Edition 4/July 2024 REFLECTING ON THE 2024 SAAPI CONFERENCE HELD ON 5 - 7 JUNE AT THE CSIR CONFERENCE CENTRE by Byron Chukwu Conference Committee Chairman 2023/2024 With the theme ENGAGE & EMPOWER, this years SAAPI conference aimed to do just that. With speakers from both SAHPRA and industry (local & international), the conference allowed for a whirlwind of experiences, learnings, and connections. Byron Chukwu At this year’s conference, we celebrated SAAPI’s 30 th year of existence. We took a walk down memory lane with Miranda Viljoen who presented us with SAAPI’s journey from 1994 to date. We also had colleagues from the first SAAPI executive committee of 1994 join us for a spectacular cocktail function. The presence and words of wisdom from the first SAAPI committee provided a sense of hope and inspiration for our young SAAPI members and current executive committee. One of the most striking aspects of this year’s conference was the variety of topics covered. From harmonisation of medicines across the African continent, feedback on various updates from our regulator, SAHPRA, to the status of complementary medicines and medical devices’ inspections, and the maintenance of quality systems among many other exciting topics. We were also provided with insights into the veterinary space, and new regulatory systems for various types of submissions. Topics on pricing, the role of supply chain in our industry, and pharmaceutical licensing were also covered. We were thrilled to have DHL as our platinum sponsor and Playbook as our gold sponsor. We were also excited to have Aspen, Strategnos, Vector Logistics, Adcock Ingram and Franklin Covey join us as additional sponsors. A big thank you to all our sponsors for contributing toward the success of this conference. Beyond the content itself, the conference was filled with diverse perspectives. Delegates had the opportunity to engage and network with fellow attendees and to exchange ideas and build lasting connections. These interactions have not only expanded professional networks but have also fostered a sense of community and collaboration. Leanne Blumenthal …/ continued on page 3 The Golden Mortar 4/2024 1
1 & 3. SAAPI Conference 4. SAAPI 2024/2025 Committee 5. SAAPI Workshops 6 - 7. SAHPRA CEO Keynote Address at 2024 SAAPI Conference 8. YPG Steering Committee 10 - 11. Wits Activities 2. July CPD 5. PSSA Book Department 14. Indemnity Insurance. 15 Museum Artefacts. 7 - 8. Labelling of Medicines in South Africa 9. SARCDA Christmas 2024 SAACP Webpage Info 12 - 14. Understanding MPox 15 FIP Congress September 2024 The Golden Mortar 4/2024 2
Some of the photos taken at Conference Navigating through a variety of sessions, each attendee was confronted with new ideas and perspectives that sparked introspection and growth. Whether it was stepping out of comfort zones to attend sessions outside one's expertise or embracing differing viewpoints, the experience was a testament to the transformative power of continuous learning. The lessons learned here will undoubtedly resonate for long after the conference, shaping future decisions and actions in profound ways. As attendees return to their respective roles and organizations, they carry with them not just new knowledge but also a renewed sense of purpose and possibility. Let us carry forward the lessons learned and connections forged as we continue to push boundaries and unlock new opportunities for growth and innovation. The Golden Mortar 4/2024 3
Byron Chukwu Vice-President Gina Partridge Immediate Past President Leanne Blumenthal Yuthika Prahladh Treasurer Lynette Terblanche Christine Ledimo Nokuthula Dube Ingrid Duvenhage President Tammy Gopal Lyzelle Worldson Thavashini Pather The Golden Mortar 4/2024 James Meakings Minoka Maharaj 4
Additional information is available at: www.saapi.org.za or email: info@saapi.org.za THE PSSA BOOK DEPARTMENT Do you know that the Book Department has a range of essential publications for pharmacists at preferential prices for members of the PSSA? From overseas publications such as Martindale, Merck Manual and Dorland’s Illustrated Medical Dictionary to local publications such as the South African Medicines Formulary (SAMF) and the Scheduled Substance Register. Ordering is this simple: Go to the PSSA website, www.pssa.org.za, click on the Hello, sign in button to order books at the discounted fee for members. Choose Book Store and complete online. Or Contact Dinette at PSSA National Office on (012) 470-9559 or at dinette@pssa.org.za The Golden Mortar 4/2024 5
2024 SAAPI CONFERENCE The South African Association of Pharmacists in Industry (SAAPI) held its 2024 conference at the Council for Scientific and Industrial Research (CSIR) International Convention Centre on 5-7 June 2024 under the theme “Engage and empower: Pushing the frontiers of the Pharma Industry”. South African Health Products Regulatory Authority (SAHPRA) Chief Executive Officer, Dr Boitumelo Semete -Makokotlela delivered the keynote address focusing on SAHPRA’s mission and vision for delivering safe, efficacious and quality medicines and other health products on the opening day of the conference. “Our mandate is to ensure that all of the developments and new innovations at the heart of what it is that we do, we keep patient safety and matters of access core to what it is that we do, but at the heart of us being agile and responsive, we will make sure that we do not compromise on safety, quality and the efficacy of products that we regulate,” expressed Dr Semete-Makokotlela. Dr Boitumelo Semete-Makokotlela Dr Semete-Makokotlela also emphasised that SAHPRA is open to engagement so that the Regulator works in shifting the needle through cooperation with the overall goal of access to safe, effective, and quality medicines and other health products to meet South Africa’s healthcare needs. The SAAPI conference programme also featured presentations from various SAHPRA officials. Colleagues from various units presented invaluable information to SAAPI conference delegates. RELIANCE APPROACH In explaining an overview of SAHPRA’s reliance approach to medicines registration, Senior Manager: Inspectorate and Regulatory Compliance, Deon Poovan said: “When you are doing a review of a dossier, it takes time, and when you can rely on somebody else that has actually done the work, we can reduce that time that we take to review a dossier. So, we have adopted the reliance review process as a pathway for registration and this approach then allows us (the Regulator) to leverage on what a recognised regulatory authority (that we recognise) has done so that we can then rely on its evaluation process and ensure better market access so that we can get drugs that we need onto the market, and then obviously Industry can then market the product”. Sasani Chauke, a Medicine Registration Officer in the Pharmacovigilance Unit, spoke to safety signal management within the Regulator. One has to have a clear idea of what a safety signal is. “A safety signal is any information on any new known adverse event that is potentially caused by a medicine and requires further investigation to determine whether there is a real risk or if there is a regulatory action that is required,” explains Chauke. Tshepiso Bokaba, Manager: Information and Communication Technology, shared perspectives on new specifications for eSubmissions across various areas. …/ continued on page 7 The Golden Mortar 4/2024 6
USE OF E--SIGNATURE Mokgadi Daphney Fafudi, Manager: Regulatory Compliance, explained how the Regulator is using E-signatures to allow for a more seamless signing process that also ensures the authenticity and integrity of documents. She emphasised the importance of industry ensuring compliance with the ALCOA+ data integrity principles in their submissions to SAHPRA, thus guaranteeing the authenticity, legibility, contemporaneity, originality, and accuracy of data within submissions. She also alluded to the fact that SAHPRA is reviewing the General information guideline in order to provide guidance on acceptable minimum requirements concerning e-signatures. Dr Alice Sigobodhla, Manager: Veterinary Medicines, shared the latest developments and status of veterinary medicine registration within SAHPRA. Dr Sigobodhla was also part of a robust panel discussion around veterinary medical devices. Lydia Motlogelwa, Manager: Medical Device Registration and Clinical Trials, provided an update on the latest developments on medical device regulation. The many speakers during the course of the conference embodied their theme of Engage, Empower – Pushing the frontiers of the Pharma Industry. LABELLING OF MEDICINES IN SOUTH AFRICA – Why are certain details essential? by Lynette Terblanche What is in a name, you might ask? (SAHPRA) as described in Section 36 of The Act. If it is a medicine that is being sold in South Africa, legislation dictates not only the fact that the name must be approved, but also positioning of the name on the label of the medicine as well as information mandated in addition to the name of the medicine. Further details regarding this information and the format requirements are available on the SAHPRA website: https://www.sahpra.org.za Of particular importance is that every medicine should, on the container, have an expiry date beyond which the medicine is not to be used as well as a batch number. The general regulations of the Medicines and Related Substances Act 101 of 1965 (as amended) (The Act), include a regulation dedicated to the requirements for the labelling of medicines for human use which is defined by Regulations 10, 11, & 12, and a separate regulation detailing the requirements for the labelling of veterinary medicines By definition in the Regulations to The Act; "minimum legibility" means a printing in 6-point Helvetica, typeface in black ink on white cartridge paper or the equivalent thereof; Every medicine that is sold must have a label attached to it which includes the minimum required information, as described in the regulations. This includes the schedule assigned to the medicine, dosage form (and in the case of injectable medicines, the route of administration), active ingredients, preservatives, sugar and alcohol content (if applicable), storage instructions, warnings specific to certain active ingredients and/or categories of medicine, and details of the holder of the certificate of registration for the medicine. Exceptions for compliance with the labelling requirements are only permissible if the holder of the certificate of registration applies for and is granted exemption from the labelling requirements by The South African Health Product Regulatory Authority The Golden Mortar 4/2024 Why are batch numbers and expiry dates important? Batch number and expiry date provide the holder of the certificate of registration of a medicine with very important information for initiating and performing an investigation following receipt of any report of an adverse reaction, or a quality complaint received from a health care practitioner or even a patient. It is therefore essential that pharmacists request the batch number and expiry date of a product when receiving information regarding a possible adverse event and /or quality complaint relating to a specific medicine. To whom should information regarding adverse events/possible quality complaints, labelling errors and even medication errors be reported, should you become aware of any such instances? …/ continued on page 8 7
The contact details of the holder of certificate of registration appear on containers and are also available online. It is crucial that any discrepancies be reported directly to the holder of the certificate of registration (i.e. the pharmaceutical company) and not to the Branch Office, PSSA National Office, a sector of the PSSA, SAHPRA or Pharmacy Council. The holder of the certificate of registration has documented procedures for processing quality and customer complaints and is obliged to investigate all complaints received. Important information that should be included in all complaints, (where possible) is the batch number and expiry dates of the medicine in question. By notifying the holder of the certificate of registration, enquiries could be initiated that may result in a safety or quality review of the medicine in question, and ultimately having a positive impact on future users of the medicine. Let us all report! The Medicines and Related Substances Act 101 of 1965 (as amended) may be accessed at: https://www.sahpra.org.za/wp-content/uploads/2019/09/Medicines-and-Related-Substances-Act_101-of1965_Act_GG-40869_2017-05-26.pdf Regulations to The Act: https://www.sahpra.org.za/wp-content/uploads/2022/07/General-Regulations-Medicines-and-RelatedSubstances-Act-25-Aug-2017-Gazetted.pdf The Golden Mortar 4/2024 8
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