standard of practice in dispensing and distribution for ... · 11 2 pharmacy department, monash...

DRAFT prepared 29.06.2020. Property of The Society of Hospital Pharmacists Australia 1

Standard of practice in dispensing and distribution for pharmacy 1

services 2

Patrick Lam, BPharm, MHlthServMt, MClinPharm, GradCertPharmPrac, FSHP,1,2 Tom Chynoweth, 3

BPharm(Hons), GradCertPharmPrac, MBA, MSHP,1,2,3 Ashley Crawford, BPharm(Hons), MPH, MSHP, 1,4 4

Christopher Giles, BPharm, MSHP,1,5 Janice Chien Lin Kho, BPharm, MSHP,1,6 Anna Wood BPharm 5

MSHP,1,7 Andrew Campbell, BPharm(Hons),1,8 Melanie Anderson,1,9 and Courtney Munro, BPharm, 6

GradCertPharmPrac, MPharmPrac, MSHP, AACPA, PhD.10 7

8

1 Dispensing and Distribution Leadership Committee, The Society of Hospital Pharmacists of 9

Australia, Collingwood, Victoria 10

2 Pharmacy Department, Monash Health, Victoria, Australia 11

3 Health Purchasing Victoria, Victoria, Australia 12

4 SA Pharmacy, Central Adelaide Local Health Network, South Australia 13

5 Pharmacy Practice Unit, Icon Group Pharmacy Services, Queensland, Australia 14

6 Pharmacy Department, Fiona Stanley Hospital, Western Australia 15

7 Pharmacy Department, Sunshine Coast University Hospital, Queensland 16

8 Sir Charles Gairdner Hospital, Nedlands, Western Australia 17

9 John Hunter Hospital, New South Wales, Australia 18

10 The Society of Hospital Pharmacists of Australia, Collingwood, Victoria, Australia 19

20

Address for correspondence: 21

Patrick Lam,1 Chair, Dispensing and Distribution Leadership Committee, The Society of Hospital 22

Pharmacists of Australia, Collingwood, Victoria, Australia. Email: [email protected] 23

24

Preface 25

This Standard references and relies upon the Society of Hospital Pharmacists of Australia (SHPA) 26

Standards of Practice for Clinical Services1 as the foremost Standard. This Standard supersedes the 27

previous SHPA Standards of Practice Hospital Pharmacy Outpatient Services2 and SHPA Standards of 28

Practice for the Distribution of Medicines in Australian Hospitals.3 29

This Standard may overlap with others and depending on the area of specialty practice it may be 30

advisable to refer to additional Standards of Practice. 31

The use of the word ‘specialisation’ in this standard is in line with the National Competency Standards 32

Framework for Pharmacists in Australia,4 where ‘specialisation’ refers to the scope of practice rather 33

than the level of performance. ‘Specialisation’, of itself, does not confer additional expertise. 34

mailto:[email protected]


This Standard is for professional practice and is not prepared or endorsed by Standards Australia. It is 35

not legally binding. 36

37

Introduction 38

In Australia, everyone shares a fundamental right to safe and high-quality healthcare. This is defined 39

in the Australian Charter of Healthcare Rights,5 which all healthcare systems must strive to uphold. 40

The Charter summarises the basic rights of patients and consumers when accessing healthcare 41

services including access, safety, respect, partnership, information, privacy and the ability to give 42

feedback. The provision of pharmacy services must encompass the Charter to deliver effective, 43

efficient, timely, and equitable patient-centred care. 44

The National Competency Standards Framework for Pharmacists in Australia6 complements the 45

underpinnings of the Charter across five domains of competency for the pharmacy profession. These 46

include professionalism and ethics, communication and collaboration, medicines management and 47

patient care, leadership and management, as well as education and research. 48

Purpose and Definitions 49

The purpose of this Standard is to describe best practice for the provision of dispensing and 50

distribution pharmacy services by pharmacists, pharmacy technicians and pharmacy assistants. 51

This Standard is intended to be used across hospital pharmacy services in Australia, irrespective of the 52

service type, or location. While this Standard is intended for hospital pharmacy services, the principles 53

and aspects of dispensing and distribution discussed herein can be applied to broader pharmacy 54

services. 55

This Standard refers to both the role of the pharmacy service and the pharmacist, pharmacy technician 56

and pharmacy assistant practice in dispensing and distribution. It is intended for pharmacy staff 57

involved in, and whose area of specialisation is, dispensing and distribution services. For the purpose 58

of this Standard, the dispensing and distribution pharmacy service will be referred to as the ‘dispensing 59

and distribution service’ and the pharmacy staff involved in dispensing and distribution services will 60

be referred to as the ‘dispensing and distribution team'. 61

On occasion, the Standard refers to dispensing and distribution pharmacists but does not intend to 62

exclude suitably qualified pharmacy technicians where appropriate.1 SHPA supports both pharmacists 63

and pharmacy technicians to operate at their full scope of practice in order to achieve optimal patient 64

and pharmacy outcomes. 65

The use of the term ‘pharmacy technician’ in this standard refers to both pharmacy technicians and 66

pharmacy assistants (hereafter referred to as technicians). It is acknowledged that there are different 67

models of recognition for technicians and assistants within Australia. The term ‘technician’ as used in 68

this Standard recognises the varying range of skills of this workforce providing dispensing and 69

distribution services. Individual health services will need to ensure that there is appropriate 70

governance in place to determine the scope of practice levels required for the various dispensing and 71

distribution roles for technicians as referred to in this Standard. 72

73


Objectives of the Service 74

The objectives of a dispensing and distribution service are to deliver the safe, efficient, effective and 75

accountable use of medicines by providing medicines to patients in an accurate and timely manner 76

and ensuring that medicines are available when required. To provide optimal care, the dispensing and 77

distribution team must deliver this service as part of a multidisciplinary collaborative team and within 78

the framework of evidence-based and patient-centred healthcare. 79

80

Scope 81

This Standard applies to the dispensing and distribution team, providing a dispensing and distribution 82

service. The dispensing and distribution service may be provided across several settings including 83

public and private hospitals, in an inpatient, outpatient or ambulatory care setting, in community or 84

domiciliary settings and in metropolitan, regional and rural settings. The scope of services is broad and 85

includes dispensing activities (often with direct patient interaction) or indirect activities such as 86

distribution and quality activities (e.g. formulary management or administrative duties). 87

The scope of services will be dependent on a variety of factors including; the setting, patient 88

population, the services the hospital or health service provides, funding models, governance 89

structures for dispensing and distribution services, health service and pharmacy department priorities, 90

organisational priorities and the scope of practice of the dispensing and distribution team. 91

The role of dispensing and distribution team should include: 92

• involvement in operational activities 93

• delivery of pharmacy services that improve medicine outcomes for patients and adds value to 94

healthcare systems, while encouraging the financial sustainability of healthcare 95

• development of and input into policies, procedures, guidelines and resources 96

• consideration of formulary requirements such as prescribing restrictions before supplying a 97

medicine 98

• provision of educational programs and training for healthcare professionals and students 99

• provision of medicines information and education appropriately tailored for the patient 100

and/or carer 101

• quality improvement activities 102

• research related to dispensing and distribution. 103

The role of the dispensing and distribution team may extend to additional activities related to the 104

administration of the Pharmaceutical Benefits Scheme (PBS) and Special Access Scheme (SAS), and to 105

facilitate medicines access programs. 106

The dispensing and distribution team should be a point of contact for other pharmacists and health 107

professionals, and for the hospital or health service for all dispensing and distribution related 108

enquiries. Pharmacists working within a dispensing and distribution team are expected to provide 109

services relevant to their scope of practice, in addition to providing Clinical Pharmacy services as 110

outlined in SHPA Standards of Practice for Clinical Pharmacy Services.1 111

Whilst some dispensing and distribution services are primarily delivered by pharmacists, work is 112

increasingly supported by technicians in clinical and non-clinical roles. 113


114

Operation 115

The Standard describes the current best care for the provision of dispensing (Box 1) and distribution 116

(Box 2) services by the dispensing and distribution team. 117

Box 1 Definition of dispensing 118

Definition of dispensing 119

Dispensing as defined by the Pharmacy Board of Australia: 120

‘is the review of a prescription and the preparation, repackaging, labelling, record keeping and transfer 121

of the prescribed medicine including counselling to a patient, their agent, or another person who is 122

responsible for the administration of the medicine to that patient’.7 123

Box 2 Definition of distribution 124

Definition of distribution 125

Distribution describes the operation of pharmacy supply chain management systems, including 126

procurement, preservation of the integrity of medicines as they move through the supply chain and 127

the availability and timely delivery of medicines.8 128

The repacking, preparation and supply of compounded medicines will not be covered in this standard 129

and is detailed in the forthcoming Standard of practice in compounding and aseptic services. 130

The supply of pre-packs must adhere to legislative requirements and be in line with professional and 131

competency standards relevant to that profession. Further commentary is outside the scope of this 132

Standard. 133

Essential services relate to services that demonstrate the full scope of pharmacy practice. These may 134

include: 135

• the dispensing of PBS and non-PBS medicines to inpatients, outpatients and on discharge, 136

which may include the clinical screening of the prescription 137

• provision of patient-centred education 138

• procurement and tender management 139

• regular review of imprest medicines which considers the cost-effective and efficacy of 140

medicines, compliance with local formulary requirements and supports quality use of 141

medicines (QUM) and medicine safety principles 142

• return of unused medicines in line with local policies 143

• ensuring the storage methods for medicines complies with the recommendations from the 144

Australian Commission on Safety and Quality in Health Care National Standards along with 145

other State or Territory regulatory requirements 146

• development of policies and/or procedures to manage out-of-stock medicines, critical 147

medicines and ensure continuity of supply 148

• coordination of appropriate actions following a medicine recall. 149

Emerging services relate to services that are innovative and future-focused and are provided in 150

addition to essential services. SHPA encourages all pharmacy services to strive to provide emerging 151

services wherever possible, in addition to essential services. Emerging services where pharmacy may 152


be involved are often a coordinated multidisciplinary approach, which broadly engages in activities 153

including, but not limited to: 154

• tech-check-tech practice model9 155

• closed Loop Medication Management Systems. 156

157

Dispensing 158

Dispensing Medicines 159

Members of the dispensing and distribution team, involved in the dispensing of medicines, must 160

comply with the Pharmacy Board of Australia Guidelines for Dispensing of Medicines.10 This includes 161

signing the prescription label and/or script, to endorse their involvement, or as otherwise mandated 162

by the health service. The dispensing and distribution pharmacist accepts responsibility for the 163

medicine dispensed by endorsing the prescription or medicines order form. These records must be 164

retained and be retrievable in line with local hospital policy and relevant legislation. 165

When medicines are dispensed to patients either on discharge from a hospital, or to an outpatient, 166

the dispensing and distribution pharmacist and/or technician is to: 167

• determine the medicines already in the patient’s possession to minimise the duplication of 168

generic medicines and prevent the use of medicines no longer required by the patient 169

• provide an appropriate quantity of the medicines required and information on how to obtain 170

further supplies of medicines 171

• ensure that the patient’s own medicines brought into the health care facility are either 172

returned to the patient or handled in line with the facility’s policies, where applicable 173

• liaise with community-based health professionals involved in the patient’s care to facilitate 174

the quality use of medicines across the continuum of care 175

• provide the patient or their carer with suitable and sufficient information for them to safely 176

and effectively use the medicines, e.g. consumer medicines information. 177

In some health services, these roles mentioned above may be completed by the clinical pharmacist at 178

the bedside/ward. The dispensing and distribution team should be satisfied that these activities are 179

completed prior to the medicines being released. 180

Pharmaceutical Benefits Scheme in the hospital setting 181

Public hospitals 182

Australian States and Territories participating in the Public Hospitals Pharmaceutical Reform 183

Agreement can access the PBS in some capacity within the hospital setting.11 In Victoria, South 184

Australia, Western Australia, Tasmania, and Queensland, the PBS medicines in hospitals program have 185

been fully embedded into the provision of public hospital pharmacy services. In the Northern 186

Territory, it has been partially adopted to support chemotherapy access. 187

Claiming for PBS medicines is governed by the National Health Act and the Commonwealth Agreement 188

with the respective States and Territories. As such, claiming under the PBS for inpatients is not 189

permissible. In order to access PBS subsidies for chemotherapy, some hospitals have developed 190

alternative mechanisms under the PBS arrangements.12 191


In New South Wales and the Australian Capital Territory, who are non-signatory, patients are not able 192

to access PBS-supported medicines in public hospitals for a range of conditions, or medicines on 193

discharge. Typically these patients receive a smaller quantity than what the PBS would otherwise 194

allow.11 195

196

Private hospitals 197

The PBS is accessible to all private hospitals across Australia, for dispensing of medicines to inpatients 198

and day patients only, and on discharge. PBS licensing limits PBS accessibility to patients of the facility. 199

Where the private hospital pharmacy holds section 90 approval under the National Health Act, PBS 200

medicines may be dispensed to outpatients. This is similar to dispensing from a community pharmacy. 201

Dispensary Layout 202

The location, security, layout, equipment and occupational health and safety (OHS) factors within the 203

dispensary are elements that must be considered to ensure that the premises are suitable for the safe 204

dispensing of medicines and meet State and Territory legislative requirements. Table 1 provides a list 205

of factors to be considered for each element. 206

Table 1 Factors to consider for a safe and suitable dispensary 207

Location • ease of patient access

• ease of staff access

• ease of access for delivery of medicines from suppliers

• appropriate signage to direct patients to the pharmacy

• close proximity to outpatient clinics

Security • maintaining staff safety while still allowing effective patient counselling to

occur

• easy access to a designated alert/duress system in the event of a breach

of security

• installation and operation of a 24-hour monitoring intrusion alarm system

• closed-circuit television (CCTV) monitoring

Layout • workflow movements including review of prescriptions and direct

supervision of technicians

• location of dispensing and checking area should provide minimal

interruptions

• there must be a separate area for preparation of extemporaneous

products

• the designated counselling areas should maintain patient privacy and

allow counselling to be undertaken with minimal distraction

Equipment • bench space must be adequate for safe dispensing

• barcode scanners available on every dispensing terminal

• ancillary equipment such as measuring cylinders, counting trays,

automated tablet counters

• all equipment must be accurate and maintained in a clean manner to

prevent contamination


• separate equipment must be available for the dispensing of oral

chemotherapy, with a process in place for regular cleaning of this

equipment

• an accurate record should be kept of the location of equipment

• equipment should be maintained according to manufacturers’

specifications

• conditions of temperature, humidity, and light suitable for the storage of

all medicines must be maintained

• an appropriate library should be maintained and include hard copy or

online texts as required by law

• other medicines information resources should be readily accessible,

including online

• telephones should be connected to allow ease of access; the number of

telephone lines should not pose a risk of removing all staff from the

dispensing process

• appropriate computer and printer equipment

OHS factors • storage space must be adequate and readily accessible, particularly for

high usage medicines

• availability and accessibility of spill kits

• ergonomics

• general noise levels which are acceptable and non-distracting

• the environment must be conducive to the comfort and safety of both the

patient and pharmacy staff and respects appropriate cultural beliefs and

practices including those of Aboriginal and Torres Strait Islander people

208

Dose Administration Aids 209

Dose Administration Aids (DAAs) are a well-sealed, tamper-evident device that allows individual 210

medicine doses to be organised according to the prescribed dose schedule. There are several 211

commercially available products on the market, including blister packs or sachet systems. The PSA 212

Professional Practice Standards,13 PSA guidelines14 and Pharmacy Board of Australia guidelines15 213

provide additional guidance on the preparation of DAA’s. 214

DAAs may assist in the safe and effective administration of a patient’s medicines and are often 215

recommended to enhance adherence. They are not routinely used in acute hospital settings but may 216

be recommended for long-stay patients, or those trialling self-administration of medicines. The 217

policies and procedures developed for the use of individual patient dose administration aids should 218

consider the SHPA Guidelines for Self Administration16 and comply with the relevant Pharmacy Board, 219

Nursing Board and Pharmacy Regulation Authority guidelines in each jurisdiction. 220

Patients or carers may choose to self-prepare DAAs, e.g. a “dosette” box. The use of self-prepared 221

DAAs for medicines administration is not recommended due to the associated safety risks. Where a 222

hospital and health services allow a DDA to be used, policies must be in place to ensure that the DAA 223

has either been packed or checked by a pharmacist. 224


Patient education 225

Patients must receive education from pharmacists about the brand and generic names of medicines 226

they are receiving, their indications, doses, potential adverse effects, medicine or food interactions, 227

and how to protect themselves from errors. The patient’s identity should be confirmed by using at 228

least three unique identifiers (e.g. full name, date of birth, address, UR number) when receiving 229

prescriptions, issuing medicines and prior to the patient education. Patient/family/caregiver 230

education needs to be tailored to the level of health literacy; show and tell and teach-back techniques 231

should be used to confirm understanding. 232

233

Distribution 234

Issuing of medicines 235

Imprest 236

An ‘imprest’ is an established range of medicines, maintained at pre-determined levels, for use in a 237

specified health service facility location. 238

Imprest systems involve the regular re-stocking of a specified range of medicines in a health service 239

facility location (hereafter referred to as imprest location) to a pre-determined level. They support a 240

less labour-intensive supply model and facilitate quick access to high use and/or time-critical 241

medicines for administration to inpatients. The supply of medicines to an imprest location rather than 242

on an individual patient basis, however, carries some important safety considerations: 243

• there may be an increased risk of selection errors during medicines administration processes, 244

due to less control over the supply chain to the patient 245

• the opportunity for the pharmacist to perform an individual case assessment of clinical 246

appropriateness and detection of prescribing errors is reduced 247

• any error in the supply of medicines to imprest locations may adversely affect multiple 248

patients. 249

Adequate measures must therefore be implemented to ensure the safest possible supply and use of 250

imprest medicines. 251

Range and nature of imprest medicines 252

The range of imprest medicines is dependent on (but not limited to) the following considerations: 253

• quality use of medicines (QUM) and medicine safety considerations, especially with respect 254

to high-risk medicines 255

• the urgency in which medicines need to be accessed for administration in a clinical area (e.g. 256

emergency, critical care, theatre) 257

• the dosage form and strength supplied must be appropriate for the indications and routes of 258

administration and should not require excessive manipulation 259

• the medicines must be appropriate for the competency of those prescribing and administering 260

medicines in a clinical location 261

• the availability of medicines from other clinical areas when access is required for 262

administration in an urgent or time-critical manner 263


• the risk of selection error due to similarities in medicines packaging must be minimised by 264

differentiated packaging, consider alternative brands and cost if changing from what is on the 265

formulary or the preferred tender brand 266

• where multiple strengths of medicines are available, minimise and standardise which 267

strengths are to be supplied via imprest, preferably use the common and/or lower strengths 268

• for monitored medicines, with dependence and/or diversion risks, packing should be 269

optimised to improve accountability and prevent/deter diversion 270

• monitoring and restricting prescribing and supply of broad-spectrum antimicrobials to 271

individual patients, in accordance with antimicrobial stewardship guidelines 272

• financial considerations (cost minimisation) including reducing medicine waste and providing 273

access to PBS funding for inpatients in the private setting. 274

Quantity of imprest medicines 275

The number of imprest medicines allocated to an imprest location should be the minimum required 276

to support the usual rate of usage, the available imprest storage space, and re-supply interval. The 277

maximum quantity of an imprest medicine, in a given location, should be slightly greater than the re-278

supply interval, in order to allow for turnaround times for shipments from suppliers, to account for 279

public holidays and facilitate re-stocking processes. 280

Minimising the number of medicines available of imprest can: 281

• reduce the risk of prescribing or administration error by ensuring pharmacist review of 282

medicines order before supply 283

• minimise the risk of selection error which may arise from overcrowded medicines storage 284

• minimise the risk of wastage due to expiry, and inadvertent administration of expired 285

medicines 286

• highlight the inappropriate or unsafe use of a medicine where large or multiple doses of the 287

medicine are being administered to the patient. 288

Adjusting range and quantity of imprest medicines 289

Adjustments to the range or quantity of imprest medicines should be implemented to improve the 290

safe, cost-effective and efficient supply of medicines to the clinical areas. All adjustments must be 291

authorised by the responsible pharmacist, in consultation with the nurse unit manager. 292

These adjustments must be processed in inventory management systems and the associated 293

documentation updated (e.g. shelf labels, imprest lists, order forms) in a timely manner after 294

authorisation. 295

The range and quantity of medicines in an imprest location may also require temporary adjustment in 296

exceptional circumstances, which include: 297

• medicines shortages that require an alternate therapeutic agent as an interim measure 298

• consolidation of different case mixes into one clinical area, e.g. ward closures 299

• spikes in usage rates due to specific patients’ requirements 300

• outbreaks and epidemics 301

• reductions in imprest replenishment, e.g. public holidays 302

• in the event of an emergency, as part of a disaster management plan. 303


Routine review of imprest holdings: min/max levels and additions/deletions 304

Review of imprest holdings against usage must be conducted for all imprest locations every six to 305

twelve months. An ad-hoc review may be appropriate in instances where: 306

• medicines have expired or are near-to its expiry date 307

• seasonality affects levels of certain medicines, e.g. winter and antimicrobial levels 308

• changes to medical staff and prescriber preferences which lead to a change in usage. 309

Usage reports, with suggested minimum and maximum levels (including additions and deletions), 310

should be utilised to inform the review process. These reports should be viewed and assessed from 311

both the clinical and logistical perspectives. 312

Adjustments must be authorised by the responsible pharmacist and the nurse unit manager. Records 313

of reviews and changes should be retained as evidence of ongoing monitoring of the appropriateness 314

of imprest holdings. 315

Non-imprest medicines (includes individual patient supply) 316

A ‘non-imprest’ medicine: 317

• is a medicine that is not routinely available in an imprest location and is supplied outside of 318

the imprest system 319

• usually involves the supply of a smaller quantity that can be used for a specific patient during 320

their admission without the need for daily reordering. 321

Before a non-imprest medicine is supplied, the medicines order must be reviewed by the dispensing 322

and distribution pharmacist, against the prescription or the inpatient medicines chart. This review 323

should be performed at the time the medicine is requested, however, a review may also be completed 324

at the time of supply where an earlier check is not possible. Either the dispensing and distribution 325

pharmacist or the appropriately credentialled person who performs the check, accepts responsibility 326

for the medicines supplied, by endorsing the prescription or medicines order form. These records must 327

be retained and be retrievable in line with local hospital policy and relevant legislation. 328

Non-imprest medicines should be issued directly to individual patients, with the quantity supplied 329

determined by hospital policy. Three to seven days is commonly used in acute care facilities, which 330

reflects the average length of stay. Non-imprest medicines should be supplied in unit dose packs or 331

individually labelled containers, with labelling specifying the intended patient’s details. Any item that 332

has directions for use included on the label must be checked by a pharmacist. Some health services 333

may have similar policies in relation to cytotoxic or high-risk medicines. Examples of commonly issued 334

non-imprest medicines are detailed in Table 2. 335

Table 2 Commonly issued non-imprest medicines 336

Medicine Reason for directly issuing to patient

Patient-specific items

including inhalers, eye

drops, ear drops, nasal

sprays and ointments

• to ensure that only that patient will be administered the item

• to ensure that the patient has directions when leaving the

hospital if the medicine is not dispensed on discharge

• to comply with legislation upon leaving the hospital

Cytotoxic medicines • ability to track the usage of high-risk medicines


Medicine Reason for directly issuing to patient

• medicine safety benefits via the ability to track supplies and

include specific dosing instructions to prevent errors, e.g.

methotrexate, cyclophosphamide, thioguanine,

procarbazine, melphalan

Non-formulary and

reserved medicines

• to ensure that usage aligns with approved indications or

approved patients

• enables tracking of the usage of high cost or reserved

medicines for reporting and clinical costing purposes

SAS medicines • enables tracking of usage and for SAS ordering and stock

management

note: an exemption may be Section 19A items used to

substitute registered stock

Opioid replacement

therapy (buprenorphine

and methadone)

• to individualise opioid replacement therapy to the individual

patient

• enables the ability to track the supply of a high-risk medicine

and to prevent inappropriate multiple supplies being issued

• facilitates compliance with legislative requirements and for

auditing purposes

Clozapine • classified as a ‘high-risk’ medicine with strict monitoring and

oversight, including re-titration for missed doses > 48 hours,

regular blood tests and patient registration with monitoring

program before initial prescribing

• use of monitoring system in the inpatient setting is

dependent on local processes

Thalidomide analogues

(Thalidomide,

lenalidomide, and

pomalidomide)

• the monitoring system requires strict oversight on how much

is dispensed and compliance with legislative requirements

• can track the usage of high cost and high-risk medicines

Unit Dose 337

A unit dose is a system of packaging whereby each dosage unit is separately packed in a protectively 338

sealed unit and labelled with the name of the medicine, strength, dose contained within the pack, 339

batch number and expiry date. To facilitate closed-loop medicines management, unit dose packaged 340

medicine should also have a barcode. The format and presentation of unit dose medicines essentially 341

minimises or eliminates the preparation of a medicine for administration. 342

Unit dose systems have numerous advantages. Each dosage unit is identifiable to the point of 343

administration. Dosage integrity minimises wastage as unused doses may be reissued. Barcoded unit 344

dose medicines support verification at the bedside and ensure that the right patient is being 345

administered the right medicine, at the right dose, at the right time and in the right form, as ordered 346

by the prescriber. 347

Currently, there are no requirements for manufacturers of medicines to provide hospital medicines in 348

a format that complies with the unit dose packaging requirements. It is recommended that discussions 349

with the Therapeutic Goods Administration (TGA) and manufacturers should promote the medicine 350


safety benefits of proprietary products being routinely provided in unit-dose packaging. Alternatively, 351

some hospitals may choose to package medicines as unit doses locally or collaboratively. 352

Storage 353

All medicines supplied in individual patient-based distribution systems must be appropriately and 354

securely stored in patient care areas. The method of storage may vary in individual health service 355

facilities depending on organisational policy. Storage, however, must comply with manufacturers' 356

instructions and State or Territory legislation. 357

Critical medicines 358

The quantity of critical medicines should be assessed and monitored to ensure the timely delivery of 359

medicines and continuity of supply, in line with local policies. The levels maintained at a given site 360

should give due regard to the available storage space, re-supply interval, turnaround times for 361

shipments from suppliers, State and Territory legislative and policy requirements, the supply and 362

distribution model that is employed and the availability (e.g. ward box model may reduce the available 363

medicines storage space) and obligations relating to the relevant register of the lifesaving and 364

emergency medicines in each State and Territory. When implementing a risk mitigation strategy, the 365

adverse impact of the unavailability of a critical medicine must be considered. 366

Dispensing and Distribution 367

Automated pharmacy solutions 368

Automated pharmacy solutions comprise several individual pieces of technology that can automate a 369

variety of steps in the process of preparation, distribution, and supply of medicines. 370

When implementing any automated pharmacy solutions, it is important to consider the following 371

factors: 372

• setting objectives regarding patient safety, accuracy standards, and resources required for 373

implementation 374

• ensuring that all members of the multidisciplinary team (medical, nursing, pharmacy, finance, 375

information technology) are involved in the planning and implementation process 376

• integration with current technologies including electronic prescribing, dispensing, 377

administration and patient management systems, and clinical decision-support technologies 378

• developing a governance model, policies and procedures to ensure patient safety is optimised 379

• provision of medicines in a form that minimises or eliminates the preparation required for the 380

medicine to be administered 381

• providing appropriate training for all staff involved 382

• ongoing monitoring of the system and auditing of data produced through the system. 383

Further information on the implementation of automated pharmacy solutions is available in the 384

Automation Practice Update.17 385

Automated pharmacy solutions can include, but are not limited to pharmacy robotics, automated 386

dispensing cabinets (ADCs) and anaesthetic ADCs, controlled substances cabinets and unit dose 387

packaging systems (Table 3). 388


Type of automated pharmacy

solution

In- pharmacy robotics

I.e. Original pack dispensing

robots

• most commonly used in the hospital setting, within the pharmacy

• are an automated system for the storage and picking of medicines and may include the labelling of

medicines in the dispensing process

• require the supply of original packs for the most effective use18

Automated dispensing

cabinets (ADCs)

Including Anaesthetic ADCs

• are computerized medicine storage devices or cabinets that allow medicines to be stored and

dispensed near the point of care, while controlling and tracking distribution2

• allow the generation of an electronic controlled substances register

• contain a profiled mode which directs the user to a patient-specific medicine profile and limits access

to medicines to those which have been reviewed and verified by a pharmacist as appropriate for the

patient, as opposed to having access to all medicines contained within the ADC19

note: to be used in profiled mode, an accurate electronic version of each patient’s currently prescribed

medicines need to be interfaced with the ADC

Controlled substances

cabinets

• are located within the pharmacy

• are a computerised medicine storage device that tracks who has accessed the cabinet and the

distribution of controlled medicines from the device

• automates the generation of an electronic controlled substances register

Unit dose packaging • is a system of packaging where each dosage unit is separately packed in a protectively sealed unit

• each dosage unit is labelled with the name of the medicine, strength, dose contained within the pack,

batch number and expiry date

• the presentation of the dosage unit should minimise or eliminate the preparation required for the

medicine to be administered20

• to facilitate closed-loop medicines management, these unit dosed packaged medicines should also have

a barcode

Table 3 Examples of automated pharmacy solutions 389


Repacking 390

Repacking medicines into an appropriate container may be required in some circumstances, for 391

example, where a smaller quantity is supplied rather than the original manufacturer’s pack. The 392

process of repacking should assure hygiene and medicine stability, prevent cross-contamination of the 393

medicine and where appropriate, protect the person handling the medicine. 394

A medicine’s stability, efficacy and toxicity must be considered when selecting an appropriate 395

container.21 In addition, reasonable efforts should be made to replicate the packaging of the original 396

container when repacking medicines, as this has been validated by the manufacturer. However, when 397

a medicine is removed from its original primary packaging, the stability data and shelf life provided by 398

the manufacturer are no longer valid. Before repackaging, stability data must be considered, where 399

available, and an appropriate expiry date assigned.21 Further information will be available in the 400

upcoming SHPA Standard of Practice in compounding and aseptic preparation for pharmacy services. 401

The dispensing label is to be attached to the primary container and must be done in accordance with 402

the Pharmacy Board of Australia Guidelines for Dispensing Medicines.10 403

Transportation 404

Once the medicine is prepared or dispensed, the medicine must be: 405

• picked up by the patient or patient representative; or 406

• delivered to the patient care area (e.g. clinic, ward); or 407

• delivered to an appropriate nominated location (e.g. patient’s home, community pharmacy, 408

medical centre). 409

The method of delivery of medicines to the patient must protect the medicine from breakage, 410

spoilage, and theft, in addition to maintaining privacy and confidentiality. Refer further to local health 411

service procedures and State or Territory legislation, as well as those for postage and/or courier 412

services. Additional procedures should be in place for the safety and security of the following classes 413

of medicines: 414

• restricted medicines (Schedule 4 restricted or Schedule 11 medicines) 415

• controlled medicines (Schedule 8) 416

• investigational products and clinical trials medicines 417

• intravenous admixtures 418

• fragile medicines 419

• cytotoxic medicines and waste 420

• radiopharmaceuticals 421

• temperature-sensitive medicines 422

• hazardous and/or dangerous goods. 423

Medicine accessibility must be duly considered when instituting an operational policy around 424

medicine delivery to patients. 425

Posting dispensed medicines 426

If the medicine is delivered to the patient via a third-party service (e.g. post or courier) the factors in 427

Table 4 must be considered. 428


Factors to consider when delivering medicines

via post/courier

Restrictions and/or special requirements on

the nature of medicines that can be delivered

via a delivery service

• delivery services may prohibit the delivery of certain items (e.g. controlled or cytotoxic

substances) or have special requirements when transporting these items (e.g. special

packaging or documentation)

• consideration must be given to other non-medicine hazardous substances that may

require additional documentation/declarations, e.g. dry ice

Typical delivery times in the context of clinical

requirements and maintaining product

integrity

• appropriate delivery service must be used to ensure the patient receives their medicine

when clinically required (e.g. before their existing supply is exhausted)

• delivery times must be considered to ensure items are packed appropriately and that

storage conditions are maintained for the time it takes for the items to reach the

patient (e.g. including an adequate amount of ice packs if the item is refrigerated)

Maintaining privacy and confidentiality

• privacy and confidentiality must be maintained when packing the delivery

• the contents of the package must be described using general terms only (e.g.

“medicines”) where a description is required

• consideration of the potential recipient must also be given, especially if the item is not

being delivered to a residential address

Appropriate packaging for the type of

medicine and duration of the delivery

• packing medicines in a manner that maintains their physical and chemical integrity

during the delivery transit time ensures they are fit for use when delivered to the

recipient

• maintaining storage temperature requirements during transit (e.g. refrigerated, frozen

mediations). use of insulated boxes with ice/dry ice may be required

• packaging must maintain privacy and confidentiality. generic outer package must be

used to prevent identification of the contents

• clear and obvious labelling of the recipient and sender address


Factors to consider when delivering medicines

via post/courier

Method of obtaining payment from the

patient, e.g. Upfront charging or invoicing

• if charges apply to the patient, they must be recouped efficiently and pragmatically, and

according to organisational requirements

The need for assurances confirming delivery,

e.g. tracking, signature on delivery

• an assessment must be performed to ascertain whether delivery assurances are

required

• this may be appropriate for items that are high risk (e.g. controlled substances) or high

cost

Costs

• the cost of the delivery service must be considered in the context of delivery times,

clinical need, special requirements and cost to the patient/pharmacy

• when sending high-cost medicines, services may determine that a means to replace

items is needed if lost in transit (e.g. insurance cover)

Table 4 Factors to consider if dispensed medicine is delivered to a patient via a third-party429


430

After-hours supply 431

There must be reasonable access to medicines, within health services, outside the normal operational 432

hours of the pharmacy service. This may be facilitated through an on-call pharmacy service and/or a 433

separate supply of medicines for after-hours supply (e.g. after-hours cupboard in the emergency 434

department). The after-hours supply need not contain all medicines, rather medicines that could 435

reasonably be expected to be required. The medicines should be stored in a secure area, large enough 436

to contain all necessary items and under appropriate storage conditions. State and Territory legislative 437

and policy requirements must be complied with. 438

A list of the medicines available for after-hours supply should be widely distributed throughout the 439

health service and may include medicines available in a separate after-hours supply or from other 440

wards. Access to these medicines should be restricted to senior, suitably qualified staff and a record 441

should be kept of all items accessed after hours. In addition, processes should be in place to ensure 442

that the authorised staff know how to access the register of the lifesaving and emergency medicines 443

in each State and Territory to obtain medicines, that are not kept within that health service, but are 444

essential to treat patients with infrequent and potentially fatal illnesses. 445

Storage of medicines outside the pharmacy department 446

Medicines stored outside the pharmacy department should remain in the containers supplied until 447

the time of their use. Processes must be in place to ensure that each medicine is stored according to 448

manufacturer’s specifications (e.g. refrigerated items are stored in a refrigerator) and in a way that 449

minimises opportunities for medicine diversion. 450

In general, medicines should be stored in generic name order. All medicines in stock should be checked 451

at regular intervals by the dispensing and distribution pharmacy team to ensure suitable storage, 452

rotation of medicines and monitoring of the expiry date of the medicines. Special storage 453

requirements may be considered for high-risk medicines and/or medicines which must be stored more 454

securely. Medicines identified as high-risk medicines with the health service should be segregated and 455

appropriately labelled e.g. concentrated potassium ampoules, neuromuscular blocking agents, 456

cytotoxic medicines. 457

Areas allocated to the storage of medicines include; 458

• medicine rooms 459

• medicine cupboards 460

• medicine trolleys 461

• patient drawers or lockers 462

• refrigerators. 463

These areas must be locked and secured at all times, other than when access to medicines is required 464

by authorised persons. The keys, access cards or codes should be limited in number and there must 465

be a system in place to ensure accountability. Some storage areas have specific requirements, see 466

table 5. 467

Table 5 Storage requirements for specific locations 468


Storage area Specific storage requirements

Medicines rooms • should be solely dedicated to the storage and/or preparation and

administration of medicines, including the equipment that is

required to prepare medicines (e.g. fluids to prepare intravenous

medicines)

• no other goods should be stored in the area and access to the room

should be limited

• the room should be secure, well lit, fitted with a water supply and

refrigerated storage

Medicine drawers

and trolleys

• medicines supplied through individual patient-based systems

should be stored separately from medicines for other patients and

retained exclusively for use by that patient

• redundant medicines should not be left in the medicine drawer or

trolley, they should be returned to the pharmacy department or

discarded according to legislative requirements

Refrigerated

storage

• the refrigerator should be fit for purpose to store medicines and/or

vaccines and solely dedicated to the storage of medicines

• it must be lockable where not stored within a secure medicine

room

• the temperature should be electronically monitored, with the

communication of this to the building management system

Controlled

medicines

• the quantity of these medicines stored in patient care areas should

be minimal

• these medicines should be stored and distributed according to

relevant legislative requirements

Medicines storage systems 469

Appropriate governance and audit processes are required to ensure that medicines storage systems 470

are assessed for safety and to reduce any opportunity for diversion. Storage processes must 471

additionally ensure the integrity of temperature-sensitive medicines is maintained. 472

Return of unused medicines 473

The return and recycling of imprest and non-imprest medicines is a time consuming and resource-474

intensive process. Wherever possible, medicines should be purchased and supplied in quantities that 475

minimise this activity. Medicines should be packaged and stored in a manner that protects the 476

medicine and allows the ready identification of the medicine for re-use. 477

The suitably trained member of the dispensing and distribution team should be responsible for 478

determining when a medicine can be re-used. Medicines should only be re-used when the integrity of 479

the product can be assured, and the suitability of its re-use is appropriate. The following factors should 480

be considered when assessing if the medicine is suitable for return and re-use: 481

• an adequate expiry date (e.g. 3-months) 482

• medicines are intact and in original packaging 483


For example: 484

o suppositories/pessaries in its original foil 485

o vials with an intact seal 486

o unopened mixtures, topical products, ear & eye products and inhalers 487

o tablets & capsules in its original foil 488

• cost of the medicines 489

• cold chain requirements have been complied with throughout the life of the product 490

• the brand of medicine is in stock and/or appropriate for return 491

• the general condition of the medicine 492

• medicine ordered for individual patients e.g. not on the formulary 493

• PBS claiming and reimbursement 494

• loose tablets/capsules taking into account stability, handling, infection control and cost 495

considerations. 496

The following medicines must not be returned for use and must be discarded: 497

• unidentifiable medicines 498

• medicines without an identifiable expiry date 499

• part used mixtures, topical products, ear & eye products, inhalers 500

• medicines that have been provided to the patient and have left the hospital (e.g. unwanted 501

discharge medicines and outpatient medicines) 502

• medicines that have been brought into the hospital by the patient (e.g. medicines in dosage 503

administration aids). 504

Safety implications of brand changes 505

Unintended safety issues may result from a brand change that was unable to be detected as part of 506

the procurement or tender process. For example, the new brand may have similar packaging or 507

presentation to medicines stored nearby within specific locations (including look-alike sound like 508

brand names). Dispensing and distribution teams must be vigilant in identifying and addressing these 509

issues. Evaluation of identified potential risks may involve consultation with clinical staff administering 510

medicines. Significant concerns must be escalated through appropriate procurement and clinical 511

governance pathways, and risk mitigation strategies may need to be employed. Any local decision not 512

to use a preferred brand must be approved by the health service. In addition, there may be a 513

requirement to escalate the decision to a state tendering body, through an exemption from the 514

contract process. 515

Medicine recalls 516

A medicine recall procedure must exist to facilitate the prompt retrieval of any medicine recalled by 517

the manufacturer or medicines manufactured or repackaged within the facility, supplier or a 518

government body. The procedure is to include instructions for a recall alert received during business 519

hours, in addition to outside of business hours. It should detail the steps required and persons 520

responsible for managing a standard recall process. In addition, the TGA Uniform Recall Procedure for 521

Therapeutic Goods (URPTG) should be referred to.22 522

To prevent affected medicines from being issued, recalled medicines must immediately be removed 523

and quarantined from the pharmacy store and working areas. In addition, all patient care areas need 524


to be checked and the recalled medicines should be quarantined in a suitable location within the 525

Pharmacy Department. 526

For consumer-level recalls, a recall notice is to be displayed in a location visible to the public in the 527

pharmacy outpatient area requesting consumers return recalled medicines to their supply site. All 528

patients that may have received the medicine from the pharmacy are to be identified and where 529

possible, the prescriber and patient are to be notified so that appropriate action can be taken. 530

Documentation of the recall is to be kept, including evidence that all appropriate areas have been 531

checked and recalled medicines removed. Recalled medicines are to be disposed of in line with 532

instructions detailed in the recall notice. The medicine should then be replaced or credited. 533

For recalls related to compounded or extemporaneous preparations refer to the Australian 534

Pharmaceutical Formulary and Handbook.21 535

Medicines shortages 536

Medicines shortages may be caused by a combination of factors throughout the supply chain. They 537

can adversely affect medicines therapy, compromise or delay medical procedures, result in medicine-538

related errors and even cause patient harm.23 As such, the dispensing and distribution service must 539

have a procedure that outlines the process for decision-making and actions required to effectively 540

manage medicines shortages when they occur. 541

When a medicines shortage is identified, a review of the current stock on hand and stock usage will 542

allow any potential shortfall to be identified, with additional consideration given to the anticipated 543

resolution date of the shortage. An action plan should be developed to manage the medicine 544

shortage. The action plan may include obtaining supply from an alternative source (e.g. overseas 545

product via the SAS), restricting its use to specific patient groups and/or identifying clinical equivalent 546

or alternative medicines. The action plan should be communicated to all pharmacy staff and affected 547

staff/areas, where appropriate. The stock holdings of the medicine, during the shortage, should be 548

reviewed regularly until resolved. 549

Use of patient’s own medicines 550

The decision to allow the use of a patient’s own medicines (POMs) during a patient's admission needs 551

to be made by the individual health services. Anticipated risks versus benefits and resource 552

implications, such as the availability of appropriately qualified staff to assess the suitability of POMs 553

should be considered when making this decision. 554

Where POMs are to be used during a patient’s inpatient admission, the health service must have a 555

policy in place and ensure that patients and carers provide consent to its use. An appropriately skilled 556

and locally authorised health care professional must check the medicines for their suitability for use 557

within the hospital. POMs that are being used during their admission must be placed in a ‘Patient’s 558

Own Medicines’ bag, stored in a locked storage facility and comply with the hospital’s inpatient 559

medicine storage guidelines. 560

POMs that are not being used during the patient’s admission needs to be stored in a ‘Patient’s Own 561

Medicines’ bag, with a patient identification label attached, in the designated locked ward storage 562

area for the patient’s own medicines. Patient’s own restricted or controlled medicines must be stored 563


in a tamper-evident bag in the medicines safe and refrigerated items need to be stored in the 564

medicines refrigerator in a separate ‘Patient’s Own Medicines’ bag. 565

POMs brought into hospital need to be reviewed prior to discharge to ensure that they are still part 566

of the current medicines regimen. Systems must be in place to allow for this review and subsequent 567

return POMs on discharge where appropriate. If medicines taken prior to admission are ceased, then 568

consent should be sought from the patient to destroy the discontinued medicines. 569

Policies, Procedures, and Governance 570

Dispensing and distribution pharmacists must have knowledge of the following documents which 571

provide a framework within which the pharmacist must practice. 572

• Australian Charter of Healthcare Rights 5 573

• National Safety and Quality Health Service Standards 24 including the National Model Clinical 574

Governance Framework 25 575

• Pharmacy Board of Australia 576

o Code of Conduct 26 577

o Guidelines for dispensing of medicines10 578

o Guidelines on practice-specific issues27 579

o Guidelines on dose administration aids and staged supply of dispensed medicines15 580

• SHPA Code of Ethics28 581

• Pharmaceutical Society of Australia 582

o Clinical Governance Principles for Pharmacy Services29 583

o National Competency Standards Framework for Pharmacists in Australia6 584

o Professional Practice Standards13 585

o Dispensing Practice Guidelines30 586

o Guidelines for pharmacists providing staged supply services31 587

• Pharmaceutical Defence Limited (PDL) Guide to Good Dispensing32 588

• Relevant State and Territory legislation. 589

590

Local, institutional and state-based policies guiding practice may include consultation and/or 591

ownership by other professions or by the pharmacy department and should cover: 592

• hospital formulary (public hospitals) 593

• procedures for individual patient approval / single patient use33 594

• policies for procurement, storage and security, supply and distribution of medicines including 595

imprest 596

• policy or procedure for labelling including consideration of health literacy and needs of the 597

patient34,35 598

• policies and procedures for inpatient, discharge and outpatient supply 599

• policies and procedures for supply, management, and reconciliation of Schedule 8 and 600

Schedule 4 recordable/restricted medicines 601

• business rules, covering PBS, charging for medicines 602

• appropriate financial management for goods receipt, ordering, and credits 603

• procedures for checking and integration (interoperability ideal) with digital health platforms 604

such as My Health Record and real-time prescription monitoring 605


• policies for stocktake and inventory management including expiry date checking 606

• policy for recall of medicines 607

• policy for handling medicines shortages 608

• policy for the return of medicines. 609

610

Recommended Staffing 611

As per the SHPA Standards of Practice for Clinical Pharmacy Services,1 there are three major factors 612

that drive staffing levels for clinical pharmacy services: 613

(1) the range of clinical pharmacy services, 614

(2) the complexity of care required and 615

(3) hospital throughput. 616

Recommended dispensing and distribution team staffing levels for hospital pharmacy services need 617

to be determined by the individual service and will depend on a multitude of factors including: 618

• the activities performed by the dispensing and distribution team, including those not classed 619

as “dispensing” 620

• the clinical complexity of prescriptions supplied 621

• throughput times required to achieve the desired rate of patient flow 622

• the extent of automation that has been implemented 623

• the supply and distribution model that is employed (e.g. ward box model may reduce the time 624

taken). 625

The workflow within the dispensing and distribution team lends itself to team-based pharmacy 626

services comprising of staff with a mixed range of experience and seniority. 627

A pharmacist in charge should be delegated to be responsible for all aspects of dispensing and 628

distribution. At least one senior staff member should be responsible for the coordination of all aspects 629

of the dispensing and distribution service. By law, across Australian states and territories, at least one 630

pharmacist must always be present in the dispensary. 631

For dispensing services, the Pharmacy Board provides that additional staffing must be considered 632

where dispensing levels for a pharmacist are in the range of 150-200 items per day.10 633

634

Training and Education 635

It is essential to develop the pharmacy workforce, through the training and education of pharmacists 636

and technicians, to enable the delivery of dispensing and distribution services. Pharmacists and 637

technicians commencing practice in dispensing and distribution teams should undertake relevant 638

orientation and training. Site-specific training may focus on key priority areas relevant to the safe and 639

quality use of medicines in that locality. 640

Dispensing and distribution pharmacists should have a scope of practice competency profile with a 641

continuing professional development (CPD) plan that covers the five domains of professional 642

performance as per the National Competency Standards Framework for Pharmacists in Australia 643

2016.6 Although the framework itself is not tied to any area of specialisation, for dispensing and 644


distribution pharmacists there are qualifications, educational activities, knowledge, and skills that are 645

recommended. These have been informed by the SHPA Dispensing and Distribution Leadership 646

Committee. 647

Credentialing and Qualification648

Desirable certification, credentialing and qualifications include, but are not limited to: 649

• a certificate or diploma that is complementary to the area of practice (for technicians) 650

• a postgraduate qualification in pharmacy (for pharmacists) 651

• credentialing as an Advancing or Advanced Practice Pharmacist provided by Pharmacy 652

Development Australia36 (for pharmacists). 653

Educational Activities 654

Recommended continuing education activities for dispensing and distribution teams include the 655

following: 656

• SHPA Seminars and webinars and SHPA online CPD activities 657

• procurement/probity (fair and transparent practices in procurement) training 658

• PBS education for Health Professionals 659

• courses around managing and de-escalating behaviour 660

• training packages around chemotherapy agents (e.g. locally developed competency or eviQ 661

course ‘Handling antineoplastic drugs and related waste safely’) 662

• professional development around soft skills including; teamwork, leadership, effective 663

communication, customer service, complex problem solving, critical thinking, conflict and 664

aggression management. 665

Educational material and resources are also provided on the SHPA dispensing and distribution stream 666

page on the SHPA online CPD website. For the dispensing and distribution team, joining and actively 667

participating in the SHPA dispensing and distribution stream at the practice group level is strongly 668

recommended. 669

Attendance at specialist conferences and educational meetings should be supported to maintain and 670

update knowledge. Relevant domestic events may include those organised by SHPA such as Medicines 671

Management and the Electronic Medicines Management Conference. Events hosted by the State and 672

Territory-based Therapeutic Advisory Groups (TAGs), Health Roundtables may also be valuable 673

learning experiences. A broad range of events may be suited to the dispensing and distribution team, 674

providing inter-related education opportunities that will help to enrich practices in dispensing and 675

distribution. International meetings and conferences include those provided by the American Society 676

of Health System Pharmacists (ASHP) and the International Pharmaceutical Federation (FIP). 677

Knowledge, Skills and Experiential Learning 678

The role of a dispensing and distribution team is based on a high level of skill in general pharmacy with 679

the later addition of specialty-specific experience. In order to provide personalised care, the 680

dispensing and distribution team should have high levels of personable skills including confidence, 681

empathy, in addition to effective communication skills. The knowledge related to dispensing and 682

distribution pharmacy practice includes the skills and application of clinical pharmacy, which may be 683

advanced by experiential learning. This Standard does not list the competencies that the individual 684

https://www.shpa.org.au/events

https://shpa.moodle.com.au/

https://www.humanservices.gov.au/organisations/health-professionals/subjects/pbs-education-health-professionals

https://education.eviq.org.au/courses/handling-antineoplastic-drugs-and-related-waste-sa

https://education.eviq.org.au/courses/handling-antineoplastic-drugs-and-related-waste-sa

https://shpa.moodle.com.au/course/view.php?id=229

https://shpa.moodle.com.au/course/view.php?id=229

https://www.ashp.org/Meetings-and-Events/Meetings-and-Conferences

https://www.ashp.org/Meetings-and-Events/Meetings-and-Conferences

https://www.fip.org/


members of the dispensing and distribution team should address as this will be dependent upon their 685

scope of practice. 686

Table 6 lists examples of knowledge, skills and experiential learning for dispensing and distribution 687

teams.688


689

Essential Desirable

Knowledge • knowledge of the principles and mechanisms of the PBS

• familiarity with Commonwealth, State or Territory legislation

• knowledge of professional practice standards (e.g. Pharmacy

Board, Guide to Good Dispensing37)

• methods of accessing unapproved medicines (e.g. section19A,

Special Assess Scheme)

• basic understanding of hospital formulary requirements

(where applicable)

• storage requirements for medicines (including Strive for 5)

• familiarity with the National Inpatient Medication Chart

(NIMC) or relevant electronic prescribing software

• familiarity with dispensing software

• familiarity with specialised charts e.g. paediatric, heparin,

insulin, chemotherapy charts

• experience with specialised online platforms for

dispensing (e.g. clozapine, thalidomide,

mifepristone/misoprostol)

• purchasing/inventory management principles

• medicine safety and quality use of medicines

principles

Skills • being able to exercise independent, responsible clinical

judgment in relation to the individual scope of practice

• well-developed communication skills including the ability to

have difficult conversations

• demonstrate confidence, competence, and cultural sensitivity

• ensure optimal medicine therapy by providing patients with

appropriate counselling and/or written information

• ability to use/ demonstrate devices according to the area of

practice e.g inhalers, injection devices

• capability to critically appraise the evidence base


Essential Desirable

• provide advice concerning relevant regulatory and procedural

issues controlling the availability of pharmaceutical products in

the hospital and the broader community

• ensure safe and appropriate medicines management practices

are undertaken on the wards

• ensure appropriate medicine treatment via the monitoring of

medicine therapies, appropriate medicine selection, dosage,

formulations, administration mode and frequency

• ability to work in a team

• good public relations skills

Activities and

experiential learning

• completion of an evaluation of clinical skills using the ClinCAT

(version 3) which can be found in Chapter 15 of the SHPA

Standards of Practice for Clinical Pharmacy Services1

• mentorship of early career pharmacists

• teaching to increase advanced capability

• engage and advocate in national health and

community policy

• effective contribution to medicine safety and clinical

governance committees

• the NPS standard medicine charts course

• Peter Mac and VicTAG Oral Anti-Cancer Therapy

Prescriptions module

• initiate or participate in pharmacy-related research

and medicine development activities

Table 6 Knowledge, Skills and Experiential Learning for dispensing and distribution teams690

https://learn.nps.org.au/mod/page/view.php?id=4278

http://www.victag.org.au/oralchemo/oralchemo.html

http://www.victag.org.au/oralchemo/oralchemo.html


Training and education will predominately be work-based education and should follow adult learning 691

principles. Further information can be found in Chapter 10 of the SHPA Standards of Practice for 692

Clinical Pharmacy Services.1 693

694

Risk management 695

The dispensing and distribution environment has inherent risks that affect the entire spectrum of 696

practice. These potential risks and associated outcomes are described in Table 7. 697

Table 7 Potential risks and outcomes that a dispensing and distribution team may experience. 698

Nature of risk Potential outcomes

Safety

Patient or staff harm

Financial

Additional costs incurred by the organisation or consumer

Legislative

Legal action taking place against organisation or individual which

may result in fines, suspension of AHPRA license or imprisonment

Operational

Inability to deliver a service to the required standard

699

Risks may be modifiable or outside of the control of the dispensing and distribution team. The diverse 700

nature of these risks, the magnitude of impact and the likelihood of them occurring should always be 701

considered systematically, in order to protect staff and improve patient care. 702

A risk mitigation strategy should be employed to effectively manage risks. This involves four key steps: 703

identification, assessment, intervention/prevention and review. 704

1. Identification may take place after an incident has occurred, after a near-miss event or 705

proactively before an incident has occurred. Risks should always be anticipated and 706

considered. If a risk has occurred, local processes must be followed with regards to reporting 707

the incident. 708

2. Assessment of the potential impact of the risk and likelihood of it occurring in the future must 709

be undertaken. This assessment allows the resulting interventions to be appropriate in 710

magnitude. Tools such as a risk management matrix can be used to assist in this process. The 711

risk in question should be reviewed for weaknesses in relevant workflows that may increase 712

the chances of it occurring. 713

3. Interventions to reduce risks can take numerous forms (Table 8). It is important to develop 714

interventions collaboratively through an appropriate level of stakeholder engagement. Expert 715

advice may be required to develop interventions. Interventions must be: 716

• legal 717

• aligned with organisational requirements 718

• pragmatic for staff and consumers and 719

• developed with the best interests of staff and patients in mind. 720


There are instances where risks may not be mitigated in a manner that is considered ideal. 721

Reasons for this may include a lack of resources, an inability to mitigate risk practically, a 722

lengthy timeline for appropriate interventions to be implemented or a lack of expertise. These 723

scenarios must be documented appropriately and brought to the attention of the relevant 724

senior staff member which may be within or outside of the Pharmacy Department. The use of 725

established documentation methods such as risk registers may assist in this activity. 726

4. A review of the intervention should be performed after a suitable period of time to assess 727

suitability and effectiveness. Undertaking a review improves the robustness of the 728

intervention, by identifying strengths and weaknesses that inform potential changes. 729

Depending on the nature of the risk and intervention, the review may be informal (e.g. 730

requesting staff feedback) or formal (e.g. auditing) in nature. 731

Table 8 Examples of interventions that may be used to mitigate risks 732

Intervention Examples

Formally defining roles and

responsibilities

Job description forms can be used to define the scope of practice. This

ensures staff of an appropriate level of expertise perform specified

duties.

Training, education and

credentialing

Providing formal upskilling in an area to address gaps in knowledge.

Credentialing processes can be used as a method of knowledge/skills

assurance. Logs that document training and education should be

utilised and maintained appropriately to track staff competencies

against new/updated procedures, policies, for example.

Documentation

Expectations surrounding the recording of incidents, near-misses and

any other activities that affect risk should be formalised. This may

involve standardising:

• what is recorded, e.g. utilising templates to maintain

consistency according to relevant requirements;

• instances when documentation is expected to take place; and

• the location of where is this information is recorded.

733

Quality Improvement 734

Quality improvement activities should demonstrate improvements in patient care, through dispensing 735

and distribution services, by targeting and achieving the best outcomes for all patient groups including 736

those at greatest risk of medicine misadventure. The dispensing and distribution team should ensure 737

that the focus is not only on the timeliness of care but also on the quality of that care in line with state 738

and national-based indicators. 739

Examples of quality improvement activities that may be considered within a Plan–Do–Study–Act cycle 740

are: 741

• patient/consumer satisfaction and feedback surveys 742

• reduction in dispensing errors through quality improvement activities 743


• improving patient health literacy and provision of appropriate medicines information 744

• implementation of Tall Man Lettering or Look Alike Sound Alike principles 745

• time in motion studies to improve workflow 746

• high-risk medicines storage audits (e.g. concentrated potassium, neuromuscular blocking 747

agents) 748

• review of medicine-related incident reports and trends 749

• SWOT/gap analysis 750

• review the scope and effectiveness of strategies in place to improve care for Aboriginal and 751

Torres Strait Islander people.38 752

Additionally, dispensing and distribution teams may wish to monitor some of the following 753

performance indicators: 754

• prescription turnaround/waiting time 755

• dispensing workload (number of items and patients) 756

• rate of prescription barcode scanning 757

• medicine wastage 758

• staffing levels relative to attendance and unexplained absence rates 759

• stockholdings 760

• stockturn measures (stock turn over) 761

• stocktake results, variance, and discrepancies 762

• percentage of expired medicines 763

• provision of medicines information at discharge (medicines list on discharge per separation) 764

• compliance with temperature-sensitive storage of medicines 765

• owing PBS prescriptions 766

• PBS rejections 767

• PBS revenue. 768

Further information on quality improvement can be found in Chapter 14 of SHPA Standards of Practice 769

for Clinical Pharmacy Services.1 770

771

Research 772

Research is vital for developing the pharmacy profession and may inform pharmacy services’ current 773

levels of, and future contributions to, advancing pharmacy and patient care. Dispensing and 774

distribution teams should initiate, conduct and supervise research that contributes to the body of 775

knowledge providing evidence of effectiveness in support of optimal use of medicines and advanced 776

pharmacy care in medicines management. Cross-sector, intersectoral and multidisciplinary research 777

is encouraged to ensure the input of key stakeholders and ensure that research is relevant to the 778

Australian community. 779

The research question and study design must be of benefit to patients and of interest to the team. 780

This may relate to everyday practice and include identifying and addressing evidence-practice gaps, 781

implementing evidence-based practice and interventions directed at reducing patient admissions and 782

improving patient safety, as well as providing evidence for pharmacy service implementation. The 783

undertaking of research must be conducted according to local and national guidelines. 784


External funding enables larger and feasibly, multi-centre studies to be conducted. The SHPA funds 785

research grants, practitioner grants, and educational grants to develop research capacity. Grants are 786

also available from other organisations including the National Health and Medical Research Council 787

(NHMRC). Presentation and publication of studies by Australian dispensing and distribution teams are 788

imperative to aid others in the implementation of dispensing and distribution services and illustrate 789

how dispensing and distribution teams are demonstrating improvements in patient care. 790

Presentation of research at relevant conferences and seminars as described in Training and Education 791

is highly recommended. The choice of journal for publication depends on the best audience for the 792

study results. The Journal of Pharmacy Practice and Research (JPPR) has a readership of primarily 793

Australian pharmacists. Journals specific to dispensing and distribution may be appropriate and are 794

listed in Appendix 1: Resources. 795

Further information on research can be found in Chapter 11 of SHPA Standards of Practice for Clinical 796

Pharmacy Services 1 797

798

Acknowledgements 799

The authors additionally wish to acknowledge the work of authors of the previous version of this 800

Standard Nicolette Burridge, Alice Chow, Andrew Cording, Karen O’Leary, Rosemary Burke, and Sue 801

Kirsa. 802

803

References 804

1. SHPA Committee of Specialty Practice in Clinical Pharmacy. SHPA Standards of Practice for 805 Clinical Pharmacy Services. Journal of Pharmacy Practice and Research 2013; 43(No. 2 Supplement): 806 S1-69. 807 2. Nicolette Burridge AC, Andrew Cording. SHPA Standards of Practice for Hospital Pharmacy 808 Outpatient Services. Journal of Pharmacy Practice and Research 2006; 36(3): 5. 809 3. O'Leary K, Burke R, Kirsa S. SHPA Standards of Practice for the Distribution of Medicines in 810 Australian Hospitals. Journal of Pharmacy Practice & Research 2006; 36(2): 143. 811 4. Australia PSo. National Competency Standards Framework for Pharmacists in Australia. 812 Deakin, 2010. 813 5. The Australian Commission on Safety and Quality in Health Care. Australian Charter of 814 Healthcare Rights. 2nd ed. Sydney; 2019. 815 6. Pharmaceutical Society of Australia. National Competency Standards Framework for 816 Pharmacists in Australia. Deakin West: PSA; 2016. 817 7. Pharmacy Board of Australia. Guidelines for dispensing of medicines. 2015. 818 8. Council on Pharmacy Management. Pharmaceutical Distribution Systems (1707). American 819 Society of Health System Pharmacists. 820 9. Hickman L, Poole SG, Hopkins RE, Walters D, Dooley MJ. Comparing the accuracy of 821 medication order verification between pharmacists and a tech check tech model: A prospective 822 randomised observational study. Research in Social and Administrative Pharmacy 2018; 14(10): 931-823 5. 824 10. Pharmacy Board of Australia. Guidelines for dispensing of medicines. Pharmacy Board of 825 Australia; 2015. 826 11. Michaels K. PBS medicines in hospitals — Australia's quiet success story. 2017. 827 https://www.hospitalhealth.com.au/content/clinical-services/article/pbs-medicines-in-hospitals-828 australia-s-quiet-success-story-888537655#axzz61A40yLKF]. 829

https://www.nhmrc.gov.au/

https://www.nhmrc.gov.au/

https://www.shpa.org.au/jppr

https://www.hospitalhealth.com.au/content/clinical-services/article/pbs-medicines-in-hospitals-australia-s-quiet-success-story-888537655#axzz61A40yLKF

https://www.hospitalhealth.com.au/content/clinical-services/article/pbs-medicines-in-hospitals-australia-s-quiet-success-story-888537655#axzz61A40yLKF


12. The Department of Health. Appendix I: Public Hospital Pharmaceutical Reforms. Canberra: 830 The Department of Health, 2014. 831 13. Pharmaceutical Society of Australia. Professional Practice Standards Version 5. Deakin West: 832 PSA; 2017. 833 14. Pharmaceutical Society of Australia. Guidelines for pharmacists providing dose 834 administration aid services. Deakin West, ACT: Pharmaceutical Society of Australia; 2017. 835 15. Pharmacy Board of Australia. Guidelines on dose administration aids and staged supply of 836 dispensed medicines. Pharmacy Board of Australia; 2015. p. 8. 837 16. SHPA Committee of Specialty Practice in Rehabilitation and Aged Care. SHPA Guidelines for 838 Self-Administration of Medication in Hospitals and Residential Care Facilities. 2002; 32(4). 839 17. The Society of Hospital Pharmacists Australia. Practice Update: Factors to consider for the 840 implementation of Automated Pharmacy Distribution Systems in Hospitals and Health Services. 841 https://www.shpa.org.au/fact-sheets-practice-updates-position-statements: SHPA; 2019. 842 18. Bloom S. Implementing Hospital Pharmacy Automation. In: Agency TNPAS, editor. United 843 Kingdom; 2007. 844 19. Institute for Safe Medication Practices. Guidelines for the Safe Use of Automated Dispensing 845 Cabinets, 2019. 846 20. Clinical Excellence Commission. Medication Safety Self Assessment® for Australian Hospitals 847 (2015). Sydney: Clinical Excellence Commission; 2015. 848 21. Pharmaceutical Society of Australia. Australian Pharmaceutical Formulary and Handbook. 849 24th ed. Canberra: Pharmaceutical Society of Australia; 2018. 850 22. Therapeutic Goods Administration. Recall procedure. 2019 (accessed 16/08/2019. 851 23. Pharmacists ASoH-S. ASHP guidelines on managing drug product shortages. Am J Health-852 System Pharm 2018; (75): 593-601. 853 24. Australian Commission on Safety and Quality in Health Care. National Safety and Quality 854 Health Service Standards. Medication Safety. Sydney: ACSQHC; 2017. p. 86. 855 25. Australian Commission on Safety and Quality in Health Care. National Model Clinical 856 Governance Framework. Sydney: ACSQHC; 2017. 857 26. Pharmacy Board of Australia. For Pharmacists Code of Conduct. March 2014 ed; 2014. 858 27. Pharmacy Board of Australia. Guidelines on practice-specific issues. Pharmacy Board of 859 Australia; 2015. 860 28. The Society of Hospital Pharmacists Australia. SHPA Code of Ethics. Collingwood: SHPA; 861 2016. 862 29. Pharmaceutical Society of Australia. Clinical Governance Principles for Pharmacy Services 863 2018. Deakin West, ACT, Australia: Pharmaceutical Society of Australia, 2018. 864 30. Pharmaceutical Society of Australia. Dispensing Practice Guidelines. 2017. p. 26. 865 31. Pharmaceutical Society of Australia. Guidelines for pharmacists providing staged supply 866 services. Pharmaceutical Society of Australia; 2017. 867 32. Roman CP, Dooley MJ, Mitra B. Emergency medicine pharmacy practice in Australia: a 868 national survey. Journal of Pharmacy Practice and Research 2019; 49(5): 439-46. 869 33. Council of Australian Therapeutic Advisory Groups. Achieving effective medicines 870 governance. Guiding Principles for the roles and responsibilities of Drug and Therapeutics 871 Committees in Australian public hospitals, 2013. 872 34. La Caze A. Safer dispensing labels for prescription medicines. Aust Prescr 2018; 41(2): 46-9. 873 35. International Pharmaceutical Federation (FIP). FIP GUIDELINES FOR THE LABELS OF 874 PRESCRIBED MEDICINES, 2001. 875 36. Pharmacy Development Australia. Advancing Practice Background and Guiding Principles, 876 2018. 877 37. Pharmaceutical Defence Limited. Guide To Good Dispensing (GTGD). 878

https://www.shpa.org.au/fact-sheets-practice-updates-position-statements


38. Australian Commission on Safety and Quality in Health Care. The National Safety and Quality 879 Health Service Standards. Action 12: Addressing health needs of Aboriginal and Torres Strait 880 Islander people. Sydney: ACSQHC. 881 39. Pharmacy Board of Australia. Guidelines on practice-specific issues - Guideline 1 (List of 882 reference texts for pharmacists), 2015. 883 40. Pharmaceutical Defence Limited. PROCEDURE TO FOLLOW IN CASE OF A DISPENSING 884 ERROR. 2010. p. 1. 885 41. Council of Australian Therapeutic Advisory Groups. Rethinking medicines decision-making in 886 Australian Hospitals. Guiding Principles for the quality use of off-label medicines, 2013. 887

888

889


Appendices 890

Appendix 1: Resources 891

Recommended texts for dispensing and distribution For the mandatory list of reference texts refer to the Pharmacy Board Australia Guidelines39 and relevant State/Territory pharmacy licensing authorities

Australian Pharmaceutical Formulary and Handbook (APF)21 Australian Medicines Handbook (AMH) Therapeutic Guidelines series (the complete set in hardcopy) or eTG AMH Children’s Dosing Companion Australian Don’t Rush to Crush Handbook Australian Immunisation Handbook Australian Injectable Drugs Handbook

Discretionary texts

Stockley’s Drug Interactions BNF and BNF for Children Toxinz – poison's information Lactmed Briggs – Drugs in Pregnancy and Lactation King Guide to Parental Admixtures Martindale The Renal Drug Handbook

Useful journals specific to dispensing and distribution

American Journal of Health-System Pharmacy European Journal of Hospital Pharmacy. Science and Practice; London; International Journal of Clinical Pharmacy International Journal of Pharmacy Practice Journal of Pharmacy Practice Journal of Pharmacy Practice and Research Journal of Research in Pharmacy Practice Research in Social and Administrative Pharmacy The Canadian Journal of Hospital Pharmacy

Guidelines

PDL Guide to Good Dispensing37 PDL Procedure to follow in case of a dispensing error40 FIP Guidelines for the labels of prescribed medicines35 CATAG. Guiding Principles for the quality use of off-label medicines41 CATAG. Guiding Principles for the roles and responsibilities of Drug and Therapeutics Committees in Australian public hospitals33

Useful Websites

Pharmaceutical Benefits Scheme (PBS) www.pbs.gov.au Medicare Pharmacists www.humanservices.gov.au/organisations/health-

professionals/pharmacists Council of Australian Therapeutic Advisory Groups (CATAG)

http://www.catag.org.au/

BloodNet www.blood.gov.au/bloodnet Hepatitis C medicines - Drug Interactions www.hep-druginteractions.org HIV medicines – Drug Interactions www.hiv-druginteractions.org Chemotherapy protocols www.eviq.org.au MotherToBaby Therapeutic Goods Association

www.mothertobaby.org/ www.tga.gov.au/

https://www-sciencedirect-com.ezp.lib.unimelb.edu.au/journal/research-in-social-and-administrative-pharmacy

http://www.humanservices.gov.au/organisations/health-professionals/pharmacists

http://www.humanservices.gov.au/organisations/health-professionals/pharmacists

http://www.catag.org.au/

http://www.blood.gov.au/bloodnet

http://www.mothertobaby.org/

http://www.tga.gov.au/


Australian Commission on Quality and Safety in Health Care

www.safetyandquality.gov.au/

Useful Apps

PBS Code (iOS, Android) http://www.pbscode.com.au/

892

http://www.safetyandquality.gov.au/

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