DS intro and pharmacy practice act

Removal of Drugs from Terminal Distributor

-Prescriber can remove drugs if needed to treat patient
-Dispenser can remove Naloxone
-A licensed healthcare provider can remove to treat patient (non-control and immunizations)

Must return within 24 hours

Faxed Prescriptions

-Require MD manual signature
-Require agents FULL name
-Fax machine number

**Original prescription placed in patients chart

Computer to Fax Prescriptions

Generally recognized as illegal, unless its under common ownership. (St. E Physicians to St. Elizabeth outpatient)

• or telecommunication power outtage

Electronic prescriptions to inpatient facility

"Drug orders" can be considered the original, as long as entering orders are restricted to authorized personnel with positive ID (login + Badge)

If its an agent putting in the "drug orders", the prescriber must be readily available.

Institution must have policies and procedures outlining the process

Readiy Retrievable

3 business days

Refuse to grant/renew

Deny licensure for 24 months

Virtual Wholesale Distributor

Someone who has title over the drugs, but does not have possession of the drugs.

• Must be licensed as a wholesale distributor with a virtual wholesale classification
• Must be an established business entity with appropriate state/local authorities
• Operate out of a commerical use plot (cannot be personal or residency)

The person who warehouses the drugs for the wholesalers would be the Third Party Logistics Provider.

Third Party Logistics Provider

Someone who coordinates with manufactures and wholesalers to warehouse, distribute, and other services on their behalf. They do NOT have title over the drugs.

• Must be licensed as a wholesale distributor with third party logistics classification
• Must be an established business entity
• Must operate out of commerical use plot (cannot be personal or residency)

Whole Sale

A entity with the purpose of purchasing medications to resell.

*A pharmacy is responsible for verifying a wholesaler is registered with the Ohio BOP (ANNUALLY)

Wholesale limit is 5% for terminal distributors.

Occasional Sale

Wholesale of a drug to another terminal distributor or person exempted from being a terminal distributor (Vet, physicians, dentist).
The 5% rule does not apply if its common ownership or common control

Employment of Felony Convictions

Any terminal distributor or wholesale distributor that is a DEA registrant may not employee anyone who has been convicted of a felon, related to control substances.

Employment of someone whose DEA registrant was denied, revoked, or surrendered

A terminal distributor or wholesaler that is a DEA registrant may not employee anyone who has had their DEA registrant revoked, denied, or surrendered "for cause" related to control substances.

Pharmacy Requirements

-Library
-Equipment
-Stock of drugs
-Prescription containers
-Space and fixtures
-Pharmacy hours must be posted
-Personnel and staffing
-Internet

All Pharmacies must have access to these resources via internet

-The boards website (pharmacy.ohio.gov)
-LAWriter (codes.ohio.gov)
-The code of laws of the USA
-The code of federal regulations

Institutional pharmacies must have a quality assurance program that monitors and evaluates

-Quality and appropriateness of patient care
-Pursue opportunities to improve patient care
-Prevent/detect drug diversion
-Resolve identified problems

Definition of Pharmacy Practice

-Interpreting prescriptions
-Dispensing drugs/devices
-Compounding
-Counseling
-Drug regimen reviews
-DUR
-Advising/Recommending
-Consult agreements
-Immunizations
-Administration of long acting injectables

Return to Stock

May return a medication to stock if:
-never left the pharmacy posession
-never left the delivery posession with tamper seal evidence/original manufacture container

IF medication returned, must have:

• Expiration on bottle (one year from dispense)
• Must have original label. you can change label with pharmacist verification, but CANNOT CHANGE expiration date, drug name, and strength.

When dispensing a return to stock to a patient - a new container must be used

Drug recall for a return to stock medication

If a drug is recalled, the return to stock medication must be removed - unless the LOT # is known

Transfer of a return to stock medication

A return to stock medication may be transferred only if:

• Common ownership
• Common control

and obviously both facilities/terminal distributors must be licensed

Pharmacist can enter consult agreements if the following are met

-Phsyician-Patient relationship maintained
-The diagnosis must be within the scope of the physician and pharmacist

Consult agreements can be with:
-Physicians
-Physician assistants (with authorization from supervising physician)
-Certified Nurse practitioners/midwives (with authorization from collaborating physician)

Termination of a consult agreement

Consult agreements must be signed by 3 individuals:

• Patient
• Physician, PA, or APN
• Pharmacist

If anyone terminates the agreement, it must be a written notice. The written notice must be recorded in medical records.
Written notice just means a method of communication that confirms delivery.

Consult agreements must include:

-Diagnosis and diseases being managed, including if the diagnosis is primary or comorbid
-Description of drugs or drug categories that can be adjusted
-Description of the procedures, decisions, plan the pharmacist must follow
-Description of how the pharmacist will comply with records of each action - in which a pharmacist must record each action taken with positive identification. (records kept for 3 years and readily retrievable)

• Quality assurance program (ensure pharmacist stays within scope, effectiveness, positive patient outcomes)

**The content of the consult agreement must be communicated to each patient that enters the consult agreement

Liability of a consult agreement

Liability is on the person making the change

• If the pharmacist made the drug change, the pharmacist takes liability (unless the physician authorized the change)
• If the physician made the drug change, the pharmacist takes liability

If the harm is independent of drug change, neither takes liability

A patient entering a consult agreement, we must tell the patient

• A pharmacist may be utilized to manage the patients care
• The patient can participate or withdrawal whenever they want
• This consent may be used as consent to treatment
• "Managing Pharmacist" just means the pharmacist managing the patients therapy.

A collaborative care agreement must have a quality assurance program

-ensure staying within scope/agreement
-ensure effectiveness
-ensure positive patient outcomes

The signatures of the collaborative agreement

Physician: can be the director of their designee (must have a physician license)

Pharmacist:

• If terminal distributor - it can be the responsible person or designee
• If not a terminal distributor - it can be a single pharmacist

Pharmacist issuing a presription can be either

• A prescriber
• The prescribers agent

Prescribers agent must:

• Include prescribes name, address, phone #
• Managing pharmacist phone #
• Positive identification of the pharmacist

A pharmacist may prescribe controlled substances based on the consult agreement if:

• Register with their own DEA
• Register with the BoP as a controlled substance prescriber
• Proof of collaborative care agreement
• Notify the board of pharmacy within 5 days if the collaborative care agreement takes away controlled substance presscriber rights
• Notify the board of pharmacy within 30 days when the DEA license is approved or changed

A pharmacist must run an OAARS report covering one year and border states if they are:

• Adding a controlled substance
• Changing the controlled substance: Strength, dosage form, route, or frequency

What a pharmacist can delegate vs not delegate

They cannot delegate the management of drug therapy to another person not within the agreement

They can delegate the administration of medications to someone outside of the agreement, as long as it is within their scope of practice. They are essentially putting an order in

The collaborative care agreement should be available upon request if a dispensing pharmacist request to ensure the pharmacist in the CCA is practicing within the scope of the agreement.

The board of pharmacy may terminate a consult agreement if

• The consult agreement does not meet the requirements
• The consult agreement poses a danger to patient safety

To have a prescriber-patient relationship, this includes

• Thorough review of patients chart
• Initial consultation with patient (phone, tele, in-person) annaully
• Order test results/analyze test results and prescribe medications
• Document each step
• Consult physician if necessary

Practinioner

Licensed healthcare professional authorized to prescribe drugs

Licensed healthcare professionals authorized to prescribe drugs adhere to what regulating laws

They do not have to adhere to board of pharmacy. AKA, board of pharmacy regulations do not apply to physicians, podiatrists, dentist, optometrists, vets, and advanced nurse practitioners.

However, all drugs must be labeled and packaged according to pharmacy regulations

Emergency dispensing per year

Can dispense a drug (non-control) without a prescription if:

• Pharmacy has record of the prescription and the prescription has no refills or is expired
• The pharmacist is unable to contact the doctor
• Pharmacist judges the medication is needed to sustain life, manage a chronic condition, or failure to dispense could result in harm

This can only be done within a 12 month peroid

• First time: 30 day supply
• Second time: 7 day supply
• Third time: 7 day supply

record the dispensing and notify the physician within 72 hours

Keep record of the emergency dispense for a year

Emergency dispensing per prescription

Can dispense a drug (non-control) without a prescription if:

• Pharmacy has record of the prescription and the prescription has no refills or is expired
• The pharmacist is unable to contact the doctor
• Pharmacist judges the medication is needed to sustain life, manage a chronic condition, or failure to dispense could result in harm

Per prescription:

• only dispense 72-hour supply

Record keeping of an emergency dispense

• Must create a new prescription document for the emergency refill
• Must maintain emergency dispense record for one year

Must include in the record:

• Patient name and address
• Name and address of person picking up if different from patient
• Amount dispensed
• Original prescription number

Copayments/Deductibles can be waived as long as the following agree

• Payer (insurance)
• Purchaser (patient)
• Third party administration (pharmacy)

**Also, a pharmacy cannot charge the patient more than the cash price for a medication. If it going through the insurance/co-pay card and the cost is more than the cash price, we must let the patient know of the cost-saving opportunity if run through cash.