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BCOP-CHUM > Practice Management > Flashcards

Practice Management Flashcards

1
Q

Quelle institut maintient une liste à jour d’Hazardous Drugs?

A

NIOSH

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2
Q

Dans la version 2016 du NIOSH, comment sont classés les HD?

A
  • Table 1: Antineoplastic drugs
  • Table 2: Non-antineoplastic drugs
  • Table 3 : Durgs with reproductive effets
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3
Q

Selon le NIOSH, quelle est la définition d’HD?

A
  • Carcinogenicity
  • Teratogenicity
  • Reproductive Toxicity
  • Organ Toxicity at low doses
  • Genotoxicity
  • Structure and toxicity profile of new drugs that mimic existing drugs determined HD
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4
Q

Le NIOSH fait partie de quelle institution ?

A

NIOSH est une agence FEDERALE faisant partie du CDC, qui lui appartient au Department of Health and Human Services (HHS)

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5
Q

Vrai ou Faux. Chaque établissement doit maintenir une liste d’HD identique à celle du NIOSH.

A

Faux.
Doit absolument inclure les HD du NIOSH, mais on peut y ajouter New drugs/Investigationnal drugs

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6
Q

À quelle fréquence un établissement doit-il réviser sa liste d’HD?

A

at least every 12 months

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7
Q

Quelle est la différence entre OSHA et NIOSH?

OSHA: Occupational Safety and Health Administration
NIOSH: National Institute for Occupational Safety and Health

A
  • OSHA veille aux ‘‘safe working conditions’’, fait partie du Department of Labor
  • NIOSH s’occupe du testing, approving, liste of HD… fait partie du Department of Health and Human Services
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8
Q

Qu’est ce que le USP?

A

The United States Pharmacopeia (USP) is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention, a nonprofit organization

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9
Q

Le chapitre USP 800 décrit les standards de pratique et de qualité pour quel sujet?

A

handling of HD

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10
Q

Le chapitre USP 795 décrit les standards de pratique et de qualité pour quel sujet?

A

Non sterile compounding

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11
Q

Le chapitre USP 797 décrit les standards de pratique et de qualité pour quel sujet?

A

Sterile compounding

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12
Q

Quels sont les types d’exposition aux HD, et le plus fréquent selon l’ASHP?

A
  • Dermal/mucosal : dermal contact with surface + fréquent
  • Inhalation
  • Injection
  • Ingestion (ex: mains sales)
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13
Q

Quels critères doit respecter une salle de déballage d’HD?

A
  • Not in sterile area
  • Neutral/normal pressure or negative pressure
  • signage must be present
  • Limited access to authorized personnel
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14
Q

Vrai ou Faux. On peut avoir une C-PEC pour sterile HD et une C-PEC pour sterile non-HD dans la même C-SEC.

A

Faux

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15
Q

Vrai ou Faux. La C-PEC doit continuellement fonctionner.

A

Vrai

Ne pas l’éteindre à la fin de la journée

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16
Q

Vrai ou Faux. Une pièce ISO 5 est plus propre qu’une pièce ISO 7.

A

Vrai

  • This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9.
  • ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class.
  • Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.
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17
Q

Vrai ou Faux. On peut avoir une C-PEC pour sterile HD et une C-PEC pour non-sterile HD dans la même C-SEC.

A

Vrai
(mais maintenir ISO 7 et à 1 m)

For entities that compound both nonsterile and sterile HDs, the respective C-PECs must be placed in separate rooms, unless
those C-PECs used for nonsterile compounding are sufficiently effective that the room can continuously maintain ISO 7 classification throughout the nonsterile compounding activity. If the C-PECs used for sterile and nonsterile compounding are placed in the same room, they must be placed at least 1 meter apart and particle-generating activity must not be performed when sterile compounding is in process.

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18
Q

Vrai ou Faux.
Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory.

A

Vrai

if permitted by entity policy.

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19
Q

Vrai ou Faux.
Sterile and nonsterile HDs may be stored together.

A

Vrai

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20
Q

Quel type de pression doit-on avoir dans une C-SEC utilisée pour du compounding d’HD (sterile ou non sterile) ?

A

negative pressure (between 0.01 and 0.03 inches of water column relative to all adjacent areas)

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21
Q

À quelle distance de la C-PEC peut-on placer un lavabo?

A
  • Si unclassified C-SCA: à 1 mètre from the C-PEC
  • Si placée dans anteroom, à 1 mètre de la porte du buffer room
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22
Q

Dans une C-SEC où on prépare seulement du nonsterile HD, quelle ACPH est nécessaire?

ACPH: air exchange per hour

A

12 ACPH

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23
Q

Dans une C-SEC où l’on prépare seulement du nonsterile HD, quels types de C-PEC sont adéquats?

A

CVE, Class I or II BSC, CACI

(Class I Biological Safety Cabinet (BSC) or Containment Ventilated Enclosure (CVE).
A Class II BSC or a compounding aseptic containment isolator (CACI) may also be used)

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24
Q

Dans une C-SEC où l’on prépare seulement du sterile HD, quels types de C-PEC sont adéquats?

A

Class II BSC or CACI

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25
Q

Si on a une anteroom et bufferroom ISO7, quelle ACPH est recommandée dans la C-SEC si on prépare que du sterile HD?

A

30 ACPH

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26
Q

Si on a une Unclassified C-SCA, quelle ACPH est recommandée si on prépare que du sterile HD?

A

12 ACPH

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27
Q

Quel type de pression doit-on avoir dans l’anteroom?

A

Positive pressure

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28
Q

Dans quelle situation est-il obligatoire d’utiliser un CSTD si la forme le permet?

A
  • Lors de l’adminsitration

but SHOULD be used for compounding

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29
Q

Selon USP800, quelles sont les recommandations pour le Wipe Sampling?

A

SHOULD be performed routinely (e.g., initially as a benchmark and at least every 6 months)

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30
Q

Quel type de gants peut-on utiliser pour manipuler des HD?

A
  • American Society for Testing and Materials (ASTM) standard D6978 (or its successor)
  • Powder free
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31
Q

Doit-on porter des gants pour manipuler des HD ‘‘reproductive risk only’’ ?

A

Oui, pour tous les HD

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32
Q

Lors du compouding de HD, à quelle fréquence doit-on changer ses gants?

A

q 30 min
(ou si torn, punctured, or contaminated)

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33
Q

Lors du compouding de HD, à quelle fréquence doit-on changer sa jaquette?

A

(must be changed per the manufacturer’s information for permeation of the gown)
If no permeation information is available for the gowns used, change them q 2–3 hours
(or immediately after a spill or splash)

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34
Q

Quel type de Gowns peut-on utiliser pour manipuler des HD?

A
  • Gowns must close in the back (i.e., no open front),
  • be long sleeved
  • have closed cuffs that are elastic or knit
  • must not have seams or closures that could allow HDs to pass through
  • disposable
  • shown to resist permeability by HDs
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35
Q

Dans quelles situations est-il permis de porter une seule paire de gants lors de Compouding of HD?

A

Si on utilise une BSC class III ou CACI (fixed-glove assembly)

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36
Q

Combien de paires de shoes cover sont nécessaires pour faire du compounding de HD?

A
  • 2 paires
  • second pair of shoe covers must be donned before entering the C-SEC and doffed when exiting the C-SEC.
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37
Q

Nommez des situations où une protection oculaire serait indiquée pour manipuler des HD.

A
  • administration in the surgical suite
  • working at or above eye level
  • cleaning a spill

(outside of a C-PEC)

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38
Q

Vrai ou Faux. Tout le PPE est considéré minimalement contaminé avec trace de HD si utilisé pour manipuler HD.

A

Vrai

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39
Q

Quelles PPE devraient être jetées dans la C-PEC avant de sortir?
De quelle façon on le jette?

A
  • gloves
  • sleeve covers (if used)

Discarded into a waste container approved for trace contaminated waste inside the C-PEC or contained in a sealable bag for discarding outside the C-PEC

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40
Q

Personnel competency must be reassessed at which frequency?

(personnel handling HD)

A

at least every 12 months

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41
Q

La définition suivante s’applique à quelle étape du nettoyage:
‘‘Render compound inert or inactive’’

Étapes du nettoyage: Deactivation, Decontamination, Cleaning, Disinfection

A

Deactivation

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42
Q

La définition suivante s’applique à quelle étape du nettoyage:
‘‘Remove HD residue’’

Étapes du nettoyage: Deactivation, Decontamination, Cleaning, Disinfection

A

Decontamination

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43
Q

La définition suivante s’applique à quelle étape du nettoyage:
‘‘Remove organic and inorganic material’’

Étapes du nettoyage: Deactivation, Decontamination, Cleaning, Disinfection

A

Cleaning

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44
Q

La définition suivante s’applique à quelle étape du nettoyage:
‘‘Destroy microorganisms’’

Étapes du nettoyage: Deactivation, Decontamination, Cleaning, Disinfection

A

Disinfection

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45
Q

Dans quel cas une Disinfection est requise?

A

for areas intended to be sterile

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46
Q

À quelle fréquence doit-on nettoyer l’élément suivant: ‘‘area under work tray of BSC’’ ?

A

at least q1mois

(deactivation, decontamiation, cleaning) Protection respiratoire requise

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47
Q

Vrai ou Faux. En cas de déversement (Spill), il est obligatoire de documenter les circonstances et le management de ce déversement.

A

Vrai
The circumstances and management of spills MUST be documented.

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48
Q

À quel pourcentage maximal devrait-on remplir une seringue avec un HD?

A

75% (3/4)

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49
Q

Vrai ou Faux. Dans une C-PEC de type BSC class III ou CACI (enclosed environment), le port d’une Gown n’est pas obligatoire lors de manipulation de HD.

A

Faux.

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50
Q

Vrai ou Faux. Un consentement écrit de l’employé avec ‘‘reproductive capability’’ est obligatoire s’il doit manipuler des HD.

A

Vrai

Compounding personnel of reproductive capability MUST confirm in writing that they understand the risks of handling HDs.

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51
Q

Comment sont désignés les CSTD à la FDA?

A
  • Class II medical devices (not requiring premarket approval)
  • Avoir le code ONB: Products that are marketed as CSTDs but have not been cleared by FDA under the product code ONB should not be considered CSTDs
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52
Q

Quelle est la définition d’Hazardous Drug selon le ASHP Guidelines for Hazardous Drug Handling (2018) ?

A

Selon OSHA Hazard Communication Standard

any chemical that is classified as a physical or health hazard, simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified. A chemical posing a health hazard risk could induce acute toxicity, skin corrosion/irritation, serious eye damage/irritation, respiratory or skin sensitization germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific organ toxicity or aspiration hazard.

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53
Q

Quels sont les 5 Standards de l’ASCO pour le Safe Handling of Hazardous Drugs?

A

1) Endorsement of existing standard (OSHA, USP800, NIOSH, ONS)
2) Medical surveillance should be included
3) CSTD: testing protocol is needed
4) External ventilation C-SEC and C-SCA
5) Alternative duty for workers trying to conceived/pregnant/breastfeeding

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54
Q

Quelles associations ont fait une Joint Position Statement pour assurer la sécurité des travailleurs manipulants des HD?

A

ONS et HOPA

(Oncology Nursing Society)

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55
Q

Quelle Loi fédérale encadre la gestion des Hazardous Waste?

A

RCRA = Resource Conservation and Recovery Act (1976)

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56
Q

Quelle agence du gouvernement administre les Hazardous Waste?

A

EPA = Environmental Protection Agency

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57
Q

Les médicaments HD se retrouvent dans quelles listes du RCRA?

A

p-list ou u-list

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58
Q

Dans quel cas peut-on considerer que notre HW est ‘‘RCRA empty’’ ?

Hazardous waste containers that are considered RCRA-empty are not subject to EPA regulations

A
  1. U-List
  2. All the contents have been removed that can be removed using normal means, such as drawing liquid out with a syringe
  3. No more than 3% by weight remains

Non applicable à p-list (qui nécessiterait triple rinse, etc…)

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59
Q

Quels médicaments se retrouvent dans la p-list du RCRA?

A
  • Acutely Hazardous : Oral lethal dose of 50mg/kg (LD50) or less.
  • Arsenic, Epinephrine, Nicotine, Physostygmine, Warfarin > 0,3%

LD50 = amount of material given all at once which causes death of 50% of group of test animals.

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60
Q

Quels HW mets-on dans un bac JAUNE?

A

trace chemo

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61
Q

Quels HW mets-on dans un bac ROUGE?

A

used needles or other items contaminated with blood

62
Q

Quels HW mets-on dans un bac NOIR?

A

HD waste >3%

63
Q

En 2019, un amendement à la RCRA a été publié. Que venait-il modifier à propos du statut de la Nicotine?

A

Nicotine replacement therapies FDA-approved OTC (patches, gums, and lozenges) can be discarded as non-HW

Nicotine continues to be listed as acute HW – this includes e-liquids in e-cigarettes/cartridges, prescription nicotine, nicotine in pesticides, nicotine used in research facilities

64
Q

En 2019, un amendement à la RCRA a été publié. Que venait-il modifier à propos des Reverse logistics/distribution ?

A

Final rule reaffirms EPA’s long-standing policy that nonprescription pharmaceuticals (e.g., OTCs) that are sent through reverse logistics are not wastes at the healthcare or retail facility if they have a reasonable expectation of being lawfully reused for their intended purpose.

65
Q

Les médicaments renvoyés à un Reverse Distributor sont-ils considérés des Waste?

A

Oui

Rx pharmaceuticals sent to reverse distributors are solid wastes at the healthcare facility

66
Q

Les médicaments renvoyés à un Reverse Logistic sont-ils considérés des Waste?

A

Non-Rx pharmaceuticals and other unsold retail items sent to reverse logistics are not solid wastes IF there is a reasonable expectation of legitimate use/reuse or reclamation

67
Q

Nommez des médicaments qui sont des RCRA HW that are also DEA controlled substances.

A

Agents include
- chloral hydrate,
- fentanyl sublingual spray,
- phenobarbital,
- testosterone,
- diazepam

Retail pharmacies and hospitals can amend DEA registration to become “collectors” of household pharmaceuticals – kiosks for collection may be installed at the facilities.
These pharmaceuticals must be destroyed after being collected.

68
Q

Qui suis-je?
Agency in the Department of Justice that provides registration for providers to prescribe, procure and dispense controlled
substances.

A

Drug Enforcement Agency (DEA)

69
Q

Qui suis-je?
Organization that Oversee licensure for individual states for pharmacists and pharmacy technicians,
Set regulations for controlled substance prescribing within a state,
and Outline standards for physical pharmacy space.

A

State Boards of Pharmacy

70
Q

Qui suis-je?
Nonprofit Organization that accredits health care organizations programs. A majority of US state governments recognize its accreditation as a condition of licensure for the receipt of Medicaid/Medicare reimbursements.

A

Joint Comission

71
Q

Qu’est ce qu’un RCA et quand est-il obligatoire d’en faire un?

A
  • RCA = Root Cause Analysis
  • Organisations accréditées par Joint Comission: Following a sentinel event (death, permanent harm, severe temporary harm)
  • for analysing an event
72
Q

Quelle est la différence entre un RCA et un FMEA ?

A

RCA: Root cause analysis (technique pour problem-solving)
FMEA: Failure Mode Effects Analysis (evaluate service failure)

73
Q

Lors qu’on fait un FMEA (Failure Mode Effects Analysis), comment calcule-t-on un risk priority number (RPN) ?

A

Rate de 1 à 10 : severity (of the failure), occurence (of the failure) and detection (effectinvess of the control)
Multiply the 3 to obtain RPN

74
Q

Quel est le Goal #1 des Joint Comission National Patient Safety Goal ?

A

Optimiser identification des patients

Two patient identifiers (name and date of birth)

75
Q

Quel est le Goal #2 des Joint Comission National Patient Safety Goal ?

A

effectiveness of communication among caregivers

76
Q

Quel est le Goal #3 des Joint Comission National Patient Safety Goal ?

A

safety of using medications

Label medication, reduce risk associated with anticoagulant

77
Q

Qui suis-je?
Certification recognizing high quality care for outpatient hemato-oncology practices developed by the ASCO.

A

QOPI

78
Q

Que veut dire QOPI?

A

Quality Oncology Practice Initiative (QOPI)

79
Q

La certification QOPI est developpée par quel organisme?

A

ASCO

80
Q

La certification QOPI se base sur les Safety Standards de l’ASCO/ONS. Que mentionne ces standards concernant les Vinca?

A

Servir en minibag si l’établissement a aussi des IT

81
Q

La certification QOPI se base sur les Safety Standards de l’ASCO/ONS. Que mentionne ces standards concernant les Intrathecal?

A
  • Storage in an isolated container/location
  • labeled with uniquely identifiable IT administration label;
  • delivered to patient only with other medication intended for CNS administration;
  • administered immediately following a time out,
  • double-check procedure that involves two licensed practitioners
82
Q

La certification QOPI se base sur les Safety Standards de l’ASCO/ONS. Que mentionne ces standards concernant les Ordonnances Verbales?

A

No verbal orders for chemotherapy are allowed except to hold or stop chemotherapy

83
Q

Selon les Safety Standards de l’ASCO/ONS, qu’est-il recommandé de faire lors de l’usage d’un protocole de chimio NON standard?

A

Policy exists to handle chemotherapy regimens that vary from standard practice
- supporting reference
or
- authorization from a second license independent practitioner are required

84
Q

La certification QOPI se base sur les Safety Standards de l’ASCO/ONS. Que mentionne ces standards concernant les signatures électroniques d’ordonnances de chimio ?

A

Elles sont acceptées

Chemotherapy orders are signed manually or by electronic signature

85
Q

Selon les Safety Standards du QOPI, à quels moments une 2e personne doit faire une verification indépendante de la chimio?

A

3 fois:
- Before preparation
- Upon preparation
- Before each chemo administration by 2 practitioners ( + documentation)

86
Q

Selon les Safety Standards du QOPI, quels sont les 8 éléments à vérifier/documenter l’exactitude avant d’aministration la chimio?

A

1) Nom du médicament
2) Dose
3) Volume
4) Débit
5) Voie d’admin
6) Expiration date/heure
7) Intégrité du produit
8) Débit seté sur la pompe

87
Q

Qui a developpé le Oncology Care Model (OCM) ?

A

Center for Medicare and Medicaid Innovation

88
Q

Nommez les 3 types de paiement inclus dans l’OCM.

A
  • fee-for-service (FFS) payments for established services,
  • monthly payments for additional care under a structured guideline
  • performance-based payments weighed against quality metrics and benchmarks
89
Q

Quel est le monthy payment inclus dans l’OCM?

A

Per-beneficiary-per-month (PBPM) payment = 160$/pt/mois (pt pendant son épisode de 6 mois)

If the beneficiary enters hospice, the payments cease.

90
Q

Vrai ou Faux. Le système de paiement OCM est seulement accepté par le Centers for Medicare and Medicaid Services.

A

Faux
The payment system is accepted by other health care coverage programs in the US

91
Q

Pendant quelle période s’applique le modèle de paiement OCM ?

A

6 mois suivant le début du traitement de chimiothérapie.

  • including endocrine therapies but excluding topical formulations of drugs.
  • Beneficiaries may initiate multiple episodes during the 5-year model performance period.
92
Q

Afin d’être admissible aux paiements de l’OCM, le MD doit continuellement respecter 6 normes de soins. Lesquelles?

A

1) Accès 24/7 à un clinicien avec accès dossier médical
2) Utiliser un Electronic Medical Record oncology-certified et atteint MU stage 1 (year#1) et stage 2 (year#3)
3) Suivre les guidelines (ex: NCCN, ASCO)
4) Document a care plan for every OCM patient
5) Provide patient navigation to all OCM patients
6) Use data for continuous quality improvement

93
Q

Nommez des OCM Quality Indicators.

A
  • # of ED visits/pt/episode
  • # of hospital admissions/pt/episode
  • % admitted to hospice for < 3 days
  • % ≥ 1 ED visit in the last 30 days of life
  • % face-to-face encounters avec un plan of care for pain
  • % face-to-face encounters with pt reported outcomes tool + psychosocial eval at least 1/episode
  • Score on patient experience survey (modified CAHPS)
94
Q

Qui suis-je?
Nonprofit Organization devoted entirely to medication error prevention and safe medication use, certified by the AHRQ.

AHRQ: Agency for Healthcare Research and Quality

A

Institute for Safe Medication Practices (ISMP)

95
Q

L’Institute for Safe Medication Practices (ISMP) établit des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant le Methotrexate?

A

MTX weekly par défaut dans le système électronique
(Require a hard stop verification si autre poso)

96
Q

L’Institute for Safe Medication Practices (ISMP) établit des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant les Vinca?

A

Dans un minibag et non dans une seringue

97
Q

L’Institute for Safe Medication Practices (ISMP) établit des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant le poids des patients?

A
  • Peser dès l’admission ou a chaque visite
  • Poids/taille en unités METRIC seulement
98
Q

L’Institute for Safe Medication Practices (ISMP) établit des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant les liquides oraux?

A
  • dispensed by pharmacy in an oral or ENFit syringe that meets the International Organization for Standardization (ISO) 80369 standard
  • only display the metric scale
99
Q

L’Institute for Safe Medication Practices (ISMP) établi des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant la ‘‘Glacial Acetic Acid’’?

A

Eliminate from all areas of the hospital.

100
Q

L’Institute for Safe Medication Practices (ISMP) établi des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant les bloqueurs neuromusculaires?

A

Segregate, sequester, differentiate,
from other drugs

101
Q

L’Institute for Safe Medication Practices (ISMP) établi des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant le sac d’eau stérile de 1L ?

A

Eliminate all 1,000mL bags of sterile water from all areas outside the pharmacy.

102
Q

L’Institute for Safe Medication Practices (ISMP) établi des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant la promethazine injectable?

A

Eliminate

When administered parenterally, promethazine may cause severe
tissue injury

103
Q

L’Institute for Safe Medication Practices (ISMP) établi des ‘‘Best practices’’ ciblées en matière de sécurité des médicaments à l’hôpital.
Quelles sont les recommandations de pratique concernant les opiacés?

A
  • Eliminate the prescribing of fentanyl patches for opioid-naïve patients and/or patients with acute pain.
  • Verify and document a patient’s opioid status (naïve versus tolerant) and type of pain (chronic vs. acute) before prescribing and dispensing extended-release or long-acting opioids.
104
Q

Vrai ou Faux.
Lorsqu’on utilise les Oncology pathways, on devrait viser un taux de compliance avoisinant les 100%.

A

Faux

Oncology pathways should recognize physician autonomy, patient variability, and recognize that 100% concordance with pathways is impossible. Clinical pathways reaching 70 to 80% is a best-case scenario given patient-specific factors such as end-organ function and performance status.

105
Q

Quel organisme a released a policy statement on clinical pathways ?

A

ASCO

106
Q

Vrai ou Faux.
Commercially available pathways are written by corporate entities such as drug wholesalers.

A

Vrai

such as drug wholesalers (e.g., Cardinal, McKesson) and large publication houses (e.g., Elsevier)

107
Q

Quelles sont les 3 grandes composantes cliniques d’un bon Electronic Medical Record (EMR) ?

A
  • Results reporting information system (RRIS)
  • computerized physician order entry (CPOE),
  • clinical decision support system (CDSS)
108
Q

Qui administre le programme 340B?

A

Health Ressources and Services Administration (HRSA) - Office of Pharmacy Affairs

(federal)

109
Q

Que doit démontrer un biosimilaire lors du approval process?

A

There is no clinically meaningful differences between the biosimilar product and the reference product in terms of safety, purity, and potency.

110
Q

Quelle Loi a permis d’avoir un ‘‘abbreviated approval pathway’’ pour les biosimialires?

A

Biologics Price Competition and Innovation Act of 2009

included in the Patient Protection and Affordable Care Act 2010

111
Q

Vrai ou Faux.
A biosimilar can be approved for an indication that is approved for the reference product even if the biosimilar is not directly studied in that indication.

A

Vrai

FDA may approve a biosimilar for indications or populations without direct clinical studies in those indications or populations if the manufacturer provides adequate scientific justification

112
Q

Vrai ou Faux.
Tous les biosimiaires sont considérés interchangeables à leur produit de référence.

A

Faux

113
Q

Qu’est ce qu’un interchangeable biosimilar ?

A
  • expected to produce the same clinical result as the approved biologic in any given patient
  • Biosimilar that may be substituted for the reference product without the intervention of the prescribing health care provider, depending on state pharmacy laws.

This is similar to how generic drugs can be substituted for brand-name drugs at the pharmacy.

114
Q

Comment un manufacturier peut-il faire approuver son biosimialire comme un biosimilaire interchangeable?

A
  • A manufacturer must specifically seek FDA approval for an interchangeable product.
  • In addition to establishing biosimilarity, needs to submit information to show that the biosimilar can be expected to produce the same clinical result as the reference product in any given patient.
  • Souvent des switching study (pts alternent entre les 2 produits)
115
Q

Qui suis-je?
Covalent processing events that change the properties of a protein by proteolytic cleavage and adding a modifying group to one or more amino acids.

A

Posttranslational modifications (PTMs)

Natural consequences of the use of eukaryotic cellular systems in the production of biologic agents

116
Q

Quel est le ‘‘Naming convention’’ pour les biosimilaires?

A

FDA adds a random, lower-case four-letter suffix to the generic name of the biologic for each biosimilar product.

117
Q

Quels sont les 2 grands types de propriétés évalués par la FDA pour les biosimilaires d’anticorps monoclonaux?

A
  • Physicochemical Properties
  • Biological Properties
118
Q

Quelle est l’opinion de l’ASCO sur le fait de limiter les prescripteurs à un seul choix de biosimilaire?

A

No system should be adopted that would limit physician choice among ”biosimilar” products or require substitution of products that have been designated “interchangeable”. In every instance, the physician should decide which among similar products should be prescribed.

119
Q

Selon la réglementation fédérale, toute recherche clinique devrait être approuvée par qui?

A

IRB: Institutional Review Board

120
Q

Est-ce que des pharmaciens peuvent faire partie de l’Institutional Review Board (IRB) ?

A

Oui

121
Q

Lors d’une étude clinique, qui est responsable d’obtenir le consentement éclairé du patient?

A

principal investigator or designee

122
Q

Quelle association a fait un Guidelines sur le management of investigation drug products ?

A

ASHP

123
Q

Quelle association a fait les Investigational Drug Service (IDS) Best Practice Standards ?

A

HOPA

124
Q

Vrai ou Faux. Selon l’ASHP, les Investigational drugs peuvent être entroposées avec le reste de l’inventaire de médicament.

A

Faux.
Separate from routine drug stocks

125
Q

Selon l’ASHP, quel suivi des temperatures des lieux où sont entreposées les Investigational Drugs est recommandé?

A
  • Continuous temperature monitoring
  • Daily record of maximum and minimum temperatures
126
Q

Qu’est ce qu’un Form FDA 1572 ?

A
  • The Statement of Investigator
  • is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations
127
Q

Qu’est ce qu’un Form FDA 1571 ?

A

Investigational New Drug Application

IND is a request for FDA authorization to administer an investigational drug to humans.

128
Q

Vrai ou Faux.
A pharmacist that only dispense the Investigatinal Drug should not be listed on FDA 1572.

A

Vrai

129
Q

Vrai ou Faux.
A pharmacist that only dispense the Investigatinal Drug should be listed in the investigator study records.

A

Vrai

Pharmacist should be listed in the investigator study records as an individual to whom specific responsibilities have been delegated (e.g., dispensing)

130
Q

Lors d’une étude clinique, où sont documentées les responsabilités de la pharmacie ?

A

Pharmacy responsibilities are documented on the Delegation of Authority form
signed by both the PI and pharmacist

131
Q

Si on doit réemballer une Investigational Drug, quel ‘‘statement’’ doit être inscrit sur l’étiquette?

A

“Caution: New Drug – Limited by Federal (or United States) law to investigational use.”

132
Q

Quel est le rôle des Clinical research associate (monitor) qui visits/audits the clinical research pharmacy ?

A
  • review records
  • verify accuracy of source documentation
  • Monitor should verify drug accountability, storage conditions and drug returns

They should document monitoring visits and reason for visit

133
Q

How long must the investigator maintain pharmacy study files after the drug has been granted marketing approval in the US?

A

for 2 years following market approval

(or 2 years after investigation is discontinued if the drug is not approved)

134
Q

Selon l’HOPA, what are the Pharmacist Roles in the Protocol Life Cycle for Investigational Drugs ?

A
  • Pharmacists should develop the medication information section of the protocol
  • Pharmacist should provide recommendation for supportive care in the protocol
  • Pharmacists should participate in Scientific Review Committees
  • Pharmacists should participate in IRB protocol review
135
Q

Quelles agences peuvent accréditer des pharmacies spécialisées ?

A
  • Accreditation Comission for Healthcare (ACHC)
  • Center for Pharmacy Practice Accreditation (CPPA)
  • Utilization Review Accreditation Comission (URAC)
136
Q

Quel % de dose-rounding est considéré acceptable pour les agents cytotoxiques, les MAb et les anticorps conjugés selon l’HOPA?

A

10%

137
Q

Vrai ou Faux. Pour le ‘‘dose rounding’’ de comprimés de chimio orale, l’HOPA recommande d’arrondir le plus près possible de la dose calculée en utilisant au besoin plusieurs teneurs différentes.

A

FAUX

idéalement 1 seule teneur (évite les erreurs et évite multiples copayments)

138
Q

Vrai ou Faux. Pour le ‘‘dose rounding’’ l’HOPA permet un arrondissement à 10% près en traitement palliatif, mais 5% en curatif.

A

Faux.

The 10% dose rounding allowance is recommended for both curative-intent and palliative-intent treatment.

139
Q

Nommez des situations dans lesquelles le dose-rounding n’est pas recommandé.

A
  • Clinical trials (ont leur propre procédure)
  • PK determined dose (ex: Busulfan)
  • mauvais ECOG
  • major organ dysfonction
  • extensive tx history
  • relevant enzyme deficiency/genetic polymorphism
  • history of dose reduction for prior toxicity
140
Q

Selon l’HOPA, à quel moment devrait-on faire le monitoring of symptoms and adherence, including patient-reported outcomes (PROs) chez les patients sous chimio?

A
  • Initially between 7 and 14 days after the start
  • should also occur at each clinical encounter or at least before each refill
141
Q

Vrai ou Faux. Le Pharmacy Technician Certification Exam (PTCE) (established in 1995) est obligatoire pour tous les ATP en oncologie.

A

Faux

not yet required in a standard fashion

142
Q

Que signifie MACRA?

A

Medicare Access and CHIP Reauthorization Act

(Loi signée en 2015)

143
Q

Quelle Loi a créé le QPP (Quality Payment Program) ?

A

MACRA

144
Q

What are the two incentive paths for clinicians implemented by the Quality Payment Program (QPP) via le MACRA ?

A
  • Merit-Based Incentive Payment System (MIPS)
    and
  • Advanced Alternative Payment Models (AAPMs)
145
Q

Parmi les 3 types de ‘‘care models’’ en pharmacie, lequel se défini ainsi:
- Specialty medication filled at a retail pharmacy, No use of standardized case management or education protocol, No programmatic approach to ensuring adherence

3 types: Traditional Patient Care, Coordinated Care, Integrated Care

A

Traditional Patient Care

146
Q

Parmi les 3 types de ‘‘care models’’ en pharmacie, lequel se défini ainsi:
- Pharmacies that focus primarily on specialty pharmaceuticals, provide reimbursement assistance, patient care coordination, and ongoing monitoring of the patients, Pharmacy likely does not have access to the patient medical record

3 types: Traditional Patient Care, Coordinated Care, Integrated Care

A

Coordinated Care

(Requires coordination between pharmacists and reimbursement specialists)

147
Q

Parmi les 3 types de ‘‘care models’’ en pharmacie, lequel se défini ainsi:
- Requires pharmacists deployed in a comprehensive medication management system and integrated into the primary medical care team,
- pharmacist often has a physical presence in the clinic with high-volume specialty pharmacy medications
- Pharmacists have full access to the patient’s medical record

3 types: Traditional Patient Care, Coordinated Care, Integrated Care

A

Integrated Care

148
Q

Quels patients ne sont pas élligible aux ‘‘Manufacturer co-pay cards’’ ?

A

patients with government provided insurance (e.g., Medicare, Medicaid, Tricare)

149
Q

Selon la FDA Safety and Innovation Act (FDASIA - 2012), quel type de rupture de stock doit être rapporté à la FDA?

A

drugs that are life-supporting, life-sustaining or
intended for prevention of a debilitating illness

150
Q

Qui a fait un Guidelines sur the Roles and Responsibilities of the Pharmacy Technician in Ambulatory Oncology Pharmacy ?

A

ASHP/HOPA

BCOP-CHUM (22 decks)

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