1
Q
DCQA
A
- Drug Compounding Quality Act
- Maintains regulation of traditional compounding with states under 503A
- BUT establishes 503B that allows facilities that are sterile compounding pharmaceuticals NOT based on patient specific prescriptions to register as “Outsourcing Facility”
2
Q
Outsourcing Facilities
A
- Exempt from new drug provisions, adequate directions for use, and drug track/trace provisions
- Outsourcing Facilities are primarily regulated by FDA and subject to cGMPs
3
Q
503A Facilities
A
- Compounding pharmacies
- May only compound pursuant to an individual prescription/med order
- Permitted to do limited anticipatory compounding
- Mainly regulated by states and subject to USP <797> (sterile)
4
Q
Outsourcing Facilities MUST
A
- Have a licensed pharmacist to oversee
- Register with FDA (FDA provides lists of facilities with locations, if compound from bulk, and if the bulk is sterile/nonsterile)
- Report to Secretary of HHS upon registering and Q6Mo
- Inspection by FDA according to risk-based scheduled and pay annual fees
- Report serious AE within 15 days and conduct follow-up investigation/reporting similar to manufacturers
- Label products with a statement identifying them as compounded drug (w/ other specified drug info)
5
Q
Outsourcing facilities may NOT include bulk substance unless…
A
- Bulk drug appears on list identifying of bulk drug substances for which there is a clinical need (503B bulk list)
- Drug product compounded from bulk appears on FDA’s shortage list at time of compounding, distribution, AND dispensing
6
Q
Interstate Distribution of 503A Compounds
A
- Limits interstate distribution of compounded drug to <5% UNLESS state is in MOU with FDA
- Inordinate amount of compounded drugs is considered when number of Rx orders distributed interstate for human drugs is >50% sum of number of scripts ordered/sent out of facilities or number of orders dispensed in a calendar year
- *Texas has not entered MOU to date**
7
Q
DSCSA
A
- Drug Supply Chain Security Act (Track and Trace)
- Uniform national framework for an electronic track/trace system for prescription drugs as they move through supply chain
- Sets national standards for states to license wholesalers
- Includes prescription drugs form human use in finished dosage form
- Provides Transaction Data passed from manufacturers to wholesalers to buyers
- Fully implemented by 2023
8
Q
Exemptions to DSCSA
A
- Blood/blood components
- Radioactive drugs
- Imaging drugs
- IV Fluid replacement
- Dialysis soln
- Medical gases
- Compounded drugs
- Medical convenience kits with drugs
- Sterile water
- Irrigation products
9
Q
Transaction Data Includes
A
- Transaction Information
- Transaction History
- Transaction Statement
10
Q
Transaction Information
A
- Product Name/Strength/Dosage Form
- Date of Transaction
- Container size/number of containers
- Name/address of person to/from transferring
- Unique product identifier or serialized numerical identifier (SNI) - identifies an individual bottle/unit of sale (pharmacies may only receive drugs with this, don’t currently have to authenticate them)
11
Q
Transaction History
A
- Paper or electronic statement
- Includes prior transaction information for each prior transaction back to the manufacturer
12
Q
Transaction Statement (5)
A
-Paper or electronic statement by seller
States the following:
1. Seller is an authorized person to sent product
2. Received the transaction info/hx from prior owner if required
3. Did not knowingly ship a suspect/illegitimate product
4. Has systems/processes to comply with verification requirements
5. Did not knowingly provide false information
13
Q
Suspect/Illegitimate Product Investigation
A
- MUST investigate and properly handle these products
- Pharmacy must verify the product identifier of at least 3 products or 10% of the suspect product (whichever is greater), OR all products if total number < 3
- Must verify any illegitimate product in notification to FDA/trading partner
- Notify FDA with FDA Form 3911 and notify trading partners within 24 hours
- Pharmacies should work with manufacturer to ensure products don’t reach the patients
14
Q
Distributor Pharmacies
A
-Distributing drugs to anyone other than the consumer/patient
-Must have wholesale license and pass DSCSA transaction data with distribution
EXCEPTIONS to license/transaction data:
1. Distribution between two entities that are affiliated/under common ownership
2. Providing product to another dispenser on patient specific basis
3. Dispenser is distributing under emergency medical reasons
4. Distributing “minimal quantities” to licensed practitioner for office use
15
Q
Animal Drugs
A
- FDA regulates drug intended to be used in animals
- Must be proven safe/effective
- FDA determines if they are prescriptions/OTC
- Can only be dispensed/ordered by veterinarians
- “Caution: Federal law restricts this drug to use by or on order of a licensed veterinarian”
- Vets can prescribe approved human drugs off-label for animals and these can be received/dispensed by pharmacies
- Guidance from FDA regarding compounding of animal drugs in specific circumstances
16
Q
PPPA
A
- Poison Prevention Packaging Act of 1970
- Administered by CPSC (Consumer Product Safety Commission)
- Requires child-resistant containers for all prescriptions and certain nonRx drugs/preparations
17
Q
ASA Child-Resistant Container Requirement
A
Human use in oral dosage form
18
Q
Methyl Salicylate Child-Resistant Container Requirements
A
Liquid preps containing >=5% unless in pressurized spray containers
19
Q
Methyl Alcohol Child-Resistant Container Requirements
A
Liquids containing >=4% unless in pressurized spray containers
20
Q
Iron Child-Resistant Container Requirements
A
Exceptions are animal feed and human iron with a total amount equivalent to 250 mg of iron
21
Q
Dietary Supplements with Iron Child-Resistant Container Requirements
A
- Contain 250 mg of iron or more
- Doesn’t include when iron is solely used as a colorant
22
Q
APAP Child-Resistant Container Requirements
A
- Human use in oral form where >1g in package
- Exceptions: effervescent and powder formulations of APAP
23
Q
Diphenhydramine Child-Resistant Container Requirements
A
- Human use in oral dosage forms
- Contains >66 mg of diphenhydramine base in single package
24
Q
Ibuprofen Child-Resistant Container Requirements
A
- Human use, oral
- >1g in single package
25
Loperamide Child-Resistant Container Requirements
- Human use, oral dosage form
| - >0.045 mg of loperamide in single package
26
Lidocaine Child-Resistant Container Requirements
- >5 mg of lidocaine in single package
| - Includes ALL forms
27
Dibucaine Child-Resistant Container Requirements
- >0.5 mg of dibucaine in single package
| - Includes ALL forms
28
Naproxen Child-Resistant Container Requirements
- Human, oral use
| - >250 mg of naproxen in single package
29
Ketoprofen Child-Resistant Container Requirements
- Human, oral use
| - >50 mg of ketoprofen in single package
30
Fluoride Child-Resistant Container Requirements
- >50 mg of elemental fluoride AND
| - >0.5% fluoride in single package
31
Minoxidil Child-Resistant Container Requirements
- Human use
- >14 mg of minoxidil in package
- Includes topical, must still meet requirement after applicator installation
32
Imidazoline Child-Resistant Container Requirements
- >= 0.08 mg in single package
| - Includes tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline (ophth. and nasal)
33
Additional Child-Resistant Container Requirements
- Controlled Drugs
| - Any drug switched from Rx to OTC
34
Child-Resistant Container Requirements Exemptions
- Requested by patient or provider
- Bulk containers not intended for household use
- Drugs distributed to institutionalized patients
- Rx drugs packaged for LTCF residents and other facilities where personnel administer meds
- One package size of OTC drugs designed for elderly
- Specific Drug Exemptions
35
Drugs Exempted from Child-Resistant Container Requirements (18)
1. Oral contraceptives
2. Medroxyprogesterone tabs
3. SL nitroglycerin/chewable isosorbide
4. ASA and APAP in effervescent tabs/granules
5. Unit dosed K supplements
6. Sodium fluoride containing no more than 264 mg per package
7. Cholestyramine and colestipol packets
8. Erythromycin granules for susp. orally, no more than 8 mg
9. Erythromycin tablets, no more than 16 g per package
10. Prednisone, max of 105 mg
11. Methylprednisolone, no more than 84 mg
12. Betamethasone, no more than 12.6 mg
13. Mebendazole, no more than 600 mg
14. Aerosolized inhalation
15. Pancrealipase
16. Sucrose prep in glyercin/water
17. Hormone replacement that relies on 1+ progestogen or estrogen substance
36
Federal Hazardous Substances Act
- 1966
- CPSC administers/enforces to protect consumers from hazardous/toxic substances
- Requires label with certain information on hazardous products
- Act doesn't apply to drugs regulated by FDA but could apply to other household products like bleach, cleaning products, antifreeze, etc.
37
Hazardous Drug Required Info (10)
1. Name/Address of manufacturer/packer/seller
2. Common/usual chemical name of each hazardous ingredient
3. "Danger" for corrosive/flammable/toxic products
4. "Caution"/"Warning" for other hazardous products
5. Affirmative statement of principle hazard product presents
6. Precautionary statements of how to avoid harm
7. Appropriate instructions for first aid if harm occurs
8. "Poison" for highly toxic substances
9. Special handling/storage instructions
10. "Keep out of reach of children" - must be hanging on a plant if applicable and be printed in any literature with the product
38
Federal Hazard Communication Standard
- OSHA enforces - requires employers to meet Hazard Communication Standard
- Classify hazards of chemicals they produce/import and prepare appropriate labels/SDS
- Capsules/tablets in final form don't count; those connected to USP <800> do
- Hazard Communication Plan required if pharmacy carries any of these
39
Hazard Comm. Plan Includes..
- List of hazardous chemicals
- Ensure all products are labeled and have SDS
- Training for workers on hazards of chemicals
- Protective measures
- Where/how to obtain additional information
40
CMS Requirements - Tamper Resistant Prescriptions
- 1+ industry features to prevent copying of completed/blank Rx form
- 1+ preventing erasure/modification
- 1+prevent counterfeit script use
41
CMS Requirements - LTCF
- Q30d with irregularities reported/acted on
- Avoid unnecessary drugs/doses/durations
- Limit psychotropics to 14 days; beyond 14d require physician evaluation to determine appropriateness
- Max of 14d cycle dispensed to LTFC (limited exceptions) - reduces waste
- Ensure routine/emergency drugs are provided in timely manner (emergency kits permitted)
42
Delivery of Scripts by Mail
- Noncontrolled allowed to be mailed pharmacy => user (no alcohol, poison, flammable)
- Controlled: prescription container must be labeled appropriately, no markings on outer container/package of any kind indicating nature of contents, can be mailed to other DEA registrants
- Any prescription can be delivered by common carrier from pharmacy to user (no restrictions)
43
Federal Tax-Free Alcohol Regulations
- Sometimes use 95% ethanol for compounding
- Alcohol is tax-free when used for scientific, medical, or mechanical purposes
- TTB regulates tax-free alcohol and AFT enforces it
- TTB user permit required and record keeping utilized
- Prohibits reselling alcohol or use in beverage
44
HIPAA
- Most pharmacies covered by HIPAA and must be compliant
- Must provide "Notice of Privacy Practices" with written acknowledgement upon first service delivery
- HIPAA privacy rule requires mandatory provisions in Notice
45
Use/Disclosure of PHI
- May be used for payment and healthcare operations without authorization from the patient
- May also be used without authorization for government functions (reporting AEs, law enforcement, health monitoring programs)
- Marketing purposes require signed authorization and remuneration provided
- Face-to-face communication about alternatives/options is treatment, not marketing
- Refill reminders isn't marketing as long as payment made for making the communication is reasonable and related to pharmacy's cost
46
Business Associates
- BA persons/entity other than pharmacy workforce that require use/disclosure of PHI
- Required to enter into business associate contracts with these BAs which require them to protect PHI as a covered entity for
47
Patients Rights/Administrative Requirements - PHI
- Patients have a right to access/obtain a copy of their PHI - ideally fulfill request within 30 days, may delay 30 days if given a reason of delay to pt
- May request an amendment of PHI and record of disclosures of PHI made by pharmacy (complete w/in 60 days, 30 day delay with notice)
- Pharmacies must establish protocol/procedures to protect from accidental use/disclosure of PHI
- Train all employees on privacy policies and sanctions for violations of policy
- Must designate person to receive complaints, AKA "Privacy Official"
48
Minimum Necessary Standard
- Minimize PHI to minimum necessary to accomplish intended purpose (use/disclose)
- Doesn't apply to HC providers for tx purposes or for patients that have signed an authorization
- DOES apply to disclosures for payment
49
Incidental Disclosures
- Unintended "incidental" disclosures are not a violation of Privacy Rule as long as safeguards are in place
- Ex: Accidental overhearing/seeing of PHI while performing job in workplace (janitors, sale person, etc.)
50
HITECH Act
- Amended HIPAA to strengthen provision
- Required covered entities to notify individuals of a breach of PHI w/in 60 days after breach discovered
- BAs to report breaches to covered entity along with identities of each affected individual
51
Breach
- Unauthorized acquisition, access, use, or disclosure of PHI that compromises its security/privacy
- Does NOT include instances where inadvertent disclosure from one authorized individual to another
- Also not a breach if BA/covered entity has a good faith belief that the PHI is not further acquired, accessed, retained, used, or disclosed
52
Breach Requirements
- Affecting < 500 individual, covered entities must maintain a log of these breaches and notify HHS of these breaches yearly
- >500, Secretary of HHS and prominent local media must be notified in addition to the affected individuals within 60 days of breach being discovered
53
Texas "HIPAA"
- Texas privacy laws have a broader definition of "covered entity"
- Also, more stringent training requirements
- Texas requires a pharmacy to respond to a patient's confidentiality record request within 15 days (stricter than HIPAA's 30-d timeline)
Texas MPJE
flashcards
Decks in class (11)
# Cards
-
Ch 1: Federal Laws51
-
Cont. Ch 153
-
Ch 2: Controlled Substances50
-
Cont. Ch 241
-
Ch 3: Texas Dangerous Drug Act (TDDA)19
-
Ch. 4: Texas Pharmacy Act (TPA)54
-
Cont. Ch 443
-
Ch. 5: Complaints, Inspections, Penalities, etc.22
-
Ch. 6: Class A Pharmacy Rules26
-
Ch. 7: Other Classes of Pharmacy46
-
Ch. 8: Compounding Laws/Rules28
