Privacy, confidentiality and consent

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Chapter 9 Privacy, confidentiality and consent

LEARNING OBJECTIVES

Upon completion of this chapter you should be able to:

• understand the legal and professional obligation of confidentiality in relation to patient and client information
• identify the legal and professional consequences when the obligation to keep information confidential is breached
• identify the professional codes of ethics and conduct that protect patient and client confidentiality
• identify and understand the practical application of the exceptions to the obligation of confidentiality
• locate and understand the application of the Privacy Act (Cth), National Privacy Principles, Information Privacy Principles, and government privacy schemes as they relate to pharmacy practice
• identify legislation that facilitates access to information contained in patient and client health records
• understand the elements of a legally valid consent.

INTRODUCTION

The nature of pharmacy practice, whether conducted in the private or public sectors, whether provided by sole owners or members of an institutional health care team, will almost always include access to patient and client information. This access to patient and client private and confidential information is based on the therapeutic relationship which exists between consumers of health services and health professionals who care for them. Indeed, it is a combination of the legal, professional and ethical obligations imposed on health professionals to keep the patient’s and client’s information confidential — and the patient’s and client’s perception that such information will be kept confidential — that underpins the therapeutic relationship. That is, a pharmacist needs patients and clients to disclose relevant health information to be able to make informed decisions regarding which treatment options may be most suitable and appropriate. The patient is only likely to disclose such information, however, if it is understood that their information will be kept confidential and used only for the purpose of clinical decision-making. It is therefore important that pharmacists have an understanding of the legal, professional and ethical obligations that maintain the confidentiality of patient information and the mechanisms by which privacy of, and access to, patient information is secured.

Various situations in pharmacy practice require pharmacists to follow privacy and confidentiality legislation, principles and guidelines. The Pharmacists Board of Queensland has identified the following practice situations that involve the improper disclosure of information:[1]

• discussing or providing counselling in open and public areas where health information and personal details may be overheard
• providing professional services such as opioid substitution programs in an insensitive manner
• leaving personal information on a public counter or in places where it can be accessed or viewed by unauthorised persons
• displaying product names on cash registers in view of other customers
• disclosing a person’s personal details or health information to a third party
• storing or carrying of medicines in a way that does not protect the nature of medicines or the identity of the person for whom they are intended
• providing identifying data for marketing purposes (either direct or analysis of usage data).

Skene notes that privacy and confidentiality are different issues in that privacy is focused on the collection of information, whereas confidentiality is focused on communication of that information.[2] Although the duties imposed on pharmacists in relation to these two issues differ conceptually, they are complimentary to one another in their application and there is a considerable overlap within a health care context.

In addition to the duties imposed on pharmacists to keep patient’s or client’s information confidential and ensure the privacy of their information, there is also the obligation to obtain a legally valid consent prior to initiating or participating in any form of care or treatment of the person. This chapter will consider the legal requirements in relation to patient information and consent to treatment.

THE OBLIGATION TO KEEP INFORMATION CONFIDENTIAL

The modern day notion of confidentiality, within the context of health care delivery by any health professional, originates in the provisions of the Hippocratic Oath. Under this oath a medical practitioner agrees to be bound by the ethical obligation to ensure:

All that may come to my knowledge in the exercise of my profession or outside of my profession or in daily commerce with men [and women], which ought not be spread abroad, I will keep secret and never reveal.[3]

The confidentiality of patient and client information is therefore one of the fundamental presumptions founding the relationship between all health professionals, and their patients or clients. Indeed, pharmacy practice takes place in an environment in which the client expects their information will be kept confidential and the pharmacist appreciates and respects the obligations imposed by that expectation. As stated in the case of Seager v Copydex [1967] WLR 923:

[A person who] has received information in confidence shall not take unfair advantage of it. He [or she] must not make use of it to the prejudice of he [or she] who gave it without obtaining consent.

It could be argued that for any health professional to provide optimum care to a patient or client they must have full and frank disclosure of all relevant information by that individual. In the case of X v Y [1988] 2 All ER 648, involving a medical practitioner, the court observed:

If people felt that there was any chance of information given to their doctor, or the doctor’s diagnosis, being passed on, people would be reluctant to seek advice and the disease would go underground. Confidentiality must be absolute or almost absolute…In the long run, preservation of confidentiality is the only way of securing public health; otherwise doctors will be discredited as a source of education, for future individual patients will not come forward if doctors are going to squeal on them. Consequently, confidentiality is vital to secure public as well as private health, for unless those infected come forward they cannot be counselled and self-treatment does not provide the best care.

The obligation to keep information confidential has both a legal and ethical basis and includes information such as the patient’s current and previous medical details, family history, social and financial circumstances and any facts in relation to current or previous treatment or medication history. The disclosure by a pharmacist that a person has attended the pharmacy may constitute a breach of the duty of confidentiality. An example of the protection of patient information is evident in the addition of clause 9(h) to Schedule 3 of the Victorian Health Professions Registration Act 2005 that specifies that pharmacists may not reveal the identity of patients’ medicines to others:

(h) the identity of a medicine being supplied or dispensed to a client of the pharmacy or pharmacy department cannot be known by another person present in the pharmacy or pharmacy department who is not a person carrying on the pharmacy business or pharmacy department or a member of the staff of the business or department.

PROFESSIONAL AND ETHICAL OBLIGATIONS

Professional codes of conduct and ethics protect the rights of patients and clients to have their information kept confidential. The Pharmaceutical Society of Australia (PSA) Code of Professional Conduct (the code) expressly recognises the obligation imposed upon pharmacists to keep client information confidential. Principle three of the code states:[4]

A pharmacist must respect the confidentiality of information acquired in the course of professional practice relating to clients and their families. Such information shall not be disclosed to anyone without the consent of the client. Exceptions may arise where the health of the client or others is at risk, where information is sought by an officer of a statutory authority empowered under legislation, where a court order requires the release of confidential information, or the information is released to those assuming responsibility for the patient (e.g. next-of-kin, parent, relative, guardian or anyone with powers of attorney).

The various pharmacy registering authorities in each of the Australian jurisdictions also make express reference to the professional obligation to maintain patient and client confidentiality. For example, the Pharmacy Board of Victoria Guidelines for Good Pharmaceutical Practice[5] includes provisions covering privacy and confidentiality and the Pharmacists Board of Queensland Guidelines on Privacy and Confidentiality[6] specifically provide guidance to registrants on privacy and confidentiality issues as they relate to pharmacy practice. Pharmaceutical Defence Limited (PDL) also refer to the pharmacists’ professional obligations to ensure privacy and confidentiality.[7]

The Society of Hospital Pharmacists of Australia’s Code of Ethics (2006) identifies that ‘ [A]ll patient services must be provided with courtesy, respect and confidentiality’. Pharmacists should also refer to the PSA document titled: Professional Practice and the Privacy Act[8] and always endeavour to maintain the relevant professional practice standards; for example, criterion 1 of the Fundamental Pharmacy Practice standard and criterion 2 of the Organisation of Pharmacy Practice standard.[9]

Strict adherence to privacy guidelines in community pharmacy is complicated by the retailing component and requires careful planning. The Pharmacists Board of Queensland suggests the following strategies:[10]

• Attention to pharmacy layout to ensure that confidential information is not communicated in the presence of other consumers. Use of a professional services area, other consumers kept at a distance by barriers or by location away from traffic areas and conversation maintained at a suitable volume may achieve this.
• Policies in place so that any information about the affairs of any person obtained as a result of his or her practice as a pharmacist is not divulged unless:

• it is to a person authorised to have access to such information (and only to the extent of that authorisation);
• the consumer authorises the disclosure of the information; or
• if in the pharmacist’s opinion it is in the consumer’s best interest to do so, he or she may divulge pertinent information to another health practitioner who has care of that person.

• Policies in place so that details of prescription and over-the-counter medications where the drug is identified should not be included in information provided to other than the patient e.g. on family accounts, to third party organisations processing accounts including service companies, or organisations collecting statistical data.

Pharmacies participating in the Diabetes Medication Assistance Service (DMAS) are required to have a separate counselling area.[11] As the profession moves towards the provision of more specialised services the requirement to have separate counselling areas may become more popular in the future. As these areas could also be used for patient counselling that is of a confidential nature, for example counselling involved in the provision of the morning after pill (MAP), this would assist the profession in complying with privacy requirements.

STATUTORY OBLIGATIONS

Legislation exists at state, territory and federal levels directed specifically to the maintenance of confidentiality in relation to patient and client information. The legislation generally provides that clients or users of health care services have the right to those services being provided in a way that respects their right to the confidentiality of their information. Health professionals, often referred to as the ‘designated person’ or ‘relevant person’, must not disclose that information either directly or indirectly to others and there is usually a statutory penalty in circumstances in which information is disclosed inappropriately. As an example, the Queensland Health Services Act 1991 sections 60–62 impose on public health sector employees a duty of confidentiality and a penalty for breach of that statutory duty. Section 62A states:

Confidentiality

A designated person, or former designated person must not disclose to another person, whether directly or indirectly, any information (confidential information) acquired because of being a designated person if a person who is receiving or has received a public sector health service could be identified from the confidential information.

Maximum penalty — 50 penalty units.

Common law obligations

The obligation imposed on pharmacists to keep patient information confidential is maintained through the various common law decisions. The following is an overview of the legal basis upon which a client may initiate an action at common law in circumstances in which they consider there has been a breach of this obligation.

Negligence

The duty to keep information confidential is part of the duty of care owed by a pharmacist to their clients. In circumstances in which this duty is breached through the pharmacist divulging client information the pharmacist may be sued in negligence for the damage caused by the breach.[12]

Contract

It is an implied term of a contract involving the provision of health care that all information disclosed in relation to that care will be kept confidential. In the public sector there are no contracts between individual providers and their clients. However, in the private sector, where the client receives a service for the fee paid directly to the provider, a contract will exist which may provide the ground for an action in breach of contract where a client’s information is inappropriately disclosed.

Defamation

An action in defamation is founded on an allegation that the pharmacist makes a statement about a patient, which though untrue, is published and thereby lowers the reputation of the patient in the eyes of their peers. The law of defamation is not uniform across Australia, with certain jurisdictions such as New South Wales, Queensland and Victoria having enacted legislation.[13]

Equity

The law recognises the power imbalance between the providers of health care services and their patients and clients. Where a pharmacist discloses information about a patient or client, that person may claim a breach of the fiduciary duty owed to them by the pharmacist that resulted in a loss. In Coco v A N Clark (Engineers) Ltd [1969] RPC 41, Megarry J held:

In my judgement, three elements are normally required if, apart from contract, a case of breach of confidence is to succeed. First, the information itself … must have the necessary quality of confidence about it. Secondly, that information must have been imparted in circumstances importing an obligation of confidence. Thirdly, there must be an unauthorised use of that information to the detriment of the party.

The patient or client information must therefore have ‘the necessary quality of confidence about it’, and ‘must have been imparted in circumstances importing an obligation of confidence’.

EXCEPTIONS TO THE DUTY TO CONFIDENTIALITY

It is clear from the foregoing that patients have the right to confidentiality of their information, however, this right is not absolute and may be overridden in particular circumstances.

Express consent

The disclosure of patient information is authorised where the pharmacist has the express consent of the patient. It is suggested that the issue of with whom, if anyone, the patient’s information may be discussed is clarified as soon as possible. There may be circumstances in which the patient consents to a spouse, parent, child or another health professional being given information about the patient’s health concerns or particular medication regime. Clearly, where a range of health care professionals and workers are caring for a patient there is an implied consent to the communication of information necessary for the patient’s ongoing health care and wellbeing between those involved in the care.

Legal duty of disclosure

In all Australian states and territories there is legislation requiring the disclosure of certain patient and client information. Though the specific requirements of each jurisdiction are set out in the respective Acts it is mandatory in all jurisdictions, other than Western Australia, for nominated professionals to report suspected child abuse.[14] In most jurisdictions the diagnosis of a communicable disease and/or the presentation of a client with suspicious injuries are also reportable. There are also legislative provisions in the respective jurisdictions to provide information, or produce documents or other materials, as part of the court process. Though in a number of the states or territories there is no legal protection inherent in the health professional–patient relationship, in Victoria, Tasmania and the Northern Territory, doctor–patient privilege is permitted in civil proceedings.[15] In both Victoria and New South Wales there is privilege in the communication between victims of sexual assault and their counsellors.[16]

There may be situations in pharmacy practice that would require of pharmacists to weigh up the legal and ethical requirements regarding patient confidentiality against legislation that permits a breach of confidentiality. This is particularly relevant in supplying the MAP when the pharmacist believes that the sexual intercourse involved an unlawful activity. This would involve three scenarios, namely:

1. rape (sexual intercourse without consent)
2. incest (sexual intercourse between family members)
3. consensual sex with a minor if there is a large age difference between the sexual partners.[17]

Public interest disclosure

The obligation imposed on a health professional to keep a patient’s or client’s information confidential may be overridden in circumstances in which the disclosure of the information is necessary in the public interest. This public interest exception is not clearly defined and arises only where there is a real and significant threat of harm, or the possibility of death; for example, where a pharmacist is told by the patient or client that they intended to kill or harm another person.[18] In the case of W v Edgell and Others [1990] 1All ER 855, the doctor was employed to provide an assessment of W, a forensic prisoner, for the purpose of his release to a less secure mental health facility. The psychiatric assessment carried out by Dr Edgell was unfavourable to the prisoner and his legal representative withdrew the application. Dr Edgell, believing W still presented a considerable danger, forwarded his report to the Secretary of State. The court dismissed W’s application based on a breach of doctor–patient confidentiality and held that the public interest in disclosing the information to the authorities outweighed W’s right to have his information kept confidential.

PRIVACY LAW

While there is an overlap between the concept of confidentiality and the privacy of patient or client information, as discussed previously, they are recognised as two different concepts and therefore the requirements in relation to privacy need to be addressed separately. The privacy of a patient’s or client’s personal information is secured under the provisions of the Commonwealth Privacy Act 1988. The Privacy Act 1988 (Cth), amended in 2001,[19] covers individuals, and the private and public sectors and establishes the 10 National Privacy Principles (NPPs),[20] which apply to parts of the private sector and to all health service providers. The Act also establishes the 11 Information Privacy Principles (IPPs)[21] which apply to the Commonwealth and Australian Capital Territory government agencies. These IPPs provide for the collection, storage, security, use and disclosure of personal information and, in addition, deal with the right of access to information and correction of information that is collected about an individual. The legislation creates the position of the Federal Privacy Commissioner to whom complaints may be directed when there is an alleged breach of the provisions.

Section 62A(2) of the Privacy Act 1988 (Cth) states that:

[An] organisation must not do an act, or engage in a practice, that breaches a National Privacy Principle.

An ‘organisation’ is defined under the legislation so as to include an individual, a body corporate and a partnership; but not a government agency. While small businesses are generally excluded those that provide a health service are not.[22]

The NPPs, which apply to private sector organisations and individuals, are summarised below over the page.

A private organisation or provider may withhold information and refuse access:

• where disclosure would ‘pose a serious threat to the life or health of an individual’
• where disclosure would ‘have an unreasonable impact upon the privacy of other individuals’
• where the ‘information relates to existing or anticipated legal proceedings between the organisation and the individual, and the information would not be accessible by the process of discovery’ [24]

NPP 1: Collection and NPP 10: Sensitive Information and NPP 8: Anonymity — identify the provider’s obligations when collecting a patient or client’s health information. This includes an obligation on a pharmacist to collect fairly and lawfully only that health information that is necessary to provide a service. The information must be collected directly from the individual (if practicable) and only with the consent of the individual unless an exemption applies. If lawful and practicable, the individual has a right to remain anonymous during the interaction.[23]

NPP 2: Use and Disclosure — identifies how health information, once collected by the pharmacist can be used within the pharmacy, health care institution or disclosed to third parties outside the practice or the institution. As a general proposition the information can only be used for the purpose for which it was collected.[6]

NPP 3: Data Quality and NPP 4: Data Security — identify the standards required for keeping information up to date, accurate and complete. The principles also address the obligation to protect information from misuse, loss, unauthorised access, modification or disclosure. When information is no longer required to be kept it has to be permanently de-identified or destroyed.[6]

NPP 5: Openness — requires the pharmacist to be open about how the client or patient’s health information is managed and made available. This includes developing a policy document (privacy policy) explaining how the information is handled.

NPP 6: Access and Correction — provides patients and clients with a general right to access and correct information about themselves that a pharmacist may hold.

NPP 7: Identifiers — imposes an obligation to limit the use of Commonwealth identifiers to the purpose for which they were intended.

NPP 9: Transborder Data Flow — identifies the obligations on a provider when transferring health information overseas.

• where provision of the information ‘would be unlawful’[25]
• ‘providing access would be likely to prejudice an investigation of possible unlawful activity’.[26]

Application of the NPPs

In relation to pharmacy practice the NPPs will be applicable to every customer transaction and must be considered when handling patient’s or client’s health care information. The Competency Standards for Pharmacists in Australia expressly refers to the obligation upon pharmacists to comply with relevant legislation and requires that a pharmacist ‘considers the impact of privacy legislation on professional practice’, ‘understands the nature of patient consent’, and ‘obtains patient consent as required for professional services including those where health information will be collated and shared with other health.[27] The pharmacist must therefore decide the following:

• Is there a need to collect the personal information from a customer or is this a transaction in which the customer can engage anonymously?
• Do you already hold information about the customer that you could or will use?
• If you do hold such information what is it, how is it stored and do the NPPs apply to it?
• Are you using the information with the customer’s consent to the use and is the use consistent with the reason for collection?
• Do you need to collect new and further information from the customer?
• Is the collection of this information necessary for your functions and activities?
• Is the collection of the information lawful, fair and with the person’s consent?
• Is the information for the purpose of research or statistics?
• Is it necessary to provide a health service in accordance with professional standards?
• Is the privacy policy of your pharmacy practice in public view and do all staff understand their obligations in protecting the privacy of patient and client information?
• Do you need to provide the customer with information about the information management practices of your business, their right to access the information and their right to make corrections?

State legislation and government schemes

In relation to health records, the Australian Capital Territory, New South Wales, Queensland and Victoria have enacted their own privacy legislation and adopted privacy schemes which operate in addition to the federal provisions.[28] The additional privacy legislation and schemes are summarised below.

Australian Capital Territory

The Health Records (Privacy and Access) Act 1997 applies to the public and private sectors. This legislation is based on the IPPs and provides patients and clients with access to their own health information.

New South Wales

The Health Records and Information Privacy Act 2002 establishes 15 Health Privacy Principles (HPPs), provides for the creation of ‘Statutory Guidelines’ to assist in the application of the principles and establishes a framework for managing complaints about the handling of health information. There are four statutory guidelines which are legally binding and apply to the use or disclosure of health information for the management of health services, for training purposes, for research purposes and the notification when collecting health information about a person from someone else. While the Health Records and Information Privacy Act 2002 applies to both the public and the private sectors, the Privacy and Personal Information Act 1998 applies only to the information held within the public sector.

Queensland

In 2000 the Queensland Cabinet determined that a privacy scheme would be introduced into the Queensland public sector. Information Statements 42 and 42A were endorsed by Cabinet and fully implemented in 2003 by administrative rather than legislative means. Information Statement 42 provides 11 IPPs applicable to the personal information held by Queensland agencies and address the:

1. manner and purpose of collection of personal information
2. solicitation of personal information from individuals
3. solicitation of personal information generally
4. storage and security of personal information
5. information relating to records kept by record-keepers
6. access to records containing personal information
7. alteration of records containing personal information
8. record-keeper to check accuracy of personal information before use
9. personal information to be used only for relevant purposes
10. limits on use of personal information
11. limits on disclosure of personal information.

Victoria

The Health Records Act 2001 creates 11 Health Privacy Principles (HPPs) and provides an individual with the right of access to health information collected and held by a health service provider (including a sole practitioner) or organisation. Under the Act (s3(1), 11(1), (2)) an ‘organisation’ as pertaining to the private sector is defined to include, a ‘natural person, body corporate, partnership, trust, unincorporated association or body that is a health service provider or collects, holds or uses health information’.

ACCESS TO PATIENT AND CLIENT INFORMATION

At common law the physical property in the patient’s file or records is with the organisation or person who made that file or record.[29] If the pharmacist establishes and maintains a patient file, that file is the property of the pharmacist who made it. This means that a patient has no legal right at common law to access their file and must therefore gain access under the relevant legislative provisions. Some of the legislation discussed above (state legislation and government schemes) facilitates access in the private and public sectors. Additionally, there are also the Freedom of Information Acts at state, territory and federal levels that provide access to and production of personal records specifically in the public sector. The Freedom of Information Act 1982 (Cth) applies to the federal sector and provides any individual, subject to express exclusions, with a legally enforceable right to obtain access to their records in accordance with the Act. Similar legislation in place in the states and territories is contained in Table 9.1.

Table 9.1 State and territory freedom of information legislation

Cth Freedom of Information Act 1982
ACT Freedom of Information Act 1989
NSW Freedom of Information Act 1989
NT Information Act 2004
Qld Freedom of Information Act 1992
SA Freedom of Information Act 1991
Tas Freedom of Information Act 1991
Vic Freedom of Information Act 1982
WA Freedom of Information Act 1992

Children

Whether a child has the right to have their information kept confidential is inextricably connected to both the child’s capacity to make decisions on their own behalf and an assessment as to what is in the best interest of the child in the particular circumstances. Generally, there is an obligation on all health professionals to keep information about their patients and clients confidential unless there is express consent by the patient or client to disclosure. It could be suggested that similar obligations are imposed in relation to the information and data collected by pharmacists about those of their patients or clients who are children. This obligation, to keep information confidential, is based on the legislation at Commonwealth, state and territory levels, common law decisions and professional codes of ethics and conduct.

It stands to reason that if the child is considered as competent, referred to as Gillick competent (explained later in this chapter), for the purpose of giving a legally valid consent to treatment they also have the right to expect that their information, in relation to that treatment, is confidential. The rationale for this proposition is that:

if the parents do not have the power to consent to the medical treatment their child seeks, they do not have the power to obtain medical information about that treatment.[30]

In circumstances in which a child confirms they want the information kept confidential, or the information is clearly confidential in nature or given in a situation where confidentiality is implicit, there is a strong argument that there is an obligation of confidentiality attached to their information. However, there are situations in which the law permits, and in some circumstances compels, the disclosure of information pertaining to a child’s health. This includes circumstances in which the child consents to such disclosure, particular situations in which a person with sufficient personal interest (usually a parent) seeks information in the child’s best interests, and when disclosure is mandated by legislation or it is in the public interest to disclose.

As with adults at common law, there is no right of access by a child to their medical records, and any person seeking such access must make an application under the existing legislative provision. The Commonwealth, state and territory legislation, in the form of the Freedom of Information Acts, operate in the public sector and give an individual a legally enforceable right to seek access to their records. While it is acceptable in most jurisdictions for a parent to make an application under this legislation on behalf of their child, they may be denied access where the information is potentially prejudicial or where it would be otherwise unreasonable for the parent to be given the access requested. The Privacy Act 1988 (Cth), in its application to health care delivery in the private sector, is silent as to the exact age at which the right to access information is acquired. A child’s right to access their own information would therefore appear to be dependent on similar criteria to that which determines their ability to give a legally valid consent. That is, their level of competence or capacity to understand the nature and effect of their decisions and their level of maturity and intelligence.

CONSENT

All health professionals who are involved in the care and treatment of patients and clients have an obligation to obtain a legally valid consent before initiating any procedure or treatment. As a general principle, obtaining the consent of a person prior to commencing any health care intervention is not only a legal requirement but is also respectful and should be undertaken as a matter of normal practice by all health professionals.

Obtaining a valid consent from a patient or client prior to providing any health care intervention converts what would otherwise be civil assault or battery into a lawful interaction. With the increase in medical technology, and the expanding role of the pharmacist into more diverse areas of patient and client care, it is essential that pharmacists are aware of their legal rights and obligations in relation to obtaining a legally valid consent from their patients and clients. The legal requirement for obtaining a valid consent from a patient or client, prior to any interference with their person, applies regardless of whether or not the patient or client would benefit from the treatment or be harmed by refusing the procedure.[31]

The common law definition of this right was stated by Justice Cardozo in Schloendorff v Society of New York Hospitals (1914) 105 NE 92 (at 93):

Every human being of adult years and sound mind has a right to determine what will be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he will be liable in damages.

In some jurisdictions the law in relation to civil assault is contained in case law while in those states with Criminal Codes the definition is contained in the code itself. As an example: in Queensland the legislative definition of ‘assault ‘ is contained in the Criminal Code Act (1899) section 245 and reads as follows:

Definition of ‘assault’

245 (1) A person who strikes, touches, or moves, or otherwise applies force of any kind to, the person of another, either directly or indirectly, without the other person’s consent, or with the other person’s consent if the consent is obtained by fraud, or who by any bodily act or gesture attempts or threatens to apply force of any kind to the person of another without the person’s consent, under such circumstances that the person making the attempt or threat has actually or apparently a present ability to effect the person’s purpose, is said to assault that other person, and the act is called ‘assault’. The Criminal Code in Queensland, in relation to the definition of ‘assault’, applies in both a criminal and civil context.

A pharmacist must therefore ensure that a valid consent is obtained prior to undertaking Home Medicine Reviews (HMRs), providing diabetes medication assistance services, initiating any weight reduction regime, carrying out any diagnostic or assessment procedures such as taking blood pressure, bone density screening, blood sugar monitoring and International Normalised Ratio testing for patients on warfarin.

All adults of sound mind have the legal authority to either consent or refuse any treatment or health care intervention. This principle of patient autonomy is embedded in Principle eight of the PSA Code of Professional Conduct that specifically states that:

A pharmacist must respect the clients’ autonomy and dignity and their right to make informed decisions relating to their treatment.[4]

It is important to note that in the provision of health care, the intention of the health professional, in initiating the health care treatment or intervention, will not be relevant. This is the case, regardless of what the health professional thinks is in the best interests of the patient or client. Therefore, that the pharmacist, doctor or nurse had the intention of doing something that was aimed at benefiting the patient or client will not exempt their conduct from being a civil assault where the adult patient or client is of sound mind and has refused treatment or intervention. It is also significant that in an action for civil assault, the patient or client does not need to have suffered damage in the form described in relation to negligence. In an action for civil assault the person bringing the action is claiming that the actual intervention without their consent is in fact the damage.

Patient consent in an emergency situation in pharmacy practice may not always be possible. In an emergency situation such as a patient in the pharmacy with an asthma attack, myocardial infarct or an anaphylactic shock due to a bee sting, legislation in the various jurisdictions gives protection through ‘good Samaritans’ provisions. For example, section 57 of the New South Wales Civil Liability Act 2002 provides protection in that a good Samaritan does not incur any personal civil liability in respect of any act or omission done or made in an emergency when assisting a person who is apparently injured or at risk of being injured. Section 56 defines a good Samaritan as a person who, in good faith and without expectation of payment or other reward, comes to the assistance of a person who is apparently injured or at risk of being injured.

Types of consent

There are a number of different types of consent that are recognised as indicative of a person giving consent prior to a health care intervention. The patient or client may be asked to provide express consent in writing, verbally or may consent by implication through their conduct. Where a written consent is required the patient or client will be requested to complete a written consent form. This is most likely to occur in a circumstance in which there will be a surgical intervention or an intervention associated with an identifiable risk. A requirement for a written consent may also form part of a hospital’s or health facility’s policy requirements. In this case, there will usually be a standard form which will contain particulars of the patient and the specific procedure or intervention. It is usual that the patient will be requested to provide a signature which will be dated and witnessed. Within the context of pharmacy practice, written consent is mostly required for the provision of specialised services. For example, a patient has to provide written consent before participating in a HMR interview.

With regard to core pharmacy services, it is most likely that consent will take the form of verbal or implied consent. Verbal consent is the type which is most frequently obtained within a health care context. The consent of a patient or client may also be implied from their conduct; for example, where a person holds out their wrist to have their pulse taken or their arm to have their blood pressure taken. However, in a health care context it is advisable to obtain a written or verbal consent so that the patient or client’s intention is clear rather than rely on the implication from their conduct.

What constitutes a valid consent?

The consent must:

• be informed
• cover the actual procedure
• be voluntarily given by the patient or client
• be obtained from a patient or client with the legal capacity to give a valid consent.

Informed consent

The law requires that health professionals inform their patients in ‘broad and general terms’ of the nature of a procedure or intervention prior to obtaining consent.

The amount of information required to defend an action in trespass was described in the case of Chatterton v Gerson [1980] 3 WLR 1003 by Bristow J who stated (at 1014):

In my judgement once the patient is informed in broad and general terms of the nature of the procedure which is intended, and gives her consent, that consent is real and the cause of action on which to base a claim for failure to go into risks and implications is negligence, not trespass. In this case … she is under no illusion as to the general nature of what an intrathecal injection of phenol solution nerve block would be and in the case of each injection her consent was not unreal.

In the case of Appleton v Garrett [1997] 8 Med LR 75, the health professional was found liable in trespass for withholding information from the patient in bad faith prior to obtaining their consent for unnecessary treatment.

As noted in Chatterton’s case, the amount and nature of information required to defend an action in trespass (civil assault and battery) is different from that required in an action in negligence. The amount and nature of information required to defend a claim in negligence, that there has been a breach of the duty to warn of risk, is set out in the respective civil liability legislation in each jurisdiction.[32] As an example, section 21 of the Queensland Civil Liability Act 2003 states:

Proactive and reactive duty of a doctor to warn of risks

(1) A doctor does not breach a duty owed to a patient to warn of risk, before the patient undergoes any medical treatment (or at the time of being given medical advice) that will involve a risk of personal injury to the patient, unless the doctor at the time fails to give or arrange to be given to the patient the following information about the risk —

(a) information that a reasonable person in the patient’s position would, in the circumstances, require to enable the person to make a reasonably informed decision about whether to undergo the treatment or follow the advice;
(b) information that the doctor knows or ought reasonably to know the patient wants to be given before making the decision about whether to undergo the treatment or follow the advice …

Consent must cover the actual procedure

The consent must be specific to the intervention or treatment discussed and agreed to by the patient or client. If the pharmacist is involved in an intervention such as taking a blood sample to determine a patient’s blood sugar level, the consent of the patient or client must specifically relate to that intervention and cannot be extended to other unrelated interventions. The only exceptions to this requirement are in circumstances in which the treatment is necessary to save the individual’s life or prevent serious damage to their health, or where the consent may be deemed in situations where the patient is unconscious and the intervention is considered reasonable in the circumstances and is undertaken in good faith.

Consent must be voluntarily given by the patient

Consent to a health care intervention must be freely and voluntarily given. That is, there must be no coercion, duress or misrepresentation. Any undue influence on the patient or client during the decision-making process will invalidate the consent.

Legal capacity to give a valid consent

Adults (18 years of age and above) of sound mind are said to have ‘capacity’ — to be legally ‘competent’ to make their own decisions about many areas of their life, including their health care. The capacity of a patient may be compromised by their particular circumstances; for example, they are a child (also referred to as a minor); they are suffering from a mental illness which is hindering their ability to assess their health needs or seek treatment; or they have an intellectual impairment due to a disability, illness or injury. In these circumstances it will be necessary for the pharmacist to identify who has the lawful authority to make decisions on the patient’s or client’s behalf.

Parents and legal guardians do not have an absolute right to consent on behalf of children. While the common law does not specify an age at which a child is competent to give a valid consent, the case law considers the intellectual ability of the child to understand and comprehend the nature of the proposed intervention. In the case of Gillick v Norfolk and Wisbech Area Health Authority [1986] AC 112, Lord Scarman stated at 188–9:

I would hold that as a matter of law the parental right to determine whether or not their minor child below the age of 16 will have medical treatment terminated if and when the child achieves a sufficient understanding and intelligence to enable him or her to understand fully what is proposed. It will be a question of fact whether a child seeking advice has sufficient understanding of what is involved to give a consent valid in law. Until the child achieves the capacity to consent, the parental right to make the decision continues save only in exceptional circumstance.

A child who has the intellectual capacity to understand the nature of the proposed treatment is said to be Gillick competent and thereby competent and capable of providing a legally valid consent. The decision in this case was approved by the High Court of Australia in Secretary, Department of Health and Community Services v JWB and SMB (Marion’s case) (1992)175 CLR 218 at 238.

In both South Australia and New South Wales there is legislation which confirms the legal right of a child to consent to treatment. Under the Minors (Property and Contracts) Act 1970 (NSW) children over the age of 14 years are presumed to be able to consent to medical and dental treatment. The Consent to Medical Treatment and Palliative Care Act 1995 (SA), provides that a person from the age of 16 years can validly consent to medical treatment.

The respective mental health legislation in each jurisdiction provides for situations in which a person’s mental illness is such that they lack capacity to seek or obtain medical assistance, assessment and treatment. In such circumstances the patient may be involuntarily detained until their condition is stabilised and they have regained their capacity to make decisions about their health care and treatment. It is important to recognise that many patients within the mental health sector are seeking treatment voluntarily and therefore have the same common law rights to consent, and to refuse consent to treatment. Where a patient is the subject of an involuntary treatment order it may not be the case in all circumstances that they have lost their capacity to make health care decisions.

Patients and clients with an intellectual disability will have varying levels of capacity to make health care decisions. The capacity of an individual to make decisions will often be contingent on the nature of the decision and context in which the specific decision is to be made. That is, a patient with a mild level of an intellectual impairment may be quite capable of consenting to the administration of a medication or the performance of a diagnostic test. However, they may not have the capacity to give a legally valid consent to a highly technical and invasive procedure. In circumstances in which a patient or client lacks the intellectual capacity to provide a legally valid consent it will be necessary to identify and consult with the substitute decision-maker. Each jurisdiction has legislation which identifies and empowers a person or statutory entity who can give a valid consent for a person who has lost their capacity to consent on their own behalf. The guardianship legislation in each of the states and territories is contained in Table 9.2.

Table 9.2 Guardianship legislation and authorities

ACT Guardianship and Management of Property Act 1991 Guardianship and Management of Property Tribunal
NSW Guardianship Act 1987 Guardianship Tribunal
NT Adult Guardianship Act 1988 Guardianship Panel, Local Court
Qld Guardianship and Administration Act 2000 Guardianship and Administration Tribunal, Queensland Civil and Administrative Tribunal
SA Guardianship and Administration Act 1993 Guardianship Board
Tas Guardianship and Administration Act 1995 Guardianship and Administration Board
Vic Guardianship and Administration Act 1986 Guardianship and Administration List, Victorian Civil and Administrative Tribunal
WA Guardianship and Administration Act 1990 State Administrative Tribunal

REVIEW QUESTIONS AND ACTIVITIES

Further reading

Attorney-General’s Department. Online. Available: www.ag.gov.au/foi

Commonwealth Attorney-General’s Department (Privacy Division). Online. Available: www.law.gov.au/privacy

Coppock J. Privacy is critical to pharmacy. Australian Journal of Pharmacy. 87, October 2006.

Office of Federal Privacy Commissioner. Online. Available: www.privacy.gov.au and www.privacy.gov.au/privacy_rights/laws/index.html#5

Office of New South Wales Privacy Commissioner. Online. Available: www.lawlink.nsw.gov.au/pc/nsf/pages/index

Privacy Act 1988 and Privacy Amendment (Private Sector) Act 2000 (Cth). Online. Available: www.comlaw.gov.au

Endnotes

1 Pharmacy Board of Queensland. Guidelines on Pharmacy and confidentiality. July 2007

2 Skene L. Law and Medical Practice-Rights, Duties, Claims and Defences, 2nd edn. Sydney: Lexis Nexis Butterworths, 2004. paras 9.1, 9.8

3 Reproduction of the Hippocratic Oath. Mason J.K., Laurie G.T., McCall Smith R.A., editors. Law and Medical Ethics, 4th edn, London: Butterworths, 1994.

4 Pharmaceutical Society of Australia. Australian Pharmaceutical Formulary and Handbook (20th edn). Pharmaceutical Society of Australia, Deakin, ACT: 358–9

5 Pharmacy Board of Victoria. Guidelines for Good Pharmaceutical Practice. Effective from 1 February 2005

6 Pharmacy Board of Queensland. Guidelines on Pharmacy and Confidentiality. July 2007

7 Coppock J. Privacy is critical to pharmacy. Australian Journal of Pharmacy. 87, October 2006.

8 Pharmaceutical Society of Australia. Professional Practice and the Privacy Act. Canberra: Pharmaceutical Society of Australia; 2001.

9 Pharmaceutical Society of Australia. Professional Practice Standards (version 3). 2006. Online. Available: www.psa.org.au [accessed 28 May 2009]

10 Pharmacy Board of Queensland. Guidelines on Pharmacy and Confidentiality. Pharmacy Board of Queensland; July 2007.

11 Australian Government Department of Health and Ageing and the Pharmacy Guild of Australia. Diabetes Medication Assistance Service, Terms and Conditions. August 2008

12 Furniss v Fitchett [1958] NZLR 396 at 404

13 Defamation Act 2005 (NSW); Defamation Act 2005 (Qld); Defamation Act 2005 (Vic)

14 Children and Young People Act 1999 (ACT); Public Health Act 2005 (Qld); Children and Young Persons (Care and Protection) Act 1998 (NSW); Community Welfare Act (NT); Children’s Protection Act 1993 (SA); Children, Young Persons and their Families Act 1997 (Tas); Children and Young Persons Act 1989 (Vic)

15 Evidence Act 1958 (Vic); Evidence Act 2001 (Tas); Evidence Act (NT)

16 Evidence Act 1958 (Vic); Evidence Act 1995 (NSW)

17 Wisewoulds Lawyers correspondence to Pharmaceutical Defence Limited. The parameters of reporting a minor’s request to dispense MAP. 26 July 2005

18 Tarasoff v Regents of the University of California 551 P 2d 334 (1976)

19 Privacy Amendment (Private Sector) Act 2000

20 Schedule 3 Privacy Act 1988 (Cth)

21 Schedule 14 Privacy Act 1988 (Cth)

22 Privacy Act, s 16A(2) 6D(4)(b)

23 Summary of obligations for pharmacists. Guidelines on Privacy in the Private Health Sector. Office of the Federal Privacy Commissioner; October 2001.

24 Privacy Act Schedule 3 NPP 6.1 (b), (c), (e)

24 Privacy Act Schedule 3 NPP 6.1 (g), (h)

26 Privacy Act Schedule 3 NPP6.1 (i), (k)

27 Pharmaceutical Society of Australia. Competency Standards for Pharmacists in Australia. Canberra: Pharmaceutical Society of Australia; 2003.

28 Federal Privacy Commissioner. Online. Available: www.privacy.gov.au/privacy_rights [accessed 2 June 2009]

29 New South Wales Law Reform Commission. Issues Paper 24. Minor’s consent to medical treatment: disclosure of and access to young people’s health information. 2004: 3

30 Breen v Williams (1995) 186 CLR 71

31 Malette v Shulman (1990) 2 Med LR 162

32 Civil Law (Wrongs) Act 2002 (ACT); Civil Liability Act 2002 (NSW); Personal Injuries (Liabilities and Damages) Act 2003 (NT); Civil Liability Act 2003 (Qld); Civil Liability Act 1936 (SA); Civil Liability Act 2002 (Tas); Wrongs Act 1958 (Vic); Civil Liability Act 2002 (WA)

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