CPD PDSA guide
A Plan, Do, Study, Act (PDSA) implementation guide
A worked PDSA cycle for introducing zoledronic acid infusion as a practice service, building the clinical protocol, and meeting CPD requirements as a whole practice team.
GPs meet a significant share of the 50-hour annual CPD requirement without leaving the practice. Submitted as a practice-based or group activity, hours log across EA, RP and MO. Nurses maintain their own CPD records and declare compliance at annual AHPRA registration. Practice managers count the activity toward AAPM certification.
A practice that runs structured QI activities absorbs a substantial share of the 50-hour CPD obligation on behalf of its GPs. The GP gets CPD done within practice time on problems relevant to their clinical work. That benefit disappears if they leave.
Introducing a new infusion service forces a full review of pathology workflows, consent, vitamin D and renal function thresholds, and adverse-event protocols. A documented PDSA is ready-made evidence for RACGP accreditation (5th edition Standards).
An in-house Aclasta infusion service captures patients who would otherwise go to a day infusion unit or hospital clinic. Practice bills an infusion fee plus associated consultations. Retention benefit is material: patients return annually for the infusion review.
Osteoporosis is one of the most common chronic conditions in general practice, and the clinical endpoint that matters is a fragility fracture. Hip, vertebral and wrist fractures carry substantial morbidity, loss of independence and, in older patients, reduced life expectancy. Despite this, osteoporosis is underdiagnosed and under-treated in Australia, and many patients who meet PBS criteria for pharmacologic therapy are either on no treatment or on a regimen they struggle to maintain.
Treatment options sit on a spectrum. Oral bisphosphonates (alendronate, risedronate) remain first-line in most guidelines because of efficacy, cost and long-term safety data. Compliance is the main issue: weekly dosing, the upright-for-30-minutes requirement, and gastrointestinal side effects mean a proportion of patients discontinue within the first year. Denosumab (Prolia) is a six-monthly injection with good BMD outcomes but carries a rebound vertebral fracture risk if a dose is missed. Intravenous zoledronic acid is a once-yearly 15-minute infusion with the strongest fracture-prevention evidence in the bisphosphonate class and a clean compliance profile by design: once it is in, it is in.
| Fact | Detail |
|---|---|
| Regimen | 5 mg in 100 mL, intravenous infusion, once yearly. Standard rate 30 minutes (45 minutes if creatinine clearance below 45 mL/min or patient over 70). |
| Fracture evidence | HORIZON Pivotal Fracture Trial: yearly infusion over 3 consecutive years reduces vertebral, hip and non-vertebral fractures compared with placebo. |
| ONJ risk at osteoporosis doses | Approximately 1 in 10,000 to 1 in 100,000 patient-years. Risk is materially higher at cancer doses and is not comparable. Patients routinely over-estimate the risk and under-estimate fracture risk. |
| PBS subsidised | Yes, for qualifying indications (see PBS criteria). No MBS item for the medication itself. There is no dedicated MBS infusion administration item for short-duration infusions in general practice. |
| Contraindications | Prior hypersensitivity to any bisphosphonate, current or recent uveitis, active dental problems likely to require invasive dental procedure within 3 months, hypocalcaemia, vitamin D below 50 nmol/L, dehydration, creatinine clearance below 35 mL/min. |
Unlike cost-avoidance topics, Aclasta infusion is a revenue-generating service. There is no dedicated MBS item for short-duration infusions in general practice. In the worked example, the practice charges a $250 infusion fee (no MBS item number) and a $50 GP supervision fee (no item). For bulk billed patients, MBS rules prevent billing for a consultation and charging an infusion fee on top, so the practice bills the infusion fee as a private charge with no associated MBS item. For private patients, the practice can bill a standard consultation item plus the infusion fee. Each practice will need to confirm its own fee structure and billing approach.
The service captures patients who would otherwise be sent to a day infusion unit or hospital clinic and builds a predictable annual patient cohort with high retention.
Up to 9 hours when submitted as a practice-based or group activity: 3 EA (evidence review, bisphosphonate comparison, clinical protocol development and team education), 3 RP (pre-infusion pathology audit, creatinine clearance and vitamin D status review, outcome tracking), 3 MO (the PDSA cycle itself). All participating GPs log via myCPD or their preferred portal. Nurses and practice managers claim separately under their own frameworks.
Note on CPD categorisation: The RACGP currently classifies PDSAs under Measuring Outcomes (MO). However, the broader project involves components that qualify separately as Educational Activities and Reviewing Performance. When submitted as a group or practice-based activity, each component can be logged to its correct category.
| Category | Focus | Hours |
|---|---|---|
| EA | Evidence review, bisphosphonate comparison, ONJ risk, clinical protocol development and team education sessions | 3 |
| RP | Pre-infusion pathology audit, creatinine clearance and vitamin D status review, outcome tracking across infusions | 3 |
| MO | PDSA cycle (plan, do, study, act with documented outcomes) | 3 |
| Total | All components when submitted as practice-based or group activity | 9 |
Note on CPD requirements: The Medical Board of Australia (via AHPRA) requires all registered medical practitioners to complete 50 hours of CPD annually, including a minimum of 12.5 hours EA and a minimum of 25 hours combined RP and MO (with at least 5 hours of each). The RACGP currently classifies PDSAs under Measuring Outcomes. When submitted as a group or practice-based activity, each component can be logged to its correct category.
Most practices that try to introduce Aclasta without a structured cycle underestimate the protocol work required to do it safely. Patient selection, pre-infusion pathology thresholds, renal function calculations, vitamin D correction, consent content, infusion rate, observation period, adverse-event pathway and recall logic all need agreement across the clinical team before the first infusion. A PDSA forces that agreement to be made explicit, documented and reviewed, which is exactly what the RACGP CPD program asks for and exactly what accreditation requires.
Each section includes a worked example from a real cycle conducted by Dr Chris Mitchell, followed by space for your practice to document your own process.
Introduce Aclasta (zoledronic acid) infusions as a practice service. Review the current evidence base. Develop, pilot and approve a written clinical protocol that supports safe care, identifies suitable patients, manages pathology work-up and governs the infusion itself.
Map the current state: how many active patients have a diagnosis of osteoporosis, how many are on oral bisphosphonates, how many are on denosumab (Prolia), and how many are on no pharmacologic therapy. Identify the subgroup most likely to benefit from switching to zoledronic acid administered annually. Draft a clinical protocol and consent form. Agree on the doctor-led recall process. Train the nursing team on the infusion procedure and observations.
The active patient list was searched on Best Practice for a diagnosis of osteoporosis. Doctors reviewed each record individually for suitability. Most patients already on oral bisphosphonates (alendronate, risedronate) had no strong case for change. The practical subgroup for switching was patients on no therapy and those on denosumab. Some clinicians in the practice view zoledronic acid as first-line, with better fracture-prevention evidence than denosumab and no evidence of increased ONJ risk at osteoporosis doses. UpToDate (January 2026) positions zoledronic acid as second-line behind oral bisphosphonates based on cost and long-term safety data. We preserved both positions in the team discussion and let each doctor make the call for each patient.
| Active patients with a diagnosis of osteoporosis | |
| On oral bisphosphonates | |
| On denosumab (Prolia) | |
| On no pharmacologic therapy | |
| Candidates for Aclasta discussion |
| Planning meeting | 23/09/2025 |
| Clinical meeting (final) | 19/02/2026 |
| Approval of final protocol | 19/12/2026 |
| Planning meeting | |
| Clinical meeting (first) | |
| Review of draft protocol | |
| Nursing training and checklist walk-through | |
| First patient infusion | |
| Mid-cycle review of experience | |
| Final protocol sign-off | |
| RACGP portal upload |
| Measure | Audit 1 | Audit 2 | Audit 3 |
|---|---|---|---|
| Patients identified as candidates for Aclasta | |||
| Patients who had a decision conversation with their GP | |||
| Patients who consented and proceeded | |||
| Pre-infusion bloods completed and in range | |||
| Infusions delivered without adverse event | |||
| Patients recalled for annual dose | |||
| Patients who declined after discussion |
A clear written protocol is essential. Without it, each infusion becomes a one-off negotiation between doctor, nurse and patient. With it, the nurse runs the infusion with confidence, and the doctor retains clinical governance.
Patients are more concerned about osteonecrosis of the jaw than about fracture risk, even though fractures are more common and have a greater impact on quality of life and life expectancy. Evidence-based reassurance on ONJ risk at osteoporosis doses (approximately 1 in 10,000 to 1 in 100,000 patient-years) is central to the consent conversation.
The evidence base is more contested than expected. UpToDate treats oral bisphosphonates as first-line. The view of some clinicians in the practice, supported by the HORIZON trial data, is that zoledronic acid has stronger fracture-prevention evidence. Reasonable doctors in the same practice reached different positions on the same patient. The protocol did not resolve this; it held space for the disagreement.
Two-yearly dosing has reasonable supporting evidence despite annual being the standard on the packaging. The practice did not adopt 2-yearly dosing as protocol, but flagged it as a conversation some patients may raise.
Targeting is harder than expected. Patients on oral bisphosphonates have little cause for change. The working cohort is patients on no therapy or on denosumab.
What worked best for us was a recall appointment with the patient’s usual GP. The GP arranges the required investigations, reviews results, and confirms Aclasta is appropriate. A separate infusion date is then scheduled with the nurse. For bulk billed patients, MBS rules prevent billing for a consultation and charging an infusion fee, so we chose to bill an infusion fee of $250 without an item number, plus a $50 GP supervision fee (no item).
Aclasta is now available for infusion at our clinics. The approved clinical protocol and nursing checklist govern every infusion. A Best Practice shortcut (ACLASTADR) documents the decision conversation and pre-infusion checklist in one place. Recalls are booked at the time of infusion for the next annual dose.
Reference from LHMC clinical protocol:
| Status | Criteria |
|---|---|
| Red: unacceptable for administration | Previous hypersensitivity to any bisphosphonate. Current or recent uveitis. Active dental problems likely to require invasive dental procedure within 3 months. Hypocalcaemia. Vitamin D below 50 nmol/L. Dehydration. Creatinine clearance below 35 mL/min. Patient unable to access zoledronic acid on PBS or other subsidised source. |
| Orange: requires discussion | Administration less frequently than 12-monthly. Patients being treated for hypercalcaemia may need pre and post-infusion hydration with normal saline 0.9%. |
| Green: accepted for administration | Medical condition assessed as stable. Clear diagnosis and prognosis, low risk of deterioration. Referrer has discussed risks and benefits. Patient meets at least one PBS eligibility criterion (see PBS criteria section). |
PBS authority requirements change periodically. Verify current eligibility criteria against the Schedule of Pharmaceutical Benefits before prescribing.
Aclasta infusion discussed with patient.
A summary of the clinical protocol used at Lennox Head and Epiq Medical Centres. Practices developing their own protocol should adapt rather than copy.
Standard rate is 100 mL over 30 minutes (gravity-fed giving set, drop factor 20, approximately 66 drops per minute). If creatinine clearance is below 45 mL/min or the patient is over 70, infuse 100 mL over 45 minutes (approximately 48 drops per minute).
The patient must have access to medical governance support for the duration of the infusion. Primary medical governance is provided by the referring specialist, the credentialed GP or the practice medical staff. The emergency department is not the primary escalation point unless the situation is an emergency.
If an adverse reaction occurs, stop the infusion, notify the GP immediately, take a full set of observations and monitor closely.
Log this PDSA via myCPD or your preferred CPD portal as a group or practice-based activity. Record time as you go and document discussions in meeting minutes for AHPRA requirements. The hours breakdown is set out in the CPD hours from this PDSA table earlier in this guide.
Using the GP-led Activity form, one GP can record the activity for multiple GPs on their behalf. Nurses log separately via AHPRA and the NMBA. Practice managers count the activity toward AAPM certification requirements.
| Activity component | AHPRA CPD type | Estimated hours |
|---|---|---|
| Evidence review, bisphosphonate comparison, clinical protocol development and team education sessions | Educational activities (EA) | 3 hours |
| Pre-infusion pathology audit, creatinine clearance and vitamin D status review, outcome tracking | Reviewing performance (RP) | 3 hours |
| PDSA cycle (plan, do, study, act with documented outcomes) | Measuring outcomes (MO) | 3 hours |
Check where you sit in the triennium before logging hours. If the project spans two triennium periods, start the new submission from the date the new triennium begins. Do not log hours to a period where you have already met your requirements.
| Doctor’s name | QI and CPD number |
|---|---|
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This section contains the educational and clinical background material that supports the PDSA. It forms part of the Educational Activities (EA) component of the CPD hours. Review and discussion of this material with your practice team contributes to the 3 EA hours.
Oral bisphosphonates are the most commonly prescribed first-line pharmacologic therapy for osteoporosis in most Australian and international guidelines. The rationale is efficacy, favourable cost and long-term safety data. Alendronate is usually suggested as the initial oral agent, with risedronate as a reasonable alternative.
Intravenous zoledronic acid is suggested for patients with contraindications or intolerance to oral bisphosphonates, including oesophageal disorders, an inability to remain upright for 30 to 60 minutes after a dose, or gastrointestinal intolerance. It is also a reasonable choice for patients already on denosumab who wish to consolidate therapy or step down.
Oral and intravenous bisphosphonates should not be used routinely in patients with chronic kidney disease and eGFR below 30 to 35 mL/min/1.73 m².
Once-yearly 15 minute intravenous infusion. In the HORIZON trials, yearly infusion over 3 consecutive years compared with placebo reduced the risk of vertebral fracture, hip fracture and non-vertebral fracture.
The majority of patients who receive zoledronic acid once yearly for 3 years do not require subsequent infusions for at least the next 3 years. For patients at high ongoing fracture risk (existing vertebral fracture, femoral neck BMD T-score below minus 2.5 after an initial course), continuing yearly infusion beyond 3 years may provide further benefit, weighed against the potential risks of long-term therapy.
There is reasonable evidence for 2-yearly dosing as an alternative to annual dosing once the initial course is complete. This is not on the standard packaging advice but has support in the literature and may be a conversation some patients raise.
Isolated reports of impaired kidney function and acute kidney injury after zoledronic acid administration, particularly in patients with multiple myeloma and rarely in those treated for osteoporosis and those on concurrent diuretic therapy. May relate to infusion administered too rapidly. Measure serum creatinine before every infusion. Ensure adequate hydration. Infuse over at least 15 minutes (30 minutes is standard in general practice; 45 minutes if creatinine clearance is below 45 mL/min or the patient is over 70). Zoledronic acid is not recommended if creatinine clearance is 35 mL/min or below.
Transient flu-like symptoms are the most common adverse effect, most often after the first dose and less likely on subsequent doses. Paracetamol before and for several days after the infusion reduces severity. Longer infusion times (45 to 60 minutes) reduce incidence.
Intravenous bisphosphonates can cause hypocalcaemia, particularly in patients with vitamin D deficiency, chronic kidney disease or a malabsorption disorder. Correct vitamin D deficiency (25-OH vitamin D above 50 nmol/L) and hypocalcaemia before infusion.
Osteonecrosis of the jaw (ONJ) is a rare complication of bisphosphonate therapy, associated with pain, swelling, exposed bone, local infection and pathologic fracture of the jaw. Most cases have been in patients treated with high-dose intravenous bisphosphonates for cancer or multiple myeloma.
At osteoporosis doses, the risk is approximately 1 in 10,000 to 1 in 100,000 patient-years. Risk factors include intravenous administration, cancer and anticancer therapy, dose and duration, dental extractions or implants, poorly fitting dentures, glucocorticoids, smoking, diabetes and pre-existing dental disease.
If a dental implant or extraction is planned, consider delaying bisphosphonate therapy for a few months until healing is complete. For patients already on bisphosphonates, the evidence does not support routinely discontinuing therapy before dentoalveolar surgery for osteoporosis indications. The American Association of Oral and Maxillofacial Surgeons position paper is the most cited source on this management question.
Rare but recognised. Current or recent uveitis is a contraindication to further bisphosphonate therapy.
Under the Medical Board of Australia registration standard, all GPs must complete 50 hours of CPD annually:
PDSA cycles are classified under Measuring Outcomes. When a PDSA is run as a practice-based project, the associated education sessions qualify as EA and the data extraction and audit components qualify as RP. Submit each component separately under its correct category via myCPD or your preferred portal as a group or practice-based activity.
Using the GP-led Activity form, one GP can record the activity for multiple GPs on their behalf.