SASOHN - Medicines and control of medication in an occupational health setting

INTRODUCTION

Occupational health nursing is a specialist field that provides for and delivers health and safety programmes and services to workers in their places of employment.1 Effective healthcare on a primary care level requires an adequate supply of appropriate medicines, as it is important for workers not to take additional time off from work to visit outside primary healthcare facilities.2 The occupational health practitioner (OHP) provides a service in the workplace, including ­primary healthcare. The service incorporates the dispensing of medication, as the OHP is often a worker’s only access to healthcare.1

The objectives of the National Drug Policy for South Africa3 commits to ensure and/or promote:

 the availability and accessibility of essential medicines to all citizens;

 the safety, efficacy and quality of medicines;

 good prescribing and dispensing practices;

 the rational use of drugs by prescribers, dispensers and patients through provision of the necessary training, education and information; and

 the concept of individual responsibility for health, preventive care and informed decision making.

The Acts that govern the use, control and dispensing of medication for occupational health practitioners are:

 the National Health Act, No. 61 of 20034

 the Nursing Act, No. 33 of 20055

 the Medicines and Related Substances Act, No. 101 of 19656  

 the Pharmacy Act, No. 53 of 19747

 

DISPENSING OF MEDICINES

Dispensing, means “the interpretation and evaluation of a prescription, the selection, manipulation or compounding of the medicine, the labelling and supply of the medicine”.8 In terms of the Health Professions Act of 1974, medicines may only be compounded or dispensed under a licence that has been granted by the Director-General.9

 

Legal requirements of practitioners dispensing in terms of the Medicines and Related Substances Act, No. 101 of 19656

A person must:

• be registered with the appropriate council;

• have completed a supplementary training course in dispensing, accredited by the SA Pharmacy Council;

• have a valid dispensing licence; and

• have a permit for acquiring, possessing and supplying medication.

 

Dispensing process

The dispensing process is divided into three phases, namely:

1. Interpretation and evaluation of the prescription;

2. Preparation and labelling of the prescribed medicine;

3. Provision of information and instructions to the patient to ensure the safe and effective use of the medicine.

 

Practitioner duties

A person who has been issued with a dispensing licence shall:

• keep records, in either hard copy or electronically, relating to medicines compounded and dispensed for a period of five years;

• 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 as indicated in the Good Pharmacy Practice Manual of the SA Pharmacy Council;10

• keep the medicines under the manufacturer’s recommended storage ­conditions, as specified on the medicine’s label and/or package insert;

• label medicines properly with the name of the patient and a reference number, linking the patient to a patient record;

• not keep expired medicines on the premises other than in a demarcated area in a sealed container clearly marked ‘expired medicines’;  such expired medicines shall be destroyed in terms of the Medicines and Related Substances Act;6

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

 in the event of a recall of a medicine, withdraw the medicine;

 conspicuously display the dispensing licence in the ­premises; and 

• comply with the conditions of his or her licence.7

 

DIAGNOSING, PRESCRIBING AND TREATING

• The occupational medical practitioner (OMP) will authorise the OHP to diagnose, prescribe medication and treat patients presenting to the clinic when he/she is unavailable.

• Every OHP will be authorised to be competent to diagnose and treat the conditions listed in the ‘Standard Treatment Guidelines and Essential Medicine List’ (published by the Department of Health, 2014), according to the treatment protocols.2

• Every OHP will assess a patient before making a diagnosis and prescribing medication.

• Referrals to other services will be made according to the referral guidelines in the Essential Medicine List,2 as well as when any medical issue arises that is beyond the scope of practice of the OHP.

• Every OHP shall maintain legible, comprehensive clinical notes in the patient file, and complete the drug register required under the permit issued under Section 22A of the Medicines and Related Substances Act.6

• The OMP will verify all the OHP’s treatments, diagnoses and prescribed medications, and countersign medicine records.

 

DRUG CONTROL

• Medication must be counted and balanced against the drug register on a monthly basis.

• The drug register shall be completed directly after supply, administering or prescribing, to comply with the requirements of Section 38A of the Nursing Act.5

• The OMP must check and sign the case notes and drug register of all ­prescribed schedules 3 and 4 drugs.

 

Drug register or prescription book

A drug register (prescription book or other permanent record) in respect of scheduled medicines and substances shall be kept on all premises where prescribed medicines are ­dispensed, and must contain the following details:

 name of the medicine or scheduled substance;

 date on which the medicine was dispensed;

 dosage form and quantity of the medicine or scheduled substance;

 name and address of the patient;

 name of the medical practitioner, or any other authorised person who issued the prescription, where applicable; and

 prescription reference number.

Records must be retained for a period of at least five years after the date of the last entry made therein.7

 

PATIENT MEDICATION RECORDS

Keeping accurate records saves you time. If there are accusations of theft or misuse of supplies, you will be able to refer to your records and provide a clear audit trail and evidence. Your records will document the movement of supplies.10

 

Minimum standards for record keeping

The following information about the patient must be captured in a patient medication record:

 full name; 

• address and telephone number; 

 age or date of birth;

 medical aid details;

 name of the prescriber and date of consultation;

 any known allergies;

 any reactions of the patient to the medicine;

 family history;

 chronic conditions or disease status; and

 other medicines or devices currently being used, and any related information indicated by a medical or other healthcare professional.10

 

Maintenance of patient records

• Any information stored about a patient must be pertinent, accurate and up to date;

• To maintain the integrity and confidentiality of patient information contained in records, and prescriptions for medicine, the system used must have adequate security, including system safeguards designed to prevent and detect ­unauthorised access, modification, or manipulation.9

 

Minimum standards regarding maintenance and disposal of confidential information relating to patients

In terms of the National Health Act, all information concerning patients, including information about his/her health status, and treatment or stay in a health establishment, is confidential. Information provided in confidence must not be used or disclosed in a form that might identify a patient, without his/her consent.4

The exception to the above is contained in the rules relating to the code of conduct for pharmacists and other persons registered in terms of the Pharmacy Act.7

Confidential information is defined as information accessed or maintained by the pharmacy, which contains personal information that could be used to identify the patient. This information may relate to, but is not limited to:

 patient’s name, address, telephone number, identity number and/or other identifying number;

• medicines (i.e. prescription and/or non-prescription medicines) or medical devices, prescribed, dispensed, sold and/or supplied to the patient, including information such as therapeutic effect, diagnosis, allergies, disease state, pharmaceutical services rendered, medical information, and drug interactions.6

Confidential documents relating to patient information refer to personally identifiable data about an individual patient. Confidential documents relating to patient information include, but are not limited to, the following:

 labels;

 prescriptions;

 prescription records and registers;

 medication records;

 medical records; and

 records relating to screening tests performed.

 

CONTROL OF MEDICATION

Access to the medicine room

• The licensed dispenser must ensure that every key, key card or other device, or the combination of any device that allows access to a medicine room when it is locked, is kept only on his/her person.

• Control of access to the medicine room and/or consulting room(s) (as applicable) must be of such a nature that only the licensed dispenser(s) has direct access to medicine.

• A procedure must be in place to ensure access to the medicine room and/or consulting room(s) (as applicable) in an emergency in compliance with the Occupational Health and Safety Act No. 85 of 1993.11

 

Stock control

Each medical facility should maintain a standard list of stock items with specifications, including form, strength and quantity per package. The list should be regularly updated, and stock records should be maintained for all products on the list. It is important to keep good records of all the medicines and related supplies in stock. This helps to understand the flow of supplies into and out of the healthcare facility.

It will also help to know:

 what items are available in stock;

 what quantity of each item in stock is available; and

 how much stock is used on a regular basis.

 In addition, keeping records serves as the basis for the information needed when ordering new stocks of medicines and other supplies.8

 

Ordering

• Ordering should include only medicines as per the Essential Drug List2 and per determination of the Section 22A permit.6

• Medicines can be ordered monthly or as per the requirements of the facility.

• Stock levels must be updated as medicines are issued to clients and new stock is received.

• The ordering form should reflect the following information:

- OHP name and South African Nursing Council (SANC) number;

- client company stamp with name and physical address;

- date;

- account number, if relevant; and

- items and quantities required.

 

Storeroom for medication

• Every health facility should have a room that can be locked, is in good condition, and is well organised.

• All supplies should be kept in the store; only those required for the day should be taken (or issued) from the store to the dispensing area.

• If the health facility does not have a room to use as a pharmacy store, a lockable cupboard or cabinet with shelves should serve as the store.

• The store should be large enough to accommodate all the supplies.

• Inside the store, there should be an additional secured area where narcotics and expensive items, such as ARV medicines, are kept.

• All openings (such as windows) with grills or bars should be secured to deter theft.

• The store should be locked and the number of keys limited, especially for areas where narcotics and expensive items are kept.

• Access to the store should be limited.

• Only the OHP should have access to the store.

• The store should be kept in good condition; extreme temperatures, light, or humidity may cause medicines to deteriorate.

• Heat affects all medicines, especially liquids, ointments and suppositories; some medicines that are light sensitive, such as injectables, spoil very quickly when exposed to light.

• Humidity can spoil tablets and capsules because they easily absorb water from the air, making them sticky and causing them to deteriorate.

• All products need to be kept in their original packaging or containers; the storage instructions on the labels should be followed.

• The store should be kept clean and organised.

• If there is a refrigerator or freezer, it should be kept in good working condition.

• No food or other non-medical items should be stored in the refrigerator.

• There should be enough space around the refrigerator so that air can move freely. The temperature inside the refrigerator or freezer should be recorded daily.8

 

Standard operating procedures in the primary health facility include:

 effective stock rotation;

 stocktaking;

• disposal or removal of scheduled damaged and/or contaminated medicines as required in Regulation 27 published in terms of the Medicines and Related Substances Act of 1965;6

 disposal of obsolete or unusable stock;

 product types requiring special storage or handling instructions;

 separation and handling of goods returned from patients;

 recall of medicines;

• receiving of medicines;

 storage of medicines;

 procurement of medicines;

 cold chain management (including procedures to be followed in the event of a refrigerator power failure).

 

Waste management

It is important to dispose of medicines appropriately to avoid serious negative consequences of improper disposal, resulting in:

• environmental impacts which may include contaminated water supplies, damage to flora (plants) and fauna (wildlife), and increases in antimicrobial resistance to medicines that have been inappropriately released into the environment;

 the diversion and resale of expired or inactive medicines; and/or

 air pollution from improperly incinerated products.

The facility’s procedures for handling damaged or expired medicines should be followed. In terms of the National Environmental Management: Waste Act No. 59 of 2008 (NEMWA) a holder of waste includes any person who generates, imports, stores, ­accumulates, transports, processes, treats, or exports waste or disposes of waste. Healthcare risk waste (HCRW) generators have a duty of care to handle, store, ­transport and/or dispose of waste in an ­environmentally sound and legally compliant manner.12

 

Report by:

Michelle Bester

Occupational Health Practitioner

Bombela Operating Company (Pty) Ltd

e-mail: michelle.bester@bombelaop.co.za

 

REFERENCES

1. South African Nursing Council. Competencies for occupational health nurse specialist (OHN); 2013. Available from:

http://www.sanc.co.za/pdf/Competencies/SANC%20Competencies-Occupational%20Health%20Nurse%20Specialist%202013-04.pdf (accessed 17 Mar 2019).

2. South Africa. Department of Health. Standard treatment guidelines and essential medicines list for South Africa: National Department of Health; 2018. Available from: http://www.health.gov.za/edp.php (accessed 16 Mar 2019).

3. South Africa. National Drug Policy for South Africa; 2014. Available from: https://www.gov.za/documents/national-drugs-policy (accessed 16 Mar 2019).

4. South Africa. National Health Act, 2003 (Act No. 61 of 2003). Available from:

https://www.gov.za/documents/national-health-act (accessed 1 Mar 2019).

5. South Africa. Nursing Act, 2005 (Act No. 33 of 2005). Available from:

http://www.sanc.co.za/pdf/Nursing%20Act%202005.PDF (accessed 1 Mar 2019).

6. South Africa. Medicines and Related Substances Act (Act No. 101 of 1965).

7. South Africa. Pharmacy Act, 1974 (Act No. 53 of 1974). Available from: https://www.gov.za/sites/default/files/gcis_document/201505/act-53-1974.pdf (accessed 15 Mar 2019).

8. South Africa. Pharmacy Act, 1974 (Act No.53 of 1974, as amended). GNR 1158 of 20 November 2000: Regulations relating to the practice of pharmacy. Available from:https://www.mm3admin.co.za/documents/docmanager/0C43CA52-121E-4F58-B8F6-81F656F2FD17/00010804.pdf (accessed 16 Mar 2019).

9. South Africa. Health Professions Act, 1974 (Act No. 56 of 1974). Available from:https://www.hpcsa.co.za/uploads/editor/UserFiles/Health%20Professions%20ACT.pdf (accessed 16 Mar 2019).

10. Good Pharmacy Practice in South Africa Manual; 2010. Pharmacy Council, Fourth Edition. Available from:

https://www.mm3admin.co.za/documents/docmanager/
0C43CA52-121E-4F58-B8F6-81F656F2FD17/00052829.pdf (accessed 16 Mar 2019).

11. South Africa. Occupational Health and Safety Act, 1993 (Act No. 85 of 1993). Available from:

https://www.gov.za/documents/occupational-health-and-safety-act (accessed 01 Mar 2019).

12. South Africa. National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008). Available from: https://www.environment.gov.za/sites/default/files/legislations/nema_amendment_act59.pdf (accessed 16 Mar 2019).

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