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53 Cards in this Set

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When may Virginia suspend a pharmacist's license or registration in an emergent manner?
A license, certificate registration may be suspended without a hearing if the Board finds that there is a substantial danger to the public health or safety

The Board must meet to discuss proceedings
- May meet by telephone if other efforts for quorum failed
- Institution of hearings must begin when individual notified of suspension
- Hearing must be scheduled within a reasonable time
When may Virginia suspend or revoke a pharmacist's license in a mandatory manner?
License suspended,revoked in another jurisdiction
- Conviction of a felony
- Deemed incapacitated

No hearing required
- Director of the Board must notify the individual or his legal guardian, etc in writing
- Information must be from court or agency and be provided with documentation

Person must seek to have license reinstated by the Board in VA
- Pending the conviction, the suspension may be delayed if person’s services necessary for public health
receipt of application to
Board seeking reinstatement
- May be represented by counsel and may summon witnesses
- Reinstatement requires affirmative vote of 3/4 of the members of the Board present at hearing
- Board sets terms for reinstatement
What is the minimum period for reinstatement after revocation?
Three years after revocation, the Board may consider the application for reinstatement

Requires payment of fees and all other procedures

3/4 of the members of the Board present at the meeting must approve reinstatement
What are Virginia's requiremenents for closing pharmacies or changing ownership?
Closings more than 1 week in length
- Owner must post conspicuous notice at least 30 days prior to closing the pharmacy or
- Mail a notice, at least 14 days before closing to every current pharmacy customer with the potential for refills

Information must include date of closing and name of pharmacy where rxes will be transferred to Board of Pharmacy at least 14 days before closing

All information regarding disposition of drugs must be reported to the Board
What are the record keeping requirements for closing pharmacies or changing ownership?
Upon change of ownership, prescription and patient records must be transferred for the period at least 2 years immediately prior to change of ownership
Explain the "business of pharmacy"
Pharmacist/pharmacy business practices, particularly pricing issues extremely controversial

Often, some controls on business of pharmacy run counter to running a business
“Inappropriate actions” by pharmacies are often accepted business practices in other areas

Wrong actions can result in civil and criminal monetary penalties, suspension/ revocation of license or jail time!
Is fee splitting by pharmacists with physicians and other health care practitioners allowed?
VA prohibits pharmacists from soliciting prescription business from prescribers in exchange for rebates, kickbacks (providing physicians remuneration for recommending business), fee splitting or special charges unless
- Disclosed in writing to patient and any third party payer
- But, government payers more stringent than 3rd party payers

If pharmacy deals with federal health care programs, then must first ensure that arrangements are proper
Explain the CVS Pharmacy vs. Wayne, NJ case
CVS selling drugs under its cost

NJ law characterizes this as grossly unprofessional conduct to offer rebates or discounts when selling rx drugs except in limited circumstances to those over age 62

This case does not represent a fundamental right--freedom of speech!

Statute deemed acceptable

(this is not a VA or federal law)
Are pharmacists prohibited from interfering with patient pharmacy selection?
YES.
VA prohibits pharmacists from interfering with patient selection of a pharmacy of its choice

Federal laws also allow patients to select pharmacy under freedom of choice provisions (Medicare & Medicaid statutes)

But, pharmacists MAY advertise the benefits of using its pharmacy…and price!
(preferred providers)

pharmacies can not say things about another pharmacy that are untrue
Explain the Pharmacists Advertising of Pricing VA Board of Pharmacy vs. VA Citizens Consumer Council case
Pharmacy advertising of prices required by the first amendment as commercial speech

Case originated in VA, went to Supreme Court of US and used as basis for advertising by professionals in general

Pharmacies usually want to keep prices secret from the public
In what situations may crediting & re-selling of prescription that are drugs already dispensed?
Prescriptions dispensed by pharmacy never picked up by patient

Prescription shortages by pharmacy because out of stock

Unused prescriptions from residents in long-term care facilities
- Partial fills - must bill insurance for qty dispensed, not entire qty

Any drugs that are returned to stock must be appropriately credited to 3rd party payers, including Medicaid and pharmacy benefit management companies
- This provision includes prescriptions owed to patients but never picked up!
- Audits could result in financial penalties
- Criminal penalties possible under federal health care program standards
In what situations may crediting & re-selling of prescription that are drugs already dispensed from LONG-TERM CARE facilities?
Unused drugs from residents of long-term care facilities

Already discussed issues associated with controlled substances in SII-V
- DEA does NOT permit any controlled substances dispensed to residents of long-term care facilities to be returned to the pharmacy and redispensed
- Exception for controlled substances in automated dispensing systems

Any drugs returned to the pharmacy must be credited to third party payer
Who may unused drugs from long-term care faicilities be redispensed to?
VA only permits unused drugs from long-term care facilities to be redispensed to the indigent free program
- Pharmacy must establish agreement with nursing home and have established policies and procedures including
- Method of delivery from nursing home to pharmacy
- Tracking system
- Procedure for assuring the integrity of all drugs for redispensing to assure that drugs meet official compendia standards

Unused or discontinued drugs must be returned to pharmacy for destruction within 30 days of discontinuation
What is the Rx Monitoring Program - for prescribers?
Pilot program established in SW VA to counter problems seen with elicit prescribing and theft of oxycodone
- Expanded to all dispensers and prescribers in June 2006
(11 million records as of April 2007)
Monitors prescribing and dispensing of drugs in SII-IV only

Prescribers may query database regarding individuals’ use of controlled substances
- Must obtain written consent from individual before tapping into database

This was initiated in response to the oxycontin theft (hillbilly heroin)
What is the Rx Monitoring Program - for pharmacies?
Pharmacies must report SII-IV dispensing information at least twice monthly to a contractor on behalf of the state of VA
- For 1st-15th of month: by 25th of same month
- For 16th-end of month must report by 10th of following month

Non-resident pharmacies that dispense to VA residents must also report

Even if pharmacy dispenses NO applicable controlled substances must still report

Compounded products must be reported
What is the Rx Monitoring Program - for long-term care facilities?
Pharmacy reporting exemptions
- LTC pharmacies that dispense to residents of nursing homes (entity must be licensed as nursing home NOT assisted living facility)
- Inpatient hospital pharmacies exempt (outpatient hospital pharmacies and clinics must report)
- Manufacturer samples provided by prescribers
- Dispensing for a manufacturer’s indigent prescription program
- Emergency rxes
- Vet rxes
- Administration of covered substances
- Administering to patients in an inpatient hospice setting (dispensing drugs to patients in home hospice settings NOT exempt)
- Waivers given on a case by case basis
How many states allow collaborative practice agreements and what medications apply?
At least 45 states have programs in place that allow pharmacists to directly or indirectly participate in prescribing or adjusting patient’s medication regimens
Most common include limited antibiotics, anticoagulation therapy, vaccines, pain management and in some cases emergency contraception
Explain collaborative practice agreements in Virginia
Regulated by the Boards of Pharmacy and Medicine

Allows pharmacists to participate with
- MDs, ODS, and doctors of podiatry

In collaborative practice agreements related to treatment using drug therapy, laboratory tests or medical devices for the purposes of improving patient outcomes
What protocol must be in place to develop a collaborative practice agreement/ arangement in VA?
Modification, continuation, or discontinuation of drug therapy
- Pursuant to written, patient specific protocols approved by the Boards of Medicine and Pharmacy that jointly develop and promulgate regulations

Patients must give consent before participating and may withdraw consent at any time

Protocols approved by a committee consisting of two individuals from the Board of Medicine and two individuals from the Board of Pharmacy
- Application fee for protocol is $750
- Protocol application must include information regarding the protocol and policies and procedures
- Protocols valid for period up to 2 years
- Pharmacies and practitioners must maintain records at place of practice
Explain OBRA 90
Mandatory Patient Counseling
Omnibus Budget Reconciliation Act of 1990 (OBRA 90)provisions
- The budget bill passed by Congress in 1990 that included extensive Medicaid pharmacy reimbursement reforms
- One provision requires states that participate in the Medicaid program to establish a mandatory counseling program for prescriptions provided Medicaid eligible beneficiaries at the point of sale
- Federal requirement applies to new rxes and only Medicaid
- Many states applied the requirement to all rxes, including Medicaid and non-Medicaid; new and refill

Requires pharmacies to maintain comprehensive databases of prescription records
What are Virginia's requirements for patient counseling?
Pharmacist must conduct a prospective drug review before each new rx is dispensed or delivered to a patient or person acting on the person’s behalf
- Pharmacists’ prospective review of patient’s drug therapy is not mandated for refills but may be conducted
- Review known as drug utilization review (DUR)

Review includes screening for potential drug therapy problems due to
- Therapeutic duplication
- Drug-disease contraindications
- Drug-drug interactions
- Interactions with OTC products
- Incorrect dosage
- Drug-allergy interactions
- Clinical misuse or abuse
How must pharmacists counsel?
Pharmacist MUST offer to counsel any person presenting a new rx for filling

The offer can be made in any manner the pharmacist deems appropriate including
- Face-to-face communication with the pharmacist or designee
- Sign posted in such a manner that can be seen by patients
- Notation affixed to bag in which rx is delivered
- Notation on rx container or
- By telephone

No set standard for counseling by VA but can include information described in §54.1-3319 Counseling

A person may opt out of the offer to counsel
What are Virginia's requirements for maintaining patient records?
Pharmacies must make a reasonable effort to obtain record and maintain the following patient information at the pharmacy
- Name, address, telephone number, date of birth or age, and gender
- Individual hx, including allergies and drugs interactions, comprehensive list of meds and devices
- Information related to the patient’s drug use including failure to accept offer to counsel

Info must be maintained in pharmacist’s manual or electronic profile or in rx signature log or any other system of records in exercise of his professional judgment
What are federal requirements for medication reviews in nursing homes?
Applies to nursing homes certified by the Medicare or Medicaid program to receive funds
- Does not apply to all long-term care facilities, ie assisted living facilities, board and care homes

Each individual residing in a Medicare or Medicaid certified nursing home must receive a monthly RETROspective medication regimen review (MRR) by a pharmacist under contract with the nursing home (used to be called Drug MR)
- Known as consultant pharmacists
- Pharmacists MUST visit the nursing home to conduct the review
- Failure of nursing homes to comply with this mandate will result in large monetary fines and citations by federal government
Distinguish DUR from DRR from MTM
MTM not fully defined but most definitions indicate “not DUR and MRR”

Potential for additional payment by third party payers and Medicare rx program for MTM for activities outside of those defined by DUR and MRR

Pharmacy profession should make concerted effort to NARROWLY define DUR and MRR to expand potential scope for MTM

Not entirely in place yet
Explain the EC controversy and pharmacists' conscience clauses/ duty to fill
Plan B became OTC through a pharmacist in 2007

At the same time, some pharmacists have objected to dispensing emergency contraception on religious and moral grounds

Issue has become highly politicized but several key issues important
- Should pharmacists be able to object to dispensing meds on moral or religious grounds?
- Should states or the federal government step in and require that pharmacists fill each and every rx?
Explain the legistlation that some states have begun enacting regarding the EC controversery and pharmacists' conscience clauses/ duty to fill and the problems this may cause
Some states have begun enacting legislation that allows pharmacists to opt out of dispensing certain medications
- VA has no conscience clause provision

Federal government has reacted by introducing legislation mandating that pharmacists have a duty to fill each prescription
- Pitfalls of federal legislation
- If enacted, pharmacists would potentially have to fill ALL prescriptions presented and COULD NOT SUBSTITE BASED ON GENERICS OR FORMULARY considerations
- Trumps state board of pharmacy oversight of pharmacists
- Decreases the professionalism of pharmacists
- Pharmacies would have to stock all medications of a type or in a class or none at all
Explain some concerns +/- benefits with mail-order pharmacies and third party plan mandations
In past 20-30 years, managed care has begun to dominate rx payer market

Most managed care health plans contract with pharmacy benefit management companies (PBMs) to administer pharmacy contracts in conjunction with providing health benefits

Pharmacies are often subjected to draconian prices established by PBMs with few opportunities to negotiate better prices
- Pharmacies often cannot negotiate favorable contract pricing because of size and market share

Many PBMs own or are affiliated with mail-order pharmacies that provide rx drugs at lower prices because of negotiated discounts
What is the Sherman Antitrust Act?
Pharmacies subject to provisions of a law called the Sherman Antitrust Act which prohibits groups of independent health care professionals from banning together to collectively negotiate with manufacturers and third parties for better prices

PBMs and third party plans NOT exempt from this provision
What standards to pharmacies/pharmacists have to maintain regarding mail-order & third party plans?
Pharmacies and pharmacists must minimum licensing and professional standards to maintain business

PBMs unless operating a mail order pharmacy do not have to directly meet these standards
- BUT, all mail-order pharmacies that deliver or ship to residents of states must comply with standards established by the state Board of Pharmacy
- In most cases, states require out of state pharmacies to register with state Board of Pharmacy
What are Virginia's requirements for non-resident pharmacies?
Applies to any pharmacy located outside of VA that ships, mails or delivers SII-VI drugs must be registered with the board and disclose the following information
- Location, name, and title of all principal corporate officers and pharmacists who dispense rx drugs or devices to residents of VA
- Must provide a report annually and within 30 days after any change of office, corporate officer, or principal pharmacist
- Must comply with all requests for info from licensing agency of state where registered and the VA Board
What licensing and record requirements are required for non-resident pharmacies?
Nonresident pharmacy must maintain a current unrestricted license, permit, certificate or registration to conduct the pharmacy in compliance with the laws of the jurisdiction that it provides rx drugs

Must provide the VA board a copy of the most recent inspection report resulting form inspection by regulatory or licensing agency of the jurisdiction where located

Must ensure that the records regarding drugs dispensed to VA residents are readily retrievable from all other drugs within 7 days upon request by Board or state police

Must comply with VA standards for dispensing, labeling, and packaging
Standard is “knowingly”
What are the operation requirements for non-resident pharmacies in Virginia?
Pharmacy must operate at least 6 days per week for a minimum of 40 hours per week and provide a toll-free phone number to facilitate communication between patients in VA and a pharmacist
Pharmacies must comply with the Rx Monitoring Program
Must pay a registration fee
Explain medicare Rx benefits and protections for pharmacies
New Medicare rx plans must offer individuals access to community pharmacy services and not force individuals into mail order or other out-of-state plans
Explain the (brief) history of long-term care pharmacy (LTCP)?
1960s
- Community pharmacies begin to service seniors who reside in nursing homes
- Pharmacies develop organized distribution systems to aid in medication administration
- “Consultant” pharmacists review medication regimens for appropriateness
- Many pharmacies begin to specialize in providing services to LTC facilities
- American Society of Consultant Pharmacists founded in 1969

1974
- Federal nursing home standards require Medicare and Medicaid certified nursing homes to provide distribution systems to control acquisition and disposition of medications
- Federal nursing home standards require consultant pharmacists to review medications on a monthly basis

1995
- Federal nursing home standards revised and require more aggressive monitoring of appropriate medications by consultant pharmacists
Describe the profile of a typical nursing facility resident
Generally admitted to a facility for multiple chronic disease states requiring around-the-clock nursing care

Usually more frail and older than average Medicare beneficiary
Average age and gender, 83 year old female

Takes 8 -10 medications daily and often takes other medications as needed for pain or other transient symptoms which might arise

Combination of multiple disease states and chronic conditions require vigilant monitoring by pharmacists and medical team
What are federally mandated services in LCTFs?
Medication distribution systems and clinical services tailored to the unique needs of individual LTC facility
- Multiple daily deliveries of medications to facility
- Around-the-clock (stat) delivery of emergency medications (within an hour of ordering)
- Consultant pharmacists interventions to optimize medication therapy and reduce medication related problems
What hours must a pharmacist be available for a LTCF?
Pharmacists available 24 hours a day, 7 days a week providing
- Emergency medications, and
- Checking for medication errors
What are special packaging systems for LTCF?
Special packaging systems
Not specific in federal mandate, but must provide an organized distribution system
Usually other than vials!

Fully-automated packaging machines meet demands for multiple prescriptions and large LTCFs
Partially-automated systems help meet needs for LTCPs servicing smaller LTCF
- Allows pharmacy to package lower quantities of medications
Explain the minimize dispensing error minimum requirement for a LTCF
Minimize dispensing errors to less than 5%
What are Virginia's requirements for LTCPs and hospital pharmacies for processing of prescriptions?
Remote processing of prescriptions
Dispensing is considered to be done at the point when the medication is administered
- Off-site pharmacy receives prescription and provides the following services
- Receipt, interpretation or clarification
- Entering rx and patient data
- Transferring rx information
- Performing perspective drug review
- Other clinical functions related to drug review process

Functions may be outsourced in a manner similar to a central fill pharmacy
- May be out of state pharmacy but pharmacists must be licensed in VA
What are Virginia's requirements for LTCPs and hospital pharmacies for dispensing of prescriptions?
Permits,but does not require, a unit dose dispensing system
- Includes carts and individually packaged medications
- VA requires system to have lock when outside of pharmacy

Consistent with DEA requirements requiring a signed SII prescription
VA also requires that hospital SII rxes be signed by MD!
Allows properly trained personnel to transcribe prescriber’s orders to patient profile card, fill medication carts, and perform other duties under supervision of pharmacist
Must label dosages with drug name, strength, lot number and expiration when indicated
What are Virginia's requirements for LTCPs and hospital pharmacies for individual patient drawers?
Individual patient drawers
- Must include patient’s name and location
- All drugs must be stored in patient-specific drawer
- Back-up dose of one drug may be stored in patient drawer
What are Virginia's requirements for LTCPs and hospital pharmacies regarding record keeping for individual patient drawers?
Recording information regarding filling drawers

Must be maintained for one year and include
- Date of filling
- Location of cart
- Initials of person filling cart
- Initials of pharmacist authorizing and approving cart contents
What are Virginia's requirements for LTCPs and hospital pharmacies regarding record keeping for dispensing meds from carts?
Recording dispensing records from carts

Patient profile record or medication administration record (MAR) must be maintained for each patient

SII-V drug records must be maintained for 2 years after completion of the MAR or patient record
- In many cases, these record multiple administrations over several days or weeks

For computerized systems: must maintain a uniform “fill list” for dispensing records of SII-VI drugs
What are Virginia's requirements for LTCPs and hospital pharmacies regarding turnaround times for unit dose dispensing systems?
Facilities with licensed personnel administering medications VA allows a maximum of a 7 day supply
- Most pharmacies ignore this standard and provide 30 day supply

Facilities with unlicensed individuals may only dispense a 72-hour supply and meet the following requirements
- Pharmacy must provide training on the dispensing system used
- Pharmacy must provide the facility with a MAR containing the full name of each drug dispensed with no abbreviations
- Deepening systems must be organized to indicate time that medications are to be administered
Explain requirements for floor stocked medications in hospitals and LTCFs
Federal DEA regulations and VA allow certain medications to be kept as floor stock for emergency purposes

DEA permits a wide variety of medications and dosages to be included in kit, including SII-V controlled substances
- States, including VA, may restrict content of emergency kits (e-kits) and stat boxes
What are Virginia's requirements for emergency kits (E-kits)?
Only applies to facilities where individuals licensed to administer drugs
- Drugs for life-threatening situations only
- LTC pharmacy determines content along with medical and nursing staff
- Limited to drugs for administration by injection or inhalation only but allows Nitro SL
What are Virginia's requirements for providing an e-kit?
Must be sealed to prevent theft or loss

Must ensure that once seal is broken cannot be re-sealed without detection

Seal must be a unique code that allows for pharmacy identification when opened

Kit must include a form to be completed upon opening and removal of items
- Must include the date, time, name and quantity of items removed
- Must be returned to the pharmacy within 72 hours upon opening
- Prescriber must provide rx within 72 hours
What are Virginia's requirements for providing Stat-drug boxes?
Different from e-kit

Designed to administer dosages prior to receipt from pharmacy

Permitted only in facilities where licensed personnel present

Similar safety and anti-theft procedures as e-kits plus
- List of content in pharmacy and facility
- Box has a single expiration date for all drugs contained within equivalent to date when first drug expires
- Content limited to those drugs that may cause harm to patient if not given within period of time after order
- No SIIs
- May not contain more than one of SIII-V drug in each therapeutic class or a total of 5 doses in each class
What are Virginia's requirements for floor stock?
Only in facilities with licensed personnel

May include
- IV fluids
- Irrigation fluids
- Hep flush kits
- Medicinal gases
- Sterile water
- Saline
- Rx devices

Determined by provider pharmacist and medical and nursing personnel
How do LTCPs contract with nursing facilities?
LTCPs selected by nursing facilities based on the services necessary for its residents

Generally nursing facility selects one LTCP based on the needs of the residents

Multiple pharmacies in nursing facilities would disrupt establish quality procedures established for delivery, administration, and clinical services
Regarding contracts with LTCPs and nursing facilities, how does this relationship comply with Medicare/Medicaid beneficiaries' freedom of choice?
Centers for Medicare & Medicaid Services (CMS) supports the use of a single LTCP selected by the nursing facility
- Federal nursing home standards require facilities to establish a safe medication distribution system
- Safe medication distribution system means facilities can restrict pharmacies
42 CFR Part 403
Medicare Program;
Medicare Drug Card Assistance Initiative
Final Rule
September 2, 2003