Pass VA Law Flashcards
How much CE is required to reinstate a license that was inactive?
The same amount that the pharmacist would have needed to renew the license each year.
Does the Board of Pharmacy have to reinstate a license that has been inactive for more than a year?
No it is at the discretion of the board if they reinstate or not.
Are there any additional requirements for a pharmacist whose license has been inactive for more than 5 years?
The pharmacist will need to produce proof of practice in another state within the last 5 years or have obtained 160 hours of practical experience as a Virginia Pharmacy Intern within the previous 6 months.
Who can sanction a pharmacist and suspend or revoke a pharmacist’s license?
The Board of Pharmacy.
What sanctions, in addition to suspension or revocation of a pharmacist’s license, are available to the Board?
Reprimand
Monetary penalty
Probation
Imposition of terms on the pharmacist’s license
What if a pharmacist’s license is suspended in another state solely due to the pharmacist’s failure to renew the license?
The Board will not sanction the pharmacist’s Virginia license.
Are pharmacists allowed to provide patient information to other healthcare providers and insurance companies to provide care to a patient?
Yes
Does a pharmacy have to provide a patient with his health records if he requests them?
Yes
Is a pharmacist allowed to provide a patient’s prescription records to a court in response to a lawfully issued subpoena duces tecum (subpoena for records)?
Yes but the pharmacist needs to carefully read and follow the directions on the subpoena because the patient is allowed to move to have the subpoena dismissed. Consult the pharmacy’s legal counsel before providing records in response to a subpoena.
Is a pharmacist always entitled to a hearing prior to the suspension of his license?
No. A pharmacist’s license can be immediately suspended if he presents a danger to the public health or safety. A hearing will be scheduled within a reasonable time.
What other circumstances can result in a pharmacist’s license being immediately suspended without a hearing by the Director of the Board of Health Professions?
- The pharmacist is convicted of a felony.
- The pharmacist is adjudicated incapacitated (not competent) by a court.
- The pharmacist has his license to practice in another jurisdiction suspended or revoked.
What if the felony conviction is not final?
The director can decline to suspend the license if there is a likelihood of injury to the public if the pharmacist’s services are not available. This applies if the pharmacist owns his own pharmacy in a small town & services would be made unavailable to his patients.
If a pharmacist’s license is suspended, how does he apply for reinstatement?
He can bring counsel and witnesses to the Board hearing and will need 3/4 of the Board members at the hearing to vote for reinstatement. The Board deems the appropriate terms and condition.
What is a pharmacy technician?
A person who is registered with the Board to assist a pharmacist under the pharmacist’s supervision.
How does a person apply to obtain registration as a pharmacy technician?
They must hold a current certification by the Pharmacy Technician Certification Board or complete an approved training program, pass the VA technician exam, complete application, and pay the licensing fee.
Does a technician who only works in a free clinic have to be registered?
Yes. The Board can issue a limited-use registration (free clinic only). The Board will waive the initial registration fee and first examination fee for this type of registration. If the tech wants to switch to unlimited, all that is required is payment of the current renewal fee.
Can unregistered technicians work as pharmacy technicians while enrolled in a training program to become registered?
Yes, as long as they are being directly monitored by a pharmacist.
How long can a technician trainee work before obtaining his registration?
9 months
When does a technician need to renew his or her registration?
Before Dec. 31 each year. A technician who is newly licensed on July 1st or later doesn’t need to renew his registration until December 31st of the following year.
Are pharmacy technicians required to complete CE every year?
Yes. Technicians are required to obtain 5 hours of CE or 0.5 CEUs every year. It is possible to get a 1 year extension with a written request- but the technician would still need to complete the full amount of CE.
What if a technician renews his or her registration late?
Within the first year, the technician must pay a late fee, the renewal fee, complete the renewal form, and certify his completion of the required CE. After 1 year, the technician pays a reinstatement fee, a renewal fee, completes the application for reinstatement and certifies his completion of the CE.
After 5 or more years, the technician will need to apply for recertification. The same requirements will apply as for initial registration of the technician.
How long is a technician required to keep her records of completion of CE?
Two years following renewal. The tech, not the employer, is required to maintain these records.
How many technicians can a pharmacist supervise at one time?
- This includes technicians, technician trainees, and pharmacy interns who are performing pharmacy technician activities.
What acts are restricted to pharmacy technicians?
*Entering prescription information and drug history into data system.
*Preparing prescription labels and patient information.
Removing drugs to be dispensed from inventory.
*Counting, measuring, and compounding drugs to be dispensed.
*Packaging and labeling drugs to be dispensed, including repackaging.
*Stocking and loading automated dispensing devices or other devices that are used in the dispensing process.
*Accepting refill authorization from a prescriber provided there are no changes from the original prescription.
*Performing any act restricted to pharmacy technicians by the Board’s regulations.
Can “acts restricted to pharmacy technicians” be completed by pharmacists or pharmacy interns?
Yes
When can a pharmacy technician at a nuclear pharmacy accept oral prescriptions?
A technician at a nuclear pharmacy can accept oral prescriptions for diagnostic non-patient specific radiopharmaceuticals.
Can a technician compound extemporaneous preparations?
Yes, but a pharmacist must personally supervise the preparation.
What documents must be maintained by a pharmacy that employs technicians?
- a site–specific training program and manual
- Documentation of completion of this training for each technician, which must be kept for 2 years after the tech leaves the employer
- For technician trainees, proof that they are enrolled in an approved training program.
What are the physical requirements for a VA licensed prescription department?
- At least 240 square feet not including patient waiting area or area for counseling, devices, cosmetics, and proprietary medicines.
- Rest rooms and stock rooms must not be accessed through prescription area. If there is a restroom in prescript. area, it must be for pharmacy personnel only.
- It must have a sink with hot and cold running water.
- There must be a refrigerator with a monitoring thermometer for drugs that require cold storage temps if such drugs are stocked in the pharmacy.
- It must be well lit, well ventilated, and the temp must meet USP standards for drug storage.
What does “storage temperature” mean?
The temps required for the safe storage of drugs as specified in the drugs’ monographs.
Freezer Temperature
-20 to -10C (-4 to 14F)
Refrigerator Temperature
2-8C(36-46F)
Cold
<8 C
Cool
8-15C(46-59F)
Room Temperature
Work area temperature
Controlled room temperature
20-25C(68-77F)
Warm
30-40C(86-104F)
Excessive heat
> 40C(104F)
Protection from freezing
means that freezing the drug subjects it to a change in potency
Fahrenheit Temperature
1.8 X Celsius Temperature + 32
Can you use a trailer as a pharmacy?
No, a pharmacy must be located in a permanent and secure structure.
What minimum equipment is required for a pharmacy?
- A current dispensing information reference source
- Either an electronic scale or a set of prescription balances (sensitive to 15 milligrams) and weights if the dispensing activities require weighing.
Are pharmacies required to have a security system?
Yes.
What is an exception to the pharmacy security system requirement?
Pharmacies that are open 24 hours a day, 7 days a week, and that are always staffed by a pharmacist do not have to have a security system. If they change hours to less than 24 they are required to purchase one.
What are requirements for pharmacy security system’s device(s)?
- must be a generally accepted device such as sound, microwave, photoelectric, or ultrasonic.
- must be in working order and have backup power supply.
- must be able to send an alarm even if the communication line is cut.
- must fully protect the prescription area and detect any type of breaking.
Who may have the code to access the alarm system?
Pharmacists working at the pharmacy who have been authorized by the pharmacist in charge (PIC) to have the access code.
When must the security system be activated?
Whenever the prescription department is closed for business.
What are the prescription department enclosure requirements?
- it must be constructed so that it protects against unauthorized entry and theft of controlled substances at all times.
- The prescription department enclosure must be locked and alarmed whenever a pharmacist is not on duty.
- It must be capable of being locked when the on duty pharmacist is not in the prescription department.
Who obtains a permit from the Board of Pharmacy to conduct (operate) a pharmacy in Virginia?
The PIC who will be in actual charge of the practice of pharmacy at the location on the application. The permit will not be issued to a business entity.
What has to be on the application for the permit to operate a pharmacy?
- The pharmacy’s corporate name and trade name
- Any pharmacists in addition to the PIC who will be practicing at the pharmacy
- The hours the pharmacy will be open
- The pharmacy owner, if someone other than the PIC
- The type of ownership (corporation, partnership) and names of the partners, directors, or officers.
Is it possible to get a special or limited-use pharmacy permit?
Yes. The Board has the discretion to issue a special or limited-use permit. The applicant will need to list the regulatory requirements he wants waived and why. The pharmacy must also maintain a policy and procedure manual outlining the type of operation, hours, method of documenting continuing pharmacist control, and schedules of drugs maintained.
Can a pharmacist be the PIC of more than one pharmacy?
Yes. A pharmacist may be the PIC of a maximum of 2 pharmacies.
What is the next step in the process after the application for the permit to operate a pharmacy is submitted?
The location of the new pharmacy must be inspected by an agent of the Board before the pharmacy permit can be issued.
If the pharmacy permit application indicated a requested inspection date, will the Board honor the request for the inspection to occur on that specific date?
Yes as long as the application provides the Board with 14 days notice prior to the requested inspection date.
What if the requested inspection date is less than 14 days from the date the application is submitted?
The board may adjust to the date to provide for at least 14 days to schedule the inspection.
What requirements will the new pharmacy have to meet for the inspector to approve the issuance of a pharmacy permit?
- all applicable physical standards (240 sq. ft.)
- sanitary conditions standard
- required minimum equipment and resource standard
- security system standards
- prescription department enclosure and access standards
What will happen if the inspector does not approve the pharmacy or if the applicant is not ready by the inspection date?
The applicant will have to pay a re-inspection fee and the pharmacy will have to be re-inspected. If the applicant provides the inspector or Board with 24 hours advanced notice that he is not ready for the inspection, the inspection will be rescheduled and he will not have to pay the additional re-inspection fee.
Before the inspection, can drugs be stocked in the pharmacy?
No. Drugs cannot be moved into a new location for an existing pharmacy either. If you don’t have a permit, you can’t stock drugs.
When can the PIC begin to stock the new pharmacy with drugs?
After passing inspection and no sooner than 14 days prior to the designated opening date.
How are the safety and integrity of the drugs ensured prior to the opening of the pharmacy?
A pharmacist has to be present at the pharmacy on a daily basis.
What if the opening date for the pharmacy changes?
The pharmacist has to notify the Board and continue to be on site on a daily basis.
Is the pharmacy required to display its permit?
Yes, it must be displayed prominently.
Under what circumstances does the PIC need to turn in the pharmacy permit and make a new application.
IF there is any change in ownership of the pharmacy, such as a change in partnership composition or acquisition.
What happens if the PIC leaves her position with the pharmacy?
The PIC must immediately surrender the pharmacy permit to the Board. Remember, the permit is issued to the PIC and not to the pharmacy.
How long can a PIC be absent for a scheduled leave before the pharmacy has to notify the Board and designate a new PIC?
The PIC may be absent for up to 30 days for a scheduled leave of absence. If she is gone for more than 30 days, the pharmacy will need to notify the Board and designate a new PIC.
What if the PIC has an unscheduled absence?
If the PIC has a 15 day unscheduled absence and no known return date within the next 15 days, the Board must be notified and a new PIC designated.
How will the pharmacy get a new permit?
The incoming PIC will apply for the new permit.
What does a new PIC have to do when taking over responsibility for a pharmacy?
Inventory all Schedule I, II, III, IV, and V drugs on the day her or she becomes the PIC. The inventory must be completed before the pharmacy opens for business that day.
When the PIC leaves, how long does the pharmacy have to designate a new PIC?
14 days
Can a pharmacy keep operating if it fails to designate a new PIC within 14 days after the old PIC leaves.
No. It is not even allowed to maintain a stock of prescription drugs unless it requests an extension from the Board of the time allowed designate a new PIC.
Who can grant a pharmacy an extension of the time allowed to obtain a new PIC?
The executive director of the Board can give the pharmacy an additional 14 days to designate a PIC for good cause shown. But, the extension request must be received prior to the original deadline.
If the pharmacy does not have a PIC and receives a notice from the Board that it does not have a valid permit, what is the pharmacy required to do?
Dispose properly of all Schedule II through VI drugs and devices on the premises within fifteen days.
What if the pharmacy fails to do dispose of the drugs?
The Board will seize all Schedule II through VI drugs and devices still on the premises and notify the owner.
Can the pharmacy’s owner get the drugs back?
Yes. The owner can claim the drugs by paying the storage costs and providing for proper disposition of the drugs.
How long does the owner have to claim the drugs?
6 months. IF the drugs have not been claimed by then, the drugs may be destroyed.
If the pharmacy is being sold, can the pharmacy permit be transferred to the new owners?
No, the permit is nontransferable and must be returned to the Board.
Does the Board need to be notified if the pharmacy is changing locations, making changes to a previously approved security system, or if structural changes are being made to the pharmacy?
Yes. The pharmacy will need to be inspected by an agent of the Board and the Board needs to be given 14 days notice before the inspection is scheduled. A new location will need to be inspected before any drugs can be stocked there.
What must be done if the hours of operation of the pharmacy change?
If the change is expected to last more than a week, the change must be reported in writing to the Board and the pharmacy must post a conspicuous notice 14 days before the change to inform the pharmacy’s patients.
What do you need to do if you want to close your pharmacy?
If it will be closed for more than a week, the pharmacy must post a notice 30 days prior to closing or mail a notice 14 days prior to closing to every patient with available refills.
What must be included in the notice?
The notice must include the date of closing and name of the pharmacy that records will be transferred to unless patients indicate a preference to the contrary.
If there is a change in pharmacy ownership, which records must be transferred?
The last 2 years of prescription dispensing records and patient records.
What happens if a pharmacy refuses to process a request for prescription dispensing records or other records tendered in accordance with law?
It constitutes closing.
When a pharmacy is closing, does the Board need to be notified?
Yes, the pharmacy must report how it intends to dispose of all CII-CVI drugs, prescription dispensing and patient records. This includes the name and address of any licensee who will receive the drugs and records, and the date of transfer.
The pharmacy is going to change ownership, does the Board need to be notified?
The pharmacy must notify the Board 14 days prior to the change in ownership, and transfer the preceding two years’ prescription and dispensing records. Remember, the PIC will have to get a new permit.
One pharmacy is being acquired by another. Do current patients need to be notified?
Only if prescription records are going to be used for something other than continuity of pharmacy services at substantially the same level. IF so, written notice must be given 14 days prior to the acquisition.
Are pharmacies required to obtain a DEA registration (DEA Number)?
Yes. A DEA registration is necessary to possess Federal controlled substances (CI-CV) drugs. A pharmacy would not need a DEA registration if it were only going to possess and dispense CVI medications.
What form does a pharmacy complete to obtain a DEA registration?
DEA form 224 for the initial registration and DEA 224a for renewal of the registration.
When will the initial registration expire?
It will expire in 28-39 months. The DEA varies the initial expiration dates so it can assign new registrants to a cohort for renewal. This prevents all the registration from having to be renewed at the same time.
After the initial registration is renewed, how often does a pharmacy need to renew its registration with the DEA?
Every 3 years. Each renewed registration will have a 3 year expiration date.
Do agents of the registrant (pharmacists) need to be separately registered?
No. In Fact, the registrant can authorize his agent (s) to order CII drugs, complete DEA 222 forms, and to renew his DEA registration by completion of a Power of Attorney. Regular employees of a pharmacy do not need to be registered either.
IF a pharmacy,. manufacturer, or other entity has more than one place of business, how many DEA registrations do they need?
One for each place of business or practice location.
How often does a manufacturer need to re-register with the DEA?
Every year.
IF a pharmacist owns two independent pharmacies at different locations, does the pharmacist have to obtain two separate DEA registrations, one for each pharmacy?
Yes. Each location must have its own DEA group.
What are the separate business activities that each require their own DEA registration number?
- Manufacturing
- Distributing
- Reverse distributing
- Dispensing
- Research (CI drugs)
- Research (CII-V drugs)
- Narcotic treatment (including compounder)
- Importing
- Exporting
- Chemical analysis
Can a pharmacy engage in the other business activities using its DEA registration to dispense medications?
No. A pharmacy’s DEA registration allows it to possess and dispense CII-CV medications. It would need a different DEA registration to engage in the other activities.
Are there any organizations that are exempt from paying DEA registration fees (but not exempt from getting the appropriate DEA registration?
Yes. Facilities operated by a United States agency (including the US Army, Navy, Marine Corps., Air Force, Coast Guard), or by any state, are exempt from paying fees.
A facility wants to handle CI drugs for research purposes. The facility has already had a DEA number. What else is the facility required to do?
Apply for a modified DEA registration by submitting 3 copies of the research protocol. There is not fee for modification and it is handled just like a regular registration application.
When is a registrant’s DEA registration considered terminated?
IF the registrant dies, if the business ceases legal existence, if the registrant surrenders his registration to the DEA, or if the person discontinues his business or professional practice.
IF a pharmacy ceases business, what are its responsibilities to the DEA?
- Notify the DEA
- Return the certificate of registration and unexecuted order forms (DEA 222 Forms)
- Dispose of Federal controlled substances properly
Can a pharmacy transfer its registration to the new owner(s) after being acquired?
Yes. The registrant must submit a written request to the Deputy Assistant Administrator, Office of Diversion Control in Washington, DC.
Can a DEA registrant discontinue business and transfer the business to another registrant?
Yes. The transferor has to provide (in person or via certified mail return receipt requested) the Special Agent in Charge of his area notice at least 14 days prior to the date of the proposed transfer.
What must be included in the transfer notice request?
- The names, addresses, DEA numbers, and authorized business activities of both the transferring and receiving registrants
- Where business will be conducted and the new address if it is different from where the transferring business was located
- The date the transfer of controlled substances will occur
- Any quota the transferor had to manufacture or procure CI or CII drugs.
Will the pharmacy receive any special paperwork from the Special Agent in Charge authorizing the transfer?
No. If the date of the transfer arrives and the pharmacy hasn’t been informed that it cannot occur, the transfer may take place.
What must be done on the date of transfer?
- A complete inventory of all CI-CV controlled substances (both transferor and transferee need to keep a copy of this inventory)
- Use a DEA 222 order form if transferring CI-CII substances
- All required records of the transferor that relate to the controlled substances must be transferred to the transferee
- Registrants that are required to file reports (e.g., registrants that routinely destroy controlled substances) must file a final report.
What else does the outgoing PIC have to do?
Return the pharmacy permit to the Board immediately.
Which entities are required to register with the Federal Food & Drug Administration (FDA)?
Manufacturers, compounders, and distributors. Pharmacies are not required to register with the FDA.
What is a drug?
An article intended for use in the diagnosis, mitigation, treatment, or prevention of disease in humans or animals. An article, other than food, that is intended to affect the structure of function of the body is also a drug for purposes of pharmacy law.
A “drug” is also an article recognized in which publications?
- The official United States Pharmacopoeia National Formulary (USP-NF)
- The official Homeopathic Pharmacopoeia of the United States
- A supplement to one of these pharmacopoeia
Is either alcohol or tobacco a drug for purposes of pharmacy law?
No
What is a “prescription drug”?
A drug that Federal law or regulations prohibits from being dispensed without a prescription. The definition includes finished dosage forms and active ingredients.
How does the FDA decide whether a drug will be an OTC product or prescription drug?
A drug will require a prescription if the manufacturer cannot write adequate directions for use by a layperson, the drug cannot be used safely without medical supervision by a licensed prescriber, or if it contains an addictive substance that is subject to abuse.
Are the labeling requirements different for RX and OTC drugs?
Yes. The requirements for OTC drugs are much more in depth because these drugs are not used under the supervision of a practitioner.
What is a “controlled substance” under Federal law?
A controlled substance under Federal law is any drug that has been classified as a Schedule I, II, III, IV, or V drug by the Federal government.
How are the drug Schedules abbreviated?
By the use of a capital letter “C” and roman numerals.
- Schedule I=CI
- Schedule II=CII
- Schedule III= CIII
- Schedule IV=CIV
Is Virginia’s definition of “controlled substance” the same as the Federal law definition?
No. Virginia’s definition of “controlled substance” includes the same drugs as the Federal definition but also includes any other drug that requires a prescription.
Does Virginia assign these other drugs to a Virginia only schedule?
Yes. Virginia places these drugs in Schedule VI(CVI). This is a schedule that does not exist in Federal law.
What Federal official assigns drugs to the Federal Schedules?
The United States Attorney General.
What factors does the U.S. Attorney General consider when adding or removing a drug from Schedules I-V?
- Its actual or relative potential for abuse
- Scientific evidence of its pharmacological effect, if known
- The state of current scientific knowledge regarding the drug
- Its history and current pattern of abuse
- The scope, duration, and significance of abuse
- What if any, risk there is to the public health
- ITs potential to produce psychic or physiological dependence
- Whether the substance is an immediate precursor of a drug that is already scheduled
Can the Virginia Board of Pharmacy schedule or de-schedule drugs under state law?
Yes.
What factors does VA consider when scheduling drugs?
The same ones the U.S. Attorney General considers.
What findings by the Board will result in its placing a drug in Schedule I?
- The drug has a high potential for abuse; and
- No accepted medical use in treatment in the US or lacks accepted safety for use in treatment under medical supervision.
What findings by the Board will result in its placing a drug in Schedule II?
- The drug has a high potential for abuse;
- currently accepted medical use in treatment in the US, or currently accepted medical use with severe restrictions
- It’s abuse may lead to severe psychic or physical dependence.
What findings by the Board will result in its placing a drug in Schedule III?
- The drug has less potential for abuse than drugs listed in Schedules I and II
- It has a currently accepted use for medical treatment in the United States
- ITs abuse may lead to moderate or low physical dependence or high psychological dependence
What findings by the Board will result in its placing a drug in Schedule IV?
- The drug has a low potential for abuse relative to drugs in Schedule III
- It has a currently accepted use for medical treatment in the US
- Its abuse may lead to limited physical dependence or psychological dependence relative to the substances in Schedule III
What findings by the Board will result in its placing a drug in Schedule V?
- The drug has a low potential for abuse relative to the controlled substances listed in Schedule IV
- It has a currently accepted use for medical treatment in the United States
- It has limited physical or psychological dependence liability compared to controlled substances listed in Schedule IV
TEST PRACTICE POINTER*****
The lower the schedule, the more addictive or abusable the drug. Schedule I is the only schedule whose drug/substances do not have a medically accepted use.
What about Virginia’s “Schedule VI” classification?
Virginia places the following drugs and devices in Schedule VI:
- EVERY DRUG OR DEVICE NOT INCLUDED IN SCHEDULES I-V THAT ARE ONLY SAFE FOR USE UNDER THE SUPERVISION OF A LICENSED PRACTITIONER.
- ANY DRUG OR DEVICE NOT INCLUDED IN SCHEDULES I-V THAT FEDERAL LAW REQUIRES BE LABELED WITH “RX ONLY” OR CAUTIONARY LABELING SUCH AS “FEDERAL LAW RESTRICTS THIS DRUG TO US BY OR ON THE ORDER OF A ____.” The blank may be filled in with “physician”,”dentist”, “veterinarian” or other licensed practitioner. The Board may also designate any compound exempted from Schedules III, Iv, or V as Schedule VI.
Are any devices included in Schedule VI?
Yes, devices are included in CVI if they are considered safe for use only under supervision of a licensed practitioner(e.g. an insulin pump).
If Virginia Board of Pharmacy wanted to regulate a drug more strictly than Federal law does (for example, place Ambien in Schedule II instead of Schedule IV), are they allowed to do so?
Yes.
What is a “label”?
The written, printed or graphic matter on a drug’s immediate container. If something is required to be on the label, it must be visible on or through the outside container.
What is “labeling”?
The drug label and any additional materials accompanying the drug. The additional materials could be a package insert, a patient information sheet or leaflet, or any other materials that accompany the medication.
Describe situations in which a drug would be considered adulterated.
- The drug is contaminated (contains “any filth, puid, or decomposed substance:).
- The drug or its container contains a harmful substance
- The drug contains an unsafe color additive
- The facilities used to make, pack, or hold the drug do not conform to cGMP(current good manufacturing practices)
- The drug was subjected (manufactured, stored, etc.) in unsanitary conditions that may have resulted in its becoming contaminated or harmful.
- It doesn’t actually contain the strength, quality, or purity of drug that it claims to contain. {practice tip: it also misbranded because its label is false or misleading}
- It is a drug listed in a compendium (USP)and it does not meet the compendium’s requirements and does not plainly state on its label that it differs from the compendium’s requirements
- IT is mixed or packed with something that reduces its quality or strength
Describe situations in which a drug would be considered misbranded.
*Its labeling is false or misleading
*The package is missing the name & location of the manufacturer, packer, or distributor
*The label or labeling is missing required information
*A habit-forming drug is missing the name and amount of substance and the statement “Warning-May Be Habit Forming”
It is a prescription drug and the established (generic) name of the drug is not printed on its label prominently and in type at least half as large as that used for the proprietary (brand) name
*All drugs must have the drug’s name on the label and prescription drugs must also have the quantity of the active ingredients (e.g.lisinopril 10mg) Any failure to meet this requirement will result in the drug being misbranded
*It is missing adequate directions for use or adequate warnings.{OTC only}
*The drug is recognized in a compendium and is not packaged and labeled as required by the compendium’s standards
*The drug is dangerous when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling or advertising
*If it is insulin or an applicable antibiotic (e.g.produced by microorganisms-streptomycin), and does not have a required batch certificate of release in effect
*If a trademark, trade name, or other identifying mark was placed on the drug or container with intent to defraud (counterfeit)
*If it is a prescription drug and its label does not contain its established name, the quantitative formula of each ingredient, and a necessary summary of information on side effects, contraindications, and effectiveness as specified by the Federal Food, Drug,& Cosmetic Act’s regulations.
*The labeling for prescription drug vials dispensed to patients by a pharmacy will be covered later in this text
Does VA or the Federal government decide who has prescribing authority in VA?
Virginia does. State law controls who can write valid prescriptions
What practitioners can write valid prescriptions for controlled substances in VA?
- Practitioners of medicine (Medical Doctor or M.D.)
- Practitioners of osteopathy(Osteopath or D.O.)
- Practitioners of dentistry (Dentist, D.D.S. or D.M.D)
- Practitioners of podiatry (Podiatrist or D.P.M.-“foot doctor”
- Practitioners of veterinary medicine (Veterinarian or D.V.M)
- Virginia licensed nurse practitioners (NO or FNP)
- Virginia licensed physician’s assistants (PA)
- Virginia TPA-certified optometrists (O.D.)
Which prescribers have unrestricted prescribing authority and can write for CII-CVI prescriptions to treat their patients without the need for an agreement with any other practitioner?
- Medical doctors
- Osteopathic doctors
- Dentists
- Podiatrists
- Veterinarians
Can a VA pharmacy fill prescriptions written by out of state practitioners?
Yes, if the prescriber is a medical doctor, osteopath, dentist, podiatrist, or veterinarian and the prescription meets all of the other requirements for a valid VA issued prescription.
Out of state prescriptions from nurse practitioners, physicians’ assistants, and optometrists are not valid unless the prescriber is licensed in VA in addition to the other state.
Are there any restrictions on the prescribing of drugs by medical doctors, osteopathic doctors, podiatrists, dentists, and veterinarians?
Yes. Medical doctors, osteopathic doctors, podiatrists, and dentists can not write prescriptions for animals.
Veterinarians can only write for animals.
Dentists can only write prescriptions for the treatment of mouth conditions and diseases. A prescription for oral contraceptives would not be valid.
Podiatrists can only write prescriptions for the treatment of conditions and diseases of the foot and ankle. A prescription for an asthma medication would not be valid.
What are the prescribing restrictions on nurse practitioners and physician assistants?
A NP prescribing authority is dependent upon entry into practice agreement with a patient care team physician that clearly states the prescriptive practices of the NP.
A PA prescribing authority is dependent upon entry into a written agreement with a licensed physician or podiatrist that provides for the direction and supervision of the physician assistant’s prescriptive practices.
How will you know if a NP or PA is prescribing a drug that is not allowed under his agreement with a team care physician, physician, or podiatrist?
You may not be able to tell if the prescription is for an approved drug. You should examine the practice the prescriber is in to make sure that the prescription is for a drug that would normally be prescribed in that practice setting. For example, if you receive a prescription for oral contraceptives from a NP at an OB/GYN practice, the prescription is most probably within the NP’s scope of practice. However, if that same NP wrote a prescription for treatment of gum disease (chlorhexidine), you would want to call the doctor’s office to verify the prescription.
Are there any prescribing limitations on TPA-certified optometrists?
Yes
What medications are TPA certified optometrists allowed to prescribe and administer?
- CIII-VI oral analgesics to relieve ocular (eye) pain
- other oral CVI controlled substances to treat diseases of the eye and it’s adnexa
- Topically applied CVI drugs *for treatment of the eye/adnexa)
- Intramuscular administration of epinephrine to treat emergency cases of anaphylactic shock
What is the “adnexa” of the eye?
This tissues immediately surrounding the eye; such as the eyelids and conjunctiva.
What certification does an optometrist (OD) need in order to prescribe?
TPA-certification. TPA stands for Therapeutic Pharmaceutical Agents.
Is TPA-certification a state or national certification?
It is a VA certification that ODs must obtain from the VA Board of Optometry.
What conditions are TPA certified optometrists allowed to treat?
Diseases and abnormal conditions of the human eye and its adnexa (tissues adjoining the eye).
Are there any conditions that TPA-certified optometrists are specifically prohibited from treating?
Yes. Optometrists cannot treat infantile or congenial glaucoma and their treatment of closed angle glaucoma is limited to initiation of immediate emergency care.
Are pharmacies allowed to supply TPA-certified optometrists with therapeutic pharmaceutical agents listed on the TPA-Formulary?
YEs.
Are medical interns and residents who work in a hospital allowed to write prescriptions?
Yes, but only within their duties as part of the residency program. This may include writing prescriptions for ER patients that will be filled at a retail pharmacy
What is a “prescription” under VA law?
An order for drugs or medical supplies, given to a pharmacist by a practitioner authorized to prescribe. The prescription may be written, oral, faxed or transmitted electronically.
What prescriber information must every VA prescription contain?
- Prescriber’s name
- Prescriber’s address
- Prescriber’s phone number
- Prescriber’s signature (except on oral prescriptions)
Are there any additional requirements for Federally controlled substance prescriptions (CII-V)?
YEs. They must also contain the prescriber’s DEA number.
Are medical interns and residents allowed to write prescriptions in VA?
Yes
Since interns and some residents do not have a DEA number, what do they use in place of their own DEA number?
They use the hospital where they are practicing DEA number plus a suffix assigned to the intern/resident by the institution. (E.g. BB1438901-1234)
Do intern and resident’s prescriptions need to comply with all of the regular requirements for a valid VA prescription?
Yes
Are the interns/residents allowed to use their identification number to write for CII-CVI controlled substances?
Yes
When can a medical intern or resident working for a hospital prescribe controlled substances under the hospital’s DEA number?
When it is in furtherance of the person’s duties at the hospital. The intern or resident cannot use the number if he/she is working somewhere else like an urgent care center that is not affiliated with the hospital.
What if the patient was seen by the intern/resident at the hospital’s emergency room?
The intern/resident can use the hospital identification number assigned to him to write a prescription for the patient.
What other information has to go on the prescription?
- The intern/resident’s signature and the legibly printed name, address, and telephone number of the resident/intern.
- the address and phone number are usually pre-printed on the hospital’s prescription blank but the intern/resident’s information is often not included and must be added by hand.
Who else is exempt from the requirement to register with the DEA?
- Agents and employees of registrants (e.g., employees of a pharmacy
- Practitioners affiliated with registrants (e.g.,doctors working at the hospital)
- Law enforcement officials
What patient information must be on the prescription?
- The patient’s first and last name
* The patient’s address
What if the patient is an animal?
The prescription must contain the :
- Owner’s name
- Owner’s address
- The species of the animal
Does the prescriber need to write the patient’s address on the prescription?
No, it can be added by the dispenser or kept in the patient’s electronic record in the pharmacy.
Does the prescription need to be dated?
Yes. It must be dated on the date it is signed by the prescriber. Postdating of prescriptions is not allowed and is illegal.
What drug information must go on the prescription?
*Drug name
*Drug strength
*Drug dosage form
*Quantity prescribed
*Directions for use
VIRGINIA DOES NOT SPECIFICALLY REQUIRE A QUANTITY ON PRESCRIPTIONS FOR CVI DRUGS PROVIDED THAT THE PRESCRIPTION CONTAINS SOME DIRECTIONS BY WHICH THE PHARMACIST CAN CALCULATE THE AUTHORIZED QUANTITY USING DIRECTIONS FOR USE AND DURATION. CII-CV PRESCRIPTIONS MUST CONTAIN A QUANTITY.
How long are prescriptions for CII-CV drugs valid?
Six months after the date of issue.
How long is a prescription for a CVI drug valid?
It is valid for one year after the date of issue, which means that you can continue to refill the prescription for up to one year after the date of issuance. However, if the prescriber specifically authorizes the dispensing or refilling of the prescription for two years, you can fill and refill the prescription for 2 years. This would apply if the prescriber wrote on the prescription: “May refill prn for 2 years.” If such instructions are not present, the prescription is only valid for one year.
Can a prescription be written in pencil?
No. Prescriptions must be written in ink, individually typed, or printed only.
How many medications can be on a single prescription form?
The general rule is only one medication per prescription.
What are the exceptions to the general rule?
*Prescriptions written as chart orders for patients in hospitals
*Prescriptions written as chart orders for patients in long term care facilities
*Patients receiving home infusion services
*Hospice patients
*Patients whose prescriptions will be filled at pharmacies operated by one of these departments; Corrections, Juvenile Justice, Health, Behavioral Health, and Development Services
*Patients residing in detention centers, jails, or work release centers operated by the Dept. of Corrections
ALL OF THE EXCEPTIONS INCLUDE THE USE OF CHART ORDERS OR GOVERNMENTAL PROVISION SERVICES.
What about prescriptions written as chart orders for a hospital or long term care patient who is then discharged?
These can be filled at an outpatient pharmacy if:
- The pharmacist has all the information necessary for a valid outpatient prescription
- The pharmacist has written or verbal directions indicating that the chart orders are intended to serve as prescription orders
- The orders include some directions related to the quantity to be dispensed or duration of the order
Can you accept a post dated CII prescription?
No. It must be signed and dated the day it was written.
Can you accept a post dated CIII-VI prescription?
No, it must be signed and dated the day it was written.
When can a prescriber use a completely preprinted prescription form?
Only for CVI prescriptions and they will still need to sign the prescription.
Can a pharmacist accept oral or telephone prescriptions for CIII-CVI drugs in VA?
Yes
Who is allowed to call in an oral prescription?
The prescriber or his authorized agent.
Who may act as the prescriber’s “authorized agent”?
- an employee under the prescriber’s immediate and personal supervision
- an individual holding a valid license allowing administration or dispensing of drugs who has been specifically directed by the prescriber (e.g. a nurse or a pharmacist)
If a pharmacist receives an oral prescription but does not have the medication, can she phone the prescription in to another pharmacy of the patient’s choice?
Yes, the pharmacist is licensed to dispense drugs and was specifically directed by the prescriber to have the medication dispensed to the patient.
Can a nurse call in a prescription for the doctor?
Yes for CIII-VI drugs
When a pharmacist receives an oral prescription, is she required to place any additional information on the prescription?
Yes. The pharmacist must reduce the prescription to writing and include the first and last name of the person who called in the prescription as well as a notation that the prescription was oral. The pharmacist must write (not sign) the prescriber’s name on the prescription as well.
Can a community pharmacist ever accept a telephone (oral) prescription for a CII drug in a community pharmacy?
Yes, but only in emergencies and the quantity dispensed must be limited to that necessary to cover the emergency time period. The pharmacist should make a reasonable effort to confirm that the prescription really came from the prescriber. For example, if the pharmacist did not know the prescriber, he should look up the prescriber in the phone book and call that number to confirm that the prescription is authentic. Only the actual prescriber can call in an emergency CII prescription.
What must the pharmacist do with the emergency CII oral prescription?
The pharmacist must reduce it to writing so that it has all of required elements for a written prescription except for the prescriber’s signature.
Does the prescriber of the emergency CII oral prescription have to do anything else?
Yes. The prescriber must provide the pharmacy with an original signed CII written prescription to cover the emergency dispensing.
Are there any special requirements for the original signed CII prescription?
Yes it must be dated and signed on the date of the emergency oral prescription and must include the words: “ authorization for emergency dispensing” on the face of the prescription. IT must meet all of the usual requirements for a CII prescription.
What is the pharmacist required to do with the hard copy emergency prescription when he receives it?
Attach it to the emergency oral prescription and file it.
How long does the prescriber have to get the pharmacy the written CII prescription?
The prescriber has 7 days to provide the pharmacy with the written CII prescription. The prescriber can meet the 7 day deadline by mailing the prescription within 7 days of calling in the prescription. So , it may actually take more than 7 days for the pharmacy receive the hard copy of the prescription.
What must the pharmacist do if the prescription is not received within 7 days?
Contact the prescriber to find out if it was mailed within the 7 day time frame. The pharmacist should call earlier to make sure that the prescriber does not miss the deadline.
Does the pharmacist have to do anything if the prescription is not received or mailed within the 7 day limit?
Yes the pharmacist has to notify the DEA that the prescription was never received.
What happens if the pharmacist doesn’t notify the DEA?
The pharmacist’s authority under law to dispense emergency CII prescription is revoked and the pharmacist can be found guilty of illegally distributing CII drugs.
Are oral orders for CII drugs allowed in a hospital?
Yes. A hospital pharmacist or nurse can take an oral order for a CII drug. IT has to be immediately reduced to writing and signed by the prescriber within 72 hours.
Can a prescriber write multiple CII prescriptions for the same drug for a single patient on the same day and place instructions on the prescriptions as to when they may be filled?
YEs. Each prescription must still be issued for a legitimate medical purpose by a prescriber acting in the usual course of his professional practice.
What are requirements for issuance of multiple CII prescriptions at the same time?
- Each prescription, other than the first one to be filled, must indicate the earliest date that it can be filled.
- The maximum days supply for multiple issued prescriptions is 90 days.
- The prescriptions must meet all other requirements for valid CII prescriptions.
Are veterinarians allowed to write CII prescriptions for animals?
YEs. The same rules apply as for human CIII prescriptions.
Are pharmacists allowed to make any changes to a written CII prescriptions?
Yes. A pharmacist may make the following changes to a hard copy CII prescription:
- Add or correct the patient’s name after verifying it
- Add the patient’s address after verifying it
- Add the prescriber’s DEA number
- After direct consultation and agreement of the prescriber, the pharmacist can add or change dosage form, drug strength, directions for use, drug quantity, and issue date
What two changes are prohibited for CII prescriptions?
The pharmacist is never allowed to change the drug prescribed, other than generic substitution, or add the prescriber’s signature to the prescription.
Are there any special requirements for a prescription that is written for gamma-hydroxybutyric acid (rohypnol)?
Yes. The medical need for the drug must be written on the prescription.
Are computer generated prescriptions allowed in VA?
YEs. The prescription must still be hand signed by the prescriber.
Does an order on a chart need to contain all the same information as a written prescription?
Not if the following are met:
- The information is contained in other readily retrievable records of the pharmacy
- The pharmacy’s policy and procedure manual sets out where this information is maintained and how to retrieve it
- The chart orders meet the minimum requirements for chart orders consistent with state and federal law and the accepted standard of care
Can prescriptions for CIII-CVI drugs be faxed to a pharmacy?
Yes
Is a faxed prescription required to have all the information required on a regularly written prescription?
YES! This includes the prescriber’s signature.
Can a prescriber give an oral prescription to his agent to be faxed?
Yes. The faxed prescription must contain the agent’s full name and language that indicates the prescription is an oral prescription. If the prescription is oral, the prescriber’s signature does not have to be on the prescription.
Are faxed prescriptions required to have any additional information on them?
Yes. They must have the following additional information:
- Date the prescription was faxed
- Printed name, address, phone number, and fax number of the prescriber
- If faxed from an institution, the name, address, phone, and fax number of the institution.
Do regular written prescriptions need to have a fax number on them?
No
Who decides where the prescription will be faxed?
The patient gets to choose the pharmacy where the prescription will be faxed.
Where can a faxed prescription originate?
- The prescriber’s practice location
- A faxed order received by a long term care facility may be forwarded to a pharmacy for filling
- A written prescription can be faxed by an authorized agent of a long term care facility if the pharmacy has written procedures. The hard copy must be delivered to the pharmacy within 7 days and attached to the faxed copy.
When can a prescription for a CII drug be faxed?
For information purposes only. This does NOT count as the original written prescription but allows the pharmacy to prepare the prescription prior to the receipt of the actual hard copy prescription. The original hard copy prescription must be received before the prescription can be dispensed to the patient. This would be done when a patient is being discharged from the hospital and should not be waiting at the pharmacy for any extended period of time.
Are there any times when a CII prescription can be faxed and actually filled?
Yes. Faxed CII prescriptions are valid for:
- Long term care facility patients
- Home infusion patients
- Medicare certified hospice patients; including home hospice patients. [The prescriber must note on the prescription that the patient is in hospice]
Does Virginia allow the electronic transmission of prescriptions from prescribers to pharmacies?
Yes.
What is an electronic prescription?
A prescription that is generated using an electronic application and transmitted to a pharmacy as an electronic data file.
What schedules of drugs can be transmitted as electronic prescriptions?
Schedules II, III, IV, V, and VI.
How does a prescriber apply for authorization to issue electronic prescriptions for CII-CV drugs?
A prescriber applies to a federally approved credential service provider (CSP) or certification authority (CA) to obtain a two-factor authentication credential or a digital certificate.
Does an electronic prescription have to be manually signed?
No. It will contain an electronic or digital signature that identifies the prescriber as the source of the prescription and indicate his approval of the information contained in the prescription.
What Federal requirements do electronic prescriptions have to meet?
Security and authentication features ; required recordkeeping by the prescriber and the pharmacy.
Are there any requirements for the provider of the electronic applications used by the prescribers and pharmacies for CII-CV electronic applications?
Yes. The provider must be reviewed and certified as compliant with the DEA’s standards by an approved certification body, which will issue it a certification report.
How will a pharmacy or prescriber know that the application provider is certified?
The application provider must provide a copy of this certification report to the pharmacy or prescriber.
Can a pharmacy process an electronic prescription and dispense a CII-CV drug before the certification report is received?
NO. The pharmacy can process and dispense CVI prescriptions in compliance with the Board’s regulations prior to receiving the report but cannot receive and dispense CII-CV prescriptions until the report is received.
Can an electronic prescription be converted to a fax and printed out on the pharmacy’s fax machine?
Only if the prescription is for a CVI substance. CII-CV electronic prescriptions are prohibited by Federal law from being converted to a faxed prescription. CII-CV electronic prescriptions are required to directly populate the pharmacy’s automated dispensing system in accordance with Federal law.
What are the requirements for transmission of electronic prescriptions?
- The prescriptions need to be transmitted by the prescriber or his authorized agent directly to the pharmacy.
- Electronic prescriptions for CII-CV medications must comply with the security and other requirements set forth in Federal law.
- Electronic prescriptions need to comply with Virginia’s security requirements related to the protection of patient health information.
Who decides which pharmacy will receive an electronic prescription?
The patient. An electronic prescription must be transmitted to the patient’s pharmacy of choice.
What information does an electronically transmitted prescription need to include?
- All of the information required for a written prescription
- The full name of the prescriber’s agent if the prescriber is not transmitting the electronic prescription
- Date of transmission
What does a pharmacist have to do when she receives a paper or oral prescription that was originally electronically transmitted to the pharmacy?
The pharmacist has to check the pharmacy’s record to make sure that the electronic version was not received and dispensed. If the pharmacy received both prescriptions, the pharmacist will have to mark one of the prescriptions as void.
What does a pharmacist have to do when she receives a paper or oral prescription that was originally electronically transmitted to another pharmacy?
The pharmacist has to check with the other pharmacy to determine if the prescription was received and dispensed by the other pharmacy. If the other pharmacy received but did not already dispense the medication, that pharmacy must mark the electronic prescription as void or cancelled. If the other pharmacy already dispensed the prescription, the pharmacist must mark the paper copy as void and not dispense it.
What is the difference between an “intangible” and “tangible” prescription requirement?
You can see a tangible prescription requirement and cannot see an intangible prescription requirement. An example of a “tangible” requirement is the signature of the prescriber, which you can see is either on or not on the prescription. You cannot see whether a prescription was issued for a medicinal or therapeutic purpose. Instead, you have to use your judgment to determine whether the prescription was issued for a valid medicinal purpose.
Are there “intangible” prescription requirements in VA?
Yes. A prescription is not valid unless it was:
- issued for a medicinal or therapeutic purpose
- to a patient with whom the practitioner has a bona fide practitioner-patient relationship.
What does the practitioner have to do to create a bona fide practitioner-patient relationship?
- obtain a medical or drug history
- provide information to the patient about the benefits and risks of the drug being prescribed
- perform an appropriate examination of the patient, either physically or by using equipment to electronically transmit images and medical records
- Except for medical emergencies, the examination of the patient should be performed by the practitioner, within the group in which he or she practices, or by a consulting practitioner
- initiate additional interventions and follow up care, if necessary, especially if a prescribed drug may have serious side effects
When is a bona fide practitioner patient relationship deemed to exist by law or not needed for the issuance of a valid prescription?
The practitioner does not have to personally examine the partner of one of his patients with whom he has a bona fide practitioner patient relationship in order to issue the partner a prescription for a CVI antibiotic to treat a communicable disease (e.g.syphilis) in accordance with CDC guidance to prevent imminent risk of death, illness, or serious disability.
Practice tip:
There are other situations where protocols, such as for the administration of vaccines in hospitals, substitute for the bona fide relationship.
What are the potential consequences for a pharmacist who knowingly fills an invalid prescription?
The pharmacist may be criminally prosecuted for drug distribution.
What does VA law require a pharmacist to do when presented with a questionable prescription?
The pharmacist must contact the prescriber or his agent and verify:
- the patient’s identity
- the name of the medication prescribed
- the quantity of the medication prescribed
If a pharmacist satisfies Virginia’s requirements for handling a questionable prescription, are the Federal DEA requirements satisfied?
NO! Simply calling the doctor’s office and verifying the information required under VA law will not satisfy the DEA. The DEA expects a pharmacist to be aware of prescribing habits, excessive quantities, multiple prescriptions, and other indicators of improper prescribing when such information is readily available or easily obtainable by the pharmacist. This would not apply to CVI prescriptions.
When does a bona fide practitioner-patient-pharmacist relationship exist?
When the practitioner prescribes, and a pharmacist dispenses, controlled substances in good faith to his patient for a medicinal or therapeutic purpose within the course of his professional practice.
What are some examples of a prescriber issuing prescriptions that are not within her course of professional practice?
- A podiatrist (DPM) issuing a prescription for treatment of a sinus infection. (Podiatrists are only allowed to treat conditions of the feet and ankles)
- A dentist (D.D.S. or D.M.D) issuing a prescription for birth control.
- A doctor (M.D.) issuing a prescription for treatment of an animal
- A veterinarian (D.V.M.) issuing a prescription to treat a human
- An optometrist (O.D.) issuing a prescription to treat a sore throat.
Practice Tip:
medical doctors and osteopaths are allowed to write prescriptions to treat almost any human condition. And, the specialty of the medical doctor or osteopath does not change this. For example: a psychiatrist can prescribe birth control pills and a surgeon can prescribe eye drops.
What must a pharmacist do if he declines to fill a prescription for any reason other than the unavailability of the drug?
Write the following on the back of the prescription:
- The word “declined”
- The name, address, and telephone number of the pharmacy
- The date the prescription was declined
- The pharmacist’s signature
What is a pharmacist required to do if he determines that a prescription is a forgery?
- refrain from returning the prescription to the patient
- maintain the prescription for a minimum of 30 days prior to destroying it
- provide the prescription to a law enforcement official who is investigating the forgery
Dispensing and Distribution
According to guidelines published on the VA Board of Pharmacy’s web site, 25% of the exam will cover dispensing and distribution. Be sure you understand which tasks may be performed by a technician or intern, and which are restricted to pharmacists. It is also important to understand refills and partial fills. As the pharmacist, you will have ultimate responsibility for ensuring that refills and partial fills are handled in accordance with the law.
How long is a CII prescription valid in VA and how many times can it be refilled?
CII prescriptions are valid for 6 months and CANNOT be refilled.
How long are CIII-CV prescriptions valid in VA for and how many times can they be refilled?
CIII-CV prescriptions are valid for 6 months and may be refilled a maximum of 5 times.
How long are CVI prescriptions valid in VA and how many times can they be refilled?
CVI prescriptions with no additional notations are valid for one year. As previously covered, the prescriber can specifically extend the time that a CVI prescription may be filled up to 2 years. There are no specific limits on the number of refills that a prescriber can include on a CVI prescription and a pharmacist can continue to refill the CVI prescription until it expires.
What can a pharmacist do if the patient needs a refill for a CVI drug and the prescriber is not available?
VA law allows a CVI medication prescription to be refilled by a pharmacist without authorization from the prescriber if:
- The pharmacist has a made reasonable effort to contact the prescriber and
- The patient’s health would be in imminent danger without the drug.
Are there any other requirements?
Yes the pharmacist has to:
- inform the patient that the refill is being made without the prescriber’s authorization
- inform the prescriber of the refill
- document on the back of the prescription the date and quantity of the refill, the prescriber’s unavailability, and the reason for the refill
Are pharmacists allowed to refill CIII-CVI prescriptions any time the patient requests a refill?
No. Authorized refills may only be dispensed in reasonable conformity with the prescriber’s directions for use. If there are no directions for use, the authorized refills may only be dispensed in reasonable conformity with recommended dosages for the particular medication. This requires the pharmacist to exercise sound professional judgment. A pharmacist can refill a prescription early provided he documents a valid reason for the early refill. This documentation should be either on the actual prescription or in the electronic recordkeeping system of the pharmacy.
Does VA allow you to partially fill a CIII, CIV, or CV prescription?
Yes. You can partially fill CIII-CV prescriptions provided that:
* The total quantity dispensed does not exceed the total quantity prescribed
*All partial dispensings take place during the 6 months that they prescription is valid
* The partial dispensings are done in reasonable conformity with the directions for use of the medication or within the pharmacist’s sound professional judgment
* Each partial dispensing is recorded in the same maner as a refill (covered later)
Partial dispensing example: A patient receives a prescription for clonazepam 0.5 mg daily, #30, with 5 refilld. The pharmacist can partially dispense 15 tablets to the patient every two weeks until the entire amount of the prescription, 180 tablets, has been dispensed. All partial dispensings have to take place before the 6 month expiration of the prescription.
Do partial dispensings appear to violate the 5 refill limit rule?
Yes. but it is the law.
Can a prescriber fax a refill authorization for a CIII-CVI medication?
Yes.
What information does a faxed refill authorization need to include?
- Date of authorization
- Patient’s name and address
- Drug name, strength, and quantity
- Directions for use
- Prescriber’s name
- Prescriber’s signature or agent’s first and last name for an oral prescription
Are pharmacists allowed to partially dispense CVI medications as well?
Yes. A CVI prescription can be partially dispensed until the prescription expires or the quantity prescribed is reached. (e.g. Synthroid 50 mcg, 90 tabs, with 3 refills equals a maximum dispensed quantity of 90 X 4= 360 tablets).
Are community pharmacists allowed to partially fill a prescription for a CII drug?
Yes, If the pharmacy does not have enough medication to completely fill the prescription.
Are there specific requirements concerning when the pharmacy can fill the remainder of the prescription?
Yes. The remainder of the prescription must be dispensed within 72 hours of the partial dispensing.
What happens if the pharmacist is unable to supply the remainder of the prescription within 72 hours time frame?
The pharmacist cannot dispense the remainder of the CII prescription and must notify the prescriber that the dispensing. The patient will need a new prescription to receive any additional medication.
Are there any additional documentation requirements that apply when a pharmacist partially fills a CII prescription for lack of drug?
Yes. The pharmacist must record on the face of the prescription the amount partially dispensed and the date.
Are there other situations when a pharmacy may partially dispense CII prescriptions?
Yes. Pharmacies are allowed to partially dispense CII prescriptions for patients who are documented as being terminally ill and for patients in long term care facilities.
What does it mean for a patient to be “terminally ill”?
The patient must have a condition from which, to a reasonable degree of medical probability, he is unlikely to recover and be either:
- close to death
- in a persistent vegetative state
How does a patient get documented as being terminally ill?
The practitioner must classify the patient as terminally ill and the pharmacist must verify and record the patient’s status on the prescription.
How long can a terminally ill or long term care patient continue to receive partial fills of a CII drug?
60 days from the date of the first partial filling unless the prescription expires earlier (6 months from date of issuance) or is discontinued by the prescriber. As always, the total quantity dispensed cannot exceed the amount prescribed. The pharmacist must continually determine that the partial fills are necessary.
Are there any special recordkeeping requirements that apply when a pharmacist is partially dispensing a CII medication for a terminally ill or long term care patient?
Yes. Every time the pharmacist does a partial dispensing he had to record the following on the back of the prescription:
- The date of dispensing
- The quantity dispensed
- The remaining quantity authorized to be dispensed, and
- The pharmacist’s identity
Can a pharmacy maintain computerized records of the partial dispensings of CII prescriptions for terminally ill patients and patients in a long-term care facility?
Yes, if the system allows immediate (real-time) updates every time a partial dispensing occurs and can produce an output showing:
- The original prescription number
- The prescription’s date of issuance
- The identification of the prescriber
- The identification of the patient
- The identification of the long-term care facility (not a terminally ill patient)
- The identification of drug, including dosage form, strength, and quantity
- The listing of each partial dispensing under the prescription, and
- The information that would go on the back of the prescription if the pharmacy were manually maintaining the records.
What is the definition of “dispense” under VA law?
To deliver a drug to an ultimate user, research facility, or practitioner pursuant to a lawful order of a practitioner. If a doctor gives medications to patients to take with them from the office, his actions meet the definition of dispensing under VA law. Transporting drugs from the doctor’s Arlington office to the Falls Church office is not dispensing.
What dispensing activities are restricted to pharmacists?
- The review of prescriptions for all legal and clinical requirements
- The receipt of a new oral prescription (technicians can take refills with no changes)
- The conducting of a prospective drug review
- The counseling of patients and the provision of drug information
- The communication with prescribers or agents regarding changes to therapy (other than refills where there are no changes to the prescription)
- The verification of the accuracy of a prescription prior to dispensing
- The supervision of pharmacy interns and technicians
Are pharmacy interns allowed to do activities that are restricted to pharmacists?
Yes as long as the intern is being directly monitored by the pharmacist.
Can a non-pharmacist owner of a pharmacy make decisions that override the clinical decisions of the PIC or the pharmacist on duty?
No. That would be considered practicing pharmacy without a license.
When is a pharmacist required to conduct a prospective drug review?
Before each new prescription is dispensed or delivered. [mandatory]
Before refilling a prescription, if needed based on pharmacist’s professional clinical judgment.
What issues are screened for during a prospective drug review?
- Therapeutic duplication
- Drug- disease contraindications
- Drug-drug interactions, including nonprescription drugs
- incorrect drug dosage
- incorrect duration of drug treatment
- drug-allergy interactions
- clinical abuse or misuse
Are hospital pharmacists required to review drug therapy for hospital patients?
Yes. Each order should be subjected to the same type of prospective drug review noted in the previous question. Ensuring that this occurs is the responsibility of the PIC.
Are there any special requirements for reviewing the drug therapy of patients in long-term care facilities.?
Yes. A pharmacist must conduct a monthly review of the drug therapy or patients in long-term care facilities to check for irregularities, such as : drug therapy, drug interactions, and drug administration or transcription errors.
Does a pharmacist have to make an offer to counsel a patient prior to the dispensing of a new prescription?
Yes, for refills the offer to counsel only needs to be made when the pharmacist deems it necessary based on her clinical judgment.
How may the offer to counsel be extended to the paint?
- face to face
- via a sign
- via a notation on the bag
- via telephone
Does a pharmacy need to make “reasonable efforts” to collect patient health information in order to provide pharmacy services.
YES.
