Domain 2: med use process 1

Prescription/Drug Order: responsibilities for determining whether prescriptions/drug orders are issued for a legitimate medical purpose, and within all applicable restrictions

General Prescription Requirements —>

• Prescriptions, prescription refills, and drug orders are dispensed:

  • Accurately 

  • To correct party 

  • Pursuant to a valid prescription 

  • Pursuant to a valid patient-practitioner relationship

  • For a legitimate medical purpose

  • In accordance with the prescribing practitioner's authorization 

• Following information is required for each new or refilled prescription drug or device:

  • Name and DOB of the patient for whom the drug is prescribed, unless for an animal. If for an animal, the name of the patient, name of the worker, and species of the animal. 

  • Full name and contact phone number of the prescriber and, in case of any controlled substances, the address and DEA registration number of the practitioner

  • name, strength, dosage form of the substance, quantity prescribed, and if different from quantity prescribed, quantity dispensed

  • directions for use

  • date of issuance and, if different from the date of issuance, the date of

  • filling

  • total number of refills authorized by the prescribing practitioner 

• A valid signature:

  • For non-controlled substances:

    • Received by the pharmacy via a hard-copy written prescription, the prescribing practitioner or practitioner’s agent manual signature.

    • Received by the pharmacy via facsimile, the prescribing practitioner or

    • practitioner’s agent manual or electronic signature.

    • Received by the pharmacy electronically, the prescribing practitioner's or practitioner’s agent electronic signature.

  •  For controlled substances:

    • Received by the pharmacy via hard-copy written prescription, the prescription must have an original manually signed signature from the prescribing practitioner.

    • Received by the pharmacy via facsimile, the prescription must have an original manually signed signature

    • from the prescribing practitioner.

    • Received by the pharmacy electronically, the prescribing practitioner’s digital signature that complies with the rules adopted by reference in OAR 855-080.

• In (g), manually signed specifically excludes a signature stamp or any form of electronic or digital signature unless permitted under federal regulations

• Any other information required for controlled substances pursuant to federal regulations.

Prospect Drug Utilization Reviews 

• Pharmacist must complete a drug utilization review (DUR) by reviewing the patient record prior to dispensing each prescription drug or device for the purpose of identifying the following:

  • Over-utilization or under-utilization;

  • Therapeutic duplication;

  • Drug-disease contraindications;

  • Drug-drug interactions;

  • Incorrect drug dosage or formulation;

  • Inappropriate duration of treatment;

  • Drug-allergy interactions; and

  • Drug abuse or misuse.

• Upon recognizing a concern with any of the items in (1)(a)-(h), the Pharmacist must take steps to mitigate or resolve the problem and document the steps taken and outcome.

PMP Requirements in Oregon 

• Requirements for reporting to PMP and accessing PMP data:

• ORS 431A.855 provides statutory authority for the Prescription Drug

• Monitoring Program (PDMP)

• Started June 2011

• Pharmacies are required to report the dispensing to the Oregon Health Authority:

  • Schedule II, III, and IV controlled medications

  • Gabapentin

  • Naloxone

• Practitioners and pharmacists have secure access to data 

• Pharmacists are not required to access the PDMP when filling Rx → can access anytime

Exceptions to dispensing/refilling 

• Where refill authority is given other than by the original prescription, documentation that such refill authorization was given, the date of authorization, and name of the authorizing prescriber or the prescriber's agent must be recorded. This documentation must be readily retrievable. Prescriptions for controlled substances in Schedules III and IV are limited to five refills or six months from date of issue, whichever comes first.

• If the practitioner is not available and in the professional judgment of the pharmacist an emergency need for the refill of a prescription drug has been demonstrated, the pharmacist may dispense a sufficient quantity of the drug consistent with the dosage regimen, provided it is not a controlled substance, to last until a practitioner can be contacted for authorization, but not to exceed a 72-hour supply. Practitioner shall be notified of the emergency refill 

• Each refilling of a prescription must be accurately documented, readily retrievable, and uniformly maintained for three years. This record must include;

  • The identity of the responsible pharmacist

  • Name of the patient; 

  • Name of the medication

  • Date of refill

  • Quantity dispensed

• Refill quantities may be combined into a single filling if the prescription is not for a controlled substance or psychotherapeutic drug and the prescriber is notified of the change.

• retail pharmacies may only dispense a prescription refill upon request of the patient or patient’s agent. A request specific to each prescription medication is required, unless the requested fill or refill is part of an auto-refill program and is a continuation of therapy 

• Auto-Refill Programs: A mail order or retail pharmacy, excluding cycle-fill for long term care, may use a program that automatically refills non-controlled prescription medications, that have existing refills available and are consistent with the patient’s current medication therapy only when the following conditions are met:

  • A patient or patient’s agent must enroll each prescription medication in an auto-refill program before a pharmacy can include the prescription medication as part of the auto-refill program

  • The prescription is not a controlled substance; and

  • The pharmacy must discontinue auto-refill program enrollment when requested by the patient or patient’s agent

  • Pick-up notification to a patient or patient’s agent may be generated upon completion of a prescription refill

  • When an auto-refill prescription is returned to stock or when delivery is refused, that prescription medication is removed from the auto-refill program for that patient.

Labeling of dispensed drug 

• Prescription must be labeled with the following information:

  • Name, address and telephone number of the pharmacy

  • Date of fill

  • Identifying number

  • Name of patient

  • Name of drug, strength, and quantity dispensed; when a generic name is used, the label must also contain the identifier of the manufacturer or distributor

  • Directions for use by the patient

  • Name of practitioner

  • 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 on prescriptions must not exceed: 

    • That on the manufacturer’s container if dispensed in the manufacturer’s container

    • The earliest date of either:

      • The manufacturer’s expiration date; or

      • One year from the date the drug was repackaged and dispensed.

  • Any drug expiring before the expected length of time for the course of therapy must not be dispensed.

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

Packaging of dispensed drugs 

• Types of packaging rules:

  • Poison Prevention Packaging Act (PPPA)

  • Customized Patient Medication Packages

Packaging Rules: Poison Prevention Packaging Act (PPPA) mechanics, including child- resistant container mandates, safety cap exceptions, blank waivers, and prescription

repackaging parameters

Poison Prevention Packaging Act 

• Enacted in 1970 

• Child resistant packaging requirements/mandates 

• Padging should be difficult for child under 5 to open, but simple for adults 

  • Hazardous household substances

  • Prescription medications

  • Over-the-counter medications

• Goal to prevent death/injury for accidental poisoning 

• Enforced by US Consumer Product Safety Commission 

Patient Med Paks 

1. Label

• The patient med pak shall bear a label stating:

  • The name of the patient;

  • A serial number for each patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein name, strength, physical description or identification, and total quantity of each drug product contained therein

  • directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein

  • Any storage instructions or cautionary statements required by the official compendia;

  • The name of the prescriber of each drug product;

  • The date of preparation of the patient med pak and the beyond-use date assigned to the patient med

  • pak (such beyond-use date shall be no later than 60 days from the date of preparation)

  • The name, address, and telephone number of the dispenser and the dispenser’s registration number where necessary

  • Any other information, statements, or warnings required for any of the drug products contained therein

• If the patient med pak allows for the removal or separation of the intact containers therefrom, each individual container shall bear a label identifying each of the drug products contained therein.

2. Labeling: The patient med pak shall be accompanied by a patient package insert, in the event that any medication therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the pharmacist for the total patient med pak.

3. Packaging:

• In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med pak shall comply with the moisture permeation requirements for a Class B single-unit or unit-dose container. Each container shall be either not reclosable or so designed as to show evidence of having been opened

• There is no special exemption for patient med paks from the requirements of the Poison Prevention Packaging Act. Thus the patient med pak, if it does not meet child-resistant standards shall be placed in an outer package that does comply, or the necessary consent of the purchaser or physician, to dispense in a container not intended to be child-resistant, shall be obtained.

Patient Med Paks 

4. Guidelines: It is the responsibility of the dispenser, when preparing a patient med pak, to take into account any applicable compendia requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container, as well as any therapeutic incompatibilities that may attend the simultaneous administration of the medications. In this regard, pharmacists are encouraged to report to USP headquarters any observed or report incompatibilities.

5. Recordkeeping: In addition to any individual prescription filing requirements, a record of each patient med pak shall be made and filed. Each record shall contain, as a minimum:

• The name and address of the patient

• The serial number of the prescription order for each drug product contained therein

• The name of the manufacturer or labeler and lot number for each drug product contained therein

• Information identifying or describing the design, characteristics, or specifications of the patient med pak sufficient to allow subsequent preparation of an identical patient med pak for the patient

• The date of preparation of the patient med pak and the beyond-use date that was assigned

• Any special labeling instructions

• The name or initials of the pharmacist who prepared the patient med pak.
  
  

6. Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is issued by the Board in writing.

Drug Product conditions and Prohibited dispensing 

• Adulterating or misbranding is prohibited

  • Pharmacies must quarantine any drugs that are outdated, adulterated, or misbranded (applies to all types of drug outlets and distributors)

• Damage to a pharmacy and drug integrity

  • Example: the pharmacy floods

    • Entire drug inventory is considered adulterated and must be destroyed unless a pharmacist deems specific items are safe

  • Example: power outage

    • Drug inventory is considered adulterated and cannot be dispensed (due to lack of temperature and humidity controls)

  • Any incident such as this must be reported to the board within 3 working days

• Controlled substances damaged, lost or stolen must be documented and reported to the DEA and the board in 1 business day

• A pharmacy that is required to temporarily close or relocate due to emergency must report to the board within 3 working days

Distribution/dispensing 

For a Schedule II controlled substance prescription, a Pharmacist may:

• Add the patient’s address based on information provided by the patient or patient’s agent with appropriate verification

• Amend or add the following information after consultation with and agreement of the prescriber:

  • Drug strength, Dosage form, Drug quantity, Directions for use,  Prescriber’s address, Prescriber’s DEA registration number.

• Amend the following information after consultation with and agreement of the prescriber, the:

  • Date the prescription was issued and Date the prescription can be filled.

• For (b) and (c), the Pharmacist must document on the prescription the date of the prescriber’s authorization, the amendment or addition authorized, and the Pharmacist’s identity.

For a Schedule II controlled substance prescription, a Pharmacist must not change the patient's name, the controlled substance prescribed except for generic substitution, and the name or signature of the prescriber.

Administering Medications 

• Pharmacists can administer medications to patients for these reasons:

  • Under the direction of a licensed practitioner

  • Using a statewide drug therapy management protocol

  • Under Collaborative Pharmacy Practice Agreement (CPA) 

  • Collaborative Drug Therapy Management (CDTM) protocol

  • Vaccinations

• According to Oregon law, a pharmacist may administer a drug or device as specified in this rule.

• A pharmacist who administers a drug or device must:

  • Observe, monitor, report, and otherwise take appropriate action regarding desired effect, side effect, interaction, and contraindication associated with administering the drug or device;

  • Ensure a record is kept for three years of such activities. This record shall include but is not limited to:

    • Pt identifier

    • Drug or device and strength

    • Route and site of admin

    • Date and time of admin

    • Pharmacist identifier 

• The pharmacist must be acting:

  • Under the direction of or pursuant to a lawful prescription or order issued by a licensed practitioner acting within the scope of the practitioner’s practice or

  • In accordance with a written protocol or collaborative drug therapy agreement with a licensed practitioner.

• pharmacists must be able to document that they have received training on the drug or device to be administered and the route of administration. Such training may include a program approved by the ACPE, curriculum-based programs from an ACPE-accredited college, state or local health department programs, training by an appropriately qualified practitioner, or programs approved by the Board.

• pharmacist may administer a drug or device in conjunction with training the patient or the patient’s caregiver how to administer or self-admin the drug or device 

Administering Vaccines

• Pharmacist can administer all vaccines recommended by ACIP

• All vaccines must be reported to the Oregon Immunization Information System (ALERT IIS)

• Must provide Vaccine Information Sheet (VIS) to patient before each dose
  
  

• A pharmacist or technician must:

  • Complete a training course approved/accepted by the OBOP and maintain competency

  • Maintain up to date CPR certification

  • Follow OHA approved vaccine protocols

• Age limits:

  • Any recommended vaccine to persons 7 years of age and older

  • Influenza vaccine to persons 6 months of age and older

  • All ages with valid prescription

  • 3 years of age and older when public health emergency declared

Dispensing Drugs: Interpretation 

• Dispensing interpretation 

  • Must offer health care interpreter

  • Interpreter must be from health care interpreter registry administered by OHA

  • May not charge patient for interpreter services

  • Pharmacist can interpret if proficient in preferred language

  • Must maintain records

• Limited English Proficiency and Accessibility

  • Upon request of a prescriber, patient or a patient’s agent, each drug dispensed by a pharmacy for a patient’s self-administration must bear a label in both English and the language requested for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker.

  • When dispensing a drug under (1), a pharmacy must provide labels and informational inserts in both English and one of the a select number of languages

Dispensing Drugs: Repackaging → defines labeling and container requirements for  repackage drugs 

Repackaging

• Drugs prepackaged by a pharmacy for later 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 expiration date, or any earlier date in pharmacist professional judgement 

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

Dispensing drug: New container

• Each pharmacy must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act

non-rx

Non-Rx: Labeling of non-prescription drugs and devices 

• Must be sold in original, properly labeled manufacturer’s container

• Label must contain name of manufacturer, packer, or distributor with place of business including address

• Product must have Drug Facts panel on packaging that includes: 

  • Active ingredient

  • Purpose

  • Uses

  • Warnings

  • Directions

  • Other information 

  • Inactive ingredients

  • Questions and phone number 

• Med device labeling: must be easy for the average person to understand

• Med device must contain:

  • Common name of device

  • Intended purpose

  • Instructions for use

  • Clear warnings and contraindications

  • Accessible information (like a website or phone number) if labeling becomes separated from device

Non-prescription: packaging and re-packaging  

• Packaging and repackaging of non-prescription drugs and behind-the-counter products

  • Regulated by the PPPA and FDA

  • PPPA required most OTC meds to be in child-resistant packaging

  •  Requires tamper-evident packaging

• Packaging of medical devices

  • Regulated by FDA and ISO standards

  • Must have sterile barrier system if applicable

  • Packaging must be non-toxic and free from defects

Non-prescription dispensing 

• If sold by “nonprescription drug outlets”, they must register with the Oregon Board of Pharmacy to sell OTC medications

  • i.e. gas stations, grocery stores, gift shops, etc.

• Dispensing restricted, non-prescription drugs

  • Example: Pseudoephedrine (Sudafed)

  • Must be in blister packs

Dispensing Pseudoephedrine 

• C-III (2006) with Rx

• Prescription no longer required (2022), and changed to Schedule V

  • Purchaser must by at least 18 years old

  • Show valid, government-issued photo ID

  • Sale must be recorded in an electronic tracking system

  • Pharmacist or pharmacy technician must complete sale (product kept behind the counter)

  • OTC transaction cannot exceed federal daily limit of 3.6 grams, or monthly limit of 9 grams (Combat Methamphetamine Epidemic Act of 2005) - not for valid rx

Oregon Medical Marijuana Act (OMMA)-1998

• Allows cultivation, possession, and use of marijuana by patients with qualifying medical conditions

• Attending provider must sign application

  • MD, DO, PA, NP, CNS, CRNA, naturopathic physician

• Adults age 21 and older

• Public use and driving while impaired remain illegal

• Qualifying medical conditions

  • Cancer, glaucoma, a degenerative or pervasive neurological condition, HIV/AIDS, Post-traumatic stress disorder (PTSD), a medical condition or treatment for medical condition that produces one or more of the following:

    • Cachexia (a weight-loss disease that can be caused by HIV or cancer)

    • Severe pain

    • Severe nausea

    • Seizures, including but not limited to seizures caused by epilepsy

    • Persistent muscle spasms, including but not limited to spasms caused by multiple sclerosis