Prescribing and dispensing by professional

nurses

November 2009

Legislative changes since 1994

• White paper on the Transformation of the Health Care System (1997)

• National Drug Policy (1996)• Pharmacy Act, 1974 amended in 1997

and 2000• Medicines and Related Substances

Act, 1965 amended in 1997 and 2002• National Health Act 61 of 2003• Nursing Act 50 of 1978• New Nursing Act 33 of 2005 - awaiting

regulations• Applicability to the State

What is a medicine?

• Medicines and Related Substances Act• Medicine is defined as -

‘Any substance or mixture of substances used or purported to be suitable for use or manufactured or sold for use in –– the diagnosis, treatment, mitigation, modification

or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or

– restoring, correcting, or modifying any somatic or psychic or organic function in man

– includes veterinary medicine’

Who may sell a medicine?

• ‘Sell’ is defined widely includes ‘offer, advertise, keep, expose,

transmit, consign, convey or deliver for sale or authorize,

direct or allow a sale, prepare or possess for purposes of

sale, barter or exchange or supply and dispose of …. whether

for a consideration or otherwise’

• No person shall sell, have in his or her possession or

manufacture any medicine or Scheduled substance, except in

accordance with the prescribed conditions

Who may sell a medicine? • Any person may sell a Schedule 0 substance (may be sold in an

open shop)

• A Schedule 1, 2, 3, 4, 5 or 6 medicine may be sold by a pharmacist in accordance with the Medicines Act

• A Schedule 1, 2, 3, 4, 5 or 6 medicine may be sold by a medical practitioner, dentist or nurse who may-

– prescribe such substance;

– compound or dispense such substance provided he/she has a

licence

• A person who has a permit issued ito Section 22A(15) of the

Medicines Act

Prescribing, dispensing and administering

• Certain medicines can be ‘supplied’ or ‘sold’ without

necessarily being prescribed or dispensed e.g. paracetamol

or aspirin in a café/supermarket.

• Medicines from Schedule 3 upwards require a prescription

• Once there is a prescription dispensing takes place

• All medicines can be administered without being dispensed

PRESCRIBEPRESCRIBE – – DISPENSEDISPENSE - - ADMINISTERADMINISTER

PRESCRIBE:

Act performed by an authorised prescriber of initiating a medicine order (usually written) for a scheduled medication to be dispensed for or administered to a particular patient

– Legal & ethical requirements ito information supplied; time length of treatment etc must be adhered to

PRESCRIBEPRESCRIBE – – DISPENSE DISPENSE - ADMINISTER- ADMINISTER

DISPENSE – defined in the legislation

• Interpret & evaluate prescription• Select, reconstitute, dilute, label, record & supply

medicine in appropriate container• Provide information & instructions for safe and

effective use of medicine by a patient

Medicine “given for taking later” or supply of multiple doses in a

single package = Dispensing

PRESCRIBE – DISPENSE – PRESCRIBE – DISPENSE – ADMINISTER ADMINISTER

ADMINISTER

The administration of medicine means the giving of unit doses of medication to an individual patient at the prescribed time, via prescribed route, in prescribed dose e.g. single oral, injection or other dose 12 or 8 hourly.

A ward medicine round is performed to administer medicines to hospitalised patients OR administration of a contraceptive injection

Prescribing of medicinesPrescribing of medicinesWHO MAY PRESCRIBE

S0-6 medicines may be prescribed by –

• Medical practitioners, dentists and vets• Nurses may be authorised by SANC to prescribe certain

specified medicines (awaiting regulations to new Nursing Act and annexures to Schedules to Medicines Act)

• Mechanism for nurses to be authorised to prescribe is via Section 38A (Sect 56) of the Nursing Act

• Other professionals registered with Health Professions Council may be authorised to prescribe certain specified medicines

Dispensing of medicinesDispensing of medicines WHO MAY DISPENSE S1- S6 ?

– Pharmacist– Pharmacist intern/pharmacist’s assistant

(post basic) (under supervision)– Doctor/dentist may dispense/compound on

prescription if licensed– Vet may compound and dispense– Professionals registered with HPCSA or SANC

may compound and dispense medicines if licensed

– Some nurses may supply medicine ito Section 38A of the Nursing Act

Licences for dispensing

The Director-General may on application in the prescribed manner and on payment of the prescribed fee issue to a medical practitioner, dentist, nurse or other person registered under the Health Professions Act, 1974, a licence to compound and dispense medicines, on the prescribed conditions

Conditions for dispensing licences Conditions for dispensing licences

Licensed dispenser must –• Ensure that premises are suitable and comply with GPP • Keep records for 5 years• No pre-packing unless authorised by DG• Label medicines correctly and link to patient record• Dispensing preceded by proper diagnosis and prescribing• Premises secured when licence holder not present• Conduct recalls• Display licence• Comply with conditions of license

EXCLUDES MEDICINE PREPARED FOR ADMINISTRATION

Dispensing coursesDispensing courses

• Training for “competence”• Pre-requisite to obtain a licence• Courses are 300 notional hours • Courses may be distance/contact• Approved courses

Licensing…..

– Fees

• Application fee

• Annual fee

– Validity

• Licence is valid for 3 years only.

• Re-application within 90 days of expiry.

Nurse Practitioners

• Medicines Act:

– No nurse ……. may prescribe a medicine or

Scheduled substance unless he or she has

been authorised to do so by his or her

Professional Council

Nursing Act

• Does not generally recognise a nurse as a prescriber of medicines.

• Concessions may be given to certain designated

health service providers

– State, local authorities

– Organisations designated by the Director-General

– Authorised by the medical officer

– Certain specified medicines only

Nursing Act 33 of 2005• Not yet fully in operation

• Existing regulations, notices, etc. under the old Nursing Act remain in force under the Nursing Act, 2005 – Section 61(1) of the Nursing Act, 2005.

Section 38A of the Nursing Act [56 (6) in the new Act]

• If a nurse is employed by the

– Department of Health (National),

– Provincial Authority,

– Local Authority or

– An organisation designated by the Director-

General after consultation with Pharmacy Council

Section 38A of the Nursing Act [56 (6) in the new Act]…

• May be authorised by the Director General, Director of Hospital Services,

medical officer of health or the medical practitioner in charge of the

organisation to

– Perform a physical examination of any person

– Diagnose any physical defect, illness or deficiency in any person

– The keeping of prescribed medicines and their supply, administering

and prescribing under prescribed conditions

• prescribe specified medicines (currently schedule 1 to 4 only) if authorised

by the MOH of the organisation

• Only if the services of a medical practitioner or pharmacist not available

Regulations Relating to the Keeping, Supply, Administering or Prescribing of

Medicines by Registered Nurses (current Nursing Act)

• Regulation 2 – an authorised nurse may

keep, supply etc. the following:

– (b) any medicine or substance listed in

schedules 1 to 4 of the Medicines Act

Regulations …….Regulation 3

– Conditions

• (a) directly after supply, administering or prescribing, enter

-

i. Diagnosis

ii. Name, quantity, strength, & dosage of medicine

iii. Schedule number of the medicine

iv. Date and time

v. Name and category of registration in block letters

vi. His or her signature

Regulations …….

(b) medicine supplied must be in an original or a repacked form and the container must be labelled with

i. Approved name, quantity and strength of medicine

ii. Number of the schedule ito the Medicines Actiii. Name of the patient and file or treatment record

numberiv. Dosage of the medicinev. Address of the body supplying the medicine

Regulations …..

• Note – Attention is drawn to the fact that in

terms of section 38A, the MOH etc…… must

authorise the registered nurse and must

determine, after consultation with the South

African Nursing Council, the acts which

such a nurse may perform

Section 22(16)(b)[Medicines Act]• Any medicine or scheduled substance may be

possessed by a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, ….. for the purposes of administering it in accordance with his or her scope of practice;

Permit - Section 22A(15)[Medicine Act]

• Certain nurses have traditionally been granted permits (mainly public sector or occupational health).

• The 22A (15) permit is usually for the

purposes of acquisition, possession, use and

supply

Some challenges at a policy level

• Numerous court challenges • Need to evaluate impact of legislative changes• Has the usage of medicine improved – selection,

procurement, storage and usage?• Has the quality of care of patients improved?• Need for better alignment between applicable

legislation• Role of pharmacy mid level workers• Ensure that nurses are not overburdened

Some challenges at a personal level

• To practise within the applicable legislation

• To stay up to date

• To provide input into the policy and legislative process

• To thrive and grow as a professional

• To do what is best for our patients

Conclusion

‘Real integrity is doing the right thing; know that nobody’s going to know whether you did it or not’

Oprah Winfrey