video surveillance of tech receiving and storing controlled substances. Pharmacist must inventory controlled substances when they are at the remote site and the pharmacist should countersign for the delivery

Written patient information

Consumer medication information leaflets (CMI) Patient package inserts (PPIs) Medication guides (MedGuides)

Veterinarian (DVM)

Independent authority; limited to scope of practice Non-controlled and C2-5; need to register with DEA and get DEA number if prescribing scheduled meds

Certified Nurse-midwife (CNM)

Dependent authority: Non-controlled and C2-5; DEA number and registration for scheduled meds

Nurse practitioner (NP)

Dependent authority: Non-controlled and C2-5; need DEA number and registration for controlled meds

Physician assistant (PA)

Dependent authority: Non-controlled and C2-5; need DEA number and registration for scheduled meds

Child resistant packaging

Designed so 80% of children < 5 years old cannot open it while at least 90% of adults can. A new plastic container and closure must be used for each prescription dispensed to avoid wear and tear damage. If glass container is used, only the top plastic closure needs to be replaced. Reversible containers are permitted if dispensed in child-resistant mode but not recommended. Prescriber can waive the use of C-R container for a single prescription at a time and the patient can provide blanket waiver for all dispensed prescriptions at a pharmacy. Exemptions to child-resistant packaging: Sublingual nitrogen Oral contraceptives Hormone replacement therapy Powdered unflavored ASA Effervescent ASA Powdered Fe preparations Effervescent APAP

Therapeutic interchange protocol

Dispensing medication by pharmacists that are chemically different but therapeutically similar to the medication prescribed. Pharmacist who substitutes one drug for another does not need to discuss the change with physician as long as the substitution is established in the institution's therapeutic interchange protocol. Therapeutic interchange can also be used in ambulatory care setting as long as the two basic requirements exist: presence of functioning formulary system and a P&T committee.

Drug classes that pose substantial risk when tracked in combination with alcohol

Disulfiram and other drugs (chlorpropamide, metronidazole, cefotetan) which can cause disulfiram-like reaction MAOI Nitrates Cycloserine Anti diabetic agents (insulin and sulfonylureas) due to risk of hypoglycemia Do not drink alcoholic beverages when taking this medication

Physical assessments

Documentation required for patient assessment, including results from initial interview, monitoring appointments, referrals and that is for every step of the process. Conduct patient interview: Begins with interview in a space that protects patient privacy and makes patient feel comfortable. Use open-ended questions uncles a simple factual response is needed. Closed-ended questions can be answered with a simple, one-word response. Active listening required for successful interview. Obtain health history, with medication use: Health history includes chief complaint, history of present illness, past medical history, social history, family history, allergies, intolerances and reaction and medication use. Social should include tobacco alcohol, and illicit drug use. Medications should include OTC and dietary and other supplements. If patient is a tobacco user and willing to try tobacco cessation, pharmacist should counsel using the 5 A's Model - counseling and medication use should be recommended in combination - achieve higher quit rates Vital sign measurement: BP, HR, RR, temp and pain: Joint Commission requires pain to be assessed as 5th vital sign in all JC-accredited facilities, which includes hospitals

Labeling requirements for prescription containers

Drug name, strength, quantity Directions Name of patient/patients Prescriber Issue date Name and address of pharmacy Prescription number Expiration date Condition or purpose of drug if written on prescription Physical description of drug (color, shape and imprint) When brand is dispensed, it should be on the prescription When generic is dispensed, label must include generic name and the state that says "generic for [insert brand name equivalent]" to indicate brand name drug equivalent, and the generic drug manufacturer since there are multiple manufacturers of generic drugs

Drug supplying at nursing stations

Drugs for use in medical emergencies must be immediately available at each nursing unit or service area. Must be stored in a clearly marked portable container which is sealed by the pharmacist. Contents of container must be listed on outside cover and must include earliest expiration date of any drugs inside - crash carts

Repackaging previously dispensed drugs into blister packs

Drugs previously dispensed can be repackaged at the patient's request into a package that is more convenient for the patient - medication blister pack or bubble blister pack or medication pill card. Can be done for patients with complicated drug regimen/lives in long-term care facility. Increases compliance and reduces medication errors. Any pharmacies providing repackaging services must have P&Ps for the repackaging process and must label the repackaged drugs with the following: All info required for a prescription label Name and address of pharmacy that initially dispensed the drugs and the name and address of the pharmacy repackaging the drugs if different

Format of drug label

Each of the following items (and only these 4 items) must be clustered into one area of the label that comprises at least 50% fo the label. Each item must be at least 12-point sans serif font and listed in the following order: Patient name Name of drug (trade name alone or generic + generic for statement + manufacturer) and strength of drug. If brand not widely used, it can be left off Directions for use Condition or purpose if this was on the prescription Label must highlight in bold typeface or color or use blank space to set off the 4 items Time periods should be species and number should be used instead of words when appropriate e.g. take 2 tablets in the morning and 2 tablets in the evening instead of two tablets twice daily. Avoid hourly intervals e.g. every 8 hours, since it requires patient to count. Specifying exact time should be avoided unless drug must be taken at exact times

Correcting errors or omissions on prescriotiosn

Errors or omissions for non-controlled can be revised if it is minor (misspelling a drug name for example) or after consultation with prescriber if it is significant, can also be re-written as an oral order

Insomnia drugs that need Medguides

Eszopiclone (Lunesta) Ramelteon (Rozerem) Temazepam (Restoril) Triazolam (Halcion) Zaleplon (Sonata) Zolpidem (Ambien)

How to give naloxone

Evzio package includes a trainer and 2 auto-injectors. Injector is nearly identical to the Audi-Q epinephrine auto-injector. Both Evzio and Auvi-Q have a safety cover that is removed. Injected straight into outer thigh by pressing device against skin or given through clothing. Both cause a hiss-and-click sound when injection is given, held against the thigh for 5 seconds to allow time to drug to disperse Nasal spray that does not need assembly: can be sprayed up one nostril by pushing plunger Nasal spray with assembly: take off yellow caps, screw on white cone, take purple cap off capsule of naloxone, gently screw capsule of naloxone into barrel of syringe, insert white cone into nostril and give short, strong push on end of capsule to spray naloxone; one half of capsule in each nostril Injectable: remove cap from naloxone vial and uncover needle, insert needle through rubber plug with vial upside down, pull back plunger and draw 1 ml, inject 1 ml into upper arm or thigh muscle, if no reaction in 3 minutes give another dose

Diabetes MedGuides

Exenatide (Bydureon, Byetta) Pioglitazone (Actos) Pioglitazone/metformin (Actoplus Met) Rosiglitazone (Avandia) Rosiglitazone/metformin (Avandamet) Canagliflozin (Invokana) Empagliflozin (Jardiance) Other SGLT2s

Furnishing PEP

Exposure can be occupational or non occupational. PEP should be started ASAP ideally within 72 hours of exposure. Pharmacist can furnish a complete course of treatment (28 days) with one of the following PEP: Truvada + Isentress 400 mg BID Truvada + Tivicay 50mg daily Truvada + Prezista 800 mg daily + Norvir 100 mg daily Must offer HIV testing to patient but patient can refuse Pharmacist must counsel which cannot be waived by the patient: side effects, safety during pregnancy and breastfeeding, adherence to regimen, importance of timely testing and treatment

Naturopathic doctors (ND)

Independent authority, limited to the following: Epinephrine to treat anaphylaxis Natural and synthetic hormones (still need to be registered with DEA and have a DEA number to prescribe controlled substances including testosterone) Vitamins, minerals, AA, glutathione, botanicals and their extracts, homeopathic meds, and others when they are available without prescription Furnishing number is required for NDs to prescribe; typically the NDs license number preceded by the letters NDF Dependent authority: All other non-controlled and C3-5

MedGuides

FDA-approved patient handouts that come with many prescriptions that have significant health concerns. FDA requires MedGuides be issued with drugs and biological that require info to help prevent serious ADRs, if adherence to specific instructions is essential. Provided by drug manufacturer via physical handout or electronic file. Must be given in the following situations: Initial fill and refills of a drug dispensed in the outpatient setting and when drug will be used by patient without supervision of a healthcare provider The first time a drug is being dispensed to a healthcare provider for administration to a patient in an outpatient setting (clinic, infusion center, or ED) When patient/caregiver asks for it If MedGuide has been revised If drug is subject to REMS which requires a MedGuide There are over 240 meds which require a MedGuide and the list can be found on FDA website. Drug classes that require MedGuides include: Antidepressants Some antipsychotics Anticonvulsants Long-acting beta-agonists Most anti arrhythmics NSAIDs

Emergency refills without prescriber's authorization

For non-controlled and C3-5 can be refilled without prescriber's authorization if pharmacist feels that failure to refill might interrupt patient's ongoing care and have a significant adverse effect on patient's well-being No quantity limit for emergency refill for non-controlled. C3-5, pharmacist can only provide reasonable amount to cover emergency period until prescriber can be contacted for refill. Must note on reverse side of prescription the date and quantity of refill and that prescriber was unavailable and the reason to refill prescription without prescriber's authorization. No emergency refill for C2 because C2 cannot be refilled. Can get emergency verbal order

Covered California

Health insurance marketplace in CA. Includes website where patients can compare different ACA plans and enroll for coverage. All plans include prescription drug coverage which are included as one fo the essential health benefits that ACA plans must include in addition to contraception. Plans sold in four levels of coverage: bronze, silver, gold and platinum. For patients < 30, another option called minimum coverage plan is available. Higher-cost plans pay higher percentage of covered medical expenses, compared with what a patient would be expected to pay in copays and annual deductibles Enroll in plans based on their individual health needs.

Monthly inspection of drug supply

Hospital drug supply must be inspected every 30 days. This includes automated dispensing machines, refrigerator, freezer and emergency stock supply. Records of inspection kept for at least 3 years. Irregularities reported within 24 hours to PIC and director or CEO of healthcare facillity

REMS

If FDA feels the drug has a very high safety concern that would not be sufficiently addresses with BBW and MedGuides, FDA can mandate the use of REMS. FDA uses REMS requirements to make sure that the risks are known and managed adequately. Four parts to REMS: Communication plans Elements to assure safe use (ETASU) Implementation systems MedGuides Thalidomide - severe birth defects; Thalomid REMS Program (STEPS previously). Negative pregnancy test required prior to dispensing Isotretinoin - severe birth defects; iPledge. Negative pregnancy test required prior to dispensing Clozapine - neutropenia; Clozapine REMS program. Monitor ANC Qsymia - severe birth defects; Qsymia REMS program. MedGuide required, healthcare training program, dispersed only through certified pharmacies Butrans, Dolophine, Duragesic, Hysingla ER, Kadian, Methadose, MS Contin, Nucynta ER, OxyContin, Zohydro ER, and all other ER/LA opioids - high abuse potential, life-threatening respiratory depression. ER/LA opioid analgesics REMS program. MedGuide required and prescriber must complete approved CE and must counsel patients Saxenda - potential risk of medullary thyroid carcinoma, risk of acute pancreatitis. Saxenda REMS program Addyi- risk of hypotension and syncope due to interaction with alcohol. Addyi REMS program. No alcohol use while taking Addyi, all REMS participants must be trained and patients must be properly counseled

Automated Drug Delivery System (ADDS)

If used to store and dispense scheduled drugs, a DEA-registered pharmacy must manage the cabinet. CBOP requires the system be under the control a pharmacist and specifies how cabinet should be stocked. For systems in a skilled or intermediate care facility, the following is required: Pharmacy and nursing facility have developed policies and procedures to ensure drugs are being stored and dispensed properly Pharmacist reviews each medication order and the patient's profile before drug is removed from ADDS. Use of override to retrieve medication before the pharmacist can review the order should be done in emergency only When cabinet is stocked directly in facility, the stocking is done by a pharmacist If ADDS uses removable pockets, the stocking is done outside the pharmacy and delivered back to the facility. The removable pockets or drawers must be transported between pharmacy and the facility in secure, tamper-evident container and once removable pockets or drawers are brought back to pharmacy, they are restocked by pharmacist, intern, or technician Pharmacies that remotely operate ADDS must register ADDS with the board within 30 days of installing the device and annually as part of license renewal. Hospitals that operate ADDS within their own facility do not need to register ADDS separately with the board

Prescriptions from deceased prescribers

If valid prescription was written when prescriber was living prescription is valid until all refills are gone and no more than 6 months from the date written for controlled substances, 1 year for non-controlled substances (standard of practice)

Self-prescribing and prescribing for family members

In CA, can self-prescribe non-controlled. Can prescribe controlled and non-controlled to family members as long as there is a valid physician/patient relationship, a legitimate medical purpose and a good faith exam

Optometrist (OD)

Independent authority, limiter to scope of practice Non-controlled and C2-4 (no C5); will need to get DEA number and register with DEA. Must be certified with Board of Optometry to prescribe drugs. These optometrists will have a letter T at the end of their license number. For codeine-containing or hydrocodone-containing products, can prescribe 3-day supply maximum. Can prescribe other drugs relevant to practice including oral analgesics, OTC drugs, oral antibiotics, topical antibiotics/antivirals/anesthetics/lubricants/anti-inflammatories (including NSAIDs and steroid eye drops)/antihistamine, diagnostic drops (atropine and mydriatics to dilate pupils) and glaucoma eye drops

Drug formularies

Includes safest and most effective drugs according to current clinical guidelines/practices, while taking cost into consideration

Dispensing 12-month supply of hormonal contraceptive at once

Includes the pill, the patch, the ring and the injection. Health plans are required to provide coverage up to a 12-month supply - many benefits which includes increased adherence which reduces number of unintended pregnancies which decreases healthcare costs by reducing number of pregnancy treats and pregnancies. At patient's request with a valid prescription, pharmacy must dispense 12-month supply of self-administered hormonal contraceptive all at one time. Total quantity dispensed including refills cannot exceed amount authorized. If prescriber notes there cannot be changes to quantity or the initial amount is medically necessary, pharmacist must dispense quantity prescriber has specified Pharmacist can also furnish annual supply of self-administered hormonal contraceptive to a patient without a prescription under the board-provided protocol

Physician (MD/DO) type of prescribing/furnishing authority

Independent authority Non-controlled and C2-5. If prescribing scheduled drugs, will need to register with DEA and get DEA number

Dentist type of prescribing/furnishing authoriyt

Independent authority, limited to scope of practice Non-controlled and C2-5; will need to register with DEA and get DEA number if prescribing scheduled drugs

Registered pharmacists (RPh)

Independent authority, limited to the following: Emergency contraception, self-administered hormonal contraceptives Travel meds recommended by CDC, not requiring a diagnosis Routine immunizations published by CDC for ≥ 3 years old Naloxone Prescription NRT PrEP max 60 days every 2 years, future fills must be by PCP PEP Dependent authority: All other non-controlled and C2-5, need DEA number

Podiatrist (PM) type of prescribing/furnishing authority

Independent authority; limited to scope of practice Non-controlled and C2-5; need to get DEA number if prescribing scheduled drugs

Prescription transfers

Information kept by each pharmacy must at least include: Pharmacists or interns involved in transferring info Name and identification code or address of pharmacy from which prescription was received or to which prescription was transferred Original date and last dispensing date Number of refills and date originally authorized Number of refills transferred (remaining refills that have not been dispensed) Non-controlled can be transferred as many times as there are refills C3-5 can be transferred once C2 can be transferred if sent electronically and has not been filled 4 critical items must be clustered into one area of the label that is at least 50% of the label, printed in at least 12-point sans serif typeface: Patient name Drug name and strength Directions for use Purpose of drug

National patient safety goals

Joint Commission't national patient safety goals (NPSGs) is to foster improvements in patient safety. Highlights problematic areas in healthcare. Each NPSG targets one area and recommends steps to improve safety and reduce risk

Internet pharmacies

Legitimate mail order pharmacies vs rogue internet pharmacies. The legitimate one dispenses meds only with a prescription from prescriber who has performed appropriate exam

Formulations that cannot be switched

Long-acting and short-acting forms e.g. Kapvay (long-acting clonidine vs IR clonidine). Substitution not permitted between combination drug products and multiple single agents e.g. BiDil (isosorbide dinitrate/hydralazine) and the two individual drugs as separate products)

Notice to consumers

Make sure consumers understand their rights which includes: Counseling with each new prescription Ask questions about their meds Easy-to-read type and interpretive services are available on request Must be posted in public view where it can be read by the consumer. Can be a PowerPoint presentation played on a monitor, poster, or legal sized papers

Medicare Part D

Medicare = Federal health insurance for people ≥ 65 or < 65 with disability and patients with ESRD. Medicare enrollees can apply for low income subsidy which pays for Part D monthly premiums, annual deductible and medication copays. Medicare uses a Star Rating System on a scale of 1 - 5 stars to determine how well Medicare advantage and Medicare Part D prescription drug plans perform. Plans with higher ratings get perks (year round open enrollment, financial bonuses). Part D rating based on several quality measures and can change from year to year. Quality measures related to drug therapy include: Annual CMR for patients enrolled in MTM program. Pharmacists providing CMRs can use three CPT for billing when there is face-to-face MTM. Codes document services and can be used to bill health plan that included Part D Adherence to non-insulin diabetes meds, statins, and RAAS antagonists (including ACE-I, ARBS, and aliskiren) Appropriate use or avoidance of high-risk medications in ≥ 65 Ensuring statin use in patients with diabetes age 40-75 years old

Furnishing emergency contraception

Meds approved for emergency contraception (EC): levonorgestrel and ulipristal. Alternatively, pharmacist can furnish high-dose birth control pills off-label to be used as EC. Ulipristal (Ella) is available by prescription only. Both medications have similar efficacy during the first 72 hors (3 days) after unprotected intercourse. Both can be recommended up to 120 hours (5 days) bu ulipristal is more effective after the 72 hours. Not shown to cause harm to developing fetus and does not impair a woman's ability to conceive in the future. If woman takes EX and does not have a menstrual period within 3 weeks, she should get a pregnancy test OTC option: Plan B One Step and similar products can be purchased OTC without sex, age or identification requirements. Some fo the generic formulations state the product is intended for women 17 and older but it is not a sale restriction. For the two-tablet levonorgestrel products, there are still age restrictions and these must be kept behind the pharmacy counter. Pharmacy staff must check ID to ensure the person purchasing is 17 or older. Prescription option: Pharmacist dispenses EC as they would other prescription drugs. Under the ACA/Obamacare, EC is only covered with a prescription written for a female patient. The only insurance plans under the ACA (can be found in Covered California) that may not cover EC are grandfathered health plans or religiously-exempt employer health plans. Protocol option: Patient can choose this if she does not have a prescription and wishes to use prescription coverage. Pharmacist must have completed 1 hour of CE on emergency contraception. Pharmacist must ask and communicate the following to the patient: Are you allergic to any medications? Treatment can begin up to 5 days (120 hours) after unprotected intercourse EC use will not interfere with an established or implemented pregnancy If more than 72 hours have passed, Ella may be preferred. For other options for EC, consult with your healthcare provider Follow up with your healthcare provider after the use of EC EC can be furnished for future use. Pharmacist can provide up to 12 non-spermicidal condoms. Pharmacy should maintain inventory of EC medications and adjunctive medications indicated for N/V. Higher incidence with estrogen-containing EC compared to levonorgestrel (progestin-only). Patients will need to be given info concerning dosing and potential adverse effects

Drug classes that can impair person's ability to operate vehicle or vessel and require warning on prescription label

Muscle relaxants Antipsychotic drugs with CNS depressant effects Antidepressants with CNS depressant effects Antihistamine, motion sickness, antipruritics, antiemetic, anticonvulsants and antihypertensive drugs with CNS depressant effects All controlled substances with CNS depressant effects Anticholinergics that may impair vision May cause drowsiness Alcohol may intensify this effect. Use care when operating a car or dangerous machinery

Furnishing naloxone

Naloxone reverses action of opioid including overdose symptoms and analgesia; in chronic users, abrupt reversal with naloxone will cause opioid withdrawal symptoms which can be severe. Protocol covers the FDA-approved naloxone formulations including injection, nasal spray (Narcan), and new auto-injector Evzio. Naloxone can be given if overdose is suspected due to respiratory symptoms of CNS depression. Prescribers must now offer naloxone with opioid prescriptions

Written, oral, electronic, and faxed prescriptions

Must have the following: Patient name and address Name and quantity of drug/device Direction for use Date of issue Prescriber info (rubber stamped, typed, or printed by hand or typeset) - name, address, and phone; prescribers license classification; DEA number if controlled substance Condition or purpose of prescribed drug if requested by patient Prescriber's signature If Rx is written by a vet for a controlled substance for animal, it must state kind of animal and name and address of owner or person with custody over animal If orally transmitted, pharmacists who received the prescription must initial the prescription. If dispensed by another pharmacist, dispensing pharmacist must also initial the prescription. Name or initials of the dispensing pharmacist must be documented for each prescription - either handwritten on duplicate copy of prescription label or use a unique login for electronic pharmacy workflow software which will electronically document who verified each prescription Prescription must be kept for 3 years

Handling hazardous drugs

NIOSH issues list of hazardous drugs that require special precautions to prevent work-related injury and illness. USP Chapter 800 has standards for handling hazardous drugs. Minimally a pharmacy or other setting handling HD must have the following: Closed system transfer devices and negative pressure ventilated cabinets. Hoods externally vent drug's toxic fumes with a negative air pressure - air moves away from staff near the hood PPE that includes chemotherapy gown, respiratory protection, goggles, two pairs of shoe covers, and chemo gloves. HDs will require either single or double gloves. Sterile HD needs double gloves - outer pair must be sterile. Safe work practices, spill kits, and disposal requirements

Patient counsleing

New drug, new strength or dosage form or new written prescription, if patient wants it, when pharmacist feels counseling is necessary Must include: Direction for use and storage Importance of compliance with directions Precautions and relevant warnings including common or severe adverse effects, interaction that can be encountered If prescription is mailed, there must be a written notice that a pharmacist is available if patient has any questions and a telephone number that the patient can call Pharmacies required to provide interpretive services during all hours the pharmacy is open - either in person by pharmacy staff who can communicate in patient's language or third-party interpretive service available by phone that is at or close to pharmacy counter Pharmacists not required to counsel inpatients but required to provide discharge counseling

Pharmacy clerk

Non-licensed person can type and enter prescription information into a computer, and request and receive refill authorizations. Clerk cannot pull drugs from shelf or fill, but can put drugs on shelf and give patients their prescriptions at POS. No max limits on number of clerks allowed to be in pharmacy at one time

Prescription refills

Non-scheduled drugs: cannot fill after one year from issue date but no refill limit Scheduled drugs: expires after 6 months from issue date. No refill limit with C5 but refill for C3-4 are limited to max 5 refills within 6 months and all refills combined cannot exceed a 120-day supply

Respiratory rate assessment

Normal: 12-20 breaths per minute. Can increase with asthma, COPD, anxiety, stress, HF, PNA, sepsis, ketoacidosis or stimulant drug use. Low RR can be due to opioids or hypothyroidism Can be measured by watching and counting number of times patient's chest rises and falls for 30 seconds then double to get per minute

Heart rate assessmenet

Normal: 60-100 BPM Tachycardia may be due to hypoglycemia, infection, dehydration, anxiety, pain, hyperthyroidism, anemia, arrhythmia, shock, caffeine or drug use Drugs that commonly cause tachycardia - stimulants, decongestants, beta-agonist over-use (albuterol), bupropion, antipsychotics and theophylline, especially with toxicity. Emotional or physical stress including BZD or opioid withdrawal will cause tachycardia. Reflex tachycardia occurs due to decrease/displacement of blood volume which causes heart to compensate by increasing HR to replace blood volume. Can occur with hydralazine, nitrates and DHP CCBs with strong vasodilation effects e.g. nifedipine IR Bradycardia may be normal for fit people. Can be due to organophosphate toxicity (pesticides) hyperkalemia, hypothyroidism, arrhythmia. Drugs that cause bradycardia: beta-blockers, non-DHP CCBs, clonidine, digoxin, antiarrhythmics including sotalol, amiodarone, and dronedarone, acetylcholinesterase inhibitors e.g. donepezil and guanfacine including the newer ADHD formulation Intuniv. Initiation of fingolimod (Gilenya) for MS requires first-dose monitoring for bradycardia which only occurs when drug is started or restarted. To measure: place index and middle finger on patient's radial artery (found on wrist) to feel radial pulse. Count for 30 seconds then double

Temperature assessment

Normal: 97.8 F (36.5 C) - 99 F (37.2 C) Hyperthermia due to fever, trauma, cancer, blood disorders, immune disorders, drugs Hypothermia due to cold exposure, excessive alcohol intake, hypothyroidism, hypoglycemia Tympanic membrane: quick, safe, reliable. Make sure ear canal is clear of earwax before aiming beam of thermometer at tympanic membrane. Wait 2-3 seconds Oral: preferred over rectal but not recommended when patients are restless or unable to close their mouth. If using electronic, place disposable cover over prove and insert thermometer under tongue, close both lips. Reading usually takes 10 seconds

Expiration dates for unit-dose containers

Per USP guidelines, BUD for unit-dose containers is no later than either of the following: One year from date the drug is packaged Expiration date on manufacturer's container

Switching formulations

Okay if selecting different formulation with same active ingredients of equivalent strength and duration of therapy as prescribed drug when changes will improve patient compliance

Patient assistance programs

Patient assistance programs (PAP) help low-income, uninsured patients get free or low-cost brand-name meds. Programs typically provided by pharmaceutical manufacturer that makes the drug. RxAssist.org

Consumer medication information leaflet

Per FDA, pharmacies need to provide useful written patient info to patients with each new prescription. CMI not reviewed or approved by FDA. To supplement oral counseling and provide basic info on what to expect

Pharmacy technician trainee

Perform everything a tech can do but must be under the direct supervision of a pharmacist. They must be supervised by a pharmacist. Each pharmacist can supervise 1 tech trainee at a time for 120 hours to 140 hours

Outsourcing facilities and section 503B

Permits specially licensed compounding facilities to operate as outsourcing facility to prepare medications in bulk and without a prescription written for individual patient as long as they meet requirements. To register as outsourcing facility under 503B, facility needs to be compounding sterile drugs for humans. The following requirements must be met: Compound in compliance with CGMPs Facility is licensed as an outsourcing facility by FDA and CBOP. Cannot be licensed as a sterile compounding facility at the same time - outsourcing facility cannot perform the functions of a pharmacy such as filling individual prescriptions for individual patients Subject to inspection by FDA and CBOP Preparations must be made by or under supervision of licensed pharmacist Must meet certain labeling requirements, drug reporting requirements, and adverse event drug reporting requirements

Pharmacist technician

Permitted to perform packaging, manipulative, repetitive, or other non-discretionary tasks under direct supervision of pharmacist. Non-discretionary = work does not include ability to make decisions according to technician's judgment

Pharmacies must inform consumers of lower costs of covered drugs

Pharmacist must make sure patients get lowest price available

Refusal to dispense based on religious, moral or ethical beliefs

Pharmacist's right to refuse dispensing certain meds (emergency contraception, oral contraceptives, abortive polls, ED drugs, and aid-in-dying) based on religious or moral grounds. In CA, pharmacist can refuse to dispense certain medications if he or she has previously notified his or her employer, in writing, and written protocols are established to ensure the patient has timely access to prescribed drug or device (another staff pharmacist can dispense it or referring the patient to a nearby pharmacy)

CLIA-waived tests

Pharmacists can perform blood glucose, A1C, and cholesterol tests that are waived under CLIA (clinical laboratory improvement amendments) - no California department of public health registration is required. All other CLIA waived clinical lab tests require CDPH registration

Duties and licensure of pharmacy staff

Pharmacists, interns, technicians, and technician trainees must wear name tags in 18-point type that contain their name and license status. All licensees must join board's email notification list within 60 days of becoming licensed

Dispensing drugs during a federal, state, or local emegencyr

Pharmacy law requirements can be waived during declared disasters and emergencies to ensure patients get their meds. A record with date, patient's name and address, and drug/device name, strength, and quantity dispensed. Board can allow deployment of a mobile pharmacy in impacted areas to ensure continuity of patient care if all of the requirements are met: Mobile pharmacy shares common ownership with at least 1 currently licensed pharmacy in good standing Retains records of dispensing A licensed pharmacist is on-site and management the pharmacy Reasonable security measures taken to safeguard drug supply Located within the declared emergency area or affected area Mobile pharmacy ceases activity within 48 hours after emergency is over

Patient med profiles

Pharmacy must keep med profiles on all patients who have prescriptions filled at the pharmacy except when pharmacist feels the patient will not come back to the pharmacy. Must keep profile for at least 1 year from the date when the last prescription was filled Need: Patient's name, address, telephone number, gender, date of birth, allergies, medical conditions Prescription drugs, OTC drugs, medical devices Other relevant pharmacist comments

Repackaging drugs in anticipation of receiving prescriptions

Pre-counted or poured (repackaged) from stock container to smaller quantities suitable for dispensing - often done for fast-movers so commonly dispensed drugs can be filled and dispensed quickly. Repackaging should be done according to Current Good Manufacturing Practices (CGMPs) and drugs must be properly labeled with at least the following: Drug name, strength, dosage form, manufacturer's name and lot number, expiration date, quantity per packaged unit

Dispensing blood clotting products for home use

Preferred method of treatment for hemophilia today is IV injection or infusion or prescription blood clotting products at a federally designated regional hemophilia treatment center. Time access and appropriate products/services in home reduces mortality and bleeding-related hospitalizations. Each provider of blood clotting products for home use must: Maintain 24-hour on-call services every day of the year, screen telephone calls for emergencies, acknowledge all telephone calls within 1 hour and have access to knowledgeable pharmacy staffing on call 24 hours a day to initiate emergency requests for clotting factors Ability to obtain all FDA-approved blood clotting products in multiple assay ranges (lope, medium, high) vial sizes Supply all necessary ancillary infusion equipment and supplies with each prescription as needed Ship products, equipment and supplies to patient within 2 business days

Medication/chart order for hospital pharmacies

Prescriber can handwrite order in physical paper chart or enter it into patient's electronic medical record. Can also issue face-to-face verbal and telephone orders. If verbal order is given to nurse, the nurse would enter the order, note the prescriber's name and sign the order. The prescriber has 48 hours to physically or electronically countersign the order. Copy of chart order for non-controlled substances kept at hospital for 3 years; controlled substances kept for 7 years.

Furnishing travel meds

Prescription drug must be for either a condition that is both self-diagnosable and self-treatable according to CDC, or for prophylaxis Must meet the following: Complete immunization certification program Complete approved travel med training program which must consist of at least 10 hours and cover each element of International Society of Travel Medicine's Body of Knowledge for the Practice of Travel Medicine Complete CDC Yellow Fever Vaccine course BLS certification 2 hours of CE focused on travel med separate from CE on immunizations and vaccines every 2 years Pharmacist must follow these steps: Provide good faith eval and assess travel needs according to patient's health status and destinations they will visit. Must include all info necessary for a risk assessment during pre-travel consultation Notify PCP of drugs dispensed within 14 days fo furnishing or enter info in a shared record system Provide patient with written record of drugs provided

Traditional compounding

Regulated by state board Standards/regulations: 503A, USP Needs individual prescription Interstate distribution allowed up to 5% of total sales

Pain assessment

Primary measurement for assessing pain is patient's own report along with behavioral observations. Ask patient to identify onset and temporal pattern, location, description (using patient's own words), intensity using a pain scale, and aggravating/relieving factors. Record previous treatments and effectiveness. Common for patients with chronic pain to have concurrent psychological and social concerns. Findings from physical assessment and any neurological and diagnostic procedure results should be included Wong-Baker FACS pain rating scale is a common tool to communicate pain level. Temperature scale (green to red) or simple numeric scale Physical exam: Involve inspection, palpation, percussion and auscultation Inspection using visual observation to note deformities or abnormalities in patient's physical appearance Palpation using hands to examine patient's body, such as palpating upper right quadrant of abdomen to assess liver for size, tenderness and masses Percussion is tapping fingers on patient's body, listening to sound produced to determine if tissue is air-filled (tympanic, drum-like sound), fluid-filled (dull sound), or solid (dull sound). Dull sounds can indicate solid mass such as healthy liver or presence of ascites. Auscultation is listening to internal sounds of patient's body (heart, bowel sounds) usually with stethoscope

DUR

Prospective DUR: evaluation of medication profile prior to dispensing. Performed by dispensing pharmacist every time a prescription is filled. Looks for therapy duplication, incorrect dosing, incorrect treatment duration, contraindications, interactions between drug/disease state, allergies, signs of abuse or diversion. Retrospective DUR: review after drug is dispensed. Conducted for many patients at one time and required by the state by a medical instruction or by an insurance company Concurrent DUR: on-going monitoring during course of the treatment. New regulation in 2018 requires hospital pharmacist to obtain medication profile for each high-risk patient to review appropriate use while in the hospital.

Traditional compounding and section 503A

Reason for use: medically necessary reasons such as changing formulation to make it easier for patient to take drug, avoiding a non-essential ingredient due to allergy or intolerance or preparing dose not commercially available. Traditional compounding used for these purposes and defined under section 503A of Drug Quality and Security ACT (DQSA). Traditional compounding is based on a prescription written for an individual patient. Section 503A allows pharmacists to prep small batches in advance if dispensing history supports the need (mainly for convenience). Traditional compounding includes: altering dosage form or delivery system, altering strength, combining components or active ingredients, preparing product from chemicals or bulk drug substances. Pharmacies can sell reasonable quantity of compounded preparations to prescribers for administration or application to patients (humans and animals) in the prescriber's office. Prescribers cannot buy compounded meds from pharmacies to furnish/dispense to human patients. Prescriber's office needs to send a purchase order or other document that lists patients that need the preparation. Quantity for each patient should be specified. Veterinarians can purchase compounded preparations for the purpose of furnishing/dispensing up to a 120-hour supply (5 day supply) to their own vet patients. Must indicate how many patients they anticipate needing the compound for and must also indicate how much they anticipate ushering per vet patient (for office use and for furnishing) What does not count as compounding: Reconstitution according to manufacturer's directions Splitting tablets Adding flavoring agents Drugs made with traditional compounding have 3 exemptions from requirements that apply to prescription drugs: Complying with FDAs current good manufacturing practices (CGMPs) Labeling with adequate directions for use The need to complete a New Drug Application in order to have the end product FDA-approved Can compound patient-specific parenteral therapy. Pharmacy enters into a contract with another pharmacy to compound a drug for parenteral therapy. Label must include the name of both compounding pharmacy and dispensing pharmacy

Manufacturing

Regulated by FDA Standards/regulations: FDA drug approval process, labeling with adequate directions for use, CGMPs Does not need individual prescription Interstate distribution allowed

Outsourcing facilities

Regulated by FDA and state board Standards/regulations: 503B, CGMPs, USP Does not need individual prescription Interstate distribution allowed

Refill pharmacies

Retail pharmacies can use a central fill/refill pharmacies to prepare new prescriptions and refills. If the two pharmacies use a common electronic file, P&Ps must be in place to prevent unauthorized disclosures. Originating pharmacy and refill pharmacy must have contract outlining refill arrangement, or pharmacies must have the same owner. Both pharmacies are responsible for accuracy of the refills. Originating pharmacy responsible for counseling, marinating medication profiles, and performing DUR before delivery

Initiating and administering immunizationa

Routine immunizations are those recommended by the advisory committee on immunization practices (ACIP) and published by the CDC. Pharmacist can initiate and administer epinephrine or diphenhydramine by injection to treat a severe allergic reaction To administer vaccine, must: Complete CDC or ACIP-approved immunization training program Maintain basic life support certification Complete 1 hour of continuing education on immunizations and vaccines every 2 years Pharmacist must comply with the following recordkeeping and reporting requirements: Pharmacist must notify each patient's PCP and each pregnant patient's prenatal care provider (if applicable) within 14 days of administration of any vaccine. If no PCP, pharmacist shold advise patient to consult with healthcare provider of their choice Report the administration of any vaccine to the California Immunization Registry (CAIR). Pharmacies must enroll in CAIR Patient vaccine administration record must be kept and readily retrievable during pharmacy's normal business hours. A pharmacist must provide each patient with a vaccine administration record

Pharmacist

Safe and proper dispensing of medications. Get new scripts, interprets prescriptions and clinical data in patient's medication records, consults with other healthcare professionals, performs drug utilization reviews, counseling, and supervises pharmacy staff. In smaller pharmacies and their is only one pharmacist on duty, pharmacist can leave for breaks and meal periods up to 30 minutes. Pharmacy can stay open and pharmacist does not need to stay in pharmacy area during the break. Ancillary staff can stay in the pharmacy if pharmacist believes that the drugs and devices will be secure when they leave. Staff can continue to perform non-discretionary duties. Only refill medications that pharmacist has already checked and don't need consultation can be dispensed. New law passed in 2018 that prohibits a community pharmacy from requiring pharmacist to work alone. It requires that another employee of either the pharmacy or establishment be made available to assist pharmacist at all times with some exceptions. SB493 expanded scope of practice for all registered pharmacists and created new type of license called APP. Under SB493 RPhs can provide the following services after meeting certain training requirements: Administer drugs and biological when ordered by prescriber. (PO, topicals, injection) Consultation, training, and education about drug therapy, disease management and disease prevention Participate in multidisciplinary reviews of patient progress (including appropriate access to medical records) Furnish self-administered hormonal contraceptives including PO, transdermal, vaginal, and injections Furnish travel meds recommended by CDC and do not require diagnosis Furnish Rx NRT for smoking cessation, including inhaler and nasal spray Independently initiate and administer immunizations published by CDC to patients 3 years and older. Physician protocol still required to administer immunizations to children younger than 3 years Order and interpret tests for monitoring and managing efficacy and toxicity of drug therapies in coordination with PCP or diagnosing prescriber To be licensed, candidate must have completed 1500 hours of pharmacy practice experience and 900 of the hours must be completed in a pharmacy with experience in community and institutional setting. Intern pharmacists that graduated after January 1, 2016 from ACPE-accredited school of pharmacy must be deemed to have satisfied pharmacy practice experience hours. 30 hours of continuing education must be completed during each 2-year license period. For license renewal after July 1 2019, at least 2 hours of pharmacy law and ethics must be included with each renewal. License expires on last day of pharmacist's birth month. The first 2-year license cycle is exempt from CE requirements since pharmacist is considered up-to-date. Certificate of completion of CE's must be kept for 4 years. Pharmacist must disclose on renewal form if any government agency issued any disciplinary action against any of their licenses that results in restriction or penalty being placed on license (revocation, suspension, probation, public reprimand, reproval). Must disclose on license renewal form if they have been convicted of any violation of law except for traffic violations that do not involve alcohol or controlled substances. pharmacists can supervise: 2 interns Community - 1 technician; every additional pharmacist can supervise 2 more technicians Hospital - 2 technicians per pharmacist 1 tech trainee at a time and for a 120 to 140 hour training period

Other drug cost-saving strategies

Same drug can be less expensive at a different pharmacy, may be useful to do a cost comparison Using generic equivalent of a brand name drug Suggest to prescriber a therapeutically similar but less expensive drug Purchasing a greater day supply (90-day instead of 30-day) if copay is the same

Depression screening

Screening consists of asking patient a series of questions which is scored. At risk for depression include substance abuse, other mental health conditions, pain, cancer or heart disease. In elderly, long-term health changes that impair functional level increases risk of depression, as does loneliness, grief and insomnia. Women who are pregnant or postpartum are at risk for depression and should be screened. Women and younger adults have higher risk. Most commonly used screening for adults is the Patient Health Questionnaire (PHQ-9) - simple check off form that correlates to score that indicates depression risk

Unit-dose containers

Should have the following: Date med was prepared BUD Name of drug Quantity of each active ingredient Special storage/handling Lot/control number assigned by centralized hospital packaging pharmacy Name of centralized hospital packaging pharmacy

Technician checking technician programs

Techs who got specialized training can participate in tech check tech (TCT) program in hospital settings. TCT can be done on unit-dose distribution system, floor stock or ward stock. Permitted only in acute care hospitals that have ongoing clinical pharmacy program and which has pharmacists located in patient care areas. Techs involved with TCT cannot approve orders, just confirm accuracy of the filling. Pharmacist must check compounded and repackaged drugs before tech uses it to fill unit-dose distribution systems and floor/ward stock. 1 tech is permitted for the first pharmacist on duty and 2 techs permitted for each additional pharmacist in community setting. E.g. 1 pharmacist = 1 tech; 2 pharmacists = 3 techs; 3 pharmacists = 5 techs. 2 techs: 1 pharmacist in institutional setting

Test ordering, interpretation, and management

Testing should be for ensuring safe and effective med therapy along with PCP or diagnosing provider Test only ordered when necessary Results must be managed appropriately and promptly and patients should receive feedback on their tests in timely manner Quality assurance should be integrated into test ordering, interpretation, and management process All actions related to test ordering, interpretation and management, including changes in drug treatment, must be documented in 24 hours in a system accessible to healthcare team members. The EHR should be available in the pharmacist's work setting. Pharmacists should include interpretation of result, rationale for decision, information provided to patient and healthcare team members

Centralized hospital packaging

The board has created a specialty license for a hospital pharmacy to perform centralized packaging for pharmacy's hospital and one or more general acute care hospitals under common ownership and located within a 75-mile radius. The centralized pharmacy can prep and store a limited quantity of unit-dose drugs in advance of a patient-specific prescription in amounts necessary to ensure continuity of care. Unit-doses reduces drug diversion, drug waste, and med errors. Barcoding essential for hospital safety - helps verify the right drug is given to right patient. Any unit-dose produced by centralized hospital packaging pharmacy must be barcoded to be machine readable at the inpatient's bedside using barcode med administration software.

Antimicrobial stewardship programs

The misuse of antibiotics contributes to spread of antibiotic resistance and creation of superbugs. Antibiotic stewardship programs (ASPs) ensure that hospitalized patients receive the right antibiotic at right dose at the right time and for the right duration. Culture and susceptibility data can be used to determine the antibiotic with the narrowest possible spectrum for continuation of therapy

HIPAA health insurance portability and accountability act

To protect health information while allowing the flow of data needed to provide high quality healthcare. Violation of HIPAA inadvertently or deliberately can result in fines up to $50,000 per violation and imprisonment up to 10 years. Individual at each facility must be designated to enforce privacy policy Protected health information includes private information in electronic, verbal, written form. Includes: Patient's past, present, or future physical or mental health condition (medical records) Healthcare provided to the patient (lab tests, surgeries) Past, present, or future payment for providing healthcare to the patient which can identify the patient (hospital bill) If identifying info is not related to health information, it is not considered PHI e.g. phone number, residential address, name but must still be secure and not available to viewers who do not require access. Examples of HIPPA violations: Prescription labels with patient identifiers in the regular trash Pharmacy employees looking around in celebrity patient records for non-work purposes Pictures or health records about patients posted on social media sites Minimum necessary info required for the job is what should be shared. Minimum necessary is designed to encourage staff to evaluate who should be accessing patient records Examples when it is permissible to share PHI: With patient Other healthcare providers providing care to patient When necessary for treatment, payment or operation (TPO) purposes Other persons when authorized by patient As part of a limited data set for research, public health or institutional operations For public health need including natural emergencies If the release of PHI is not for TPO purposes, pharmacist must receive patient's written authorization prior to release Incidental disclosures are not HIPAA violations - being accidentally overheard when counseling a patient, discussing patient's care during medical rounds. Prescriptions can be picked up by family or friend unless pharmacy has reason to believe that this would be against patient's wishes HIPAA requires a site-specific notice of privacy practices to protect patient info and to make known whom it may be shared with. Privacy notice must be given to patient on first day that service is provided. Pharmacy must make good faith effort to obtain patient's written acknowledgment that they received primary notice. Pharmacy cannot deny service if patient refuses to sign. Patient has right to obtain copy of their records. CA patients must be able to inspect their medical records within 5 business days or making written request and receive copies within 15 business days.

Patient package inserts

Widespread use began with estrogen-containing birth control pills and the clotting/VTE risk. FDA requires pharmacies to provide PPI to patients whenever estrogen-containing drugs are dispensed in the outpatient setting. Approved by the FDA. In institutional setting, PPI must be provided to patient before administration of first dose of estrogen-containing medication and every 30 days thereafter.

Administering injectable drugs and biologics

With SB493, all pharmacists can administer drugs and biologics by other routes including injection. If pharmacist will be administering injectable drugs and biologics as part of their practice, they should receive adequate training IM injections in adults given in deltoid muscle. Adults require a 1" needle of a 1.5" needle for women greater than 200 pounds or men greater than 260 pounds. Use a 22-25 gauge needle inserted 90 degrees. SC injections are given in the fatty tissue over the triceps with a 5/8" needle 23-25 gauge at a 45 degree angle.