Australian Capital Territory
Health Professionals (ACT Pharmacy Board Standards Statements) Approval 2009 (No 1)
Notifiable instrument NI2009–332
made under the
Health Professionals Regulation 2004, Section 134 (Standard’s Statement) 

1.	Name of instrument
This instrument is the Health Professionals (ACT Pharmacy Board Standards Statements) Approval 2009 (No 1).
2.	Revocation
This instrument revokes NI2008-106.
3.	Commencement
This instrument commences on the day after notification.
4.	Standards Statements
In accordance with Regulation 134 (3) of the Health Professionals Regulation 2004 the ACT Pharmacy Board has approved the following Standards Statements. 

Bill Kelly
President

10 July 2009

ACT PHARMACY BOARD

STANDARDS STATEMENTS

CONTENTS

1.	Standards of Practice for ACT Allied Health Professionals
2.	Competency Standards for Pharmacists 
3.	Professional Practice Standards
4.	Continuing Professional Development
5.	Premises and Reference Works
6.	Pharmacist Only Medicine (Schedule 3) and Pharmacy Medicine (Schedule 2)
7.	Duty of Care
8.	Dispensing Guidelines and Errors
9.	Guidelines for the Supply of β2 Agonist Inhalers
10.	Delivery of Prescriptions
11.	Mail Order Dispensing
12.	Fair Handling of Information
13.	Maintenance of Pharmacy Records
14.	Impaired Practitioners 
15.	Pseudoephedine
16.	Tobacco and Alcohol
17.	Dispensary Assistants
18.	Incorporated Pharmacies
19.	Notification of Ownership
20.	Professional Indemnity Insurance
21.	Standard of Practice - Drugs
22.	Conduct of Business
23.	Inappropriate Behaviour
24.	Issuing of Medical Certificates
25.	Dose Administration Aids
26.	Returned Medicines
27.	Dispensing Multiple Repeat Prescriptions
28.	Pre-registration Training for Pharmacists
29.	Methadone and Buprenorphine Dispensing
30.	Conditional Registration – Non-Practising

Standards Statements issued by the ACT Pharmacy Board are designed to raise awareness of the standard of practice required from a registered pharmacist to be competent to practise, or to help the practitioner improve his or her suitability to practise.  The information contained in these statements is to be used as a guideline for pharmacists to follow and reflects the interpretation of the Health Professionals Act 2004 by the Board.  Non-adherence or breach of the statements may be grounds for a finding of a breach of the Act.	

Disclaimer

In the case of any conflict or discrepancy between this document and legislation, the legislation prevails.

PREFACE

The ACT Pharmacy Board has developed a number of standards statements to guide practitioners on professional, legal and ethical issues.  The Board believes that these standards reflect the high standards of care expected of practitioners in the ACT.  The legislation governing practice in the Territory is the Health Professionals Act 2004.  In the case of any conflict or discrepancy between the standards statements and Act, the Act prevails.

The Board intends to review the standards statements regularly and add new policy statements as they are developed.

Comments about the policies would be welcomed and should be directed to the Board’s Executive Officer.

Members of the Board hope you will find these statements useful.

ACT PHARMACY BOARD

STANDARDS STATEMENT

1.	Standards of Practice for ACT Allied Health Professionals

1.	The Board endorses the Standards of Practice for Allied Health Professionals ACT Health September 2004 published in May 2005 – Publication No 05/0471 (2000).  Pharmacists are required to comply with the standards of practice included in that publication.

2.	Incorporated pharmacists will meet the Board’s standard if each director of the incorporated pharmacist meets the standard.

ACT PHARMACY BOARD

STANDARDS STATEMENT

2.	Competency Standards for Pharmacists 

1.	Pharmacists must be competent to provide the services that they offer.  A pharmacist must not practise pharmacy in an area in which he or she is not competent to practise unless under the supervision of a pharmacist who is competent to practise in the area until competency is established.

2.	The Board endorses the Competency Standards for Pharmacists in Australia published by the Pharmaceutical Society of Australia (current edition together with any supplements, addenda or amendments).  

3.	Incorporated pharmacists will meet the Board’s competency standard if each director of the incorporated pharmacist meets the competency standard.

4.	A pharmacist must provide evidence that he or she is competent to provide the services that he or she offers when applying for registration or for renewal of registration.  A person may declare that he or she is competent if the person has appropriate qualifications, has recency of practice and has complied with the Board’s standards statement on continuing professional development.  

5.	Registrants who have not practised in the last two years may be required to demonstrate to the satisfaction of the Board that they have maintained competencies during the period in order to be registered.  The Board may require a period of supervised practice and/or a refresher course to be completed.  Persons who have not practised for five years will have to complete a period of supervised practice and a refresher course to the Board’s satisfaction before registration will be granted.

6.	The Board may require applicants to complete, to the satisfaction of the Board, training courses and/or supervised practice determined by the Board before approving applications for renewal of registration or re-registration.

7.	A person who wishes to change their registration from ‘non-practising’ to ‘practising’ will need to satisfy the Board that he or she is competent to practise.  If the person satisfies the Board’s recency of practice and continuing professional development requirements then the change will be approved.  In other instances the Board may require a period of supervised practice and/or a refresher course.

8.	A person with overseas pharmacy qualifications, who is not registered in an Australian jurisdiction, who applies for registration as a pharmacist in the ACT must complete a minimum of four weeks of supervised practice to receive approval.  This is to ensure familiarisation with local legislation and practice to meet units of competency standards for registered pharmacists.

ACT PHARMACY BOARD

STANDARDS STATEMENT

3.	Professional Practice Standards 

1.	The Board endorses the Professional Practice Standards published by the Pharmaceutical Society of Australia (Current edition together with any supplements, addenda or amendments).

2.	The Board endorses the Society of Hospital Pharmacists of Australia Standards of Practice (current edition together with any supplements, addenda or amendments).

3.	The Board endorses the Australian Pharmaceutical Formulary and Handbook published by the Pharmaceutical Society of Australia (current edition together with any supplements, addenda or amendments).

4.	Incorporated pharmacists will meet the Board’s standard if each director of the incorporated pharmacist meets the standard.

ACT PHARMACY BOARD

STANDARDS STATEMENT

4.	Continuing Professional Development (CPD)

Executive Statement

1.	Every practising Pharmacist has a legal, ethical and personal responsibility to remain competent and safe to practice pharmacy. The Board requires that every pharmacist meet the minimum requirements of CPD as outlined below.

Board Requirements

2.	The Board endorses the “Continuing Professional Development information for Health Profession Boards” published by ACT Health in May 2005 – Publication number 05/0471 (2000).

3.	The board requires a minimum of twenty (20) hours of CPD activities (i.e. Continuing Education) each year. A minimum of ten (10) hours must be face-to-face activities.

4.	The Board recognises CPD programs provided by other professional pharmacy organisations as evidence of competency achievement - where the achievements are equal or greater than the minimum requirements of the Board. A Pharmacist must be able to provide documentary confirmation from a professional organisation attesting to their adequate completion of that organisation’s CPD requirements.

5.	The Board may conduct audits of Pharmacist CPD as deemed appropriate. When requested, a Pharmacist must provide documentary evidence of competency maintenance in compliance with these standards.

Continuing Professional Development

Practice needs

6.	To remain competent and engage in lifelong learning a Pharmacist must complete an annual program of Continuing Professional Development (CPD). The intention of any CPD program is not to meet minimum Board requirements, but rather to remain competent after initial registration and to continually improve aspects of performance in the interest of patient care. CPD generally refers to a framework that assists practitioners in addressing the personal needs, knowledge gaps and changing requirements of their specific area(s) of practice. 

Practice settings 

7.	Examples of different practice areas include:
	(a)	Community pharmacy
	(b)	Consultant pharmacy
(c)	Hospital pharmacy
	(d)	Pharmacy management
	(e)	Quality use of medicines and medicines policy
	(f)	Pharmaceutical industry
 	(g)	Academia
(h)	Staying current will demand different requirements of the practitioner working in each area.

CPD framework

8.	CPD should follow a planned approach with specific objectives. The process should be conducted each year in a cyclical fashion. The following basic components are part of a sound CPD program:
	Assessment/identification of deficiencies and needs
	Determination of activities required to gain the required knowledge and skills
	Participation in structured learning activities 
	Reflection on changes to practice and success of the program
Any program must allow for learning opportunities that are not planned but still beneficial to the Pharmacist.

Role of professional associations 

9.	Some professional pharmacy organisations currently offer CPD programs. It is strongly recommended that a Pharmacist access one of these existing CPD frameworks to ensure compliance with board requirements. Pharmacists need not be a member of such organisations to access a CPD program. 

Continuing Education (CE)

Relevance

10.	A CPD program is comprised of individual continuing education (CE) activities. CE activities should be directly relevant to the competencies required of the practitioner. A pharmacist should examine all education undertaken to ensure that it does indeed link to the competencies required of a pharmacist. 

Competencies

11.	Standards of competency are provided by the “Competency Standards for Pharmacists in Australia, 2003” published by the Pharmaceutical Society of Australia. These are endorsed by the Board as encompassing the capabilities required of a practicing pharmacist. Pharmacists should read and be familiar with these competency standards.	 

Annual targets

12.	The board requires a minimum of twenty (20) hours of CPD activities (i.e. CE) each year. Ten (10) of these hours must be comprised of face-to-face activities.

Types of CE

13.	Continuing education may be self-directed such as:
(a) 	Journal and book reading
(b)	Quality Assurance activities
(c)	Professional contacts and discussions
(d)	Reflection on day-to-day practice
(e)	Committee involvement
(f)	Information sharing
(g)	Internet research

Or it may be formally structured such as:
	(a)	Conferences*
	(b)	Seminars*
	(c)	Workshops*
	(d)	Inservice education*
	(e)	University Courses and Postgraduate Study*
(f)	Research	
	(g)	Delivering education
	(h)	Teaching 
	(i)	On-line learning
	
* Face to face activities

Information, knowledge, skills

14.	Most CE activities listed above involve information delivery. These are passive activities where participation alone is no guarantee that the information is retained or applied to practice. Ideally a Pharmacist should aim to participate in activities where this learning is assessed. In addition to knowledge CE should address skills and performance. Those activities that assess and promote positive changes in practice are considered the best to ensure competence. These might include: leading quality improvements in the workplace, teaching, research, etc. A Pharmacist should always consider how any CE undertaken can be personally applied to affect their practice for the better. 

Recording

15.	Appropriate records of all CE activities should be kept as proof of compliance with CPD requirements. Activities that are not recorded may be considered to have not been completed. The records should include all the ideal aspects of CPD programs and CE activities outlined above. 

Audits

16.	The Board may conduct regular or spot audits of CPD. If selected for audit, a Pharmacist must provide suitable evidence of CPD activities, such as records of completed CE activities. These records may be scrutinised on the grounds of relevance to practice areas and links to competencies, educational quality, outcomes and demonstrated effects on practice. 

Role of professional associations

17.	A Pharmacist may access CE from any provider as long as it is of sufficient quality and suitably relevant to their practice. Professional pharmacy organisations currently offer many CE activities – Pharmacists are encouraged to access this CE as it is more likely to be high quality, relevant, educationally valid and state which pharmacist competencies are addressed. In these cases a Pharmacist should ideally seek education that is “accredited” by a recognised authority. In general pharmacists are required to either be a member to access these activities or pay for the individual services used.  

ACT PHARMACY BOARD

STANDARDS STATEMENT

5.	Premises and Reference Works 

Premises
1.	Premises at which a business consisting of or involving pharmacy should:
(a) 	consist of an enclosed area with direct access to a public place;
(b) 	contain an area set aside for the dispensing of items on prescription that is not less than 8 square metres or such lesser area as the Board may approve;
(c)	be in a hygienic condition and be adequately ventilated;
(d) 	have adequate lighting;
(e) 	contain facilities for the secure and appropriate storage of drugs and pharmaceutical products, including refrigeration;
(f)	 be constructed in such a manner as to allow a pharmacist to supervise effectively the whole of that part of the premises used in the practice of pharmacy and the activities of persons in that part of the premises;
(g) 	have appropriate equipment for the accurate dispensing of all prescriptions including the compounding of extemporaneous preparations;
(h)	have at least 1 square metre of free working space, which is not less than 40cm wide for the dispensing of prescriptions;
(i)	be so constructed such that the pharmacist can supervise the sale of the scheduled drugs and that a space is provided for the confidential counselling of patients;
(j)	have a dedicated fax facility for the receipt of urgent communications.

Legislation
2.	Access* to the following legislation must be in place at any premises at which pharmacy is practised:
(a)	Medicines, Poisons and Therapeutics Act 2008 
(b)	Medicines, Poisons and Therapeutics Regulation 2008
(c)	The Public Health Act 1997
(d)	Public Health Regulations 2000
(e)	Health Professionals Act 2004
(f)	Health Professionals Regulation 2004
(g)	Occupational Health and Safety Act 1989.
* Note:  The legislation may be kept in hard copy form or in electronic form on CD-ROM or on a Disk or via the Internet.  All ACT legislation is accessible at www.legislation.act.gov.au.  If the Internet is the means of access then access must be permanent with the reference bookmarked or included in “Favourites”.

Reference Works
3.	Current editions of the of the following reference works, together with any supplements, addenda or amendments, are compulsory and must be kept at any premises at which pharmacy is practised. The legislation may be kept in hard copy form or in electronic form on CD-ROM or on a Disk or via the Internet.  The information must be available to the pharmacist immediately during the dispensing process. If the Internet is the means of access then access must be permanent with the reference bookmarked or included in “Favourites”. Substitution of the references listed below with unlisted texts is not acceptable.
(a)	the Australian Pharmaceutical Formulary and Handbook (APF)
(b)	the Australian Medicines Handbook (AMH)
(c)	a reference work on prescription proprietaries – one of either:
(i)	the Australian Prescription Products Guide (APPG) including amendments; or
(ii)	MIMS Annual together with bi-monthly addenda or eMIMS.
(d)	Copies of the legislation controlling the practice as listed in previous section on Legislation
(e)	A scheduling guide – one of either:
(i)	the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); or
(ii)	the Guide to the ACT Poisons and Drugs Schedules (Pharmacy Guild of Australia ACT Branch)
(f)	a reference work on drug interactions – one of either:
(i)	Drug Interaction Facts – Facts and Comparisons (the edition with quarterly amendments not the soft cover annual publication); or
(ii)	Drug Interaction Analysis and Management, Hansten and Horn; or
(iii)	Drug Interactions, Stockley.
(j)	a reference work on therapeutics – one of either:
(i)	the Merck Manual of Diagnosis and Therapy, Merck, Sharp and Dohme
(ii)	Goodman and Gilman’s Pharmacological Basis of Therapeutics;
(iii)	Applied Therapeutics: Clinical Use of Drug, Koda-Kimble (not the accompanying handbook)
(iv)	Therapeutic Guidelines Limited Series including:
-	Analgesic Guidelines
-	Antibiotic Guidelines
-	Cardiovascular Guidelines
-	Dermatology Guidelines
-	Endocrinology Guidelines
-	Gastrointestinal Guidelines
-	Neurology Guidelines
-	Palliative Care Guidelines
-	Psychotropic Guidelines
-	Respiratory Guidelines

(v)	An evidence-based reference work on complementary and alternate medicines – one of either:
-	Herbs and Natural Supplements: An Evidence Based Guide. Braun and Cohen; or
-	Herbal Medicines. A Guide for Health Care Professionals, Phillipson; or
-	Professionals Handbook of Complementary and Alternate Medicines. Fetrow and Avila; or
-	The Review of Natural Products. Facts and Comparisons.

(vi)	the Paediatric Pharmacoepia. Royal Children’s Hospital.

4.	The following texts are recommended for inclusion in a pharmacist’s professional library but are not compulsory:
Books
(a)	AusDI – Australian Drug Information for the Health Professionals.
(b)	Clinical Pharmacy. A Practical Approach. Society of Hospital Pharmacists of Australia.
(c)	Counselling Guide for Non-Prescription Medicines. (Shelf Talkers) Pharmaceutical Society of Australia.
(d)	Handbook of Non-Prescription Drugs. American Pharmacists Association
(e)	Martindale: The Complete Drug Reference. Pharmaceutical Press (UK).
(f)	A medical dictionary (various available e.g Dorland’s, Stedman’s, Mosby’s)
(i)	Professional Practice Standards. Pharmaceutical Society of Australia.
(ii)	Quality Care Pharmacy Standards. The Pharmacy Guild of Australia.
(g)	Standards for the Provision of Pharmacists Only and Pharmacy Medicines. Pharmaceutical Society of Australia
(i)	Symptoms in the Pharmacy. Pharmaceutical Press (UK)
(ii)	United States Pharmacoepia – Drug Information (USPDI)
Volume 1 - For the Health Care Professional
Volume 2 – Advice for the Patient

Journals
(a)	Adverse Drug reactions Advisory Committee (ADRAC) Bulletin.
(b)	Australian Journal of Pharmacy (published by APPCo)
(c)	Australian Pharmacist (published by PSA)
(d)	Australian Prescriber (published by NPS)
(e)	Journal of Pharmacy Practice and Research (published by SHPA)

ACT PHARMACY BOARD

STANDARDS STATEMENT

6.	Pharmacist Only Medicine and 
Pharmacy Medicine 

1.	The Board endorses the Pharmaceutical Society of Australia document “Standards for the Provision of Pharmacist Only and Pharmacy Medicines in Community Medicine (2005)”.

2.	The classification of medicines available without prescription into Pharmacy Medicine and Pharmacist Only Medicine is in the public interest, in that the controls placed on those scheduled medicines bring an appropriate level of supervision over their supply.  Scheduling of non-prescription medicines places responsibilities on pharmacists to ensure the quality use of medicines in the public interest.

3.	These controls are commensurate with the need to ensure that consumers use medicines safely and effectively, and with the risks inherent in the medicines themselves.

4.	Pharmacists owe a duty of care to consumers to act in accordance with the highest standards of good pharmaceutical practice and the law in dispensing Pharmacy Medicine and Pharmacist Only Medicine.

5.	The ACT Board, with the assistance of the pharmacy inspectors of the Health Protection Service, closely monitors the performance of pharmacists in relation to the sale of Pharmacy Medicine and Pharmacist Only Medicine products.

ACT PHARMACY BOARD

STANDARDS STATEMENT

7.	Duty of Care 

1.	Consumer expectations and professional standards are rising, and it is always timely for all pharmacists to take stock of the way they practise.  The Board advises all pharmacists to be specially aware of the increasing duty of care they are expected to show consumers.

2.	As individuals, pharmacists are expected to deal with consumers at the highest possible standard of care, and ensure that their best interests are always put first.  If you are a proprietor or manager of a pharmacy, you are also responsible for ensuring that those in your employ are provided with the resources and the managerial guidance to do this properly.  In particular you should take care to monitor the workloads of your staff to ensure that understaffing - which can lead to poor standards - does not occur.

3.	This duty of care applies to all of the professional responsibilities of pharmacists, and in particular to the supply of medicines on prescription and over the counter.  It not only applies to consumers who come to your pharmacy but also to those who are provided with service away from the practice - eg those in residential care facilities, nursing homes or hospitals.

4.	With Pharmacy Medicines, this duty extends to ensuring there is always professional oversight of all requests for the supply of medicines, including always being available to intervene in a supply when it is necessary for the safety or well being of the consumer, or to give advice when it is needed.  With Pharmacist Only Medicines, the duty extends to always being personally assured that a genuine therapeutic need exists for the medicine, and to counselling consumers on its safe and effective use.

5.	With all medicines, pharmacists clearly have a duty of care to ensure that the safety and well being of consumers is always considered, and that they are always appropriately and effectively counselled on their use.  This implies not only that the pharmacist provides information in a way that ensures that consumers understand, but also effectively allows consumers to seek further information from the pharmacist, so that the desired outcome of the medicine is achieved.

6.	Like all professionals, pharmacists are continually being assessed by consumers and authorities to ensure that they practise at an acceptable standard, and the proper duty of care is given to their clients.  In the public interest, the Board will be playing an active role in ensuring that pharmacists practise at this standard, in their distribution of medicines to consumers.

ACT PHARMACY BOARD

STANDARDS STATEMENT

8.	Dispensing Guidelines and Errors 

1.	This guide, prepared by Pharmaceutical Defence Limited (PDL) is based on the Quality Care Pharmacy Program. It is designed to minimise the potential for dispensing errors and to save time and expense. A number of routine checks and procedures have been prepared for pharmacists’ guidance. Pharmacists are strongly advised to observe them on each occasion a prescription is dispensed. 

	Prescription Check 

2.	Patient Details 				Prescription Details
(a) 	Name 					(a) 	Date 
(b) 	Address 				(b)	Doctor’s Signature
(c) 	Phone Number 			(c)	S4 requirements
(d)	Mobile Phone Number 		(d) 	S8 requirements
(e) 	Concessional Entitlements 		(e) 	HIC Authority Approval
(f)	Medicare Number 
(g) 	Allergies 
(h) 	Child’s Age 
(i) 	Weight 

	Computer Input 

3.	Using Pharmacist original copy of prescription check: 
(a) 	Medication profile for consistency of treatment 
(b) 	Interactions 
(c)	Evidence of misuse 
(d)	Then generate labels. Repeat Authorisations and CMI’s where applicable 

Drug Selection 

4.	Using Pharmacist original copy of prescription SELECT & CHECK: 
(a)	Drug 
(b)	Strength 
(c)  	Quantity 

	Labelling 

5.	Label each item CHECKING: 
(a)	Expiry Date 
(b) 	Drug, strength and quantity against pharmacist original copy of prescription 
(c)  		When attaching label, do not obscure important information on
manufacturer’s label (especially name, strength and expiry date). 
6.	Label Check 

(a)	Swipe bar code with scanner and check on computer screen for drug name/patients name/address, date. 
(b)	For multiple item dispensing, it is recommended to keep all items together in an appropriate container. 
Suggestion: Selecting drugs prior to computer input has in many cases reduced selection errors, especially in peak dispensing periods and for locums unfamiliar with the dispensary layout. 

7.	Assembling Prescription 
(a)	Assemble dispensed medicines with all documentation and counselling aids. 
(b)	Check all containers belonging to the prescription. 
(c) 	Store finished prescription out of the reach of the public and so it is not identifiable by the public. 
(d)	 Place in a container, which leaves all items visible. 

8.	Collection of Prescription 
(a)	Consider whether counselling is required for this patient. 
(b)	 Is a CMI printout required? 

9.	Final Check
(a)	The drug, strength and quantity against the pharmacist original copy of the prescription. 
(b)	Verify correct person is receiving prescription by checking name and address or cross-check if numbering system used. 

10.	Guidelines to Follow in Case of a Dispensing Error 
(a)	When presented with a complaint, ensure the matter is handled by the pharmacist. 
(b)	Show concern and willingness to correct any error. 
(c)	Check out the alleged error and if established, replace the offending item immediately. If it was dispensed at another pharmacy, check with that pharmacy and replace if possible. Take care not to compound the problem. Retain the incorrect item to prevent further misuse. 
(d)	Apologise and show concern. Give a sensible explanation if possible. If the error is obvious there is no point in being evasive - admit the mistake. 
(e)	Determine whether any of the wrong drug had been administered.  Has any harm been suffered? Has any expense been incurred?  If so, it may be sensible at this stage to say that you will, of course, cover these expenses.  DO NOT OFFER COMPENSATION - This may be regarded as an attempt to bribe your way out of trouble. 
(f)	Show empathy with the patients. This gives them the opportunity to vent their feelings so you might learn where you truly stand. 
(g)	At all times remain calm, sympathetic and co-operative. Advise that you will investigate how this occurred and take action to tighten procedures.  Obtain a phone number for any follow-up. 
(h)	Telephone PDL (GIC) and notify the problem. You will be advised of what further action to take. It is important that you report all incidents 
PDL immediately. 
(i)	Record the details and all relevant information in your diary. 
(j)	When the patient has left the pharmacy, if you suspect that an error has been made, act speedily to correct the problem, without causing any unnecessary alarm. 
(k)	When a complaint is initiated by correspondence it is MOST IMPORTANT that you do not reply without first asking advice from PDL. Do not put anything in writing without advice from PDL. 
(l)	If confronted by an investigating officer seeking information relating to drugs dispensed for a patient who has died or whose health has been compromised, it is recommended that PDL be contacted immediately so that legal advice can be provided. 
(m)	When any incident occurs contact the prescriber as a matter of professional courtesy. 
(n)	Pharmacists should identify types and frequencies of medication errors and advise appropriate bodies such as the Therapeutic Goods Administration and pharmaceutical companies/organisations to minimise possibilities for errors and thereby to minimise public risk. 

ACT PHARMACY BOARD

STANDARDS STATEMENT

9.	Guidelines for the Supply of β2 Agonist Inhalers

1.	In 1989 the National Health and Medical Research Council issued a report on asthma in Australia which concluded that one of the risk factors leading to Australia having one of the highest death rate in the world from asthma was the non-prescription supply of Schedule 3 B2 agonist inhalers coupled to the lack of a physician-initiated “Asthma Plan” which included the use of inhaled corticosteroids. 

2.	Following this report the National Drugs and Poisons Schedule Committee recommended to the NH & MRC’s Public Health Committee that such inhalers be placed in Schedule 4, so that patients may be properly evaluated by a physician before using them. The Public Health Committee, aware that pharmacists were accepting increasing responsibility for medication and disease management, recommended an alternative approach, namely that if a patient requested a Schedule 3 ß2 agonist inhaler and the pharmacist had evidence to show that the asthma was subject to an asthma plan initiated by a physician and that the patient was having regular asthma checks with the doctor, then the pharmacist could issue an “asthma card”. This would allow the patient to obtain an inhaler without having to go to the physician each time.

3.	The Board endorses the Asthma Card concept, as a proactive professional activity in the interests of patient health. These Guidelines are designed to ensure that the patient receives appropriate medication and counselling.

4.	The Board recommends that the pharmacist supply a ß2 agonist inhaler in the following situations:

(a)	Where the patient is in possession of a prescription from a medical practitioner; or
(b)	where the pharmacist issues an Asthma Card, having being satisfied (after questioning the patient and/or consulting their prescription history and/or phoning their doctor) that their asthma is being controlled and monitored through regular visits to their physician; or
(c)	where the patient provides an Asthma Card issued at another pharmacy 

5.	The Board recommends the following procedures when dealing with the above situations:

(a)	When the supply is made on the basis of a prescription from a medical practitioner, the pharmacist should also issue an Asthma Card, noting the names of all the other prescribed asthma medications on the card and the date of this first supply next to the specific entry for the ß2 agonist inhaler.
(b)	When the supply is made at the time of issuing a first Asthma Card the pharmacist should write the names of all the other prescribed asthma medication on the card, as well as the specific entry for the ß2 agonist inhaler. A pharmacist may exercise professional judgement and duty of care and not issue an Asthma Card and refer the patient to their doctor.

6.	When the supply is made where the patient provides an Asthma Card issued at another pharmacy the pharmacist must be satisfied as to the following criteria, prior to supply:
(a)	The frequency of use of the inhaler does not appear to be excessive (which could suggest the asthma was inadequately controlled); and
(b)	the patient is taking other appropriate prescribed medication and their asthma is being controlled and monitored through regular visits to their physician.

7.	The pharmacist may exercise professional judgement and duty of care by refusing supply if it is considered that the above criteria are not met satisfactorily. In such a case the patient should be referred to their physician prior to further supply.

8.	Alternatively, if the situation warrants it, the pharmacist may make a supply and endorse the card with words to the effect “No further supply until prescription obtained from doctor”. 

9.	In extreme cases, the pharmacist could assist the patient in an acute attack by providing an inhaler for immediate use and phoning an ambulance.

10.	When the supply is made where the patient provides an Asthma Card issued at another pharmacy the pharmacist signs and dates the patient’s Asthma Card and if relevant, provides counselling on available information on asthma, asthma products, and details of other health professionals who can assist their achieving optimal asthma management.

11.	In relation to supply of ß2 agonist inhalers the Board expects the following:
(a)	The pharmacist to personally hand the ß2 agonist inhaler to the patient
(b)	All B2 agonist products are stored away from public access in the dispensary.

ACT PHARMACY BOARD

STANDARDS STATEMENT

10.	  Delivery of Prescriptions 

1.	An essential part of the dispensing process, COUNSELLING, occurs when the pharmacist hands the drugs to the patient or the patient’s carer.  It is therefore important when prescriptions are delivered that the pharmacist dispensing the medication ensures that counselling occurs.  The pharmacist should either deliver the medication and counsel when delivering or counsel the patient when the prescription is left in the pharmacy for dispensing and delivery.  Another alternative is for the pharmacist to counsel via telephone contact.  Where in those exceptional circumstances it is in the consumer’s interest to dispatch medicines, drugs or appliances by post or courier a pharmacist must ensure that the consumer receives the same advice and instructions that would have been given if the consumer was present in the pharmacy.

2.	When prescriptions are left at collection point (other than the pharmacy where the dispensing of the prescription occurs) or when prescriptions are faxed to the pharmacy for dispensing and delivery there is less opportunity for appropriate counselling of the patient by the pharmacist to occur.  

3.	All ACT pharmacists offering a home delivery service to their customers should check their procedures to ensure that counselling by a pharmacist is available on each occasion.

ACT PHARMACY BOARD

STANDARDS STATEMENT

11.	  Mail Order Dispensing 

1.	The Board endorses the principles of Quality Use of Medicines, which encourage the direct and personal contact between a patient and the pharmacist as the most effective way to ensure the safe and correct use of medicine.  The delivery of medication, prescriptions or scheduled items, by mail or other courier service, is therefore not encouraged.

2.	In those cases where medications are supplied on mail order directly to patients the responsible pharmacist is required to fulfil all professional requirements to ensure safe and correct use of the medicine, and to exercise proper and reasonable care in respect of that supply.

3.	This will ensure that patients thus supplied enjoy the same high quality of professional care, which is available with personal appearance by the patient or agent in a pharmacy.

Protocol

4.	Standard Operating Procedure
Because there is no opportunity for face to face consultation with patients or their agents, which is a prime component of Quality Use of Medicines there is a greater potential for medication error.  Therefore the Board requires that all functions performed by either the pharmacists or auxiliary staff of a pharmacy providing a mail order service must be described by way of a written standard operating procedure designed to minimise dispensing errors.

5.	Premises
The premises from which a mail order dispensing service take place must comply with all regulations relating to the practice of pharmacy.

6.	Patient Medication Record
A patient medication record must be kept for all patients and include the following information as a minimum: 
		(a)	Patients full name
		(b)	Address
		(c)	Telephone number
		(e)	Unique patient identifying number
		(f)	Name and telephone number of the patient's doctor
		(g)	Age and sex
		(h)	Medication history (at this pharmacy)
(i)	Dates of prescriptions, dates of dispensing, name of dispensing pharmacist.
		(j)	Other relevant information such as known allergies

7.	In the case of new patients, this information must be obtained by way of a comprehensive form or by the PHARMACIST telephoning the patient directly.

8.	Dispensing
Before dispensing, a PHARMACIST must assess each prescription and evaluate it in light of the patient's medication record.  In the event of any discrepancy, or concern with a prescription, the pharmacist must contact the client or failing that, the prescriber.

9.	Reviewing
After dispensing and before dispatch a PHARMACIST must check all details of the medication and prescription.

10.	Information and Advice
(a)	On supply of each medication, the pharmacist must ensure that sufficient information is given in relation to indications, dosage and possible adverse reactions so as to enable patients to make informed assessments of their medication.
(b)	Each item must carry the appropriate Cautionary Advisory Labels.
(c)	Each item must have complete information on dosage frequency, time of administration and method of use, either on the label or on a separate printed sheet.
(d)	If the directions on the prescription are "take as directed", or other non specific instruction, the pharmacist must take appropriate steps to ensure that the patient knows and understands what the directions are.
(e)	Labelling must include: 
			(i)	Name, strength and description of the medication.
(ii)	The dosage form, dose, route of administration and duration of therapy.
			(iii)	Special directions applicable in individual cases.
			(iv)	Correct storage information expiry date and batch number.
			(v)	Identity code of pharmacist taking responsibility.
(f)	Advice about telephone access at no more than the cost of a local call must be provided.  A pharmacist must be available on that number to give information and advice in normal business hours, at least between the hours of 9.00am and 6.00pm.  That pharmacist must have immediate access to prescription details and patient medical history.
(g)	When, in the opinion of the pharmacist, direct patient counselling is desirable, the pharmacist should contact the patient by telephone for that purpose.

11.	Packaging and Posting
(a)	All medication must be dispensed in child-resistant containers.
(b)	The packaging must not indicate that the article contains a scheduled poison.
(c)	All medication must be despatched in packaging that is sufficient to ensure its safe arrival in good condition to the addressee.  Special attention must be given to the storage requirements of temperature sensitive medication.
(d)	The pharmacy must keep a formal record of the date of dispatch, method of dispatch, and address to which the medication was despatched.
(e)	A control system must be in place so that the pharmacist becomes aware that the medication has been received by the patient.

	Note:   All packaging should comply with the "Dangerous & Prohibited Goods and Packaging Guide", published by Australia Post.

11.	This might include requiring the patient to telephone the pharmacy on receipt, OR the pharmacist telephoning the patient after a suitable interval, OR the provision of a reply paid envelope for the patient to mail back on receipt of the medication, OR other procedures.

12.	Other Legislation
This protocol addresses proper professional practice and pharmacists' obligations under the Health Professionals Act 2004.  Pharmacists should also address their obligations under the National Health Act, the Medicines, Poisons and Therapeutic Goods Act 2008 and the Medicines, Poisons and Therapeutic Goods Regulation 2008 or any other legislation. 

ACT PHARMACY BOARD

STANDARDS STATEMENT

12.	  Fair Handling of Information 

1.	Pharmacists are required to comply with the provisions of the Health Records (Privacy and Access) Act 1997(ACT) and the Privacy Act 1988 (Commonwealth). This legislation prescribes how an individual's information is to be handled by a health provider.  The Community and Health Services Complaints Commissioner can provide advice on the provision of access to records by persons.

ACT PHARMACY BOARD

STANDARDS STATEMENT

13.	  Maintenance of Pharmacy Records 

General

1.	The Pharmacy Board is responsible for the maintenance of professional standards of the pharmacy profession in the ACT. Given the importance of pharmacy records in the ongoing treatment of patients as well as the growing community interest in pharmacy records, the Board is concerned that practitioners are provided guidance on the maintenance of such records.

2.	This paper takes into consideration the provisions of the Health Records (Privacy and Access) Act 1997 (Health Records Act).

Aim

3.	This paper details the Board's policy on the maintenance of pharmacy records by Pharmacists.

Types of Records

4.	For the purposes of this paper, pharmacy records are those clinical notes and supporting documentation maintained by pharmacists on their patients.  Records maintained by public or private hospitals are not included as part of the discussion in this paper.

5.	Any reference in this paper to pharmacy records encompasses both written and electronically stored information.  Pharmacy records, whether paper based or on computer, should meet the Board’s policy requirements.  In addition, electronic records should be capable of being printed on paper when required.  Prescriptions must be kept for two years.

Privacy Principles

6.	Privacy principles as they relate to the collection and maintenance of pharmacy records now have force of law in accordance with the Health Records Act.  Practitioners are advised to consult the Health Records Act in relation to privacy matters, in particular in relation to:
(a)	the manner and purpose of collection of personal health information is to be lawful and relate to the health of a patient;
(b)	the purpose of the collection of personal health information is to be made known to the patient before the collection is made including purpose of the collection, the identity of any persons who have access and to whom it might be disclosed;

(c)	information collected must be relevant to the medical condition being treated and must not intrude on the personal affairs of the patient;
(d)	information collected must be reasonably secured against loss, unauthorised access, modification or disclosure or other misuse;
(e)	record keepers are to, on request, advise consumers that they have possession of pharmacy records as well as the nature and purpose of the records and the steps a person might take to obtain access to the records;
(f)	members of the treating team may have access to pharmacy records as far as reasonably necessary for them to provide a health service;
(g)	information in a pharmacy record shall not be deleted unless as part of an archival program of destruction;
(h)	records are to be kept up to date and accurate and be relevant to the purpose of collection;
(i)	pharmacy records are not to be used for any other purpose other than the reason for collection unless the patient consents to their use, their use is required to lessen a significant risk to life or health, or their use is authorised by a law of the Territory, Commonwealth or an order of a court of competent jurisdiction;
(j)	disclosure of information is limited to members of a treating team to the extent necessary to treat a condition.  Other disclosure is not to occur without the consent of the patient, or a risk to life or health of a patient, or authorised by a law of the Territory, Commonwealth or an order of a court of competent jurisdiction;
(k)	on transfer or closure of a practice, practitioners are to take reasonable steps to inform patients of the arrangements for dealing with the pharmacy records, and ensure that all records are transferred to another practitioner, a competent record keeper or the patient;
(l)	where requested by the patient, practitioners are to transfer pharmacy records (or a copy or written summary) to another health provider; and
(m)	written consent of the patient is required prior to the provision of a health status report to another person.

7.	The privacy principles have been paraphrased in this policy paper and practitioners are advised to refer to the Health Records Act for more detailed information on individual principles.

Maintenance of Records

8.	Good pharmacy practice demands that adequate patient records that cover history, diagnosis and treatment of the patient by the treating pharmacist be created and maintained.  This obligation is not based on law but on the ethical and practical necessities of pharmacy practice.

9.	In relation to the content of pharmacy records, the following should apply:
(a)	The record should be legible.
(b)	The record should contain sufficient information to allow another pharmacist to carry on the management of the patient.
(c)	The record should contain accurate statements of fact or statements of clinical judgement and should be contemporaneous with the patient consultation.

(d)	The pharmacist should record information on every pharmacist/patient consultation with significant clinical content, particularly when treatment is changed.  All face-to-face consultations will require a record.  The entry should be dated and it should be possible to identify who made the entry.
(e)	Any changes to paper records should be initialled and changes should be made in such a way as to make the previous entry visible.  Computerised records must be established in such a way that, for every entry to the record, there is a record of when the entry was made, by whom and when changes were made.
(f)	The record should contain subjective information obtained on history, objective information obtained on physical examination, an assessment (usually with a diagnosis or problem), results of tests and a treatment plan.  Medications prescribed should be recorded.  Appropriate alerts such as allergies should be documented clearly.
(g)	The pharmacy record should not contain terms or comments that are derogatory or emotive.
(h)	Abbreviations or ‘short hand’ expressions should be recognisable and comprehensible within the context of the patient’s care.

10.	In addition, pharmacy records should not include thoughtless or unnecessary remarks about colleagues or their form of treatment.

The Need for Records

11.	A pharmacist’s duty of care requires a pharmacist to maintain records associated with the treatment of a patient.  Adequate records are essential to enable proper management of a patient by the pharmacist and possibly his/her successors.  In addition, the pharmacist might be called upon to produce appropriate pharmacy records during legal proceedings.

12.	It is the view of the Board, that in both sets of circumstances, the failure to maintain adequate records could constitute unsatisfactory professional conduct.

Confidentiality

13.	Records should remain confidential to those directly involved with the care of the patient.  In the case of computerised records, use of the record should be controlled by a password or other security system to protect against unauthorised access.

14.	Pharmacists should not, without the consent of their patient, disclose to any third party information acquired by reason of their professional relationship.  The obligation of confidentiality is an implied term of the contract of service between them.

15.	This confidentiality extends to family relationships.  Pharmacists should not (within reason) disclose the medical condition of one member of a family to another family member without the consent of the first person.

16.	The need for confidentiality extends to clerical staff employed by the pharmacist, who might have access to patient records.  Appropriate instructions should be given to staff regarding the release of information over the telephone.

17.	No pharmacist or those directly involved with the care of the patient should disclose information to anyone other than the patient without the patient’s permission or unless compelled by court order or other legal obligation.

Storage of Records

18.	Records should be stored securely and safely and should be accessible when necessary.

Retention of Records

19.	Current legislation does not specify how long pharmacy records are to be maintained.  Ethically, pharmacists should retain information sufficiently long in order for adequate treatment of patients to occur.  In essence this could mean the maintenance of at least a summary of any significant treatment, or as long as a person remains a patient of a pharmacist.

20.	From a practical perspective, records should be retained for at least seven years after the last treatment of a patient by the pharmacist.  In the case of children, records should be maintained for at least seven years after the patient turns 21 years of age.  Medicare requirements to maintain prescriptions for two years must be observed.

Destruction of Pharmacy records

21.	A person shall not destroy, deface or damage a pharmacy record with intent to evade or frustrate the operation of the Health Records Act.

Ownership of Records

22.	A pharmacist in private practice owns the records created in that practice.

23.	In a group practice, the right of ownership of records will depend on the terms and conditions of the form of partnership or association.  Records created by an employee pharmacist or a locum remain the property of the employing pharmacist or group.

Right of Access to Records

24.	The Health Records Act provides a patient with a right of access to a medical record held by a pharmacist.  The patient may gain right of access:
(a)	by inspecting the health record (If held in electronic form, by way of a print out);
(b)	by receiving a copy of the record; or
(c)	by viewing the record and having its content explained by the pharmacist holding the record or by another suitably qualified health practitioner;

25.	Under the Health Records Act, it is a term of contract (oral or written) for the provision of a health service for a patient to have access to his or her medical record, providing that one of the following circumstances apply:
(a)	the contract is made in the Territory,
(b)	the contract is performed wholly or partly in the Territory, or
(c)	the patient is present or resides in the Territory.

Grounds for Non-Production

26.	The Health Records Act allows the following grounds for non-production of the whole or any part of a medical record:
(a)	that the record is not in the possession, custody or control of the practitioner;
(b)	that the record or part of it does not relate to the person requesting access; or
(c)	that production of the record would contravene a law of the Territory, the Commonwealth or an order of a court of competent jurisdiction.

Transfer of records

27.	When a patient changes pharmacist, the Health Records Act requires that on written request of the patient, at least a summary of the medical record maintained by the first practitioner to be transferred to the second practitioner.

28.	Pharmacists must ensure therefore, that a sufficient medical history is made available on request to any subsequent treating practitioner thus ensuring that the continued good management of the patient.  Whilst the Board accepts that such transfers can at times be stressful due to professional or commercial relationships, it is firmly of the belief that the primary duty of care to a patient must override other factors.

29.	The failure of a pharmacist to provide the medical record is a breach of the Health Records Act and may be considered by the Board as being unsatisfactory conduct.

Costs of Reports

30.	The Board accepts that reasonable charges sufficient to meet the costs of researching and documenting information sought on pharmacy records, may be charged to patients or their legally authorised agents for the provision of such information.

Death or Retirement of a Practitioner

31.	In a partnership, the records will be taken over by the remaining partners.  In a solo practice, the personal representatives of the deceased pharmacist should attempt to transfer patient records to the new treating pharmacist, and an attempt to contact patients made to request how they would prefer their records to be dealt with.  Any other remaining records must be passed onto a competent record keeper.

Disclaimer

32.	In the case of any conflict or discrepancy between this document and the Act, the Act prevails.

ACT PHARMACY BOARD

STANDARDS STATEMENT

14.  Impaired Practitioners 

General

1.	The Pharmacy Board is responsible for the administration of the provisions of the Health Professionals Act 2004 (the Act) in relation to pharmacists and the maintenance of the standard of the profession in the ACT.  The Board’s duties include administering to the rehabilitation needs of the mentally and/or physically impaired pharmacist (practitioner) and in so doing protecting the public.

2.	The Board prefers to assist the impaired pharmacist to overcome any health problem or impairment well before any need for disciplinary action arises.

Aim

3.	The aim of this standards statement is to detail the Board policy on the identification and rehabilitation of the impaired pharmacist.

4.	Protection of the public can often be achieved by allowing the pharmacist, to continue to practise, subject to appropriate conditions being placed on practice whilst undergoing treatment.  In this way, rehabilitation of the practitioner can occur and the public interest be served.

The Impaired Practitioner

5.	Like the rest of the community, pharmacists from time to time suffer physical and mental illnesses.  Such illnesses or impairment can affect the performance of their duties and possibly endanger the public.

6.	Impairments that particularly concern the Board are psychiatric conditions, dependence on alcohol or drugs, stress and a general decline in competence brought about by age or illness or both.  Some of these impairments allow the pharmacist to practise without detection and thereby possibly endanger the public.  Continued practice without professional assistance means that it is probably only a matter of time before serious problems occur.

7.	Experience has shown that early intervention often enables pharmacists to continue practice whilst receiving treatment.

Legislation

8.          The Health Professionals Act 2004 and the Health Professionals Regulation 2004 establish a health professions tribunal and authorise the Board to establish a personal assessment panel (PAP) to consider the conditions of registration of a registered pharmacist whose ability to practise may be affected by his or her mental or physical health.  

Notification to the Board

9.	The Board relies upon being notified of an impaired pharmacist by complaints, by the police/courts, by the Pharmacy section of the ACT Health Protection Service and by notification by family, the pharmacist or treating medical practitioner or by hospitals/facilities where the pharmacist is being treated.

10.	Members of the profession have a professional responsibility to notify the Board of any impaired colleagues who come to their attention where the impairment hinders the ability to practise pharmacy.

Performance Review

11.	Once the Board becomes aware of the impaired pharmacist, an initial review is undertaken by a personal assessment panel to ascertain the need for the pharmacist to be further investigated as to the pharmacist’s suitability to practice.

Personal Assessment Panel

12.	The Board may establish a personal assessment panel (as per the Health Professionals Act 2004, Part 2, Section 20) and refer a report to it if the report suggests that a practitioner’s mental and/or physical health may be affecting the pharmacist’s ability to meet the required standard of practice or if the Board is satisfied that the pharmacist may need to be rehabilitated.

13.	It is at this stage that it is ascertained whether the pharmacist is a danger to the public or not.  If there is a potential danger to the public, the pharmacist will become subject to formal consideration by the personal assessment panel.  If there does not appear to be any danger to the public, consideration will be given to including the pharmacist on the rehabilitation program.

Psychiatric Assessment

14.	Where necessary, the treating medical practitioner will arrange for a psychiatric assessment.  This is normally conducted by a psychiatrist of the choosing of the Board but will not limit the practitioner from attending a psychiatrist of his or her choice for any necessary psychiatric treatment whilst on the program.  Following that assessment the treating general medical practitioner provides recommendations to the personal assessment panel of the Board, which will resolve which conditions (if any) are to be placed on the ongoing registration of the pharmacist.

Discussion with the Pharmacist

15.	Once the personal assessment panel recommends conditions to be placed on the ongoing practice of the pharmacist, the treating medical practitioner, on behalf of the Board discusses them with the pharmacist.  A pharmacist who does not discuss the matter with the treating medical practitioner, will then become subject to a formal personal assessment panel hearing and will not be permitted to enter the program.

16.	If at any time during this early stage of the process the treating medical practitioner believes the pharmacist might be a danger to himself or herself, then discussions with the pharmacist cease and the Board is advised of the circumstances.  Formal Board action would then commence.

17.	As a result of the initial interview with the pharmacist, an initial report is prepared by the treating medical practitioner for the personal assessments panel of the Board stating the background of the matter, the attitude of the pharmacist and a recommendation regarding the suitability or otherwise of the pharmacist for placement on the program.

Form of Undertaking

18.	(a) The pharmacist needs to agree in writing to the voluntary placement of conditions on his or her registration (see Attachments 1 to 4 for precedent conditions.).  Should the pharmacist not do so, formal proceedings will commence.

(b) The pharmacist needs to agree in writing to pay any costs incurred, as per paragraph 30.

Management of the Program

19.	The program is closely managed by the PAP to ensure its objectives are achieved, but this is undertaken at arms length from the full Board.

20.	The personal assessment panel acts as the conduit for information to and from the Board on the program.

21.     	To assist in the process of management of the program by the treating medical practitioner the following documents, are attached to this policy paper:

•	ACT Pharmacy Board Protocol for Urinalysis (Attachment 5)

•	Brief Summary of the Procedure  (Attachment 6)

•	Conduct of an Impairment Interview  - Notes for treating medical practitioner (Attachment 7); and

•	Evaluation of Review Interview (Attachment 8)

Reports to the Board

22.	The treating medical practitioner is to receive regular reports from every other treating physician and/or psychiatrist.  The treating medical practitioner will advise the Board every two months of the progress of rehabilitation.  These reports (see Attachment 8) summarise the progress of the patient and reports from treating specialists.

23.	Board appointed psychiatrists will be requested to provide reports direct to the Board (through the personal assessment panel) at intervals determined by the Board, normally at the commencement of the rehabilitation program, then at three or six monthly intervals.

24.	All reports provided to the Board on pharmacists on the program will remain confidential to the personal assessment panel.  The panel will provide only a précis of any report to the Board, not including any reference that can identify the pharmacist.

25.	In any statistical information collected, the identity of individual pharmacists on the program is not used.  Information that can identify pharmacists will not be made available to the public or other members of the profession unless the Board decides that this should occur in the interests of protecting the public.

Urinalysis Protocols

26.	Some impaired pharmacists will need to undertake random urinalysis.  The Board’s protocol (see Attachment 5) addresses how the urinalysis samples are to be taken and assessed.

27.	The conduct of the urinalysis program is the responsibility of the treating medical practitioner.  Reports are be passed to the Board through the personal assessment panel on a monthly basis indicating the success or otherwise of the urinalysis schedule.

Reviews

28.	Conditions placed upon the practice of the pharmacist will be regularly reviewed as the pharmacist progresses through the program.

29.	At least three reports from the treating medical practitioner (who is to consolidate reports any reports received from other physicians/psychiatrists) as well as two quarterly reports from the Board nominated psychiatrist need to be provided before the Board will consider any amendments to the conditions of registration. In general, the personal assessment panel will recommend variation of conditions in terms of less restriction but will not make them tighter without agreement of the pharmacist or the holding of a hearing.

Costs of the Program

30.	The costs associated with the program are those direct costs associated with medical examinations and the indirect costs associated with the administration of the program.  The Board will pay for the initial medical examinations as well as for the periodic psychiatric examinations by the Board nominated psychiatrists.  The Board will also meet the agreed costs of the reports prepared by the treating medical practitioner.  All other treatment costs remain the responsibility of the impaired pharmacist.

Disclaimer

31.	In the case of any conflict or discrepancy between this document and the Act, the Act prevails.

								

Attachment 1 
to Standard Statement 14

PRECEDENT CONDITIONS

Practitioners with Infectious Diseases and Related Health Problems

1.	To adhere to the Pharmacy Board’s standards statement regarding infected pharmacists.

2.	To attend for treatment with Dr _________________________, at a frequency to be determined by the treating practitioners.  To authorise Dr ______________ to inform the Board of termination of treatment if there is a significant change in health status.

3.	To attend for review by Dr _______________, the Board nominated psychiatrist/physician, initially on a six monthly basis, at the expense of the Board.

4.	To attend for review by Dr _________________, the Board nominated immunologist, initially on six month basis at the expense of the Board.

5.	The extent of duties to be guided by my health status and the advice of my medical attendants.

6.	These conditions may be eased at the discretion of the Board at such time it considers variance is appropriate.

Optional Conditions

•	To refrain from the practice of Pharmacy until reviewed by the Pharmacy Board in three months (delete condition 6 and reduce time period in 3 & 4).

•	To continue taking medication as prescribed by the treating physician(s)

•	To advise his/her employer (and supervisor) of the conditions imposed on his/her registration.

•	To seek Board approval prior to commencing practice/changes in the nature or place of practice.

•	To work only in a supervised position approved by the Board.

•	To undergo a neurological assessment by a Board-appointed neurologist as soon as possible with regular reviews at intervals to be determined by the neurologists.

•	To undergo regular neurological assessments at times to be determined by the treating or Board nominated specialist.

•	To advise the Board of any exacerbation of my infectious condition.

Attachment 2
to Standard Statement 14

PRECEDENT CONDITIONS

Practitioners with Psychiatric Problems

To attend for treatment by a psychiatrist of choice, at a frequency to be determined by the treating medical practitioner.  To authorise the treating psychiatrist to inform the Board of termination of treatment or if there is a significant change in health status.

To attend for review by Dr _________________ ,the Board nominated psychiatrist/physician, initially on a six monthly basis, at the expense of the Board.

Attend a review interview at the Board in twelve months unless reports from the Board nominated psychiatrist recommends an earlier review.

These conditions may be eased at the discretion of the Board at such time it considers variance is appropriate.

Optional Conditions

•	To refrain from the practice of Pharmacy until reviewed by the Pharmacy Board in three months (delete conditions 3 & 4 and reduce time period in 2).

•	To continue taking medication as prescribed by the treating psychiatrist.

•	To advise his/her employer (and supervisor) of the conditions imposed on his/her registration.

•	To seek Board approval prior to commencing practice/changes in the nature or place of practice.

•	To work only in a supervised position approved by the Board.

Attachment 3
to Standard Statement 14

PRECEDENT CONDITIONS

Practitioners with an Alcohol Problem

1.	To totally abstain from alcohol.

2.	That blood be taken for measurement of carbohydrate deficient transferring levels at monthly intervals and for liver function tests every three months.  The results of all tests to be forwarded to the treating medical practitioner and Board nominated physician(s).

3.	To contact the AA group and attend their meetings.

4.	To attend for treatment by a psychiatrist/physician of choice, experienced in treatment of alcohol abuse, at a frequency to be determined by the treating medical practitioner.  To authorise the treating psychiatrist/physician to inform the Board of termination of treatment or if there is a significant change in health status.

5.	To attend for review by Dr _________________ ,the Board nominated psychiatrist/physician, initially on a six monthly basis, at the expense of the Board.

6.	Attend a review interview at the Boards professional assessment panel in twelve months unless reports from the Board nominated psychiatrist recommends an earlier review.

7.	These conditions may be eased at the discretion of the Board at such time it considers variance is appropriate.

Optional Conditions

•	To refrain from the practice of Pharmacy until reviewed by the Pharmacy Board in three months (delete conditions 6 & 7 and reduce time period in 5).

•	To continue taking medication as prescribed by the treating psychiatrist.

•	To advise his/her employer (and supervisor) of the conditions imposed on his/her registration.

•	To seek Board approval prior to commencing practice/changes in the nature or place of practice.

•	To work only in a supervised position approved by the Board.

Attachment 4
to Standard Statement 14

PRECEDENT CONDITIONS

Practitioners with a Drug Problem

1.	Prohibited from dispensing S8 drugs.

2.  	Not self administer any Schedule 4 or Schedule 8 drugs or narcotic derivatives (this includes non-prescription compound analgesics and cold preparations unless ordered by his/her treating medical practitioner(s).  Notify the Board nominated psychiatrist/physician of any instances of illness requiring the administration of medications described above.

3.	To attend for random urinalysis in accordance with the Board’s protocol.

4.	To attend for treatment by a psychiatrist of choice, experienced in treatment of drug abuse, at a frequency to be determined by the treating doctor.  To authorise the treating psychiatrist to inform the Board of termination of treatment or if there is a significant change in health status.

To attend for review by Dr ________________, the Board nominated psychiatrist/physician, initially on a six monthly basis, at the expense of the Board.  At six months, if appropriate, the Board nominated psychiatrist may recommend a change to random urinalysis for consideration by the Board.

Attend a review interview at the Board in twelve months unless reports from the Board nominated psychiatrist recommends an earlier review.

These conditions may be eased at the discretion of the Board at such time it considers variance is appropriate.

Optional Conditions

•	To refrain from the practice of Pharmacy until reviewed by the Pharmacy Board in three months (delete condition 7 and reduce time period in 6).

•	To advise his/her employer (and supervisor) of the conditions imposed on his/her registration.

•	To continue taking medication as prescribed by the treating psychiatrist.

•	To seek Board approval prior to commencing practice/changes in the nature or place of practice.

•	To work only in a supervised position approved by the Board.

Attachment 5
to Standard Statement 14

ACT PHARMACY BOARD

Protocol for Urinalysis

General

1.	The following is the protocol for the collection of urine samples from pharmacists participating in the Pharmacy Board’s rehabilitation program as a result of self-administration of drugs.

Requirements

2.	At commencement of urinalysis, the subject pharmacist is to advise the Board of the name and location of the laboratory conducting the analysis and the type of supervision of the collection of specimens.

3.	Urine specimens are to be collected under direct supervision or equivalent method of accurately verifying the origin of the specimen.

4.	Drug screens are taken to include tests for Benzodiazepines, Barbiturates, Narcotics and Amphetamines.  The request from completed by the referring practitioner must identify the matter as ‘medico-legal’ to ensure a repeat analysis is conducted when a positive result is detected.

5.	Urinalysis results must be forwarded to the treating medical  practitioner or, if so ordered, the Pharmacy Board.

6.	The Board nominated treating medical practitioner is responsible for notifying the Board PAP of any drugs detected in urine screens or any failure to attend for urinalysis.

7.	Practitioners undertaking urinalysis are prohibited from self administering any Schedule 4 drugs or narcotic derivatives (this includes non-prescription compound analgesics and cold Pharmacy) unless ordered by the treating practitioner.  The impaired practitioner is to notify the Board nominated psychiatrist of any instance of illness requiring the administration of medications described above.

Random Urinalysis

8.	Random urinalysis means a minimum of fifteen screens in each consecutive period of six months.  The time of random collection will be determined by either the treating practitioner, or in some cases the Pharmacy Board Secretariat.

9.	The subject practitioner is required to attend for urinalysis on the day that he or she is notified by either the treating practitioner or the Pharmacy Board Secretariat, within eight hours of being so ordered.

10.	The decision to cease random urinalysis can only be made by the Pharmacy Board.

Changes in Routine

11.	The impaired practitioner is required to notify the treating medical practitioner and the Board nominated psychiatrist (or the Pharmacy Board where the pharmacist is subject to random urinalysis) in advance of any proposed holidays.  This information should indicate the date and duration of the proposed leave.

Breaches in Providing Urinalysis

12.	Both a positive urine or a fail to attend and provide urine as required without a reasonable excuse are regarded by the Board as breaches.

13.	A pharmacist in breach of the urinalysis protocol will be required to attend his/her Board nominated psychiatrist for an assessment.  The impaired practitioner will be responsible to pay for the cost of this assessment.

14.	The Board nominated psychiatrist’s assessment will be considered by the personal assessment panel of the Board.  If the panel is of the opinion that sanctions should be imposed, then it is to refer the matter to the board for decision.

Attachment 6
to Standard Statement 14

BRIEF SUMMARY OF THE PROCEDURE

The Program

1.	The Impaired Practitioner Rehabilitation Program is a non-disciplinary process.  The program is designed to assist registered pharmacists to deal with impairment while remaining in practice.

Initial Consultation

2.	The Board requires that any consultation or interview with the impaired practitioner be conducted in an informal manner.

3.	You will be required to meet with a medical practitioner representing the Board.  The board strongly suggests that you be accompanied by an adviser from your professional indemnity insurance provider.  Attendance by supporting family members is also encouraged.

4.	You will receive copies of all documentation considered by the Board in this matter.

Treating medical practitioner

5.	Whilst the treating medical practitioner is undertaking a coordinating role on behalf of the Board in the management of the Program, he or she is more concerned with developing a regime in a consensual fashion that will assist in the treatment of your disability while allowing you to continue in practice.  This is achieved by a process of discussion concerning the circumstances surrounding the pharmacist and the negotiation of an appropriate outcome.

6.	Such possible outcomes could be the institution of counselling measures or the agreed placement of conditions upon registration.  The treating medical practitioner may also recommend other action by the Board as appropriate.  In circumstances where no agreement is reached between yourself and the treating medical practitioner on an appropriate outcome, the matter will be referred to the Board for further consideration. 

Report to the Board

7.	At the conclusion of the consultation, the treating medical practitioner is to prepare a report for the personal assessment panel of the Board, which will consider the report.  Any agreed conditions will be in force from that time.  There are strict protocols in place concerning the confidentiality of proceedings and reports are only forwarded to those persons directly involved in your treatment and monitoring.

Attachment 7
to Standard Statement 14

CONDUCT OF AN IMPAIRMENT INTERVIEW

Notes for the Treating Medical Practitioner

Introduction

1.	Introduce yourself and any other participants present.

2.	Advise that the process is non-disciplinary and is designed to assist impaired practitioners to deal with impairment and remain in practice.

3.	Possible outcomes of this consultation are counselling or agreement reached on the placement of conditions on registration or voluntary suspension for a specific period.  You, as the treating medical practitioner, may also recommend other action to the board as appropriate.

4.	We would envisage that counselling or agreed conditions as being the usual outcome.

5.	As the treating medical practitioner I am required to report to the Board on the results of the consultation and agreed action.

6.	There are strict protocols regarding the confidentiality of this consultation.

7.	I have copies of a number of reports.  I understand that you have received copies of these reports.

8.	Commence the consultation.

General Discussion

Outcome

1.	I am supposed to reach an agreement with you as to an approach to rehabilitation involving agreed conditions upon registration.

2.	Do you have any thoughts about appropriate conditions?

3.	Our experience has been that the following conditions have assisted practitioners with similar problems in the past.  Would you like a few minutes to consider these?

Agreement on Recommendation

1.	I am asking you to sign a copy of these agreed voluntary conditions.

2.	I will now report to the Board that the recommended conditions agreed upon today is placed on your registration.

Attachment 8
to Standard Statement 14

ACT PHARMACY BOARD

EVALUATION REPORT

Registrant: ___________________________________________	  Date: ____________

Treating Practitioner: ___________________________________

PRACTITIONER’S EVALUATION

Attitude of Registrant

1.	How did the registrant appear to you?			Inappropriate   Appropriate

2.	Does the registrant recognise the			No	  Ambivalent	Yes
	seriousness of his/her problem?

3.	Does the registrant accept the role			No	Ambivalent	Yes
	of the Pharmacy Board in this matter?

4.	Since the last Board review has there			No		Yes
	been a breach of conditions?

5.	If yes, has the registrant acknowledged			No	Yes	N/A
	the breach?

6.	Do you think the registrant has the 			No	Some	Yes
	support of :

	Colleagues:								

	Friends:									

	Family:									

Outcome

7.	Do you think the registrant has				Worse	Better	Stable
	progressed since the last review?

8.	Identify the source of information that
	has been significant in determining the
	outcome of this review.
	
Please rate according to scale				Helpful	       Unhelpful

Psych report					1_____2_____3_____4_____5

Presentation at this review			1_____2_____3_____4_____5

Improvements since last review,			1_____2_____3_____4_____5
based on the last report

Board briefing paper				1_____2_____3_____4_____5

Direct correspondence from the registrant	1_____2_____3_____4_____5

Other  (please specify)_________________  	1_____2_____3_____4_____5

9.	Have you recommended that conditions		No	     Some	Yes
	be altered as a result of this review?

10.	The next Board review will be held in ___ months.

11.	Please provide any additional comments you believe might be relevant.

	ACT PHARMACY BOARD

STANDARDS STATEMENT

15.  Pseudoephedrine

1.	Pharmacists are encouraged to limit criminal opportunities for diversion of drugs by exercising caution in supply of products containing pseudoephedrine and to provide information to aid in early detection.

2.	The Board supports participation by pharmacists in structured programs for managing supply of pseudoephedrine, such as Project STOP.  The Board requires pharmacists to comply with legislation requiring the recording of pseudoephedrine supply.

 

ACT PHARMACY BOARD

STANDARDS STATEMENT

16.  Tobacco and Alcohol

1.	The Board has resolved that the sale of tobacco products and alcoholic beverages (except medicines) by pharmacists to be unprofessional conduct.

ACT PHARMACY BOARD

STANDARDS STATEMENT

17.  Dispensary Assistants

Introduction

1.	It should be clearly and unequivocally recognised that pharmacists remain, at all times, responsible for the activities of dispensary assistants.  In addition, the activities of dispensary assistants should never involve the exercise of professional judgement.  Pharmacists may be said to be exercising professional judgement if, when considering a situation, they call upon any knowledge acquired while gaining their qualification or subsequent to achieving it, take into account any other relevant matters, and integrate all of that information into a judgement which in the pharmacist’s opinion is in the best interest and wellbeing of the patient.

NOTE: Throughout this document the general term “Dispensary Assistant” has been used.  However, when this document is applied to Community Pharmacy, the term “Pharmacy Assistant in the Dispensary” may be more appropriate.  Similarly, in Hospital Pharmacy practice, the term “Pharmacy Technician” may be more applicable to assistants with a particular level of training.

Responsibility of the Pharmacist

2.	The pharmacist shall ensure:
(a)	that dispensary assistants are aware of, and adhere to, the requirement that confidentiality in regard to patient information is observed;
(b)	that dispensary assistants are personally supervised by a pharmacist;
(c)	that the activities of dispensary assistants do not require the exercise of professional pharmaceutical judgement by the assistant;
(d)	that a position description and duty statement is maintained for dispensary assistants and that it be available for inspection;
(e)	that dispensary assistants comply with policies, procedures and legal obligations.

Limitations of Duties of Dispensary Assistants

3.	A pharmacist shall not allow dispensary assistants to undertake the following tasks associated with prescription medicines:
(a)	patient counselling;
(b)	issuing dispensed medicine unless checked, authorised and approved by a pharmacist;
(c)	receiving prescriptions by telephone;
(d)	authenticating prescriptions;
(e)	interpreting prescriptions;
(f)	deciding the brand to be used when filling generic prescriptions;
(g)	making other clinical judgements.

Duties of Dispensary Assistants

4.	The range of tasks that dispensary assistants may carry out under the supervision of a pharmacist include:
(a)	receipting, unpacking and checking stock;
(b)	checking expiry dates and rotating stock;
(c)	monitoring imprest stock in nursing homes and hospitals;
(d)	packing pharmaceuticals for dispatch from the Pharmacy;
(e)	completing records of delivery of non-recordable drugs;
(f)	maintaining records of invoices and other documents;
(g)	indexing, retrieving and filing patient medication records;
(h)	performing clerical functions associated with the prescription dispensing, including the entering of prescription records provided that a pharmacist personally checks each patient’s medication history before the dispensed medicine is supplied;
(i)	selecting items for dispensing when specifically directed by the pharmacist;
(j)	selecting cautionary advisory labels as directed by the pharmacist;
(k)	repackaging pharmaceuticals;
(l)	assisting in the preparation of sterile and non-sterile products;
(m)	providing general administrative support.

Training of Dispensary Assistants

5.	Pharmacists who use dispensary assistants should ensure that those dispensary assistants successfully undertake training programs acceptable to the Pharmacy Board.  The satisfactory completion of a Level 3 course for the national competency standards for dispensary assistants or hospital pharmacy technicians is the minimum requirement.  Dispensary assistants/hospital pharmacy technicians may perform duties while undertaking a level 3 course.

Note: The Board does not recognise in house training unless it has been accredited by the Australian Pharmacy Council or by the Board. 

Clarification of Some Aspects of the Guidelines 

6.	In issuing the Guidelines the Board is not indicating or promoting that pharmacist should use dispensary assistants but rather setting the professional parameters to be followed by pharmacists who find that their use can facilitate the dispensing process in a way that continues to protect the public interest.

7.	The Board emphasises that dispensary assistants ARE NOT PHARMACISTS and in their activities are always responsible to the pharmacist and operate under his/her supervision and direction.

8.	The pharmacist owners of pharmacies and pharmacists in charge of pharmacies will continue to be held professionally-responsible and liable for the activities of the assistants.

9.	The Board considers that these guidelines will act to facilitate the development of new and possibly more beneficial modes of pharmaceutical services delivery.

10.	The Board would expect pharmacies to identify those persons who are being used as dispensary assistants publicly and to hold, for Board inspection, the details of the approved training undertaken by them.

11.	Pharmacists are reminded of their obligations under the provisions of the Pharmacy Act and/or the Health Professionals Act, Regulations and Pharmacy Schedule, in that a pharmacist must be present on the premises and in charge of an operating pharmacy practice. Clearly the activities of a dispensary assistant cannot proceed if there is no pharmacist upon the premises.

12.	The Board endorses the Pharmaceutical Society of Australia document “The Role of Non-Pharmacist Dispensary Assistants/Technicians (Nov 2003)”.

ACT PHARMACY BOARD

STANDARDS STATEMENT

18.  Incorporated Pharmacies

Company ownership of pharmacies

1.	A company that owns a pharmacy is practising pharmacy and that company must be a registered pharmacist.

Approval of company names

2.	The Australian Securities and Investments Commission has legal requirements for the registration of company names.

3.	In addition, the Board must approve a company’s name before the company can be registered as a pharmacist.

Using business names

4.	If an incorporated pharmacist wishes to carry on business in a name which is different to its company name, it must register the business name with the Registrar-General of Business Names.  

	Company directors and members

5.	Only registered pharmacists, or their specified relatives, may own shares in an incorporated pharmacist.  All directors of an incorporated pharmacist must themselves be registered pharmacists.

6.	A registered pharmacist may be a director of more than one incorporated pharmacist only with the consent of the Board.   If a registered pharmacist wants to be a director of more than one company, he/she will need to ensure that the Board consents to his/her directorship of all companies.  

7.	A pharmacist may be involved with more than one incorporated pharmacist as an employee member without the need for consent by the Board. 
 
	Special obligations of companies

8.	An incorporated pharmacist must comply with the provisions of its constitution as set out in Schedule 5 to the Health Professionals Regulation 2004, and must notify the Board in writing within 14 days of any failure to do so.  

9.	An incorporated pharmacist that changes its name or constitution must first seek the approval of the Board, or it will automatically cease to be registered.

10.	An incorporated pharmacist must not practice in partnership with another person without the approval of the Board, or it will automatically cease to be registered.
11.	If the membership of an incorporated pharmacist or the board of directors of an incorporated pharmacist changes, the incorporated pharmacist must notify the Board in writing within 1 month of the change.

12.	On or before 31 October each year, an incorporated pharmacy must provide the Board with a written return.  The return is to specify the names and addresses of the company and all directors and all shareholders.

13.	The Board requires incorporated pharmacies to provide it with a copy of all returns submitted to ASIC.
	
Business of incorporated pharmacists

14.	The business of an incorporated pharmacist must be carried on under the actual personal supervision of a registered pharmacist who is an individual.
Maintenance and demonstration of professional development, continued competence and recency of practice for corporate pharmacists 
15.	A corporation demonstrates adequate professional development, continuing competence and recency of practice when applying for registration as a pharmacist if each director of the corporation could, if the director were applying for registration as an individual, demonstrate adequate professional development, continuing competence and recency of practice when the corporation applies for registration.  (In this section: registration includes renewal.) 

ACT PHARMACY BOARD

STANDARDS STATEMENT

19.  Notification of Ownership

1.	A pharmacist who has or who acquires or who changes an ownership interest in a community pharmacy or a hospital pharmacy must advise the Pharmacy Board of that interest or of any change within 30 days of the change.  The advice needs to state the names, addresses, contact numbers and registration numbers of all parties who have an ownership interest in the pharmacy and it needs to state the address and contact number of the pharmacy.

ACT PHARMACY BOARD

STANDARDS STATEMENT

20.  Professional Indemnity Insurance

1.	A pharmacist must maintain a policy of professional indemnity insurance and provide evidence of the policy when required by the board. 
2.	However, this does not apply to a pharmacist if the pharmacist— 
(a) 	is covered by professional indemnity insurance other than insurance maintained by the pharmacist; and 
(b) 	only practises pharmacy that is covered by that professional indemnity insurance. 

ACT PHARMACY BOARD

STANDARDS STATEMENT

21.  Standard of Practice - Drugs

1.	In this standard: 
(a)	controlled therapeutic substance—see the Therapeutic Goods Act 1989 (Cwlth), Australian Register of Therapeutic Goods. 
(b)	the Australian pharmaceutical formulary means the latest edition of the Australian Pharmaceutical Formulary, published by the Pharmaceutical Society of Australia (the PSA), as amended by any amendments published by the PSA since the last edition. 
2.	A pharmacist fails to meet the required standard of practice, if the pharmacist uses or supplies, or allows the use or supply of a drug or medicine that is not— 
(a) 	for a drug or medicine that is a controlled therapeutic substance—of the standard applicable to the controlled therapeutic substance under the Therapeutic Goods Act 1989 (Cwlth), Australian Register of Therapeutic Goods; or 
(b) 	for a drug or medicine (other than a controlled therapeutic substance) for which a standard, method or policy is stated in the Australian pharmaceutical formulary—of the standard or in compliance with the method or policy required for the drug or medicine in the Australian pharmaceutical formulary. 

3.	Complementary medicine is part of continuation of pharmaceutical practice and the Board expects the same level of information to be provided on these products as orthodox medicines.  The Board endorses the Australian pharmaceutical formulary and Australian Drug Information (AusDI) as references.

ACT PHARMACY BOARD

STANDARDS STATEMENT

22.  Conduct of Business

1.	A person who is registered as a pharmacist must not practise under a name other than the name under which the person is registered.  The names of all persons practising as a pharmacist in a community pharmacy must be displayed in a public place in a clearly legible notice in the premises.  The name of the pharmacist in charge must be displayed followed by the words ‘Pharmacist in Charge’.

2.	A person who is not registered as a pharmacist must not—
(a)	practise pharmacy in a community pharmacy or in a hospital pharmacy except as a pharmacy student, pharmacy pre-registrant, pharmacy assistant or pharmacy technician under the supervision of a pharmacist; or

(b)	advertise or hold himself or herself out as being, or in any way pretend to be or to possess the status, or take or use the name or title (alone or in conjunction with any other title, word or letter) implying, or that may be construed to imply, that he or she is a person registered or entitled to be registered under this Act, or that he or she is qualified to practise pharmacy or is carrying on the practice of  pharmacy or is entitled to use that name, title, word or letters. 

3.	A person shall not in the course of a business carried on by the person, permit a person employed or engaged by him or her to practise pharmacy unless that other person is a registered pharmacist. 

4.	A person shall not in the course of a business carried on by the person, by advertisement or otherwise, hold out a person employed or engaged by him or her as being a person who—
(a)	is qualified or authorised to practise pharmacy; or

(b)	practises pharmacy; 
unless that other person is a registered pharmacist.

5.	A pharmacist must keep a record of every prescription dispensed, compounded or made up by the pharmacist.

6.	A registered pharmacist who is an individual must not—
(a)	keep or maintain any shop for selling or supplying medicines or drugs, or for compounding or dispensing prescriptions unless the shop is, while open for business, constantly under his or her own control or that of some other registered pharmacist who is an individual; or

(b) 	permit any person, other than a pharmacy student, pharmacy pre-registrant, pharmacy assistant or pharmacy technician in the course of his or her employment and under his or her supervision, or a registered pharmacist who is an individual, to sell or supply medicines or drugs or compound or dispense prescriptions; or 

(c)	practise pharmacy in a shop except under the supervision of himself or herself or some other registered pharmacist who is an individual; or

(d)	allow his or her name to be used in connection with the practice of pharmacy at any premises where there is not a registered pharmacist who is an individual in attendance when the premises are open; or

(e) 	aid or assist any person other than a registered pharmacist who is an individual to practise pharmacy except in accordance with the provisions of this Act; or

(f)	allow any person other than a registered pharmacist to hold a key to a pharmacy or to have access to the pharmacy unless a pharmacist is present, except in an emergency.

7.	The business of an incorporated pharmacist must be carried on under the actual personal supervision of a registered pharmacist who is an individual.

8.	A registered pharmacist must not enter into an agreement, arrangement or understanding with another person where any person can have undue influence on the professional practice and appropriate use of pharmaceutical products by the registered pharmacist.

9.	A pharmacist may dispense a prescription only if the prescription is given to the pharmacist by: a person named in the prescription; a close relative of that person; or a named person (an agent).

ACT PHARMACY BOARD

STANDARDS STATEMENT

23.   Inappropriate Behaviour 

1.	Members of the public have an expectation that they will receive health care in a trusting and safe environment.  As such, the professional relationship between a patient (client/consumer) and a pharmacist is one where the health of the patient is to be of paramount concern.  To maintain confidence in the pharmacist profession, as well as in an individual pharmacist, it is important that an appropriate professional relationship between a pharmacist and a patient is maintained.  

Recognised professional standards
2.	The Board approves as a Standards Statement:

Keeping Children and Young People Safe 2006 ACT Department of Disability, Housing and Community Services.

		Professional boundaries 
3.	A pharmacist has the responsibly to maintain professional boundaries with a patient at all times.  In the professional relationship the pharmacist is seen to have unequalled power over the patient as the patient is seeking assistance and guidance.

		Guiding principles
4.	The guiding principles for a pharmacist in a professional relationship with a patient include:
	(a)	no exploitation of a patient, and 
	(b)	no abuse of the pharmacist’s powers.

	Inappropriate behaviour
5.	The Act, Regulation, Standards Statements and Board Policies are crucial in defining inappropriate behaviour.  Inappropriate behaviour by a pharmacist incude (but are not limited to):
(a)	bullying
(b)	criminal behaviour
(c)	dishonesty
(d)	exploitation of a person
(e)	harassment, and
(f)	sexual misconduct, and
(g)	unethical behaviour

		Reporting
6.	A pharmacist who reasonably believes that another pharmacist has engaged in inappropriate behaviour shall report the matter in writing to the Board.  This is in addition to any requirements for reporting such matters to the police, Care and Protection Services or Community and Health Services Commissioner.

7.	In the event that a pharmacist is informed by a patient, that the patient may have been subject to inappropriate behaviour with another pharmacist, then the informed pharmacist has an obligation to encourage the patient to make a complaint to the Community and Health Services Commissioner or the Board.

ACT PHARMACY BOARD

STANDARDS STATEMENT

24.   Issuing of Medical Certificates 

1.	The Board endorses the Joint Guidelines for Pharmacists Issuing Medical Certificates published by the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia in January 2008 (ISBN: 978-0-908185-96-2) – current edition together with any supplements, addenda or amendments.  

2.	The Workplace Relations Act 1996 provides that registered health practitioners may issue medical certificates for sick leave and carer’s leave.  Pharmacists may issue such certificates for the purposes of informing a person’s employer in relation to sick leave or carer’s leave.  The certificates may not be valid for other purposes and consumers must be advised accordingly when issued with certificates.

3.	Pharmacists who issue medical certificates must comply with the publication endorsed by the Board in paragraph 1.

ACT PHARMACY BOARD

STANDARDS STATEMENT

25.   Dose Administration Aids 

1.	The Board endorses the Dose Administration Aids Service Guidelines and Standards for Pharmacists published by the Pharmaceutical Society of Australia in the Pharmaceutical Society of Australia’s Professional Practice Standards (version 3 (2006) – current edition together with any supplements, addenda or amendments.  

2.	The person packing dose administration aids should be a pharmacist or an accredited pharmacy technician under the personal supervision of a pharmacist.

3.	A pharmacist must sight the manufacturer’s pack from which the medication was taken.

4.	A pharmacist checking prepared dose administration aids must keep a signed daily log of dose administration aids checked.

5.	It is unacceptable to mix more than one client’s medications to make a common pool from which packing is done.

6.	It is unacceptable to use returned medications in dose administration aids.

7.	On receipt of a “stop” notification from the prescriber for a particular medication to be no longer included in the dose administration aid of a patient, any remaining medication should be placed in appropriate bins for unwanted medicines immediately.  A pharmacist should obtain assignment of such a right when contracting with the client to perform the dose administration aid service.

ACT PHARMACY BOARD

STANDARDS STATEMENT

26.   Returned Medicines 

1.	Medicines that are returned to a pharmacy must not be reused, recycled or re-supplied in whole or in part to any other person.  

2.	Medicines returned under the Return Unwanted Medicines (RUM) program and medicines returned from residential care facilities in dose administration aids must not be reused, recycled or resupplied.

3.	Pharmacists who accept a returned medicine cannot be certain that the product has been stored correctly and cannot be certain that the product’s integrity is intact.  

4.	Any returned medicine should be placed in appropriate bins for unwanted medicines immediately.  

5.	Pharmacists must keep an audit trail of Schedule 8 medications coming back into their possession for destruction.

ACT PHARMACY BOARD

STANDARDS STATEMENT

27.   Dispensing Multiple Repeat Prescriptions 

1.	A pharmacist must consider the wishes of the prescriber when asked to supply multiple prescriptions of the same item on one occasion.  The patient’s consent and the prescriber’s consent should be obtained before supplying multiple repeat prescriptions on one occasion in most circumstances.  Multiple dispensing of repeat prescriptions should only occur when the prescriber has endorsed the prescription in line with Regulation 24 of the National Health Regulations.

2.	A pharmacist must consider the need for ongoing monitoring of a patient when asked to supply multiple repeat prescriptions on one occasion.

3.	A pharmacist must consider the need for monitoring the efficacy of a medicine when asked to supply multiple repeat prescriptions on one occasion.

4.	A pharmacist must consider the risk of hoarding, overdose and misuse and weigh this against the principles of the quality use of medicines when asked to supply multiple repeat prescriptions on one occasion.

5.	A pharmacist must consider the risk of a patient losing access to the “Safety Net” at a later stage when asked to supply multiple repeat prescriptions on one occasion.

6.	Supply of multiple repeat prescriptions at once that does not accord with the prescriber’s intention is contrary to good pharmaceutical practice.

ACT PHARMACY BOARD

STANDARDS STATEMENT

28.   Intern Training for Pharmacists 

1.	The Board endorses the Manual titled “ACT Pharmacy Board Intern Requirements” published by the ACT Pharmacy Board on the Board’s website at http://health.act.gov.au/c/health?a=da&did=10031979&pid=1068520539 (current edition together with any supplements, addenda or amendments).  

2.	The Board requires all applicants for initial registration as a pharmacist to comply with the intern requirements detailed in the manual or to meet the intern requirements of a local jurisdiction in Australia.  

ACT PHARMACY BOARD

STANDARDS STATEMENT

29.   Methadone and Buprenorphine Dispensing 

1.	A pharmacist must undertake sufficient training to be familiar with National Guidelines, ACT legislation, policies and procedures before undertaking any methadone or buprenorphine dispensing.  

2.	Administration and supply of methadone or buprenorphine must take place in a pharmacy that is an approved opioid dependency treatment centre (approved pharmacy).

3.	Patients requesting methadone or buprenorphine must be referred by an accredited prescriber (either through the public clinic as a Tier 2 consumer or through an accredited medical practitioner as a Tier 3 consumer).

4.	A pharmacist must record and reconcile all drug transactions in accordance with the Medicines, Poisons and Therapeutics Goods Act 2008 and Medicines, Poisons and Therapeutics Goods Regulations 2008 and be able to provide an audit trail of drug movements from the wholesaler to the consumer.

5.	A pharmacist must dose a patient strictly in accordance with the terms of the original prescription.   All takeaway doses must be authorised in writing by the prescriber.

6.	A pharmacist must consult with the prescribing medical practitioner (or duty doctor in the case of a public clinic) in cases of erratic dosing or requests for replacement of doses that have been vomited or for requests for replacement of takeaway doses, or if presenting intoxicated.

7.	No more than three regular takeaway doses are usually permitted in a seven-day period. Check with Doctor and the Chief Pharmacist that an authorisation exists if more are prescribed.

8.	A sober patient on a daily dosing regime, who has missed one or two days’ doses, may receive a full dose on the next day.  Referral to the prescriber is required if three or more days’ doses are missed.  A patient who has missed seven days’ doses must be discharged from the treatment program by the pharmacists and the patient must be referred to the prescriber.

9.	Volume expansion or dilution of methadone takeaway doses is required, in accordance with the ACT Guidelines.

10.	Takeaway doses of methadone are to be in individual, child-resistant containers (that do not react with the drug) for each day’s dose.  Containers are to be labelled with the dosage, volume of dilution, patient’s name and instructions on usage, storage and safety.

11.	No takeaway doses of buprenorphine (Subutex) are permitted, except for pregnant patients if the total daily dose is below 2mg. Buprenorphine and naloxone (Suboxone) takeaways are permitted but they must remain in original foil.

12 	A pharmacist who accepts a patient, who has been treated by another pharmacy (including a hospital pharmacy), must have a full dosing history in writing from the transferring pharmacy and must confirm it with the prescriber before dosing the patient.  A new prescription is required before the first dose is dispensed.

ACT PHARMACY BOARD

STANDARDS STATEMENT

30.	    Conditional Registration – Non-Practising

1.	The ACT Pharmacy Board will consider applications for non-practising registration as follows.

2.	Non-practising registration is available to individuals who are eligible for registration, but who may not be working for a range of reasons.  The reasons may include, for example, retirement, parenting, being overseas.  A person must hold practising registration at some time prior to applying for non-practising registration.

3.	A person who is registered as a non-practising pharmacist may not practise pharmacy.  He or she will receive conditional registration, with the condition being that he or she does not practise pharmacy.

4.	Non-practising registration is not available to pharmacy owners.

5.	Those pharmacists who take up conditional non-practising registration for a time, but who do intend to return to the workforce, for example, those out of the workforce for parenting reasons, are to maintain their continuing professional development.  In order to be restored to the practising register, pharmacists will be required to comply with the board’s standards statements on competency, including recency of practice and continuing professional development.

Conditional Registration – Non-practising Fee

6.	The fee for Conditional Registration – Non-practising will be specified in the Board’s Disallowable Instrument on fees.  No pro rata fee applies.

 Notes:
1.	Those intending to return to the workforce should make themselves familiar with the Recency of Practice standard, as, if they are out of the workforce for more than five years, a period of supervised practice will be required before they will be eligible for re-registration to practise as a pharmacist.
2.	Pharmacists working in non-clinical practice areas, but who are imparting or providing information or advice, such as those in teaching or government positions, are considered to be practising pharmacy and full registration applies.
3.	Pharmacists who own a pharmacy in the ACT are considered to be practising pharmacy and full registration applies as per the Health Professionals Act 2004, Schedule 5, Section 5.4. (3).