state regulation of pharmacy practice

State Regulation of Pharmacy Practice

• Abood - Chapter 7 (pgs. 280-300)• Pharmacy is “self-regulated” profession• Board of Pharmacy regulates• Legislature grants power to Board• Board members appointed by Governor

and approved by Senate• See ORS 689.115 Membership;

qualifications; appointment; vacancy.

Basis for Regulation

• ORS 689.025 Policy; purpose. (1) The practice of pharmacy in the State of Oregon is declared a professional practice affecting the public health, safety and welfare and is subject to regulation and control in the public interest. It is further declared to be a matter of public interest and concern that the practice of pharmacy, as defined in this chapter, merit and receive the confidence of the public and that only qualified persons be permitted to engage in the practice of pharmacy in the State of Oregon. This chapter shall be liberally construed to carry out these objects and purposes.

Basis for Regulation

• (2) It is the purpose of this chapter to promote, preserve and protect the public health, safety and welfare by and through the effective control and regulation of the practice of pharmacy and of the registration of drug outlets engaged in the manufacture, production, sale and distribution of drugs, medications, devices and such other materials as may be used in the diagnosis and treatment of injury, illness and disease.

Pharmacy Regulations

• Not a “How to Practice Pharmacy” manual• Establish minimum requirements• Practicing to the minimum standard is unsafe!• Board relies on “voluntary compliance”• Board receives calls daily from pharmacists asking

how to get as close to minimum standard as possible

• Pharmacists must hold managers and employers accountable for safe working environments

• Professional associations in Oregon have not been effective advocates for high standards of practice

Oregon Board of PharmacyMission:

...to promote, preserve, and protect the public health, safety and welfare by regulating the practice of pharmacy and the quality and distribution of drugs and medical devices.

Oregon Board of Pharmacy• What the mission is NOT:

– promote, preserve, and protect the profession of pharmacy

– promote, preserve, and protect the profits of pharmacies

– promote, preserve, and protect the status quo

Board of Pharmacy• Members appointed by Governor• Approved by the Senate• Two four-year terms possible• Accountable to the Governor and

citizens of Oregon• Legislature controls budget• OSPA-assembled Task Force may

recommend appointees to Governor

Powers of the Board (ORS 689.135)

• Set and collect fees• Adopt rules (rulemaking)• Investigate violations of statutes and rules• Discipline licensees

– pharmacists, interns, drug outlets, manufacturers, technicians (?)

• Elect officers, hire Executive Director, have meetings, meet pharmacy students...

ORS 689.155 Authority of Board over medications, drugs, devices and other materials;

rules.

• The State Board of Pharmacy shall also have the following responsibilities in regard to medications, drugs, devices and other materials used in this state in the diagnosis, mitigation and treatment or prevention of injury, illness and disease:

(1) The regulation of the sale at retail, the administering by pharmacists to the extent provided in ORS 689.645 and 689.655 and the dispensing of medications, drugs, devices and other materials including the right to seize any such drugs, devices and other materials found to be detrimental to the public health and welfare by the board after appropriate hearing as required under ORS 183.310 to 183.550.

(2) The specifications of minimum professional and technical equipment, environment, supplies and procedures for the compounding, administering and dispensing of such medications, drugs, devices and other materials within the practice of pharmacy and any drug outlet.

(3) The control of the purity and quality of such medications, drugs, devices and other materials within the practice of pharmacy and any drug outlet.

(4) The issuance and renewal of certificates of registration of drug outlets for purposes of ascertaining those persons engaged in the manufacture and distribution of drugs, receiving and collecting annual fees therefrom and suspending, revoking or refusing to renew such registration in the manner provided in this chapter… And the list goes on and on...

Rulemaking

• ORS 689.205 Rulemaking. The State Board of Pharmacy shall make, adopt, amend and repeal such rules as may be deemed necessary by the board, from time to time, for the proper administration and enforcement of this chapter. Such rules shall be adopted in accordance with the procedures specified in ORS 183.310 to 183.550.

Enforcement

• ORS 689.145 Enforcement powers of board. The responsibility for enforcement of the provisions of this chapter is vested in the State Board of Pharmacy. The board shall have all of the duties, powers and authority specifically granted by and necessary and proper to the enforcement of this chapter, as well as such other duties, powers and authority as it may be granted from time to time by law.

Grounds for Discipline

• false statements when applying for license• violation of statutes or rules• conviction of a felony• conviction of an act involving moral turpitude• unprofessional conduct• immoral conduct or character• gross immorality• habitual impertinence• incompetence

Range of Discipline

• “Letter of Concern”• Order of Reprimand• Fine (civil penalty)• Suspension of license• Revocation of license• “Creative” discipline

– pass MPJE, CE, supervision, no preceptor...

Impaired Pharmacists

• Chemical dependency• Pharmacists encouraged to “self-refer”• Board does not know of self-referrals• Encourages pharmacists to seek

assistance• Applies to interns, technicians• Pharmacist Recovery Network (PRN)• See ORS 689.342 (and come on

Thursday!)

Diversion Program• ORS 689.342 Pharmacists Diversion

Program Supervisory Council; appointment; term; compensation and expenses. (1) There is established a Pharmacists Diversion Program Supervisory Council consisting of five members appointed by the State Board of Pharmacy for the purpose of developing and implementing a diversion program for chemically dependent licensees regulated under this chapter. No current board member or staff shall serve on the council.

Differences in Philosophy

• How much regulation??• Pharmacist in Charge (PIC) rule• Counseling• Technicians• Response to pharmacist shortage

“Regulating for Outcomes”• Board “micro-manages” pharmacy• Rules should reflect desired outcomes,

not process• Pharmacists are professionals and will “do

the right thing”• Pharmacists have (or should have) control

over their work environment• Pharmacists will naturally practice safely -

it is bad for business to harm your customers!

Standards of Practice• Higher standard than statutes and rules• Promoted by professional associations

– ASHP, ASCP, APhA, etc.

• Board does not establish S of P– they set minimum standards

• Standards of Practice can be difficult to determine

• “Peer review” panels can help

Standards of Practice

• The Board exists because market forces do not protect the public

• The profession can not “self regulate” and rely on the Board to intervene only after bad outcomes happen!

• In Oregon, who determines S of P??– prevailing practice S of P

Medication Errors

• A major topic in the press recently• Processes to make medication use safer• Pharmacists must improve accuracy of

dispensing• Standardize processes, minimize

distractions• Accountability for appropriateness of

medication, dose, drug interactions

DIVISION 035: OPERATION OF NONPRESCRIPTION AND MEDICAL DEVICE AND GAS OUTLETS

• Minimum Standards for Nonprescription Drug Outlets– Drug outlets shall have floor space and shelving

to insure that drugs are stocked and stored in sanitary, well-lighted areas. Where applicable, temperature, ventilation and moisture controls shall be employed.

– Expiration dates on drug outlet drugs shall be the responsibility of each drug outlet to insure products are in date.

– There shall be no advertisements of any kind by a drug outlet using the following or similar terms: "drug store", "pharmacy", "apothecary".

DIVISION 041OPERATION OF PHARMACIES (RETAIL AND INSTITUTIONAL DRUG OUTLETS)

CONSULTING PHARMACISTS AND OPERATION OF DRUG ROOMS

• Pharmacies shall be registered as either retail drug outlets or institutional drug outlets or both.

• Pharmacy registration expires March 31 annually.• A change of ownership requires the approval of

the Board and a new certificate of registration.• No pharmacy shall be operated until a certificate

of registration has been issued to the pharmacy by the Board.

Personnel (Both Retail and Institutional Drug Outlets) 855-041-0020

• Pharmacist-in-Charge:– responsible for the daily operation of the

pharmacy.– along with other licensed pharmacy

personnel involved with management of the pharmacy, must ensure that the pharmacy is in compliance with all state and federal laws and rules governing the practice of pharmacy and that all controlled substance records and inventories are maintained in conformance with the keeping and inventory requirements of federal law and board rules.

Personnel (Both Retail and Institutional Drug Outlets) 855-041-

0020• Pharmacist-in-Charge:

– No pharmacist shall be designated pharmacist-in-charge of more than two pharmacies without prior written approval by the Board.

– conduct an annual inspection of the pharmacy by February 1st.

– shall verify, on employment and annually, the licensure of pharmacists and the registration of technicians under their supervision.

Personnel (Both Retail and Institutional Drug Outlets) 855-041-

0020• Pharmacists:

– All pharmacists while on duty, shall be responsible for complying with all state and federal laws and rules governing the practice of pharmacy.

– All pharmacists and pharmacist-interns shall notify the Board of Pharmacy in writing of any change in employment location or change of residence address within 15 days.

Operation of Pharmacy(Both Retail and Institutional Drug

Outlets)855-041-0025

• Supervision: – A pharmacy may only be operated when a

pharmacist licensed to practice in this state is present. This means that the pharmacist must be physically present in the pharmacy or institutional facility.

• Sanitation:– Pharmacies shall be kept clean.– Persons working in a pharmacy shall

practice appropriate infection control.

Reporting Drug Loss855-041-0037

• Disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices shall immediately be reported to the Board.

• When there are reasonable grounds to believe that drugs have been stolen, the pharmacist shall immediately notify the Board.

• At the time a Report of Theft or Loss of Controlled Substances (D.E.A. Form 106) is sent to the Drug Enforcement Administration, a copy shall be sent to the Board. When loss of controlled substances is due to burglary or robbery, a copy of the police report shall be sent to the Board.

New Containers855-041-0055

In filling the original prescriptions, nothing but new containers may be used. A patient's original container may be refilled if clean and the label is legible and up to date. The container shall comply with the current provisions of the Federal Consumer Packaging Act (Public Law 91-601, 91st Congress, S. 2162) and rules or regulations adopted thereunder. It must also conform with the current United States Pharmacopeia/National Formulary monographs for preservation, packaging, storage and labeling.

Defines Labeling and Container Requirements for Repackaged Drugs -

855-041-0056

• Drugs prepackaged by a pharmacy for later on own use dispensing on prescription shall be in a container meeting USP standards and labeled to identify at a minimum:– Brand name, or generic name and manufacturer;– Strength;– Lot number;– Manufacturer's expiration date, or any earlier date

which, in the pharmacist's professional judgment, is preferable.

• An internal control number which references manufacturer and lot number may be utilized.

Customized Patient Medication Packages855-041-0057

• “Salad Packs”• two or more prescribed solid oral

dosage forms.• 60-day expiration from package

date• labeling - see OAR

Prescription Files855-041-0060

• storage of the information on the prescription

• safeguarded and readily retrievable.

• Keep for at least three years

Sterile Parenteral Products855-041-0063

• 48-hours or less expiration vs. > 48 hr• documentation of training and QA• procedure for verification by the pharmacist

of the preparation of each completed parenteral product:– The drug and dose ordered are appropriate for

the patient;– The correct drug and solution were selected;– The label is correct and complete; and– The calculation of the amount transferred is

correct.

Sterile Parenteral Products855-041-0063

• Labeling: In addition to regular labeling requirements:– Rate of infusion, as appropriate;– Expiration date;– Storage requirements or special conditions, if

applicable;– Name and concentration of all ingredients

contained in the parenteral products, including primary solution; and

– Handwritten initial of the pharmacist certifying for accuracy.

• Written policies and procedures

Requirements for Prescriptions - Prescription Refills 855-041-

0065• See OAR for specifics• Generic substitution prohibited when

MD writes:– No substitution;– N.S.;– Brand medically necessary;– Brand necessary;– Medically necessary;– D.A.W. (Dispense As Written); and– Words with similar meaning.

Labeling 855-041-0065

• Name, address and telephone number of the pharmacy;

• Date;• Identifying number;• Name of patient;• Name of drug, strength, and quantity

dispensed; when a generic name is used, the label shall also contain the name of the manufacturer or distributor;

• Directions for use by the patient;• Name of practitioner;

Labeling 855-041-0065• Required precautionary information regarding

controlled substances;• Such other and further accessory cautionary

information as required for patient safety;• An expiration date after which the patient should

not use the drug or medicine. Expiration dates must be the same as that on the original container unless, in the pharmacist's professional judgement, a shorter date is warranted; and

• any dispensed prescription medication, other than those in unit dose packaging, shall be labeled with its physical description, including any identification code that may appear on tablets and capsules.

Transfer of Prescription Information Between Pharmacies 855-041-0075

• Prescriptions may be transferred between pharmacies for the purpose of refill dispensing provided that:– the prescription is invalidated at the sending

pharmacy; and– the receiving pharmacy obtains all the information

constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability.

• Prescriptions for controlled substances (III-V) can only be transferred one time.

• Pharmacies using the same electronic prescription database are not required to transfer prescriptions for dispensing purposes.

Duties of the Pharmacist Receiving an Oral Prescription

855-041-0085• (1) The date when the oral prescription was

received.• (2) The name of the patient for whom, or the

owner of the animal for which, the drug is dispensed.

• (3) The full name and, in the case of controlled substances, the address and the DEA registration number of the practitioner or other number as authorized under rules adopted by reference under OAR 855-080-0085.

• See OAR 855-041-0085 for the rest!

• Each pharmacy registrant is accountable for establishing, maintaining, and enforcing their written procedures for:– Securing their legend drugs and the area in which they are

prepared, compounded, stored or repackaged;– Performing mandatory prospective drug utilization reviews;– Verifying the accuracy of all completed prescriptions and

medical orders before they leave the pharmacy’s secured legend area;

– Documenting the identification of the pharmacist(s) responsible for the verification of each dispensed medication;

– Ensuring the delivery of each completed prescription to the correct party;

– Providing appropriate confidential professional advice concerning medications to patients or their agents; and

– Ensuring that all who work in the pharmacy are appropriately registered and adequately trained to perform their duties.

Drug Outlet Procedures

Institutional Drug Outlets

• Definitions 855-041-0105• Absence of Pharmacist 855-041-0120• Drug Distribution and Control 855-041-

0130– director of pharmacy shall establish written

procedures for the safe and efficient distribution of pharmaceutical products.

– pharmacy shall be operated at least part time, five days a week.

– span of supervision shall extend to all areas of the hospital where drugs are stored.

Institutional Drug Outlets• Hospitals With Drug Rooms• Supervision of Consulting Pharmacist 855-

041-0135• the drug room must be supervised by a

licensed pharmacist...to act in the capacity of a part- time director;– The pharmacist shall provide on-call service at all

times;– Adequate storage facilities for drugs will be

provided; and– All drugs supplied shall be labeled so as to insure

that recalls can be effected and that proper control and supervision of such drugs may be exercised.

Institutional Drug Outlets• Emergency Kits• Emergency kit drugs are those drugs which

may be required to meet the immediate therapeutic needs of inpatients, and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining such drugs from such other source.

• Supplying Pharmacist. All emergency kit drugs shall be prepared by a licensed pharmacist.

Pharmacists Serving Long Term Care Facilities and Community Based Care

Facilities

• “Long term care facility” means a facility with permanent facilities that include inpatient beds, providing medical services, including nursing services but excluding surgical procedures except as may be permitted by the rules of the director, to provide treatment for two or more unrelated patients. “Long Term Care facility” includes skilled nursing facilities and intermediate care facilities but may not be construed to include facilities licensed and operated pursuant to ORS 443.400 to 443.455.

• = NURSING HOME! ADULT CARE HOMES!


Facilities

• “Community Based Care Facility” means a home, facility or supervised living environment licensed or certified or otherwise recognized by an agency of the state of Oregon which provides 24-hour care, supervision, and assistance with medication administration. These include but are not limited to Adult Foster Homes, Residential Care Facilities (RCF), Assisted Living Facilities (ALF), Group Homes for the Developmentally Disabled and Mentally Retarded and Inpatient Hospice.


Facilities• Drug Distribution and Control 855-041-

0160• Pharmacies or pharmacists that supply

emergency drug kits to and/or accept returned medications from long term care facilities or community based care facilities must:– Assist in the establishment and supervision of:

• The policies and procedures for the safe storage, distribution, administration, and disposition of drugs;

• The maintenance of controlled drug accountability records; and

• The policies and procedures for professional advice/ medication counseling of patients and/or their care givers.


Facilities

• Continued:• Have some pharmacists visit and provide

consultant services on a regular basis;• Have some pharmacists perform the quality

assurance activities defined in OAR 855-041-0132; and

• Supervise the implementation of the policies and procedures involving the security, storage, stocking, labeling, and notification of use of emergency drugs kits and supplemental drug supplies.

Correctional Facilities

• Drug dispensing in a correctional facility shall be from a pharmacy or from a drug room. The facility shall have a pharmacist who acts as a consultant to the institution, develops policies and procedures on drug distribution, procurement and management, monitors for compliance, performs drug utilization reviews, and may delegate registered nurses to withdraw drugs for administration to patient/inmates.

Collaborative Drug Therapy Management 855-041-0400

• A pharmacist shall engage in collaborative drug therapy management only under a written protocol that includes;– The identification, either by name or by

description, of the participating pharmacist(s);– The identification, by name, of the

participating practitioner(s);– The name of the principal pharmacist and

practitioner who are responsible for development, training, administration, and quality assurance of the arrangement;


• A detailed description of the collaborative role the pharmacist(s) shall play, including but not limited to:– Written protocol for specific drugs pursuant to which

the pharmacist will base drug therapy management decisions for an individual patient.

– Circumstances which will cause the pharmacist to initiate communication with the practitioner, including but not limited to the need for new prescription orders and reports of patients’ therapeutic responses or adverse effects.

– Training requirement for pharmacist participation and ongoing assessment of competency, if necessary.

– Quality assurance and periodic review by a panel of the participating pharmacist(s) and practitioner(s).


• Authorization by the practitioner(s) for the pharmacist(s) to participate in collaborative drug therapy.

• A provision for the collaborative drug therapy arrangement to be reviewed and updated, or discontinued at least every two years; and

• A description of the mechanism for the pharmacist(s) to communicate to the practitioner(s) and for documentation of the implementation of the collaborative drug therapy.


• Collaborative drug therapy management is valid only when initiated upon the prescription order of a participating practitioner for each individual patient.

• Nothing in this rule shall be construed to allow therapeutic substitution.

• The collaborative drug therapy protocol must be kept on file in the pharmacy and made available to the Board of Pharmacy and to the Board of Medical Examiners upon request.

Administration of Vaccines By Pharmacists

• A pharmacist may administer vaccines to persons who are over the age of eighteen as provided by these rules.

• A pharmacist may administer vaccines to a person who is over the age of eighteen only if:– The pharmacist has completed a course of training

accredited by the Centers for Disease Control and Prevention, the American Council on Pharmaceutical Education or a similar health authority or professional body approved by the Board and the Oregon Health Division;

– The pharmacist holds a current basic Cardiopulmonary Resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross;


– The vaccines are administered in accordance with an administration protocol approved by the Oregon Health Division; and

– the pharmacist has a current copy of the CDC reference, "Epidemiology and Prevention of Vaccine-Preventable Diseases".

• No pharmacist may delegate the administration of vaccines to another person.


• Protocols, Policies and Procedures 855-041-0510– pharmacists must follow written protocols approved by the

Oregon Health Division for administration of vaccines and treatment of adverse events following administration of a vaccine(s).

– The pharmacy must maintain written policies and procedures for handling and disposal of used or contaminated equipment and supplies.

– The pharmacy must give the appropriate Vaccine Information Statement (VIS) to the patient or legal representative with each dose of vaccine covered by these forms. The pharmacist must ensure that the patient or legal representative is available and has read, or has had read to them, the information provided and has had their questions answered prior to administering the vaccine.

– The pharmacy must report adverse events to VAERS, and PCP

• Record Keeping and Reporting 855-041-0520

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