Section 1: Medication details
- Generic name: A fundamental principle of the Essential Drug Programme is that of generic prescribing. Most clinical trails are conducted using the generic name.
- Proposed indication: There will usually be many registered indications for the medication. However, this section should be limited to the main indication which is supported by the evidence provided in section 2.
- Prevalence of the condition in South Africa: This information is not always readily available. However, it is an important consideration in the review of a proposed essential medicine.
- Prescriber level: Here the proposed prescriber level should be included. If more than one level is proposed each relevant box should be ticked.
Section 2: Evidence and motivation
- Estimated benefit
- Effect measure: this is the clinical outcome that was reported in the clinical trial such as BP, FEV, CD4, VL etc.
- Risk benefit: this should reported in the clinical trial and, in most cases, includes the 95% confidence level (95% CI). Absolute risk reduction, also termed risk difference, is the difference between the absolute risk of an event in the intervention group and the absolute risk in the control group.
- Number Need to Treat (NNT): gives the number of patients who need to be treated for a certain period of time to prevent one event. It is the reciprocal of the absolute risk or can be calculated using the formula.
- Motivating information (Level of evidence based on the SORT system )
- The National Essential Drug List Committee has endorsed the adoption of the SORT system for categorising levels of evidence. This system* contains only three levels:
*Ebell MH, Siwek J, Weiss BD, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician. 2004;69:550-6.
A: Newer product : for most newer products, level 1 evidence such as high quality systematic reviews or peer-reviewed high quality randomised controlled trials should be identified and referenced in the space provided.
B: Older products : many of these products were developed prior to the wide use of randomised controlled trials. However, there maybe level 1 evidence where the product was used as the control arm for a newer product. If no level 1 evidence can be identified, then level II data from poorer quality controlled trials or high quality observational studies should be referenced in the space provided.
- Cost considerations
- Where a published reference supporting the review of cost is available comments should be made regarding its applicability to the South African public sector environment.
- Possible unpublished information that can be included:
- Cost per daily dose or course of therapy – for long term or chronic therapy such as hypertension the usual daily dose should be calculated (Dose x number of times a day) and converted into the number of dosing units e.g. tablets. This is then used to calculate the cost per day. For medications used in a course of therapy such as antibiotics this is then multiplied by the number of days in the course of therapy.
- Cost minimisation is used where there is evidence to support equivalence and aims to identify the least costly treatment by identifying all the relevant costs associated with the treatment.
- Cost-effectiveness analysis is used to compare treatment alternatives that differ in the degree of success in terms of the therapeutic or clinical outcome. By calculating a summary measurement of efficiency (a costeffectiveness ratio), alternatives with different costs, efficacy rates, and safety rates can be fairly compared along a level playing field.
Where any of these have been performed tick the relevant block and send as an attachment with all the calculations. If possible, the spread sheet should be supplied electronically.
Section 3: Motivator’s Details
The receipt of all submission will be acknowledged. In addition, all decisions with supporting arguments will be communicated where appropriate. This section therefore forms a vital link between the motivator and the decision making process.
