Legal limitations for nurse prescribers: afpnl.co.za/web/files/Presentations2016/Andy Gray... · Discipline of Pharmaceutical Sciences. ... any registration or enrolment, any removal

Legal limitations for

nurse prescribers: a

focus on dispensing

Andy GrayDivision of Pharmacology

Discipline of Pharmaceutical Sciences

Outline

What is prescribing?

What is dispensing?

Enabling legal frameworks

Medicines and Related Substances Act, as amended (and not)

“New” Nursing Act, “old” Regulations

Challenges

Overly restrictive interpretations

New urgencies, but not everywhere

Policy/law

Forum for Professional Nurse Leaders 2016 2

National Drug Policy, 1996 Prescribing of drugs above schedule 2 by pharmacists, except as

provided in the regulations of the Medicines and Related Substances Control Act (101 of 1965), will not be permitted. Similarly, prescribing by nurses will only be in accordance with the provisions of Act 101 of 1965.

The objective is to ensure that all health personnel involved in diagnosis, prescribing and dispensing of drugs receive adequate theoretical and practical training.

At primary level prescribing will be competency, not occupation, based.

Only practitioners who are registered with the relevant Council and premises that are registered and/or licensed in terms of the Medicines and Related Substances Control Act (No 101 of 1965) may be used for the manufacture, supply and dispensing of drugs.


NDP (1996), contd

Medical practitioners and nurses will not be permitted to dispense drugs, except where separate pharmaceutical services are not available. In such instances/situations where dispensing by doctors and nurses has to take place, such persons will be in possession of a dispensing licence issued by the Medicine Control Council. Criteria for the granting of such licences will include inter alia, the application of geographical limits. Special concessions will be granted with regard to certain categories of providers such as occupational health services. Proven competency of such persons to dispense drugs will be by virtue of the successful completion of a suitable training programme. All licences will be reviewed and renewed annually. These inspection functions will be delegated to the provinces.


What is prescribing? Section 22A(5) of the Medicines and Related Substances Act (Act 101 of

1965):Any Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance shall

not be sold by any person other than-a) a pharmacist, pharmacist intern or a pharmacist's assistant acting under the

personal supervision of a pharmacist, who may sell only Schedule 2 substances without a prescription;

b) a pharmacist or a pharmacist intern or pharmacist's assistant acting under the personal supervision of a pharmacist, upon a written prescription issued by an authorised prescriber or on the verbal instructions of an authorised prescriber who is known to such pharmacist;

c) a manufacturer of or wholesale dealer in pharmaceutical products for sale to any person who may lawfully possess such substance;

d) a medical practitioner or dentist, who may-i. prescribe such substance;

ii. compound or dispense such substance only if he or she is the holder of a licence as contemplated in section 22C (1) (a);

e) a veterinarian who may prescribe, compound or dispense such substance;

f) a practitioner, a nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, who may-i. prescribe only the Scheduled substances identified in the Schedule for that purpose;

ii. compound and dispense the Scheduled substances referred to in subparagraph (i) only if he or she is the holder of a licence contemplated in section 22C (1) (a).


A key definition

s22A(17) For the purposes of this section-

(a) 'authorised prescriber' means a medical

practitioner, dentist, veterinarian,

practitioner, nurse or other person

registered under the Health Professions Act,

1974;


Are all nurses authorised prescribers?

s22A(14) Notwithstanding anything to the

contrary contained in this section-

a) …

b) no nurse or a person registered under the

Health Professions Act, 1974, other than a

medical practitioner or dentist, may prescribe

a medicine or Scheduled substance unless

he or she has been authorised to do so by

his or her professional Council concerned.


But, also a “back door”

s22A(15) Notwithstanding anything to the contrary

contained in this section, the Director-General may, after

consultation with the Interim Pharmacy Council of South

Africa as referred to in section 2 of the Pharmacy Act,

1974 (Act 53 of 1974), issue a permit to any person or

organisation performing a health service, authorising

such person or organisation to acquire, possess, use or

supply any specified Schedule 1, Schedule 2, Schedule

3, Schedule 4 or Schedule 5 substance, and such permit

shall be subject to such conditions as the Director-

General may determine.


Listed in the Schedules?


Examples – for now


The “new” Nursing Act

• Government Notice R4, Government Gazette No. 29634, 16 February 2007 -which brought into effect sections 1 to 4, 8, 11, 13, 17 to 29, 30, 31, 37, 40, 58, 59, 61 and 62;

• Government Notice R18, Government Gazette No. 30159, 8 August 2007 -which brought into effect sections 5, 6, 7, 9, 10, 12, 14, 15, 16 and 60

• Government Notice R6, Government Gazette No.3086, 13 March 2008 -which brought into effect sections 32 to 36, 38 and 39, 41 to 57

• In other words – the whole Act has been promulgated, and the old Act repealed in its entirety – but many regulations are still missing, and the transitional arrangements are not always clear….


Repeal of laws … extensiveRepeal of laws

60. (1) The laws set out in the first and second column of the Schedule are

repealed to the extent set out in the third column of the Schedule.

(2) The repeal does not affect the transitional arrangements contained in

section 61.


Transitional arrangements

61. (1) Any proclamation, notice, regulation,

authorisation or order issued, made or granted,

any registration or enrolment, any removal from

a register or roll or any appointment or any other

thing done in terms of a provision of any law

repealed by section 60(1) is, unless inconsistent

with any provision of this Act, deemed to have

been issued, made, granted or done under the

corresponding provision of this Act.


The “Old” Nursing Act

38A. Special provisions relating to certain nurses Notwithstanding the other provisions of this Act and the provisions of the Medicines and Related

Substances Control Act, 1965 (Act No. 101 of 1965), of the Pharmacy Act, 1974 (Act No. 53 of 1974), and of the Medical, Dental and Supplementary Health Service Professions Act, 1974 (Act No. 56 of 1974), any registered nurse who is in the service of the Department of Health, Welfare and Pensions, a provincial administration, a local authority or an organisation performing any health service and designated by the Director-General: Health, Welfare and Pensions after consultation with the South African Pharmacy Board referred to in section 2 of the Pharmacy Act, 1974, and who has been authorized thereto by the said Director-General, the Director of Hospital Services of such provincial administration, the medical officer of health of such local authority or the medical practitioner in charge of such organisation, as the case may be, may in the course of such service perform with reference to—

(a) the physical examination of any person;

(b) the diagnosing of any physical defect, illness or deficiency in any person;

(c) the keeping of prescribed medicines and the supply, administering or prescribing thereof on the prescribed conditions; or

(d) the promotion of family planning,

any act which the said Director-General, Director of Hospital Services, medical officer of health or medical practitioner, as the case may be, may after consultation with the council determine in general or in a particular case or in cases of a particular nature: Provided that such nurse may perform such act only whenever the services of a medical practitioner or pharmacist, as the circumstances may require, are not available.


Regulations - Government Notice

No. R. 24182 November 1984Regulations relating to the keeping, supply, administering or prescribing of medicines by

Registered Nurses

In terms of section 45 of the Nursing Act, 1978 (Act 50 of 1978), the Minister of Health and Welfare, acting on the recommendation of the South African Nursing Council, has made the regulations set out in the Schedule hereto.

SCHEDULE

1. In the Schedule "the Act" shall mean the Nursing Act, 1978 (Act 50 of 1978), and any expression to which a meaning has been assigned in the Act shall bear such meaning and, unless the context otherwise indicates-

"authorised nurse" shall mean a registered nurse mentioned in section 38A of the Act [Note (1)];

"Medicines Control Act" shall mean the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965);

"prescribed medicine" shall mean a medicine or related substance mentioned in regulation 2;

"re-packed form" shall mean packaging of prescribed medicine prepacked from bulk for the immediate use of a patient;

"section" shall mean a section of the Act;

"unscheduled medicine" shall mean any medicine or related substance not listed in any Schedule to the Medicines Control Act.

2. An authorised nurse may, subject to the provisions of section 38A and the conditions listed in regulation 3, keep the following and supply, administer or prescribe it for the use of a person:

(a) An unscheduled medicine;

(b) any medicine or substance listed in Schedule 1, Schedule 2, Schedule 3 or Schedule 4 to the Medicines Control Act.


Regulations contdConditions under which an authorised nurse may supply, administer or prescribe a prescribed

medicine

3. An authorised nurse who supplies, administers or prescribes a prescribed medicine to a patient in terms of these regulations shall-

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

(i) the diagnosis made by the nurse in respect of the health condition of the patient;(ii) the name, quantity, strength and dosage of the medicine supplied, administered or prescribed, as the case may be;(iii) the number of the Schedule to the Medicines Control Act in which such medicine is listed (if any);(iv) the date and time of supply, administering or prescribing,

on the patient's file or treatment record, as the case may be, and against that entry the date and time of the entry, his name and category of registration in block letters as well as his signature;

(b) ensure, that in the case where such medicine is supplied to a patient, the medicine is in an original or in a repacked form and the container in which the medicine is supplied is labelled with-

(i) the approved name, quantity and strength of the medicine;(ii) the number of the Schedule to the Medicines Control Act (if any) in which such medicine is listed;(iii) the name of the patient and his file or treatment record number, as the case may be;(iv) the dosage of the medicine; and(v) the address of the body which supplies the medicine.

Note (1). - Attention is drawn to the fact that, in terms of section 38A, the Director-General, the relevant director of hospital services, the relevant medical officer of health or the medical officer in charge of a relevant organisation which renders a health service and who is designated by the Director-General in consultation with the South African Pharmacy Board, must authorise the registered nurse and must determine, after consultation with the South African Nursing Council, the acts which such a nurse may perform.


New Act: Special provisions relating to certain

nurses

56. (1) Despite the provisions of this Act or any other law, the Council may register

a person who is registered in terms of section 31(1)(a), (b) or (c) to assess, diagnose,

prescribe treatment, keep and supply medication for prescribed illnesses and health

related conditions, if such person-(a) provides proof of completion of prescribed qualification and training;

(b) pays the prescribed registration fee; and

(c) complies with subsection 6.

(2) The Council must issue a registration certificate to a person who complies with the requirements referred to in subsection (1).

(3) The registration certificate referred to in subsection (2) is valid for a period of three

years.

(4) The Council may renew a registration certificate referred to in subsection (2) subject to such conditions as the Council may determine.

(5) A person registered in terms of subsection (1) may -(a) acquire, use, possess or supply medicine subject to the provisions of the Medicines

and Related Substances Act, 1965 (Act No. 101 of 1965); and

(b) dispense medicines subject to the provisions of the Medicines and Related Substances Act, 1965.


And – a retro-fit of s38A(6) Despite the provisions of this Act, the said Medicines and Related Substances Act, 1965,

the Pharmacy Act, 1974 (Act No. 53 of 1974), and the Health Professions Act, 1974 (Act No. 56 of 1974), a nurse who is in the service of-

(a) the national department;

(b) a provincial department of health;

(c) a municipality; or

(d) an organisation performing any health service designated by the Director-General after consultation with the South African Pharmacy Council referred to in section 2 of the Pharmacy Act, 1974, and who has been authorised by the Director-General, the head of such provincial department of health, the medical officer of health of such municipality or the medical practitioner in charge of such organisation, as the case may be, may in the course of such service perform with reference to-

(i) the physical examination of any person;

(ii) the diagnosing of any physical defect, illness or deficiency in any person; or

(iii) the keeping of prescribed medicines and their supply, administering or prescribing on the prescribed conditions;

any act which the said Director-General, head of provincial department of health, medical officer of health or medical practitioner, as the case may be, may, after consultation with the Council, determine in general or in a particular case or in cases of a particular nature, if the services of a medical practitioner or pharmacist, as the circumstances may require, are not available.

(7) A person contemplated in subsection (1) is not entitled to keep an open shop or pharmacy.

(8) For the purpose of subsection (7) “open shop” means a situation where the supply of medicines and scheduled substances to the public is not done by prescription by a person authorised within the scope of practice concerned to prescribe medicine.


The NDOH format – s38A/56(6)

Only these “protocols”?

Where can one find these protocols?


What the medical practitioner

authorises … links two Acts “You are hereby authorised to diagnose and

prescribe medicines for the conditions listed in the standing orders of the clinic according to the treatment protocols listed below subject to the limitations imposed by the medicines list of the dispensing licence.”

“You are to maintain legible, comprehensive clinical notes in the patient file and to complete the drug register required under the licence issued in terms of section 22C (1)(a) of the Medicines and Related Substances Act (Act 101 of 1965) as amended.”


The NDOH format – s22A(15)



What does ‘dispensing’ involve? R1158, Regulations issued in terms of the

Pharmacy Act (Act 53 of 1974), issued in 2000 “dispensing” means the (1)interpretation and

evaluation of a prescription, the selection, (2)manipulation or compounding of the medicine, the (3)labelling and supply of the medicine in an appropriate container according to the Medicines Act and the provision of (4)information and instructions by a pharmacist to ensure the safe and effective use of medicine by the patient

The same applies to a person licensed to dispense (s22C(1)(a) of Act 101 of 1965)


R510 – Regulations to the

Medicines Act, issued in 2003 "dispense"-

a) in the case of a pharmacist, means dispense as defined in the Regulations Relating to the Practice of Pharmacy made in terms of the Pharmacy Act, 1974; and

b) in the case of a medical practitioner, dentist, practitioner, nurse or any authorised prescriber to dispense medicines, means i. the interpretation and evaluation of a prescription;

ii. the selection, reconstitution, dilution, labelling, recording and supply of the medicine in an appropriate container; or

iii. the provision of information and instructions to ensure safe and effective use of a medicine by a patient;


What is “administering”?

R510, Regulations issued in terms of Act

101 of 1965:

For the purposes of this regulation,

"compounding and dispensing" does not refer

to a medicine requiring preparation for a

once-off administration to a patient during a

consultation.

.


But, what about “supplying”

Included in the definition of “dispense” in

the General Regulations to the Medicines

Act (R510)


Dispensing licences (s22C(1)(a))

Licence to Dispense

Compound and dispense

Process Supplementary training course (accredited by the SA

Pharmacy Council)

Application for license, no longer based on “need” –application may precede doing the course

Applicable 2 May 2004 (survived court challenge with some minor changes in 2005; some further relaxation in 2010 in terms of process/duration and costs)


Demonstration of “need” removed

General Regulation 18 Location

Motivation

Existence of other facilities

Patients to be served, disease patterns, special needs

Representations from interested parties

Requirements Diagnose, prescribe and dispense for patients, under

full “good pharmacy practice” conditions


Conditions of the licence(7) A person referred to in subregulation (1) who has been issued with

a licence shall:

(a) keep sales records either in hard copy or electronically relating

to medicines compounded and dispensed for a period of 5 years

from the date of sale;

(b) ensure that the dispensary and any premises where medicines are kept are suitable for dispensing or compounding and dispensing in

accordance with good pharmacy practice;

(c) keep the medicines under the manufacturer's recommended storage

conditions as specified on the medicines label and/or package insert;

(d) not pre-pack medicines at the premises unless authorised to do so

by the Director-General and in terms of regulation 33(a)(ii);

(e) label medicines properly with the name of the patient and a reference number linking the patient to a patient record;


Conditions contd.(f) not compound and dispense medicines to patients unless the

sale is

preceded by a proper diagnosis and a prescription for a particular

patient;

(g) not keep expired medicines on the premises other than in a

demarcated area in a sealed container clearly marked: EXPIRED

MEDICINES and such expired medicines shall be destroyed in terms of regulation 27;

(h) secure the premises where the compounding and dispensing is carried out whenever he or she is not physically present at those premises;

(i) in the event of a recall of a medicine, withdraw the medicine;

(j) conspicuously display the licence in the premises referred to in paragraph (b); and

(k) comply with the conditions of his or her licence.


Demanding standards …

the final stage in a long process

of legislative reform

a set of enforceable standards,

not aspirational statements


The “New” Nursing Act – enabling

new categories of nurses

31. (1) Subject to the provisions of section 37, no person may practise as a practitioner unless he or she is registered to practise in at least one of the following categories:(a) Professional nurse;

(b) Midwife;

(c) Staff nurse;

(d) Auxiliary nurse; or

(e) Auxiliary midwife.

(2) The Minister, after consultation with the Council, may by notice in the Gazette make such other categories of persons to be registered to practise nursing as he or she considers necessary in the public interest.


Approach of the NDOH


Challenges

Applying s56(6) without new Regulations (thus limiting to S4, not S5 or S6)

Certainty about the new categories of nurses implied in s56(1-5)

How many?

What qualifications?

Only then can an application be made to the MCC for listing of medicines in the Schedules


Evidence of progress - slowly

35BN 2015

Only the Primary Care Nurse

Specialist competency

standard mentions

prescribing ….but, as yet no

approach has been made to

the MCC regarding the list of

medicines to be prescribed…

The burning question

Can a pharmacist (or pharmacist’s

assistant) dispense a prescription written

by a nurse holding a section 56(6) permit? Is s/he an “authorised prescriber”, as envisaged in

s22A(14) and (17)?

If not, what does “Despite the provisions of this Act,

the said Medicines and Related Substances Act,

1965, the Pharmacy Act, 1974 (Act No. 53 of 1974),

and the Health Professions Act, 1974 (Act No. 56 of

1974)” mean?



Who can dispense? “We confirm that ART medicines are Schedule 4 and therefore

in terms of Section 22A of the Medicines and Related Substances Act, 101 of 1965 may only be dispensed by a pharmacist on a valid prescription by a medical practitioner or an authorized prescriber.”

“We confirm that currently the South African Pharmacy Council is unaware of any nurses being identified/licensed as authorized prescribers in terms of the nurse initiated ART role out.”

“We further confirm that nurses who are registered in terms of Section 33A (old Nursing Act) / Section 56 (new Nursing Act) are permitted to dispense medicines they have prescribed, i.e. nurse initiated treatment in terms of prescribed regulations.

“However, it was and will at this stage continue to be the status quo that pharmacists can not dispense nurse initiated treatments unless such prescription has been authorized by a medical practitioner.”

“In conclusion we confirm that nurses (issued with a S38A/S56 registration) may dispense medicines on their own initiated treatments, and a pharmacist may only dispense on a valid prescription from an authorized prescriber.”




How long must we wait?


For:1. A clear set of competencies, with

associated qualifications and

accredited providers, for a full range

of prescribing nurse practitioners.

2. A relatively minor amendment to

section 56 (getting rid of 56(1)(c)

and (3)).

3. Listing of the medicines for each

category of prescribing nurse

practitioner in the Schedules.

Thanks!


Documents

Legal limitations for nurse prescribers: afpnl.co.za/web/files/Presentations2016/Andy Gray... · Discipline of Pharmaceutical Sciences. ... any registration or enrolment, any removal