Sterile Compounding Final

What are the challenges of treating peds?

Unfamiliarity of diff w/ adults

Need custom doses for various weights

Need to consider volume to avoid fluid overload

Drug delivery method

Why is pediatric medication safety important?

Increased risk of harm b/c

Limited capacity to tolerate med errors

Possibly unsuitable commercial products

Complex calculations (BSA, etc.)

What is the best practice for pt weights?

Weigh on admission and each encounter

USE METRIC ONLY b/c conversion can cause errors and dosing references use metric only

What are the best practices based on the fact that pediatric drugs are high risk?

Perform independent verification to ensure proper volume prior to each addition esp there is no technology or automation for compounding CSPs

What are the possible methods of parenteral delivery?

IV push

IVPB bag

IVPB syringe

IV syringe continuous inf

Larve volume parenteral

What is IV push?

Rapid drug admin over 1 to 2min

Usually no dilution and dont at bedside

What is IVPB bag?

AKA small parenteral bags

Med delivery in standard volumes of 50, 100, 250ml

Can be commercially made w/ long shelf life and can customize pt-specific dose in standard bag volume

What are the benefits and uses IVPB syringe?

Enhanced ability to customize dose and volume

Controlled drug delivery of intermittent med over set amount of time

Accurately deliver <0.1ml/hr

Extremely common in ped doses that cannot be given using commercially available options

What is continuous infusion and when is it used?

Used for certain meds that you want to administer over time (REQUIRES UNIT OF TIME FOR THE RATE)

Sedation/analgesia for critically ill

CV agents

Meds w/ short HL

What are large volume parenterals?

Deliver continuous infusion to provide pt w/ maintenance fluids

Can be commercially available or customized

What is the process of using IVPB syringes?

Start with original drug product and reconstitute w/ NS or SWFI if needed (may be liquid already)

Dilute reconstitute/liquid even farther to standardized concentration to create stock soln

Transfer proper volume of stock soln into individual unit-dosed syringes

Label syringes w/:

Pt name and identifier

Dose

Diluent and volume

Date prep

BUD

pharmacy tech preparing/RPh check

Why are stock solutions mades at standardized concentrations?

Safety and efficiency

What is the rule of 6s?

Used to calculate infusion rate based on pt weight

6 * weight (kg) = mg drug added to 100ml of diluent

If you infuse at 1ml/hr, then 1mcg/kg/min

NOT USED ANYMORE

What is the downside of rule of 6s?

Risk of 10x error

Each pt on different mg dose since weights are different

Dose may not be w/in stability range

No standard concentration so no standard compounding

When are standard concentrations not used?

Settings where lots of ages treated such as NICU and PICU

What are the safety advantages of standard concentrations?

Less compounding variability

Validated stability references

Interoperability b/w IV room, EMR, syringe inf pump

What is standardize 4 safety and its goals?

Nationwide effort to standardize concentrations of drugs in order to improve transitions of care

Conc and dosing units for IV continuous meds for adults

Conc for compounded oral liquid meds

Conc and dosing units for IV continuous meds for peds

Doses for oral liquid meds

Conc for IV intermittent meds

Conc for PCA and epidural meds

What are smart pumps?

Deliver fluids, meds, blood products at low inf rates in small increments

Have standardized concentration and guardrails to alert practitioner when inf rate is outside of pre-determined limits

What is important about using smart pumps?

Ensuring syringe size and models are compatible w/ syringe pump

Using smallest syringe b/c larger syringe can lower rate

Tubing: for example microbore requires small priming volume

What are the special considerations in neonates in compounding?

Consider fluid status in order to ensure meds are at optimal conc to avoid fluid overload while still ensuring stability

Safety of excipients is important as well as the drug so preservative-free forms are preferred

What are the excipients that can be problematic in neonates?

Benzyl alcohol (bacteriostatic)

Propylene glycol

Ethanol

What are the effects of benzyl alcohol in neonates?

Gasping baby syndrome:

Metabolic acidosis

Resp distress

Seizures

HoTN & CV collapse

Death

What are the effects of propylene glycol in neonates?

CNS tox

Hyperosmolarity

Arrhythmia

Lactic acidosis

What are the effects of ethanol in neonates?

Neurotox

Impaired brain devo

How are pediatric medications usually dosed?

Weight or BSA

What are the BSA equations?

sqrt(in*lb/3131)

What are the meds that are dosed based on BSA?

Chemo

Steroids

What do we have to consider when thinking of med concentrations?

Fluid status and conditions that may decrease fluid reqs like RDS, decreased renal function

Stability

What are the common products that require pediatric stock solutions?

Antibiotics

Analgesia

Anti-convulsants

Electrolytes

Diuretics

What is CAPS?

Central Admixture Pharmacy Services

Worlds largest parenteral makers

What is the purpose of CAPS?

Outsourcing compounding for health systems

What are the things that CAPS offers?

Parenteral nutrition

Cardioplegia

Chemo

CRRT

Standardized drug delivery

Controlled substances

Prefilled anesthesia syringes

Prefilled pain pumps

What do 503b do?

Made for no specific patient in mind

What do 503a do?

Local customers w/ more customized CSPs for specific pt

When does cleaning occur at CAPS?

B/w every drug every day

What are the quality assurance measures by CAPS?

Rapid sterility testing

Barcode automation

Extended BUD validation

QA reports

How fast is the turn around for CAPS?

4hrs

What is the reception and administration building at nephron?

HR

Executives

Marketing

Inside sales

Regulatory

What is home infusion therapy?

Pharmacy-based decentralized pt care org w/ UP797 expertise

Provides care to pt w/ acute or chronic conditions related to parenteral admin of drugs, biologics, nutrition through canths and/or needles

Extensive professional pharmacy services, care coordination, infusion nursing services, supplies and equipment

What is the Hx of home infusion?

Started in 1970s

$12.8B but will be $87B

1500 infusion pharmacies in US

What are the types of home infusion companies?

Independent companies

National companies

Part of health system

Entities providing 1 or 2 therapies

Entities providing multiple therapies

What are the advantages of home infusion?

Treatment at home

Nurse vitis home to maintain vascular access and ensure pt safety

Pt can resume work and lifestyle

Cost savings b/c decreased LoS

Safe and effective

Pumps are small, portable, and easy to use

Avoid nosocomial infections

Qualified RPh/nurse available 24/7

WHat are the limitations of home infusion?

Not all drugs appropriate

Pt/caregiver must be willing and able to be educated

Home environment requires electricity, running water, safe, clean

Refrigerator may be required

Pt/caregiver must have phone and willing to be in contact abouts meds, progress, deliveries

What is the workflow of home infusion?

Intake

Nursing

Pharmacy department

Distribution

Reimbursement

What does intake in home infusion do?

Case manager at hospital, MD office, HUB receive referral through portal, fax, HCP call

Set up EMR w/ demographics, insurance info

Coordinate benefits for inf materials, nurse visits, lab facilities, supplies

Communicate w/ pt about financial responsibilities

Receive Rx and other clinical info needed for authorizations

What does nursing in home infusion do?

Call referral source back after benefits approved and discuss venous access if 1st dose and what dose to start at home

Set up nursing vitis to change dressing, take blood for labs, change bags, and/or admin meds

Monitor ADRs, anaphylaxis, line care, disease progression

Initiate IV access if hep-lock or midline and may remove PICC once therapy completed

What are the parts of pharmacy department in home infusion?

Pt service associate

Pharmacist

IV techs

What does pt service associate in pharmacy department of home infusion do?

Set up pt chart while verifying pt demographics, address, allergies

Discuss med storage w/ pt/caregiver

Create delivery tickets listing meds and supplies to be sent

What does pharmacist in pharmacy department of home infusion do?

Confirm orders, review pt profile, create care plan, monitor labs

Call pt weekly to review compliance, ADRs, supplies

Conduct MTM if needed

Stage drug checks prior to mixing, QA final orders, check final supplies and drugs for delivery

What do IV techs in pharmacy department of home infusion do?

Stage and label preps

Compound all meds based off compounding order sheet using aseptic tech

Pull all supplies needed to admin med based on delivery ticket

Maintain clean room: document temps, humidity, pressure, cleaning

Inventory

What does distrubtion of home infusion do?

Oversee ordering and inventory

Oversee delivery drivers and 3rd party couriers

What does reimbursement of home infusion do?

Bill insurance (primary and 2ndary) and pts

Collect payments

Post payments

What are the common disease state that are treated by home infusion?

Cancer

CHF

Crohns

Dehydration

GI diseases

Immune disorders: immune thrombocytopenia, lupus

Infection: OM, endocarditis

MS

Pain: hospice, cancer-related pain

RA

What are the drugs given by home infusion?

IV Abx: ceftriaxone, ertapenem, vanc, etc.

IVIG

TPN

IV opioids: opioids, hydromorphone

Chemo: 5FU, cytarabine

Inotropic therapy: milrinone, dobutamine

Specialty infusions: remicade, stelara, etc.

ANYTHING THAT CAN BE SAFELY ADMINISTERED AT HOME

What are the important factors to consider when thinking of home infusion?

IV access type

Evaluate therapy prescribed

Monitoring requirements

What are the types of IV access and what are the factors that need to be considered when thinking of home infusion?

PICC, port, hep-lock, midline, SC access

Verify access suitability for med being administered

Large volume?

Vesicant?

What needs to be considered when evaluating therapy prescribed for home infusion?

CSP stability

Duration and freq of treatment

Mode of admin

Storage and admin requirements: reconstituting, priming, flushing, etc.

Requirement of ANAKIT if 1st dose of therapy at home

What are the monitoring requirements that need to be considered for home infusion?

Labs if ordered

Weight if therapy is weight-based

ADRs

Signs of disease progress/improvement

Signs of infection

Pt specific factors: allergies, height, weight, age, sex, lifestyle

What are the characteristics of hep-lock IV including insertion steps?

Inserted by nurse Q3-5d

After blood return, remove needle and keep access

Tegaderm used to stabilize access

Add extension set so pt can give own meds

Add clamp and cap to prevent blood spilling

Acceptable for short-term home care

SASH flushing

Only certain meds given

Easily removed

What are the characteristics of midline IV including insertion steps?

Inserted and removed by RN w/o x-ray

Cath placed into large veins in arm and extends into peripheral vasculature up to shoulder

Add extension set

Use tegaderm to stabilize access

NOT CENTRAL LINE: cannot give TPN, vesicants, irritants

SASH flushing

What are the characteristics of PICC including insertion steps?

Line threaded through major vein in arm/chest into SVC w/ xray confirmation of line placement

Dressing changed QW

Removed by certified nurses

Good for pt who require freq/cont access

Lasts ~6 months

2-way valve: blood backs up, requires clamping, SASH flush, (if not being used, heparin BID)

1-way valve: no blood, no clamping, SAS

What are the characteristics of port cath including insertion steps?

Inserted underneath skin and goes into vena cava

Needs to be accessed

1-way valve: no heparin needed (SAS)

Needle inserted after palpating and can easily take shower

Used for chemo mostly

What are the characteristics of tunneled caths including insertion steps?

Single, double, or triple lumen

End hangs out chest

2-way valve: needs clamp and SASH

Dressing changed 3/week after 1st inserted

What are the characteristics of SC access including insertion steps?

Small needle goes into leg w/ long line

Remove needle and keep cath in

Can last 1 week

Used for hospice (morphine), hyperemesis, high Fe pt

What are the modes of delivery for home infusion?

IV push

Gravity flow

Home pump

Pole-mounted pump

Ambulatory pump

How do you take care of IV lines?

Sock-like to prevent pulling

Disposable cuffs to take showers

What are the characteristics of IV push?

Easiest for pt

Small volume (10 to 20ml) given over 2 to 10min

Pt/caregiver must be competent

What are the characteristics of gravity flow and types?

30min to 1hr

Requires bole, tubing, +/- rate control device

Cost effective

Straight tubing: count drops

Dial-a-flow: use wheel to calculate flow

Rate-limiting: IV cath access (kinks, size, etc.)

What are the characteristics of elastomeric device (home pump)?

100ml or 250ml balls

Filled w/ saline then medication

Rate determined by size of ball and tubing

Attach, unclamp, then go on w/ day

What are the characteristics of ambulatory pump?

Most accurate (follows programmed dosing schedule)

Spike bag, attach to pump

Put pump and bag in fanny pack (can be cumbersome)

Great for Q4H meds (Abx)

Can be used for TPN (backpack)

PCA mode for pain control

What are the 4 settings of ambulatory pumps and examples of drugs?

Continuous: milrinone, 5FU

Intermittent: Abx

TPN (run 12 to 18hrs) w/ adj for tapering up or down during 1st and last hors

PCA (locked out): morphine, hydromorphone

What is the clinical monitoring done for home infusion?

RPh must have ongoing clinical monitoring including:

Documentation

Collaboration w/ HCPs about monitoring results

Interpreting clinical monitoring to make dose adj, continuation or D/C of therapy recommendations

Pt counseling and MTM

What are the types of lab monitoring done for home infusion?

CBC: infection resolution

WBC count, ANC, CRP, ESR

Vanc: trough and kidney function

Daptomycin: CPK QW at least

Milrinone/dobutamine: BMP, CMP, CBC, Mg, K

Warfarin: INR, PT

What is the type of pt counseling done for home infusion?

Med info: drug, dose, route, freq, duration

Goals and how to monitor goals

Hand hygiene and how to care for vascular access

How to admin meds and precautions

How to inspect meds, containers, supplies

How to use equipment appropriately and troubleshooting

Potential ADRs, DDIs, CIs

How to prepare, store, handle, dispose of meds, supplies, biomedical waste

When to contact MD/RPh and what to do in emergencies

What is tonicity?

Concentration of nonpermeable solutes inside cell vs conc outside cell

MOVEMENT OF WATER

What is osmolarity?

Measure of PERMEABLE and nonpermeable solute concs

Number of osmotically active particles in 1L of soln

What is hypotonic, isotonic, hypertonic in terms of osmolarity?

Hypotonic: <280mOsm/l

Isotonic: 280 to 300mOsm/l

Hypertonic: >300mOsm/l

How is osmoles calculated from moles?

Number of moles * number of particles

What is the equation of osmolarity (mOsm/L)?

Osmoles * 1000/volume (L)

What is the use of osmolarity?

Determine if central or peripheral line can be used by adding Osm of each component

See effect of soln

How is mOsm calculated from mEq?

Calculate mOsm for each measurable ion in soln

Univalent: mEq = mOsm

Divalent: mEq/valence = mOsm

Add mOsm for all ions to obtain total

How can you calculate osmolarity (mOsm) of base solution?

Weight (g/L) x number of species x 1000/MW

Add mOsm for each additive

(Osmolarity of A x volume of A) + (osmolarity of B x volume of B)/total volume

What is the basic brain anatomy in terms of miedications?

CSF protects tissues from mechanical and metabolic insults and is made from choroid plexus

Blood-CSF barrier

BBB restricts chemical access

When is intracerebroventricular administration used?

Certain indications

Infections: severe meningitis, encephalitis

Cancer

Refractory pain

IC hemorrhage

What are the drug delivery routes to CNS?

Lumbar cistern (thecal sac): intrathecal

Lateral ventricle: intraventricular

What are the pros and cons of intrathecal drug delivery?

Bedside

Low risk

Local anesthetic

Separate puncture for each inj leading to cumulative risk

IC hemorrhage risk

What are the pros and cons of intraventricular drug delivery?

Dangerous to repeatedly tap so can but Ommaya reservoir SC w/ cath to ventricle

Infection, IC hemorrhage risk

What are the properties of drugs to be considered before ICV or intrathecal admin and why?

pH

Osmolarity: 281mOsm/L

Volume: rigid skull and non-compressible fluid can lead to increasing CL of drug and/or damage equal to volume injected

CL: hydrophilic drugs trapped

Concomitant systemic admin

Excipients: dont want any preservatives

What is the importance of excipients in intrathecal or IVC admin and what is an example?

Dont want preservatives b/c benzyl alcohol can cause metabolic acidosis, cerebral palsy, IV hemorrhage

Abx like pen G can cause seizures in systemically

Only certain products have preservative-free forms

What are the indications of parenteral nutrition (PN)?

Gut dysfunction

Malabsorption

Critically ill/trauma/catabolic

Severe pancreatitis

No enteral access

Enteral nutrition not possible to be resumed in 7 to 10d

What is the classification of PN by ISMP?

High alert b/c complex and many aseptic manipulations

What are the typical components of PN?

Base: AAs, dextrose, ILE, sterile water

Electrolytes

Vits and trace elements

Others (not recommended): famotidine, insulin, heparin

What are the 2 delivery methods of PN?

Traditional dextrose-AA (2-in-1) w/ ILE separate

Total nutrition admixture (TNA AKA 3-in-1 or all-in-1) w/ ILE included

24hrs of nutrition at constant rate or cyclic

What is the hang time of ILE?

12hrs b/c infection risk

What are the filters for PN?

ILE: 1.2 microns b/c fat globulins require larger filters

2-in-1: 0.22 microns which can filter micro-precipitates and bacteria

Y-site: 1.2 and 0.22 micron filters (0.22 near 2-in-1 and 1.2 micron downstream of ILE)

What are the advantages and disadvantages of 2-in-1 PN?

More stable

0.22 micron used: bacterial and micro-precipitate

Clear

Decreased cation interactions

Some premixes available

Might need multiple inf

More complex admin

What are the advantages and disadvantages of 3-in-1 PN?

Increased convenience

Reduced entries into central venous cath

More efficient prep

Convenient for home-care pharmacies

Possibly improved fat CL

Requires 1.2 micron filter (doesnt elim bacteria)

Admix w/ ILE is less stable over time b/c more incompatibilities

Difficult to visualize precipitates

Home admin may increase catheter occlusion risk

What is the process of ILE destabilization?

Addition of low pH (like dextrose) or electrolytes leading to deflocculation, coalescent, then creaming/breaking

What does the choice in delivery method of PN depend on?

Pt served

Convenience

Compatibility/stability issues

Logistics: ordering process, labeling format