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

No error

Error, no harm

Error, harm

Error, death

Category A-I

No error

• Category A → potential to cause error

Error, No harm

• Category B → did not reach patient

• Category C → reached patient, no harm

• Category D → reached patient, require monitoring

Error, Harm

• Category E → intervention needed

• Category F → hospitalization needed

• Category G → permanent damage

• Category H → intervention to sustain life needed

Error, Death

• Category I → death

Will define all the categories on the exam but not give you the colors

Need at least…acceptable patients identifiers

• 
  

Patient family can access patient medication profile if…

• (2)

Need at least 2 acceptable patient identifiers

• Name, DOB

• Medical record #

• Exact address or telephone number, SSN

---

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

Institute for Safe Medication Practices (ISMP) → set…

The Joint Commsion (TJC) → sets…

---

Practice 5 rights of med administration (high yield)

Institute for Safe Medication Practices (ISMP) → set guidelines to prevent medication error

The Joint Commission (TJC) → sets National Patient Safety Goals (NPSG)

---

PMDRT

Right Patient

Right Medication

Right Dosage

Right Route

Right Time

Medication Reconciliation at every…

Comprehensive Medication Review (CMR) vs Targeted Medication Review (TMR)

• Error of omission →

• Error of commission →

Medication Reconciliation at every transitions of care

Comprehensive Medication Review (CMR) longer than Targeted Medication Review (TMR)

• Error of omission → Missing a med they needed

• Error of commission → Adding a med they shouldn’t have added

SMART SAFE MEDS MME

SMART

Single dose vials >>> Multi dose vials

Metric system

Avoid abbreviations → QD, OD, QOD etc

Report results on time

Two patient identifiers

SAFE

Separate look/sound alike → tall man lettering, separate them in the pharmacy

Auxiliary labels/alerts

Formulary control → Pharmacy managing crash carts and high alert meds

E-prescribing

• Clinical decision support

MEDS

Medication indication on every Rx

Enhance system design (ie proper workflow)

Dont reply on packaging → actual med needs to be verified

Standardized process

MME

Medication reconciliation in every transition of care

• Come in → ED → ICU → Med surg → D/C

Medication Therapy Management (CMR → all meds, TMR → only some med)

Education (ie patients, peers)

ISMP High Alert Meds

Pneumonic

Very Sick Patients Need Big Calm Nurses Managing High Risk Meds

Vasopressor / Adrenergics (EPI, BB)

Sedatives (Lorazepam, Midazolam)

Paralytics (neuromuscular blockers)

Narcotics (oopiods)

Blood thinners (anticoags, thrombolytics)

Chemo agents

Nutrition/glucose (insulin, sulfonylureas)

Magnesium + Methotrexate

K potassium (KCl, KPhos)

Hypertonic (NaCl, dextrose)

Meds → Catch All

• Inotropes (digoxin, milrinone)

• Anesthetics (propfol, ketamine)

• Nitroprusside / Flolan

• Liposomal drugs

• Sterile water

Methotrexate → frequency

Vinca Alkaloids → formulation

Sterile water vs NS → bags

Methotrexate → upside down → Weekly

Vinca Alkaloids → NEVER intrathecal, ONLY IV

Sterile water vs NS → 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)

Insulin

• Formulation

• …before…

• Long-acting insulin prepared…

Pen vs Multi dose vials

Insulin

• SQ/IV, don’t give IM

• Clear before cloudy

• Long-acting insulin prepared by pharmacy (harder to reverse effect)

Pens

• 1 pen per patients but $$$

• Need separate pen needle Rx, use new needle with each injection

Multi dose vials

• Can use multi-dose vials for multiple patients and $

• Do not leave in the carts/hospital floors

TPN

Simple vs Complex

Filter size (with/without filter)

---

Trace Elements → Acronym (5)

Electrolytes

• Always add →

• Never add → (2)

• First…then…

Mixing…with lipids cracks emulsion

TPN

Simple → D5W

Complex → D5W, lipids, AA, electrolytes

• 1.2 filter with lipids

• 0.22 filter if no lipids

---

Trace Elements → Acronym (5)

Crazy Cats Munch Zinc Secretly:

• Chromium

• Copper

• Manganese

• Zinc

• Selenium

Electrolytes

• Always add → Na, Cl — K, Mg — Ca, PO4

• Never add → HCO3 (precipitates Ca), extra Ca (precipitates PO4)

• First phosphate, then Ca

Mixing iron with lipids cracks emulsion

TPN Complications

Short term

• (3)

Long term

• (4)

Short term

• Refeeding syndrome (bc feeding too fast, rapid excretion of insulin) → hypokalemia, hypomagnesium, hypophosphatemia

• Hyperglycemia (bc tapered up too fast)

• Hypoglycemia (bc tapered down too fast while still secreting insulin)

• Volume overload

• ADE to lipid emulsions

• Catheter related sepsis/pneumothorax

Long term

• Vitamin deficiencies

• Vit D and Ca deficiency → Osteoporosis, Osteomalacia

• Hepatic complications

• Cholelithiasis, Cholecystitis (infected gallstones)

Crash cart

• (3)

Broselow carts

• (2)

Crash cart

• Unit dose = single use

• Pharmacy is responsible for restocking and check for exp dates on 1st day of each month

• Tamper proof

Broselow carts

• Pediatric crash cart

• Color coded drawers for children with different weights

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)

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

Opioid naive → start off with… (avoid…)

Opioid tolerance → defined as

Tapering in chronic opioid use →

5 As of smoking cessation

Opioid naive → start off with IR (avoid ER, XR, patches)

Opioid tolerance → 60 MME/day + at least 1 week

Tapering in chronic opioid use → slowly, typically 10% per week

5 As of smoking cessation

• Ask

• Advise to quit

• Assess willingness

• Assist in quitting

• Arrange follow up

Automated dispensing cabinet (ADC)

• Blind count →

• Profiled vs Non-profiled

• Override →

Open Matrix Drawer

Automated dispensing cabinet (ADC)

• “Locked and lidded pockets”

• Blind count -> user physically count and enter the quantity of the controlled substance before the machine dispenses drug. If user types a number that doesnt match sytem's expected balance, discrepancy is instantly flagged

• Profiled (required review/verification of order) vs Non-profile (bypass verification)

• Override → removing controlled substance without verified order, strictly for emergent situations where it may impact patient’s health

Open Matrix Drawer

• Contains meds with lower risk for harm

Veracity →

Fidelity →

Beneficence and nonmaleficence →

Justice →

Confidentiality →

Autonomy → 

Violation of anti-kickback laws →

Veracity → telling the truth, not giving false hope (ie counseling points)

Fidelity → follow thru/up

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)

SBAR

SBAR

Situation → Dr wants new insulin Rx

Background → pt is taking…

Assessment → Pharmacist sees metformin can be titrated

Recommendation → pharmacists recommends increasing metformin dose

Know the order if you had to rearrange a question based on SBAR format

Root Cause Analysis (RCA) →

Failure Mode and Effects Analysis (FMEA) →

What if error is discovered?

Root Cause Analysis (RCA) → error already happen

Failure Mode and Effects Analysis (FMEA) → prevent error in the future

What if error is discovered?

• Patient and prescirber immediately notified

• QA (with date, location, participants, pertinent info and recommended changes)

• P&T commitee

Kangaroo pump

Function

Hold the feed with…

Do not crush…

Always…

Helps timing of food to be administered when taking meds

Hold the feed with Phenytoin and Cipro 1-2 hrs before/after giving meds

Do not crush ER or enteric coated pills down tube

Always flush tube before and after any meds

Things that can go down the sink

• Fluids without meds (NS, D5W)

• Electrolytes

• Vitamins

• TPN (without meds) or lipids

• Any foods such as enteral feeds that dont contains meds

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

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

Preceptorship embodies ….

• Instructing →

• Modeling →

• Coaching →

• Facilitating →

• Mentoring →

Preceptorship embodies beneficence and nonmaleficence

• 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.

known the order too, may need to rearrange

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

Exclude the following medications from Automated dispensing cabinet

All insulin

Vincristine

Neuromuscular blockers (vecuronium, rocuronium, succinylcholine)

Meds that require multiple dilutions, reconstitution

Highly conc oral liquid, parenteral opioids, electrolytes (esp K)

Droplet Precautions

Organsims →

Use… protection

COVID

Organsims →

• Influenza, RSV and other resp viruses

• Diphtheria, Pertussis, and Neisseria meningitidis

Use mask and eye protection

COVID transmission precautions recommend contact + droplet precautions

Remember contact precautions (C diff, Noravirus, Rotavirus, VRE, MRSA)

Remember airborne precautions (Measles, Varicella, active TB, SARBS)

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)

Remember contact precautions (C diff, Noravirus, Rotavirus, VRE, MRSA)

Remember droplet precautions (influenza, RSV and other resp viruses, Diphteria, Pertussis, and Neisseria meningitidis)

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 

COVID transmission precautions recommend contact + droplet precautions

Mask and eye protections are used with droplet precautions

Remember droplet precautions (influenza, RSV and other resp viruses, Diphteria, Pertussis, and Neisseria meningitidis)

Remember airborne precautions (Measles, Varicella, active TB, SARBS)

Drug recalls Classes

• 3

Managing recalls in hospitals

• Steps

Drug recalls Classes

• Class 1 → severe adverse health consequences or death

• Class 2 → temp/reversible health consequences

• Class 3 → unlikely to cause ADE

Managing recalls in hospitals

• Receive timely notification

• Remove product from patient care areas

• Notify and tx patients with received product. Give alternatives

• Return product

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