OHIO
PHARMACY PRACTICE ACT
- This set of code sections deals with the practice of pharmacy in Ohio
- Sections to be aware of will be listed on slides and in outline
- Sec 4729.01 Definitions
- Practice pharmacy
- Dangerous drugs
- Prescription
- Practitioner
- Price Information
- Wholesaler, manufacturer, and terminal distributor of dangerous drugs
Sec 4729.01 Definitions
(B) Practice Pharmacy - Pharmacist care
1.Managing drug therapy, interpreting RX’s
2.Dispensing and compounding drugs.
3.Dispensing devices.
4.Counseling patients.
5.Reviews of drug regimens.
6.Reviews of drug utilization.
7.Drug therapy advice.
8.Consult Agreement
(C) Compounding
the preparation, mixing, assembling, packaging, and labeling of one or more drugs in any of the circumstances listed in division (C)
(D) "Consult agreement"
an agreement to manage an individual's drug therapy that has been entered into by a pharmacist and a physician authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery.
(F) "Dangerous drug"
- A drug that may be dispensed only upon a prescription;
- Any drug that contains a schedule V controlled substance and that is exempt from Chapter 3719. of the Revised Code
- Any drug intended for administration by injection into the human body other than through a natural orifice of the human body.
(H) "Prescription"
A written, electronic, or oral order for drugs or combinations or mixtures of drugs to be used by a particular individual or for treating a particular animal, issued by a licensed health professional authorized to prescribe drugs.
(I) "Licensed health professional authorized to prescribe drugs" or "prescriber"
(1) A dentist
(2) An advanced practice nurse
(3) An optometrist
(4) A physician authorized under chapter 4731. of the revised code to practice medicine and surgery, osteopathic medicine and surgery, or podiatry;
(5) A veterinarian
(N) Price Information
(O) Wholesaler, manufacturer, and terminal distributer of dangerous drugs
Sec 4729.02 State board of Pharmacy
- nine members, eight of whom shall be pharmacists
- one of whom shall be a public member at least sixty years of age
- appointed by the governor for four years
- No member of the board shall be reappointed to the board more than once.
4729.08 Qualifications for pharmacist
- 18 years old
- Good moral character and habits
- Pharmacy degree
- Completed internship requirements
4729.09 Reciprocal registration
- Current certificate to practice and must have been registered by exam in other state
- Good moral character
- Similar credentials at time od registration
- Oher state must reciprocate with Ohio. Ohio does not reciprocate with Cal & Fla
4729.12 Identification Card and Certificate of Registration
- Renewed every year by September 15
- Must carry ID card with you at all times when practicing and certificate must be displayed at principal place of employment
- Lapsed for>60 days but <3 years - only have to pay fee to renew
4729.13 Renewal of Identification card after 3 year lapse
- If ID card lapsed for more than 3 years
- And if not actively practicing in another state
- Must take exam again
- Note - If registered and practicing in another state only needs to pay fee
- 4729.15 Fees for interns and pharmacists
- 4729.16 Revocation, suspension, probation, fine, refuse to renew
- Notice and opportunity for hearing
- Grounds spelled out in Section (A)
- Board can take action even if no court action taken
- 4729.27 Pharmcy must be conducted by RPh
- 4729.28 Unlawful selling of dangerous drugs
Section 4729.281 Pharmacist dispensing drug without a prescription; Conditions
Any drug other than a schedule II if:
1.Rx on file but no refill
2.R.Ph. Unable to obtain authorization for refill
3.(a) essential to patient’s therapy and
(b) failure to dispense would result in harm to patient
4.72 hour supply
5.Maintain record and notify prescriber
Section 4729.29 Prescriber dispensing and labeling
- When a prescriber personally furnishes drugs to a patient pursuant to division (a)(1) of this section, the prescriber shall ensure that the drugs are labeled and packaged in accordance with state and federal drug laws and any rules and regulations adoptedpursuant to those laws.
- Records of purchase and disposition of all drugs personally furnished to patients shall be maintained by the prescriber in accordance with state and federal drug statutes and any rules adopted pursuant to those statutes.
Section 4729.36
Only a pharmacy can use words like pharmacy, drug store, etc.
Section 4729.361
Disclosure of price information
4729.37
- Prescriptions to be kept for 3 years
4729.38 Generic substitution
- Definition of "Generically equivalent drug" See Section 3615.01(16)
- Prescriber must WRITE D.A.W. or Dispense as Written to avoid substitution
4729.38 More Generic substitution
- Price to the patient is less than or equal to the price of the prescribed drug.
- Inform purchaser of price difference and right to refuse the drug selected
- Label must contain brand name or generic name & distributor
- Labeling requirements - Section (B)
- Notify of generic subsitution
Section 4729.39
Consult agreements authorized; conditions
1.Agreement between R.Ph. and physician
2.- Separate agreement for each patient
3.- May include monitoring and modifying a prescription
4.- Must be signed by physician, R.Ph. And patient
More Consult Agreements
5.R.Ph. To maintain records
6.- Prior to taking action R.Ph. must attempt to contact physician and must must contact physician within 48 hrs
7.- Any one of the parties may terminate the agreement
8.- Boards to adopt rules
Ohio’s Dangerous Drug Distribution Act
- This set of code sections deals with the selling and distribution of dangerous drugs between manufacturer, wholesaler, terminal distributor, and practitioner
- 4729.51 Who may sell and distribute DD
- 4729.53 Wholesaler Qualifications
4729.54 Categories of terminal distributors
(1) "Category I" means single-dose injections of intravenous fluids
(2) "Category II" means any dangerous drug that is not included in category I or III.
(3) "Category III" means any controlled substance that is contained in schedule I, II, III, IV, or V.
4729.55 Terminal Distributor Qualifications
4729.60 Certificate required by wholesalers
1. Wholesaler must obtain certificate of licensure from terminal distributor before selling DD
2. Terminal distributor must obtain wholesaler’s certificate number before purchasing DD
Ohio Board of Pharmacy Regulations
- Pharmacy Practice-Internship (Chapter 4729-3)
- Pharmacy Practice - Administration (Chapter 4729-05)
- Pharmacy Practice—Impaired Pharmacists (Chapter 4729-6)
Board Regulations (Continued)
- Pharmacy Practice—Continuing Education (Chapter 4729-7)
- Dangerous Drugs (Chapter 4729-9)
- Nonresident Terminal Distributor of Dangerous Drugs (Chapter 4729-10)
- Controlled Substances (Chapter 4729-11)
- Ephedrine (Chapter 4729-12)
Board Regulations (Continued)
- Institutional Facilities: Drug Control (Chapter 4729-17
- Fluid Therapy Prescriptions (Chapter 4729-19)
- Peritoneal Dialysis Solution Prescriptions (Chapter 4729-27)
- Consult Agreements (Chapter 4729-29)
Pharmacy Practice-Internship
(Chapter 4729-3)
- 4729-3-01 Definitions
- 4729-3-02 Registration as a pharmacy intern
- 4729-3-03 Application for registration as a pharmacy intern
- 4729-3-04 Pharmacy intern identification card renewal
- 4729-3-05 Internship credit
- 4729-3-09 Expiration of pharmacy intern registration
4729-3-01 Definitions
- (A) "Pharmacy internship"
- (B) "Supervised practical experience"
- (C) "Internship site"
- (D) "Preceptor"
- (F) "In good standing"
- (G)"Statement of Preceptor"
4729-3-01 Definitions (Cont.)
- (H)"Practical experience affidavit"
4729-3-02 Registration as a pharmacy intern
- Intent of registration
- Qualifications
- 4729-3-03 Application for registration as a pharmacy intern
- 4729-3-04 Pharmacy intern identification card renewal
- 4729-3-05 Internship credit
- No credit before registration
- Statement of preceptor form
- Submit PEA’s by March 1 of following year
Pharmacy Practice - Administration
(Chapter 4729-05)
- 4729-5-01 Definitions
- 4729-5-02 Identification card
- 4729-5-03 Renewal of registration
- 4729-5-04 Violations as evidence of denial
4729-5-01 Definitions
- (A) Practice Pharmacy
- (B) Dispense
- (C) Compound
- (D) Interpret prescriptions
- (I) Personal supervision
- (J) Preprinted order
4729-5-01 Definitions (cont)
- (L) Protocol
- (M) Prescriber
- (N) Positive identification
4729-5-02 Identification Card
- Must be signed. Photo no longer required
4729-5-03 Renewal Of Registration
ID card must be renewed every year by September 15
4729-5-04 Violations as evidence of denial
- Felony
- Violation of pharmacy or drug law
- Moral character or habits
- Addicted or abusing
4729-5-05 Name change
Report name change within 60 days
4729-5-06 Report change of address or place of employment
Within 30 days
4729-5-09 Prescription Filing
- Three files
- Schedule II
- Schedule III,IV and V
- Non-controlled drugs
4729-5-11 Responsible Pharmacist
- Only a pharmacist may be a responsible person.
-Cannot be responsible pharmacist for more than 1 location
4729-5-11 Responsible Pharmacist (cont)
- Need board approval for more than 1 location
- Change in responsible pharmacist to be reported within thirty days
4729-5-13 Prescription Format
-Must comply with 4729-5-30
-Preprinted forms are permitted if
- no controlled substances
-one prescription per form
4729-5-13 Prescription Format (cont)
Format for controlled substance prescriptions
-4729-5-30
-One prescription per form
-Quantity written both numerically and alphabetically
4729-5-13 Prescription Format
Format for controlled substance prescriptions (cont)
-If preprinted, only one drug and strength per form
-Remember rule for residents and staff physicians (See examples)
4729-5-15 Prescriber
- Dentist
- Optometrist
- Physician, osteopath, podiatrist
- Veterinarian
- Advanced practice nurse
- Non resident practitioner
4729-5-16 Labeling
- Name and address of pharmacy
- Name of patient
- Name of prescriber
- Directions
- Date of dispensing
- Cautions
- Serial(Rx) number (more on next slide)
4729-5-16 Labeling
- Name or initials of pharmacist
- Trade name or generic name and name of distributor
- Quantity dispensed
- Special rules for small containers
4729-5-18 Patient profiles
- Be familiar with information required for patient data record and drug therapy record
- Profile shall be maintained for one year after last entry in profile
4729-5-19 Serial numbering of prescriptions
- Serial number must appear on prescription
- Must be complete and consecutive
- Prescriptions with no refills must be assigned a new serial number
- Addditional refills OK within time period. Must be noted on original Rx
4729-5-20 Prospective Drug Utilization Review
- Before dispensing, RPh shall review patient profile for items listed
- If any problems encountered RPh to take appropriate action
4729-5-22 Patient Counseling
- Pharmacist or designee shall personally
- Offer to counsel
- To patient or caregiver
- New or Refill
- If counseling refused then refusal to be documented
- Written offer if patient not present
4729-5-22 Patient Counseling
- Pharmacist or intern must counsel patient
- See items listed in 4729-5-22
4729-5-24 Prescription Copy
- Copies transmitted only between pharmacists
- Copy transferred
to contain
- Rx number
- Name, address of transferring pharmacy & DEA number if controlled substance
- Original date of Rx
4729-5-24 Prescription Copy(more)
- Original Date of Dispensing
- Original # of refills
- Date of last refill
- Refills remaining
- Name of transferring pharmacist
- Note federal law requires date & location of each refill for CS
- Write "TRANSFER" on face of Rx and date of transfer
4729-5-24 Prescription Copy (Cont.)
- Transferring copy
to contain:
- Original Rx must have "VOID" written on face
- Reverse of Rx to contain(note computer reqs)
- Date of transfer
- Signature of transferring pharmacist
- If oral copy, record name of RPh, and name & address of pharmacy (DEA of pharmacy if CS)
4729-5-24 Prescription Copy (Cont.)
- Computer systems have different requirements
- Prescription record must contain
- Date of transfer
- Name of transferring pharmacist
- Name and address of receiving pharmacy
- Controlled substance prescriptions must comply with division A and B of this rule
4729-5-24 Prescription Copy (Cont.)
- Pharmacies with central database may transfer copies
- Prescription copies may be transferred by fax machine. Keep in mind positive identification requirements of transferring and receiving pharmacists.
4729-5-25 Dispensing and compounding
- Only pharmacist or intern is permitted to dispense or compound
- Others may assist pharmacist,
- Pharmacist is responsible for drug dispensed
- System must assigned responsibility to pharmacist
4729-5-26 Partial dispensing
of Schedule II drugs
- Much the same as federal regulations
- Only for terminal patients or patients in long term care facility
- Note record keeping requirements
- All partial dispensing to occur within 60 days
4729-5-27 Recordkeeping
- Long, technical regulation
- For original prescription pharmacist must record date and manually record initials or if approved by board may use computerized positive ID
- Be aware of different methods of keeping track of refills(Slide 41)
4729-5-27 Recordkeeping (More)
- If written for generic, either brand name or generic name and distributor must be recorded on face of prescription.
- Note section D. Patient not to receive more drug than intended
- Note section (E)(4) If larger quantity dispensed. MD approval must be obtained
4729-5-27 Recordkeeping (More)
- Be aware of all of division (E) requirements
- Keep for three years
4729-5-28 Computerized record Keeping Systems
- Longest regulation
- Immediate retrieval of last twelve months prescriptions
- Three day retrieval of prescriptions from previous 36 months
4729-5-28 Computerized record Keeping Systems
- Three ways of keeping refills records
- Initial and date back of original Rx
- Computer generated printout signed by all pharmacists
- Tamper evident log
4729-5-28 Computerized record Keeping Systems
- Various printouts may be required
- Know procedure for down time
- Purged records must be maintained for 36 months
- System must produce audit trail
4729-5-29 Confidentiality of patient records
- Rx records are not public record
- Cannot be released to anyone except those listed.
- Records may be released to authorized law enforcement officials. They must provide receipt.
4729-5-30 Manner of Issuance of Rx
- Most important rule for retail pharmacists.
- Rx must be for legitimate medical purpose
- Dated and signed on date issued
- Must there full name and address of patient and prescriber.
- All
written prescriptions must be manually signed by prescriber
4729-5-30 Manner of Issuance of Rx
- Prescriptions may be transmitted orally or by fax. However sender must identify themselves
- Rx must have specific number of refills specified or period of time.PRN refills are not permitted.
- First dispensing must occur within six months.
4729-5-30 Manner of Issuance of Rx
- Rx for dangerous drugs and Schedule V drugs are valid for one year
- Schedule III and IV drugs are valid for six months or five refills
- Refills only as authorized
- No coded prescriptions are allowed
- Agents of practitioners must identify themselves with their full names
4729-5-30 Manner of Issuance of Rx
- Pharmacy must receive original copy
- Automated paperless systems must be approved by pharmacy board.
- Answering machines or voice mail may be used to record prescriptions when pharmacist not available.
- See Rx Board Comp Bulletin 98-001 & Med Bs Rule 4731-11-04(Wt. Reduction)
4729-5-31 Criteria for licensure by examination
- Must store 75 on NAPLEX exam and 75 on jurisprudence exam
- If license lapsed for three years must meet above requirements.
4729-5-35 Automated drug delivery systems
- Must receive prior approval from pharmacy board.
- Must maintain on-going quality assurance programs