Pharmacist Drug Therapy Management and Prescription Guidelines, Exams of Nursing

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PA PHARMACY LAW PG 98-127 - DR.

GALLAGHER 2024

Independent Prescriptive Authority - correct answer✔✔ This group of prescribers have full prescribing authority that is not limited or dependent on any supervisory practitioner. Medication prescribing, however, must be conducted within the prescriber's scope of practice: a. Physicians (MD, DO)

• doctor of medicine
• doctor of osteopathy
• doctor of podiatric medicine
• doctor of dental medicine
• doctor of veterinary medicine
• psychiatrist
• ophthalmologists b. Inters and Residents
• authorized to prescribe only within scope of practice at facility
• name must be handprinted or stamped on Rx in addition to signature
• utilize DEA # of facility plus assigned internal code number Limited Independent Prescriptive Authority - correct answer✔✔ Optometrists (O.D)

1. 1st category - may not prescribe or utilize drugs in the course of practice - NO drugs at all

• License bears an "L"

2. 2nd category - use of pharmaceutical agents in the course of the examination is permitted for purposed of diagnosis, however NO prescriptive authority - CAN USE drug CAN NOT prescribe drugs

• License bears a "P"

3. 3rd category - Therapeutically Certified Optometrist - may prescribe and administer medications from a limited formulary as determined by the Department of Health

• License bears a "T"

• Max of 6 weeks from initiation of therapy, unless consultation with a physician
• NO C2s
• May NOT treat glaucoma

4. 4th category - Optometrists certified to treat glaucoma

• License bears a "G"
• can prescribe more than 3rd category Limited Depended Prescriptive Authority - correct answer✔✔ HCP can only operate under the direction of a supervising physician who is registered with the Board as the practitioner's supervisor. A written collaborative care agreement must be in place. Physician Assistants - limited dependent - correct answer✔✔ Written agreement with supervising physician must detail functions delegated to the PA as well as a list of the categories of medications which the PA is not permitted to prescribe.

1. If so authorized and noted int he collaborative care agreement: a. May initiate prescription for C2s limited to a 72 hour supply & must notify supervising physician within 24 hours b. May authorize up to 30 day supply of a C2 for therapy that is on-going and designation of "initial" or "ongoing" must be noted on face of the prescription if authorized by supervising physician.
2. Prescription Blanks must bear: a. name and license # of PA b. name and license # of supervising physician c. signature of PA followed by the initials pa-c d. DEA # of PA (if needed( e. PA must notify supervising physician within36 hours of the issuance of any non C2 prescription f. patient medican records (not the prescription) must be countersigned by supervising physician within 10 days g. supervising physician may not have primary responsibility for more than 4 PAs (unless waiver is granted) Certified Registered Nurse Practitioners - limited dependent - correct answer✔✔ Written collaborative agreement must be with physician and identify areas of practice, and categories of drugs from with

CRNP can prescribe. The agreement must be kept on site and filed with bureau of professional and occupational affairs.

1. A CRNP CANNOT prescribe from: a. gold compounds b. heavy metal antagonists c. radioactive agents d. oxytocics e. C1 Controlled Substances
2. Further Limitations: a. C2s are limited to a 30-day supply and collaborating physician must be notified within 24 hours b. C3-C5 limited to a 90-day supply c. CRNP may not delegate prescriptive authority
3. Prescription Blanks must contain: a. Name of CRNP printed on top b. Certification Number of CRNP c. Space for DEA # if necessary d. Identification of collaborating physician
4. Physician may not supervise more than 4 CRNP's with prescriptive authority at once. Nurse Mid-Wives - limited dependent - correct answer✔✔ Nurse Mid-Wife must apply and meet conditions for authority to prescribe. Written collaborative agreement must be with supervising physician and nurse mid-wife identifying category of drugs from with the nurse mid-wife can prescribe
5. Limitations - can prescribe only if detailed in protocol a. C2s limited to a 72 hour supply b. C3-C5 limited to 30 day supply c. Psychotropics may only be prescribed after consultation with collaborating physician
6. Prescription Blanks must contain: a. license number of the nurse mid-wife and the name and contact info, including phone #, as well as the initials C.N.M.

b. signature of the nurse mid-wife followed by the initials C.N.M. Pharmacist (general) - correct answer✔✔ The services permitted under Act 102 and Act 29 do NOT convey precriptive authority to pharmacists. Pharmacist - Drug Therapy Management in an Institutional Setting - correct answer✔✔ a. Must have a written agreement or protocol with a licensed physician, or pursuant to a medical order by a licensed physician, a pharmacist may engage in drug therapy management b. physician must have an active license and the scope of the agreement and protocol must be within the physician's scope of practice c. Pharmacist must maintain liability coverage in the minimum amount of $1,000,000 per occurrence or claims made. Pharmacist - Drug Therapy Management in an Institutional Setting - Written Agreement/Protocol requirements - correct answer✔✔ - be in writing, dated, signed by the pharmacist and physician and be filed with the Bureau of professional and occupational affairs

• specify the functions and tasks which are the subject of the agreement or protocol
• allow for termination of the agreement or protocol at the request of any part at any time.
• require that drug therapy regimens be initiated by a licensed physician. A pharmacist may not initiate therapy because they have no authority to prescribe/diagnose.
• require that patients be notified of pharmacist's role in managing their drug therapy
• require the pharmacist to notify physician of any drug therapy changes within 72 hours
• be renewed at least every 2 years
• be available at the pharmacist and physician's site, at the institution where the agreement or protocol is in place and to state agencies and any patient whose drug therapy is affected by the agreement
• further comply with State Board of Pharmacy Pharmacist - Drug Therapy Management in an Community Setting (Pending) - correct answer✔✔ a. Pursuant to a written collaborative agreement with a licensed physician a pharmacist may engage in drug therapy management in a setting other than an institutional setting
• this arrangement is commonly referred to as Collaborative Drug Therapy Management (CDTM)
• a CDTM must be initiated by a written referral from the physician to a pharmacist which must indicate the frequency in which the pharmacist must conduct drug therapy management services

b. Physician must have an active license and the scope of the agreement and protocol must be within the physician's scope of practice c. Pharmacist must have access to patient's medical records and must ensure patient confidentiality and all records must be properly maintained per electronic health care records requirements. d. Pharmacist must maintain liability coverage in the minimum amount of $1,000,000 per occurrence or claims made. e. A pharmacist may not provide economic incentives to a physician for purpose of entering into a CDTM Pharmacist - Drug Therapy Management in a Community Setting - Written Agreement/Protocol requirements - correct answer✔✔ a. Comply with the requirements for an Institutional Setting, which includes compliance with the applicable PA State Board of Pharmacy Regulations b. Specify the terms under which a pharmacist providing the management of drug therapy is permitted to adjust drug regimen or to adjust drug strength, frequency of administration or route without prior written or oral consent by the collaborating physician Pharmacist - Administration of injectable medications - correct answer✔✔ 1. Eligibility to immunize a. active pharmacist license in PA b. successful completion of a course of educations within 2 years prior to application

• include study materials plus hands-on experience
• successfully complete test
• complete a minimum of 10 hours of instruction
• ACPE must approve course
• Topics listed in notes pg. 106 c. possess a current CPR certificate Pharmacist - application and renewal - correct answer✔✔ 1. Formal Application to board with evidence of eligibility, renewable every 2 years along with license, 2 hours of CE relative immunization required, evidence of current CPR certificate

2. Limitations a. Immunization administration limited to persons who are 9 years of age or older, provided parental consent is obtained for the influenza vaccine. Other vaccines are for people 18 years of age and older. b. interns will be able immunize.

3. Immunization authorized by prescription order or written protocol a. prescription order must bear the following:

• Prescriber name, patient name, immunization, date of original order and schedule, if applicable, for subsequent administration

4. Pharmacy must notify prescriber within 72 hours of administration: patient name, medication administer, route, side, dose and date of administration
5. The written protocol is valid for 2 years and must be approved by physician or authorize medical staff of an institution contain required information.
6. Emergency Event a. pharmacist must notify physician within 24 hours of any adverse event or reaction experienced by patient
7. Immunization Record must include the required information and be maintained by the pharmacy. 2 ways you can immunize - correct answer✔✔ 1. Doctor's prescription
8. Via protocol with physician Required information in a written protocol for a pharmacist - correct answer✔✔ 1. identity of pharmacist and physician/institution
9. identification of medications to be administered
10. identity of patients authorized to receive medications
11. identity of routes and sites of administration
12. course of action for emergency situations
13. length of time patient must be observed for adverse events
14. identity of location for administration
15. record keeping procedures Immunization Record must include - correct answer✔✔ 1. name, address and birth day of patient
16. date of administration
17. site of injection
18. name dose, mfr, lot number, expiration date of medication

5. name and address of patient's primary health care provider
6. name/initials of pharmacist
7. documentation of informed consent
8. identification of vaccine information statement provided to the patient
9. date of publication of vaccine information statement
10. date and to who vaccine information statement is provided
11. when applicable, adverse reaction and who was notified Unauthorized to Prescribe - correct answer✔✔ 1. Chiropractors
12. EMT's/Paramedics
13. Psychologists Special Conditions - correct answer✔✔ Rx must be within the scope of the prescriber's practice Deceased or Retired Prescriber - correct answer✔✔ prescription dies with the prescriber a. once a license is inactive, a patient can no longer be considered to be under the prescriber's care b. new and refill prescriptions are no longer valid. Self-Prescribing - correct answer✔✔ frowned upon, but generally okay a. for a prescription to be considered valid, the board of medicine states that a valid and objective patient-prescriber relationship must exist b. self-prescribing or prescribing for family/friends is frowned upon and show me reserved for occasional emergency situations - usually okay Out-of-State Prescribers - correct answer✔✔ 1. PA recognizes prescribers appropriately licensed in their respective states and a pharmacist may fill the prescription so long as a valid patient-prescriber relationship exists
14. prescriptions written by prescribers licensed outside of the US are not recognized as valid and cannot be dispensed.

You can fill any prescriptions from any out-of-state prescriber as long as they are in the country. Agents of the prescriber - correct answer✔✔ 1. can verbally convey a prescriber order

2. cannot independently prescribe or authorize refills Illegal arrangements/agreements - correct answer✔✔ 1. compounding or dispensing of coded Rx's (doesn't happen anymore)
3. rebates or kickbacks for recommendation of services
4. health care prescribers with beneficial interest in pharmacy
5. supplying of Rx blanks to prescribers for advertising purposes
6. supplying equipment to prescriber (ex. dedicated phone line, fax, electronics) New Prescription Requirements - correct answer✔✔ 1. Name and address of the patients
7. Name/address of the prescribers
8. Name and quantity of Drug Prescribed (pharmacist may decrease quantity on prescription in accordance with 3rd party, insurance, restrictions)
9. Directions for use
10. Cautions communicated to consumer by means of auxiliary labels or other means
11. Date prescription dispensed
12. Name or initials of dispensing pharmacist
13. Controlled Substance Requirements (if applicable): a. prescription issue date b. strength and dosage form of medication c. DEA # of prescriber d. if patient is an animal - name and address of owner and species of the animal e. ink, indelible pencil, typewriter, computer f. manual signature of the prescriber, unless emergency, e-script or meets fax requirement exclusion. C needs a manual signature.
14. If a generic is dispensed: a. must include generic name dispensed and name of manufacturer

10. OBRA Requirements File Maintenance for prescription requirements - correct answer✔✔ 1. Prescription must be maintained in readily retrievable fashion for 2 years.
11. In an institutional setting the patient medical chard serves as the prescription record. Expiration date on C2s - correct answer✔✔ C2s may not be filled more than 6 months from the date of issue on the prescription Refill Prescription Documentations - correct answer✔✔ Must record on back of the prescription or in a computerized record keeping system:
12. date of refill
13. name or initials of dispensing pharmacist
14. quantity dispensed Refill Restrictions - correct answer✔✔ 1. Reasonable intervals - prescription cannot be refilled prior to time when contents should be completed
15. Handwritten designation
16. "prn" pr ad lib (12 refills) - may be refilled for 1 year from the date of the prescription. Refills may be authorized at any time during the 1-year period
17. Controlled drug substances - C2s are not refillable, C3-C5mot more than 5 times or 6 months from the date of issue, non-controlled no technical expiration date but for insurance purposes usually 1 year.
18. Time Restrictions - insurances carriers have own restrictions and limitation, acute illnesses - pharmacist must use professional judgment, Chronic medications - patient must be under prescriber's care to continue to receive medications refills.
19. Automatic stop orders in Acute Care Institutions or LTCF - drugs designated to be dangerous must be auto-stopped after reasonable time as determined by facility, prescribers must be notified within 48 hours prior to dose being stopped and given opportunity to continue medications Verbal Prescription Orders - correct answer✔✔ 1. C2 Substances a. for emergency orders and emergency supply only b. hard copy follow-up must be provided by prescriber within 72 hours.

2. Pharmacist a. a prescription by means of an oral order, telephone or otherwise, must be received and transcribed only by a registered pharmacist or pharmacy intern.
3. Institutions a. LTCF - verbal orders must be noted on patient record; signed and dated by receiver; countersigned by prescriber within 48 hours b. Acute Care - verbal orders must be noted on patient record; signed and dated by receiver; countersigned by prescriber within 24 hours. Faxed Prescription Orders - correct answer✔✔ 1. C3-C5 and Noncontrolled a. fax serves as original hardcopy for filing b. pharmacist must ensure authenticity c. quality of paper must be adequate for record keeping purposes
4. C a. original prescription required prior to dispensing, unless one of the following exception apply and in such a case the faxed copy can serve as the original record:

• narcotic for home-infusion
• LTCF
• hospice care program b. within an institution setting a fax for C2 may serve as the hard copy original Electronically Transmitted Prescriptions - correct answer✔✔ PA law follows federal law by permitting electronic prescriptions for all prescriptions including C2s, provided that the computer application utilized by the revoking pharmacy meets all DEA requirements. All prescriptions must include: a. signature or the electronic equivalent of the prescriber's signature b. information that is required to be contained on a prescription under state and federal law; c. prescribe's phone number d. date of transmission e. name of pharmacy intended to receive transmission f. electronic encryption

A hard copy or readily retrievable image must be stored for at least 2 years from the date of the last refill or activity. A pharmacist or pharmacy may not provide electronic equipment to a prescriber for the purposed of transmitting prescriptions. Computerized Record keeping Requirements - correct answer✔✔ Computerized Systems must: a. be capable of providing immediate retrieval of patient records within the last 12 months b. be capable of retrieval within 3 working day of patient records that are within the last 24 months. c. provide the info to be transferable to hardcopy within 3 working days

• DEA requires that controlled substances hardcopies be available within 48 hours.

4. provide for identification of the pharmacist responsible for computer entry of info
5. provide for safeguards to prevent unauthorized access or accidental erasure Central Fill Pharmacy - correct answer✔✔ 1. A pharmacy which is a part of a larger network of pharmacies that serves those pharmacies by serving to central fill and refill prescriptions, which includes preparation and packaging of medication.
6. May process request from patient, prescriber, or originating pharmacy a. conflicts with fed law regarding controlled substances
7. Must have a contract with or same owner as originating or delivery pharmacy
8. Rx container must bear name, address, phone #, DEA # of the delivering pharmacy
9. Operating policies and procedures must include prescription audit trial
10. All pharmacies involved must share a common electronic file
11. Delivering pharmacy must fulfill OBRA requirements. Central Processing Center - correct answer✔✔ 1. A pharmacy which is part of a larger network of pharmacies that serves those pharmacies by only processing prescription, not by actually filling prescriptions. a. must have a contract with or same owner as originating or delivery pharmacy b. operating policies and procedures must include prescription audit trial c. all pharmacies involved must share a common electronic file d. central processing pharmacies are exempt from:

• the requirement of maintaining an inventory of at least $5000 worth of nonproprietary drugs and devices
• minimum pharmacy size requirements
• sink used solely for pharmaceutical purposes only requirement. Automated Medication Systems - correct answer✔✔ Those systems which are used to store, package, dispense or distribute prescriptions Do you have to maintain records for drugs in a robot? - correct answer✔✔ Yes, you absolutely must. Robots are terrible at keeping their own inventory. If C2s are in the robot, at the end of the month do you have to physically take the pills out or can you rely on the robot's inventory? - correct answer✔✔ You must physically take all C2 drugs out of the robot for perpetual inventory. Prescription Labels - correct answer✔✔ 1. Name, address, phone #, and DEA #

2. Name of the patient
3. Full directions for use
4. Name of the Prescriber
5. Prescription file number
6. Date prescription originally filled
7. Cautionary statements, if any
8. Trade or brand name of the drug

• if generic, the name of the manufacturer must be listed

9. Strength, dosage form, quantity dispensed
10. For controlled drugs, the following statement "Federal law prohibits the transfer of this drug to any patient other than the patient for whom it was prescribed.:
11. Expiration date - one year from date of dispensing or if less than 1 year, the actually expiration date. Acute Care Institutional drug orders - correct answer✔✔ Unit doses are exempt

Other medication orders:

1. patient name
2. drug name and strength
3. dosing instructions
4. lot number Acute Care Institutional Parenteral - correct answer✔✔ 1. patient name, ingredient name, strength and quantity
5. diluent, expiration date, RPh initials Emergency Prescription Refills ONLY for non-controlled prescriptions that have no refill - correct answer✔✔ - Following Conditions must be met:
6. must make an attempt to obtain authorization from prescriber
7. cannot be a controlled drug substance
8. must be essential to maintenance of life
9. must be essential to continuation of therapy in chronic conditions

• Documentation Required:

1. date of refill
2. quantity dispensed
3. pharmacist's signature

• Quantity Limitations

1. One refill
2. 72 hour supply (max)

• Notification to prescriber must be with 72 hours Prescription Transfers/Copies Requirements - correct answer✔✔ 1. Prescription must be refillable

2. Cannot be a C2 controlled substance
3. Cannot require new prescription by law.

Prescription Transfers/Copies Record keeping requirements - correct answer✔✔ TRANSFERRING PHARMACIST

• cancel original prescription - "VOID" Record the following: a. name of receiving pharmacy b. name of receiving pharmacist c. date of transfer d. name or initials of transferring pharmacist RECEIVING PHARMACIST
• note the prescription is "TRANSFER" Record the following: a. prescription date of issue b. original dispense date c. original number authorized refills d. complete refill record e. number valid refills remaining f. original prescription number g. name of transferring pharmacy h. name of transferring pharmacist Prescription Transfers/Copies Controlled Drug Substances - correct answer✔✔ 1. Both transferring and receiving pharmacies must note complete pharmacy name, address, and DEA #

2. One-time Transfer

• exception: pharmacies electronically sharing a real-time, online database may transfer up to maximum number of refills permitted by law as authorized by the prescriber. Prescription Copies - correct answer✔✔ 1. Patient Copy: a. must clearly indicate on the face of the prescription that it is a copy b. cannot be used to obtain a new prescription c. original prescription must remain in the pharmacy files

2. Record keeping requirements: a. verify patient's identification b. note day of copy c. note to whom copy given d. note name of the pharmacist Exempt Narcotics - correct answer✔✔ 1. Restrictions: a. distribution must be made by a licensed pharmacist b. purchaser must be at lease 18 or older c. purchaser must present valid identification d. sale of C5 cough preparations require a prescription in PA
3. Quantity/time limitations a. no more than 240 ml (8oz) of any substance containing opium b. more more than 120 (4oz) of any other controlled substance in C5 within a 72 hour period
4. Proper Record keeping: a. name and address of the purchaser b. name and quantity of the controlled substance c. date of purchase d. name or initials of dispensing pharmacist
5. Maintain Record Book:

• 2 years from the date of last entry. Labeling for OTC Sale - correct answer✔✔ 1. Affix to bottle/container a. name and address of the pharmacy b. initials of the dispensing pharmacist c. date of sale d. dos not obscure any of the manufacturer's original labeling Poison Sales (schedules) - correct answer✔✔ 1. Schedule A

ex. arsenic, cyanides, mercury compounds, thallium

2. Schedule B - lab chemicals ex. HCl, HNO3, H2SO4, Acetic acid, KOH, NaOH, Chloroform, Ether, Formaldehyde Poison Sales - OTC conditions - correct answer✔✔ a. distribution must be made by a licensed pharmacist b. purchaser must be at least 16 y.o. c. must make inquiry of purchaser as to purpose of use Poison Sales - Labeling - correct answer✔✔ 1. "Poison" must appear in red ink
3. name of business
4. name of poison
5. do not obscure any of the manufacturer's original labeling Poison Sales - proper record keeping (bound logbook) - correct answer✔✔ 1. Schedule A poisons only: a. date of sale b. name, address and signature of purchaser c. name and quantity of poison sold d. statement of purchaser as to purpose of use e. name of the pharmacist dispenser f. list of antidotes maintained by the board. Hazardous Substances - correct answer✔✔ Under Federal Hazardous Substances Act, products for direct sale must be properly labeled "for household or consumer use" with all of the appropriate warnings and precautions attached Needles/Syringes - correct answer✔✔ The sale of hypodermic needles and syringes must be made by a pharmacist or under the direct supervision of a pharmacist in accordance with the following: a. they may be sold without a prescription

b. the must be kept in the prescription area of the pharmacy and be accessible only by pharmacists and pharmacy personnel authorized to be in the prescription area of the pharmacy while the pharmacy is open c. there is no mandated quantity limitation - however, many pharmacies make their own policies d. there is no record keeping requirements Paraphernalia - correct answer✔✔ Capsules, quinine, lactose (diluents) sold in unusually large quantities must be reported to the board of pharmacy. Medication Returns - Undelivered Medications - correct answer✔✔ 1. Medications that were never picked up by patient nor delivered by driver - can be returned to stock

2. If lot # and expiration date unknown, cannot mix with stock - keep in prescription bottle and make expiration date 6 months
3. can be maintained in repackaged container provided pharmacy has an internal method of identification and date
4. product must be re-dispensed within 6 months. Prescription Samples - correct answer✔✔ Cannot engage in the sale or purchase of drugs or devices whose package bears the inscription "sample" or "not for resale" Prepackaging Requirements - correct answer✔✔ 1. Must be used within own facility
5. Must be subsequently dispensed and relabeled as a Prescription for a patient
6. Not for direct sale to patient or to another licensed pharmacy
7. Performed under direct, personal supervision of a licensed pharmacist
8. Proper Labeling
9. Maintain Pharmacy Log Prepackaging Labeling Requirements - correct answer✔✔ 1. Name of drug, if generic, name of manufacturer
10. Strength of drug
11. Manufacturer's control number or other code control number
12. Expiration date

Prepackaging Pharmacy Log Requirements - correct answer✔✔ 1. Name of drug, if generic, name of manufacturer

2. Strength of drug
3. Manufacturer's control number or other code control number
4. Expiration date of medication
5. Date and quantity repackaged USP Guidelines for Prepackaging - correct answer✔✔ Repackaged medications are good for no more than 1 year or the manufacturer's expiration date which ever is less Mailing - correct answer✔✔ 1. First class/common carrier a. unless purchaser agrees to a slower method
6. Cannot ship reconstitution antibiotics
7. Cannot ship medications subject to deterioration due to heat, cold, fermentation, prolonged agitation
8. Must comply with postal regulations a. plain outer wrap with no markings that would indicate nature of contents Advertisements Requirements - correct answer✔✔ 1. Must be a licensed pharmacy/pharmacist to advertise prescription filling/refilling 2. cannot promote sale of controlled substances
9. must be for commercially reasonable quantity and include price per unit
10. percentile prices must include original price
11. cannot imply professional superiority
12. abide by all other federal, state, municipal restrictions