New Prescribers Course for Dietitians

New Prescribers Course for Dietitians

School of Pharmacy, University of Auckland

Module 1: Basis of Prescribing Practice

1Objectives:

This module aims to outline the legal definition of a prescription, medicines and roles and obligations of the prescriber, and dispenser and their statutory obligations and responsibilities.

2Prescribing

2.1Medicines Regulation 41:Form of prescription

A prescription outlines the information that both the pharmacist and the patient needs to be able to take the prescribed medicine safely and with maximum benefit. It order to become a prescription the instructions must meet the requirements outlined in Regulation 41 of the Medicines Regulations.

What is required on a prescription?

3Labelling of Medicines

Medicines Regulation 1984 Regulation 23Labels on containers of medicines sold by authorised prescribers or pharmacists

A medicine that is packed, supplied, or sold by an authorised prescriber or a pharmacist with reference to the needs of a particular patient or a particular customer, will include the following information on the label:

• (a)Either—
• (i)A statement of the general nature of the medicine, and a recognised code indicating the precise nature of the contents or being a reference to a prescription book or similar entry; or
• (ii)The name of, or a description of the nature of, the contents; and
• (b)The name of the patient; and
• (c)The name and address of the seller; and
• (d)In the case of a medicine for internal use, the dose and frequency of dose; and
• (e)In the case of a medicine for external use, a statement of the directions for use and frequency of use, and one or other of the following statements, or words of similar meaning:

“Caution: Not To Be Taken”, or “For External Use Only

3.1Self Assessment Case 1

A 72 year old man suffers a stroke which leaves him aphasic and unable to swallow. After six weeks of nasogastric feeding his lack of swallow does not appear to be resolving so he has a percutaneous endoscopic gastrostomy placed as part of discharge planning. His current weight (and well weight) is 72 kg. You have determined that his requirements are 1800 ml of a standard polymeric enteral feed. However for discharge you convert that to six containers of a 1.5 kcal polymeric supplement for ease of application and delivery at home. You provide the patient and caregivers with detailed instructions about administering the feeds at home together with additional water bolus’s. You write a prescription for 30 days supply ie: 180 bottles but do not put any instructions on the prescription as you provided this information separately to the patient. No dose or frequency of use is outlined on the prescription. The patient takes the prescription to the local pharmacy. The pharmacist calls the prescriber (you) and is told that the patient is already aware of what and how to take the item.

Outline the issues that this prescription may present:

Issues / Law / Recommendation

4Who can prescribe Medicines?

39Conditions under which authorised prescribers and veterinary surgeons may prescribe prescription medicines

40Prescriptions to comply with regulations

40AUrgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing

41Form of prescription

42Dispensing of prescription medicines

Dentists, Midwifes, medical practitioners, veterinary surgeons, nurse practitioners, and optometrist prescribers may prescribe medicines for patients under their care. What medicines and how much and the duration of supply is restricted based on the prescriber. Please see the resource on prescribing medicines for further information.

Dieticians who have fulfilled the requirements and extended their scope of practice will be able to prescribe, and authorise subsidiseddispensing of, the following products in addition to all Special Foods. Note that all of theseproducts are classified as General Sale Medicines, Pharmacy Only Medicines, or areconsidered to be dietary supplements.

Some of the issues around application for new special authorities for special food are not yet clear, but will be addressed later.

Chemical / Formulation
Vitamin products
Vitamin A with vitamins D and C / Soln 1000 u with Vitamin D 400 u and ascorbic acid 30 mg per 10 drops
Pyridoxine hydrochloride / Tab 25 mg
Tab 50 mg
Thiamine hydrochloride / Tab 50 mg
Vitamin B complex / Tab, strong, BPC
Ascorbic acid / Tab 100 mg
Alpha tocopheryl acetate / Water solubilised soln 156 iu/ml, with calibrated dropper
Multivitamins / Tab
Powder
Oral liq
Vitamins / Tab (BPC cap strength)
Cap (fat soluble vitamins A, D, E, K)
Mineral products
Calcium carbonate / Tab 1.25 g (500 mg elemental)
Tab 1.5 g (600 mg elemental)
Tab 1.75 g (1 g elemental)
Sodium fluoride / Tab 1.1 mg (0.5 mg elemental)
Ferrous fumarate / Tab 200 mg (65 mg elemental)
Ferrous fumarate with folic acid / Tab 310 mg (100 mg elemental) with folic acid 350 μg
Ferrous sulphate / Tab long-acting 325 mg (105 mg elemental)
Oral liq 30 mg per 1 ml (6 mg elemental per 1 ml)
Ferrous sulphate with folic acid / Tab long-acting 325 mg (105 mg elemental) with folic acid 350 μg
Oral electrolyte replacement products
Compound electrolytes / Powder for soln for oral use 5 g
Dextrose with electrolytes / Soln with electrolytes
Potassium bicarbonate / Tab eff 315 mg with sodium acid phosphate 1.937 g and sodium bicarbonate 350 mg
Potassium chloride / Tab eff 584 mg (14 m eq) with chloride 385 mg (8 m eq)
Tab long-acting 600 mg

To determine the brand of each of the above that is currently subsidised, please see the resource called Brands of Vitamins, Minerals & Oral rehydration products subsidised for prescribing by dietitians.

5Prescribing for patients under their care?

Under regulation 39 (1) of the Medicines Regulations 1984, prescribers may only prescribe for patients under their care. The Medical Councils Good Prescribing Guide is a useful resource and can be found at: The Medical Council’s view is that for a patient to be ‘under his or her care’, a doctor must have had a face to face consultation with the patient or have discussed that specific patient’s treatment with another New Zealandregistered health practitioner who can verify physical data and identity. If you are providing locum cover for an absent colleague or are discharging a patient from hospital it is also permissible to complete a prescription for a patient if you have access to that patient’s notes.[1]

5.1Self Assessment Case 2

A patient that you have seen regularly seen for the past has moved to Australia. You have not seen her for 2 years. Recently she emails you requesting her usual supply of medicines that you had previously prescribed for her. She also requests a number of medicines that she has been regularly taking prescribed by her GP. Outline the issues that this request may present:

Issues / Law / Recommendation

6Prescription Errors: Whose responsibility is it anyway?

Where a prescription error is not queried by a pharmacist and dispensed, both the pharmacist and the prescriber may be held responsible. A case where a pharmacist dispensed adult strength codeine, incorrectly prescribed by a GP, to a seven-week-old baby, the HDC concluded that the pharmacist had breached the Code. A section of article: Medication errors: who carries the can?is outlined below:

“The pharmacist should have been alerted to the inappropriateness of the dosage of the medication by the age of the patient, which was clearly recorded on the prescription. In dispensing an adult strength dosage, the pharmacist failed to provide services with reasonable care and skill, in breach of Right 4(1).

In failing to consult with the prescribing doctor, the pharmacist did not comply with the ethical standards, thus breaching Right 4(2) of the Code. Rule 2.11 of the Code of Ethics imposes a responsibility on pharmacists to verify the appropriateness of prescriptions, and Rule 2.18 requires consultation with the prescriber if there are reasonable grounds for believing the prescribed medication could be detrimental to the consumer's health.

This case also led to disciplinary proceedings before the DCPS. The Committee accepted that the pharmacist had breached a duty of care owed to the patient. However, it found that such conduct did not amount to a disciplinary offence because the pharmacist was 'inadvertently led into making an error by the GP'. This was also a one off-error, and the pharmacist had learnt a salutary lesson.

Professional responsibility
Interestingly, the Medical Practitioners Disciplinary Tribunal found that the GP who prescribed adult strength codeine to the baby was guilty of professional misconduct.

The Tribunal stated that 'it is a medical practitioner's obligation to determine that a prescription is safe', although noting that 'the consequences for the GP have been out of all proportion to the mistake'.

The Pharmaceutical Society's ruling on the pharmacist's failure to check with the GP why an adult strength dosage had been prescribed sits uneasily with the statements of professional responsibility quoted at the start of this article, and with the decision of the MPDT. Although the DCPS seems prepared to hold pharmacists strictly to account for dispensing errors, in the case of prescription errors it seems that pharmacists are not expected to 'carry the can'.”

New Zealand GP, 14 November 2001

Quality assurance
Right 4(4) of the Code of Health and Disability Services Consumers’ Rights states that consumers have a right to services that minimize the potential harm to that consumer. A pharmacist who queries an individual prescription with a prescriber and is not satisfied with the response, and remains concerned about patient safety, may decline to dispense the medicine.[2] (

7Health & Disability Code of Health & Disability Services Consumers Rights

Patient rights and health care professional obligations to affect these rights are outlined in the HDC Code of Rights. These are outlined below:

The HDC Code of Health and Disability Services Consumers' Rights Regulation 1996

1. Consumers have Rights and Providers have Duties:

1) Every consumer has the rights in this Code.

2) Every provider is subject to the duties in this Code.

3) Every provider must take action to -

a) Inform consumers of their rights; and

b) Enable consumers to exercise their rights.

2. Rights of Consumers and Duties of Providers:

The rights of consumers and the duties of providers under this Code are as follows:

RIGHT 1
Right to be Treated with Respect

1) Every consumer has the right to be treated with respect.

2) Every consumer has the right to have his or her privacy respected.

3) Every consumer has the right to be provided with services that take into account the needs, values, and beliefs of different cultural, religious, social, and ethnic groups, including the needs, values, and beliefs of Maori.

RIGHT 2
Right to Freedom from Discrimination, Coercion, Harassment, and Exploitation

Every consumer has the right to be free from discrimination, coercion, harassment, and sexual, financial or other exploitation.

RIGHT 3
Right to Dignity and Independence

Every consumer has the right to have services provided in a manner that respects the dignity and independence of the individual.

RIGHT 4
Right to Services of an Appropriate Standard

1) Every consumer has the right to have services provided with reasonable care and skill.

2) Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.

3) Every consumer has the right to have services provided in a manner consistent with his or her needs.

4) Every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of, that consumer.

5) Every consumer has the right to co-operation among providers to ensure quality and continuity of services.

RIGHT 5
Right to Effective Communication

1) Every consumer has the right to effective communication in a form, language, and manner that enables the consumer to understand the information provided. Where necessary and reasonably practicable, this includes the right to a competent interpreter.

2) Every consumer has the right to an environment that enables both consumer and provider to communicate openly, honestly, and effectively.

RIGHT 6
Right to be Fully Informed

1) Every consumer has the right to the information that a reasonable consumer, in that consumer's circumstances, would expect to receive, including -

a) An explanation of his or her condition; and

b) An explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and

c) Advice of the estimated time within which the services will be provided; and

d) Notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval; and

e) Any other information required by legal, professional, ethical, and other relevant standards; and

f) The results of tests; and

g) The results of procedures.

2) Before making a choice or giving consent, every consumer has the right to the information that a reasonable consumer, in that consumer's circumstances, needs to make an informed choice or give informed consent.

3) Every consumer has the right to honest and accurate answers to questions relating to services, including questions about -

a) The identity and qualifications of the provider; and

b) The recommendation of the provider; and

c) How to obtain an opinion from another provider; and

d) The results of research.

4) Every consumer has the right to receive, on request, a written summary of information provided.

RIGHT 7
Right to Make an Informed Choice and Give Informed Consent

1) Services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any enactment, or the common law, or any other provision of this Code provides otherwise.

2) Every consumer must be presumed competent to make an informed choice and give informed consent, unless there are reasonable grounds for believing that the consumer is not competent.

3) Where a consumer has diminished competence, that consumer retains the right to make informed choices and give informed consent, to the extent appropriate to his or her level of competence.

4) Where a consumer is not competent to make an informed choice and give informed consent, and no person entitled to consent on behalf of the consumer is available, the provider may provide services where -

a) It is in the best interests of the consumer; and

b) Reasonable steps have been taken to ascertain the views of the consumer; and

c) Either, -

i. If the consumer's views have been ascertained, and having regard to those views, the provider believes, on reasonable grounds, that the provision of the services is consistent with the informed choice the consumer would make if he or she were competent; or

ii. If the consumer's views have not been ascertained, the provider takes into account the views of other suitable persons who are interested in the welfare of the consumer and available to advise the provider.

5) Every consumer may use an advance directive in accordance with the common law.

6) Where informed consent to a health care procedure is required, it must be in writing if -

a) The consumer is to participate in any research; or

b) The procedure is experimental; or

c) The consumer will be under general anaesthetic; or

d) There is a significant risk of adverse effects on the consumer.

7) Every consumer has the right to refuse services and to withdraw consent to services.

8) Every consumer has the right to express a preference as to who will provide services and have that preference met where practicable.

9) Every consumer has the right to make a decision about the return or disposal of any body parts or bodily substances removed or obtained in the course of a health care procedure.

10)No body part or bodily substance removed or obtained in the course of a health care procedure may be stored, preserved, or used otherwise than

(a)with the informed consent of the consumer; or

(b) For the purposes of research that has received the approval of an ethics committee; or

(c) For the purposes of1 or more of the following activities, being activities that are each undertaken to assure or improve the quality of services:

(i) a professionally recognised quality assurance programme:

(ii) an external audit of services:

(iii) an external evaluation of services.

RIGHT 8
Right to Support

Every consumer has the right to have one or more support persons of his or her choice present, except where safety may be compromised or another consumer's rights may be unreasonably infringed.

RIGHT 9
Rights in Respect of Teaching or Research

The rights in this Code extend to those occasions when a consumer is participating in, or it is proposed that a consumer participate in, teaching or research.

RIGHT 10
Right to Complain

1) Every consumer has the right to complain about a provider in any form appropriate to the consumer.

2) Every consumer may make a complaint to -

a) The individual or individuals who provided the services complained of; and

b) Any person authorised to receive complaints about that provider; and

c) Any other appropriate person, including -

i. An independent advocate provided under the Health and Disability Commissioner Act 1994; and

ii. The Health and Disability Commissioner.

3) Every provider must facilitate the fair, simple, speedy, and efficient resolution of complaints.

4) Every provider must inform a consumer about progress on the consumer's complaint at intervals of not more than 1 month.

5) Every provider must comply with all the other relevant rights in this Code when dealing with complaints.

6) Every provider, unless an employee of a provider, must have a complaints procedure that ensures that -

a) The complaint is acknowledged in writing within 5 working days of receipt, unless it has been resolved to the satisfaction of the consumer within that period; and

b) The consumer is informed of any relevant internal and external complaints procedures, including the availability of -

i. Independent advocates provided under the Health and Disability Commissioner Act 1994; and

ii. The Health and Disability Commissioner; and

c) The consumer's complaint and the actions of the provider regarding that complaint are documented; and

d) The consumer receives all information held by the provider that is or may be relevant to the complaint.

7) Within 10 working days of giving written acknowledgement of a complaint, the provider must, -

a) Decide whether the provider -

i. Accepts that the complaint is justified; or

ii. Does not accept that the complaint is justified; or

b) If it decides that more time is needed to investigate the complaint, -