How to Use These Guidelines

Principles

Local Formularies

Navigating the Guidelines

Prescription Writing

NEMLC Reports

Other Initiatives

Medicines Safety

Feedback

PRINCIPLES

The National Drug Policy¹ provides for an Essential Drugs Programme (EDP) - a key component of promoting rational medicines use. Medicines are included or removed from the Essential Medicines List (EML) based on an evidence-based review of safety and effectiveness, followed by consideration of cost and other relevant practice factors. All reasonable steps are taken to align the Standard Treatment Guidelines (STGs) with Department of Health guidelines that are available at the time of review. Some recommendations might not be aligned with the SAHPRA registered label/package insert; but are guided by health needs assessment and the best available scientific evidence.

The perspective adopted in the Primary Healthcare (PHC) STGs is that of a competent prescriber practicing in a public sector facility. The STGs serve as a standard for practice, but do not replace sound clinical judgment. It is important to remember that the treatments recommended are guidelines only based on the assumption that prescribers can manage patients with the relevant conditions. This includes rational prescribing in the elderly and palliative care, as the use of some medicines, especially as people get older or more ill, can cause more harm than good. Optimizing medication through targeted de-prescribing is a vital part of managing chronic conditions, avoiding adverse effects, improving outcomes, reducing pill burden and maintaining or improving quality of life.

The Primary Healthcare (PHC) EML and STGs allow for the management of patients with relatively common conditions at primary level of care. They also guide referral of patients with more complex or uncommon conditions to facilities with the skills and resources to provide further investigation and management. As such, they serve as a progression to Adult and Paediatric hospital level EMLs and STGs.

¹National Drugs Policy, 1996. https://www.gov.za/documents/national-drugs-policy

Given that the STGs and EMLs for the various levels of care are reviewed at different times, there may be periods when they are not perfectly aligned. Likewise, updated STGs and EMLs will not always be synchronised with public sector pharmaceutical tenders, and PTCs should facilitate the phase in/out of the relevant essential medicines.

LOCAL FORMULARIES

The EML has been developed down to generic or International Non-Propriety Name (INN) level. Each Province is expected to review the EML and prevailing tenders and compile a formulary which:

• Lists formulations and pack sizes that will facilitate care in alignment with the STGs and EML
• Selects the preferred member of the therapeutic class based on cost
• Implements formulary restrictions consistent with the local environment; and
• Provides information on medicine prices

Therapeutic classes are designated in the “Medicine treatment” sections of the STGs which provide classes of medicines followed by an example of each class, such as ‘HMGCoA reductase inhibitors (statins) e.g. simvastatin’. Therapeutic classes are designated where none of the members of the class offer any significant benefit over the other registered members of the class. It is anticipated that by listing a class rather than a specific medicine there is increased competition and hence an improved chance of obtaining the lowest possible price in the tender process.

Where therapeutic classes are listed in the STGs always consult your local formulary to identify the specific medicine that has been approved for use in your facility. A therapeutic interchange database has been developed that lists evidence-based reviewed medicines that have been grouped into each therapeutic class for a specific condition, as outlined in the policy for classifying medicines into therapeutic classes for purposes of therapeutic interchange. The database and policy are available on the National Department of Health website.

NAVIGATING THE GUIDELINES

Each chapter covers a broad organ system, with cross-referral to other chapters where necessary. Within each chapter, conditions are usually listed alphabetically. Conditions and medicines are cross referenced in two separate indexes of these guidelines.

ICD10 codes

Diagnosis codes from the International Statistical Classification of Diseases and Related Health Problems (ICD-10) are included for each condition to facilitate accurate recording of diagnoses. The primary ICD-10 code may be accompanied by a secondary code that is bracketed to differentiate a secondary manifestation from the primary aetiology. (For example, uncomplicated broncho-pneumonia with severe penicillin allergy would be coded as: J18.0+(Z88.0)). All the rules and guidelines for the use of ICD-10 must be applied as per the World Health Organisation (WHO), the agreed South African Morbidity Coding Standards and Guidelines document, and the South African Master Industry Table (MIT).

Available at: http://www.health.gov.za/

Diagnosis

• A brief description and diagnostic criteria for each condition are included to assist healthcare workers to make a diagnosis

Medicine treatment

• Medicines may be listed according to a preferential order (e.g. first medicine as first-line option, second medicine as second-line option, etc). The dosing regimens provide the recommended doses for usual circumstances. The final dose should take into consideration capacity to eliminate the medicine, interactions and co-morbid states

Paediatric dose calculation

• Paediatric doses are usually provided in the form of weight-band dosing tables according to age. Doses should be calculated by weight, described as mg/kg. If this is not possible, choose a dose from the weight-band tables. Only use the dose according to age as a last resort. In particular, do not use age bands if the child appears small for his/her age or is malnourished
• Different conditions may require different doses of medicine. ‘Standard’ paediatric weight-band dosing tables for medicines are contained in an appendix. Where a specific condition is not listed in the appendix, refer to the STG in the main text of the guidelines for the dose specific to that condition

EML Clinical Guide tools

• The mobile application also provides tools to assist healthcare workers. These include calculators for BMI, Cardiovascular Event Risk (cholesterol- and BMI-based), eGFR, and Paediatric dose

PRESCRIPTION WRITING

All prescriptions must:

• Be written legibly in ink by the prescriber with the full name, identification number and address of the patient, and signed with the date on the prescription form
• Specify the age and, in the case of children, weight of the patient
• Have prescriber details including contact details i.e. name, qualification, registration number, address and contact telephone number
• Indicate the diagnosis on the prescription, where there patient has provided consent. 

In all prescriptions:

• State the treatment regimen in full:
  • Medicine name, strength and formulation
  • Dose or dosage,- dose frequency
  • Dose route
  • Duration of treatment
  • E.g. Amoxicillin 250 mg capsules, 8 hourly orally for 5 days
• Write the name of the medicine/preparation in full using the generic name
• Avoid abbreviations to reduce the risk of misinterpretation. Avoid the Greek mu (ų): write mcg as an abbreviation for micrograms
• Avoid unnecessary use of decimal points. If necessary, write a zero in front of the decimal point only, e.g. 2 mg not 2.0 mg; or 0.5 mL not .5 mL
• Avoid Greek and Roman frequency abbreviations that cause considerable confusion (qid, qod, tds, tid, etc). Instead either state the frequency in terms of hours (e.g. ‘8 hourly’) or times per day in numerals (e.g. ‘3x/d’)
• In the case of “as required”, a minimum dose interval should be specified, e.g. ‘every 4 hours as required’
• Most monthly outpatient scripts for chronic medication are for 28 days; check that the patient will be able to access a repeat before the 28 days are completed
• Prescriptions for schedules 6 medicines are not repeatable, requiring to be issued monthly; and the quantity to be issued should be expressed in words

After writing a prescription, check that the dose, dose units, route, frequency, and duration for each item is stated. Consider whether the number of items is too great to be practical for the patient, and check that there are no redundant items or potentially important drug interactions. Check that the script is dated, that the patient’s name, identification number and diagnosis/diagnostic code are on the prescription form. Only then should you sign the prescription and provide some other way for the pharmacy staff to identify the signature if there are problems (print your name, use a stamp, or use a prescriber number from your institution’s pharmacy).

Nurses granted authorisation provided in terms of Section 56(6) of the Nursing Act 33, 2005 may prescribe medicines in accordance with the PHC STGs and EML and their scope of practice. The STGs generally provides for nurse prescribers except where designated as “doctor prescribed” only or “doctor initiated”. The latter refers to an initial prescription prescribed by a doctor and which may be repeated by a nurse prescriber.

NEMLC REPORTS

To promote transparency of medicine selection decisions, NEMLC reports, summary slide decks, medicine reviews and costing reports are available on the National Department of Health website: http://www.health.gov.za/

OTHER INITIATIVES

The PHC STGs and EML supports the Ideal Clinic Framework (https://www.idealclinic.org.za/) and the Central Chronic Medicines Dispensing and Distribution (CCMDD) programme 

MEDICINES SAFETY

Provincial and local PTCs should develop medicines safety systems to obtain information regarding medication errors, prevalence and severity of adverse medicine events, interactions, and medication quality. These systems should not only support the regulatory pharmacovigilance plan but should also provide pharmacoepidemiology data to inform future essential medicines decisions as well as local interventions to improve safety.

In accordance with the SAHPRA’s guidance on reporting adverse drug reactions in South Africa, healthcare workers (with the support of PTCs) should report all relevant adverse reactions to the National Adverse Drug Event Monitoring Centre (NADEMC). To facilitate reporting, a copy of the Adverse Drug Reaction form and guidance on its use has been provided at the back of the guidelines.

Feedback

Comments that aim to improve these treatment guidelines are appreciated. The submission form and guidelines for completing the form are included. Motivations will only be accepted via Provincial PTCs.

These guidelines are also reviewed on a regular basis. During the review process, comments are requested during a comment period and should be forwarded directly to the EML Secretariat.

Standard Treatment Guidelines and Essential Medicines List for South Africa, Primary Healthcare Level, 2020 Edition