How To Use These Guidelines
Standard Treatment Guidelines and Essential Medicines List for South Africa, Hospital Level, Adults 2019 Edition
Principles
The National Drug Policy1 makes provision for an Essential Drugs Programme which is a key component in promoting rational medicines use.
The perspective adopted in the Adult Hospital Level Standard Treatment Guidelines (STGs) is that of a competent medical officer practicing in a public sector hospital. The STGs serve as a standard for practice, but do not replace sound clinical judgement. It is important to remember that the treatments recommended are guidelines only and are 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 and improving outcomes. The goal of de-prescribing is to reduce pill burden and maintain or improve quality of life.
All reasonable steps were taken to align the STGs with Department of Health guidelines that were available at the time of review. Each treatment guideline in the Adult Hospital Level STGs and Essential Medicines List (EML) was designed as a progression in care from the current Primary Health Care (PHC) STGs and EML. Given that the PHC STGs and EML were reviewed prior to the Adult Hospital Level STGs, the two STGs are not always perfectly aligned. Where referral to a tertiary facility is recommended, the relevant medicines have either been reviewed or included in the tertiary level EML, or are in the process of being reviewed.
Each medicine was included or removed from the EML using an evidence based review of safety and effectiveness, followed by considerations of cost and other relevant practice factors, such as availability and storage requirements. 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 dosing regimens provide the recommended doses used in usual circumstances. However, the prescribed dose should take into consideration drug-drug interactions and co-morbid states, notably renal or hepatic failure, critical illness, and morbid obesity.
1 National Drugs Policy, 1996. https://www.gov.za/documents/national-drugs-policy
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. The designation of medicines into therapeutic classes may also assist with remedial actions to mitigate challenges to security of supply, by providing suggested alternatives which have already been approved by the ministerially appointed National Essential Medicines List Committee (NEMLC)2
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: http://www.health.gov.za/edp.php
2 NEMLC is tasked to formulate and revise the Standard Treatment Guidelines (STGs) and Essential Medicines List (EML) using a peer review consultative process.
Navigating the guidelines
It is important that you become familiar with the contents and layout of these guidelines in order to use the STGs effectively.
The STGs are arranged into chapters according to the organ systems of the body. Conditions and medicines are cross referenced in two separate indexes of these guidelines. In some therapeutic areas that are not easily amenable to the development of a STG, the section is limited to a list of medicines.
This edition of the Adult Hospital Level STG and EML provides additional information: Appendix III - guidance on the use of certain medicines in pregnancy; and Appendix IV - guidance on extemporaneous preparation of certain medicines using a standardised formula.
Revisions to previous recommendations are accompanied by the level of evidence that is cited and hyperlinked accordingly. All evidence is graded according to the Strength Of Recommendation Taxonomy (SORT) (a patient-centered approach to grading evidence in the medical literature), described in detail on Guideline for the motivation of a new medicine on the National Essential Medicines List. To further promote transparency of medicine selection decisions, NEMLC reports, medicine reviews and costing reports are available on the National Department of Health website: http://www.health.gov.za/edp.php
The section on Patient Education in Chronic Conditions aims to assist health workers to improve patient adherence and health, generally. Information on the Central Chronic Medicines and Distribution (CCMDD) programme is available at: nhiccmddadmin@health.gov.za
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/index.php/shortcodes/2015-03-29-1042-47/2015-06-10-09-23-36/2015-06-10-09-26-11
Medicines safety
Provincial and local Pharmaceutical and Therapeutics Committees (PTCs) should develop medicines safety systems to obtain information regarding medication errors, prevalence and importance of adverse medicine events, interactions, and medicines quality. These systems should not only support the regulatory pharmacovigilance plan, but should also provide pharmacoepidemiology data that will be required to inform future essential medicines decisions as well as local interventions to improve safety.
In accordance with SAHPRA's guidance on reporting adverse drug reactions in South Africa, the medical officer with the support of the PTC should report the relevant adverse reactions to the National Adverse Drug Event Monitoring Centre (NADEMC). To facilitate reporting, a copy of the form and guidance on its use has been provided.
Feedback
Comments that aim to improve these treatment guidelines will be appreciated. The submission form and guidance for completing the form are included with these guidelines. Motivations will be accepted from Provincial PTCs only.
Standard Treatment Guidelines and Essential Medicines List for South Africa, Hospital Level, Adults 2019 Edition