1
Q
Corresponding Responsibility
A
- Legitimate medical purpose by individual practitioner acting within usual scope of their practice
- Proper prescribing/dispensing of CS is on prescribing practitioner; BUT corresponding responsibility on pharmacist to ensure script is valid further than valid DEA number
- Recognize red flags that require further investigation to legitimacy of CS scripts
2
Q
Practitioner that can Prescribe CS (TX)
A
- Physicians (MD or DO)
- Dentists
- Podiatrists
- Vets
- Therapeutic optometrists or optometric glaucoma specialists
- APRN and PAs in Texas (CIII-CV and CII in SOME settings)
3
Q
Designated Agents
A
- Communicate CIII-CV when electronic prescription isn’t required (not authorize or prescribe)
- CANNOT verbally communicate emergency CII to pharmacist, this task CANNOT be delegated
- There must be written, formal appointment of the agent by the prescriber if not employed by them (think LTCF or nursing homes)
4
Q
Acute Pain Prescription Limits
A
- May not exceed 10-d supply
- Predicted/physiological response to trauma/disease/operation
- DOESN’T include chronic pain, cancer pain, hospital/EoL care, palliative care, or treatment of substance addiction (approved by FDA)
- Dispenser cannot be penalized for filling/refusing to refill a script that exceeds these limits
5
Q
Changing Info/Information Omitted
A
- Applies to paper and electronic records (documentation required to be made in electronic record)
- Strength/dosage form/quantity/directions can be changed if pharmacist contacts practitioner to get permission and documents on script that change was authorized by whichever individual and pharmacist initials this
6
Q
CS Items that CANNOT be Changes
A
- Name of Patient
- Name of drug
- Name of prescribing physician
- Date of script
7
Q
Mandatory Electronic Scripts for CS
A
- TEXAS: All scripts for CS must be electronic as of January 2021
- UNLESS exemption applies or in emergency cases
8
Q
Electronic Script Exemptions (11)
A
- Written by vet
- Temporary tech/electronic failure
- Written by prescriber outside of Texas
- Prescriber/dispenser at same location under same license
- Necessary elements aren’t supported by national data standard
- DEA requires additional info on script that can’t be done electronically
- Non-patient-specific scripts that are related to standing order, approved protocol, collaborative drug management, or public health emergency
- Drug under research protocol
- Waiver received for requirement (issued by agency that licenses practitioner and last 1 year)
- Electronic scripts are impractical for patient and delay could adversely impact patient’s medical condition
- Medical order written for patient who is admitted to hospital at time order is written/filled
9
Q
EPCS
A
- Electronic scripts for CS, including CII, are valid if both computers used meet all DEA security requirements
- Prescriber and pharmacy requirements, see flashcards
10
Q
Prescriber Security Requirements
A
- Third-party certification system
- Credentialing to verify a provider has authorization to prescribe controlled substances
- Two-factor authentication for providers who sign EPCS script
11
Q
Pharmacy Security Requirements
A
- Third-party certification system
- Ability to sign/archive CS scripts
- System must electronically accept/store all information DEA requires to document dispensing of script
- System must allow pharmacy to limit access for annotation, alteration, or deletion of CS to specific individuals/roles
- Internal audit trail that documents script altered/received/annotated/deleted
- Internal audit daily to identify potential security problems (system generated report every few days of pot. problems)
- Pharmacy system backed up daily
- eRx records kept electronically, hard copy NOT REQUIRED to be kept
12
Q
Written CS Scripts
A
- Must be manually signed/dated (issue date) by practitioner
- Pharmacists may not pre-populate controlled substance script with all required information to then fax/send to practitioner to sign
13
Q
Written CS Scripts must have… (FEDERAL)
A
- Full name/address of patient
- Drug name/strength/dosage form
- Quantity
- Name/address/DEA of practitioner
- Earliest fill date for CII if applicable
14
Q
TEXAS Requirements for Written CS Scripts
A
- Quantity written numerically and in words (if not written, needs to be verified by pharmacist)
- DOB or age of patient
- Practitioner phone number at usual place of business
- Intended use of drug unless practitioner determines furnishing this info isn’t in best interest of patient
* *2-4 for ALL scripts in Texas, not just CS**
15
Q
Verbal CS Scripts
A
- For emergency use, must get written copy w/in 7 days
- CIII-CV okay to get verbal
- TCSA technically only allows CIII-V verbal if emergency but TSBP allows the fill to occur… must get electronic or written script within 7 days due to TCSA rule
16
Q
Faxed CS Scripts
A
- Generally treated the same as verbal scripts
- CII faxed scripts only allows in limited circumstances
- CIII-CV technically allowed to be faxed federally but TCSA requires emergency use
- Original prescriber signature must be provided
17
Q
CII Written Scripts
A
- Must meet one of the exceptions to electronic prescribing (previous flashcard deck)
- Issued on Texas Official Prescription Form and signed by pracitioner
- No refills, per Texas must be filled within 30 days of date issued/first date to fill
- Can write multiple CII scripts on one date, but max of 90-DS and earlier fill dates must be specified (no quantity limits per Texas law)
18
Q
CII Faxed Scripts
A
- Treated the same as verbal and therefore aren’t allowed for CII scripts
- Exceptions: narcotic to be compounded for direct administration to patient (IV, IM, SQ, inf…), utilized for LTCF patient, or being enrolled in hospice care (not necessarily facility, can be at home) certified/paid for my Medicare or licensed by the state
- Practitioner or agent can notify that hospice patient
- Texas Official Prescription Form still required
19
Q
Emergency Dispensing of CII
A
- Practitioner can call in CII in emergency situation
- Emergency meaning immediate administration of drug is necessary for proper tx of patient, no alternative is available, and written script can’t be provided at time
- Quantity given must be limited to what is needed to treat patient during emergency
- Order must be reduced to writing and have all info sans signature of practitioner
- Make reasonable effort to ensure phone authorization is coming from valid prescriber
- Get valid electronic prescription within 7 days of emergency from practitioner, if not received contact nearest DEA office
20
Q
72-Hour Rule
A
- Can give partial quantity of CII to patient as long as remaining quantity is provided within 72 hours
- If remaining quantity can’t be provided, contact provider
- Includes emergency verbal scripts
- Must be ready within 72 hours limit, but patient doesn’t have to pick up within 72 hour timeframe
21
Q
30-Day Rule
A
- Can provide partial quantity of CII to patient if requested by provider or provider, patient can pick up additional quantities for up to 30 days
- Total quantity dispensed may not exceed original quantity prescribed
- Applied to written and eRx, but not emergency supplies
22
Q
60-Day Rule
A
- Terminally-ill/LTCF patients, allows partial fills of CII as many times as needed as long as partial fills are recorded on prescription or maintained on computer system
- All partial fills must be completed within 60 days
23
Q
Texas Official Prescription Forms
A
- Must be used for written CII scripts in Texas
- Contain unique control number, pantograph with VOID if copied, thermochromic ink with Rx on front that disappears briefly if rubbed, and watermark of Seal of Texas visible with regular light
- Still valid if another drug is also written with CII on form, but a direct image of script must be kept in each file category in pharmacy’s prescription records
24
Q
Exemptions to Use of Official Rx Forms (8)
A
- Hospital inpatient medication orders
- Hospital inpatients requiring emergency quantity of CII upon discharge (7-DS and filled by hospital pharmacy)
- Tx received from emergency helicopter, ambulance, or paramedic medical team
- Tx received while inmate in correction facility operated by TX Dep of Criminal Justice
- Animals admitted to hospitals/facilities
- Therapeutic optometrist administering topical cocaine as permitted under Texas Optometry Act
- Rx from out-of-state if pharmacy has TSBP approved plan
- eRx
25
General CIII-CV Rules
- Expiration 6 months after date of issuance
- Must be electronic unless exemption met or prescriber has waiver (then written)
- 5 refills or 6 months, unless opioid for acute pain use
- Allows emergency refills for specific circumstances
- Classes IV and V can have automatic refills
26
Verbal/Faxed Scripts: CIII-CV
- TSCA only allows CIII-CV to be verbal in cases of emergencies; however, pharmacist doesn't have to verify that script is exempt from electronic submission
- Therefore, TSBP states that pharmacists can dispense CIII-V scripts from a valid verbal prescription
- Due to TSCA's specification, need a written script provided within 7 days
- TCSA also requires emergency use for faxed scripts and for prescriber's original signature to be present
27
Transfers: CIII-CV
-Transferred to another pharmacy ONE time
-IF they share online database of scripts, can transfer up to number of refills permitted by law/prescriber
-Only refills can be transferred, not the original script
(Exception: if both pharmacies have EPCS forwarding/receiving capabilities, then even okay w/ CII)
28
OTC Sale of CV
- In Texas, stricter laws about limits for opium products (codeine in cough suppressants)
- Therefore, no commercially available CV products that can be purchased without a script here (therefore TSBP doesn't enforce the federal law associated with this since you MUST have a script for CV here)
29
PMP
- Texas PMP is administered by TSBP and collects dispensing data on all CII-CV products from Texas pharmacies and/or for all Texas residents (even if filled out of state)
- Help identify pts visiting multiple providers/pharmacies
- Pharmacists and those acting at their discretion can access PMP AWARxE portal on TSBP website
- Unauthorized access of PMP is a violation of TCSA/Texas Pharmacy Act/TSBP rules
30
Mandatory Use of PMP
1. Practitioners/Pharmacists must check PMP before prescribing/dispensing carisoprodol, benzos, barbituates, or opioids
2. Not required if diagnosed with cancer or sickle cell disease or in hospice and this is indicated on Rx
3. Unable to access PMP after good faith effort to do so
4. Dispensing pharmacist responsible for review unless another designated pharmacist has been recorded in computer system as doing so
5. If PMP is integrated into pharmacy management system, reviewing this integrate data meets the requirement
31
Electronically Sending CS Info to TSBP
- Must transmit dispensing information no later than the next business day after script was COMPLETELY filled
- If no CS dispensed in last seven consecutive days, send a report to TSBP saying so unless waiver received
- Must submit correct dispensing data to PMP w/in 7 days of identifying omission, error, or inaccuracy
32
Required CS Info to Submit to TSBP (8)
1. Official Rx control number
2. Prescriber's DEA
3. Patient's name/animal owner, age/DOB, address (all info)
4. Date prescription was issued/filled
5. NDC of substance dispensed
6. Quantity dispensed
7. Pharmacy Rx number
8. Pharmacy DEA
33
Methadone
- Used for severe pain and detoxification/maintenance of narcotic addicts
- Any pharmacy can stock methadone for pain tx
- DEA requests 40 mg methadone is ONLY sold to hospitals and narcotic tx centers
- Can only be dispensed for narcotic addict tx at narcotic tx centers
- These centers must be registered with DEA by CSAT and with the Texas Department of Health/Human Services in Texas
- Prescriber may administer methadone for a 3 day period only until enrolled in a tx program
- Hospitals can administer narcotics to dependent individuals for detox/maintenance if being treated for a condition that ISN'T addiction
34
Short vs Long-Term Detoxification
- Short-Term: dispensing narcotic in decreasing doses over a period not to exceed 30 days
- Long-Term: dispensing narcotic in decreasing doses over a period of 30-180 days
35
DATA 2000
- Allows office-based, trained practitioners to prescribe certain narcotics (CIII-V) to opiate dependent patients in conjunction with counseling/behavioral therapy (MAT)
- These practitioners = "Qualified Practitioner" - apply for a waiver with SAMHSA => provided with "X" code DEA
- Can verify DATA waiver on SAMHSA's Buprenorphine Pharmacy Lookup
- Only allowed drugs: Subutex (buprenorphine) or Suboxone (buprenorphine + naloxone) - CIII
- QP can treat 30, 100, or 275 patients based on their authorization
36
Additional DATA Info
- Pharmacies can deliver medications to QP for patient injection/implantation... if CS must be administered within 14 days of delivery
- HHS allowed QP who treat no more than 30 patients to apply for a waiver to reduce DEA certification requirements
- DATA-waived APRN/PA must be supervised by a DATA-waived physician
37
Combat of Meth Act
- 2005 (3.6 g/d and 9 g/month)
- If PSE held in locked cabinet on floor, must be within 30 feet and in direct sight of pharmacy
- Texas requires purchasers to be at least 16 yo
- Must be in blister/unit-dosed packaging (excluding liquids... including in gel packs)
38
Logbook Requirement for PSE Products
- Must maintainer electronic/written log that identifies product name, quantity sold, name/address of purchaser(s), and date/time of sales
- Not needed for single "convenience" package sale with <60 mg PSE
- Purchaser must present valid photo ID and sign the logbook (enter the above info)
- Retailer must verify name in logbook corresponds to ID
39
Mail/Mobile Retail Vendors
- Mail service must confirm identity of purchaser(s)
- Mobile vendors ("flea markets") must place product(s) in locked cabinet
- Both must limit sales to 7.5 g/month
40
Delivered Prescription Requirement - Texas
- Record name of authorized delivery person
- Person known to pharmacist/intern/delivery person
- Address if mailed
41
Inspection Differences DEA/TSBP
- DEA must get pharmacist consent to inspect financial, sales, and pricing data
- TSBP doesn't need pharmacist consent to inspect financial records in course of an investigation of a complaint
Texas MPJE
flashcards
Decks in class (11)
# Cards
-
Ch 1: Federal Laws51
-
Cont. Ch 153
-
Ch 2: Controlled Substances50
-
Cont. Ch 241
-
Ch 3: Texas Dangerous Drug Act (TDDA)19
-
Ch. 4: Texas Pharmacy Act (TPA)54
-
Cont. Ch 443
-
Ch. 5: Complaints, Inspections, Penalities, etc.22
-
Ch. 6: Class A Pharmacy Rules26
-
Ch. 7: Other Classes of Pharmacy46
-
Ch. 8: Compounding Laws/Rules28
