Section K, L, M
Primary care provider needs to report by when, what method, and notifications requirements?
**See showmevax
ShowMeVax must be reported by when, what method, and notifications requirements?
**See showmevax
How long are immunization protocols good for?
1 year and a new protocol must be signed every year
Licensees shoudl report to ShowMeVax within how many days?
14 days after immunizing
If the board asks for a digitized rx image, how long do you have to provide that information?
2 hours
CE for pharmacists should be kept for how many years?
2 years
Class Q records should be kept for how many years?
2 years
Class R records should be kept for how many years?
2 years
Compounding logs should be kept for how many years?
2 years
Compounding records should be kept for how many years?
2 years
Controlled substance inventories should be kept for how many years?
2 years
Controlled substance transfer DEA 222 forms should be kept for how many years?
2 years
Distribution records should be kept for how many years?
2 years
Drug invoices should be kept for how many years?
2 years
Drug take back records should be kept for how many years?
2 years
Electronic final product verification records should be kept for how many years?
2 years
How long should vaccine records be kept for?
2 years
Immunization records should be kept for how many years?
2 years
Proof of tech/intern has meet required training to adminster training should be kept for how many years?
2 years
Remote supervision training/ competency assesment should be kept for how many years?
2 years
Sterile compounding recordsshould be kept for how many years?
2 years
TAV system records should be kept for how many years?
2 years
If adminstered by the pharmacy, how long are records kept?
2 years and must be seperate from pharmacy rx records
If an electronic data processing system is used, what filing system must be used?
3 file system. One for control II, Control III-IV, and non-controls
Audit of Class I records should be kept for how many years?
3 years
Controlled substances rx orders should be kept for how many years?
5 years
For non-controlled hard-copies, how long are they maintained in the pharmacy?
5 years
Remote Data entry records should be kept for how many years?
5 years
Rx orders should be kept for how many years?
5 years
Technology assisted supervision activity records should be kept for how many years?
5 years
MTS patient records should be kept for how many years?
7 years
What is the youngest age you can administer a vaccine to?
7 years old or CDC recommended age, whichever is older
MTS protocol should be kept for how many years?
8 years
Immunization protocol should be kept for how many years?
8 years after termination
How long are immunization protocols kept for?
8 years after the protocol has terminated
What is required to renew an NOI?
A curretn CPR/BLS certification, 2 CE hours for vaccines
If a non-electronic system is used, what must be maintained?
A seperate prescription file for: Schedule I and II rxs, Schedule III, IV, and V rxs, and non-controlled drug rxs
For each original and refilled prescription, whatt must be maintained for an EDP?
A unique label and squential number/ Date rx was prescribed /date of initial filling/ unique Identifier/ name of patient, if animal: species and owner name/ prescirbers name for oral rxs or signature for written or faxed rxs/ if controlled, prescriber address, patient address, prescirber DEA number/ Name, strength, dosage of drug and directions for use/number of refills/ quantity dispensed/ date of refill/ identity of pharmacist reviewing accuracy of data, verifying/dispensing final product/ any change made to the rx on contact made with prescriber/ authorized refills indicating the method and source of the authorization must be part of the manual record or hard copy/ expiration date of the orignal rx / the manner the rx was recieved
The authorizing protocol phycisian needs to report by when, what method, and notifications requirements?
As required by protocol/ As required by protocol and can choose not to be notified/ As required by protocol and can choose not to be notified
Where are you allowed to immunize?
At any Mo licensed pharmacy and off site if authorized in their governing protocol
If a vaccine is adminstered at a pharmacy where should the records be kept?
At the pharmacy
How must drugs be stored?
Based on manufacturer labels and CDC guidelines
Who can answer ShowMeVax questions?
DHSS
For each original and refilled prescription, what must be maintained for a non-electronic system?
Date rx was prescribed /date of initial filling/ unique Identifier/ name of patient, if animal: species and owner name/ prescirbers name for oral rxs or signature for written or faxed rxs/ if controlled, prescriber address, patient address, prescirber DEA number/ Name, strength, dosage of drug and directions for use/number of refills/ quantity dispensed/ date of refill/ identity of pharmacist reviewing accuracy of data, verifying/dispensing final product/ any change made to the rx on contact made with prescriber/ authorized refills indicating the method and source of the authorization must be part of the manual record or hard copy/ expiration date of the orignal rx
Poliecies and procedures must include:
Drug administration/authorized routes of administration/ drug storage/ pre and psot adminstration assessment and counseling/ disposing of biohazard waste and used/contaminated supplies/ identifying and handling acute adverse events or immunization reactions, and record keeping
Pharmacists are not required to report all vaccines to ShowMeVax. T/F
False. Must report unless patietn wants to opt out
A tech can administer medicaiton if?
Has a tech license, worked in the US as a tech for 1 year, has CPR or BLS certification, has completed medication administration and emergency proscedures program by ACPE, has an initial and annual assessment of competency, and under supervision of a pharmacist
A MO intern pharmacist can adminster medication if?
Has active CPR or BLS certification, has completed a qualifying administration/emergency procedures program by ACPE , and must be under direct supervision of pharmacist
Intern pharmacists can immunize if?
Have CPR/BLS certification, has completed a program administering vaccines, and is working under the supervision of a pharmacist
Pharmacist can immunize if?
Have a MO RPh license/ Have a protocol with a MO phycisian/NOI filed with the board/ CPR or BLS with an in person assessment/ complettion of a certificate program to adminster vaccines approved by the Board and must include: Current CDC vaccine recomendations and guidlines, basic immunology and vaccine protection, pre and post vaccine screeing, physiology and techniques, and identifying and treating adverse reactions
A pharmacist can administer medication if?
Have a MO RPh license/ NOI filed with the board/ CPR or BLS with an in person assessment/ complettion of a certificate program and emergency procedure accreddited by ACPE: Drug storage and handling, infromed consent requirements, pre and post adminstration assessment and counseling, biohazard waste disposal, identifying and treatinf adverse reactions, administration techniques
What should a protocol incldue?
Identity and signature of teh participatign pharmacist and physcisian/time period of the protocol/authorized vaccines/patient or groups of patients who may be vaccinated/allowed routes of administration/provisions for creating a rx for each administration under the phycisians name/ emergency response procedures/ length of time the pharamcist is required to observe a patient/ disposal procedures/ authorization to adminster vaccines at non-pharmacy locations/ record keeping and notification requirements/ and provisions for terminatign the protocol at the request of any partu at any time
If not adminstered by the pharmacy, where are records kept?
In a secure location and must be retrievable within 3 days at the board's request.
What vaccines can be administered by a MO pharmacist?
Influenza, Shingles, Meningitis, Pneumonia, Hep A/B, Tetanus, diptheria, and pertusis
What is an electronic record keeping system?
Input, storage, processing, communicaitons, output, and control functions for digitized images of origianl prescriptions
What is ShowMeVax?
It is Mo's statewide immunization registry operated by DHSS. Allows HCP to monitor vaccine inventory and upcoming doses for patietns. Also provides a single location for recording immunization history and status
What is qualified as an ERS?
Must be able to capture an exact digitized image of the rx including the reverse side of the rx
Notification of Renewal must be filed when?
NOI must be refiled when MO license is renewed (every even numbered year) To renew, must have BLS or CPR certification
When adminstering vaccines, what records should be kept?
Name, address, DOB of patient/ Date, route of administration/ name, dose, lot number, and expiration date/ name, address of PCP/ name or initials of pharmacist and adminstering pharmacist or intern or tech/ any adverse event
Are specific street addresses of non-pharmacy locations have to be listed in immunization protocol?
No
Do protocol physicians have to be within 50 miles of the pharmacist?
No but must be actively engaged in the practive of medicine
Do interns and techs have to sign an NOI?
No but must maintain proof that they have met the required training for 2 years
If a pharmacy keeps an image of a hard copy in an ERKS, is the hard copy still needed?
No, as long as the image is transmitted in a compliant record-keeping system
If a control is e-scribed, is a hard copy required?
Not required under federal law. State law requires that a hard copy or image must be maintained
Is PCP notification required?
Only if the PCP is known and should document if patient does not provide PCP
What records must be kept after each adminstration?
Patient name, address, DOB/ date, route and anatomic sit of administration/ medication name and dose/ manufacturer, expiration date, and lot number for vaccines and biologics/ PCP for vaccine or an indication that PCP was not given/ Identity of pharmacist, intern or tech administering medicaiton with name of supervisng pharmacist
If a patient opts out of ShowMeVax reporting, what must occur in writing within 14 days after immunizing?
Patient name/ vaccine administered/ administration route/ Anatomic site of adminstration/ administration date
If the patient opts out of ShowMeVax what must occur?
Pharmacist must notify PCP within 14 days
Within 72 hours of administering a vaccine by protocol, what shoudl occur?
Pharmacist shoudl obtain an rx from the authorizing phycisian for the vaccine or create a rx under the protocol phycisian. Protocol phycisian must be listed as the presciber and not the pharmacist/inter
What is required to report to ShowMeVax?
Pharmacists have to register with DHSS
To administer a medication, what must be on the rx?
Prescriber name/patietn name/ name of drug and dose/route of adminstration/date of original order / date or schedule of administration
If vaccines are adminstered via medical rx order where must it be reported?
ShowMeVax unless patient opts out of reporting
If a new pharmacist is added to a protocol who has to sign it?
The new pharmacist and the physcisian.
Techs can immunize if?
They have a tech license, has been working as a tech for 1 year in the U.S, has CPR/BLS certificate, has completed a program in adminstering vaccines, and has an initial and annual documneted assessment of competency, and is under direct supervision of a pharmacist
When should pharmacists renew theri NOI?
They must refile when their MO licensse is renewed every even numbered year
Pharmacist is responsible for information entered in an EDP by techs/interns. T/F
This is true.
Adverse events must be reported when?
To prescriber within 24 hours after learning of an adverse event. This is mandatory and canno tbe waived
PCP notification of ShowMeVax reporting is not required if a patietn doesn't proved PCP information. T/F
True.
Signatures of the pharmacist and phycisian can be electronic or manual. T/F
True.
The patient must be informed on an electronic or manual form that their information will be entered in ShowMeVax and have an option to opt out. T/F
True.
When is does a pharmacist have to resign a protocol?
When protocol provisions are changed
When does a pharmacist have to resign a protocol if a non-pharmacy is added or removed?
When the protocol changes
Adverse events must be reported when, what method, and notifications requirements?
Within 24 hours after finding out/ in the pharmacist's discretion unless defined in protocol/ authorizing physcian and patient's PCP must be notified
VAERS must be reported by when, what method, and notifications requirements?
Within 30 days after finding out/online via VAERS system/ As provided by the U.S DHHS
Federal Vaccine Adverse event reporting system must be reported when?
Within 30 days of adverse event or reaction
Can primary record keeping systems be electronic data processing systems or non-electronic system?
Yes
If a control is faxed, is a hard copy required?
Yes
If a control is written, is a hard copy required?
Yes
Can notification be electronic, manual, or bia an EMR/EMH?
Yes and proof mus tbe maintained in the pharmacy's record
Can pharmacists delegate their administration authority to other non-pharmacy HCP?
Yes but the HCP must: have their own authority or own protocol with a phycisian/ HCP must administer vaccine in compliance with their authority/ pharmacy can use their system to bill/vaccine report for admisntrations provided by the HCP. The rx must state that it is a billing records and not an Rx record/ pharmacy must account for pharmacy vaccine adminstration record should be physically seperated from pharmacy administration records/ HCP does not have to registerted as a tech unless they have independent access to drug inventory
Can a non-pharmacy location be added to a protocol to immunize?
Yes if the phycisian signs and dates the protocol to approve the change
Can pharmacists delegate med administration to other health care providers?
Yes if: HCP has legal authority to administer medication/ hard copy records shoudl be seperated from other records/ can bill or report functions for medication adminstered by a HCP but should clearly indicate that it is a billing record and not an RX/ must b ebale to account inventory used for administration via billing or distribution records
Do patients have to stay in the pharmacy after a vaccine is administered?
Yes unless the patient refuses. Board recommends to document if they decline to stay.
Does a patient have to stay in a pharmacy after a vaccine for a certain amount of time?
Yes, the time is up to the pharmacist. Board recommends to document if a patient refuses to stay.
Can a written or electronic notification form be electronically or faxed/emailed?
Yes.
Must a manual with policies and procedures be in place for ERS?
Yes.
Is an EDP the same as an ERS?
no.
If a control is transferred, is a hard copy required?
yes
If a control is verabl/telephoned, is a hard copy required?
yes