Medication Preparation

Background

The pharmacist all medication preparation:- non-sterile creams, ointments;- sterile compounds e.g. eye drops; - sterile products e.g. TPN, IV admixtures and Cytotoxic drugs.

The pharmacist knowledge of:- ingredients,- equipment, - compatibility,- stability, - technique needed to compound sterile and non-sterile

extemporaneous prescriptions.

Background

Personnel- proficiency in the art of compounding,- knowledge, - experience,- ability to assume the responsibility. - continuing competency and training programs.

Apparel- clean clothing. - protective apparel, e.g. lab coats/jackets, apron or gloves.

- to protect drug products from contamination during processing or packaging.

- to help protect employees.

Background

Area

- specifically designated area.

- adequate lighting and ventilation.

- the compounding area for sterile products shall be separate and distinct from the area used for compounding of non-sterile drug products.

Equipment

- appropriate design, composition, size and suitably located.

- cleaned and sanitized to prevent contamination.

Background

Packaging- containers used in compounding shall be stored in a manner

to prevent contamination.- bagged or boxed containers shall be stored off the floor.- containers shall not be reactive, additive or absorptive.- containers shall provide adequate protection against

foreseeable external factors in storage.

Expiration date- Expiration dates should be derived using any of the following:

a) the manufacturer’s expiry date of the product with the shortest expiration,b) pharmaceutical compendia,c) professional literature,d) in-house stability and/or sterility studies.

Cytotoxic Drug Preparation

Personnel- All pharmacy personnel involved in any aspect of Cytotoxic

agent handling shall be trained in:- appropriate handling techniques, - preparation, - reconstitution, - administration,- disposal of Cytotoxic agents.

- All pharmacy staff shall be informed:- health hazards of working with Cytotoxic agents, - handling of Cytotoxic agents by pregnant, breastfeeding women or

individuals actively try to conceive should be prohibited. - the effect of exposure to hazardous drugs on human reproduction is

not fully understood.

Cytotoxic Drug Preparation

Apparel- wear protective clothing “special clean, low particulate generating

disposable garments, with a back closing, long sleeves, tight fitting cuffs and neck”.

- remove wristwatches, and jewelry.- wash hands and arms up to the elbows with antimicrobial skin cleanser. - wash hands before and after the preparation session.- wear sterile, powder free gloves and disinfect regularly with 70% isopropyl

alcohol.- change the disposable gloves every 30-60 minutes or when contaminated

or punctured.- wear head and facial hair coverings, covering the ears and all the hair to

minimize particulate shedding.- wear face mask. - wear garments prior to entering the aseptic preparation area, and remove

upon exiting the area.

Cytotoxic Drug Preparation

Cytotoxic Drug Preparation

Area

- dedicated solely to the preparation of sterile products.

- limited access.

- secluded from general traffic to minimize air turbulence.

- well lit.

- nonporous washable floors, walls and counters.

- untrained personnel shall not enter the aseptic preparation area unless they are supervised .

- an eyewash station should be located within 7 meters of the work area.

Cytotoxic Drug Preparation

Equipment

- laminar air flow hood equipped with a HEPA filter to prevent contamination with microorganisms and particulate matter.

- the hood should be kept running continuously.

- if turned off, it should not be used for at least 30 minutes after being turned on, or as specified by the manufacturer.

- a qualified technician shall certify the hood at least annually.

- Biological Safety Cabinets shall be cleaned and disinfected before and after each preparation session:- water for injection or irrigation and a small amount of cleaner,

- 70% isopropyl alcohol.

Cytotoxic Drug Preparation

Cytotoxic Drug Preparation

Cytotoxic Drug Preparation

Definition of Hazardous Drugs:Carcinogenic

Teratogenic

Reproductive toxicity

Organ toxicity at low doses

Genotoxic

By definition; a drug is deemed hazardous if it causes harm to organs:

Liver damage was reported in the literature on three nurses (working 6, 8 and 16 years) with chemotherapeutic agents.

Cardiotoxicity related to the use of anthracyclines.

Cytotoxic Drug Preparation

Cancer Risk in WorkersLeukemia in nurses (Skov et al, 1992) (RR = 10.65)Cyclophosphamide (Sessink et al, 1993) (1.4-10 excess cases/million)NHL & skin cancer (Hansen & Olsen, 1994) (SIR = 3.7) Overall increased cancer risk (Martin, 2005) (OR = 3.27)

Reproductive Risks in WorkersFetal abnormalities (Hemminki et al, 1985)Spontaneous Abortions (Stucker, 1990)Infertility (Valanis et al, 1997)Miscarriages (Valanis et al, 1999)Infertility, premature labor, low-birth weight, learning disabilities in offspring

(Martin, 2005)Infertility (Fransman, 2007)

TeratogenicityConflicting opinion on exposure during 2nd and 3rd trimesters.Greatest danger during 1st trimester.

Cytotoxic Drug Preparation

Modes of Contact for Drug Exposure to Healthcare Worker

Cytotoxic Drug Preparation

Policies and Procedures- Ensuring Cytotoxic ampoule heads are clear of liquid.

- Wrapping the ampoule neck with an alcohol swab before cracking.

- Dissolving powders in ampoules and vials by introducing diluents slowly down the wall (wetting minimizes dusting) “but it’s not always possible”.

- Measuring final volumes before removing the needle from the vial.

- Wrapping the needle and vial top with an alcohol swab before withdrawing the needle to minimize aerosol escape and removes last drop from needle tip.

Cytotoxic Drug Preparation

- Using syringes and IV infusion administration sets with luer-loc fittings.

- Attaching and priming IV infusion administration sets prior to adding Cytotoxic agent.

- Needles shall not be recapped or clipped after use, but discarded directly into a designated Cytotoxic sharps container to prevent accidental skin punctures.

- Using a negative pressure technique by injecting a small amount of air into a vial permitting the removal of the required volume.

Cytotoxic Drug Preparation

- All cases of exposure to Cytotoxic agents must be reported and documented. - An incident report must be completed documenting the cause and corrective action taken.- Detailed treatments shall be developed and available in the event of Cytotoxic exposure via skin

puncture, skin or eye contact or inhalation.

- A clearly defined, formal procedure for handling Cytotoxic agent spills must be developed. - Clearly labeled spill kits must be kept in or near all preparation, administration and storage

areas. - All broken containers, contaminated packaging and cleanup materials must be disposed of

appropriately in Cytotoxic waste containers.

Cytotoxic Drug Preparation

Vinca Alkaloid Administration- In setting where a patient has an order for a lumbar puncture and a

combination of intrathecal and intravenous therapy, the following procedures must be in place:

a) ensure that vinca alkaloids (vincristine, vinblastine, vindesine, etc..) are NEVER in the same treatment area where a lumbar puncture is being performed.b) prevent cross labeling in the pharmacy by physically separating intrathecal and intravenous doses during all stages of preparation and labeling. c) clear the hood of all intravenous medications prior to mixing drugs for intrathecal use.d) prominently warn that vincristine and other vinca alkaloids are fatal if given intrathecally. Ensure the warning label is affixed DIRECTLY to the label on the syringe barrel (i.e. WARNING: FATAL IF GIVEN INTRATHECALLY).

Potassium Chloride Injections

Potassium chloride (KCl) injection infused too rapidly or given by direct IV can cause cardiac arrest.

KCl poly-ampoules have been mistaken for normal saline, sterile water and heparin.

KCl concentrate shall be removed from all nursing units, including medication storage sites, medication carts, unit dose carts, and after hours cabinets.

Potassium Chloride Injections

Strategies to reduce risk of KCl concentrate:

a) educating prescribers and nursing staff about the risks and potentially fatal consequences of KCl medication errors,

b) encourage prescribers to use oral KCl whenever possible,

c) premixed KCl large volume Parenteral and minibags are commercially available. The increased cost far outweighs the potential consequences of a KCl error.

d) prohibit the addition of KCl concentrate to premixed KClsolutions. KCl concentrate can pool at the injection port, effectively delivering a “bolus” of KCl to the patient.

Double Check

Critical work Risk management Double check.

Double check: negative/positive sides.

Double check problems:- the process takes extra time.

- staffing shortages and other time resource issues plaguing healthcare.

- could lead to more mistakes as staff learn to rely upon others to catch problems.

- the checker may, based upon his colleague’s past performance, assume that the work is sound, and so be less observant during the double-check process.

- many facilities have experienced errors that reached patients despite double-checks !

Double Check

Double check importance:

- Double-checks identify a higher rate of errors than people realize.

- The average “checking error rate” (errors missed during a double-check) is about 5%.

- It’s hard to find your own mistakes “In a pharmacy simulation, for example, participants were significantly better at finding other’s mistakes rather than their own”.

Double Check

- Limit checks to high-risk situations:

- certain high-alert medications, very complex processes, and high-risk patient populations “ e.g. IV chemotherapy, IV and epidural opioids, IV insulin, IV heparin, neonatal parenteral medications, TPN compounding, and manual compounding of electrolyte solutions”.

- Double-checks work best when they are conducted independently:

- e.g. the independent double-check that occurs when a pharmacist dispenses medication and a nurse checks the accuracy,

- or when certain designated drugs are returned un-administered and pharmacy staff investigate to learn why the drug wasn’t given.

Assignment

What kind of IV fluids are present in the hospital? Classify according to: tonicity, type (crystalloid vs. colloid), composition, quantity of the ingredients (per 100 ml), total volumes available.