Dispelling the Myths: Electronic Prescribing in South Africa - Clarity, Compliance, and Patient Safety

The COVID-19 pandemic accelerated the adoption of digital health solutions, including electronic prescribing. However, this rapid uptake also led to confusion and the adoption of workarounds that deviate from South Africa's legal framework for e-prescriptions. It's time to set the record straight and ensure that both prescribers and pharmacists understand their obligations and prioritise patient safety.

The Law is Clear: Two Types of Legal Prescriptions

South African legislation, specifically Regulation 33 of the Medicines and Related Substances Act, clearly defines two valid prescription formats:

1. Paper Prescription: Handwritten or printed and signed with a wet-ink signature.
2. Electronic Prescription: Generated by an "electronic agent" (as defined by the Electronic Communications and Transactions Act (ECTA)) and signed with an Advanced Electronic Signature (AES) as defined by ECTA.

The PSSA Raises the Alarm

A recent Pharmaceutical Society of South Africa (PSSA) newsletter distributed to PSSA members raised concern about prescriptions that do not comply with the legislation. In the newsletter the PSSA has advised they have called on relevant authorities to enforce compliance with the existing legislation. Our take on this is that  prescribers and dispensers should take heed: fines and penalties for non-compliance are on the horizon.

EMGuidance Script: Exceeding Legal Requirements

EMGuidance Script is a prime example of a platform that not only meets but exceeds the legal requirements for electronic prescribing in South Africa. Here's how:

• Compliance with Regulation 33 of the Medicines and Related Substances Act and the relevant definitions included in the ECTA: EMGuidance Script adheres to the definition of an "electronic agent" and facilitates signing of digital scripts with a prescriber’s advanced electronic signature (AES) certificate.
• Verification Made Easy: While AES verification involves encryption using 2FA and is not visible to the naked eye on the document, the platform clearly indicates if a script PDF is AES-signed by the prescriber and displays the Trustfactory seal, providing pharmacists with an easy way to verify the level of digital signature used to sign the script. It would be illegal to state this if it weren't and copies or digital previews of the AES signed PDF are clearly identified as such. 
• Enhanced Tracking History: Through our accessible pharmacy portal, EMGuidance Script provides a detailed audit trail for each prescription. This offers valuable information to pharmacists about previous access to the script to support their assessment of script validity. It may even be further enhanced by dispensing information if available from capturing via our portal or from some integrations.

Debunking Common Misconceptions

• S5 and S6 scripts must be sent from the doctor's office: This is NOT the law and should be challenged as this is far less secure than an electronic script prepared using an electronic agent and signed using AES.
• Accepting WhatsApp/email scripts for Schedule 4 and lower medicines: This practice is deeply concerning and non-compliant. It allows for potential script alteration and multiple dispensing without a trace, jeopardising patient safety.
• In both of these scenarios the dispensing pharmacist never holds the original signed script. 

The Need for a Paradigm Shift

Prescribers and pharmacists must embrace a new mindset regarding electronic prescribing. This involves:

• Understanding the Legislation: Familiarise yourselves with Regulation 33 of the Medicines and Related Substances Act and the ECTA's definitions of electronic agents and signatures.
• Adopting Secure Platforms: Choose platforms like EMGuidance Script that prioritise security, compliance, and ease of verification. Bear in mind that each prescription must be verified on its own merit. 
• Rejecting Unsafe Practices: Abandon workarounds like WhatsApp and email for transmitting non-compliant prescriptions.
• Prioritising Patient Safety: Recognise that compliance with the law is essential for protecting patients.

Conclusion

The era of ambiguity and workarounds in electronic prescribing must end. By understanding the legislation, utilising secure platforms, and rejecting unsafe practices, prescribers and pharmacists can ensure that electronic prescribing in South Africa truly benefits patients and upholds the highest standards of care.