De Mpje - Rules & Regulations: Non-Controlled Substances

Front 1

Who may counsel a patient?

Back 1

Pharmacist or intern/student under direct supervision

Front 2

When is counseling required?

Back 2

Each NEW medication dispensed

Front 3

Is an inpatient pharmacist required to counsel?

Back 3

NO. Counseling laws do not apply when a medication dispensed for inpatient use in a hospital is to be administered by a nurse or other health care provider.

Front 4

Is counseling required if a patient refuses the offer?

Back 4

No. However, there must be a uniform place documenting the acceptance or refusal of counseling.

Front 5

The pharmacist is out for lunch and there are no students or interns present. The prescription department is open for business. May a patient pick up a new prescription for an antibiotic without counseling.

Back 5

Yes, as long as the patient receives written information with the prescription AND informed that the pharmacist will be available for a consultation.

Front 6

In addition to the general requirements for a prescription, what other items need to be included on electronically submitted prescriptions?

Back 6

1. Transmitter's phone number
2. Date of transmission
3. Time of transmission
4. Identity of the pharmacy

Front 7

Is it okay to transmit prescriptions electronically by an authorized agent of the prescriber?

Back 7

Yes as long as the identity of the agent is revealed.

Front 8

In addition to the general requirements for a electronic prescriptions, what other items need to be included on FAXED submitted prescriptions?

Back 8

1. Fax number of transmitter
2. Number of transmitted pages
3. Confidentiality statement
4. Fax number of pharmacy

Front 9

Are electronic signatures permissible for faxed CS orders?

Back 9

No. Faxed CS orders must be hand signed.

Front 10

Under what conditions may medications be returned to a pharmacy for re-dispensing purposes?

Back 10

1. A health-care professional returns it
2. It was unopened and never used
3. In unit dose or tamper proof manufacturer containers
4. Tamper proof seal is intact
5. Stored in USF conditions

Front 11

May medications ever be returned by patients?

Back 11

Yes. Only for disposal NEVER for re-dispensing.

Front 12

What 5 requirements must be met for a pharmacy to utilize centralized prescription processing?

Back 12

1. Must have the same owner
2. Must have a written contract specifying the responsibilities of each party
3. Must share a common electronic database
4. Must have a QA program to record/ track med errors/ potential errors
5. Must have a P & P manual

Front 13

If a central fill pharmacy is to be employed what labeling requirements exist? Signage requirements?

Back 13

1. Must bear a label having an identifiable code to provide an audit trail

2. Must have a sign in the pharmacy clearly visible to the patients letting them know their scripts may have been processed at a centralized location

Front 14

Under what conditions may the pharmacist utilize a pharmacy technician for compounding?

Back 14

1. The tech is certified
2. The RPh comes up with the formula
3. The RPh checks each ingredient
4. The RPh checks each weight and measure
5. The RPh checks the final product
6. A log is in place that identifies both the tech and pharmacist completing each check

Front 15

When may a compounding log be waived?

Back 15

If a P and P manual ensures that adequate checks will occur b the pharmacist per the compounding regulation

Front 16

May a pharmacist sell compounded medication to a practitioner?

Back 16

Yes. As long as the doctor uses it for administration purposes only. May not re-sell.

Front 17

What 5 items of information must be on a cell of an automated dispensing device? When are these requirements waived?

Back 17

1. Drug name
2. Drug manufacturer
3. Expiration date
4. Batch (lot?) number
5. Date filled

Waived if this information is stored electronically & readily retrievable.

Front 18

I come in early in the morning and refill all low and "kinda low" cells in my ScriPro machine, even if they are not 100% empty. Is this legal?

Back 18

Maybe. Only if the medication comes from the same batch, manufacturer, and has the same exp dating.

Front 19

When do refills expire on a script?

Back 19

1 year after date of original script

Front 20

From whom may a prescription copy be requested?

Back 20

Pharmacist, student, or intern

Front 21

When a pharmacy receives a copy what must be recorded:

Back 21

1. Identify the verbal as a copy
2. Rx number
3. Original date of script
4. Last fill date
5. Refills remaining on script
6. Name of pharmacist giving copy (first and last name)
6. Name & address of pharmacy from which the script is received

Front 22

When is the requirement to write COPY or TRANSFER waived?

Back 22

If the transfer is completed electronically

Front 23

Patient profiles must be maintained for at least

Back 23

1 year from date of last entry

Front 24

Records of dispensing must be kept online and immediately accessible for a period of

Back 24

1 year from date of last entry

Front 25

Records of dispensing must be kept for

Back 25

3 years

Front 26

If authorities request records of dispensing, you must provide them the records within

Back 26

5 days

Front 27

What is the maximum you can transfer drugs pursuant to emergency medical reasons?

Back 27

5% of total drug sales revenue of either the transferor or transferee pharmacy during any consecutive 12 month period

Front 28

Beyond use date for single-use/ unit dose containers?

Back 28

1 year or less; unless mfgr stability data indicates otherwise.

Front 29

A repackager wants to use the mfgr suggested expiration date which is beyond 1 year away. What are the 2 requirements this repacker must meet?

Back 29

1. Drug must be stored at a temperature NTE 25 degrees Celsius

2. Plastic must provide better moisture protection than PVC

Front 30

How many contact hours of instruction are required to become a nuclear pharmacist?

Back 30

200

Front 31

How many training hours must be completed under the direction of a qualified nuclear pharmacist?

Back 31

500

Front 32

What educational requirements must a pharmacist complete and provide to the BOP in order to provide injectable medications?

Back 32

1. Satisfactory completion of an academic and practical curriculum approved by the BOP

2. Current CPR certificate

Front 33

Greg is a pharmacist that has completed the board approved APhA immunization training and is Red Cross CPR certified. It is legal in Delaware for pharmacists to provide depo-provera injections. May Greg provide a Depo shot to Nancy his patient?

Back 33

No. A registered Rph may only administer injections consistent with the academic curriculum and training provided.

Front 34

How many CE hours dedicated to indictable medications are required per licensure period?

Back 34

2 hours (0.2 CEU) of the 30 hours (3.0 CEU)

Front 35

A pharmacist may give a vaccination pursuant to either:

Back 35

1. Prescription

2. Protocol

Front 36

Before administering a vaccination, the pharmacist must counsel the patient (or patient's representative) about:

Back 36

1. Risks and benefits (in writing)

2. Contraindications

Front 37

Before administering a vaccination, the pharmacist must obtain from the patient:

Back 37

A written and signed informed consent

Front 38

The pharmacist must document all injections. What pieces of patient information are required to be documented?

Back 38

1. Name
2. DOB
3. Address
4. Phone
5. Gender

Front 39

The pharmacist must document all injections. What pieces of vaccine information are required to be documented?

Back 39

1. Name
2. Dose
3. Route
4. Lot
5. Exp date
6. Date administered

Front 40

The pharmacist must document all injections. What pieces of prescriber information are required to be documented?

Back 40

Only the doctor listed on the prescription or protocol

Front 41

The pharmacist must document all injections. What pieces of pharmacy-related information are required to be documented?

Back 41

Only the pharmacist responsible for injection

Front 42

The pharmacist must document all injections. How long must vaccine records be kept?

Back 42

3 years

Front 43

Pharmacy technicians must complete a training program. When does it begin?

Back 43

Immediately upon initiation of employment

Front 44

Pharmacy technicians must complete a training program. When must it be completed?

Back 44

Within 90 days

Front 45

Who is responsible for ensuring proper training for all pharmacy technicians?

Back 45

PIC

Front 46

Can tech training be delegated? If so, to whom?

Back 46

Yes. TO another RPh or trained tech.

Front 47

What is the minimum hours of didactic training required for tech training?

Back 47

10 hours

Front 48

Certified pharmacy technicians must be at least _____ years old?

Back 48

18

Front 49

What may a CPhT do that a non-certified tech may not? What is the exception; what would grant a non-certified tech power to also complete these duties?

Back 49

1. Reconstitute
2. Assist with compounding
3. Call for refills
4. Call for non-clincial information

If a non-certified tech completes a BOP approved training program, he/she may perform the above functions only at THAT SPECIFIC practice setting.

Front 50

May a technician receive verbal orders?

Back 50

No

Front 51

May a technician contact a doctor for prescription clarification?

Back 51

No

Front 52

Intern hours required for licensure?

Back 52

1500

Front 53

Maximum non-retail, non- hospital intern hours?

Back 53

500

Front 54

When may an student register for an intern license?

Back 54

Entering the P1 year of college

Front 55

How many years of experience must a pharmacist have in order to be a preceptor?

Back 55

2 years

Front 56

If you change preceptors how and when must the intern notify the BOP?

Back 56

In writing; within 10 days.

Front 57

May a graduate of a pharmacy school take the NAPLEX or MPJE before completing the intern hours?

Back 57

Yes

Front 58

Failure of the NAPLEX. Must wait:

Back 58

at least 91 days before re-examination.

Front 59

What years of the month have 31 days?

Back 59

30 days has September, April, June, & November. The rest have 31 except February which has 28 except in leap years when it has 29 days.

Front 60

Failed NAPLEX 3 times. What are my options?

Back 60

1. Full time intern for 6 months

OR

2. 12 Credits course work, minimum 1 semester of college

Front 61

Failed MPJE. Must wait:

Back 61

31 days before re-examination.

Front 62

Failed MPJE 3 times:

Back 62

1. Full time intern x 3 months

OR

2. 1 Semester in college jurisprudence

Front 63

How long is a license period?

Back 63

Biennial

Front 64

How many CE's for a license period?

Back 64

3.0 CEUs or 30 hrs

Front 65

How many CEs for med safety?

Back 65

MINIMUM 2

Front 66

A non-ACPE approved program of 1-2 hours in length failed to provide you with a post-test. What % deduction will be incurred?

Back 66

25%

Front 67

A non-ACPE approved program of 3+ hours in length failed to provide you with a pre and post-test. What % deduction will be incurred?

Back 67

25%

Front 68

CE credits for first aid?

Back 68

MAX 2

Front 69

CE credits for BOP meeting?

Back 69

MAX 2

Front 70

CE credits for CPR/BCLS

Back 70

MAX 2

Front 71

How often must pharmacists submit proof of CE credits?

Back 71

NEVER. They keep records for 6 years and old need to show records if audited. BOP randomly audits 10%.

Front 72

Late renewal of license. May be renewed at any time within _____ days following expiration.

Back 72

60

Front 73

When must the PIC self inspection sheet be conducted?

Back 73

By Feb 1 of each year

Front 74

Must notify BOP w/in ____ days if a PIC has changed

Back 74

10

Front 75

New PIC must complete PIC self inspection report within _____ days after taking over.

Back 75

30. And also complete again for the FEB 1 requirement

Front 76

How many years must the PIC self inspection sheet be maintained at the pharmacy?

Back 76

3 years

Front 77

If there has been a change in pharmacy ownership when must the BOP be notified?

Back 77

Within 10 days of the change

Front 78

What equipment is required inside a pharmacy.

Back 78

There are no requirements. If there is equipment it must be clean and must be able to accurately weigh and measure ingredients.

Front 79

What reference material must be available to the pharmacist inside every pharmacy?

Back 79

1. Pharmacology/ therapeutics
2. Counseling information
3. Therapeutic equivalents
4. Compounding reference
5. DE and Fed law books

MAY BE EITHER HARD COPY OR ELECTRONIC

Front 80

Between what temperature must the pharmacy be maintained?

Back 80

59-86 F

Front 81

Between what temperature must the pharmacy refrigerator be maintained?

Back 81

36-46 F

Front 82

Between what temperature must the pharmacy freezer be maintained?

Back 82

(-)13 - 14 F

Front 83

What requirements are there regarding running water inside a pharmacy?

Back 83

1. There must be running water
2. It must be hot and cold

Front 84

How many copies of floor plans of the pharmacy must be maintained?

Back 84

3

Front 85

What are the requirements for patient counseling areas?

Back 85

1. 9 sq ft.
2. 5 foot dividers on 2 sides
3. Assures adequate privacy

Front 86

If you remodel a pharmacy when must you contact the BOP? What must you give them? Who must give it to them?

Back 86

1. 15 days AFTER THE REMODEL IS COMPLETE
2. New floor plans
3. PIC

Front 87

Joe is deciding to shut down his Indy because CVS and the evil PBMs ran him out of business (and he was a horrible businessman). When must he notify the BOP?

Back 87

14 days before the scheduled date of closing.

Front 88

Joe is the PIC at a local Indy. He died. When must the BOP be notified?

Back 88

Immediately

Front 89

Joe is the PIC at a local Indy. He discovered fire damage from the apocalypse. When must the BOP be notified?

Back 89

Immediately

Front 90

Joe is the PIC at a local Indy. He discovered water damage from hurricane Sandy. When must the BOP be notified?

Back 90

Immediately

Front 91

Joe is deciding to shut down his Indy because CVS and the evil PBMs ran him out of business (and he was a horrible businessman). When and how must he notify the public?

Back 91

Newspaper article x 7 days:

1. When the pharmacy will close
2. Emergency contact #
3. Where the scripts are being transferred

Sign in the window 14 days before closing & 14 days after closing:
1. Where the scripts are going to be transferred

Front 92

Joe is deciding to shut down his Indy because CVS and the evil PBMs ran him out of business (and he was a horrible businessman). When must he remove all signage referring to "pharmacy"?

Back 92

Within 30 days of closing.

Front 93

Joe is deciding to shut down his Indy because CVS and the evil PBMs ran him out of business (and he was a horrible businessman). What permits/ registrations must be surrendered and to whom must they be surrendered?

Back 93

1. DEA 222s - DEA in DC
2. DEA CS registration - DEA in DC
3. DE CS permit - OCS
4. DE Pharmacy permit - DE DPR

Front 94

Joe is deciding to shut down his Indy because he wants to go on vacation. How long must the pharmacy be closed down to necessitate contact with the BOP?

Back 94

7 consecutive business days is considered a temporary close

Front 95

Joe is deciding to shut down his Indy because he wants to go on vacation which will require his pharmacy to be closed for 9 consecutive business days. When must the BOP be contacted of such a closure?

Back 95

5 days before anticipated closure

Front 96

Joe is deciding to shut down his Indy because he wants to go on vacation which will require his pharmacy to be closed for 9 consecutive business days. How must Joe notify the public?

Back 96

Sign that is highly visible in both the Rx dept and a window at least 5 days before closing:

1. Dates of closing
2. # to call for emergency

Front 97

Where MUST medications be stored in a nursing home?

Back 97

1. Cabinets OR 2. med carts

Front 98

Do nursing home cabinets need to be locked?

Back 98

YES it is a requirement

Front 99

Who may access a nursing home med cabinet?

Back 99

1. pharmacist
2. RN
3. LPN

Front 100

Can internal and external medications be kept together in nursing homes?

Back 100

NO. They must be separated.

Front 101

How must CIIs be stored in a nursing home?

Back 101

1. Under 2 locks
2. In a securely fixed box, drawer in the med storage area/ med cart/ or emergency use med supplies

Front 102

For how long must accountability records for CS use be maintained?

Back 102

2 years.

Front 103

Differentiate between interim vs. emergency use medications.

Back 103

EU: Injectable
IU: not injectable

both are required to meet the immediate therapeutic needs of the patient where delay in access could harm patient

Front 104

Stock supply of interim use medications shall not exceed:

Back 104

60 medications w/o the review and approval of the BOP

Front 105

After using an emergency/ interim use medication, when must the pharmacy be contacted?

Back 105

w/in 24 hours

Front 106

After using an emergency/ interim use medication, when must the pharmacy replenish the stock?

Back 106

Within a reasonable amount of time

Front 107

After using an emergency/ interim use medication, how long must records of the use be kept?

Back 107

Min 2 years

Front 108

Mrs. Jones passed away at XYZ nursing home. She has unfinished bottles of lipitor, cardura, and valium. What is the proper way to dispose of this medication?

Back 108

1. For non controlled meds: You have 72 hours to either destroy or return to the pharmacy for destruction.

2. Her valium needs to be destroyed by 2 authorized licensed personnel. Both parties must sign a record of the destruction and then store the record for NLT 2 years.

Front 109

Mrs. Jones lives at XYZ nursing home. She was recently hospitalized for a diabetic foot infection. She has unfinished bottles of lipitor, cardura, glucovance, and valium. What is the proper way to dispose of this medication?

Back 109

These medicines must be isolated and held until patient's return.

Front 110

Nina recently started as a consultant pharmacist at XYZ nursing home in Dover. She previously worked at ABC nursing home in Wilmington. When must she contact the BOP for A) her BOP interview and B) her notification that she has begun as a consultant?

Back 110

A. She will not need to interview because she has already held this position within the state

B. She still must notify the BOP within 10 days of starting at XYZ pharmacy

Front 111

Nina recently started as a consultant pharmacist at XYZ nursing home in Dover. She has only worked at Rite Aid prior to assuming this position. When must she contact the BOP for her BOP interview?

Back 111

Within 90 days after assuming the position

Front 112

The consultant pharmacist must make inspections of each nursing station and drug storage areas at least _____ and keep the report of such inspections for _____.

Back 112

Monthly; 2 years

Front 113

Each patient shall have his/her med regimen reviewed by the consultant pharmacist at least _______.

Back 113

Monthly

Front 114

Nina, the consultant pharmacist, reviews JS's medication regimen. She finds that all of his medications are at the proper dose, he's tolerating the medications well, and all conditions are being appropriately managed. What is Nina's course of action?

Back 114

1. Document in JS's chart: " I find no irregularities"
2. Sign and date this note
3. Maintain this record x 12 months

Front 115

Nina, the consultant pharmacist, reviews JS's medication regimen. She finds that all of his medications are at the proper dose, however he is complaining of dizziness, fatigue, and dry mouth after being started on his 3rd anti-cholenergic medication. What is Nina's course of action?

Back 115

1. Document in JS's chart her recommendations regarding JS's drug therapy
2. FOrward the recommendation to the attending provider
3. Maintain original written documentation in JS chart.

Front 116

May interns assist with chart reviews?

Back 116

YES. REGISTERED interns may.

Front 117

May a pharmacy support person assist with the monthly nursing station inspections?

Back 117

Yes, as long as its under the direct supervision of a pharmacist.

Front 118

If a pharmacist is not on duty in a hospital how may drugs be provided to a physician.

Back 118

2 ways:

1. Night cabinets

2. Direct access to pharmacy (emergency only)

Front 119

If the pharmacy needs to be accessed for emergency use in a hospital, who may enter?

Back 119

Nurse or physician with another nurse, physician, or security guard.

Front 120

If the pharmacy needs to be accessed for emergency use in a hospital, what must be documented?

Back 120

Date and time of entry

Names (signatures) of the 2 individuals entering

Name, strength, quantity of medication

Patient name and bed

Front 121

What are the 2 conditions that drugs may be removed from an "emergency drug supply"?

Back 121

1. Pursuant to an order

2. By authorized personnel

Front 122

If a drug has been removed from emergency drug supply when must the pharmacy be notified? When must the pharmacy re-plenish/ replace/ restock/ reseal the supply?

Back 122

24;48 hours

Front 123

How long must a hospital patient profile be maintained after discharge?

Back 123

30 days

Front 124

How often must a pharmacist be available for consultation regarding sterile compounds/ anti-neoplastics?

Back 124

24 hours by telephone

Front 125

May technicians assist the pharmacist with sterile/ anti-neoplastic compounds?

Back 125

Yes. Only if specially trained.

Front 126

Beyond-use date for an admixture?

Back 126

MAX 72 hours when stored under refrigerated conditions. Unless: mfgr recommends to store @ RT and/or longer storage times can be substantiated with documentation.

Front 127

How long must cleaning records of the sterile compound/antineoplastic area(s) be kept in the pharmacy?

Back 127

1 year

Front 128

How often must the pharmacy obtain certification of clean air by an outside agency for their sterile compound/antineoplastic area(s)?

Back 128

Yearly

Front 129

Antineoplastics and other parenterals are prepared in the same hood. How long must you purge the air after the compounding of the antineoplastic before you can compound other parenterals?

Back 129

20 minutes

Front 130

Basic safety standards in a P & P manual for antineoplastics?

Back 130

1. Protective garb: eyes, hands, face, gowns

2. Vertical airflow hood

Front 131

In order to compound antineoplastics/sterile preps, you must have at least one class_____ environment?

Back 131

100