GUIDELINES ON OPERATIONS OF AN INDUSTRIAL

CLINIC
Effective 1st June 2002

1. PREAMBLE

The Medicines Control Authority of Zimbabwe (MCAZ) licenses industrial clinics to provide dispensing
services for employees of a company or companies involved in the retailing, manufacturing, wholesaling,
mining, agriculture, commercial (including banking) and tourism industry. The clinics mostly provide
services to the employees and/or their dependants.

In most instances a qualified nurse or nurses are employed on a daily basis to run the clinics. The nurses
therefore diagnose, prescribe and dispense medicines from these clinics. As nurses are currently not
prescribers in terms of the Medicines and Allied Substances Control (General) Regulations, 1991, (SI
150 of 1991) (hereafter referred to as “the regulations”) for certain categories of medicines the clinics
have employed qualified Medical Practitioners to provide medical services. The Medical Practitioner
may therefore be employed on a part-time or full- time basis depending on the clinic’s circumstances and
requirements for services. The purpose of these guidelines is therefore to define the responsibilities
expected of the medical practitioner and nurse employed at an industrial clinic licensed by the MCAZ.
The guidelines will also provide conditions under which the clinics may be licensed.

2. SCOPE:

These guidelines apply to industrial clinics licensed by the MCAZ.

3. DEFINITIONS

Industrial Clinic: A clinic providing health services to employees and/or dependants of employees of a
particular company or a group of affiliated companies.

Affiliated companies: more than one company that belong to the same corporate holding or have written
contractual arrangements with a common provider of health services.

4. REQUIREMENTS FOR THE CLINIC

4.1 To comply with the requirements of the Regulations or any other requirements set by the MCAZ
from time to time.

4.2 To have opening times which are clearly displayed at all times and indicating the doctor’s attendance
times.

4.3 For a clinic to be licensed it should be intended to provide services to at least 50 persons (i.e. a
catchment of not less than 50 persons) excluding contract employees.

4.4 Services to be provided only to employees and/or the dependants of one company or group
of affiliated companies.

Companies pooling resources to provide clinic services for their employees only are
included. Specific clinics with unique settings may be granted authority to provide services
 to dependants.4.4.2 An independently operated clinic that is contracted by more than one
company to provide services may be licensed provided evidence of the written contractual
arrangements is provided and motivation for approval of the service provision is provided
from each company to be provided with the services. The contract must, amongst other
matters, indicate the expected beneficiaries (employees only), their numbers and that the
clinic will be expected to comply fully with these guidelines.

The clinics opening times when medicines may be dispensed will be as stated on the
premises licence. The licensee must therefore indicate the proposed opening times when
applying for issue or renewal of a licence.

4.5 The medicines that may be prescribed at an Industrial Clinic will be determined by the MCAZ on
the following classification. The particular clinic classification will be stated on the premises
licence:
4.5.1 Class A – where there is a supervising medical practitioner all the times that the clinic is
open – all categories of medicines
4.5.2 Class B Clinic – where there is a supervising doctor as specified in (5) below – All
categories of medicines when the medical practitioner is present.
No PIM, PP, PP10 or N category medicines to be prescribed or dispensed in the
absence of the supervising medical practitioner. Countersigning of prescriptions after
the fact is also not permitted except in cases of emergency when the conditions in 5.6
below apply.
4.5.3 Class C Clinic – where there is no supervising medical practitioner – only those
medicines in the Household Remedy (HR) and Pharmacy Only (P) categories.

4.6 A licenced clinic should not supply medicines for use at any other premises including:

4.6.1 Other clinics except those of affiliate companies;

The Supervising Medical practitioner’s surgery

even if they hold valid licences or permits.

4.7 Should the clinic have more than one nurse dispensing medicines from the clinic, be it for a few
hours a day, the nurse’s name must appear on the premise’s licence.
Any nurse to provide locum services must hold a valid person's licence for not more than two
industrial clinics or have prior written approval of the MCAZ to provide such locum services for
the clinic. Such approval will not be for a period of more than 3 calendar months after which only
permanent supervisors will be acceptable.

4.8 In the case where a clinic is operated on behalf of a company or affiliated companies, access to the
medicines by those persons not appearing on the clinic’s licence is prohibited particularly when the
approved supervisors are not on the premises.

5. REQUIREMENTS FOR THE SUPERVISING MEDICAL PRACTITIONERS

5.1 Holder of a valid unrestricted practising certificate from the Medical and Dental Council

5.2 Approved by MCAZ as supervising medical practitioner.

5.2.1 In the case of a medical practitioner who is employed in the Public Service, Local
Authority or Defence forces on a full time basis, prior written permission from the Secretary for

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 Health and Child Welfare or respective Director of Medical Services to engage in such practice
should be obtained respectively.

5.3 To visit the clinic not less than once a week for a period of not less than 2 hours per
visit.

5.4 To ensure proper records are kept for all prescription preparation (including PIM)
medicines.

5.5 To ensure that medicines that require a prescription (including PIM) are
dispensed by licensed persons endorsed on the clinics licence only, on the basis of the
Medical Practitioner’s written instructions (prescription).

5.6 In the case of an emergency the Medical Practitioner may order the medicine over the
phone on condition he provides a prescription or records his instruction in writing within seven
days thereof.

5.6.1 When the nurse effects the order they should indicate on the dispensing
records that it was an emergency and the nature of the emergency.

5.7 Should the Medical Practitioner cease to be the supervising medical practitioner for that clinic
he should notify the MCAZ in writing within seven days of cessation of provision of those
services.

5.7.1 Should the Medical Practitioner fail to comply with the above he will be
held liable for all the activities supposedly under his control at the Industrial
clinic until or unless the notification is received in writing by the MCAZ.

5.8 Any Medical Practitioner who knowingly makes a false declaration in any way to the
MCAZ that they are the supervising medical practitioner of any clinic will be liable for
prosecution.

5.9 The Medical Practitioner may make the availability of an “emergency medicines tray”
which may only be used in his absence in an emergency under the following conditions:

5.9.1 The tray will be sealed at all times with a temper evident seal.

5.9.2 The medicines which may be contained in the emergency tray are
listed under Appendix I.
5.9.2.1. Regular stock checks to include checks on validity of
expiry dates of the stock in the tray should be done.

5.9.3 In the event of use of medicines in the tray the nurse should advise the
Medical Practitioner as soon as possible of such use;

5.9.3.1 the supervising medical practitioner will evaluate the

incident to determine whether it was an emergency. In
cases where he deems the case not of an emergency nature
appropriate action must be taken.
5.9.3.2 If the supervising medical practitioner is satisfied that
the event was an emergency he may confirm this on the
records.

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 5.9.3.3 The supervising medical practitioner will supervise
the replenishment and re-sealing of the emergency tray.

5.10 There should be a written contract which stipulates the responsibilities of the supervising
medical practitioner at the clinic.

5.10.1 The contract should be available for inspection by inspectors of the MCAZ.

5.10.2 The contract should stipulate that the supervising medical practitioner is
available to provide medical services in emergencies at times other than those
indicated in sections 4.2 and 5.4 above.

5.11 The supervising medical practitioner should not attend to other patients who are not employees
or dependants of the company from the clinic except in an emergency.

5.12 Should the supervising medical practitioner be unavailable to provide services, he may make
arrangements for another medical practitioner to cover for him provided that: -

5.12.1 he complies with requirements of Sections 5.1, 5.3,5.4, 5.5, 5.6,5.9,5.10 and
5.11 of these guidelines

5.12.2 the period of absence is not more than three calendar months in which
instance prior written approval should be sought from the MCAZ.

5.13 The supervising medical practitioner should ensure that medicines are only handled by approved
and qualified persons and compliance with these guidelines and relevant statutes are adhered to.

5.13.1 Access to the medicines is restricted to those people whose names are
endorsed on the clinic licence

5.13.3 The supervising medical practitioner and those other persons with names
endorsed on the licence are responsible for reporting to the MCAZ any changes to the
conditions under which the licence was issued, any deviations (intended or otherwise).
Loss of medicines due to theft must be reported to the MCAZ and the Police within
twenty-four hours..

5.14 A Medical Practitioner may supervise more than one clinic provided the clinics are within
reasonable distance to allow for the minimum visiting times indicated in section 5.3

6. REQUIREMENTS FOR THE NURSE

6.1 Holder of a valid unrestricted practising certificate from the Nurses Council

6.2 Licensed with MCAZ to dispense medicines at that particular clinic (valid persons licence)
6.2.1 In case a nurse is granted authority by the MCAZ to supervise more than one clinic the
times of attendance will be stipulated on their persons licence.
6.2.2 The nurse must also have passed the forensic examination for nurses or attended such
forensic refresher course every three years as set by the MCAZ from time to time

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 6.2.3 Transition to full compliance – those nurses that already hold valid person’s licences
should attend a course and an examination as specified in 6.2.2 above within three years
of the effective date of these guidelines (1st June 2002)

6.3 To ensure that medicines are dispensed by those persons appearing on the clinics licence
only
6.3.1 To dispense only those categories of medicines stipulated on the clinics licence.

6.4 In the event of an emergency and the Medical Practitioner makes a verbal order to the
nurse for medicine to be made available to a patient, the nurse should indicate on the
dispensing records that it was an emergency and the nature of the emergency.

6.5 Should the nurse cease to be employed at that clinic the nurse should notify the MCAZ in
writing within seven days of cessation of provision of those services and ensure that the
employer does so too.

6.5.1 Should the nurse fail to comply with the above they will be held
liable for all activities supposedly under their control until or
unless the notification is received in writing.

6.6 To ensure that only registered medicines that are procured only from sources approved by the
MCAZ are used at the premises and adequate records of use are kept.

6.7 To conduct regular stock control of all medicines the nurse dispenses, administers, disposes of.

6.8 To ensure that medicines are dispensed with the appropriate labelling, in appropriate containers
and under appropriate conditions of Good Dispensing Practice.

APPENDIX I

EMERGENCY TRAY MEDICINES FOR INDUSTRIAL CLINICS