The governor shall appoint 7 pharmacist (different setting!), and 4 public members, for a total of 13 members.
At least 5 of 7 RPh shall be actively practicing
One RPh must be from each of the following practice setting: community chain, LTC, hospital, independent pharmacy.
Members appoint for 4 years, and can not serve more than 2 consecutive terms. (just like U.S president)
Report to board w/in 30 days (except if a pharm declare bankrupt, report immediately)
Most of record keeping are retained 3 years (drug acquisition and disposition) except:
6 yr: HIPPA info
4 yrs: CE records
2 yrs: CS records, pseudoepherine logs, transfer of C.S. prescription
1 yr: non-CS records, pt med profile, quality assurance records
30 hrs CE per 2 year (40hrs for advanced RPh).
RPh license and pharmacy permit renews every 2 years (Even and odd years)
RPh
RPh may administer vaccine to person 3 y/o.
Rph may provide nicotine replacement product if certified in smoking cessation and completed 1 hr CE in this area biennially, notifies patient care provider of drugs and devices provided to pt., and maintain records for at least 3 years.
Can dispense epinephrine auto-injectors with a written order from a physician to school system exclusively for use in the school site.
RPh : tech = 1 : 1, Rph: intern = 1:2, can have unlimited # of clerks.
EC-emergency contraceptive can be sold OTC to >17 y/o, or under 17 with an Rx.
PIC completes biennial pharmacy self-assessment on odd number yrs, before 7/1.
PIC can manage 2 stores within 50 miles distance
RPh may administer vaccines listed on the routine immunization schedule for patients 3+yo
Rph may provide self-administered hormonal contraceptive under standardized protocols, if they completed a training program on E.C of at least 1 hr of continuing ed. Pharmacy shall not directly charge pt a consultation fee, but may charge admin fee < $10 (but not for patients who are insured)
Pharmacy operation
Store records can be stored off side if obtain an approval from bop, they must be retrievable w/in 2 days.
Dm - Dextromethorphan, otc sale for 18yo+, or Rx <18 yo
Advanced practice pharmacist can
Order and interpret drug therapy related test
Refer patients to other health care providers
Initiate, adjust, or D/C drug according to protocol ( and provide notification in pt record to prescriber)
Can register with DEA if initiate or adjust a C.S. therapy
Perform pt assessment.
Satisfy two of the following: residency, certification in a relevant area of practice, provide clinical service, filed an application as an advanced RPh
The position is valid for 2 years.
Prescribing
A prescriber can dispense a drug to an ER pt if
the hospital pharmacy is closed, it is in the best interest of patient, the qty of drug shall not exceed 72 hr supply, the prescriber is responsible for any error, and report to department of justice if the drug is a CII-IV.
Finish statement on security Rx: prescription is void if the number of drugs prescribed is not noted
Id number on security Rx pad are from the dept of justice, it is not tracked by state.
The designated prescriber who orders CS Rx forms must maintain records for 3 years
If prescriber doesn't have CS form and needs to prescribe a C.S., he can orally order or E order or fax, if it contains all required info. Rph must put into hard copy, and must receive rx by 7 days.
MD must hand write Date and Signature.
If for terminally ill pt, the C.S can be written on regular Rx form, and it must be filled w/in 60 days.
Persons authorized to issue a Rx
MD/DO, dentist, veterinarian, podiatrist, optometrist (license number starts a T)
Under a protocol : PA, NP, CNM - certified nurse midwives (only for peri-delivery and family planning needs), naturopathic doctors (no CII, must have "NDF" after license number。They don't need to write under protocol for epinephrine for anaphylaxis, hormones like thyroid, but NOT controlled testosterone) and pharmacists
The third party logistic provider is an individual
Completed a training program, at least 18 y/o
Provides warehousing or other logistic service for a drug or device in intrastate or interstate commerce.
Compound sterile drug
The license is renewed annually.
Provides to board of any disciplinary action w/in 10 days
Notify board w/in 10 days of suspension of any accreditation
Notify board w/in 12 hrs of recall notice of any sterile product
Report AE to the board w/in 12 hours and immediately to Med Watch program of FDA
The board shall review revisions of USP797 and the national formulary (USP-NF) about the sterile compounds no later than 90ds after the official revision.
A temp license may be issued if the ownership of pharmacy is transferred to another. The temp license may not exceed 180 days.
Recall of a sterile produce is 12 hours if :
Serious AE or death
The drug is dispensed directly to patient, prescriber, a pharmacy.
Compound sterile inj. From non-sterile ingredients.
ISO class 5 laminar airflow hood w/ a positive air pressure differential about adjacent area.
Barrier isolator provide ISO class 5 environment.
Surplus of med collection and distribution intermediary
The purpose is to facilitate donation of meds b/t participating entities.
They are exempt from licensure as wholesaler
The record shall keep on file for 3 years
Consulting pharmacist
Requires to visit the clinic regularly at least quarterly.
Certifies in writing at least twice a year of whether the veterinary food-animal drug retailer is operating in compliance
Control Substance
CURES - controlled utilization review and evaluation system: Effort to reduce Rx diversion of CII-IV (NOT CV). RPh must report weekly.
CII-V rx are valid 6 months, can get 5 refills or 120 days worth of refills (not including original Rx)
Oral and E order of CII is permitted for pts in skilled nursing facilities, intermediate care, home care, hospice.
CII rx must be filed separately from C3-5
When pt requests less that what is ordered by prescriber, Rph must contact MD for approval of smaller amount and indicate on Rx
S inventory is completed every 2 years. Records of C.s rx maintained at least 2 yrs.
Sale of C.S to other pharmacy or prescriber can not exceed 5% of total cs dosage unit dispensed per yr
If Cs Rx not obtained w/in 7 days of oral order, Rph reports to CA bureau or narcotic enforcement w/in 6 days.
Cs drug loss must be reported to DEA immediately, to CA bop w/in 30 days
Investigation of med error initiated within 2 business days.
Primary purpose of QA is error prevention
Records keep at least 1 yr
Automated drug unit at SNF or intermediate care facility
Licensed by dept. of public health
Drugs stored in an automated drug unit are part of pharmacy inventory.
Stocking is done by Rph, but restocking can be done by intern or tech under Rph supervision
Rph does not need to be physically present at the site and may supervise the system electronically.
Do not store: insulin, warfarin, high dose narc: eg hydromorphone 10mg/ml, morphine 20mg/ml
P&T - Pharmacy & Therapeutic committee
Formulary management
Therapeutic interchange
Educational updates on new drug
Quality improvement
Drug use evaluation
Tier 1, 2, 3
1: $5, 2. Branded drugs similar to generic. 3. specialty drugs >$35.
OTC syringes
To reduce the risk of infectious disease through needle sharing.
Syr can be provided to person Rph knows need (insulin users or for animal)
A MD or pharmD can furnish unlimited syringes, for 18 yo+, to prevent spread of STD.
Option in community for return Used syr: Pharmacies, Police and fire Dept, Public drop boxes and mail boxes, Hazardous waste pick-up days or collection sites
Compounding
Rph can prep and store a limited qty of drug in advance, only for the amount that is necessary to ensure continuity of care of an identified pt population.
Furnish a compounded drug to prescriber office, use for pt in precriber office: NTE 72 hr supply
Specific drugs
Neuromuscular blocking agents (vecuronium, succinylcholine etc) can only be given to pt who is already on both an analgesic and anesthetic.
Epinephrine (high alert med - assigned by ISMP) concentrations: 1mg/ml - 1:1000, 0.1mg/ml - 1:10,000
HIV meds need refrigerate: ritonavir (Norvir), lopinavir/ritonavir (Kaletra)
Thyroid med need refrigerate : thyrolar (Liotrix)
ADE Vs ADR Vs SE
ADE: an injury related to use or non-use of med
ADR: subset of ADE., includes any undesirable unintended or unexpected clinical manifestation associated with use of a med.
SE: common and less severe than ADR which is known complication that is rare and more severe.
FMEA - failure mode and effects analysis
Identify pathways that could lead to errors to identify ways to reduce error risk
Flushing drugs
Exposure to even low levels of drugs has negative effects on aquatic species. Dumping medicines in the toilet negatively affects human health. Disposing of medication waste properly is the law. Most streams, rivers and oceans bordering the U.S. have measurable concentrations of prescription and nonprescription drugs, steroids, and reproductive hormones.
A voluntary program that allows any health care professional to report a serious AE, product problem, med errors with the use of a FDA regulated product.
Mfg must file a report to FDA if an AR reported
Provides info on safety labeling changes to package insert.
ISMP - institute for safe medication practice
Contains a list of high alert med
Safeguarding
Use a single size infusion bag or concentration product
Use commercially prepared products
Centralize IV soln by prepare pediatric IV in pharmacy and outsources TPN and cardioplegic solutions.
Use Tall man letter
Use stickers, labels, markers to make products look different
