As doctors, many of us prescribe on a daily basis. We are rightfully focused on making sure it's the right medicine at the right dose for the right patient. However, ensuring that our prescriptions meet the legal requirements set forth by the General Regulations of the Medicines and Related Substances Act 1965 in South Africa is essential.
In 2017 the Regulations were amended to allow for digital prescriptions and ensure safer prescribing and dispensing with less fraud and abuse.
A recent poll of over 300 pharmacists shows that about 15% of all scripts in SA are received digitally, and almost all of them fall short of the legal legislation putting you, your patient, and the pharmacy at risk.
Two most common reasons that scripts are non-compliant is missing patient information and non-compliant signatures. This article provides an overview of what doctors need to know to ensure their scripts are valid and legally compliant.
Patient Information needed on a script
First and foremost, a script is a legal document; as such, you must ensure that the person you are prescribing for is correct.
Mandatory information for the patient is:
• Patient ID number or passport number (Changed in 2017, new addition and now mandatory)
• For neonates, you need to record the guardian's or parent's ID or passport number
• Address
• Age
• Gender
•And in the case of a veterinary medicine, the animal species
It is crucial to verify and record this information correctly to ensure the script is associated with the correct patient and prevent potential errors or confusion during dispensing.
Prescriber Information
The following prescriber information is required:
According to the Regulations of the Medical Scheme Act 131 of 1998, a practice number and diagnostic code (ICD 10) are required for medical scheme claiming purposes. This information not only adds legitimacy to the script but also assists in tracing and accountability.
Medication Details
Accurate and comprehensive medication details are paramount on a valid script. Include the full name and strength of the prescribed medication, the dosage, administration route, and the treatment duration. This information helps the pharmacist dispense the correct medication in the appropriate dosage and aids patient understanding.
Quantity
Clearly state the quantity of medication to be dispensed, required explicitly for Schedule 6 medication. It also needs to be written in words and numbers. Ensuring accuracy prevents confusion and mistakes during dispensing.
Date
Include the date of issue of the script. The date serves as a reference point for the script's validity and helps monitor the appropriateness of the prescribed medication over time.
Additional Requirements
Certain medications may have specific additional requirements. For example, controlled substances may require additional information such as batch numbers, expiry dates, and additional documentation for record-keeping and regulatory purposes. Stay informed about any special requirements for specific medications to ensure compliance.
Signature
Currently, there are two types of signatures accepted: a wet ink signature or, when scripts are generated electronically, the use of AES (advanced electronic signatures). This is in line with the Electronic Communications and Transactions Act (ECTA) of 2002. Compliance with these regulations ensures the integrity and security of the prescription process. Sadly most EHRs, telemedicine platforms and other electronic systems in SA do not currently use AES. A reliable indicator of compliance with AES is the use of One-Time Password (OTP) usage for signing scripts. If your current system does not utilise OTP for script signing, it is likely non-compliant
Conclusion
Ensuring the legality of your scripts is crucial for the welfare of your patients and the adherence to the laws and regulations governing medicine in South Africa. You can be confident that your scripts are valid and compliant by including accurate patient information, complete prescriber details, comprehensive medication information, proper quantities, and adhering to legal requirements for your signature. Remember to stay informed about any additional requirements for specific medications to provide accurate and legally compliant prescriptions that promote patient safety and well-being.
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