Compounding, Med Safety-Management-Ethics, Drug Resources

Compounding pharmacies are licensed/registered by…

Accreditation →

Compounding pharmacies are licensed/registered by State Board of Pharmacy

Accreditation → Pharmacy Compounding Accreditation Board (PCAB) voluntary

Compounding vs Manufacturing

Compounds:

• NOT FDA approved

• Prepared for specific patient

• Does NOT replicate commercially available drug products

Manufacturing:

• FDA approved

• Mass produced

Which compounded products MUST be sterile

Injections, inhalations and ophthalmic (eye) ointments must be sterile (otic products dont need to be)

Oral suspension/solution, topicals dont need to be sterile

USP standard ->

Non-sterile -> USP… (use…)

Sterile preparation -> USP…

Hazardous -> USP…

USP standard -> national standards for compounding

Non-sterile -> USP 795 (use purified water)

Sterile preparation -> USP 797

Hazardous -> USP 798

ISO (International Organization of Standardization) 

Sterile compounding hood and Biological Safety Cabinets -> ISO class..

Buffer room -> ISO class..

Ante room (btwn common pharmacy area and clean room) -> ISO class..

Sterile compounding hood and Biological Safety Cabinets -> ISO class 5 air 

Buffer room -> ISO class 7 air

Ante room (btwn common pharmacy area and clean room) -> ISO class 8 air 

Category 1, 2, and 3 CSP all use the same ISO classes, except for immediate use products (ie things that are used in the ER)

Before getting ready to enter clean room

• Remove coat, hat, makeup, artificial nails and jewelry

• Gowning from dirtiest to cleanest: toe → head → face

  • Shoes cover, hair cover, facial mask

  • Wash hands up to elbows

  • Dry hands with non-shedding disposable towels

  • Low lint gown

  • Clean hands again with alcohol based hand rub

  • Enter clean room, put on gloves (2 sets for chemo

  • Santizes the gloves with 70% sterile isopropyl alcohol and allow gloves to dry

Chemo agents should be compounded with…like biological safety …-> prevent…

What protection

Red bin ->  

Blue bin ->

Yellow bin ->

Black bin ->

Non-hazardous preparations -> horizontal flow

Chemo agents should be compounded with glass shield protecting compounder in vertical flow like biological safety class II cabinets -> prevent bone marrow suppression 

Eye protections, double gloves

Hood recertified every 6 months

Red bin -> sharps 

Blue bin -> non-hazardous

Yellow bin -> trace hazardous

Black bin -> hazardous

• Warfarin, all nicotine products, chemo agents

• Estrogen, EPI

• Azathioprine, Cyclosporine,

• Phentermine, Physostigmine

• Any agents containing mercury, heavy metals or m-cresol

Non-hazardous preparations -> horizontal flow

Avoid…with iodine when compounding

Avoid stainless steel spatulas with iodine when compounding

Cream ->

…opaque

Gel ->

Lozenge aka

Elixir has … -> avoid with…

Cream -> opaque and non-greasy to moderately greasy 

Cream lotion paste opaque

Gel -> translucent, NOT greasy

Lozenge or torche

Elixir has alcohol -> avoid with Flagyl, Cefotetan and Disulfiram

Emulsion -> …that are normally immiscible 

Cream and lotion both…preparations

• Cream -> larger…% 

• Lotion -> larger…%

Emulsion -> liquid-in-liquid that are normally immiscible 

Cream and lotion both oil in water preparations

• Cream -> larger oil % 

• Lotion -> larger water %

Solution …mixture -> cannot tell the solid/liquid contents apart

Suspension: …-in-… particles (vs emulsion) -> must…

Solution homogenous mixture -> cannot tell the solid/liquid contents apart

Suspension: solid-in-liquid particles (vs emulsion) -> must shake before use

Eutectic mixture has a…than any of its components

Eutectic mixture has a melting point lower than any of its components

BUD

Category 1 CSPs

• …at RT 

• … in the fridge

Category 2 CSPs

• If non-sterile components 

  • RT ->

  • Fridge ->

• If sterile components

  • RT ->

  • Fridge ->

• Freezer ->

Immediate use CSP must be used within…

Category 1 CSPs

• 12 hrs at RT 

• 24 hrs in the fridge

Category 2 CSPs

• If non-sterile components 

  • RT -> 1 days

  • Fridge -> 4 days

• If sterile components

  • RT -> 4 days

  • Fridge -> 10 days

• Freezer -> 45 days

Immediate use CSP must be used within 4 hrs

Red book ->

Orange book ->

Yellow book ->

Red book -> prices/packaging info

Orange book -> therapeutic equivalence

Yellow book -> travel vaccinations and health information

Emulsifying agent

• Low HLB (…) are more…

  • -> better for…emulsions 

• High HLB (….) are more… 

  • -> better for…emulsions

Emulsifying agent

• Low HLB (<10) are more oil soluble 

  • -> better for water-in-oil emulsions 

• High HLB (>10) are more water soluble 

  • -> better for oil-in-water emulsions

Think Low = Lipid

Single dose vials 

• If used in ISO Class 5 environment -> good for…

• If not -> good for…

Multi dose vials 

• Has…

• Good for…

Single dose vials 

• If used in ISO Class 5 environment -> good for 6 hours

• If not -> good for 1 hr 

Multi dose vials 

• Has preservatives 

• Good for 28 days

Balances must meet…standards

Weights can be picked up by…(never by hand)

If weighing ointment -> use…paper (wont break from all the oil)

Balances must meet national Bureau of Standards

Weights can be picked up by plastic tweezers (never by hand)

If weighing ointment -> use glassine weighting paper (wont break from all the oil)

What is an Autoclave? 

…used to sterilize…equipment and heat-resistant compounded products in 15-20 min

• Heat…

• Pressure…

Destroys…but NOT…

What is an Autoclave? 

Steam pressure chamber used to sterilize aqueous solutions equipment and heat resistant compounded products in 15-20 min

• Heat 121 C (249 F) 

• Pressure at 15 PSI

Destroys bacteria, viruses, fungi and spores but NOT endotoxins 

Sterilization by filtration uses…micron filter

Can trap…, but NOT…

Must be capable of…

Sterilization by filtration uses 0.22 micron filter

Can trap bacteria and fungi, but NOT viruses or endotoxins

Must be capable of retaining 100% of a culture of 10^7 microorganisms of a strain of Brevundimonas (Pseudomonas) diminutas

Trituration -> Levigation -> Geometric dilution

Trituration (grinding dry powder) -> Levigation (add non-soluble liquid to continue grinding) -> Geometric dilution (adding diluent)

Diluent / filler (3)

Diluent / filler (during geometric dilution step)

• Lactulose powder 

• Starch 

• Magnesium stearate -> most commonly used as “lubricant” diluent to prevent sticking to machinery

Levigating agents 

3 aqueous

3 oily

Levigating agents 

Aqueous (for creams -> water based)

• Water, glycerin, PEG, PEG 400

Oily (for ointments -> oil based) 

• Mineral oil, castor oil, cottonseed oil

Suspending agents

Natural hydrocolloids

Semisynthetic hydrocolloids

Synthetic hydrocolloids

Memory tip -> things with “gum” or “-cellulose” are all suspending agents

Preservatives

(4 lines)

Preservatives

Benzalkonium chloride (BAK) -> Most common preservative in eye drops 

Parabens

Benzoic Acid and Sodium Benzoate

Thimerosal, Nitromersal

High efficiency particular air filter -> HEPA filters 

Remove particles bigger than…micron with…% efficiency

Require…

High efficiency particular air filter -> HEPA filters 

Remove particles bigger than 0.3 micron with 99.97% efficiency

Require ISO 5

Dry-heat sterilization

Generally for glass containers and products not penetrated by hot steam of autoclaving (oils and powders)

Destroys all microbes and also endotoxins (autoclave doesnt hit endotoxins, this methods uses higher heat and longer times)

Class of ointment bases from most greasy to least

Gloves and hood surfaces disinfected with…during the process 

Gas sterilization ->

Gloves and hood surfaces disinfected with sterile 70% Isopropyl alcohol during the process 

Gas sterilization -> Ethylene Oxide

What kind of medium is used to simulate the compounding environment and test for aseptic technique under USP 797 (sterile) guidelines?

Sterile tryptic soy broth

Aseptic technique tested every 6 months

Capsules

Largest 00 → Small 5

Bigger number →

NCC MERP Index for Categorizing Medication Errors

Acceptable patient identifiers prior to administering medication or carrying out clinical procedure

Name, DOB

Medical record #

Exact address or telephone number

Duragesic patches disposal

Folded in half and flushed down the toilet

Contact precautions

Organisms:

HCP must do the following before entering the room

• (3) 

HCP must do the following when exiting the room

• (2)

Contact precautions

Organisms: C. diff, Norovirus, Rotavirus, VRE and MRSA

HCP must do the following before entering the room

• Wash hands with soap. Alcohol doesnt work on C. diff

• Wear a gown

• Wear gloves 

HCP must do the following when exiting the room

• Take off gown and gloves

• Wash hands with soap a second time 

Mask and eye protections are used with droplet precautions

Medication reconciliation completed in…

Medication reconciliation completed in any transitions of care (ie ICU -> cardiology telemetry floor)

Any unit dose medication from the central pharmacy should have the following information (4) retrievable from the barcode

Which medications flushed down the toilet to dispose of remaining unused meds

Flush Dangerous Meds

F - Fentanyl (Duragesic)

D - Diazepam (Diastat)

M - Methylphenidate (Daytrana patches)

Best pratices for MTX

Best practices for vinca alkaloids

Luer Lock vs Luer Slip

Luer Lock → twists onto any IV line, prevents leakaged

Luer Slip → oral, enteral meds only → NOT compatible with connecting to an IV line

Dose Error-Reduction Systems (DERS) are…

integral computer software in smart infusion pumps used to prevent infusion programming-related errors

Best practices of opioids

Opioid tolerance defined as…

Opioid tolerance defined as patients receiving the following for at least 1 week

• 60 mg PO morphine or hydrocodone a day

• 30 mg oral oxycodone a day

• 25 mg oral oxymorphone a day

• 8 mg oral hydromorphone a day

• 25 MCG transdermal fentaNYL an hour

Meds that can be removed from an automated dispensing cabinet (ADC) using the override function

Quality Assurance Report

Medication Error Report

• Does NOT…

  • (2)

• Prepare report within…

• Kept on file at the pharmacy for…

• Does NOT…

  • Have to place to name of the employee that caused the error, just job title

  • Have to be sent to the Board of Pharmacy, just keep within the hospital

• Prepare report within 48 hrs

• Kept on file at the pharmacy for at least 1 yr

Veracity →

Fidelity →

Beneficence and nonmaleficence →

Justice →

Confidentiality →

Autonomy → 

Violation of anti-kickback laws →

Veracity → telling the truth (ie counseling points)

Fidelity → keeping promises

Beneficence and nonmaleficence → doing good while avoiding harm

Justice → ensuring fairness of resource distribution

Confidentiality → protecting patient privacy and health info

Autonomy → respecting patient’s choices despite counseling

Violation of anti-kickback laws → prohibit offering or receiving payment/remuneration to attract/give services (including samples)

Patient family can access patient medication profile if…

Patient is a minor or mentally incapacitated and family is legal guardian

Family holds healthcare power of attorney

The following must be confirmed prior to Suboxone dispensing (4)

DEA #

Valid patient-prescriber relationship

Dosing is within therapeutic range
Prescription is for opioid use disorder, not pain only

Instructing →

Modeling →

Coaching →

Facilitating →

Mentoring →

• Instructing → Directly teaching specific, structured information (like didactic education on disease states).

• Modeling → Demonstrating correct behaviors (like inhaler technique) for the patient to observe and imitate.

• Coaching → Providing ongoing guidance, feedback, and motivation to help a patient achieve specific health targets.

• Facilitating → Allowing resident to perform independently (after coaching phase)

• Mentoring → Offering long-term professional guidance, career support, or developmental advice to junior staff or students.

Types of leadership

• Autocratic →

• Transformational →

• Laissez-faire →

• Autocratic → centralized control without staff input

• Transformational → focuses on inspiring and motivating team members to boost morale and achieve shared goals

• Laissez-faire → uses hands-off approach with minimal guidance and maximum autonomy for staff

Asymptomatic bacteriuria

Do NOT treat unless…

Don’t culture urine…

Do NOT treat unless pregnant or before urologic procedures

Don’t culture urine without compatible symptoms

Exclude the following medications from Automated dispensing cabinet

All insulin

Concentrated electrolytes

Heparin, warfarin

Neuromuscular blockers

Meds that require multiple dilutions

Highly conc oral liquid and parenteral opioids

Droplet Precautions

Organsims →

Use… protection

Organsims →

• Influenza, RSV and other resp viruses

• Diphtheria, Pertussis, and Neisseria meningitidis

Use mask and eye protection

COVID transmission precautions recommend contact + droplet precautions

Airborne Precautions

Organism →

Need

Organism → Measles, Varicella, active TB, SARBS

Need

• Airborne infection isolation room

• Clean hands

• N95 mask or powered air-purifying resp (PAPR)

Opioids stewardship

Avoid …MME/day unless absolutely necessary

Tper slowly in patients with chronic opioid use, typically … per week

5 As of smoking cessation

Avoid >90 MME/day unless absolutely necessary

Tper slowly in patients with chronic opioid use, typically 10% per week

5 As of smoking cessation

• Ask

• Advise to quit

• Assess willingness

• Assist in quitting

• Arrange follow up

Medication safety tips 

• Preventions in issues with similar name medications →

• Always measure in…(ie kg and mL, for consistency)

• Saline: Eliminate all …from areas outside the pharmacy and use …to prevent mistaking them for…

• Do NOT use the…for verification due to high risk of error

• C-II are valid for up to…

Medication safety tips 

• Similar name medications → tall man lettering, separate them in the pharmacy

• Always measure in metric units (ie kg and mL, for consistency)

• Eliminate all 1 liter bags of sterile water from areas outside the pharmacy and use 2 liter bags or bottles of sterile water to prevent mistaking them for D5W or NS (prevent death from hemolysis)

• Do NOT use the syringe pull-back method for verification due to high risk of error

• C-II are valid for up to 30 days federally

Martindale: The Complete Drug Reference →

Facts and Comparisons →

American Hospital Formulary Service →

Martindale: The Complete Drug Reference → Foreign Drugs

Facts and Comparisons → Comparative drug tables

American Hospital Formulary Service → Med availability, drug monographs

DailyMed →

United States Pharmacopeia →

Trissel’s, Handbook on Injectable Drugs →

Hansten and Horn’s →

DailyMed → Package inserts, inactive ingredients

United States Pharmacopeia → compounding reference

Trissel’s, Handbook on Injectable Drugs → IV compatibility

Hansten and Horn’s → complex drug interaction

The Harriet Lane Handbook, Nelson’s, Teddy Bear Book →

Beers criteria →

Sanford Guide →

Brigg’s, Hale’s (LactMed) →

The Harriet Lane Handbook, Nelson’s, Teddy Bear Book → Pediatric resources

Beers criteria → what meds to avoid in adults

Sanford Guide → ID, antimicrobial therapy

Brigg’s, Hale’s (LactMed) → drug safety during pregnancy and lactation

Yellow book →

Red book →

Orange book →

Purple Book →

Pink book →

Green book →

Yellow book → vaccine requirements

Red book → drug prices

Orange book → therapeutic equivalence

Purple Book → biological products, biosimilar and interchangeable products

Pink book → epidemiology, vaccine-preventable disease

Green book → animal products

Guidelines Names

HTN, HF, PAD, Afib, Dyslipidemia →

Dyslipidemia →

VTE: PE/DVT →

HTN, HF, PAD, Afib, Dyslipidemia → AHA/ACC

Dyslipidemia → NCEP/AACE

VTE: PE/DVT → CHEST

Guideline Names

Asthma →

COPD →

DM →

Mental disorders →

Infections →

Asthma → GINA

COPD → GOLD

DM → ADA; ACCE/ACE

Mental disorders → DSM-V

Infections → IDSA