Pass VA Law Flashcards

Question

Can "acts restricted to pharmacy technicians" be completed by pharmacists or pharmacy interns?

Answer 1

A technician at a nuclear pharmacy can accept oral prescriptions for diagnostic non-patient specific radiopharmaceuticals.

Answer 2

Yes, but a pharmacist must personally supervise the preparation.

Answer 3

* 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.

Answer 4

* 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.

Answer 5

The temps required for the safe storage of drugs as specified in the drugs' monographs.

Answer 6

-20 to -10C (-4 to 14F)

Answer 7

2-8C(36-46F)

Answer 8

8-15C(46-59F)

Answer 9

Work area temperature

Answer 10

20-25C(68-77F)

Answer 11

30-40C(86-104F)

Answer 12

>40C(104F)

Answer 13

means that freezing the drug subjects it to a change in potency

Answer 14

1.8 X Celsius Temperature + 32

Answer 15

No, a pharmacy must be located in a permanent and secure structure.

Answer 16

* 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.

Answer 17

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.

Answer 18

* 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.

Answer 19

Pharmacists working at the pharmacy who have been authorized by the pharmacist in charge (PIC) to have the access code.

Answer 20

Whenever the prescription department is closed for business.

Answer 21

* 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.

Answer 22

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.

Answer 23

* 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.

Answer 24

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.

Answer 25

Yes. A pharmacist may be the PIC of a maximum of 2 pharmacies.

Answer 26

The location of the new pharmacy must be inspected by an agent of the Board before the pharmacy permit can be issued.

Answer 27

Yes as long as the application provides the Board with 14 days notice prior to the requested inspection date.

Answer 28

The board may adjust to the date to provide for at least 14 days to schedule the inspection.

Answer 29

* 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

Answer 30

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.

Answer 31

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.

Answer 32

After passing inspection and no sooner than 14 days prior to the designated opening date.

Answer 33

A pharmacist has to be present at the pharmacy on a daily basis.

Answer 34

The pharmacist has to notify the Board and continue to be on site on a daily basis.

Answer 35

Yes, it must be displayed prominently.

Answer 36

IF there is any change in ownership of the pharmacy, such as a change in partnership composition or acquisition.

Answer 37

The PIC must immediately surrender the pharmacy permit to the Board. Remember, the permit is issued to the PIC and not to the pharmacy.

Answer 38

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.

Answer 39

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.

Answer 40

The incoming PIC will apply for the new permit.

Answer 41

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.

Answer 42

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.

Answer 43

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.

Answer 44

Dispose properly of all Schedule II through VI drugs and devices on the premises within fifteen days.

Answer 45

The Board will seize all Schedule II through VI drugs and devices still on the premises and notify the owner.

Answer 46

Yes. The owner can claim the drugs by paying the storage costs and providing for proper disposition of the drugs.

Answer 47

6 months. IF the drugs have not been claimed by then, the drugs may be destroyed.

Answer 48

No, the permit is nontransferable and must be returned to the Board.

Answer 49

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.

Answer 50

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.

Answer 51

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.

Answer 52

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.

Answer 53

The last 2 years of prescription dispensing records and patient records.

Answer 54

It constitutes closing.

Answer 55

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.

Answer 56

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.

Answer 57

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.

Answer 58

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.

Answer 59

DEA form 224 for the initial registration and DEA 224a for renewal of the registration.

Answer 60

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.

Answer 61

Every 3 years. Each renewed registration will have a 3 year expiration date.

Answer 62

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.

Answer 63

One for each place of business or practice location.

Answer 64

Every year.

Answer 65

Yes. Each location must have its own DEA group.

Answer 66

* Manufacturing * Distributing * Reverse distributing * Dispensing * Research (CI drugs) * Research (CII-V drugs) * Narcotic treatment (including compounder) * Importing * Exporting * Chemical analysis

Answer 67

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.

Answer 68

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.

Answer 69

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.

Answer 70

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.

Answer 71

* Notify the DEA * Return the certificate of registration and unexecuted order forms (DEA 222 Forms) * Dispose of Federal controlled substances properly

Answer 72

Yes. The registrant must submit a written request to the Deputy Assistant Administrator, Office of Diversion Control in Washington, DC.

Answer 73

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.

Answer 74

* 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.

Answer 75

No. If the date of the transfer arrives and the pharmacy hasn't been informed that it cannot occur, the transfer may take place.

Answer 76

* 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.

Answer 77

Return the pharmacy permit to the Board immediately.

Answer 78

Manufacturers, compounders, and distributors. Pharmacies are not required to register with the FDA.

Answer 79

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.

Answer 80

* The official United States Pharmacopoeia National Formulary (USP-NF) * The official Homeopathic Pharmacopoeia of the United States * A supplement to one of these pharmacopoeia

Answer 81

A drug that Federal law or regulations prohibits from being dispensed without a prescription. The definition includes finished dosage forms and active ingredients.

Answer 82

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.

Answer 83

Yes. The requirements for OTC drugs are much more in depth because these drugs are not used under the supervision of a practitioner.

Answer 84

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.

Answer 85

By the use of a capital letter "C" and roman numerals. * Schedule I=CI * Schedule II=CII * Schedule III= CIII * Schedule IV=CIV

Answer 86

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.

Answer 87

Yes. Virginia places these drugs in Schedule VI(CVI). This is a schedule that does not exist in Federal law.

Answer 88

The United States Attorney General.

Answer 89

* 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

Answer 90

The same ones the U.S. Attorney General considers.

Answer 91

* 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.

Answer 92

* 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.

Answer 93

* 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

Answer 94

* 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

Answer 95

* 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

Answer 96

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.

Answer 97

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.

Answer 98

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).

Answer 99

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.

Answer 100

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.

Answer 101

* 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

Answer 102

*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

Answer 103

Virginia does. State law controls who can write valid prescriptions

Answer 104

* 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.)

Answer 105

* Medical doctors * Osteopathic doctors * Dentists * Podiatrists * Veterinarians

Answer 106

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.

Answer 107

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.

Answer 108

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.

Answer 109

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.

Answer 110

* 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

Answer 111

This tissues immediately surrounding the eye; such as the eyelids and conjunctiva.

Answer 112

TPA-certification. TPA stands for Therapeutic Pharmaceutical Agents.

Answer 113

It is a VA certification that ODs must obtain from the VA Board of Optometry.

Answer 114

Diseases and abnormal conditions of the human eye and its adnexa (tissues adjoining the eye).

Answer 115

Yes. Optometrists cannot treat infantile or congenial glaucoma and their treatment of closed angle glaucoma is limited to initiation of immediate emergency care.

Answer 116

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

Answer 117

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.

Answer 118

* Prescriber's name * Prescriber's address * Prescriber's phone number * Prescriber's signature (except on oral prescriptions)

Answer 119

YEs. They must also contain the prescriber's DEA number.

Answer 120

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)

Answer 121

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.

Answer 122

The intern/resident can use the hospital identification number assigned to him to write a prescription for the patient.

Answer 123

* 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.

Answer 124

* 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

Answer 125

* The patient's first and last name | * The patient's address

Answer 126

The prescription must contain the : * Owner's name * Owner's address * The species of the animal

Answer 127

No, it can be added by the dispenser or kept in the patient's electronic record in the pharmacy.

Answer 128

Yes. It must be dated on the date it is signed by the prescriber. Postdating of prescriptions is not allowed and is illegal.

Answer 129

*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.

Answer 130

Six months after the date of issue.

Answer 131

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.

Answer 132

No. Prescriptions must be written in ink, individually typed, or printed only.

Answer 133

The general rule is only one medication per prescription.

Answer 134

*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.

Answer 135

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

Answer 136

No. It must be signed and dated the day it was written.

Answer 137

No, it must be signed and dated the day it was written.

Answer 138

Only for CVI prescriptions and they will still need to sign the prescription.

Answer 139

The prescriber or his authorized agent.

Answer 140

* 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)

Answer 141

Yes, the pharmacist is licensed to dispense drugs and was specifically directed by the prescriber to have the medication dispensed to the patient.

Answer 142

Yes for CIII-VI drugs

Answer 143

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.

Answer 144

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.

Answer 145

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.

Answer 146

Yes. The prescriber must provide the pharmacy with an original signed CII written prescription to cover the emergency dispensing.

Answer 147

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.

Answer 148

Attach it to the emergency oral prescription and file it.

Answer 149

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.

Answer 150

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.

Answer 151

Yes the pharmacist has to notify the DEA that the prescription was never received.

Answer 152

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.

Answer 153

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.

Answer 154

YEs. Each prescription must still be issued for a legitimate medical purpose by a prescriber acting in the usual course of his professional practice.

Answer 155

* 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.

Answer 156

YEs. The same rules apply as for human CIII prescriptions.

Answer 157

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

Answer 158

The pharmacist is never allowed to change the drug prescribed, other than generic substitution, or add the prescriber's signature to the prescription.

Answer 159

Yes. The medical need for the drug must be written on the prescription.

Answer 160

YEs. The prescription must still be hand signed by the prescriber.

Answer 161

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

Answer 162

YES! This includes the prescriber's signature.

Answer 163

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.

Answer 164

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.

Answer 165

The patient gets to choose the pharmacy where the prescription will be faxed.

Answer 166

* 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.

Answer 167

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.

Answer 168

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]

Answer 169

A prescription that is generated using an electronic application and transmitted to a pharmacy as an electronic data file.

Answer 170

Schedules II, III, IV, V, and VI.

Answer 171

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.

Answer 172

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.

Answer 173

Security and authentication features ; required recordkeeping by the prescriber and the pharmacy.

Answer 174

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.

Answer 175

The application provider must provide a copy of this certification report to the pharmacy or prescriber.

Answer 176

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.

Answer 177

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.

Answer 178

* 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.

Answer 179

The patient. An electronic prescription must be transmitted to the patient's pharmacy of choice.

Answer 180

* 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

Answer 181

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.

Answer 182

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.

Answer 183

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.

Answer 184

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.

Answer 185

* 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

Answer 186

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.

Answer 187

There are other situations where protocols, such as for the administration of vaccines in hospitals, substitute for the bona fide relationship.

Answer 188

The pharmacist may be criminally prosecuted for drug distribution.

Answer 189

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

Answer 190

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.

Answer 191

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.

Answer 192

* 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.

Answer 193

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.

Answer 194

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

Answer 195

* 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

Answer 196

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.

Answer 197

CII prescriptions are valid for 6 months and CANNOT be refilled.

Answer 198

CIII-CV prescriptions are valid for 6 months and may be refilled a maximum of 5 times.

Answer 199

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.

Answer 200

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.

Answer 201

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

Answer 202

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.

Answer 203

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.

Answer 204

Yes. but it is the law.

Answer 205

* 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

Answer 206

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).

Answer 207

Yes, If the pharmacy does not have enough medication to completely fill the prescription.

Answer 208

Yes. The remainder of the prescription must be dispensed within 72 hours of the partial dispensing.

Answer 209

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.

Answer 210

Yes. The pharmacist must record on the face of the prescription the amount partially dispensed and the date.

Answer 211

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.

Answer 212

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

Answer 213

The practitioner must classify the patient as terminally ill and the pharmacist must verify and record the patient's status on the prescription.

Answer 214

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.

Answer 215

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

Answer 216

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.

Answer 217

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.

Answer 218

* 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

Answer 219

Yes as long as the intern is being directly monitored by the pharmacist.

Answer 220

No. That would be considered practicing pharmacy without a license.

Answer 221

Before each new prescription is dispensed or delivered. [mandatory] Before refilling a prescription, if needed based on pharmacist's professional clinical judgment.

Answer 222

* 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

Answer 223

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.

Answer 224

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.

Answer 225

Yes, for refills the offer to counsel only needs to be made when the pharmacist deems it necessary based on her clinical judgment.

Answer 226

* face to face * via a sign * via a notation on the bag * via telephone

Answer 227

* the patient's name, address, date of birth, gender, and phone number * the patient's medical history, including any allergies and drug reactions * A list of the patient's current medications and devices * whether the patient accepted or failed to accept the pharmacist's offer to counsel

Answer 228

The law ill presume that the offer was accepted and that counseling was provided.

Answer 229

The pharmacist must inspect the order, verify its accuracy in all respects, and initial the dispensing record to certify the accuracy of the prescription.

Answer 230

The pharmacy has to make a photocopy or electronic copy of the person's ID or record the full name and address of the person.

Answer 231

At least one month.

Answer 232

Yes. A pharmacist has the discretion to require proof of identity for CIII-CV prescriptions but is not mandated to do so.

Answer 233

* driver's license * a government-issued identification card * other photo identification along with documentation of the person's current address

Answer 234

The delivery method must require signature of the recipient as confirmation of receipt.

Answer 235

Yes. The patient must consent and the prescription must be eligible for filling and refilling.

Answer 236

CII prescriptions cannot be transferred.

Answer 237

* orally by direct communication between 2 pharmacists * by fax machine * by electronic transmission

Answer 238

Write "VOID" on the face of the invalidated prescription. Record the following information on the back of the prescription: * Date of the transfer * Name of the receiving pharmacy * Address of the receiving pharmacy * The DEA number of the receiving pharmacy for CIII-CV drugs * For oral transfers, the first and last name of the pharmacist receiving the prescription

Answer 239

* Write the word "TRANSFER" on the face of the transferred prescription * Obtain and record all required information for a regular prescription

Answer 240

* The date of issuance of the original prescription * The original number of refills authorized on the original prescription * The date of original dispensing, if applicable * The number of valid refills remaining and the date of the last dispensing * The transferring pharmacy's name, address, DEA registry number (Unless a CVI drug) * The original prescription number from the transferring pharmacy * The first and last name of the transferring pharmacist, if transferred orally

Answer 241

Both the original and transferred prescription must be maintained for two years from the date of last refill.

Answer 242

You may give the patient a copy of the prescription marked "For Information Only". You can do this for any prescription in your pharmacy.

Answer 243

Yes, as long as the system meets the requirements for storage and retrieval of dispensing information for automated dispensing systems.

Answer 244

Not if the pharmacies share a common database that is capable of generating a hard copy of the transferred prescription upon request.

Answer 245

Until the prescription runs out of refills.

Answer 246

NONE! Trick question.

Answer 247

One time only; unless the pharmacies share a common database.

Answer 248

Until the prescription is out of refills or expires.

Answer 249

Yes. You are required to record the date (s) and locations of previous refills. [State law only requires you to record the date of the original and last dispensing and does not require you to record the location of each refill]

Answer 250

Therapeutically equivalent drug products.

Answer 251

A drug product that has the same active ingredient(s), strength or concentration, dosage form, and route of administration as the brand name product. It must also be classified as being therapeutically equivalent in the FDA's most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange book".

Answer 252

* When a therapeutically equivalent drug product is not available * When the prescriber writes "brand medically necessary" on the prescription * When the prescriber requested the brand name drug on an oral prescription * When the patient requests the brand name drug

Answer 253

* Inform the patient * Indicate on the patient record and the prescription label the therapeutically equivalent drug product and the name of the drug's manufacturer or distributor * Label the prescription vial with the drug product dispensed followed by "generic for" and the brand name. (see labeling section) * Charge the patient less than the cost of the brand name product prescribed

Answer 254

* The pharmacy or pharmacist's name | * The pharmacy's address

Answer 255

* The prescription number * The date of the prescription or of its filling * The patient's name * The owner's name and species of the animal if for an animal * The drug name * The drug strength, if applicable * The directions for use; including cautionary statements if included on the prescription * The quantity dispensed; in dosage units or milliliters for a liquid * For any single ingredient brand name drug dispensed, the drug's generic name in addition to the brand name * IF the prescription was written for a brand name drug and a generic drug is being dispensed, the words "generic for" followed by the brand name, and the generic drug's manufacturer or distributer * For CII-IV drugs, "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed

Answer 256

Not if the drugs are being administered by persons who are licensed to administer medications.

Answer 257

The direct application of a controlled substance to the body of a patient or research subject by a practitioner or her agent, or by the patient under the direction of the practitioner.

Answer 258

Compounding batch does IVs for future use. For example, a hospital pharmacy may compound diltiazem, vancomycin, and phenylephrine IVs for future use.

Answer 259

* Drug name * Drug strength * Lot or control number. This can be one assigned by the pharmacy or you can list the manufacturers or distributors name and its lot or control number * Appropriate expiration date determined by the pharmacist in accordance with USP guidelines.

Answer 260

A drug that has been removed from the manufacturer's original package and placed in different packaging.

Answer 261

* USP-NF approved packaging * Well-closed containers * Compliance packaging when requested by the patient, or for use in hospitals or long-term care facilities

Answer 262

A container that protects the contents from extraneous solids and drug loss during normal shipping and storage

Answer 263

Packaging for solid oral dosage forms that consists of a series of containers designed to assist the user with correct administration or self-administration in accordance with the directions for use (e.g. a "pill minder").

Answer 264

A container that meets the requirements of the Federal Poison Prevention Packaging Act of 1970, which are as follows: * Out of a group of 200 children age 41-52 months, 85% cannot open the package in 5 minutes * After a demonstration of how to open the package, and 5 more minutes, 80% of the children still cannot open it, and * 90% of adults can open and close it

Answer 265

Packaging that is designed to be difficult for children under 5 years of age to open. This is Virginia's version of a safety closure container.

Answer 266

Yes. The patient can even make a valid request for all of his prescriptions to be dispensed in non-special packaging.

Answer 267

Yes, but the request is only valid per prescription. The pharmacy cannot honor a prescriber's request to dispense all of a patient's prescriptions in non-special packaging.

Answer 268

Yes. A notation must be made on the dispensing record or other retrievable record and maintained for at least 2 years.

Answer 269

The pharmacist must have the patient sign a release covering a period of time or a single delivery, that releases the pharmacist from civil liability for not using a safety closure container. This will not protect a pharmacist who acted with willful and wanton disregard for safety.

Answer 270

Yes. Certain prescription drugs such as sublingual nitroglycerin, Medrol does packs and non-oral dosage forms are not required to be in special packaging.

Answer 271

The U.S. Consumer Product Commission's website: http://www.cpsc.gov/PageFiles/114277/384.pdf

Answer 272

No. The prescription department must be locked down and alarmed when a pharmacist is not on duty.

Answer 273

Only pharmacists who practice at the pharmacy and who are authorized by the PIC may have the keys and alarm code to the pharmacy.

Answer 274

Yes. If they are dispersed throughout the pharmacy. Or, the CII drugs can be stored separately provided they are locked in a drawer, cabinet, or safe.

Answer 275

They must be kept in the prescription department separated from the other drugs.

Answer 276

Yes, the key and alarm access code may be placed in a sealed envelope or other container with the pharmacist's signature across the seal. It must be kept in a safe or vault within the pharmacy or other secured place for use by another pharmacist to gain access to the pharmacy.

Answer 277

Yes. But only in an emergency. An emergency includes an unplanned absence of a pharmacist scheduled to work during regular pharmacy hours and an inability to obtain alternate pharmacist coverage. The technician must be accompanied by a member of the pharmacy's management or administration.

Answer 278

Yes, the verbal permission (via phone) of the PIC or another pharmacist regularly employed by the pharmacy is required.

Answer 279

A record must be made that includes: * Date and time of entry * The name and signature of the pharmacy technician * The name, title, and signature of the person accompanying the pharmacy technician * The pharmacist's name who granted the technician permission to enter the pharmacy * The telephone number where that pharmacist was reached * The name of the patient initially requesting the needed medication * The nature of the emergency * A listing of all prescriptions retrieved during that entry * The time of the technician exited and re-secured the prescription department.

Answer 280

For one year.

Answer 281

The technician is required to reseal the key and alarm code and place it back in the safe or vault.

Answer 282

Yes. The PIC must change the alarm access code within 48 hours of the technician's entry.

Answer 283

Yes, they may be placed in a secure area outside the prescription department provided that access to the prescriptions is restricted to designated clerical assistants.

Answer 284

Yes. A record must be kept that includes: * The patient's name * The prescription number(s) * The date of delivery * The signature of the person receiving the prescription

Answer 285

Yes. The pharmacy cannot employ and provide access to Federal controlled substances to: * Any person convicted of a felony offense relating to controlled substances * Any person who had a DEA registration application denied or registration revoked or surrendered for cause.

Answer 286

Yes, in small quantities. The drugs that can be sold are: opium, codeine, dihydrocodeinone, ethylmorphine, and diphenoxylate. The most commonly dispensed product in this category is Robitussin with codeine or its generic.

Answer 287

The product will not be a prescription only product and will not have the "RX Only" symbol on it.

Answer 288

* 200 mg of opium * 270 mg of codeine * 130 mg of dihydrocodeinone * 65 mg of ethylmorphine * 32.5 mg of diphenoxylate

Answer 289

NO. The labeling of the OTC CV product will have adequate directions for use and warnings against misuse that an RX product would not be required to have. These directions and warnings are much more detailed than what is placed on a prescription label. ***Be careful not to remove any of an OTC CV product's labeling or it will be misbranded!***

Answer 290

* It must be dispensed by a pharmacist * It must be dispensed directly to the person requesting it * The customer must provide proof of age (18 years or older) * The pharmacist must use professional discretion to ensure that the preparation is being dispensed for medicinal use only.

Answer 291

* date of sale * name and quantity of the preparation * name and address of the person to whom the preparation is dispensed * The initials of the dispensing pharmacist

Answer 292

Two years from the date of sale.

Answer 293

Yes. Many regular, NPH, and 70/30 insulins are available without a prescription.

Answer 294

It will not have the "RX ONLY" symbol on its labeling.

Answer 295

Insulin may only be sold by a licensed pharmacist or under the supervision of a licensed pharmacist.

Answer 296

* hypodermic needles & syringes * gelatin capsules * quinine or any of its salts in excess of 1/4 ounce

Answer 297

* Identification, including proof of age when appropriate. * A written, legitimate purpose for which the controlled paraphernalia is being purchased. This is not required for a "customer of known good standing."

Answer 298

* date of dispensing * named and quantity of device, item, or substance * price at which it was sold * name and address of the person to whom the device, item, or substance was dispensed * reason for its purchase * pharmacist's initials

Answer 299

Controlled paraphernalia cannot be sold to someone under the age of 16 except by a physician or with a prescription.

Answer 300

Yes, the pharmacy must "exercise reasonable care in the storage, usage, and disposition of such devices" to prevent diversion. Controlled paraphernalia and medical devices must be stored in or adjacent to the prescription department where the pharmacist can exercise "reasonable supervision and control."

Answer 301

The pharmacist may be found guilty of a Class 1 misdemeanor.

Answer 302

Ephedrine and pseudoephedrine base along with their salts, isomers, or salts of isomers. These are referred to as scheduled listed chemical products ("SLCPs") in Federal law.

Answer 303

3.6 grams per day 9 grams per 30 day period The Federal mail order limit is 7.5 grams per 30 day period

Answer 304

Behind the store counter where it cannot be accessed by consumers or locked in a case that requires store employee assistance for access.

Answer 305

Yes and the id must have been issued by a governmental or educational institution.

Answer 306

The pharmacy has to maintain a written log or electronic system that contains the following information: * Purchaser's name and address * Purchaser's birth date * Purchaser's signature * The product name and quantity sold; and * The date and time of the transaction

Answer 307

Yes, unless the pharmacy has obtained an exemption it must use an electronic recordkeeping and monitoring system to report all nonprescription sales of SLCPs.

Answer 308

Not unless the seller has a reasonable fear of imminent bodily harm if the sale is not completed.

Answer 309

Yes. The acknowledgement also has to include that the provision or a false statement or misrepresentation can subject the purchaser to penalties under Title 18 of the United States Code.

Answer 310

For at least two years from the date of last entry.

Answer 311

No. The provisions only apply to OTC sales of SLCPs.

Answer 312

The person can be found guilty of a Class 1 misdemeanor.

Answer 313

No. Federal law prohibits the purchase of SLCPs by minors under the age of 16.

Answer 314

Yes. The purchaser must produce a federal, state, or local government issued identification document that contains the purchaser's date of birth and picture.

Answer 315

Yes, prescriptions may be: * Directly hand delivered to patient or to the patient's agent * Delivered to the residence of the patient * Delivered to a place holding a current permit, license, or registration with the Board that authorizes the possession of controlled substances * Delivered to an alternate location only if allowed by Federal law and the VA Board of Pharmacy

Answer 316

Yes. The general rule is that CII-CV prescriptions should only be hand delivered to: * The patient * His agent * The patient's residence

Answer 317

Only if the doctor is licensed to practice pharmacy or to sell controlled substances.

Answer 318

Only if the person or entity that has a controlled substances.

Answer 319

Only if the person or entity is authorized to sell the drug.

Answer 320

A notice alerting the consumer that chemical degradation of drugs may occur under certain circumstances, and providing a toll-free or local number the consumer can call with questions.

Answer 321

Pay particular attention to use of DEA form 222 and Schedule II drug transfers. Also compounding and prescription monitoring programming worthy of attention.

Answer 322

Anybody who is authorized to administer, prescribe, or dispense the drug/device.

Answer 323

* Another permitted manufacturer or wholesaler* * A licensed pharmacist, permitted pharmacy, or licensed practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine* * A person or entity that has been issued a Virginia Controlled Substances Registration Certificate if authorized by the certificate(the certificate specifies what schedules the holder is allowed to have)* * A Federal, state, territorial, district, county, municipal, or insular government official when necessary for that person's official duties; a special written order and certificate of exemption is required. * A ship or aircraft captain ("Master"), if there is not regular doctor on board, for the actual medical needs of persons on board. The vessel cannot be in port. This transfer requires approval of a special order from by a U.S. Public Health Service official or commissioned medical official or commissioned medical officer. * A person in a foreign country in compliance with relevant federal laws. *These persons and entities are also required to have a DEA registration to receive CII-CV drugs.

Answer 324

Yes. A DEA form 222 (written or electronic) is required for all transfers of CII drugs. The only times a DEA Form 222 is not required is when a CII drug is being dispensed or administered to a patient, which requires a prescription or order, or when the CII drug is going from a central fill pharmacy to a retail pharmacy.

Answer 325

Wholesale distributors and warehousers that have a license or registration from the Board.

Answer 326

In an emergency, a pharmacy may purchase CII-CVI drugs from another pharmacy. Remember the transfer of a CII drug will require the use of a DEA222.

Answer 327

Yes, if they are under common control. Remember, the transfer of a CII drug will require the use of a DEA 222.

Answer 328

Only when the medication is in the manufacturer's original sealed container and USP storage requirements are assured. For example: the dispensed prescription was for #20 Augmentin tablets and the pharmacy dispensed the unopened original stock bottle of 20 tablets to the patient. The patient was a pharmacist or physician who can reasonably be relied upon to inform the dispensing pharmacy of the conditions under which the prescription was held. This is a very rare circumstance as the pharmacist should not rely upon a layperson's word as to how the drug was stored.

Answer 329

No. It's been out of the possession of pharmacy personnel and the pharmacist cannot be assured that it was stored in compliance with USP standards.

Answer 330

If it hasn't left the pharmacy premises, the medication can be accepted for return and re-dispensing.

Answer 331

An expiration date must be placed on the prescription label prior to returning the drug to stock.

Answer 332

The restocked drug must be used to fill the next prescription received for that product. If the drug is not dispensed prior to the newly assigned expiration date, the drug must be removed from stock and disposed of in accordance with the Board's regulations. If the pharmacy knows the lot number it should place it on the label so that it can be returned in the event of a manufacturer's recall. IF lot unknown, the drug must be removed from stock and returned to the manufacturer or disposed of in the event that there is a recall of the drug. **The medication cannot be returned to the stock bottle.**

Answer 333

A device is an instrument, apparatus, or contrivance, including their components, parts and accessories, that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals.

Answer 334

Yes, provided the device is in the manufacturer's original sealed packaging.

Answer 335

Yes. Wholesale controlled substances sales can't exceed 5% of the pharmacy's total CII-CV annual sales in dosage units. Example: if your pharmacy dispenses 100,000 dosage units of CII-CV drugs in a year, it can sell up to 5,000 dosage units that year without being a licensed wholesaler. The 5% is based on total dosage units and is not tied to any one specific drug. Wholesale oxygen sales cannot exceed 5% of total oxygen sales.

Answer 336

No. Prescriptions are only for patients. The doctor can order medications for his office using either an appropriate order form or invoice. The content of an invoice/order form will be covered in the recordkeeping section of this text. A DEA Form 222 is required if the medication is a CII drug.

Answer 337

The forms are given to registrants by the DEA when they are first registered if requested on the application form.

Answer 338

The DEA 222a form is used to order subsequent DEA 222 forms.

Answer 339

* registrant's name * registrant's address * registrant's DEA number * The number of forms requested (the books come in quantities of 7 or 14) * The signature of the registrant or someone who has received power of attorney. * **Registrants can also order new DEA 222 forms online at: www.DEAdiversion.usdoj.gov***

Answer 340

Yes, the registrant can give power of attorney to one of more agents. The power of attorney must be retained in the files with the executed DEA 222 forms. The power of attorney can be revoked at any time be execution of a notice of revocation.

Answer 341

Yes, but must the forms must be promptly provided to the registered location if it is being inspected.

Answer 342

The purchaser. The pharmacy fills out the form when purchasing drugs.

Answer 343

The pharmacy will let the distributor know what CII drugs the pharmacy is returning and the distributor will fill out one of its DEA 222 forms and send it to the pharmacy.

Answer 344

The doctor or receiving pharmacy would have to complete its DEA 222 form and send it to the distributing pharmacy.

Answer 345

* The date it was issued * The registrant's DEA number * The registrant's name * The registrant's address * The Schedules, CI, CII, or both, that the registrant is allowed to order * The registrant's business (e.g. retail pharmacy, wholesaler, etc.) * The DEA 222 Form's serial number (each one has its own number)

Answer 346

* The name of the supplier * The address of the supplier * The date the form is completed * The number of packages for each drug ordered * The size package for each ordered (e.g. 100 tabs or 10 mL) * The name of each drug order (e.g. morphine inj. 10 mg/mL) * The last line completed * Signature of the person completing the DEA 222

Answer 347

The purchaser fills out the form (in triplicate), and keeps Copy 3. Copies 1&2 are sent to the supplier. After the order is filled, the supplier completes Copies 1 and 2. The supplier keeps Copy 1 and sends Copy 2 to the DEA Special Agent in Charge.

Answer 348

* The number of packages received in the packages shipped column on the form. * The date each package was received in the "date shipped" column on the form.

Answer 349

* The NDC of each drug * The number of packages shipped of each drug * The date each package is shipped

Answer 350

The supplier has 60 days from when it is executed to fill the order.

Answer 351

The supplier can partially fill the order and provide the balance in additional shipments during the 60 day validity of the DEA Form 222.

Answer 352

By the close of the month in which the shipment was filled. If the order was filled in partial shipments, the close of the month in which the last shipment was sent or when the 60-day validity period expires.

Answer 353

When the DEA 222 is : * Incomplete * Illegible * Not properly prepared, executed, or endorsed * Altered * Erased; or * Has a change in the drug's description.

Answer 354

The supplier will return Copies 1 & 2 of the DEA 222 to the purchaser with a statement of the reason for refusal.

Answer 355

The pharmacy is required to retain all 3 copies of the DEA 222 together plus the statement from the purchaser in their files. The DEA 222 cannot be reused.

Answer 356

* Copy 1- kept by supplier for 2 yrs. * Copy 2- kept by DEA * Copy 3- kept by the purchaser for 2 yrs. * Unaccepted or defective forms- kept by the purchaser for 2 yrs. along with the statement of the reason for rejection.

Answer 357

At the location printed on the form. CII records must be filed separately from CIII-VI records!

Answer 358

The purchaser executes another form, attaches a statement with the serial number and date of the lost form, and a statement that the drugs were not received.

Answer 359

The supplier gets Copies 1&2 of the new form and the statement fills the order as usual. ***If the supplier eventually gets the lost form, they must mark it "Not Accepted" and return it to the purchaser. The purchaser will attach copies 1 & 2 of the "lost" form to Copy 3 of the form and the statement. This creates the necessary record of what happened.***

Answer 360

Upon discovery of the loss, it must be immediately reported to the special agent in charge of the DEA divisional office for that area. The report must include the serial number of each form lost or stolen. IF an entire book (7 or 14 forms) is lost or stolen and the pharmacist does not know the serial numbers of the forms, he reports the date the forms were issued or an approximate date if he does not know the exact date. If the form(s) are subsequently located, this must be immediately reported to the special agent in charge.

Answer 361

They may get partial shipments at different times, to locations other thank the location printed on the DEA 222, for a period of 6 months from date of the order. They must be buying drugs for delivery to armed services establishments within the United States.

Answer 362

Request assistance from the Special Agent in Charge by submitting three copies of a DEA Form 41. The Special Agent in Charge may authorize the pharmacy to dispose of the drugs by: * Transfer to another registrant authorized to possess the substance * Delivery of the drugs to the DEA * Destruction of the drugs in the presence of a DEA agent or other authorized person * In such other manner as the DEA agent deems will not result in the diversion of controlled substances. * **Federal law also allows Federal controlled substances to be disposed of in accordance with the procedures set forth in a state's statutes and regulations.***

Answer 363

The drugs can be transferred to any of the following provided the entity has a valid DEA registration (for CII-CV drugs): *Manufacturer *Wholesaler *Practitioner (e.g. doctor or osteopath) *Another pharmacy * Any other person, or entity that is authorized to possess (DEA registrant) or provide for the disposal of the drugs. Remember, any transfer of CI or CII drugs must be done using a completed DEA Form 222. The pharmacy may also destroy the drugs by burning in an incinerator or other Board of approved method in accordance with the following procedures: *Give the Board at least 14 days prior written notice *The notice must contain the date, time, and manner of destruction and the names of the pharmacists who will witness the destruction.

Answer 364

The Board must be notified and a new notice provided at least 14 days prior to the new date of destruction.

Answer 365

The PIC and another pharmacist not employed by the pharmacy.

Answer 366

The pharmacy must maintain a completed DEA 41 drug destruction form as a record of the destruction. The form must be kept for 2 years and retained in the pharmacy with its inventory records.

Answer 367

* Date * Kind and quantity of drugs * Signature of PIC * Signature of the non-employee pharmacist witness

Answer 368

The drugs may be transferred to: * Another pharmacy * A practitioner authorized to possess them (DEA registrant) * A licensed manufacturer or wholesaler

Answer 369

* Prior to opening on its first day of business (initial inventory) * At least every 2 yrs. after it's last full inventory (biennial inventory) * When there is a new PIC, before opening for business that day * When there is a theft or loss of CI-CV drugs and what was taken is not known * When the pharmacy closes or transfers its business * **It would be very unusual for a pharmacy to have CI drugs in stock because they do not have a medically accepted use. Therefore, inventories are generally done of CII-CV medications.***

Answer 370

There must be a complete inventory of CI-CV drugs before opening on the FIRST day of business. If there are no Federal controlled substances on hand, that fact must be recorded as the initial inventory.

Answer 371

Biennially (every 2 yrs.)

Answer 372

No. As long as a full inventory (e.g.theft or change of PIC) of CI-CV drugs is taken within 2 years of the initial or last biennial inventory, it can serve as the new biennial inventory.

Answer 373

Yes as long as the inventory is promptly reduced to writing.

Answer 374

*Date of the inventory *Time of the inventory; before opening, after closing, before or after shipment/distribution for a 24 hour pharmacy *For each drug in finished form: Drug name, dosage form (e.g., capsule, tablet, suspension), quantity (use milliliters for liquids), number of commercial containers (e.g., 3 bottles of 500) Signature of the person taking the inventory

Answer 375

Whether the receipt or distribution of drugs on the inventory date occurred before or after the inventory was taken.

Answer 376

Whether the inventory was taken before the pharmacy opened or after the pharmacy closed on the date of the inventory.

Answer 377

The outgoing PIC is not required to take an inventory but must be provided an opportunity to take a complete inventory of CI-CV drugs unless their is good cause to deny him this opportunity (e.g. he is charged with diversion).

Answer 378

if you are an outgoing PIC, take an inventory and keep a copy for yourself.

Answer 379

She must take a complete inventory of all CI-V drugs on the date she becomes PIC. This must be taken prior to opening for business.

Answer 380

A minimum of 2 years.

Answer 381

Chronologically. And, the CI-CII inventory records have to be filed separately from the CIII-CV inventories. CIII-CV inventory records can be filed with CVI records.

Answer 382

At the site where the stock of drugs inventoried are maintained.

Answer 383

Yes. You must maintain a perpetual (ongoing) inventory of your CII drugs and reconcile the CII inventory (account for discrepancies) every 30 days. Electronic records are acceptable, but discrepancy reports must be reviewed at least once a month. ***A pharmacy's CI and CII drugs must still be inventoried by an incoming PIC, in the event of a theft or loss, and along with the biennial inventory.***

Answer 384

Yes. You must do an exact count of your CI and CII drugs but you do not have to open unopened bottles.

Answer 385

No. You are allowed to do an estimated count of your opened containers as long as the bottle size is less than 1,000 tablets. You do not have to open unopened bottles.

Answer 386

Yes. For CVI prescriptions, an electronic image is sufficient if it is legible and can be made available within 48 hours.

Answer 387

The pharmacy does not need a hard copy if the prescription was an electronic automated transmission from the prescriber. In that case, the automated transmission serves as the hard copy and must be maintained for no less than 2 years.

Answer 388

Oral prescriptions need to be reduced to writing and maintained for 2 years. They must also be filed chronologically.

Answer 389

The date of dispensing, and the dispensing pharmacist's initials. Electronic records are acceptable. If manual records are used, the information must be placed on the back of the prescription. The failure to indicate the quantity dispensed will result in the presumption that the entire quantity ordered was dispensed.

Answer 390

No. CII prescriptions must be stored separately.

Answer 391

Yes but the CIII-V prescriptions need to be "readily retrievable." There are two ways to accomplish this: * Stamp a red letter C at least 1 inch high in the lower right corner of each CIII-CV prescription, OR * Use an electronic data processing system that allows identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled.

Answer 392

* date or receipt * name and address of the supplier * the kind of drug received (e.g. oxycodone IR 5 mg tablets) * The quantity of drug received * The signature of the pharmacist receiving the order

Answer 393

The copies (DEA 222 copy 3) must be maintained separately from other records and be available for inspection for 2 years at the site where the drugs were received. The invoices for the CII medications received can be maintained with the completed DEA Form 222s and must also be kept for 2 years.

Answer 394

They can be stored off site if authorized by the DEA provided they are made available for audit or inspection within 48 hours of request.

Answer 395

Chronologically.

Answer 396

Yes, anyone who sells, administers, or dispenses, or otherwise disposes of drugs needs to keep this type of record. For example, a record must be kept when a nurse administers a dose of lorazepam in a hospital. These records are kept 2 years.

Answer 397

The system needs to maintain the information from the previous two years.

Answer 398

Yes, the pharmacy must make a daily printout summarizing all transactions that occurred during the day. The printout is signed by each pharmacist who dispensed prescriptions that day to certify that the transaction were correct and assume responsibility for them. The pharmacy can choose to maintain a logbook instead and the pharmacists would sign it every day as certification for the prescriptions.

Answer 399

Chronologically Chart orders may be filed using another method if: *Dispensing data can be produced showing a complete audit trail for any requested drug for a specified time period. *Chart orders are readily retrievable upon request *The filing method is clearly documented in a current policy and procedure manual.

Answer 400

If the drug is floor stock, no additional filing is necessary. If the drug is dispensed from a pharmacy, the original order is filed with records of CII drugs and a copy of the order is placed in the file for the other schedules. A log book may be used in place of a printout.

Answer 401

One year or until expiration, whichever is greater.

Answer 402

* Date repackaged * Drug name& strength, if applicable * Quantity prepared * Assigned lot or control number (by pharmacy) * Manufacturer or distributor's name and lot/control number * Expiration date * Pharmacist's initials

Answer 403

* The VA Board of Pharmacy and its agents * The VA State Police Drug Diversion Unit and its officers * The agents of the Drug Enforcement Administration * The Inspectors of the Federal Food & Drug Administration

Answer 404

The Board of Pharmacy. Its agents can enter and inspect a VA pharmacy any time it is open and they do not need a warrant or probable cause.

Answer 405

Yes, if they think there is a reason to inspect. They do not need an administrative inspection warrant. The FDA's inspection authority comes from its responsibility to assure that drugs shipped in interstate commerce are safe, effective, and properly labeled.

Answer 406

Yes, for each inspection (but not for each entry during an inspection?

Answer 407

Yes. If you are required to keep the records, the FDA is authorized to inspect the records. Inspections must be conducted at reasonable times in a reasonable manner.

Answer 408

Every 2 years.

Answer 409

The State Police's Drug Diversion Unit must be allowed to inspect a pharmacy's records during normal business hours but their authority is limited to records related to specific investigations. Unlike the Board of Pharmacy, they cannot come in and go through all of your prescription and drug records. Their review ill be limited to the specific patients or prescribers whom they are investigating.

Answer 410

Yes but only if the records are relevant to a specific investigation.

Answer 411

The officer must leave a receipt and provide a copy to the person maintaining the records within a reasonable time afterwards.

Answer 412

The officer must leave a duplicate with the person who maintains the records (e.g. the pharmacist).

Answer 413

Yes. They must leave a receipt that describes the sample taken.

Answer 414

Yes. The drug diversion officers and the Board's agents cannot inspect: * Financial data * Sales data, other than shipment data * Pricing data * Personnel data * Research data

Answer 415

*Agents of the Board of Pharmacy *VA State Police Drug Diversion Unit *DEA agents FDA inspectors

Answer 416

A pharmacy, or any other place in VA where drugs, cosmetics, or devices are manufactured, distributed, stored, or dispensed.

Answer 417

During normal business hours.

Answer 418

He has to leave a receipt with the pharmacy and provide a copy of the record within a reasonable time.

Answer 419

The general rule is that DEA agents need either an administrative inspection warrant or the pharmacy owner's written consent to inspect it.

Answer 420

* The inspection is required prior to the DEA granting some kind of authorization (e.g.a license) * The Constitution does not require a warrant. * It is an emergency and there is not time to get a warrant. * There is an imminent threat to public health and safety. * The owner consents in writing. * The inspection is of a conveyance (something being moved) and there is reasonable cause for a warrant.

Answer 421

Administrative probable cause. This is different from criminal probable cause. Administrative probable cause exists when the facility carries on a regulated function and has not been recently inspected.

Answer 422

Every year.

Answer 423

Every year.

Answer 424

As needed.

Answer 425

* Financial data * Sales data other than shipment data * Pricing data * Personnel data (other than data as to qualification of technical and professional personnel) and * Certain research data.

Answer 426

A unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

Answer 427

Prescribers and health system pharmacies. Most health system pharmacies avoid possessing drug samples because of the risk of inadvertently billing for a drug sample.

Answer 428

A written request from a prescriber and a written receipt for the samples provided. The prescriber may authorize the drugs to go to a hospital or pharmacy instead of his or her office. The manufacturer must keep the records for 3 years.

Answer 429

Yes. this is permitted.

Answer 430

The Board waives that requirement when a robot is being used but pharmacists must do daily random checks of 5% of the medications that the robot selected.

Answer 431

* That all prescription orders entered into the computer are accurate * That pharmacy technicians restock the robot accurately * That unit-dosed drugs are packaged and labeled accurately * That expired drugs are removed from the robot

Answer 432

The pharmacy must report the error to the Board and a pharmacist must check 100% of all doses until the pharmacy provides the Board with documentation showing the error has been identified and fixed.

Answer 433

The pharmacy must report it to the Board.

Answer 434

Yes, the pharmacy must maintain records listing: *Any downtime, dircrepencies, or errors *The total number of doses packaged and total number of doses picked by the robot *The number of doses checked when conducting the 5% check These records may be stored off site or electronically as long as they are retrievable within 48 hours.

Answer 435

Schedules II through IV

Answer 436

* The patient's name, address, and date of birth * The drug and quantity dispensed * The date of dispensing * The prescriber and dispenser's identifier numbers * The method of payment for the prescription * Any other information required to comply with state and federal laws

Answer 437

It must be reported within 7 days of dispensing.

Answer 438

Yes, reporting is not required for: *A pharmaceutical manufacturer dispensing drugs as part of an indigent patient program *A physician dispensing to a patient in a bona fide medical emergency or when pharmaceutical services are not available *Administration (as opposed to dispensing) *Dispensing within a narcotic maintenance treatment program *Dispensing to inpatients in hospitals, hospices, or nursing homes Veterinarians dispensing to animals within the usual courses of practice

Answer 439

Yes. Improper disclosure of this information is a Class I misdemeanor.

Answer 440

Yes. Access to the PMP can be delegated to another person licensed, registered, or certified by a health regulatory board provided that the person is employed at the same facility and is under the direct supervision of the pharmacist.

Answer 441

* Immediately notify the Board (or when they open if the Board is closed) * If the exact kind or quantity of drug lost is not known, do a complete inventory of all CI-CV drugs * Within 30 days of discovery of the loss, furnish the Board with a listing of the kind, quantity, and strength of the drugs lost. * Notify the area Field Division office of the DEA in writing within 1 business day. (for theft or a "significant" loss) * Complete and submit DEA form 106 to the DEA field division office.

Answer 442

By considering the following factors: * Quantity lost in relation to the business * Specific drugs lost * If the loss can be associated with an individual or a unique activity * Whether there is a pattern or random series of losses * Whether the drugs are likely to be diverted * Evidence of the diversion potential for the missing drugs

Answer 443

A completed DEA Form 106, Report of Theft or Loss of Controlled Substances.

Answer 444

The pharmacy has to report what was taken. If the pharmacy does not know what was taken, it must do a complete inventory of its CI-CV drugs.

Answer 445

The pharmacy has 30 days to provide the list of missing drugs to the Board and the list must include: * The kind of each drug lost/stolen (e.g. oxycontin 40 mg tabs) * The quantity and strength of each drug lost/stolen.

Answer 446

Whichever pharmacy contracted with the contract carrier must notify the DEA and submit the completed DEA Form 106.

Answer 447

No. Any doctor may use narcotics for pain control, but treating addiction requires special registration.

Answer 448

CIII-CV drugs that are specifically approved by the FDA for maintenance or detoxification. Examples include Subutex and Suboxone.

Answer 449

No. CII prescriptions cannot be issued for maintenance or detoxification. Appropriately licensed practitioners may administer or dispense CII drugs directly to the patient but cannot prescribe CII drugs for these uses.

Answer 450

YEs. The doctor needs to receive a waiver under the Drug Addiction Treatment Act of 2000 (DATA 2000). The Substance Abuse and Mental Health Services Administration (SAMHSA) maintains a list of doctors authorized to prescribe buprenorphine. These doctors may prescribe using a DEA number that is the same as their usual DEA number, but with an X in place of the first letter. Prescriptions for Subutex and Suboxone must have the doctor's "X" DEA number on the prescription. There is a good faith exception for practitioners who are not registered. They are required to write a notice on the prescription. A pharmacist should rarely, if ever, see a prescription with such a notice on it.

Answer 451

To use CII drugs (e.g., methadone), the doctor must obtain separate registration from DEA number for this purpose. They still cannot write CII prescriptions for detoxification or maintenance.

Answer 452

The prescriber may use narcotics for pain control but cannot treat addiction without the special registration.

Answer 453

Methadone can be administered and dispensed, but not prescribed. A pharmacist can fill a prescription for methadone if it is used for pain control, but not for the treatment of addiction.

Answer 454

When it is necessary as an adjunct to medical or surgical treatment of conditions other than addiction. An example would be an addicted patient who was involved in a motor vehicle accident in which he sustained major injuries. Under these circumstances, the patient may need to have his addiction maintained in the hospital so that he is able to recover from his injuries.

Answer 455

* Establishing procedures for and assuring maintenance of the proper storage, security, and dispensing of all drugs used throughout the hospital * Providing for reviews of drug therapy

Answer 456

No, but most of them do.

Answer 457

Yes. The satellite will need to be inspected and have an appropriate alarm system. Drugs cannot be stocked in the satellite until after the inspection is completed and approval given.

Answer 458

* Large volume parenteral solutions that contain no active therapeutic drug other than electrolytes (e.g. normal saline; 1/2 normal saline with 20 meq of potassium, etc.) * irrigation solutions * contrast media * medical gases * sterile sealed surgical trays that may include a Schedule VI drug * Blood components and derivatives and synthetic blood components and products that are classified as prescription drugs

Answer 459

They must be in a locked location when authorized staff are not present.

Answer 460

Nitrous oxide.

Answer 461

Yes, if the PIC authorizes it, an nurse may get emergency medications that are in a secured area outside of the pharmacy. The drugs must be in the manufacturer's original packaging or in units prepared and labeled by a pharmacist.

Answer 462

* date of withdrawl * patient's name * drug's name, strength, dosage form, and dose prescribed * number of doses taken * nurse's signature

Answer 463

No the drugs must be kept in an area where access is restricted to authorized persons.

Answer 464

* The drugs must be under the pharmacy's control. * The PIC must have established procedures for stocking, storage, security, and accountability of the automated dispensing system. * Medications are only removed from an automated dispensing cabinet pursuant to a valid order or prescription. A pharmacist has to verify most orders before the drug can be removed for administration to a patient. * Drugs in the automated dispensing cabinet must be in their original sealed packaging or unit-dose containers packaged by the pharmacy. * The automated dispensing system must be capable of producing a hard-copy record of the drugs distributed, including the identity of the patient and of the nurse who withdrew the drug. * Personnel are only able to access the automated dispensing cabinet using a personal access code. * Proper use of the automated dispensing cabinets is set forth in the pharmacy's policy and procedure manual.

Answer 465

The PIC. The actual filling and stocking can be delegated to another pharmacist or pharmacy technician as long as the individuals are employees of the facility who have been properly trained. IF a pharmacist does it, the pharmacist is responsible. If a technician does it, the PIC is responsible. The PIC may require pharmacists to verify the actions of the technician.

Answer 466

* They must undergo a monthly audit * Their operation must be reviewed periodically * They must be inspected periodically

Answer 467

A delivery record must be made that includes: * date * drug name, dosage form, strength, and quantity * hospital unit where the device is located * a unique identifier for the device receiving the drug * the initials of the person loading the automated dispensing machine * the initials of the pharmacist reviewing the transaction (verifies that the technician has the correct medications for the machine; e.g. amlodipine 5mg vs. 10 mg)

Answer 468

* verify that the count of that drug in the automated dispensing device is correct * note any discrepancies on the dispensing record and report them to the PIC. The technician is always responsible for correctly filling the machine.

Answer 469

The PIC or someone the PIC designates must audit the machines monthly.

Answer 470

The audit must be initialed and dated by the pharmacist who conducted the review- or by a pharmacist if a technician conducted the review.

Answer 471

* The count of all CII-V drugs dispensed from pharmacy is checked against the quantity loaded into the machines. * The count of CII-CV drugs on hand is checked. * A 24 hour sample of administration records from each device is checked for possible diversion by fraudulent charting. * Medical records are checked to ensure a valid order exists for a random sample of doses recorded as administered. * The records are checked for compliance with the pharmacy's written procedures.

Answer 472

The discrepancy must be resolved by the PIC (or someone the PIC designates) within 72 hours of the time the discrepancy was discovered.

Answer 473

It must be reported to the Board of Pharmacy.

Answer 474

Yes, the devices must be inspected monthly. Inspection includes checking for: * Proper storage * Proper location of drugs within the device * Expiration dates * Security of drugs * Validity of access codes The machines do not need to be physically inspected if the system can track refrigerator/freezer temperatures, expiration dates, and uses technology such as barcoding to isolate and identify each drug within the device. In that case, the reports and alerts generated by the machine are sufficient to meet the requirements.

Answer 475

yes, under the following conditions: * The records can be readily retrieved upon request. * The records are maintained in a read-only format which does not allow alteration. * A log is maintained showing the dates of audit and review, including which machines were reviewed, the time period reviewed, and the initials of all reviewers.

Answer 476

A separate record is not required provided that: * The automated record distinguishes dispensing from administration. * The device records the identity of the physician who is doing the dispensing.

Answer 477

It is considered dispensing when patients are given drugs to take home with them from an emergency room. It is considered administration when a nurse or other licensed person gives the drug to the patient.***

Answer 478

The pharmacy needs to get a separate registration for each facility. IF another pharmacy also wants to put an automated dispensing machine at the site, the second pharmacy needs their own DEA number for that site as well.

Answer 479

NO. But, it does need a controlled substance registration form the Board of Pharmacy.

Answer 480

The drugs are under the control of the pharmacy providing services to the nursing home. The pharmacy has on-line communication with and control of the machine. The nursing home has a controlled substances registration.

Answer 481

Yes. A nurse or other person authorized to remove drugs from that device must sign for the controlled substances when they are loaded. The records are kept by the pharmacy.

Answer 482

No. A pharmacist has to review and approve the order (done electronically). This means that the PIC must ensure there is a pharmacist with on-line access to the system available at all times to review prescriptions.

Answer 483

The rules are the same as in the hospital: * the machines must be audited and inspected monthly. * The PIC must resolve discrepancies within 72 hours. * The drugs in the drawer must be counted when the drug is restocked.

Answer 484

The records of administration are acceptable for drugs distributed as floor stock. These records are referred to as MARs, which stands for medication administration records.

Answer 485

Any schedule but a receipt is required for all CII-CV medications.

Answer 486

No records are required for CVI drugs. For CII-V the pharmacy needs: * A deliver receipt-including the hospital unit receiving drug alone with the signatures of the dispensing pharmacist and receiving nurse. * A record of the disposition/administration of the medications must be returned to the pharmacy within three months of the drug's use.

Answer 487

No. The electronic capabilities of these systems create a sufficient record, which floor stock does not.

Answer 488

No! There are significant auditing requirements. The PIC or someone assigned by the PIC must periodically (e.g., monthly): * Match returned records with dispensing receipts- to make sure they reconcile. * Audit for completeness- records must include the patient name, dose, date/time of administration, signature/initials of person administering drug, and the date the record was returned. * Verify that the inventory is correct- that additions and deductions from inventory are correctly calculated, and sums are correctly carried from one record to the next. * verify that does documented on administration records are reflected in the medical record.

Answer 489

* The records must be initialed and filed chronologically. * They must be maintained for 2 years. * CII-V records must be stored onsite at the pharmacy. * CVI records may be stored off site if they can be retrieved within 48 hours.

Answer 490

It is acceptable provided that the CII drugs are listed in a separate section of the record. The record should be copied and the original placed with the pharmacy's CII records while the copy is placed with the other records.

Answer 491

Yes but only if the persons administering the medications at the facility are licensed to administer drugs.

Answer 492

* Intravenous fluids * Irrigation fluids * Heparin flush kits * Medicinal gases * Sterile water * Saline * Prescription devices

Answer 493

The pharmacist, in consultation with the medical & nursing staff of the facility.

Answer 494

* The drugs may be returned to the pharmacy for destruction or donation to an indigent program. * The facility can destroy the drugs at the facility (this procedure is not controlled by the Board of Pharmacy).

Answer 495

* The facility must have a record of destruction and a record of drugs returned to the pharmacy. * The record of destruction must be signed and dated by the persons witnessing the destruction. * Copies of the records must be kept for 2 years. * The pharmacy serving the facility must receive a copy of the record(s) and maintain the records for 2 years.

Answer 496

Within 30 days of a drug being discontinued.

Answer 497

The PIC and another pharmacy employee. The drugs may also be transferred to another pharmacy licensed to accept returns for destruction.

Answer 498

The director of nursing. If there is no Director of Nursing, the destruction may be witnessed by the facility administrator and one other person. The other person can be a pharmacist providing pharmacy services to the facility or another facility employee authorized to administer medication.

Answer 499

The original record of destruction must be signed and dated by the people witnessing the destruction. The long-term care facility maintains this record for two years and the pharmacy maintains a copy of the record for two years.

Answer 500

This may be allowed at a long-term care facility.

Answer 501

Multiple drugs placed in unit dose packaging dispensed in a single container (such as a medication bin) labeled with a patient's name. Directions for administration are not provided by the pharmacy and are obtained from the order or medication administration record.

Answer 502

A unit dose container holds a single dose of a drug that is not to be administered parenterally and is administered directly from the container.

Answer 503

A unit dose package contains a particular dose ordered for a patient.

Answer 504

*drug name *drug strength * lot number * expiration date *** Remember the patient's name, location, and dosage are on the MAR. *

Answer 505

* date of filling * cart location * initials of the person who filled it * initials of the verifying pharmacist

Answer 506

A patient profile or medication card-the record of dispensing is entered at the time the drug drawer is filled. An electronic "fill list" that lists drugs dispensed to patients' drug drawers.

Answer 507

2 years for CII-V drugs.

Answer 508

If only licensed persons will be administering drugs to patients, a 7-day supply of solid oral dosage form drugs may be dispensed. If any unlicensed persons administer the drugs, only a 72 hour supply of solid oral dosage form medications may be dispensed.

Answer 509

Yes it must: * Train the long term care facility staff how to use the unit dose system * Provide a medication administration record that lists each drug to be administered with full dosage direction- no abbreviations * Medication placed in unit dose drawer slots must be labeled or coded to indicate the time of administration

Answer 510

Yes, as long as the drugs are locked and secure.

Answer 511

In an individual drug drawer or tray that is labeled with the patient's name and location. All unit dose drugs intended for internal use must be placed in the patient's individual drawer or tray unless special storage conditions are necessary.

Answer 512

Yes. Only one backup dose unit may be maintained in the patient's drug drawer along with the other drugs for that patient.

Answer 513

Yes, provided these are done under the personal supervision of a pharmacist.

Answer 514

Compounding is the combining of two or more ingredients under any of the following circumstances: * Pursuant to the receipt of the prescription * In expectation of receiving a valid prescription based on observed prescribing practices. * For delivery to a practitioner for administration in the course of his professional practice * For purposes of research, teaching, or chemical analysis

Answer 515

Manufacturing! And, it is illegal unless the pharmacy has a manufacturer's license and is approved by the FDA.

Answer 516

Yes, in accordance with USP-NF standards.

Answer 517

* name and strength of the medication or a list of the active ingredients and strengths * quantity of the product * pharmacy's assigned control number that corresponds with the compounding record * an appropriate beyond-use date

Answer 518

No. Not even to another pharmacy under common ownership. There is an exception that allows veterinarians to dispense small quantities (72 hours) of pharmacy compounded medications for an animal for treatment in an emergency situation when timely access to a compounding pharmacy does not exist.

Answer 519

No. If the drugs are compounded pursuant to valid prescriptions, the pharmacy can deliver them to a nursing home or hospital.

Answer 520

Yes, for administration to patients in the course of their professional practice, either personally or under their direct and immediate supervision. The practitioner must be licensed to prescribe the drug.

Answer 521

* "For Administering in Prescriber Practice Location Only" * The name and strength of the compounded medication or list of the active ingredients and strengths * Quantity of the drug * The pharmacy's control number * An appropriate beyond-use date in accordance with USP-NF standards.

Answer 522

A technician may compound if a pharmacist supervises the process. The pharmacist must complete a final check to verify: * Accuracy * Correct ingredients * Correct calculations * Accurate and precise measurements * Appropriate conditions and procedures * Appearance of the final product

Answer 523

Yes, in accordance with USP-NF standards.

Answer 524

Not usually. But if the compounding would be for a use outside of the scope of the recall, it may be permitted. For instance, a drug may be safe for topical use but not for internal use. A product may also have been recalled because of an issue with the manufacturing process but the drug itself is safe for use.

Answer 525

Not regularly. However, it is permitted if: * There is a change in the product ordered by the prescriber for an individual patient. * The product is unavailable from the manufacturer or supplier. * The pharmacist is mixing two or more commercially available products together regardless of whether the end product is a commercially available product

Answer 526

* name and quantity of all components * date of the compounding and dispensing * prescription number or other identifier of the prescription order * total quantity of the finished product * signature or initials of the pharmacist or pharmacy technician performing the compounding * signature or initials of the pharmacist responsible for supervising and verifying

Answer 527

* The generic name of each component * The manufacturer or brand name of each component * The manufacturer's lot number & expiration date for each component (if unknown, the source of the component) * The pharmacy's assigned lot number, if subdivided * The unit or package size and the number of units or packages prepared * The beyond-use date * The criteria used for establishing the beyond-use date must be available for inspection by the Board

Answer 528

Yes, if the instructions are necessary to replicate a compounded product or where the compounding is difficult or complex and must be done by a certain process in order to ensure the integrity of the finished product.

Answer 529

Yes, the pharmacy musts have a formal written quality assurance plan that describes how compounding is monitored and evaluated in compliance with USP-NF standards. This must include training of personnel involved, and initial and periodic competence assessment.

Answer 530

Pharmacies that produce sterile products must notify the Board of Pharmacy. The Board maintains a list of pharmacies that compound sterile products.

Answer 531

They are also used in unit dose packaging systems to produce unit doses.

Answer 532

A bin filling record that includes: * Date of filling * Drug name & strength, if applicable, and quantity prepared * Manufacturer of distributor's name * Manufacturer or distributor's lot/control numbers and expiration dates * Assigned lot number * Expiration date in accordance with USP guidelines * Pharmacist's initials

Answer 533

The lot that expires first will be the expiration date for the entire bin.

Answer 534

So that they can be cross-referenced to the filling record to determine expiration dates and lot numbers.

Answer 535

* The device must dispense the first lot before the second lot and the expiration date will be the date assigned to the first lot. * Allow the bin to "run dry" (all product removed prior to filling) once every 60 days with a record made of the run dry dates.

Answer 536

All drugs in the bin must be removed unless: * The technology used can ensure that the recalled lot has cleared, or * The bin was run dry (no drug left in it) after the recalled lot was added to it and a record was made of the run dry date.

Answer 537

Yes. This is called a central prescription processing pharmacy arrangement. The pharmacy that does the prescription processing is called the remote processor. *** This is different from a central fill pharmacy.

Answer 538

It is when a pharmacy outsources prescription processing functions to another VA pharmacy or a registered nonresident pharmacy.

Answer 539

It can: * Receive, interpret, analyze, or clarify prescriptions * Enter prescription and patient data into a data processing system * Transfer prescription information * Perform a prospective drug review * Obtain refill or generic substitution authorizations, or otherwise communicate with the prescriber concerning a patient's prescription * Interpret clinical data for prior authorization for dispensing * Perform therapeutic interventions * Provide drug information or counseling concerning a patient's prescription to the patient or patient's agent

Answer 540

* The two pharmacies must have the same owner or there must be a written contract, including scope of services between the pharmacies. * The pharmacies must share a common electronic file or technology that provides the information necessary for non-dispensing functions. * The central or remote pharmacy must comply with Virginia's laws and regulations for the supervision of and duties restricted to pharmacy technicians. * The pharmacy technicians must be registered in VA or possess credentials similar to those required in VA. * A VA licensed pharmacist must perform an accuracy check of all processing does by the remote processor. * Both locations must have a policy and procedure manual. * Records of processing tasks and the people performing tasks, which functions as a "who did what where" record, must be available or retrievable for inspection.

Answer 541

For each prescription processed: * Each individual processing task performed * The identity of the person performing each task. This includes both pharmacists and technicians. * The identity of the pharmacist who checked the task, if applicable. * The location where each task was performed.

Answer 542

* The record may be maintained separately by each pharmacy or in a common electronic file shared by the pharmacies. * The primary dispensing pharmacy must be able to retrieve, at an minimum, the records for the previous two years and these records must be available for inspection by the Board.

Answer 543

* Both pharmacies must follow Virginia law for supervision of technicians and activities restricted to pharmacists. * Technicians must be certified in VA or possess "substantially equivalent" credentials. * A pharmacist licensed in VA must perform a final check for accuracy. This pharmacist can be at the remote pharmacy or the dispensing pharmacy.

Answer 544

* A one-time written notification or | * A sign posted in the pharmacy in a location that is readily visible to the public.

Answer 545

* The name of the pharmacy providing central or remote prescription processing * If the pharmacy uses a network of pharmacies under common ownership, this must be disclosed.

Answer 546

* The responsibilities or each pharmacy * A list of the name, address, telephone numbers, and permit/registration numbers of all pharmacies involved in central or remote processing * Procedures for protecting the confidentiality and integrity of patient information * Procedures for ensuring that pharmacists performing prospective drug reviews have access to appropriate drug information resources * Procedures for maintaining required records * Procedures for complying with all applicable laws and regulations to include counseling * Procedures for objectively and systematically monitoring and evaluation the quality of the program to resolve problems and improve services * Procedures for annually reviewing the written policies and procedures for needed modifications and documenting such review.

Answer 547

* It may act on clinical data (e.g. changing a dose) * Provide drug information to the nursing or medical staff of the facility * Authorize administration of drugs to patients by appropriate facility staff

Answer 548

Yes, as long as the pharmacy established controls to protect the privacy and security of confidential records.

Answer 549

There is one exception. Any pharmacist participating in remote prescription processing must be licensed in VA.

Answer 550

Yes. It has to be available by prescription order or by patient name and must be maintained for 2 years.

Answer 551

A pharmacy that delivers filled prescriptions to a retail pharmacy for dispensing to the patient.

Answer 552

It is provided by the retail pharmacy.

Answer 553

* The central fill pharmacy's name * The central fill pharmacy's address * The central fill pharmacy's DEA number

Answer 554

* The retail pharmacy's name * The retail pharmacy's address * The retail pharmacy's DEA number

Answer 555

Yes, upon the DEA's request.

Answer 556

Yes. The pharmacies must either have a common owner or have a written contract or agreement that specifies the services and responsibilities of each pharmacy and how the pharmacies will comply with applicable law.

Answer 557

At both the central fill and the retail pharmacies.

Answer 558

How each pharmacy will comply with applicable law How dispensing records will be maintained; including: * Prescription records for refills * Maintenance of hard copy prescriptions * Access to prescription information * Identification of the counseling pharmacist * Identification of the counseling pharmacist * Provision of records to the Board, if requested * How prescriptions will be tracking during the filling, dispensing, and delivery process * How the prescription labels will identify the pharmacies involved in the filling and dispensing processes * How patient confidentiality will be protected * How accuracy and accountability in the delivery process will be assured * How prescriptions that are not picked up will be returned to the central fill pharmacy and recorded * How patient consent for the dispensing and delivery processes will be obtained

Answer 559

No. The DEA registration is the same as for a retail pharmacy.

Answer 560

* Drug kit for licensed Emergency Medical Services program (ambulance) * Emergency drug kit (e.g., a crash cart in a hospital, or other facility where licensed practitioners administer drugs) * Stat drug box *e.g., in a long term care facility, for situations where waiting for the first does might endanger the patient.) * Stat drug boxes and emergency drug kits may also be supplied for correctional facilities, or other facilities where licensed practitioners administer drugs.

Answer 561

Yes, under the following conditions: * Only licensed persons open the kit and administer the drugs * Only drugs necessary for patient survival are kept in the kit * Only drugs for injection or inhalation, or sublingual nitroglycerin, are kept in the kit

Answer 562

The pharmacist, in consultation with the medical and nursing staff of the facility.

Answer 563

It must be sealed to preclude possible loss of the drug. Once the seal is broken, it must not be able to be resealed without detection. There are two kinds of acceptable seals: Seals with a unique numeric or alphanumeric identifier. The pharmacy keeps records of seals currently used on kits it has provided. A built in mechanism preventing resealing or relocking once opened. The pharmacy resets this mechanism.

Answer 564

* Fill out the form inside the kit with the name of person opening the kit, the date, the time, the name, and the quantity of items used. * Make sure any drug used from the kit is covered by a prescription, signed by the prescriber when legally required, within 72 hours.

Answer 565

Yes, but only if the persons administering the drugs are licensed to administer drugs.

Answer 566

Yes, but drugs at the facility may only be administered by persons licensed to administer.

Answer 567

* If delaying therapy could result in harm to the patient, then the drug may be kept in a stat-drug box. * Schedule II through V drugs may be kept in the box. * At most, 20 solid dosage units of drugs in each schedule are allowed (20 CII's, 20 CIII's, etc.) * Liquid dosage units may be substituted for solid, but a bulk bottle may not be used for multiple patients * CVI drugs may be kept in the stat-drug box as well.

Answer 568

The same people who decide what is in an emergency drug kit- the pharmacist in consultation with the medical and nursing staff of the facility.

Answer 569

The requirements are the same as for an emergency drug kit.

Answer 570

* Fill out the form inside the kit with the name of person opening the kit, the date, time, name, and quantity of items used. * Make sure any drug used from the kit is covered by a prescription, signed by the prescriber when legally required, within 72 hours. * Return the opened box to the pharmacy.

Answer 571

A list of the contents of the box-attached to the box, and included in the facility's policy& procedure manual. An expiration date- the earliest date that any drug in the box will expire.

Answer 572

Yes, if the facility employs one or more full-time physicians, registered nurses, licensed practical nurses, physician assistants or correctional health assistants.

Answer 573

yes, but it has to be sealed to preclude any possibility of loss of drugs.

Answer 574

* An authorized practitioner orders them (either orally or with a written standing order). * An emergency medical technician (EMT) administers them. * The practitioner signs the orders afterwards. * If the practitioner refuses to sign the order, the operational medical director for the EMS agency must sign and return the orders with the kit to the pharmacy within 7 days.

Answer 575

Return it to the pharmacy for exchange.

Answer 576

Yes, the pharmacy maintains a record of the drugs administered for two years just like any other prescription or order. A record of the kit exchange is maintained for one year.

Answer 577

However, as pharmacists' responsibilities continue to grow, this section is likely to expand also.

Answer 578

It is a voluntary, written, or electronic arrangement between a pharmacist and his designated alternate pharmacists with a licensed practitioner of medicine, osteopathy, or podiatry, a physician's office, a licensed physician assistant or a licensed nurse practitioner that authorizes cooperative procedures with respect to the practitioner's patients.

Answer 579

Procedures related to drug therapy treatment, laboratory tests, or medical devices under defined conditions or limitations for the purpose of improving patient outcomes.

Answer 580

* Implement, modify, continue, or discontinue drug therapy. * Order lab tests * Other patient care management measures for monitoring or improving the outcomes of drug or device therapy

Answer 581

They may only be used for conditions that have protocols that are clinically accepted as the standard of care, or are approved by the Boards of Medicine and Pharmacy.

Answer 582

No, the pharmacist may designate other pharmacists (such as staff pharmacists) to participate in the agreement.

Answer 583

Yes, but it must be fully disclosed in writing to the patient and any third party payer.

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