Unit 4 PHRM 2022

Identify federal and provincial legislation and standards of practice relevant to the preparation of compounded sterile products.

Federal:Health Canada

• • Policy on “Manufacturing and Compounding Drug Products in Canada”

  • Outlines the factors that determine if a product falls under compounding or

  manufacturing

   Manufacturing:

  ▪ Preparation of product for sale to pharmacies for dispensing to their

  patients

  ▪ Defined and governed by the Food and Drug Act and Regulations

  ▪ Mostly done by pharmaceutical companies

   Compounding:

  ▪ Preparation of product for use by a specific patient based on a

  prescription within an established pharmacist-patient-prescriber

  relationship

  ▪ Governed provincially

  ▪ Mostly done by pharmacy personnel

• ACCORDING TO NAPRA: In situations involving requests to compound preparations outside of a prescriber–patient–pharmacist relationship,

  in the absence of a patient-specific prescription, the preparation activities fall under the federal legislative framework.

  For example, the bulk preparation of compounded preparations in the absence of a prescriber–patient–pharmacist

  relationship would fall under the federal legislative framework.

• ACCORDING TO NAPRA: Health Canada is the federal department responsible for the Food and Drugs Act and the Controlled Drugs and Substances

  Act and their associated regulations. In January 2009, Health Canada developed its “Policy on Manufacturing and

  Compounding Drug Products in Canada”7

  . At the time these Model Standards were prepared, Health Canada was

  examining this policy with a view to creating new standards for situations not covered within the practice of pharmacy

  or under the current federal licensing framework, such as commercial compounding manufacturing.

Provincial: NAPRA

• Introduction: The new NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations have been

  adapted from standards originally developed by the Ordre des pharmaciens du Quebec, which are in turn based on

  General Chapter <797> of the United States Pharmacopeia – National Formulary (USP–NF) in effect in the United

  States since 2004. Their preparation was led by the NAPRA ad hoc Committee on Pharmacy Compounding and involved

  extensive consultation with experts and stakeholders.

• Objective: To provide pharmacists and pharmacy techs who compound non hazardous sterile preparations with the standards necessary to evaluate their practice, develop service-related procedures and

  implement appropriate quality controls for both patients and compounding personnel, with a view to guaranteeing the

  overall quality and safety of sterile preparations. The Model Standards will come into effect in each province/territory

  once they have been adopted by the respective provincial/territorial pharmacy regulatory authorities. THE MINIMUM requirements to be applied in compounding sterile preparations, but should aim to exceed these standards.

• NAPRA’s professional competencies for Canadian pharmacists and pharmacy technicians at entry to practice provide

  guidance for developing an ethical, legal and professional practice. One of these competencies specifies that a pharmacist

  or pharmacy technician must seek guidance when uncertain about his or her own knowledge, skills, abilities or scope of

  practice. Therefore, individuals who do not have the knowledge, training, expertise, facilities or equipment required to

  compound sterile products must refer patients to a colleague who does have the competencies and facilities required to

  do so or, where permitted by provincial/territorial legislation, ask another pharmacy to compound the product for them

• • In 2016, the Alberta College of Pharmacy approved the Model Standards of Non-hazardous Sterile Preparations for the province. These standards are based on 797 standards.

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• Regulatory Framework:

• Compounded sterile preparations are prepared by many health care professionals, including nurses, physicians,

  pharmacists and pharmacy technicians. However, the majority of sterile compounding is performed by pharmacy

  personnel under the supervision of pharmacists.

• Pharmacy Compounding must always be carried out within a prescriber, patient, and pharmacist relationship.

• Provincial/territorial pharmacy regulatory authorities are responsible for regulating a pharmacy’s compounding services

  in these situations.

• Pursuant to model standards, sterility is also required for the reconstitution and certain manipulations (according to manufactureres instructions) of sterile products approved by Health Canada and for repackaging of approved sterile products, regardless of the route of administration.

• Compounded Sterile Preparations Include these medications:

• • nasal inhalation solutions

  • respiratory therapy solutions

  • solutions for live organ and tissue or graft baths

  • injections (e.g., intramuscular, intravenous, intrathecal, intradermal, subcutaneous)

  • irrigation solutions for wounds and body cavities (e.g., thoracic, spinal, abdominal, pelvic)

  • ophthalmic drops and ointments

  • otic drops for intratympanic administration

  • parenteral nutrition

  • dialysis solutions

• allergen extracts

  • topical preparations (where sterility is essential to the therapy, e.g., for patients with burns)

  • radiopharmaceuticals

USP <797>

• The United States Pharmacopeia (USP) is an official publication used by both

pharmacists and pharmacy technicians in their practices. It is the official

standard authority for all prescription and over-the-counter medications in

the United States.

• In 2004, USP Chapter 797 became official in the U.S., and has been used in

sterile compounding environments since, improving the concepts and

standards of compounded sterile preparations (CSP’s).

• USP 797 pertains to all personnel involved in preparation, storage, and

transportation of CSPs prior to administration.

CSHP – Canadian Society of Hospital Pharmacists

• CSHP Compounding: Guidelines for Pharmacies 2014

• Created a set of compounding guidelines for pharmacies to use as a

complement to any legislative provincial/federal practice requirements. The

guidelines cover sterile and non-sterile compounding, as well as

radiopharmaceuticals and hazardous preparations, in pharmacies where such

preparations are intended for human use, regardless of route of

administration.

ASHP – American Society of Health-System Pharmacists

• Strives to improve medication use and enhance patient safety

• Developed the “ASHP Guidelines on Compounding Sterile Preparations”

CETA (Controlled Environment Testing Association)

• Provides certification of secondary engineering controls. The controls include

equipment such as cleanrooms, laminar flow hoods, fume hoods, biological

safety cabinets, isolation rooms, and other controlled environments.

• More information, Appendix 5 in the NAPRA Model Standards outlines the

Minimum Indicators for Certification of Controlled Areas and Primary

Engineering Controls

Alberta College of Pharmacy (ACP)

• Activities are governed by the Health Professions Act

• Pharmacies must meet guidelines and standards that ensure quality and

safety of the pharmaceuticals they compound

• Standards of Practice for Pharmacists and Pharmacy Technicians

National Institute for Occupational Safety and Health (NIOSH)

• The NIOSH list can be used to determine whether a particular product is

hazardous

• Compiles and reviews drugs that can pose an occupational hazard to

healthcare workers

• The drugs outlined in NIOSH are organized into three tables, depending on the

potential handling risks

• Provides recommended standard precautions that should be taken when

handling hazardous drugs, such as engineering controls and personal

protective equipment (PPE)

USP <800>

• Describes practice and quality standards for handling hazardous drugs in

health care settings and help promote patient safety, worker safety, and

environmental protection

• Standards were written to protect all workers, patients, and the general

public who may be accessing facilities where hazardous drugs are prepared.

2. Identify potential sources of contamination in sterile compounding.

• Touch Contamination: People (skin, exposure poor technique), products (exterior packaging, product itself), Faculty (walls, ceiling, floor, furniture)

• Air Contamination: Viable and non viable contaminants found in air (facilities are designed to reduce contamination by 99.9% so if this is not working properly ((Laminar flow hood fails to work properly) CONTAMINATION occurs

• Water Contamination: Sneezing, coughing

• Shadowing: obstruction of airflow

Non-Viable Contaminants:

is a particle that does not contain a living

microorganism but acts as transportation for viable particles.
VIable Contaminants:

Viable

contaminants contain one or more living microorganisms. Bioburden is defined

as the number of bacteria living on a surface that has not been sterilized.

Factors that Affect Contamination Include:

• Duration of Contact

• Surface Texture: porous or rough textures are harder to clean and more likely to contain contaminiants than smoother surfaces

• Surface Area : risk of contamination increases with larger surface area.

Examine infection control in institutions in terms of the following: a. Germ theory of disease (microorganisms and disease)

• Originated with the french scientist Louis Pasteur and further studied by german physician Robert Koch

• Theory: “Microorganisms (pathogens / germs) can lead to disease, expecially if they permitted to multiply without limitation and overwhelm the body’s immune system.

• Contaminant: particulate matter or microbial orgamisun (Ex. bacteria (structural transformer), fungi, virus..,)

• Microorgamisms normally reside in a particular body site are called resident / normal flora (microbiome).

• Microorganisms that colonize a person for hours to weeks but do not stay permanently = transient flora.

Examine infection control in institutions in terms of the following: b. Asepsis and types of sterilization

Asepsis:

Sterilization: Process which renders substance, surface or area sterile by the elimination or destruction of microorganisms and their spores. The Types Include: Moist Heat, dry heat, radiation, mechanical, chemical.

Tyopes of Sterilization:

1. Moist Heat:

a. Tyndallisation: otherwise known as fractional sterilization, is the

repeated heating to boiling and application of steam over a number of

sessions.

b. Autoclaving: heating under pressure in a sealed chamber.

Page 13 of 140 NorQuest College – PHRM 2022: Learner Guide

2. Dry heat:

a. Directly by flame

b. Indirectly by convection, the circulation of heated air within a sealed

chamber, either:

i. Passively by gravity: heated air is less dense than cool air and thus

rises, or

ii. Actively by mechanical means: a fan or blower directs heated air

onto or into the materials, substances or surfaces being sterilized.

3. Radiation: The use of photons with either non-ionizing radiation (UV light)

or ionizing radiation (gamma rays or X-rays.)

4. Mechanical: Passage of a fluid through a screen-like material with small

pores that block microorganisms

a. 0.22-micron pore size removes bacteria

b. 0.01 microns removes viruses

5. Chemical: Few chemicals produce complete sterility, but may reduce

microbial numbers to safe levels

a. Liquid: Applying a reactive substance in a liquid state on to a surface,

area, or material. Examples include formaldehyde or hydrogen

peroxide. This is also referred to as cold sterilization.

b. Gas: Passing a reactive substance in a gaseous state on, through, or

over a surface, area, or material. Examples include ethylene oxide,

nitrogen dioxide, or ozone.

Differentiate between asepsis and sterilization.

Asepsis: State of absense of disease causing microorganisms. Antiseptics are agents that are used to kill miccroorganisms on living skin and mucous membranes. Germicidal agents are used to kill pathogenic microorganisms such as viruses, bacteria, spores, molds, and fungi. Sporicidal agents = kills spores.

Sterilization: is any process which renders a substance, surface, or area sterile by the elimination or destruction of microorganisms and their spores. Sterile refers to the state of absence of ANYYY microorganisms, not just the disease causing ones.

1. Describe the types of primary engineering controls (PECS) and how they work.: PECS

Primary Engineering Controls (PECS) highly specialized pieces of equipment of specialized rooms used for preparing sterile compounds.

PECs include laminar

airflow workbenches (LAFW) and compounding aseptic isolators (CAI). LAFWs

are also referred to as Laminar Airflow Hoods (LAFH).

2. Describe the types of primary engineering controls (PECS) and how they work.: CPECS:

For compounding of hazardous sterile preparations, a containment primary

engineering control (C-PEC), such as a biological safety cabinet (BSC) or

compounding aseptic containment isolator (CACI), must be used. They are

designed to protect personnel from any undesirable exposure to airborne

medicinal products during compounding and the transfer of hazardous

material during preparation.

Describe the types of primary engineering controls and how they work: Secondary Engineering Controls

controlled areas in which the

PECs are placed. In general, the engineering controls in sterile compounding

facilities are designed to reduce circulating airborne contamination. Primary

and secondary engineering controls work together to create a particle free

environment.

Describe the types of primary engineering controls and how they work: International Orgamization of Standards (ISO)

The International Organization of Standards (ISO) environmental class of

spaces within facilities is determined by the count of particles of a specific

size per cubic metre of air (see table below). A Primary Engineering Control

(PEC) is a device or room that provides an ISO Class 5 environment.

2. Explain the principles for working in a primary engineering control using aseptic technique.

Sterile compounding involves the use of aseptic technique. This technique

involves processes and physical preparation methods used by personnel who

prepare sterile compounds. It is meant to prevent the introduction of

pathogenic organisms or other contaminants into a sterile environment or

preparation. Sterile compounding can range from aseptic manipulation of

commercially available products to patient-specific ones or batching for

products which are not commercially available. Batching is making several,

sometimes dozens, of the same product in one sitting.

To ensure these aseptic practices are followed, sterile compounding personnel

must be orientated, trained, and evaluated consistently. These steps assist in

preventing medication errors, contamination of the final products, and allows

compounding personnel to achieve the highest standards of quality control.

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ISO CLASSES

3. Examine infection control in institutions in terms of sterile compounding facilities including the anteroom and clean room.

1. Determine the conditions required for aseptic drug product preparation.

2. Describe the procedure and importance of routine cleaning of PECs.

The methods and procedures for cleaning the PEC

will vary depending on the policies in place at each institution. Refer to the

charts below for more information. Figure 4.3-3 outlines the minimum

frequency and areas to be cleaned and disinfected, as per NAPRA.

Cleaning a horizontal PEC: (overlapping motion for cleaning, top to bottome cleanest to dirtiest)

❑ The ceiling of the hood; wiping

back to front, working from side

to side

❑ The filter grate

❑ The horizontal bar and hooks,

if applicable

❑ The first side panel from back

to front working from top to

bottom

❑ The second side panel from

back to front working from top

to bottom

❑ The work surface wiping back

to front, working from side to

side

❑ Ensure you wipe the front

edges of each section as well

Cleaning a Vertical PEC:

❑ Push up the view screen, if applicable

❑ The filter grate

❑ The back panel; wiping top to bottom,

working from side to side

❑ The horizontal bar and hooks, if applicable

❑ The first side panel from back to front

working from top to bottom

❑ The second side panel from back to front

working from top to bottom

❑ The work surface wiping back to front,

working from side to side

❑ If applicable, lower the glass front panel

and wipe the inside of the glass in one

sweeping motion from top to bottom. Then

wipe the outside of the glass

❑ Ensure you wipe the front edges of each

section as well

sweeping motion includes: Examples include

Cleaning of side panels starts at the

interior upper back corner (x) close to

the HEPA filter. It proceeds in

overlapping motions that move towards

the outer edge of a horizontal PEC

Figure 4.3-5

Cleaning of the work surface starts at

the interior back corner (x) close to the

HEPA filter. It proceeds in overlapping

motions that move towards the outer

edge of a horizontal PEC

3. Explain the purpose of hand hygiene and protective equipment in sterile

product preparation.

4. Describe the procedure for applying and removing protective apparel:

a. Hair covers

b. Masks

c. Shoe covers

d. Gowns

e. Gloves

f. Goggles

5. Examine infection control in institutions in terms of the following:

a. Hand hygiene

b. Protective equipment/apparel

1. Identify the documentation requirements related to sterile products

preparation.

2. Determine information to be included on the label for a sterile product.

3. Explain the storage requirements for sterile products.

4. Apply your knowledge of drug stability, instability, and incompatibility to sterile products.

5. Navigate resources to compile stability and sterility data.

6. Identify the information found in a parenteral drug manual

1. Identify and describe supplies required for the compounding of sterile

products for each of the following:

a. Needles

b. Syringes

c. IV bags

d. Venting devices

e. Filters

2. Differentiate among small-volume parenteral (SVP), IV piggyback, and

large-volume parenteral (LVP) preparations.

3. Describe the different types of intravenous solutions and their uses.

4. Describe the proper arrangement of supplies in the different types of

Primary Engineering Controls.

5. Explain the various techniques required to manipulate the following

products:

a. Vials

b. Vials requiring reconstitution

c. Ampoules

d. IV bags

6. Describe the steps involved in finishing a sterile product.

7. Explain how waste generated in the production of sterile products is safely handled and discarded in the pharmacy.

1. Describe and explain the significance of the following in relation to

parenteral products:

a. Osmolality

b. Osmolarity

c. pH

d. Tonicity

2. Describe total parenteral nutrition (TPN) and apply your knowledge of

pharmaceutical calculation to its preparation.

. Identify the conditions for which TPN is used.

4. Explain the advantages and disadvantages of TPN.

5. Identify the different components/ingredients of TPN preparations.

6. Describe the steps involved in preparing TPN product.

7. Explain the safety considerations to be followed in the preparation and

administration of TPN.

8. Differentiate between central administration and peripheral intravenous

administration of TPN.

1. Identify and describe routes of parenteral drug administration.

2. Describe the characteristics of intravenous (IV) products.

3. Describe intravenous infusion devices and methods.

4. Calculate the concentration of IV infusions and rates of infusion

1. Describe quality management to ensure the accurate compounding and integrity of a sterile product

1. Identify and describe supplies required for the compounding of sterile

products for each of the following:

a. Needles

b. Syringes

c. IV bags

d. Venting devices

e. Filters

• syringes can be used 5 times, but only for the same drug. ?, make sure that

2. Differentiate among small-volume parenteral (SVP), IV piggyback, and

large-volume parenteral (LVP) preparations.

3. Describe the different types of intravenous solutions and their uses.

4. Describe the proper arrangement of supplies in the different types of

Primary Engineering Controls.

5. Explain the various techniques required to manipulate the following

products:

a. Vials

b. Vials requiring reconstitution

c. Ampoules

d. IV bags

6. Describe the steps involved in finishing a sterile product.

Explain how waste generated in the production of sterile products is safely handled and discarded in the pharmacy.