Records Flashcards

1
Q

Is there a required filing method for patient records?

A

No specifics, just as long as they can be readily retrieved when needed

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1
Q

How long must patient records be maintained for inspection and copying?

A

5 years

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2
Q

How long do C2 prescriptions need to be held?

A

5 years

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3
Q

How long do C3-5 prescriptions need to be held?

A

5 years

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4
Q

Who can request or receive records? Family, friends, etc. Any restrictions?

A

Patient records can only be given to others upon patient consent.

If a friend or family member comes in asking for records, best move is to offer to mail it to the patient’s address.

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5
Q

Are pharmacists required to report to the PDMP?

A

Yes, must report filling any CS within 24 hrs

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6
Q

Are pharmacists required to check the PDMP prior to dispensing CS?

A

No

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7
Q

Requirements for reporting suspected fraud or abuse?

A

none specified

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8
Q

Requirements for reporting ADRs to pharmaceuticals?

A

Optional
May report to FDA MedWatch

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9
Q

Reporting requirements for ADRs to vaccines?

A

Mandatory
report to VAERS within 14 days

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10
Q

Requirements for reporting licensure violations?

A

none specified

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10
Q

Requirements for reporting individual privacy violations?

A

1 to 500 pts affected
Without reasonable delay but at most within 60 days provide:

Written notice sent via first class mail; Or e-mail if patient has consented to this method of communication

If there is out of date contact info for 10 or more patients involved
- post notice on homepage for at least 90 days
- post notice via major print or broadcast for at least 90 days
- Must provide toll free number for patients to find out if they were affected for at least 90 days

Secretary: must report breaches of fewer than 500 individuals via the HHS website yearly no later than 60 days after the end of the calendar year

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11
Q

Requirements for reporting mass privacy violations?

A

Breach affecting more than 500 patients:
Without unreasonable delay within 60 days:

Notify individuals via first class mail; or email if they consent

AND

provide notice to prominent media outlets serving the state or jurisdiction.

AND

notify the Secretary by submitting a breach report form on the HHS website without unreasonable delay within 60 days

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12
Q

How long must patient profiles be maintained?

A

5 years

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13
Q

What must a pharmacist review on a patient’s profile before dispensing?

A

screen for potential drug therapy problems due to…
- duplication
- DDI
- dosage
- allergy
- misuse

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14
Q

Clozapine REMS requirements

A

pharmacy must be enrolled in the REMs program

Must complete Clozapine REMS Knowledge Assessment for HCPs

Must check ANC

15
Q

Isotretinoin REMS:

A

Before dispensing:
Pharmacies must register for iPLEDGE

get and RMA and authorization number