Knowledge Type: Clinical Articles

The gold standard to treat chronic insomnia is cognitive behavioural therapy for insomnia (CBTi). However, most patients in the primary care setting with insomnia are initially managed with sedative hypnotics (benzodiazepines or non-benzodiazepines) or provided with ‘sleep hygiene’ recommendations. Only around 1% of patients are referred for CBTi.

Sleep hygiene (also known as healthy sleep habits or healthy sleep behaviours) involves the use of good sleeping practices and environmental conditions that promote healthy sleep. Examples include getting out of bed at a consistent time every morning, avoiding late and/or excessive caffeine consumption, and avoiding the use of electronics in bed.

Evidence-based guidelines such as the insomnia guideline produced by the American Academy of Sleep Medicine, do not support the use of sleep hygiene as a stand-alone treatment for chronic insomnia.

CBTi is a multi-component treatment that includes several cognitive, behavioural and educational strategies that aim to identify and gradually treat the underlying psychological and behavioural perpetuating factors of insomnia. Evidence based CBTi components include:

• Stimulus control therapy (reinforcing the bedroom as a stimulus for sleep)
• Bedtime restriction therapy (temporarily restricting the time in bed to consolidate sleep periods and reduce time spent awake in bed)
• Sleep education (education on factors that control the timing/quality of sleep)
• Relaxation techniques (techniques to reduce mental and physical arousal)
• Cognitive restructuring (identifying and challenging of thoughts, feelings and behaviours which impact sleep)

Patients can be referred to their GP for a Mental Health Treatment Plan which may facilitate access to a psychologist at a subsidised cost to access to CBTi. Another option would be trying self-guided digital CBTi programs like, This Way Up, Sleep Better Without Drugs and A Mindful Way.

In some cases, a condensed brief behavioural therapy for insomnia (BBTi) program can be considered. This can be delivered by GPs and typically consists of four sessions that uses foundational components of CBTi (sleep education, sleep hygiene, stimulus control therapy, bedtime restriction therapy). Suitably trained pharmacists may also be able to deliver certain evidence-based components like stimulus control therapy.

The Sleep Health Foundation is a not-for-profit Australian sleep advocacy and consumer facing organisation that develops and promotes evidence-based sleep health resources.

CBTi can help people fall asleep faster and wake up less during the night. This means they spend more time sleeping while in bed, which is called sleep efficiency. CBTi has been shown to improve insomnia symptoms in up to 80% for people with this problem, and 90% of them also reduce or stop using sleep medications. It may also benefit people who do not have insomnia but have trouble sleeping, and for those with mental health issues such as depression, anxiety or post-traumatic stress disorder, as well as other health conditions like cancer.

CBTi has very few side effects. The potential negative effects are limited and usually mild, such as feeling uncomfortable when dealing with unhelpful thoughts and behaviours. Unlike sleep medications, the CBTi addresses the underlying causes of insomnia, so the benefits tend to continue after therapy ends. Sleep may keep improving if the strategies learned are maintained.

In summary, simple information about healthy sleep habits may have an important role to play in preventive sleep health (before a sleep problem occurs), and in the management of short term or subthreshold insomnia symptoms. However, patients with insomnia that has started to become maintained by psychological and behavioural factors or a state of conditioned insomnia generally require CBTi in addition to simple sleep hygiene information.

On 1 July 2026, some significant changes were made to the recommendations for pneumococcal vaccination in adults. Considerable changes were also made to the childhood schedule in September last year.

Pneumococcal disease is caused by Streptococcus pneumoniae, a bacterium which commonly colonises the nose and throat. Most carriers remain asymptomatic, but infection can lead to serious disease.

Pneumococcal disease can be classified as either invasive or non-invasive. Non-invasive disease includes otitis media, sinusitis, bronchitis, and non-bacteraemic pneumonia. Invasive pneumococcal disease (IPD) is rare but associated with significant morbidity and mortality. It includes serious infections such as bacteraemia, sepsis, meningitis, and bacteraemic pneumonia.

Groups at highest risk of severe disease include:

• Children <5 years
• Adults ≥65 years
• Aboriginal and Torres Strait Islander people
• People with certain conditions, i.e. immunocompromising conditions or chronic medical conditions (e.g. chronic heart, lung, liver or kidney disease).

Epidemiology in Australia

Invasive pneumococcal disease has been a nationally notifiable disease since 2001. Pneumococcal disease is vaccine preventable. Following the introduction of pneumococcal conjugate vaccines into the National Immunisation Program (NIP), IPD rates fell significantly across all age groups, but particularly in young children. Herd protection has also reduced disease in unvaccinated populations.

In 2025, Australia recorded 2,638 notifications of IPD:

• 369 cases (14%) in children <5 years
• 966 cases (37%) in adults ≥65 years

Despite the success of vaccination programs, pneumococcus remains one of the leading causes of community-acquired pneumonia, meningitis and bacteraemia in Australia. Disease burden remains disproportionately higher among Aboriginal and Torres Strait Islander peoples.

Serotype replacement has occurred following widespread use of conjugate vaccines, whereby disease caused by vaccine-covered serotypes declines but is partly offset by increases in non-vaccine serotypes. This phenomenon informed the development of higher-valency vaccines such as 20vPCV and 21vPCV.

Pneumococcal vaccination

Modern pneumococcal conjugate vaccines (PCV) protect against the pneumococcal serotypes responsible for most severe disease and have significantly reduced vaccine-type IPD.

There are currently two PCVs funded under the NIP: Prevenar 20^® (20vPCV) for individuals under 18 years, and Capvaxive^® (21vPCV) for eligible adults. However, many other pneumococcal vaccines may be encountered in vaccination histories.

Key Differences

Conjugate vs Polysaccharide

Polysaccharide vaccines do not provoke a strong reaction in children and do not induce anamnestic reactions at any age. Their response occurs primarily via T-cell-independent mechanisms without the establishment of B-cell memory. Pneumovax 23^® is an example of a polysaccharide vaccine. Following recent updates to the NIP, Pneumovax 23^® is no longer routinely recommended or funded as part of standard pneumococcal vaccination schedules in Australia, having largely been replaced by higher-valency conjugate vaccines.

The other available pneumococcal vaccines are classified as conjugate vaccines. These vaccines contain polysaccharides that have been conjugated onto an immunogenic protein. This stimulates a T-cell dependent immune response along with the establishment of a B-cell memory response.

The advantages of conjugate vaccines include:

• Better immunogenicity
• Longer-lasting protection
• Immunological memory
• Improved responses in older adults and immunocompromised patients
• Reduced nasopharyngeal carriage and herd protection

Serotype coverage

The number in the name of each pneumococcal vaccine refers to the number of serotypes the vaccine covers. There are over 100 serotypes of pneumococci, although not all serotypes cause disease. The predominant serotypes vary by age group and geography with a very small number of serotypes responsible for the majority of disease.

As shown in Table 1, conjugate vaccines are available that cover up to 21 serotypes. While Pneumovax^® 23 does cover more serotypes, there has been a shift away from this vaccine towards the newer conjugate vaccines, particularly Prevenar 20^® (20vPCV) and Capvaxive^® (21vPCV). These newer conjugate vaccines are expected to provide broader protection against currently circulating disease-causing serotypes and more durable immune responses than polysaccharide vaccines, despite covering slightly fewer serotypes than Pneumovax^® 23.

Historically, Pneumovax^® 23 was used after Prevenar 13^® as it covered 10 additional serotypes. However, the newer conjugate vaccines now cover many of the serotypes responsible for current IPD in Australia. For example, Prevenar 20^® added seven important serotypes beyond Prevenar 13^®; Capvaxive^® 21 was specifically developed to target the serotypes causing the greatest burden of adult IPD.

As a result, the incremental benefit of administering Pneumovax^® 23 after these higher-valency conjugate vaccines became much smaller.

Table 1. Pneumococcal vaccines commonly seen in Australia

Vaccine	Vaccine type	Serotypes Covered	Age Registration	Current Australian Use
Prevenar 20® (20vPCV)	Conjugate	20	≥6 weeks	NIP-funded for individuals <18 years
Capvaxive® (21vPCV)	Conjugate	21	≥18 years	NIP-funded for eligible adults.
Vaxneuvance® (15vPCV)	Conjugate	15	≥6 weeks	Registered but not NIP-funded.
Pneumovax 23® (23vPPV)	Polysaccharide	23	≥2 years	No longer routinely recommended
Prevenar 13® (13vPCV)	Conjugate	13	≥6 weeks	Superseded by newer vaccines.

Simpler vaccination schedule

Previous vaccine schedules were complex, often requiring a conjugate vaccine (e.g. Prevenar 13^®) followed by Pneumovax 23^®. There were also multiple revaccination recommendations depending on patient age and presence of risk factors.

Australia’s updated program now uses a single higher-valency conjugate vaccine in most situations, i.e. Prevenar 20^® for children and Capvaxive^® for adults. The NIP-recommended dosing schedules are:

• Prevenar 20^® (20vPCV) for children
  • Universal childhood schedule: 1 dose at 2 months, 4 months, and 12 months
  • Additional dose at 6 months for Aboriginal and Torres Strait Islander children and children with specified medical risk conditions for pneumococcal disease
  • Adolescents with specified medical risk conditions – single dose at diagnosis
• Capvaxive® (21vPCV) for adults
  • 18 years and over with specified medical risk condition – dose at diagnosis
  • 25 years and over (Aboriginal and Torres Strait Islander adults)
  • Adults 65 years and over

Children who started their vaccination course with a lower valency PCV (e.g. Prevenar 13^® or Vaxneuvance^®) can complete their course with Prevenar 20^®.

This simplified schedule may improve adherence, reduce administration errors, and make vaccination programs easier to implement.

Summary

Widespread use of conjugate vaccines has altered circulating pneumococcal serotypes through herd effects and serotype replacement. The Australian Technical Advisory Group on Immunisation (ATAGI) reviewed contemporary disease epidemiology and their recommendations have recently been implemented on the NIP. Changes to the adult schedule include replacing 13vPCV with 21vPCV and lowering the age for vaccination of adults without a risk condition from 70 years to 65 years. Changes to the childhood schedule include replacing 13vPCV with 20vPCV, updating advice for Aboriginal and Torres Strait Islander children so that recommendations are consistent nationally, and removing Pneumovax 23^® from the recommendations for higher risk children.

Annex 1 of PIC/S PE 010 is one of the supplements to the core chapters of PIC/S PE 010 Guide. It focuses exclusively on the Sterile Preparation of Medicinal Products in healthcare establishments. Its primary objective is to eliminate the risk of microbiological, particulate, and pyrogen contamination during the compounding of sterile medicines. The standard emphasizes that sterility cannot be tested into a finished product; it must be built in by design through strict environmental, physical, and behavioral controls. Below are summaries of each section:

Section 1: Personnel

This section outlines the training, competency, and qualification requirements for personnel involved in the sterile preparation of medicinal products

1.1 Personnel Qualifications & Roles

• Responsible Person: Must possess current practical and theoretical knowledge of sterile product preparation and formal training in microbiology.
• Production Supervisors: Must be competent, understand cleanroom/clean air device technology (e.g., HEPA filters, ventilation, isolators), and hold written authorization from the Responsible Person.

Key Training Requirements:

All staff must undergo training and competency assessments prior to performing sterile work, covering five core areas:

• Good Manufacturing Practice (GMP) or Good Preparation Practice (GPP).
• Local practices, including health and safety regulations.
• Competence in specific sterile skills and technical manipulations.
• Pharmaceutical microbiology.
• General working knowledge of the department, products, and services.

Compliance & Safety Protocols

• Specialist Training: Radiopharmacy staff must be trained in national Ionising Radiation Regulations.
• Risk Awareness: Staff must be fully aware of how deviations from validated procedures affect product integrity and patient safety, reinforced by regular reminders.
• Continuous Assessment: Staff must undergo regular competency reassessments, with retraining provided as necessary.

Section 2: Premises and Equipment

This section establishes strict requirements for cleanroom design, environmental control, and operational boundaries to minimize contamination and ensure operator safety in health establishment preparation units.

2.1. Facility Design & Contamination Control

• Airlock Control Mandate: All entries for personnel, materials, and equipment must progress sequentially through designated airlocks.
• Prohibition of Sinks: Sinks and hand-washing fixtures are completely forbidden inside preparation rooms or the final stage of changing areas. Sinks in adjacent staging areas require scheduled monitoring and disinfection.
• Operational Clean-Up Window: Systems must achieve a guidance recovery period of 15–20 minutes, transitioning the room from an “in operation” state back to its unmanned “at rest” baseline.
• Dedicated Footprints: Cross-contamination controls require independent, dedicated rooms for processing high-risk categories including penicillins, blood products, biologicals, cytostatics, and radiopharmaceuticals. Campaign manufacturing is restricted to exceptional, risk-assessed scenarios.

2.1.1. Dynamic Zoning & Processing Requirements

The facility operates across strict environmental tiers (Grades A to D) leveraging terminal HEPA filtration for Grades A through C. Minimum environments are divided by operational methodology:

Manufacturing Pathway	Room Grade	Allowed Operations & Equipment
Terminally Sterilised	Grade D	Preparation of standard solutions and component handling before filling
	Grade C	Solution preparation for high-growth-risk formulations; routine filling.
	Grade A (with C background)	Filling operations carrying heightened risk (e.g., slow filling, wide-necked containers).
Aseptic Preparations	Grade D	Component handling post-washing;  serves as the required background for pharmaceutical isolators.
	Grade C	Formulation of solutions designed to undergo downstream sterile filtration.
	Grade B	The non-negotiable background environment surrounding Laminar Flow Cabinets (LFCs) and Biohazard Safety Cabinets (BSCs).
	Grade A	Core aseptic preparation and compounding. Must occur within a laminar flow cabinet, biological safety cabinet, or Isolator zone.

2.1.2. Hazardous Compound Processing & Safety

• Containment Controls: Compounding cytotoxic drugs, radiopharmaceuticals, or radio-labelled blood products requires negative pressure environments matched with positive pressure airlock containment systems.
• Equipment Prohibitions: Traditional Laminar Flow Cabinets (LFCs) are strictly illegal for hazardous medications due to horizontal airflow directing contaminants toward the user.
• Safety Cabinet Mandate: Hazardous preparations require Biohazard Safety Cabinets (BSCs) featuring vertical downward air vectors that exhaust safely away from the operator.

2.1.3. Controlled Gowning Framework

All garments must be non-shedding and matched directly to the destination zone classification:

• Grade D: Total coverage of hair, arms, and facial hair. Requires a general suit and facility overshoes.
• Grade C: Single or two-piece high-neck clothing featuring gathered wrists. High filtration, low-fibre textiles only.
• Grade A/B: Complete head enclosure tucked directly into the suit collar. Mandatory droplet-barrier face masks, sterile unpowdered gloves, and fully sterilized or disinfected footwear.
• Specialised Material Rule: Handling live viruses, radiopharmaceuticals, or blood products commands completely separate, dedicated clothing lines.

2.2. Clothing

This details the strict gowning, garment quality, and laundering mandates required to prevent human-borne contamination in cleanroom environments.

2.2.1. Core Gowning Rules by Cleanroom Grade

Garments must match the destination zone classification and prevent particles or fibers from shedding into the environment:

• Grade D: Hair, arms, and facial hair must be covered. Requires a general protective suit and facility-specific shoes or overshoes.
• Grade C: Hair, arms, and facial hair must be covered. Requires a high-neck single or two-piece trouser suit gathered at the wrists, along with dedicated shoes or overshoes. Garments must be virtually non-shedding.
• Grade A/B: Headgear must totally enclose all hair and facial hair, tucked directly into the suit neck. A droplet-barrier face mask is mandatory. Requires sterile, non-powdered rubber or plastic gloves, and sterilized or disinfected footwear. Trouser bottoms must tuck into footwear, and garment sleeves must tuck into gloves. Garments must retain body particles and shed virtually no fibers.

2.2.2. Facility Control & Changing Protocols

• Outdoor Clothing Prohibitions: Outdoor garments are strictly banned from entering changing rooms that lead into Grade B and C areas.
• Fresh Garment Mandate: Every worker in Grade A/B areas must be provided with fresh, clean, sterile (or adequately sanitized) protective clothing for every single working session.
• In-Process Disinfection: Gloves must be regularly disinfected with a sanitizing agent during ongoing cleanroom operations.
• Mandatory Replacements: Masks and gloves must be changed out completely at least once per working session.
• Specialised Material Separation: Processing live viruses, radiopharmaceuticals, or blood products requires entirely independent, dedicated clothing lines.

2.3 Cleaning

This section outlines the requirements for the cleaning, disinfection, and environmental monitoring of cleanrooms.

2.3.1. Personnel and Procedures

• Approved Protocols: All clean areas must be cleaned according to documented and approved procedures.
• Documented Training: Staff must complete and document training for each relevant elements and pass a competency assessment before working unsupervised.

2.3.2. Materials and Equipment Controls

• Dedicated Tools: Cleaning equipment must be dedicated and stored properly to minimise microbial contamination.
• Mop Head Management: Mop heads must be either disposed of or re-sterilised after every cleaning session.
• In-Use Expiry Dates: Facilities must define and enforce clear in-use expiry dates for sterile alcohol sprays and other materials transferred into clean areas.

2.3.4. Disinfection Agent Specifications

• Grade A and B Rules: Cleaning and disinfecting agents used in Grade A and B zones must be sterile and spore-free.
• Microbial Controls: All sanitising agents across all grades must be completely free from viable micro-organisms.
• Specialised Agents:
  • Sporicidal Agents: Must be used periodically to eliminate spore-forming micro-organisms.
  • Virucidal Agents: Must be used to decontaminate areas where blood products or live viruses are handled.

2.3.5. Verification and Monitoring

• Routine Sampling: The efficacy of the cleaning process must be routinely proven using microbiological surface sampling, such as contact plates or swabs.

Section 3: Documentation

It defines the strict documentation, traceability, and record retention standards required for sterile manufacturing quality systems.

3.1 General Governance & Formats

• GMP Compliance: General Good Manufacturing Practice (GMP) documentation guidelines apply to all sterile processing quality systems.
• Master Formats: Individual processing instructions and records must be reproduced from a formally approved master template and signed off before use.
• Document Integration: Units can combine processing instructions and records into a single document (“worksheets”) specifically designed to minimize transcription errors.

3.2 Traceability & Audit Trails

• Comprehensive Detail: Processing records must contain sufficient granular detail to trace all starting materials, components, and personnel actions.
• Audit Trail Mandate: Documentation must establish a complete, uninterrupted audit trail for every finished medicinal product.

3.3. Record Retention Schedules

Establishments must store completed documentation to fulfill legislative mandates, adhering to these minimum timelines:

• Completed Processing Records: Retain for at least one year after the expiry date of the finished product.
• Procedures & Preparation Instructions: Retain formulas, standard operating procedures, and prescriptions for at least five years after their last use.

Section 4: Sterile Processing

It outlines the strict regulatory controls required for general sterile processing, moist heat sterilization, and aseptic manipulation.

4.1. General Sterile Processing & Cross-Contamination Controls

• SOP Governance: All manual steps must be governed by comprehensive Standard Operating Procedures (SOPs) to guarantee sterility.
• Validation Verification: Every sterilisation process must be validated initially, when significant equipment or process changes occur, and at scheduled intervals based on performance history. Non-pharmacopoeia methods require heightened scrutiny.
• Line Clearance Mandate: Processing different formulations simultaneously in the same workstation is prohibited. A complete line clearance (removal of all materials) must occur between different product runs to prevent mix-ups.
• Multi-Workstation Rooms: Running different products concurrently across multiple workstations in the same room requires a formal, documented risk assessment.

4.2. Special Requirements for Terminally Sterilised Products

• Contamination Minimization: Management must keep fiber-generating materials to an absolute minimum in clean areas and protect final cleaned components from re-contamination.
• Moist Heat (Autoclave) Controls:
  • Loading & Records: Units must use validated loading patterns backed by photographs or drawings. Sterilisation logs must be reviewed and approved for product release.
  • Parametric Logging: Temperature and pressure must be logged mid-cycle, cross-referenced with steam tables, and compared against chart recorders.
  • Chamber & Steam Tests: Operators must frequently conduct leak and air-removal tests. Clean steam requires periodic testing for dryness, superheat, and non-condensable gases.
  • Physical Segregation: Thermal indicators are mandatory on all loads to visually differentiate sterile and non-sterile batches.

4.3. Comprehensive Aseptic Processing Mandates

• Environmental Controls: Only sterile materials are permitted inside Grade A or B zones. Non-sterile solutions must pass through a sterile filter (≤ 0.22 micron) before entry.
• Personnel Restrictions: Only authorized personnel may perform aseptic tasks. Room occupancy must be minimised, except during validation trials.
• Material Transfer Protocols: Transferring items into Grade A zones requires a validated surface sanitisation SOP. Combining spraying and wiping is explicitly required over spraying alone. The guide highly recommends utilizing multi-wrapped, bulk gamma-irradiated components.
• Component & Bulk Limits: Sterile disposable items (needles, tubing, filters) cannot be used beyond a single working session. Unpreserved bulk starting solutions have a strict maximum 24-hour in-use expiry after opening. Filter integrity tests must be conducted on every multi-container batch.

4.4. Aseptic Process Simulations (APS / Media Fills)

• Worst-Case Simulation: Media fills using a nutrient broth must mimic routine operations, including all critical steps, production interventions, and the maximum permitted personnel presence.
• Incubation & Investigation: Vials must be incubated and periodically inverted. Any detected growth or contamination must undergo a full investigation, regardless of container integrity.
• Intervention Policy: All permitted operational interventions must be documented in a formal policy, simulated during media fills, and recorded on batch documents when they occur during real production.

Section 5: Quality Control

This section outlines the quality control (QC), materials testing, final product evaluation, and laboratory governance requirements for sterile preparations.

5.1. Materials and Product Inspection

• Pre-Use Checks: All starting materials, component pieces, and packaging configurations must be visually verified against strict specifications before processing begins.
• Testing Exemptions: Licensed medicinal products used as raw ingredients generally do not require re-testing. Single-patient custom formulations are exempt from end-product testing.
• Radiopharmaceutical Exceptions: Radiopharmaceuticals deviate from general exemptions; they require active ingredient verification during raw staging and a mandatory radioactivity measurement for every final dose.

5.2. Risk-Based Testing and Sampling

• Risk Assessment Framework: The frequency and scope of physical, chemical, and microbiological testing must be formally defined using a documented risk assessment.
• Permitted Sample Sources: Analytical samples can only be gathered from unused overages, dedicated surrogate units prepared alongside the batch, or an in-process pull taken immediately before final sealing inside the Grade A critical zone.
• Destructive Sampling Ban: Post-completion sampling of the final container before issue is prohibited due to contamination risks. However, containers sealed by fusion (such as glass or plastic ampoules) must undergo 100% integrity testing.

5.3. Microbiological Surveillance

• Batch Testing Alternative: Testing every single batch for sterility is not mandatory. Facilities can instead run a structured program of periodic product testing combined with regular Aseptic Process Simulations (media fills).
• Investigation Mandate: Any detected microbial growth across any sample must trigger an immediate investigation and be logged in a formal deviation report.

5.4. Laboratory Quality Assurance

• Method Validation: All analytical testing methods must be stability-indicating and fully validated.
• Laboratory Oversight: The Responsible Person must verify that testing laboratories have extensive microbiology expertise and validated workflows. Off-site contract testing facilities must undergo regular, documented quality audits.

Section 6: Monitoring

This section outlines the mandatory cleanroom monitoring framework, separating facility classification in the unmanned state from routine physical and microbiological checks during active production.

6.1. General Monitoring & Risk-Based Frequency

• Dual Control Mandate: Because microbiological methods can be imprecise and variable, environmental control must combine active microbial sampling with practical physical monitoring.
• Risk-Based Adjustments: Testing frequencies must be established via formal risk assessment. Frequencies must increase following deviations, cleanroom modifications, or higher workloads. Frequencies may only be reduced if closed systems are utilized, products are terminally sterilized, or workloads drop significantly.
• Reporting: Written data reports detailing result significance and required corrective actions must be delivered directly to relevant staff and filed securely.

6.2. Cleanroom Classification (“At Rest”)

The Responsible Person must audit all cleanrooms in an unmanned state during commissioning, after major maintenance/changes, and at regular intervals.

Recommended Annual Classification Tests:

• Laminar flow cabinets + biohazard safety cabinets
  • Particle counts
  • Room air changes per hour
  • Air velocities on workstations
  • HEPA filter integrity checks
• Isolators
  • Isolator alarm functional tests
  • Isolator leak test
  • HEPA filter integrity checks

6.3. Environmental Monitoring “In Operation”

Units must execute a structured, documented schedule of routine tests to catch contamination risks early, as many products are administered to patients before final microbial results are returned.

6.3.1. Physical Monitoring Frequencies

Laminar flow cabinets + biohazard safety cabinets
Pressure differentials between rooms	Before beginning work (usually daily)
Pressure differentials across HEPA filters (workstation)
Particle counts	Quarterly in operational state
Isolators
Pressure differentials across HEPA filters	Before beginning work (usually daily)
Isolator glove integrity	Visual checks each session
Isolator pressure hold test (with gloves attached)	Weekly

• Daily (Before Work): Room-to-room pressure differentials, plus pressure differentials across workstation HEPA filters (for LFCs, BSCs, and Isolators). Visual check of isolator glove integrity every single session.
• Weekly: Isolator pressure hold test with gloves attached.
• Quarterly: Airborne particle counts inside LFCs and BSCs during active operations.

6.3.2. Microbiological Monitoring Frequencies

	Direct working environment (grade A)	Background environment
Settle plates	Each working session	Weekly
Glove finger dabs	End of each working session
Surface samples (swabs / contact plates)	Weekly	Monthly
Active air samples	Quarterly

• Every Working Session: Settle plates in the Grade A zone; glove finger dabs in both Grade A and background zones (taken at the end of the session).
• Weekly: Settle plates in background environments; surface samples (swabs/contact plates) inside the Grade A zone.
• Monthly: Surface samples (swabs/contact plates) in background environments.
• Quarterly: Active air samples across both Grade A and background zones.

6.4 Physical Limits & Air Sampling Criteria

This part provides precise environmental thresholds for airborne particles, air exchanges, and pressure differential to adjacent low class room.

Limits for physical monitoring of controlled areas and devices:

Grade	Maximum permitted number of airborne particles/m3 equal to or above				Air changes (per hour)	Air velocity (m/s +/-20%)	Pressure differential to adjacent low class room (Pa)
	At rest		In operation
	0.5 μm	5 μm	0.5 μm	5 μm
A	3,520	20	3,520	20	N/A	0.45 HLF 0.30 VLF	N/A LFC >15 isolator
B		29	352,000	2,900	>20	N/A	>10
C	352,000	2,900	3,520,000	29,000
D	3,520,000	29,000	Not defined		>10

Abbreviations: LFC: laminar flow cabinet; HLF: horizontal laminar flow; VLF: vertical laminar flow

6.5 Microbiological monitoring:

Recommended limits for microbiological monitoring and clean areas in operation:

Grade	Air sample (cfu/m3)	Settle plates, 90mm (cfu/4 hours)*	Contact plates, 55mm (cfu/plate)	Glove print, 5 fingers (cfu/glove)
A	<1
B	10	5
C	100	50	25	–
D	200	100	50	–

*Limits should be reduced accordingly for individual settle plates exposed for <4 hours

Implementing the PIC/S PE 010 standard for the aseptic preparation of medicinal products marks a critical shift for healthcare establishments, moving operations from traditional pharmacy compounding to structured, small-scale Good Manufacturing Practice (GMP) standards. The standard establishes that patient safety cannot rely on reactive testing of a finished product. Instead, sterility must be intentionally built into the daily workflow through rigid environmental, physical, and behavioral controls.

Aseptic preparation in a pharmacy environment is a critical, high-risk process involving the compounding and manipulation of sterile medicines to ensure they remain free from microbial and particulate contamination.

In Australia, aseptic preparation is regulated by Therapeutic Goods Administration (TGA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide. It involves compounding or manipulating sterile medicines under strict contamination controls to prevent microbial contamination and ensure patient safety. By implementing specific quality control strategies, pharmacies protect patient health, especially when preparing high-risk medications like parenteral nutrition, cytotoxic infusions, and eye drops.

Pharmacy sterile compounding is governed primarily by two interconnected PIC/S standards depending on the operational scale:

• PIC/S PE 010-4: The Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments, which specifically dictates public and private hospital pharmacy operations.
• PIC/S PE 009 (Annex 1): The Guide to Good Manufacturing Practice for Medicinal Products. Its critically updated Annex 1 focuses on the Manufacture of Sterile Medicinal Products, reinforcing principles like Quality Risk Management (QRM).

The PIC/S PE 010-4 guide mirrors the structural framework of the main industrial drug manufacturing guide (PE 009), condensing it into nine Core Chapters and three Specialised Annexes optimised for clinical, small-scale healthcare settings. Annex 1 provides guidelines on the standards required for sterile preparation of medicinal products.

PIC/S PE 010-4 Core Chapters:

Chapter 1: Quality Assurance System

Establishes the foundation that all compounded medicinal products must be fit for their intended purpose, safety, and effectiveness.

• Mandates a fully documented Quality Assurance (QA) framework.
• Requires structured oversight ensuring that products are correctly processed, verified, and stored throughout their shelf life

Chapter 2: Personnel

Focuses on the responsibility, authority, and health requirements of a pharmacy team.

• Places ultimate compliance responsibility onto a designated Responsible Person.
• Mandates structured, documented initial and continuing training.
• Sets strict rules for hygiene, mandatory protective apparel, and the immediate reporting of infectious diseases or open lesions.

Chapter 3: Premises and Equipment

Defines environmental control, facility architecture, and equipment maintenance to minimise human error and physical defects.

• Dictates logical workflows and physical segregation to prevent mix-ups and cross-contamination.
• Requires dedicated rooms for handling hazardous preparations (e.g., cytotoxic, radiopharmaceuticals).
• Demands routine, documented calibration and precision checking of all weighing and volumetric instruments.

Chapter 4: Documentation

Enforces standard paperwork or equivalent validated digital entry rules to avoid the high risk of verbal errors.

• Outlines specifications and instructions for two tracks: extemporaneous individual prescriptions vs. regular stock preparations.
• Mandates comprehensive batch production records, including master formula definitions and raw sample tracking logs.
• Requires a record retention policy (typically at least 1 year past product expiry and 5 years for master sheets).

Chapter 5: Production

Governs the physical assembly, handling, and formulation steps of medication compounding.

• Enforces a mandatory independent double-check (by a second operator or validated barcode system) for raw component weights and identities.
• Requires a formalised Product Risk Assessment based on the route of administration, scale of operation, and product complexity.
• Details lines-clearance steps, packaging material integrity checks, and restricted re-processing criteria.

Chapter 6: Quality Control

Establishes checking, sample gathering, and official chemical/microbiological testing parameters.

• Requires complete operational independence between Quality Assurance/Quality Control tasks and production steps.
• Dictates that raw material confirmations must align with the active Pharmacopoeia.
• Outlines release verification criteria before stock transfers from quarantine to clinical wards.

Chapter 7: Work Contracted Out

Regulates third-party vendors providing technical services that affect compounding safety.

• Requires formal Service Level Agreements (SLAs) or technical contracts for utilities maintenance (heating, ventilation, air-conditioning, water), cleanroom monitoring, pest control, and equipment calibrations.
• Holds the hospital pharmacy accountable for auditing contract acceptors and formally reviewing their technical data.

Chapter 8: Complaints and Product Recalls

Provides a mechanism to react swiftly when compounded products fail to meet physical or microbiological standards.

• Mandates clear, written SOPs to investigate internal compilation defects or ward complaints.
• Demands an immediate recall infrastructure and immediate notification to state regulatory bodies if a defect poses a direct clinical threat.

Chapter 9: Self Audits

Ensure long-term operational consistency through self-regulation.

• Mandates a structured internal audit program executed at least annually.
• Requires objective internal or external auditors to cross-verify facilities, logging practices, and past corrective/preventative actions (CAPA).

A stye is a small painful lump that develops on the inner or outer surface of the eyelid. It is a common and usually self-limiting eyelid infection involving the sebaceous glands. Most cases are caused by bacterial infection, most commonly caused by Staphylococcus aureus. (Willman D, et al., 2025)

Styes can be classified into two types:

• External hordeolum: common type which affects the glands of Zeis or Moll near the lash line
• Internal hordeolum: less common type and it is a deeper infection which involves the meibomian glands on the tarsal plate of the eyelid

Styes are usually self-limiting and benign, often resolving without intervention. However, they can cause significant discomfort, cosmetic concern and may occasionally require referral to a medical practitioner. Pharmacists frequently encounter styes in community practice, where they play a key role in patient care. They recognise the condition, offering conservative management strategies, reinforce eyelid hygiene and identify any red flags that require referral.

Clinical Features

A stye typically appears as a localised, tender, erythematous and swollen along the eyelid margin.

Days	Description
1–2	Eyelid tenderness and initial swelling.
2–4	Formation of a red bump, sometimes progressing to a pustule.
4–6	The pustule typically comes to a head and may spontaneously drain, relieving pressure and pain.
7–8	The lesion usually resolves, with eyelid tissue returning to normal. In some cases, residual inflammation may continue for several weeks.

Most styes are uncomplicated, persistent swelling or deeper involvement may suggest a chalazion, preseptal cellulitis or other pathology requiring medical attention.

Risk Factors

Several risk factors have been identified in the development of styes. (Eberhardt M, et al., 2026; Kaur K, et al., 2026)

• Blepharitis and ocular rosacea: chronic inflammation and mechanical obstruction at the eyelid margin increase the likelihood of glandular infection.
• Seborrheic dermatitis: altered lipid composition and deposition, which can contribute to inflammation of eyelids and promote gland blockage.
• Individual between 30 to 50 years: due to higher sebum viscosity, meibomian gland dysfunction and greater rates of rosacea within this age group.
• Elevated serum cholesterol: changes in lipid composition is associated with glandular blockage.
• Poor eyelid hygiene: Inadequate eyelid hygiene and inappropriate use of contact lens may introduce pathogenic bacteria and it significantly increases the risk of infection.

Differential Diagnosis

A stye must be distinguished from a chalazion, which is a non-infectious granulomatous inflammation resulting from meibomian gland obstruction. Unlike styes, a chalazion forms deeper within the eyelid and is usually painless, without the presence of a pustule. Chalazion is slowly enlarging and non-tender, it is usually benign and self-limiting however it may develop chronic complications. If a lesion does not drain or shows no pustule formation in the middle of swollen lump, a chalazion is more likely. (Jordan GA & Beier K, 2025)

Key distinguishing features:

• Chalazia are painless, gradually enlarging nodules.
• Styes are acutely painful, erythematous and tender.

Complications

Preseptal cellulitis is a potential complication, which is a bacterial infection of the eyelid and periorbital tissues without orbital involvement. Preseptal cellulitis may progress to orbital cellulitis which is a medical emergency due to risks of vision loss, intracranial spread, sepsis or death. Symptoms and signs of orbital cellulitis include severe headache; fever; swelling; painful, restricted eye movement; proptosis or diplopia; and erythema of the eyelid and surrounding soft tissues.

Referral to an optometrist or general practitioner is appropriate in cases where there is clinical evidence of extension of infection beyond the localised lesion, including involvement of the surrounding eyelid or periorbital tissues, or for patients who are immunocompromised. Further evaluation is also warranted when the lesion persists for several weeks and demonstrates recurrent episodes or fails to respond to appropriate conservative measures such as warm compresses. In addition, referral should be considered for large or progressively painful lesions, which may require pharmacological management or surgical intervention such as incision and drainage.

Management and Treatment

In most cases, a stye doesn’t require specific treatment and will resolve spontaneously. The most effective treatment is a warm compress which is the application of heat to the glands through the closed eyelids for 2-5 minutes several times a day. This is the cornerstone of treatment, as it softens the lesion and promotes spontaneous drainage.

Also, maintaining good hygiene practice is important. Patients should clean the eyelids regularly using a damp cotton pad soaked in a diluted baby shampoo solution or with a commercially available eyelid cleanser. Patients should be advised not to touch, rub or squeeze the affected area as this may exacerbate inflammation or increase the risk of secondary infection. Lifestyle modification is also a key component of the treatment and prevention of stye. Contact lens wearers should be reminded to wash their hands before handling contact lenses and the use of eye makeup on the affected eyelid should be avoided as it may introduce bacteria and worsen irritation. Topical or systemic antibiotics are not usually required unless in cases of secondary infection or preseptal cellulitis. In the majority of cases, styes are self-limiting, however surgical intervention may be needed when the lesion is large, painful or persistent for a couple of weeks.

Pityriasis lichenoides is a rare skin disorder of unknown cause, which can present in both an acute form (pityriasis lichenoides et varioliformis acute (PLEVA)) and a chronic form (pityriasis lichenoides chronica (PLC)) with many patients showing overlapping features of both (1,2). PLEVA can also evolve into PLC (1).

Although the cause is unknown, it is hypothesised to occur in the setting of a recent bacterial, viral or parasitic infection (2), or an inflammatory reaction to some medications, such as vaccines, or that it may be a low-grade lymphoproliferative disorder (1).

The skin disease most commonly tends to affect children and young adults under 30 years of age, with a slight male predominance. However, all ages and races can be affected, and it does not appear to be hereditary (1,2).

Pityriasis lichenoides can be difficult to diagnose, and diagnosis is often made on clinical grounds but is usually also confirmed with a skin biopsy (1,2). Referral to a dermatologist is important.

The clinical features and histological features of PLEVA and PLC are summarised below:

PLEVA	PLC
Clinical features
Rapidly progressive rash, but typically resolves within a few weeks, or can evolve into PLC	Presents more slowly over several days, but can last several months and wax and wane for several years
10-50 pinkish or reddish or brownish flat spots, around 5-15mm in diameter	The spots look less red or inflamed than in PLEVA but are covered with a firm shiny scale of skin
Rash presents mostly on trunk, arms and legs, but in children they may appear more on the face than on other areas of the body	The scale can be scraped off by a dermatologist to reveal a shiny, reddish brown or discoloured surface underneath
Rash evolves into vesicles, pustules, hemorrhagic crusts and ulcers and most lesions heal with transient or persistent hyper or hypo pigmentation	The spots usually flatten within 3-4 weeks and the scale becomes loose, often leaving marks which appear darker than the person’s skin colour but these marks gradually fade away
Spots can come up at different times so the rash often consists of spots at various stages of development	Lesions can appear at various stages of evolution
Itchiness or burning sensations can be present
Histological features
A wedge-shaped deep dermal and superficial lymphohistiocytic infiltrate	A superficial dermal infiltrate
Parakeratotic scale and crust, with thinning of the granular layer	Focal parakeratosis
Interface dermatitis with basal cell necrosis and vacuolation	Preservation of the granular layer
Epidermal spongiosis and necrosis in more developed lesions	Focal loss of the dermo-epidermal interface
Extravasated erythrocytes

Pityriasis lichenoides may present as a rare form known as Febrile Ulceronecrotic Mucha-Habermann Disease, which has systemic features of malaise, fever, lymphadenopathy, arthritis and/or bacteraemia. There may also be mucosal, gastrointestinal, and pulmonary involvement and mortality of up to 25% has been reported (1). Psychological implications should also be considered, as skin lesions may appear on more visible areas such as the face (1).

There are no randomised controlled trials for the treatment of pityriasis lichenoides. However, various treatments exist, with varying levels of efficacy (1,2):

1. PLEVA is most commonly treated with a three-month course of erythromycin in younger children or with doxycycline. These are used primarily for their anti-inflammatory effects, rather than their antibacterial properties. Erythromycin has been used at a dose of 30 to 50mg/kg per day given in three to four divided doses for one to four months, however a dermatologist should guide treatment doses (3).
2. Topical corticosteroids and topical tacrolimus may relieve symptoms but do not make the rash disappear more quickly
3. Phototherapy with ultraviolet-B is often the preferred treatment for PLC.
4. Methotrexate and other immunosuppressants may be considered for refractory or very severe cases.
5. Antihistamines may be used to reduce itching.

Chronic Kidney Disease (CKD) is a major global public health burden, affecting more than 10% of the general population. The global prevalence estimates indicate that approximately 13.4% (11.7–15.1%) of people are living with CKD, and between 4.9 and 7.1 million individuals with end-stage kidney disease (ESKD) require renal replacement therapy. CKD is a progressive condition marked by a sustained and usually irreversible decline in renal function.

The diagnosis of CKD is primarily based on objective laboratory results, which includes the estimation of glomerular filtration rate (eGFR) using validated equations incorporating filtration biomarkers such as serum creatinine or cystatin C, as well as the assessment of urinary markers of kidney damage, particularly albuminuria. CKD can be formally defined by a persistent reduction eGFR to <60 mL/min/1.73 m² for a duration of at least three months, irrespective of the presence of kidney damage, albuminuria or haematuria.

Risk Factors

CKD arises from a combination of modifiable and non-modifiable factors.

Modifiable risk factors:

• Diabetes: Diabetes is the leading cause of CKD and high blood glucose levels impairs kidney filtration and accelerates diabetic nephropathy. It is a very common underlying cause of CKD progression to end-stage kidney disease, which requires dialysis or kidney transplantation.
• Hypertension: Uncontrolled hypertension is a major contributor to CKD progression, and sustained elevations in blood pressure may damage the blood vessels in the kidney and increase the overall risk of kidney damage.
• Cardiovascular Disease (CVD): CVD can impair kidney function by reducing blood flow to the kidney and it is also a common consequence of CKD.
• Obesity: Overweight and obesity increase the risk of CKD by contributing to hypertension, diabetes and dyslipidemia. Obesity also increases mortality for people who already have CKD.
• Smoking: Smoking contributes to CKD progression by increasing blood pressure, reducing oxygen and damaging the blood vessels.

Non-modifiable risk factors:

• Ageing: The risk of CKD increases markedly in individuals over 60 years of age, attributable to the age-related decline in renal function.
• Genetic predisposition: Family history of CKD and a personal history of CKD, particularly hereditary disorders such as Polycystic Kidney Disease (PKD), are associated with an increased risk of CKD. The severe, recurrent or poorly recovered Acute Kidney Injury (AKI) also increases the risk of progression to CKD particularly among older adults with comorbidities.
• Aboriginal and Torres Strait Islander ≥18 years: Aboriginal and Torres Strait Islander populations experience a higher prevalence of CKD, with earlier onset and more rapid disease progression.
• Low birth weight or premature birth: low birth weight or premature birth may be linked to a reduced nephron number, thereby increasing the lifelong risk of hypertension and CKD.

Pathophysiology

CKD is defined by a gradual and irreversible loss of nephrons, resulting in a gradual decline in renal function. Initial injury to nephrons may damage the glomeruli or tubules and it reduces the number of functional nephrons. Glomerular injury facilitates albuminuria, which triggers tubular inflammation and promotes interstitial fibrosis and cellular injury. Sustained inflammation further reduces microvascular supply, leading to chronic hypoxia and accelerates nephron loss, thereby worsening the renal function over the time.

The progressive decline in kidney function disrupts systemic homeostasis, leading to azotaemia, electrolyte and acid-base imbalances, anemia due to decreased erythropoietin production, mineral and bone disorders, fluid overload, hypertension and multiple other complications, reflecting the multisystem impact of CKD.

Classification

Clinical Practice Guidelines published by Kidney Disease: Improving Global Outcomes (KDIGO) categorise CKD into five stages based on eGFR (G1-G5) or albuminuria (A1-A3) (Table 1 & 2). Guideline suggests that both decreased eGFR and increased levels of albuminuria are independently related to mortality, cardiovascular complications and end-stage kidney disease.

Table 1. GFR categories in Chronic Kidney Disease

Category	GFR (ml/min/1.73 m²)	Terms
G1	≥ 90	Normal or high
G2	60–89	Mildly decreased
G3a	45–59	Mildly to moderately decreased
G3b	30–44	Moderately to severely decreased
G4	15–29	Severely decreased
G5	< 15	Kidney failure

Table 2. Albuminuria categories in Chronic Kidney Disease

Category	Albumin Excretion Rate (mg/24 h)	Albumin-to-Creatinine Ratio (mg/mmol)	Terms
A1	< 30	< 3	Normal to mildly increased
A2	30–300	3–30	Moderately increased
A3	> 300	> 30	Severely increased

Clinical Presentation

CKD is typically asymptomatic until over 90% of kidney function has declined. Early signs may include albuminuria, nocturia and polyuria. As renal impairment progresses, patients may develop uraemic symptoms such as fatigue, nausea, pruritus and cognitive changes.

Advanced disease results in systemic manifestations including:

• CVD (heart failure, left ventricular hypertrophy, hypertension)
• Metabolic acidosis
• Bone and mineral disorders
• Anaemia due to reduced erythropoietin
• Hyperkalaemia and fluid overload
• Reduced drug clearance leading to toxicity risks

These systemic complications contribute to impaired quality of life and increased hospitalisation.

Management Principles

CKD is generally irreversible, but timely and effective management can slow its progression, reduce the risk of CVD and manage complications. Individuals with advanced chronic kidney disease experience a significant polypharmacy burden (average of 12 medications per day). Approximately 70–80% of patients are prescribed five or more medications and which increases the risk of polypharmacy-related adverse effects. With early detection and appropriate management, the progression of CKD may be reduced by up to 50%. Patients with CKD should be referred to nephrologists no later than the point at which the eGFR reaches 30 mL/min. (Coritisidis GN et al., 2011)

Pharmacological Management

Drug class	Role in CKD	Key considerations
ACEi/ARBs	First-line for reducing proteinuria and BP	Titrate to highest tolerated dose
SGLT2 inhibitors	– Recommended with or without diabetes. – Slow progression and improve CVD outcomes	– Avoid initiation at eGFR <25 mL/min/1.73m² – Dapagliflozin can be used until 15 mL/min/1.73m²
Non-steroidal MRAs (finerenone)	Persistent albuminuria in T2DM despite ACEi/ARB	Avoid if potassium >5.0 mmol/L or eGFR <25 mL/min/1.73m²
GLP-1 receptor agonists	Improve glycaemia and reduce CVD risk	TGA-approved for reducing kidney decline in T2DM and CKD
Statins ± ezetimibe	CVD risk reduction	Recommended in most adults with CKD not on dialysis

Abbreviations: Angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARBs) blood pressure (BP); Sodium-glucose co-transporter 2 inhibitors (SGLT2i); Mineralocorticoid receptor antagonists (MRA); Glucagon-like peptide-1 (GLP-1)

The STOP-ACEi trial of 411 participants with chronic kidney disease, investigated that discontinuing renin-angiotensin system inhibitors (RASi), including ACEi and ARBs did not result in clinical benefit in patients with advanced and progressive CKD. (Bhandari et al., 2024)

Non-Pharmacological Care

Lifestyle modification remains a cornerstone of CKD management, as it improves the clinical outcomes and slows the rate of disease progression. Important lifestyle strategies include smoking cessation, adequate physical activity, healthy diet and limiting alcohol intake.

Smoking cessation is strongly recommended, as tobacco use accelerates renal decline through vascular injury, oxidative stress and promoting systemic inflammation. Nutritional intervention should be individualised and adjusted according to the metabolic changes associated with each stage of CKD. In earlier stages, a general healthy balanced diet is recommended, including balanced nutrition, sodium intake reduction, and limiting highly processed foods. In later stages, dietitian involvement is essential, as patients may need to restrict foods high in potassium and phosphate to prevent complications such as hyperkalaemia and bone disease. Alcohol consumption should be no more than 10 standard drinks per week and no more than 4 drinks on a single day. Regular physical activity is also strongly encouraged. The goal is to achieve 2.5–5 hours of moderate to intensity aerobic exercise each week, along with strength training to maintain muscle mass and physical function.

Conclusion

CKD represents a major public health challenge in Australia, affecting a substantial proportion of the population and contributing markedly to morbidity and mortality. According to the Australian Institute of Health and Welfare (AIHW), CKD contributed to approximately 11% of all deaths in 2022, emphasising its significant burden on national health outcomes.

CKD imposes a significant economic burden, particularly in advanced stages requiring dialysis or transplantation. It is also associated with high rates of hospitalisation and healthcare services. Cardiovascular complications are the predominant drivers of both morbidity and mortality among CKD patients, highlighting the need for integrated care strategies that address both renal and cardiovascular health. With early recognition and appropriate treatment, progression to kidney failure can often be significantly delayed and improve the quality of life and reducing healthcare burden.

Dyshidrotic eczema, also known as pompholyx, vesicular dermatitis, or vesicular hand and foot dermatitis, is a type of dermatitis which presents as small 1-2 mm fluid-filled vesicles on the palms, along the fingers and on the soles of the feet (1). It usually resolves after two to three weeks with scaling and peeling, and is typically extremely itchy, chronic, recurrent and often symmetric (2).

It is unclear what causes dyshidrotic eczema, but it is associated with atopic dermatitis and the occurrence does not seem to correlate with any specific age or gender (2). The condition may be precipitated by acute inflammatory tinea, or molluscum contagiosum. Other aggravating factors include overheating, irritants, stress, immunoglobulin therapy, hyperhidrosis, smoking, and taking the oral contraceptive pill or aspirin (1,2).

Early treatment is important as dyshidrotic eczema is often difficult to treat and specialist involvement is usually required (1). Secondary infections may occur and a bacterial swab should be taken if clinical signs of infection are present. The condition may also lead to inflammation of the skin around the finger or toenail as well as nail dystrophy (2).

First line treatment for dyshidrotic eczema includes potent corticosteroids, such as betamethasone dipropionate 0.05% cream or ointment, or betamethasone valerate 0.1% cream or ointment, or mometasone furoate 0.1% cream or ointment (1). The cream or ointment should be applied once or twice daily until the skin is clear and with or without a modified dressing (1).

For recurrent episodes of acute dyshidrotic eczema, betamethasone dipropionate 0.05% ointment in an optimised vehicle should be used once or twice daily until the skin is clear or for up to two weeks, with or without a modified dressing (1).

Oral corticosteroids such as prednisolone or prednisone may be required for dyshidrotic eczema where significant blistering and extreme itching occurs (1). The recommended dose is 15-25mg orally once daily for 3 to 4 days, then tapered over 1-2 weeks to minimise rebound flares (1).

General measures to treat dyshidrotic eczema include avoiding aggravating factors where possible, and using potassium permanganate soaks during the acute phase, which helps to dry exudative lesions (2). Regular use of emollients and moisturisers and antihistamines for itching may also be helpful (2). Dermatologists may also use phototherapy with ultraviolet light A, as well as second-line agents such as methotrexate, depending on the severity and behaviour of the disease (2).

 

 

 

 

Psychotropic medicines are central to the management of many mental health conditions. However, their use is associated with clinically significant metabolic adverse effects, including weight gain, dyslipidaemia, impaired glucose tolerance and type 2 diabetes, hypertension, and ultimately increased cardiovascular risk. These adverse effects are commonly associated with antipsychotics, although some antidepressants and mood stabilisers may also contribute.

Monitoring of metabolic adverse effects is not always optimal, which may contribute to the substantial morbidity and premature mortality in people living with severe mental illness.

Why metabolic monitoring matters

People with severe mental illness already experience poorer physical health outcomes than the general population.

An Australian report found that people living with mental illness are:

• Twice as likely to have cardiovascular disease;
• Twice as likely to have respiratory disease;
• Twice as likely to have metabolic syndrome;
• Twice as likely to have diabetes;
• Twice as likely to have osteoporosis;
• 65% more likely to smoke; and
• Six times more likely to have dental problems.

This population also accounts for around one third of all avoidable deaths. People living with severe mental illness are particularly at risk and are estimated to die between 14 and 23 years earlier than the general population.

Cardiovascular disease is a leading cause of premature death in this population. People with serious mental illness are more likely to have risk factors, such as smoking and poor diet. However, psychotropic medicines can further exacerbate this risk through multiple mechanisms, including:

• Weight gain (via increased appetite, reduced satiety, sedation-related inactivity);
• Reduced insulin sensitivity;
• Dyslipidaemia; and
• Hypertension.

Some studies have found that around 40% of people with chronic schizophrenia meet the criteria for metabolic syndrome.

Antipsychotics and relative metabolic risk

While all antipsychotics may contribute to metabolic abnormalities, the risk differs significantly between agents. Clozapine and olanzapine are considered high risk, while chlorpromazine is considered medium to high risk. It may be appropriate to avoid these agents in patients who are overweight, at high risk of cardiovascular disease, or have a family history of diabetes.

Antipsychotics associated with a medium risk include quetiapine, risperidone, and paliperidone. Asenapine, aripiprazole, brexpiprazole, cariprazine, haloperidol, lurasidone, and ziprasidone are considered low risk, although metabolic adverse effects can still occur.

Significant weight gain can occur within 6-8 weeks of initiating an antipsychotic, and early weight gain may be a predictor of long-term weight gain. Weight gain may be the most visible sign of metabolic disturbances and is often the most concerning for patients. However, it is important that weight is not the only focus of monitoring.

Dyslipidaemia and impaired glucose tolerance can develop even with minimal weight change, particularly in people with pre‑existing risk factors. Therefore, normal weight does not necessarily equal low cardiometabolic risk. Routine laboratory monitoring is essential, even when weight appears stable.

The potential for metabolic effects to develop early highlights the importance of baseline assessment and early follow-up.

Baseline assessment

Baseline data should be documented so that early changes can be identified. The Therapeutic Guidelines recommend assessment of the following parameters prior to initiating a psychotropic:

• Blood pressure and heart rate
• Weight, waist circumference and body mass index (BMI)
• Blood glucose and glycated haemoglobin (HbA1c) concentration
• Lipid concentrations, including triglycerides
• Level of physical activity
• Movement (involuntary or voluntary)
• Full blood count
• Blood prolactin concentration
• Electrocardiogram (as many antipsychotics can prolong the QT-interval).

Waist circumference is particularly important, as it may identify central adiposity even when weight or BMI fall within a healthy range.

Ongoing monitoring

Metabolic abnormalities often develop soon after antipsychotic initiation or dose escalation and guidelines emphasise the importance of early follow‑up. The Therapeutic Guidelines recommend monitoring of weight, waist circumference and BMI at 1 month, 2 months, 3 months, and 6 months after starting treatment, and every 6 months thereafter. Fasting blood glucose and HbA1c should be measured at 3 months and 6 months after initiating therapy and every 6 months thereafter. It is also recommended to measure fasting lipids every 6 months.

Clozapine requires especially close metabolic and physical health surveillance in addition to mandatory haematological monitoring.

Metabolic risk persists throughout treatment and may accumulate over time. Therefore, monitoring must continue long term. Transitions of care, such as discharge from inpatient units or changes between prescribers, are high‑risk points where monitoring responsibility can be lost.

Addressing abnormal results

Abnormal findings should trigger timely intervention, which may include lifestyle support or adjustment of psychotropic therapy.

Weight gain is often considered clinically significant when it increases by 7% or more from baseline. Lifestyle interventions are the first-line options and should be tailored to the patient. Studies suggest that a weight loss of at least 5% of body weight is associated with reduced cardiovascular risk and mortality.

A review of all other concurrent medications should be undertaken to identify any other drugs that may be contributing to the metabolic abnormalities. For example, hyperglycaemia is a common adverse effect of glucocorticoids, and weight gain can occur with the antiepileptics valproate and carbamazepine.

In some cases, switching to an antipsychotic with a lower metabolic risk profile may be considered. However, this must be carefully weighed against the risk of psychiatric destabilisation.

Where lifestyle interventions are not effective and adjusting antipsychotic therapy is either ineffective or inappropriate, metformin may be considered to treat antipsychotic-associated weight gain. Studies in patients with schizophrenia or schizoaffective disorder found a mean weight loss of 3.27kg (95% CI: −4.66 to −1.89, p < 0.001) and a reduction in BMI of −1.13 kg/m² (95% CI: −1.61 to −0.66). Additional benefits may include improved insulin sensitivity, reduced hepatic glucose production, and improved peripheral glucose uptake.

Pharmacological treatment may also be required for established dyslipidaemia, hypertension, or diabetes, in line with standard clinical guidelines.

Summary

Metabolic monitoring is a core safety requirement for patients receiving psychotropic medicines, particularly antipsychotics. Baseline assessment, early follow‑up, and long‑term monitoring is required to ensure the safe use of these medicines.

Monoclonal antibodies (mAbs) are biologic medicines that bind to specific antigens with high specificity. The targets for these proteins are varied and include cancer cells, inflammatory mediators, and pathogens. Their use has grown considerably over the past few years with an expanding range of indications.

It is important to identify medicines that fall into this category as mAbs often have specific requirements for storage, administration, and monitoring. Currently, these medicines can be easily identified by the suffix -mab. However, this suffix has been discontinued and mAbs named after 2021 will no longer end in -mab.

Naming conventions

Biological medicines supplied in Australia are identified using the Australian Approved Biological Name. This name is invariably an international non-proprietary name (INN), supplied by the INN committee of the World Health Organization (WHO). In the absence of an INN, an appropriate name is agreed between the sponsor of the new medicine and the Therapeutic Goods Administration (TGA) during the medicine registration process.

Monoclonal antibody names follow a structured naming convention established by the WHO. The original system, introduced in 1991, assigned all mAbs the suffix –mab (e.g. adalimumab, infliximab). However, a large number of mAbs with increasing structural complexity have been developed since then which has led to various revisions of the nomenclature system.

Original naming pattern: Prefix + Target Substem + Source Substem + Suffix

1. Prefix

• Unique and arbitrary
• Helps distinguish between drugs

2. Target Substem

Indicates what the antibody targets:

• -tu-: tumour (e.g., cancer therapies)
• -li-: immune system (e.g., inflammatory diseases)
• -vi-: viral targets

3. Source Substem

Historically indicated how “human” the antibody is:

• -o-: murine (mouse)
• -xi-: chimeric
• -zu-: humanized
• -u-: fully human

4. Suffix

• -mab: identifies the drug as a monoclonal antibody

Example: Adalimumab

• ada- (prefix)
• -li- (immune system target)
• -u- (fully human)
• -mab (monoclonal antibody)

This tells us that adalimumab is a fully human monoclonal antibody targeting the immune system.

Recent Changes to Nomenclature

In recent years, the WHO has simplified mAb naming by removing the source substem (e.g., -xi-, -zu-). This change reflects advances in biotechnology and reduces confusion, as most modern antibodies are highly humanised regardless of classification.

While mAbs have previously shared the common suffix -mab, this naming system has become unsustainable. With over 800 mAbs already named using “-mab”, it has become increasingly harder to create distinct, recognisable, and clinically meaningful names. Secondly, the structural diversity of this drug class has also increased (e.g., fragments, bispecific antibodies, engineered constructs), making the single suffix overly simplistic.

In response, the WHO formally revised the INN system in 2021, eliminating the universal “-mab” suffix for new agents. Medicines named prior to 2021 retain their original names..

The New Naming System

Under the updated INN scheme, monoclonal antibody-based therapies are now grouped into four categories, each with a unique suffix that reflects structure and function:

1. -tug → Unmodified immunoglobulins

• Full-length antibodies with no engineered changes in constant regions
• Structurally closest to naturally occurring antibodies

2. -bart → Engineered (artificial) immunoglobulins

• Full-length antibodies with intentional modifications (e.g., altered Fc function, glycoengineering)

3. -mig → Multispecific antibodies

• Includes bispecific or multispecific constructs
• Designed to bind multiple targets simultaneously

4. -ment → Antibody fragments

• Includes partial antibodies or fragments lacking full Fc regions
• Often used for improved tissue penetration or specific targeting

These four suffixes will be used in place of the suffix mab for all mAbs approved after 2021.

There are also some new infixes which denote the target, as shown in the updated list below:

• ami – serum amyloid protein (SAP)/amyloidosis
• ba – bacterial
• ci – cardiovascular
• de – endocrine
• eni – enzyme inhibition
• fung- fungal
• gro – skeletal muscle mass related growth factors & receptors
• ki – cytokine & cytokine receptor (formerly: interleukin)
• ler – immunomodulating allergen
• pru – immunomodulating immunosuppressive
• sto – immunomodulating immunostimulatory
• ne – neural
• os – bone
• ta – tumour
• toxa – toxin
• vet – veterinary use
• vi – viral

While the infix can provide an idea of how the drug works, it is important to remember that this is assigned according to the proposed mechanism of action at the time of naming. The mechanism of action may not be completely understood at that time and may vary by indication.

The new naming structure follows the pattern of: Prefix + infix + suffix

• Prefix: unique, arbitrary (chosen by pharmaceutical company for distinctiveness)
• Infix: may indicate therapeutic target
• Suffix: indicates structural class

The pipeline for biologics is rapidly expanding. Many investigational therapies already use the new naming scheme. For example, etentamig is currently being evaluated in phase 3 clinical trials for the treatment of relapsed or refractory multiple myeloma.

Understanding the new naming conventions helps to avoid confusion once these drugs reach clinical practice.

Conclusion

The shift away from the “-mab” suffix reflects the evolution of mAb therapies, which have emerged as a diverse and complex class of medicines.

While the naming changes occurred in 2021, the average clinical development time for mAbs is around six to nine years. As a result, the full impact of this naming system is only beginning to emerge and will become increasingly relevant in clinical practice as new therapies are approved.