How To Use this book

Principles

The National Drug Policy makes provision for an Essential Drugs Program (EDP), which is a key component in promoting rational medicines use.

Each treatment guideline in the Paediatric Hospital Level Standard Treatment Guidelines (STGs) and Essential Medicines List (EML) has been designed as a progression in care from the current Primary Health Care (PHC) STGs and EML. In addition, where a referral is recommended, the relevant medicines have either been reviewed and included in the tertiary level EML, or are in the process of being reviewed.

The STGs serve as a standard for practice, but do not replace sound clinical judgment. It is important to remember that the recommended treatments provided in this book are guidelines only, and are based on the assumption that prescribers are competent to handle patients with the relevant conditions presenting to their facilities.

All reasonable steps have been taken to align the STGs with Department of Health guidelines that were available at the time of review. A medicine is included or removed from the list using an evidence based medicine review of safety and effectiveness, followed by consideration of cost and other relevant practice factors.

The EML has been developed down to generic or International Non-propriety Name (INN) level. It is anticipated that each Province will review the EML and prevailing tenders to compile a formulary which:

  • lists formulations and pack sizes that will facilitate care in alignment with the STG;
  • selects the preferred member of the therapeutic class based on cost;
  • Implements formulary restrictions consistent with the local environment; and
  • provides information regarding the prices of medicines.

Therapeutic classes are designated in the "Medicine treatment” section of the STGs which provides a class of medicines followed by example such as, HMGCoA reductase inhibitors (statins) e.g. simvastatin. These therapeutic classes have been designated where none of the members of the class offers a significant benefit over the other registered members of the class. It is anticipated that by limiting the listing to a class there is increased competition and hence an improved chance of obtaining the best possible price in the tender process. In circumstances where you encounter such a class always, consult the local formulary to identify the example that has been approved for use in your facility.

The perspective adopted is that of a competent medical officer practicing in a public sector hospital. As such, the STGs serve as a standard for practice but do not replace sound clinical judgment.

Navigating the book

It is important that you become familiar with the contents and layout of the book in order to use the STGs effectively.

Where relevant this book is consistent with the Standard Treatment Guidelines for Primary Health Care, Integrated Management of Childhood Illness Strategy (IMCI) guidelines and other National Programme treatment guidelines.

The ICD-10 number, included with the conditions, refers to an international classification method used when describing certain diseases and conditions. A brief description and diagnostic criteria are included to assist the medical officer to make a diagnosis. These guidelines also make provision for referral of patients with more complex and uncommon conditions to facilities with the resources for further investigation and management. The dosing regimens provide the recommended doses used in usual circumstances however, the final dose should take into consideration capacity to eliminate the medicine, interactions and comorbid states.

It is important to remember that the recommended treatments provided in this book are guidelines only and are based on the assumption that prescribers are competent to handle patients' health conditions presented at their facilities.

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 the book. In some therapeutic areas that are not easily amenable to the development of a STG, the section is limited to a list of medicines.

The Paediatric Hospital Level STG and EML provides additional information regarding Patient Adherence in Chronic Conditions, Measuring Medication Level and Prescription Writing. The section on Patient Education in Chronic Conditions aims to assist health workers to improve patient adherence and health, generally.

Furthermore, to promote transparency, in this fourth edition, revisions 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).

Finally, the guidelines make provision for referral of patients with more complex and uncommon conditions to facilities with the resources for further investigation and management.

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 that may be required to improve safety.

In accordance with the Medicines Control Council'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 at the back of the book.

Feedback

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

MEASURING MEDICATION LEVELS

Potentially toxic medicines, medicines with narrow therapeutic indices and those with variable pharmacokinetics should be monitored to optimise dosing, obtain maximum therapeutic effect, limit toxicity and assess compliance.

Routine measurement is rarely warranted, but rather should be tailored to answering a specific clinical question, and is of most value in medicines with a narrow therapeutic index or where there is considerable individual variation in pharmacokinetics.

Aminoglycosides

Peak levels will be adequate if dosing is adequate. Trough levels taken immediately before the next dose are valuable in identifying potential toxicity before it manifests as deafness or renal impairment. Aminoglycosides are contraindicated in renal impairment.

Anti-epileptics

Levels may be helpful to confirm poor adherence or to confirm a clinical suspicion of toxicity. Routine measurement in patients with well controlled seizures and no clinical evidence of toxicity is not appropriate. Individual levels may be difficult to interpret - if in doubt, seek assistance from a clinical pharmacokineticist.

Therapeutic Drug Level Monitoring

Guidance on therapeutic drug level monitoring has been added to this edition of the Paediatric STGs and EML in certain indications requiring vancomycin and gentamycin.

PRESCRIPTION WRITING

Medicines should be prescribed only when they are necessary for treatments following clear diagnosis. Not all patients or conditions need prescriptions for medicine. In certain conditions simple advice and general and supportive measures may be more suitable. In all cases, carefully consider the expected benefit of a prescribed medication against potential risks.

All prescriptions should:

  • be written legibly in ink by the prescriber with the full name 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;
  • signature of prescriber and practice/prescriber number;
  • have contact details of the prescriber e.g.name and telephone number.

In all prescription writing the following should be noted:

  • The name of the medicine or preparation should be written in full using the generic name.
  • No abbreviations should be used, due to the risk of misinterpretation.
  • Avoid the Greek mu (µ): write mcg as an abbreviation for micrograms.
  • Avoid unnecessary use of decimal points and only use where decimal points are unavoidable. A zero should be written in front of the decimal point where there is no other figure, e.g. 2 mg not 2.0 mg or 0.5 mL and not .5 mL.
  • Frequency: 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. 3 times daily).
  • State the treatment regimen in full:
    • medicine name and strength,
    • route,
    • dose or dosage,
    • dose frequency,
    • duration of treatment,
      e.g. amoxicillin, oral, 250 mg 8 hourly for 5 days.
  • 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.
  • After writing a script, 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 and that the patient's name and folder number are on the prescription form. Only then sign the script, and provide some other way for the pharmacy staff to identify you if there are problems (print your name, use a stamp, or use your institution issued prescriber number).