Specialist Forum April 2024

DEXILANT DDR:

• the MOST POWERFUL inhibitory effect on the proton pump of ALL available PPIs.4

• TRUE once-daily dosing.5

reflux disease - comparative efficacy and outcomes of dexlansoprazole MR. Ther Clin Risk Manag 2015;11:1649-56. doi: 10.2147/TCRM.S66680. 6. Dexilant Professional Information. Takeda (Pty) Ltd, South Africa; August 2021. 7. Sharma P, Shaheen NJ, Perez MC, et al Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther 2009;29(7):731-41. doi: 10.1111/j.1365-2036.2009.03933.x. 8. Fass R, Chey WD, Zakko SF, et al. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with

Navigating the medical maze: Insights and innovations across specialties

As the calendar flips to April, it’s somewhat overwhelming to realise that the first quarter of 2024 has simply flown by – marking the swift passage of time. However, the enduring impact of misinformation looms large, often unchallenged for years.

Misinformation and medical myths can perpetuate misconceptions, hinder patient care, and undermine trust in the medical community.

As healthcare professionals, it is your duty to challenge these myths, debunk falsehoods, and uphold the principles of evidence-based practice.

In our monthly medical myths feature, we look at some of the most common misconceptions which continue to persist about hepatitis C, leading to stigma and barriers to care. In anticipation of World Hepatitis Month in May, let us challenge these misconceptions and promote accurate information, to improve awareness, facilitate early diagnosis, and enhance access to life-saving treatments for individuals affected by hepatitis C.

In our gastroenterology section we look at whether sustained heartburn is possible for individuals living with gastro-oesophageal reflux disease and who is eligible for switching from twice-daily proton-pump inhibitor therapy, to once-daily step-down therapy. We also take a brief look at a recent webinar hosted by Prof Sian Hemmings focusing on the gut-brain connection and mental well-being.

In our pain article we explore the relationship between perception of pain and time, challenging the notion that pain intensity is solely determined by physiological factors. Through a deeper understanding of the biopsychosocial aspects of pain, clinicians can adopt holistic approaches that address not only the physical symptoms but also the psychological and social dimensions of pain experience, leading to more effective pain management strategies and improved patient outcomes.

We introduce the imniquidmod pump in the dematology article as a novel solution that simplifies dosing regimens and improves patient compliance. One of the challenges in the treatment of actinic keratosis is that patients often view treatment as complex. The Imiquimod pump offers a convenient and user-friendly alternative, enhancing treatment adherence and optimising therapeutic outcomes for patients with various dermatological conditions.

Don’t miss the article on the potential of digital health applications in cancer care. Contrary to the perception that technological innovations are peripheral to oncological practice, digital health applications offer unprecedented opportunities for remote monitoring, personalised treatment planning, and patient engagement, thereby improving clinical outcomes and enhancing the quality of cancer care delivery.

The infectious disease feature highlight the importance of influenza vaccination. By promoting vaccination as a critical preventive measure and debunking views that downplay the seriousness of influenza, we can mitigate the burden of flurelated morbidity and mortality, safeguard public health, and protect vulnerable populations from preventable illness.

Lastly, the report from the South African Society for Reproduction and Gynaecological Endoscopy Congress stresses the significance of a multidisciplinary approach in fertility care. By embracing multidisciplinary collaboration and addressing the holistic needs of patients, fertility clinics can optimise outcomes and empower individuals and couples on their journey towards parenthood.

As healthcare professionals, it is imperative that you remain vigilant in challenging medical myths, promoting evidencebased practices, and advocating for the highest standards of patient care. By cultivating a culture of critical inquiry and continuous learning, we can navigate the complexities of healthcare with integrity, compassion, and scientific rigor, ultimately advancing the wellbeing of our patients and communities.

Hope you enjoy the read!

Regards

Challenging hepatitis C myths

An estimated 600 000 South Africans are living with chronic hepatitis C (hep C) virus (HCV) infection. Currently there are no vaccine available for the prevention of transmission. As a result, prevention focuses on reducing transmission and treating potential transmitters like people who inject drugs (PWID) and men who have sex with men.1

Myth: HCV infection is not curable

Fact: The introduction of highly potent and safe direct-acting antivirals (DAAs) has transformed the landscape of hep C treatment. Effective DAA therapy offers a viable option for viral eradication, potentially diminishing the urgency for a vaccine. 2

Myth: All individuals with hep C show visible symptoms

Fact: Both acute and chronic hepatitis C infections can be symptomatic or asymptomatic, with 85%-90% of acute cases showing no symptoms. Acutely symptomatic individuals develop symptoms within six to seven weeks, including nausea, loss of appetite, jaundice, fatigue, abdominal pain, malaise, dark urine, and grey-coloured stool. Between 25%52% of acutely symptomatic cases spontaneously clear the virus, while the rest progress to chronic hepatitis C. Additionally, 85%90% of asymptomatic cases develop chronic hepatitis C. Risk factors for chronicity include alcohol consumption, male gender, age >40-years, and co-infection with HIV/hepatitis B. Most chronic cases are asymptomatic, but 20% may experience liver damage leading to cirrhosis within one to 30 years. Cirrhosis can cause abdominal inflammation, and it’s a risk factor for hepatocellular carcinoma (liver cancer). Some patients may also develop extra-hepatic conditions affecting various systems.6

Myth: HCV infection is not a serious public health issue

Fact: According to the World Health Organization (WHO), HCV is a significant global public health issue. Hepatotropic viruses currently cause more than one million deaths annually, placing them on par with the mortality rates associated with human immunodeficiency virus (HIV) infections, tuberculosis, and malaria. Recent epidemiological data show that there are ~59 million individuals living with hep C globally. 2

Myth:

HCV infection only affects individuals with a history of drug use

Fact: Hep C is caused by a bloodborne virus and while it is true that the prevalence of the infection is high (46%) in people who inject drugs, exposure to blood through unsafe injection practices (eg vaccinations), inadequate healthcare procedures, unscreened blood transfusions, and certain sexual practices that involve exposure to blood can result in infection.3,4

Myth: Once cured, you cannot be infected again

Fact: Even if you have previously cleared the virus or undergone successful treatment and cure, there is a risk of reinfection. Therefore, current intravenous drug users who individuals share needles, syringes, or other drug preparation equipment, as well as those undergoing maintenance haemodialysis, should undergo regular testing for hepatitis C.5

Myth: Hep C can be transmitted through mosquito bites

Fact: Humans are the only carriers of the hepatitis C virus. Therefore, hep C cannot be transmitted through mosquito or any other insect bites.5,6

Myth: You cannot get hep C from tattooing if the equipment is sterilised frequently

Fact: While some studies have suggested a potential association between tattoos and hepatitis C infection, others have not. The process of tattooing involves injecting ink pigments into the dermal layer of the skin through rapid puncturing, occurring hundreds of times per second. This practice poses a potential risk of transmission when tattoo equipment comes into contact with blood and body fluids, especially if instruments are reused without proper sterilisation or hygiene measures. Transmission of hepatitis C may occur at various stages of the tattooing process, such as through the reuse of needles or the use of contaminated ink carrying hepatitis C-positive blood. Additionally, as tattoo dyes are not typically stored in sterile containers, they could serve as potential carriers for the transmission of hepatitis C.7

Myth:

HCV infection is only a concern for adults

Fact: According to the World Health Organization, an estimated 3.2 million adolescents and children have chronic hep C. Of every 100 infants born to mothers with hep C, about six will become infected with HCV. The risk is greater if the mother has both HIV and hep C. Hep C cannot spread through breast milk, food, water, or casual contact like hugging, kissing, and sharing food or drinks with an infected person. Transmission can also occur through certain sexual practices that involve exposure to blood, such as those involving individuals with multiple sexual partners and men who have sex with men. It is important to note that these modes of transmission are less common.3,5

Sustained relief from heartburn after switching to once daily

dexlansoprazole

Proton pump inhibitors (PPIs) and lifestyle modifications are the mainstay of gastrooesophageal reflux disease (GORD) management in patients without alarm features. The goals of GORD management are to relief symptoms and prevent complications such as erosive oesophagus (EO), Barret’s oesophagus (BO), or oesophageal adenocarcinoma.1,2

Following a diagnosis of GORD, initial steps in the management involve optimising PPI therapy and ensuring proper administration to enhance adherence to treatment. In cases of persistent symptoms, increasing the PPI dosage to twice daily may be considered for select patients. 2

However, it is crucial for primary care providers to investigate the origin of symptom generation, distinguishing between reflux and non-reflux mechanisms, particularly when symptoms do not

DEXILANT DDR:

• the MOST POWERFUL inhibitory effect on the proton pump of ALL available PPIs.4

• TRUE once-daily dosing.5

reflux disease - comparative efficacy and outcomes of dexlansoprazole MR. Ther Clin Risk Manag 2015;11:1649-56. doi: 10.2147/TCRM.S66680. 6. Dexilant Professional Information. Takeda (Pty) Ltd, South Africa; August 2021. 7. Sharma P, Shaheen NJ, Perez MC, et al Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther 2009;29(7):731-41. doi: 10.1111/j.1365-2036.2009.03933.x. 8. Fass R, Chey WD, Zakko SF, et al. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with

respond well to optimal PPI therapy, stress

Liang et al 2

Effectiveness

of PPIs and switching to once-daily dosing

While numerous studies have demonstrated the effectiveness of PPIs in providing relief from symptoms in GORD, up to 40% of patients report a less-than-optimal response to once-daily PPI therapy. For these patients increasing PPI dosage to

1 Firstline therapy recommendations:

Initial GORD management strategies prioritise first-line treatment with a PPI coupled with lifestyle modifications, highlighting the fundamental approach to symptom relief and prevention of complications.

3 Comprehensive disease management:

Dexlansoprazole not only improves GORD symptoms but also plays a crucial role in preventing complications like EO, BO and oesophageal adenocarcinoma, offering a comprehensive approach to disease management.

twice daily may be appropriate. 2,3

In patients who are successfully managed with twice-daily PPI therapy, step-down therapy to once-daily PPIs may be considered – especially when taking into consideration that the prolonged use of high-dose PPI therapy can increase the risk of osteoporosis-related fractures of the hip and spine, bacterial overgrowth, Clostridium difficile colitis, and community-acquired pneumonia. 2,3

2 Risk mitigation through step-down therapy: Recommending step-down therapy for wellcontrolled patients on twice-daily PPIs aims to mitigate potential risks associated with prolonged high-dose PPI usage, ensuring a balanced and safe treatment approach.

Fass et al investigated whether switching to once-daily dexlansoprazole modified release (MR), a PPI with a dual-delayed release formulation (see box 3), can be used to effectively manage heartburn in patients living with GORD who were initially on twice-daily PPI therapy. 3

Effective heartburn control was defined as an average of one symptom or fewer per week during the last four weeks of screening and treatment. Participants were

Take-away messages

4 Optimised PPI therapy: Overcoming conventional PPI limitations, dexlansoprazole’s dual delayed-release mechanism optimises pharmacokinetics and pharmacodynamics. This innovation prolongs acid suppression, minimising breakthrough symptoms and the need for frequent dosing.

5 Success in stepdown therapy:

Dexlansoprazole showcases effectiveness in transitioning from twice-daily to once-daily PPI treatment. A significant majority of patients maintain well-controlled heartburn, ensuring prolonged symptom relief and enhanced overall QoL.

6 Comparative pharmacodynamic superiority: In a direct comparison with dexlansoprazole outperformed esomeprazole, achieving higher intragastric pH levels over a 24-hour period. The dual delayed-release technology reinforces dexlansoprazole’s unique and superior clinical efficacy in GORD management.

7 Flexibility in administration:

Dexlansoprazole’s efficacy remains consistent regardless of meal timing, offering patients the convenience of administration before, after, or during meals without compromising its impact on intragastric pH.

Dexlansoprazole indications and mode of action In South Africa, dexlansoprazole is indicated for the treatment of adult and adolescent (12- to 17-years) patients living with EO, the maintenance of healed EO, and the maintenance heartburn relief. Recommended treatment duration is six months for adults and four months for adolescent patients. Dexlansoprazole is also indicated for the short-term treatment of heartburn and acid regurgitation associated with symptomatic NERD adults and adolescents. 5

The limitations of conventional PPI therapy include mealtime dosing before meals to maximise efficacy (parietal cell proton pumps are activated with meals) and short half-lives. Dexlansoprazole MR has been developed to specifically address these limitations. 6

Dexlansoprazole MR has a distinctive dual delayed-release mechanism, delivering the drug in two distinct phases. Within the capsule, granules are equipped with coatings designed to dissolve at specific pH levels.7

Granules sensitive to pH 5.5 release in the proximal duodenum,

switched to masked dexlansoprazole MR 30mg and placebo for six weeks. 3

The primary efficacy endpoint was the proportion of patients maintaining well-controlled heartburn after step-down. Additionally, GORD-related symptoms and quality of life (QoL) were assessed. 3

Results indicated that after switching to once daily dexlansoprazole MR 30mg, 88% of patients sustained wellcontrolled heartburn. The results suggest that a significant majority of patients effectively managed their heartburn by switching from twice-daily PPI therapy to once-daily dexlansoprazole 30mg, demonstrating sustained control over symptoms and maintaining overall QoL related to GORD. 3

while those sensitive to pH 6.8 release in the distal ileum. This innovative technology ensures a targeted and phased release of the medication for optimal therapeutic efficacy.7

Consequently, 25% of the drug is released in the proximal duodenum, and the remaining 75% is released in the distal ileum. This dual-phase release results in a distinctive dual-peak time–concentration profile, setting it apart from regular delayedrelease PPIs that exhibit a single peak.7

Dexlansoprazole MR, administered once a day, extends therapeutic plasma levels over time, allowing sustained inhibition of newly formed or active proton pumps beyond the initial PPI effect. Importantly, the drug’s efficacy does not appear to be influenced by meals, as it can be taken before, after, or during a meal with minimal impact on the drug’s effect on intragastric pH.7

Overall, the pharmacodynamic profile of dexlansoprazole MR is unique and is anticipated to translate into improved clinical efficacy for patients living with GORD, according to Fass and Frazier.7

values (4.3 for dexlansoprazole vs 3.7 for esomeprazole) compared to esomeprazole. 4

This significant difference was observed in the >12-24-hour post-dose interval. While no statistically significant difference was noted in the 0-12-hour post-dose interval, the authors concluded that dexlansoprazole 60mg achieved higher average intragastric pH levels over 24 hours compared to a single dose of esomeprazole 40mg. 4

References are available on request. SF

In patients who are successfully managed with twice-daily PPI therapy, step-down therapy to oncedaily PPIs may be considered

Comparative efficacy of single doses of dexlansoprazole

In a study conducted by Kukulka et al, the pharmacodynamic effects of single doses of dexlansoprazole MR 60mg and esomeprazole 40mg were compared in healthy adult participants. 4

Participants were randomised to either dexlansoprazole or esomeprazole. The primary endpoints, covering 24-hours postdose, included the percentage of time with intragastric pH >4 and mean pH, while secondary endpoints focused on specific time intervals. Both drugs were administered after an overnight fast and one hour before breakfast, with continuous pH recording spanning from pre-dose to 24-hours post-dose. 4

Results showed that over the entire 24-hour post-dose period, dexlansoprazole demonstrated a statistically significant increase in the mean percentage of time with pH >4 (58% for dexlansoprazole vs 48% for esomeprazole) and average mean pH

The microbial mind: Exploring the gutbrain connection for mental well-being

Specialist Forum recently hosted a webinar presented by Prof Sian Hemmings, head of the Psychiatric Genetics Laboratory and Research Group at the Faculty of Medicine and Health Sciences, Stellenbosch University. Prof Hemmings delved into the complex links between the gut-brain connection and mental health. This webinar was sponsored by Viatris in the interest of education, awareness, and support. The content and opinions expressed are entirely the speakers’ own work and not influenced by Viatris in any way. This webinar is accredited for one (1) CPD point and is intended for healthcare professionals practicing in South Africa.

Over 2000 years ago, Hippocrates recognised the pivotal role of the gut in disease, setting the stage for contemporary research on the gut microbiome. This complex ecosystem, primarily composed of bacteria, constitutes around 95% of the trillions of microbes evolving in tandem with humans. Lifestyle, stress, diet, age, and genetics influence the composition of the microbiota, predominantly residing in the gut.

The neonate microbiome’s establishment, influenced by factors such as birth mode, maternal health, gestational age, and infant diet, lays the foundation for longterm health. In adults, a core microbiome comprising six to seven bacterial phyla is essential for health, but the diversity is vast due to individual differences, explained Prof Hemmings.

Link between gut microbiome and neuropsychiatric disorders

Disruptions in the gut barrier and increased permeability can lead to systemic inflammation, affecting the blood-brain barrier and contributing to neuroinflammation associated with psychiatric disorders.

Animal studies have highlighted the profound impact of the microbiome on

stress responses and mental health. Key findings from these studies emphasise the microbiota’s crucial role in shaping the stress response’s normal development and highlight a critical window for appropriate gut colonisation.

Studies also indicate changes in the microbiota in patients with major depressive disorder (MDD). Fecalibacterium prausnitzii has been identified as a potential contributor to these changes, and reductions in colonisation may lead to an improvement in symptoms.

Furthermore, limited research suggests a link between post-traumatic stress disorder (PTSD) and the gut microbiome. Specific bacteria genera associated with PTSD have been identified, showing higher abundance in affected individuals, which correlate with symptom severity.

Proposing a hypothesis connecting PTSD, gut microbiota, and periodontal disease, Prof Hemmings suggested that periodontitis-induced inflammation may influence PTSD susceptibility. Earlylife trauma is implicated in altering the oral microbiome, potentially leading to periodontal disease and subsequent neuropsychiatric disorders.

Behavioural changes have been observed in children with autism spectrum disorders (ASD) following antibiotic courses.

ASD symptoms showed improvement following faecal microbiota transplants.

Possible effective interventions

Psychobiotics (live bacteria conferring mental health benefits), dietary changes, and faecal microbiota transplants have been suggested as potential effective interventions alongside pharmacotherapy for patients with neuropsychiatric disorders. Systematic reviews have revealed promising results in patients with MDD and schizophrenia, particularly with psychobiotics containing Bifidobacterium or Lactobacillus

Conclusion

Prof Sian Hemmings’ webinar has provided a deep dive into the complex connections between the gut and the brain, offering insights that could reshape our approach to mental health.

If you missed the webinar, a replay video is available on www.medicalacademic.co.za Navigate to the webinar/events page.

Once you have finished watching the replay video, send an email to john. woodford@newmedia with your name and surname, the name of the webinar (The microbial mind: Exploring the gut-brain connection for mental well-being) and your MP number. SF

The clock, the mouth and the ladder

Pain is defined as an unpleasant blend of sensory and emotional perceptions, often akin to those associated with actual or potential tissue damage, according to the International Association for the Study of Pain (IASP). The definition stresses the deeply personal nature of pain, shaped by a complex interplay of biological, psychological, and social elements.1

The IASP stresses the need to distinguish between pain and nociception, the latter referring to the neural processing of noxious stimuli by the central and peripheral nervous systems, such as those induced by tissue injury or extreme temperatures. The IASP cautions that activity in sensory neurons cannot definitively indicate the presence of pain.1

Additionally, the IASP states that it is importance to respect an individual’s verbal expression of their pain experience. Verbal communication is acknowledged as just one of many behavioural cues indicative of pain. Thus, the inability to articulate pain verbally does not discount the possibility of experiencing pain, a phenomenon observed in both humans and non-human animals.1

Pain is classified into three types:2

1 Nociceptive pain: This type of pain is caused by damage to body tissues. It is typically sharp, aching, or throbbing in nature and is often localised to the site of tissue damage. Examples include pain from cuts, burns, fractures, or inflammation.

2 Neuropathic pain: Neuropathic pain arises from damage or dysfunction of the nervous system, particularly the peripheral or central nerves. It can manifest as shooting or burning pain, tingling, or numbness. Conditions such as diabetic neuropathy, post-herpetic neuralgia (shingles), and nerve compression injuries can cause neuropathic pain.

3 Neuroplastic pain: This type of pain is related to changes in the nervous system, particularly in response to chronic musculoskeletal conditions such as arthritis or repetitive strain injuries. It involves alterations in neural pathways and processing, leading to increased sensitivity and pain perception.2 Understanding the different types of pain is crucial for appropriate management and treatment strategies. Effective pain management often involves a multidisciplinary approach that addresses both the physical and psychological aspects of pain. 2

Chronic versus acute pain

The IASP defines acute and chronic pain as:

1 Acute pain has a sudden onset, short duration (lasts from a few minutes to <6-months) and is clearly associated with a cause (eg injury, surgery, illness, trauma, or painful medical procedures).3

2 Chronic pain is defined as pain that lasts or recurs for >3 months. In chronic pain syndromes, pain can either be the primary concern or a prominent symptom that necessitates specialised treatment and attention. Conditions like fibromyalgia or nonspecific low-back pain may be regarded as chronic primary pain, where pain itself is considered a distinct condition. Conversely, in six other subgroups, pain is secondary to an underlying disease. These subgroups include chronic cancer-related pain, chronic neuropathic pain, chronic secondary visceral pain, chronic posttraumatic and postsurgical pain, chronic secondary headache and orofacial

Pain causes: Nurture, nature or both?

The perception of pain is shaped by a complex interplay between environmental factors and genetic predispositions. Environmental influences, including psychological, social, and cultural factors, significantly impact pain perception and behaviour. 6

pain, and chronic secondary musculoskeletal pain. In these cases, pain is initially perceived as a symptom of an underlying condition and is categorised as chronic secondary pain.4 According to a South African study, one in five South African are living with chronic pain. Women have a higher risk of chronic pain (20.1%) compared to men (15.8%). Furthermore, the prevalence of chronic pain showed an increase from 11.3% in the age group of 15- to 24-years to 34.4% among individuals aged >65-years. The body regions most affected by chronic pain were the limbs, with a prevalence of 43.6%, followed by the back, with a prevalence of 30.5%.5

Psychological factors such as past pain experiences, emotional state, and coping mechanisms, as well as social factors like socioeconomic status and cultural beliefs, contribute to variations in pain sensitivity and response across individuals and populations.6

Cultural factors play a significant role in how pain is expressed and managed, with differences observed in coping styles and attitudes toward pain medication among different cultures.6

Ethnic disparities in pain sensitivity and tolerance highlight the influence of socioeconomic disparities, chronic stress, and limited social support on pain experiences among minority populations.6

Demographic factors such as gender and age also influence pain perception, with women generally reporting higher pain intensity and being at greater risk for chronic pain disorders compared to men. Ageing can affect pain sensitivity due to physiological and psychosocial changes. Lifestyle habits such as exercise, smoking, and alcohol consumption further impact pain perception, with varying effects on pain severity and chronicity.6

Psychosocial and biobehavioural factors, including personality traits, mood disorders, and sleep disturbances, significantly influence pain perception and behaviour, with catastrophising linked to heightened pain intensity and maladaptive responses.6

Clinical factors, including disease-related variables and treatment outcomes, also play a role in pain perception and management, emphasising the importance of addressing acute pain to prevent its transition into chronic pain.6

Research into the molecular genetics of pain has shown genetic risk factors that contribute to pain phenotypes across species. Heritability studies have provided insights into the genetic basis of pain perception, highlighting distinct genetic mechanisms for processing different types of stimuli.6

Monogenic pain disorders caused by mutations in specific genes underscore the role of rare genetic variants in pain conditions and offer potential therapeutic targets.6

Candidate gene association studies have identified numerous genes contributing to different types of pain, suggesting shared genetic pathways underlying various pain conditions. The influence of genetic variants extends beyond functional pain disorders to impact acute and chronic pain responses in diverse conditions.6

Evoked pain is a valuable tool in dissecting the genetic basis of clinical pain phenotypes, with genetic studies revealing variability in pain sensitivity influenced by specific genes. Investigations into analgesic response have identified genetic variations affecting drug

metabolism and response, with implications for pain management.6

While numerous pain-related genes have been identified, genome-wide association studies offer promise in identifying novel genetic variants associated with pain phenotypes, paving the way for personalised pain management approaches.6

Advances in sequencing technologies hold potential for uncovering rare mutations contributing to extreme pain phenotypes, further enhancing our understanding of the genetic underpinnings of pain.6

The 5 As of pain management

A widely used comprehensive strategy for addressing persistent pain is the five As of pain management:7

1. Analgesia

2. Activities of daily living

3. Adverse effects

4. Affect

5. Aberrant drug-related behaviours (eg addiction).

Shifts in these five domains over the course of opioid treatment indicate potential complications, therapy shortcomings, and increased vulnerability to advancing toward opioid dependence and addictive disorders.7

The World Health Organisation’s (WHO) analgesic ladder, is based on three key principles:8

1. By the clock

2. By the mouth

3. By the ladder.

In essence this means timely administration, oral delivery, and stepwise escalation. 8

The WHO’s analgesic ladder recommends:8

Step 1

Mild pain: Non-opioid analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen with or without adjuvants.

Step 2

Moderate pain: Weak opioids (hydrocodone, codeine, tramadol) with or without non-opioid analgesics and with or without adjuvants.

Step 3

Severe and persistent pain: potent opioids (morphine, methadone, fentanyl, oxycodone, buprenorphine, tapentadol, hydromorphone, oxymorphone) with or without non-opioid analgesics, and with or without adjuvants.

FDC tramadol/paracetamol offers swift action and long-lasting pain relief Tramadol and paracetamol are some of the most prescribed painkillers in the world. Fixed-dose Tramadol/paracetamol is also available in a fixed-dose combination (FDC) with paracetamol for the symptomatic treatment of moderate to severe pain. FDC tramadol/paracetamol is a swiftly acting, long-lasting, multi-faceted pain reliever,

exhibiting efficacy and generally favourable tolerability among patients living with moderate to severe pain.9,10,11

Across several meticulously conducted clinical trials, both single and multiple doses of tramadol/paracetamol demonstrated efficacy in alleviating pain in adult patients following minor surgical procedures, those suffering from various forms of musculoskeletal pain (acute, subacute, or chronic), painful diabetic peripheral neuropathy, or migraine pain.11

Studies have also shown that FDC tramadol/paracetamol is effective as an adjunctive analgesic for individuals experiencing moderate to severe musculoskeletal pain (such as osteoarthritis or rheumatoid arthritis pain) despite ongoing NSAID and/or disease-modifying antirheumatic drug therapy. Furthermore, in patients contending with postoperative pain, ankle sprain discomfort, or subacute lower back pain, the analgesic prowess of tramadol/paracetamol surpassed that of paracetamol, generally matched or exceeded tramadol alone, and generally equalled ibuprofen or FDCs such as hydrocodone/ paracetamol, codeine/paracetamol, and codeine/paracetamol/ibuprofen.11

Additionally, the analgesic effectiveness of tramadol/paracetamol did not significantly deviate from that of gabapentin in patients enduring chronic pain associated with diabetic peripheral neuropathy.11

Notably, tramadol/paracetamol exhibited no additional tolerability concerns compared to its individual components, and overall, its tolerability profile closely resembled that of other active comparators (be they fixed-dose combinations or single agents). However, incidences of certain adverse events were lower among tramadol/ paracetamol recipients compared to those receiving active comparators.11

Conclusion

The rapid onset and long-lasting efficacy of FDC tramadol/paracetamol make it a viable option for patients living with moderate-to-severe pain caused by various conditions, including postoperative recovery, musculoskeletal disorders, diabetic neuropathy, and migraines. Studies have shown its comparable or superior performance to widely utilised analgesics such as paracetamol, standalone tramadol, and even ibuprofen. Additionally, the favourable tolerability profile and limited occurrence of adverse events associated with FDC tramadol/paracetamol reinforce its status as a valuable therapeutic option for individuals seeking effective pain relief.

References are available on request. SF

Ensuring safe moderate sedation practice

Sedation involves the pharmacologically induced reductions in consciousness across various states, each characterised by differing levels of consciousness, ranging from minimal to complete unconsciousness. These states include minimal sedation/ anxiolysis, moderate sedation and analgesia (also known as conscious sedation), dissociative sedation, deep sedation, and general anaesthesia.

Moderate sedation/analgesia involves inducing a state of reduced consciousness where patients maintain the ability to respond purposefully to verbal commands and light tactile stimulation.

This practice is widespread in healthcare settings, including minor procedures in various locations such as cardiac catheterisation

laboratories, endoscopy suites, emergency rooms, and dentist offices, and can be administered by different healthcare providers, including physicians and dentists.

Indications for moderate sedation/analgesia include procedures causing significant discomfort, with the sedation level tailored to the anticipated pain and the necessity for patient immobility. Patient stability during the procedure is also a crucial factor in decision-making, with attention given to vital sign stability.

Preparation for conscious sedation/analgesia is vital and should ideally occur in a simulated environment before the procedure. Selection of agents and techniques relies on factors such as practitioner expertise, patient-related medical conditions, and procedural nature, with considerations given to the risk of inadvertently inducing deeper sedation than intended.

Practitioners must be prepared to manage unexpected changes in sedation levels, particularly for moderate sedation, which may involve addressing compromised airway or hypoventilation and supporting cardiovascular function in patients experiencing fluctuations in blood pressure or heart rate.

Pre-procedure patient preparation, according to the American Society of Anesthesiologists (ASA) guidelines, involves consultation with medical specialists when needed, informing patients about the benefits and risks of sedatives/analgesics, providing pre-procedure instructions and counselling, and ensuring appropriate fasting.

During the procedure, assessing the time and nature of the last oral intake and evaluating the risk of pulmonary aspiration of gastric contents are recommended before determining the target level of sedation and deciding whether the procedure should proceed.

Following standardised operative checklist procedures, such as the World Health Organization template, is recommended, including verifying identity, procedure, and consent, marking the site/side; checking for needed medications and monitoring devices, assessing for airway difficulties/anomalies; confirming team members’ roles and preparation, and displaying necessary images.

At the end of the procedure, ensuring each team member confirms stability in their role before leaving the procedure room is essential for patient safety and continuity of care.

References are available on request. SF

SEDALPHA® (Dexmedetomidine):

- Provides co-operative sedation without risk of respiratory depression or airway compromise1,2

- Ensures patients are easily rousable and co-operative1

- Reduces post-operative delirium incidence1

- Is associated with a decrease in the length of intensive care unit stay1,2

The generic sedative with the well-established alpha molecule you’ve come to trust.

*Sales data IMS MAT period February 2022 – March 2023

References:

1. Liu X, Li Y, Kang L, et al. Recent advances in the clinical value and potential of dexmedetomidine. Journal of Inflammation Research 2021:14 7507–7527.

2. Scott-Warren VL, Sebastian J. Dexmedetomidine: its use in intensive care medicine and anaesthesia. BJA Education. 2016;16(7):242-246.

S5 SEDALPHA 100 μg/ml (Concentrate for solution for infusion). Each ml of concentrate for solution for infusion contains dexmedetomidine hydrochloride equivalent to 100 μg dexmedetomidine. Reg No.: 48/2.9/0969. For full prescribing information please refer to the professional information approved by the Regulatory Authority (SAHPRA).

Exciting news: Updated SA guideline mometasone/olopatadinerecommends combo

The South African Allergic Rhinitis Working Group (SAARWG) recently updated their allergic rhinitis (AR) recommendations to align with local needs. An exciting new addition to their recommendations is the use of combination mometasone/ olopatadine nasal spray for seasonal and perennial AR.1

AR affects between 10% and 40% of the global population and is often underdiagnosed. The impact of AR extends beyond mere discomfort, significantly impacting productivity and quality of life (QoL).1

The consequences of AR include exacerbations of asthma, comorbidities like rhinosinusitis and otitis media, increased susceptibility to viral illnesses, interference with taste and smell, as well as poor sleep quality.1

Poor sleep quality linked to AR can lead to chronic fatigue, daytime sleepiness, and learning difficulties – especially in children. Additionally, AR can exacerbate mood disorders such as depression and impair concentration.1

Clinical assessment essential to diagnose AR

The diagnosis of AR relies on clinical assessment, including a detailed history of symptoms and allergen exposure, along with laboratory tests indicating allergic sensitisation. Symptoms of AR include nasal signs such as rhinorrhoea, sneezing, nasal blockage, and itching, as well as non-nasal symptoms such as allergic conjunctivitis, and cough.1

Clinical examination, including signs of atopy, evaluation of the inferior turbinate, and assessment of concomitant allergic diseases, is crucial for diagnosis. Imaging, particularly plain film sinus X-rays, has no place in diagnosis, while computed tomography scanning should be reserved for suspected chronic sinus disease.1

The seven pillars of AR management Effective AR management should incorporate the following seven pillars:1

1 Education: Inform patients that AR is a chronic disease and provide information of the various treatment options.

2 The importance of adherence allergen avoidance: Common outdoor allergens are pollens and fungal spores, while the major

indoor allergens include house dust mites, pets, moulds and cockroaches.

3 Nasal douching/irrigation and rinses: Irrigation with saline, either hypertonic or isotonic, is a cost-effective method to remove allergens, irritants, and mucus, improving clearance.

4 Pharmacological treatment: Evidence-backed options include intranasal corticosteroids [INCS], intranasal antihistamines [INAH], combination INCS/ INAH and leukotriene receptor antagonists.

5 Patient evaluation for allergen immunotherapy (AIT): The only disease-modifying treatment for AR, alleviates short- and long-term symptoms, reducing medication dependency and hindering AR-to-asthma progression. Indicated for patients inadequately managed with pharmacotherapy, those who have high-dose requirements, to reduce the risk of adverse events and aversion to prolonged medication use, in children to prevent sensitisations and asthma, and for individuals with pollen-food syndrome.

6 Measuring response to therapy: Visual analogue scales or AR control tests, can be used to assess treatment response and control. They are quick and to use in clinical practice.

7 Referral to a specialist: Is warranted for patients who have a poor response to treatment, those who require AIT or aeroallergen assessment, patients who experience atypical symptoms or have nasal abnormalities, severe comorbidities, and immune deficiency, as well as in patients who have severe ocular involvement.

Recommended pharmacotherapies

INCS are recommended as first-line therapy for all forms of AR, effectively targeting a broad range of symptoms. Their intermittent use is recommended for seasonal disease, while continuous use is suitable for perennial disease. Efficacy assessment should occur two- to four-weeks into treatment, and if

symptoms persist, combining an INCS with an AH is recommended.1

INCS are effective in reducing the release of inflammatory mediators, providing symptomatic relief when used consistently or in extended treatment blocks. They pose a lower risk of systemic side effects compared to oral and inhaled CS due to lower doses and bioavailability.1

Short-term use of INCS drops is acceptable for severe congestion, but longterm usage, especially compared to nasal sprays, is strongly discouraged due to higher systemic bioavailability and increased likelihood of systemic side effects.

Depot intramuscular steroid injections are not recommended due to associated complications.1

Systemic antihistamines, particularly H1-AH, effectively counteract the effects of histamine during allergic reactions. They address itching, sneezing, and rhinorrhoea but have limited efficacy against congestion. The use of first-generation H1-AH, with poor receptor selectivity and significant side effects, are strongly discouraged.1

Second- and third-generation formulations are safer and more efficacious, with reduced sedation. The SAARWG recommends exclusively using newer generation AH, with careful consideration based on individual patient profiles. Topical INAHs are fast-acting and are more effective than oral AH in AR control. They are also safe and effective for children with AR.1

Conclusion

The updated recommendations from the SAARWG provide a comprehensive and tailored approach to managing AR. The seven pillars of AR management outlined by SAARWG emphasise education, allergen avoidance, nasal irrigation, pharmacological treatment, AIT, monitoring response, and specialist referral when necessary.

Reference is available on request. SF

RECOMMENDED BY THE SA ALLERGIC RHINITIS (AR)

WORKING GROUP 2023:

INCS* are the treatment of choice for AR INAH** act rapidly within 15 minutes ecific reference was made to the INCS/INAH combination of mometasone/olopatadine as contained in Ryaltris®.

FAST RELIEF, LASTING COMFORT TM

Comprehensive Relief in Allergic Rhinitis 2,3

Rapid symptom relief within 15 minutes

Better quality of life (QoL) vs monotherapy

Dual benefits of olopatadine and mometasone

Statistically significant improvements in ocular and nasal symptoms

Well tolerated

*Intranasal corticosteroids

References:

**Intranasal antihistamines

1. Richards GA, McDonald M, Gray CL, et al. Allergic rhinitis: Review of the diagnosis and management: South African Allergic Rhinitis Working Group. S Afr Fam Pract. 2023;65(1), a5806. https://doi.org/10.4102/safp.v65i1.5806. 2. Patel P, Salaptek AM, Tantry SK. Effect of olopatadine-mometasone combination nasal spray on seasonal rhinitis symptoms in an environmental exposure chamber study. American College of Allergy, Asthma & Immunology. 2019;122(2):160-166.e.1. 3. Gross GN, Berman G, Amar NJ, et al. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol, 2019;122:630-638.

S2 RYALTRIS® (Nasal spray). Reg. no. 53/21.5.1/0457. Each spray delivers 600 μg olopatadine (as olopatadine hydrochloride) and 25 μg mometasone furoate (as mometasone furoate monohydrate). Contains the preservative benzalkonium chloride 0,02 % w/w. Sugar free. For full prescribing information refer to the professional information approved by the South African Health Products Regulatory Authority. Date of revision: 18 July 2022.

HCR: Glenmark Pharmaceuticals South Africa (Pty) Ltd. 2nd Floor, Building D, Stoneridge Office Park, 8 Greenstone Place, Greenstone, Edenvale, Gauteng, 1609. (Office) +27 11 564 3900. www.glenmarkpharma.com. ZAR/03/2024/03

Glenmark, touching the lives of patients for over three decades

Imiquimod pump takes the hassle out of dosing

Actinic keratoses (AK) are common in individuals with light skin – especially those with a history of cumulative sun exposure. AK lesions can disappear, persist or, rarely develop into non-melanoma skin cancer (cutaneous basal cell carcinoma [cBCC] 0.5%, or cutaneous squamous cell carcinoma [cSCC] <1%).1,2

Arecent (2023) comprehensive and updated analysis found that the global prevalence of AK is ~14%. In tropical and temperate regions, the AK prevalence rate is ~18% and in subtropical regions it is ~2%. South Africa is divided into subtropical and temperate regions, which implies that the prevalence of AK is between 2% and 18%. Therefore, the potential number of people affected by AK in South Africa could range from ~1.2 million to ~10.8 million. 3

Among individuals aged >60-years, the overall prevalence rate is 19%, whereas for those aged <60-years, it was 15%. Notably, in men, the overall prevalence rate is 24% with high heterogeneity, while in women, it is 14%.3

The development of AK is influenced by five key independent risk factors:4

1. Age

2. Gender

3. Phototypes I and II

4. Previous history of cutaneous neoplasms

5. Occupational sun exposure. The history of previous skin neoplasms is particularly significant as it reflects individual genetic factors affecting sensitivity to UV radiation and chronic

UV exposure. Assessing the impact of occupational sun exposure reveals a twoto-three times higher risk for AK in outdoor workers, with an increased risk for all cutaneous neoplasms (odd ratio [OR]: 3.45 for AK, 3.67 for cSCC, 3.32 for cBCC, and 1.97 for melanoma). 4

Additional risk factors include episodes of painful sunburn before age 20 (OR = 1.21), lack of sunscreen use (OR = 1.81), and a positive family history of cutaneous neoplasms (OR = 1.85). Painful sunburn episodes before 20 years may initiate carcinogenesis, leading to p53 gene mutations and clonal keratinocytic expansion due to acute and chronic UV radiation exposure.4

Patients with chronic use of systemic immunosuppressive pharmacotherapy constitute a specific risk group for developing cutaneous neoplasias and dysplasias due to the carcinogenic effects of UV radiation. 4

Clinical signs and symptoms

AK manifest as erythematous macules, papules, or plaques, typically exhibiting poorly defined borders and often covered by adherent dry scales. Palpation may

prove more effective than visual inspection for accurate identification, and varying degrees of hyperkeratosis are observed. 4

The lesions can appear as either singular or multiple entities, showcasing colours ranging from pink to erythematous or assuming a brownish hue, especially in the case of pigmented actinic keratoses. The degree of infiltration varies based on the intensity and extent of lesion dysplasia. While these lesions are largely asymptomatic, some patients may report discomfort, including sensations of burning, pain, bleeding, or pruritus. 4

AK may take on various forms, exhibiting clinical variants including hyperkeratotic AK, non-hypertrophic AK, pigmented lichenoid AK, cutaneous horn, and actinic cheilitis. Each variant possesses distinct clinical and morphological characteristics, underscoring the importance of accurate recognition for proper management. This differentiation is crucial, as certain subtypes of actinic keratoses respond more effectively to specific therapeutic modalities. 4

No pain, no gain

Treatment options for AK can be broadly

categorised into lesion-directed and field-directed therapies. The prevailing notion associated with AK treatment is the ‘no pain, no gain’ approach, suggesting that effective treatment may entail some discomfort or side effects. 5

Lesion-directed therapies target individual actinic keratoses, employing methods such as cryotherapy, curettage, or surgical excision. These approaches effectively address specific visible lesions. However, recurrence is more common than other methods. 5

Conversely, field-directed therapies offer the advantage of treating multiple, widespread, and subclinical AK within an area of chronic sun damage. Examples include topical medications such as imiquimod, light-based therapies like photodynamic therapy (PDT), or laser resurfacing, aiming to treat the entire affected skin field. These treatments address both visible and subclinical lesions. 5

In South Africa, imiquimod is approved for the topical treatment of superficial cBCC, and of external genital/perianal warts and clinically typical, non-hyperkeratotic, nonhypertrophic AK on the face or scalp in adult patients. 6

Considerations when selecting a treatment strategy

Treatment strategies must be personalised, considering factors such as lesion characteristics, patient preferences, treatment availability, adherence, adverse effects tolerability, and cost. Urgent intervention is warranted in cases of numerous lesions, bleeding, pain, or rapid lesion growth to prevent potential complications. 5

Patient communication about anticipated treatment adverse effects, including blistering, erosion, crusting, burning,

discomfort, pain, pruritus, erythema, and oedema, is crucial. Clear instructions on post-treatment skin care and the expected healing process are essential. 5

with hyperkeratotic/hypertrophic lesions demonstrated comparable responses.7

Field-directed therapies offer the advantage of treating multiple, widespread, and subclinical AK within an area of chronic sun damage

Safety, efficacy, cosmetic outcomes and recurrence

Notably, local skin reactions were the most frequently reported adverse effects, prompting treatment discontinuation in only four patients. The severity of these local skin reactions emerged as a robust predictor of treatment outcomes.7

Stokfleth et al conducted a non-controlled interventional clinical study to assess the effectiveness of imiquimod in treating multiple, multiform AK. Patients exhibiting clinically typical and visible AK lesions on the head were subjected to a fourweek regimen of 5% imiquimod cream, administered three times per week, followed by a four-week treatment pause.7 In cases where lesions persisted, a second course of treatment was initiated. The primary outcome measure was the complete clearance rate, indicating the absence of clinically visible AK lesions in the treated area.7

Treatment with imiquimod resulted in an overall complete clearance rate of 40.5% after the first course of treatment and 68.9% after the entire treatment course. Remarkably, 85.4% of the 7 427 baseline lesions exhibited clearance. Patients

Adverse effects are dose-dependent and is attributed primarily to the direct immunomodulation effects of imiquimod on the skin. Recovery is achieved after discontinuation or a reduction in use. However, it should be noted that intense local reactions tend to result in better results for treatment. 8

The findings of the study by Stokfleth et al suggest that patients with multiple, multiform AK on the head can be effectively and safely treated with topical imiquimod in routine clinical practice. Importantly, patient education on proper drug administration is crucial for ensuring treatment success.7

A study by Kawtchenko et al compared the efficacy and cosmetic outcomes of topically applied 5% imiquimod cream, 5% 5-fluorouracil (5-FU) ointment, and cryosurgery for AK treatment. Patients underwent one or two courses of cryosurgery, topical 5-FU, or one or two courses of topical imiquimod. Results showed that imiquimod not only demonstrated superior initial clinical clearance (85%) compared to cryosurgery (68%) and 5-FU (96%), but sustained clearance at 12 months (73%) over cryosurgery (4%) and 5-FU (33%). Imiquimod also yielding the best cosmetic outcomes. The study suggests imiquimod as a first-line therapy for sustained AK treatment.9

Recurrence is common, and the healing duration varies, necessitating vigilant monitoring. In cases of treatment failure, further investigation is crucial. Reasons may include non-adherence, misdiagnosis, or, rarely, the potential for malignant transformation to cBCC or cSCC. 5

In a study led by Gollnick et al, the team assessed the prolonged (60 months) clinical effectiveness and safety of oncedaily application of imiquimod 5% cream, administered five times per week for six weeks, for treating superficial BCC. Interim results showed an initial clearance rate of 90% was observed 12 weeks posttreatment. At the 12-month follow-up period, ~79.4% of participants remained clinically clear.10

At the end of the study (60 months), Gollnick et al reported that the overall treatment success estimate for all treated patients at the end of follow-up was 77.9% (80.9% considering histology).11

StaminoGro is a 5-in-1 supplement with amino acids, antioxidants, B vitamins, and other essential vitamins & minerals that works synergistically to help promote energy, well-being, immune defence and mental vitality.

Non-adherence to treatment a huge stumbling block

A recent study by Koch et al showed that 46.9% of patients living with AK are nonadherent and 30.9% were non-persistent. Non-adherence refers to a patient’s failure to follow the recommended treatment plan, including medication schedules or lifestyle changes. It indicates a deviation from the prescribed instructions, such as missing doses or not adhering to dietary recommendations. On the other hand, non-persistence refers to discontinuing the recommended treatment prematurely before completing the prescribed duration.12

Koch et al found that lack of information about the application time (leave-on time) of the medication play a big role in non-adherence. Patients independently adjusted the therapy’s duration and dosing frequency regardless of their physician’s instructions. Interestingly, patients who had a more extended pre-treatment consultation tended to adhere to the correct treatment regimen.12

Additionally, patients with lower clearance rates showed significantly less awareness of application times and treatment duration, suggesting a link between pre-treatment consultation, adherence to application, and treatment success.12

Notably, patients gave low ratings for items such as ‘occurrence of adverse events’ (2.7/10), ‘fear of adverse events’ (2.1/10), and ‘discontinuation of therapy due to adverse events’ (2.1/10), with no discernible differences between adherent and non-adherent patients. This suggests that concerns related to adverse events do not significantly impact treatment adherence.12

How to patients feel about treatment with imiquimod?

A multi-centre, open-label study used the Skin-dex-17 and Treatment Satisfaction Questionnaire for Medication (TSQM) surveys to evaluate the impact of 5% imiquimod cream treatment on patientreported outcomes and health-related quality of life (HRQoL). The study revealed no clinically relevant impact on HRQoL, despite a low baseline impairment in HRQoL observed in both surveys.13

In a non-randomised pilot study, imiquimod 5% and another therapy achieved higher median TSQM scores for effectiveness and global satisfaction than previous treatments. Imiquimod 5% received the highest satisfaction scores for side effects. Unlike some treatments with known resolution of local skin reactions by

week three, imiquimod side effects typically peaked in the initial two weeks and resolved by weeks three to four post-therapy.14

In a comparative study with 5% imiquimod cream and PDT with MAL, patients reported comparable tolerance levels, though a higher percentage treated with PDT expressed greater satisfaction a month after treatment cessation. Nevertheless, a significant portion of imiquimod-treated patients (72%) preferred the same retreatment, emphasising patient preference for imiquimod.15

As noted by Caperton and Berman, patients tend to prefer self-administration of imiquimod treatment due to the perceived advantages of ease, convenience, privacy, and autonomy compared to modalities administered by physicians.16

Innovation to improve accuracy and convenience

Imiquimod is now offered in a distinctive storage and dispensing system, employing a pump mechanism, designed to enhance patient satisfaction. The advantages of this innovative pump system can be seen in the graphic alongside.17

Dispensing a controlled and precise amount of cream with each application.

Offering a simple and convenient usage experience.

Minimising the occurrence of degradation during storage.

Userfriendly for all patients, including the elderly and those with limited agility.

Enhancing adherence to treatment.

The advantages of this innovative pump system include:17

Reducing excessive patient contact.

Minimising product waste and loss.

Providing a consistent dose, thereby improving efficacy.

Not interfering with the imiquimod application technique.

Overall, the pump system is a more accurate, effective, and user-friendly method for delivering imiquimod. It effectively addresses several drawbacks associated with traditional packaging, such as imprecise dosing, manual delivery, and product wastage. Additionally, the pump system is more compact and portable, facilitating easier storage and transportation.17

Conclusion

The global prevalence of AK, as highlighted in a recent comprehensive analysis, is ~14%. Understanding the risk factors, clinical manifestations, and effective treatment modalities is crucial for managing AK successfully.

Imiquimod, a topical treatment option, has demonstrated promising results in terms of efficacy, safety, and cosmetic outcomes. Studies have shown its effectiveness in treating multiple AK lesions, and its superior outcomes and cosmetic benefits compared to other therapies.

The introduction of an innovative pump system for imiquimod aims to further enhance patient satisfaction by providing controlled and precise dosing, userfriendliness for diverse patient groups, improved adherence, and minimized product waste. This advancement addresses existing challenges associated with traditional packaging and administration methods.

References are available on request.

A digital health application in oncology: An opportunity to seize

A collaboration between Altron HealthTech and Dischem Oncology in improving clinical efficiencies, cost reduction, improved safety, and standardisation in the oncology practice domain through a leading digital health technology.

Digital health advances have transformed many clinical disciplines. However, digital health innovation is relatively nascent in cancer care, which represents the fastest growing area of healthcare spending.

Various opportunities for digital health innovation in oncology include patient-facing technologies that improve patient experiences, safety, and patient-clinician interactions, clinicianfacing technologies that improve their ability to diagnose pathology and quality of care, and technology infrastructure to improve clinical workflows and documentation.

Oncologists spend most of their time in diagnosis and treatment of cancer patients and face many operational challenges in cancer care delivery daily. Resource intensive cancer care delivery demands leaders to take charge of their operations. An operation focused delivery with the aim to reduce costs, increase safety, improving clinical outcomes will allow an organisation to compete effectively in an aggressive marketplace.

According to the American Institute of Cancer Research, cancer costs the world approximately US$895 billion a year. This means that while advancements in cancer treatments are increasing, so are costs.

This year’s conference theme is: “INTEGRATING EXPERTISE: THE ROLE OF MULTI-DISCIPLINARY TEAMS IN ONCOLOGY.”

dates: 10 – 12 May 2024

venue: Indaba Hotel and Conference Centre, Johannesburg

REGISTER ATTENDANCE:

The Independent Clinical Oncology Network in South Africa estimates that, depending on the type of cancer, treatment locally can cost anything between R10 000 and R1 million per patient, per year. Everyone has a role to play in helping to keep medical costs under control. From individuals to medical schemes to the regulator and governments, we can all ensure pharmaceutical research and development is fair and transparent, while striving to drive increased use and access to generic drugs and biosimilars (drugs that are developed to have the same active properties as the original) that can lower costs and give individuals greater access to treatment. This also creates more opportunities for funding of newer therapies.

And, according to Cancer Research United Kingdom, the cost of cancer drugs is increasing by 10% per year. Alongside drugs, the cost of diagnosis, radiation, chemotherapy, imaging, pathology, surgery, and end-of-life care are also increasing exponentially.

Various options for digital health innovation in oncology that focuses on patients experiences and safety amongst other benefits are available

Owing to the vast potential for digital health technologies to improve quality and reduce spending in cancer care it is incumbent upon all players in the value chain to envision new ways to deliver oncology care and to facilitate broader, patient-centric integration of digital health in cancer care.

A collaboration between Altron HealthTech and Dischem Oncology aims to provide clinicians the opportunity of standardising EHR data to enable interoperability, increased patient access to and control of health data, and establishing payment reforms to offset the costs of digital health infrastructure.

Enhancing the inclusion of certain structured data elements in the EHR as it relates to standardised clinical workflows and approved treatment protocols could greatly improve the ability to display critical data to clinicians and care coordinators at the time of care.

In oncology practice, many data elements needed to understand the patient journey are documented in unstructured documents, such as clinician notes and diagnostics reports. Gathering and optimally displaying critical data could not only facilitate more efficient care but also supports safer care and more robust decision support tools, if implemented in a way that does not add to the administrative burden for the clinician and their workflows.

Despite current successes in digital health deployment in oncology, there remains several potential barriers to broad deployment of digital health tools. Attention to implementation factors that seamlessly integrate or simplify clinician workflows, access to approved treatment protocols, ease of pharmacy dispensing and operations, and reduced cost of technology infrastructure are critical to enable broad-based adoption.

Further, a barrier to good care coordination, along with other aspects of oncology care, is a lack of interoperability and standardisation of EHRs, as well as tools to aid clinicians in documentation with structured data.

The Altron HealthTech and Dischem Oncology collaboration removes the technology implementation cost barrier, allows access to approved treatment protocols and clinical workflows that tracks and manages the cycle of treatment activities, includes pathology integrations, authorisation flows with early warning on expiring treatment plans and authorisation numbers, user specific workflows by clinician, nurse, authorisation team and pharmacists, and ensures resilient billing functionality based on the treatment plan with seamless claims processing capability to funders.

In a nutshell, the technology solution will support the clinician, patient, nurse, pharmacist, and funder in improving the quality of care, cost and operational efficiencies, improved safety and optimisation of the financial metrics across the domain.

Keen to know more? Contact Altron HealthTech to book a demo TODAY or drop us an email at healthtech.sales@altron.com

Flu season nothing to sneeze about

Annually, between 290 000 to 650 000 patients die as a result of seasonal influenzarelated complications. In South Africa, an annual fatality range of 7000 to 12 000 has been linked to complications. A recent study looked at the conventional belief that the influenza or flu season in South Africa starts with the onset of winter (June).1

According to Motlogeloa et al, the specific onset of influenza season in the country before their study was unclear, which impacted the healthcare sector’s ability to timeously administer flu vaccinations, and facilities to prepare for a potential increase in cases.1

So, when does influenza season start in South Africa?

Motlogeloa et al set about exploring statistical intensity thresholds to determine the actual start date of influenza season in South Africa. The teams used medical insurance claims data, which showed that South Africa’s influenza season starts in autumn (April) with a spike in cases during winter months (June to August).1

Don’t confuse a common cold with influenza

The common cold and influenza are both contagious but are caused by different viruses. A cold, which has a gradual onset, can be caused by a number of different viruses, including rhinoviruses, para-influenza, and seasonal coronaviruses. Cold symptoms such as sneezing, a stuffy nose and a sore throat, are usually milder than flu symptoms.2

Influenza is characterised by a sudden onset of symptoms such as fever, myalgia, cough, sore throat, rhinitis and headache. Uncomplicated influenza typically resolves after three to seven days, although cough

and malaise can persist for >2 weeks. 3

Influenza is only caused by influenza viruses. In humans, the influenza virus is categorised into two main types: A and B. Influenza A is further subdivided into distinct subtypes, including influenza A(H1N1) pdm09 and A(H3N2). The subtype A(H1N1) pdm09 – commonly referred to as swine flu (but the term is frowned upon by the South African National Institute of Communicable Diseases [NICD]) – has similar symptoms to other seasonal influenza strains and should receive similar treatment as uncomplicated influenza, recommends the NICD. 2,3

At the time of writing this article, limited data were available about circulating influenza strains for the 2024 southern hemisphere influenza season. According to information published by the NICD at the end of January 2024, influenza B viruses have been detected earlier this year. According to the institute, clinicians should have a high index of suspicion for influenza in travellers presenting with respiratory symptoms, who have travelled from the northern hemisphere.4

Can influenza be prevented?

Influenza vaccination is the most effective method to prevent and control influenza infection. However, cautioned the NICD, vaccination does not rule out influenza infection. Ideally, vaccines should be administered at least 14 days before the start of the influenza season for the body

to build immune responses to protect against infection. So, based on the data by Motlogeloa et al, mid-March is the ideal time to get vaccinated. 5,6

Who should be vaccinated?

Risk groups for severe/complicated influenza disease include:5

_ Pregnant women and women up to six weeks post-partum

_ People living with HIV

_ Individuals living with tuberculosis (TB)

_ Individuals of any age with chronic diseases:

• Pulmonary diseases (eg asthma, chronic obstructive pulmonary disease [COPD])

• Immunosuppression (eg individuals treated with immunosuppressive medication, or those living with malignancies)

• Cardiovascular diseases (eg congestive cardiac failure, chronic heart disease, hypertension, stroke)

• Metabolic disorders (eg diabetes)

• Renal disease

• Hepatic disease

• Neurologic and neurodevelopmental conditions

• Haemoglobinopathies (eg sickle cell disease)

_ Individuals aged ≥65-years

_ Individuals ≤18-years receiving chronic aspirin therapy

_ Individuals living with morbid obesity (body mass index BMI ≥40/172kg2)

The 1st medicine in South Africa registered to reduce the risk of CV death or HHF across ejection fractions†‡1-4

• Protects the kidneys by slowing the decline in renal function over time ¶1,3,4

• Demonstrated efficacy in hospitalised patients with HFpEF and HFrEF after stabilisation 5

• Established safety and tolerability profile 1,3,4,5

• Simple dosing: 10 mg once daily, no titration #1

†JARDIANCE® is indicated in adult patients with heart failure independent of LVEF, with or without type 2 diabetes mellitus to reduce the risk of CV and HHF and to slow kidney function decline.1

‡Adult patients with chronic heart failure (NYHA class II, III, or IV) and reduced ejection fraction (LVEF ≤ 40 %). Adult patients with chronic heart failure (NYHA class II, III, or IV) and preserved ejection fraction (LVEF > 40 %).3,4

||In the EMPEROR-Preserved trial, a randomised, double-blind, parallel-group, placebo-controlled study of 5988 patients with HFpEF, the efficacy and safety of JARDIANCE® 10 mg (n=2997) were evaluated vs placebo (n=2991).

The primary endpoint in the EMPEROR-Preserved trial was a composite of CV death or HHF, analysed as time to the first event. Patients treated with JARDIANCE® experienced a 21 % RRR in this endpoint (HR=0,79; 95 % CI: 0,69, 0,90; p < 0,001).3 ARR was estimated as the absolute difference in the proportion of events by treatment arm.

ARR calculation: JARDIANCE® number of patients with events 415/total number of patients 2997=13,8 %; placebo number of patients with events 511/total number of patients 2991=17,1 %; 17,1 %–13,8 %=3,3 %.3

§In the EMPEROR-Reduced trial, a randomised, double-blind, parallel-group, placebo-controlled study of 3730 patients with HFrEF, the efficacy and safety of JARDIANCE® 10 mg (n=1863) were evaluated vs. placebo (n=1867).

The primary endpoint in the EMPEROR-Reduced trial was a composite of CV death or HHF, analysed as time to the first event. Patients treated with JARDIANCE® experienced a 25 % RRR in this endpoint (HR=0,75; 95 % CI: 0,65, 0,86; p < 0,001).4 ARR was estimated as the absolute difference in the proportion of events by treatment arm. ARR calculation: JARDIANCE® number of patients with events 361/total number of patients 1863=19,4 %; placebo number of patients with events 462/total number of patients 1867=24,7 %; 24,7 %–19,4 %=5,3 %.4

¶The rate of decline in eGFR was a prespecified secondary outcome of the EMPEROR-Preserved and EMPEROR-Reduced trials.3,4

#When JARDIANCE® is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia.1

ARR=absolute risk reduction; CV=cardiovascular; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; HHF=hospitalisation for heart failure; LVEF=left ventricular ejection fraction; NYHA=New York Heart Association; RRR=relative risk reduction

References: 1. Ingelheim Pharmaceuticals (Pty) Ltd. JARDIANCE® film-coated tablets approved professional information, 10 July 2023. 2. Data of file. 3. Anker SD, Butler J, Filippatos G, et al; EMPEROR-Preserved Trial Investigators. Empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med. 2021;385(16):1451-1461. 4. Packer M, Anker SD, Butler J, et al; EMPEROR-Reduced Trial Investigators. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383(15):1413-1424. 5. Voors AA, Angermann CE, Teerlink JR, et al. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022;28(3):568-574.

BOT1602899. For full prescribing information refer to the package insert approved by the Medicines Regulatory Authority. Pharmacovigilance: Healthcare Physicians can report any adverse event. To report an adverse event please send an email to PV_local_South_Africa@boehringer-ingelheim.com

_ Young children (particularly <2-years)

_ Healthcare workers.

Additional groups that would benefit from influenza vaccination, provided there are sufficient vaccine supplies after prioritising the above-mentioned groups, include:5

_ Individuals (adults or children ≥6-months) with an increased risk of influenza and related complications due to underlying medical conditions. This includes those receiving regular medical care for conditions such as TB, chronic renal disease, and metabolic disorders like inherited metabolic disorders and mitochondrial disorders

_ Residents of old-age homes, chronic care facilities, and rehabilitation institutions

_ Adults and children who are family contacts of individuals at a high risk of severe influenza

_ Any individual who wants to minimise the risk of influenza infection – particularly in workplace settings where widespread absenteeism could result in significant economic losses.

Recommended treatment for influenza viral infection

The NICD recommends antiviral therapy as an adjunct to the influenza vaccine. Treatment initiation depends on clinical judgment, considering factors like disease severity, age, underlying conditions, and time since symptom onset. 5

Antiviral treatment should ideally start within 48 hours of symptom onset, but it may still be beneficial for severe cases or hospitalisations beyond this timeframe. 5

Neuraminidase inhibitors such as oral oseltamivir are recommended, showing reduced symptom duration and potential benefits against severe outcomes, although large-scale trials specifically evaluating severe outcomes are lacking. The standard adult dose for oseltamivir is 75mg twice daily orally for five days. 5

Inhaled zanamivir is no longer recommended due to insufficient evidence. Adamantanes (amantadine and rimantadine) are not recommended due to high resistance levels. 5

In the context of influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) co-circulation, treatment for influenza remains the same for all patients, irrespective of co-infection. 5

Secondary complications

The NICD describes influenza as uncomplicated – until it is not. Influenza is associated with more severe complications including: Lower respiratory tract infection (LRTI), secondary bacterial or viral

infection (including pneumonia, sinusitis, acute bronchitis), multi-organ failure, and exacerbations of underlying diseases (eg COPD, chronic bronchitis, and acute bronchiectasis). Rare complications include encephalopathy, encephalitis, transverse myelitis, myocarditis, pericarditis and Reye syndrome. 5

Secondary bacterial infections increase the risk of morbidity. Bacterial infections can occur during or after an initial viral infection, particularly from viruses like influenza, RSV, parainfluenza virus, and human metapneumovirus.7

Streptococcus pneumoniae, Haemophilus influenzae and Staphylococcus aureus are among the bacteria commonly associated with secondary infections, leading to increased disease severity, including complications such as pneumonia.7 S. pneumoniae is the most common bacteria found in viral secondary bacterial infections and is associated with high mortality and morbidity rates during influenza season.7

Secondary H. influenzae infection is also associated with severe complications during influenza season. H. influenzae is a significant cause of bacterial meningitis, otis media and exacerbations of chronic lung disease such as COPD.7

S. aureus is transiently carried in the nose of 30% of the population, whilst 20% of the population have persistent nasal colonisation. Similar to H. influenzae and S. pneumoniae, S. aureus is an opportunistic pathogen and a major cause of bacteraemia and pneumonia –specifically necrotising pneumonia, caused by community acquired Methicillin-resistant S. aureus (MRSA), which is associated with a 30% mortality rate.7

Up to 75% of individuals infected with influenza that progress to pneumonia, have a confirmed bacterial co-infection. In South Africa, influenza is detectable in about 7% of children <5-years hospitalised with pneumonia and 9% of individuals ≥5-years diagnosed with pneumonia, increasing to 20%-40% during the influenza season. Notably, influenza should be considered a potential cause of community-acquired pneumonia (CAP) during influenza season. 5,7

The severity of secondary bacterial infections during viral infection –particularly influenza – is influenced by numerous factors, ranging from surface antigens to the production of specific toxins. The surface antigens haemagglutinin (HA) and neuraminidase (NA) play pivotal roles in viral infectivity.7

HA facilitates virion binding to host cells, with its specificity impacting infection

site and severity. The cleavage of HA, influenced by host proteases, is crucial for virion entry into host cells. NA enables the release of newly formed virions by hydrolysing sialic acid.7

In addition to these factors, the production of viral toxins, such as the cytotoxin polymerase basic protein 1-frameshift 2, contributes to increased inflammation, host cell damage, and bacterial adherence, ultimately intensifying morbidity and mortality.7

The molecular co-pathogenesis involves various interactions facilitating bacterial adhesion and penetration. Influenza-induced immunosuppression, impaired immune responses, and altered inflammatory pathways contribute to bacterial superinfection.7

The reduction in phagocytic activity, prolonged bacterial growth, and impaired bacterial clearance exemplify the complex relationship between viral and bacterial infections.7

Furthermore, damaged host cells provide additional adhesion sites, promoting bacterial adherence. Co-infection results in a synergistic increase in pro-inflammatory responses, affecting tissue damage and creating more attachment sites for bacterial infection.7

What are the most common conditions caused by secondary bacterial infections?

World Health Organization (WHO) data show that South Africans between the ages of 55- to 74-years are at greatest risk of mortality due to LRTIs. The National Department of Health recommends following the WHO guidelines for the treatment of LRTIs in paediatric patients. As mentioned above, some of the most common secondary bacterial influenza coinfections include CAP, acute bronchitis, and acute bacterial rhinosinusitis.7,9,10 Antibiotics are not recommended for uncomplicated cases, considering concerns about resistance and potential side effects. Antiviral treatment may be considered for influenza, but the benefits should be carefully weighed against potential adverse effects. Decision regarding treatment should be guided by microbiological testing. Narrow-spectrum agents are most effective against the identified organism. 8,11

Community-acquired pneumonia

The latest South African guideline (2018) for the treatment of adult CAP, recommends oral high-dose amoxicillin in patients <65-years without recent antibiotic exposure or comorbidities as initial therapy.8

S3 TICARDA 40: Each tablet contains 40 mg telmisartan and 162,6 mg mannitol. Reg. No.: 47/7.1.3/1094. S3 TICARDA 80: Each tablet contains 80 mg telmisartan

For the same group but with severe betalactam allergy or low macrolide resistance, an oral macrolide/azalide is an option.

Individuals ≥65-years and, those who used antibiotics recently, or with comorbidities should receive oral amoxicillin-clavulanate or a second-generation cephalosporin. 8

In the hospital setting, patients <65-years without recent antibiotic use or comorbidities should receive intravenous ampicillin or penicillin. Meanwhile, those ≥65-years, with recent antibiotic use, or comorbidities should get intravenous (IV) amoxicillin-clavulanate, cefuroxime, or a third-generation cephalosporin. Severe pneumonia cases demand a combination of amoxicillin-clavulanate or cefuroxime with a macrolide antibiotic. 8

Respiratory fluoroquinolones are an alternative but are not the first-line choice due to their activity against TB. They may be reserved for cases with severe betalactam allergy or as an alternative when no other options are available. Antibiotics are advised to be administered early, preferably within the emergency unit, for confirmed CAP cases.

8

Ceftaroline is recommended for highlevel penicillin-resistant S. pneumoniae or MRSA, while ertapenem is suggested for resistant Enterobacteriaceae, such as ESBL-producing pathogens. 8

Therapy for Pneumocystis jirovecii pneumonia (PCP) and TB should be considered based on clinical criteria and severity. Oseltamivir is recommended during the influenza season for severe pneumonia, and adjunctive therapies, including statins, macrolides, and corticosteroids, are recommended. 8

Duration of antibiotic therapy may be extended for specific scenarios, such as S. aureus bacteraemia or confirmed Legionella pneumonia. Complications, such as para-pneumonic effusion, empyema, lung abscess, CV events, and aspiration pneumonia, require specific considerations and interventions based on clinical responses and imaging findings. 8

Acute bacterial bronchitis

Bacterial pathogens play a role in ≤10% or less of cases. Among these bacterial pathogens, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Bordetella pertussis are the most common.11

Acute bronchitis is typically a self-limiting condition, and symptomatic and supportive therapies are recommended. To alleviate cough, various non-pharmacological methods such as hot tea, honey, ginger, and throat lozenges can be considered, although their efficacy lacks clinical trial evaluation.11

Antitussive agents like dextromethorphan are commonly used in clinical practice, though there’s a lack of specific trials for acute bronchitis. Codeine, due to its addictive potential, should be avoided.11

The role of mucolytic agents is uncertain, with conflicting data on their efficacy. Betaagonists are administered for wheezing, but their benefit for cough remains inconclusive.11

Analgesics and antipyretics manage associated symptoms, and steroids may address inflammation, especially in patients with underlying conditions like COPD or asthma.11

Acute bacterial rhinosinusitis

Acute bacterial rhinosinusitis is categorised based on the duration of symptoms. Acute sinus issues last less than four weeks, subacute cases persist for four to 12 weeks, and chronic instances extend beyond 12 weeks. Recurrent conditions involve four episodes with complete symptom resolution between each, each lasting less than four weeks.12

Causes of acute bacterial rhinosinusitis are S. pneumoniae, H. influenzae, and Moraxella catarrhalis infection. Prescribing decisions should be guided by local antibiotic resistance, patient risk factors, and symptom severity.12

First-line therapy includes amoxicillin/ clavulanate. Alternatives for penicillinallergic individuals include third-generation cephalosporins plus clindamycin or doxycycline. Fluoroquinolones are an option but carry a higher risk of adverse events.12

Antibiotic efficacy, especially in adults, may not significantly impact symptom duration or complication rates, with many cases resolving spontaneously. First-line therapy includes amoxicillin/clavulanate. Symptoms should improve within three to five days.12

Symptomatic relief can be offered with nasal steroids and saline irrigation, as recommended by guidelines, although evidence is limited. Nasal steroids reduce mucosal swelling, aiding obstruction relief. Nasal saline irrigation is effective in reducing obstruction, and antihistamines are only suggested for cases with a clear allergic component.12

Is Mother Nature driving antibiotic resistance?

The rise of antibiotic-resistance, exacerbated by climate change, poses a significant threat to global health. In 2020, antibiotic-resistant infections became at least 15% more common than in 2017, reports the WHO.13

While it is true that antibiotic-resistance are driven by overuse or misuse, climate change-related events such as floods,

droughts, and hurricanes can worsen the situation by reducing access to clean water and promoting unsanitary conditions. Furthermore, extreme weather events also drive an increase in injuries and infections, prompting more antibiotic use and increasing the risk of resistance.13

Studies show a correlation between rising temperatures and antibiotic resistance. A 1°C increase in average air temperature is associated with a 14% rise in antibioticresistant Klebsiella pneumoniae 13

Bacteria exposed to higher temperatures can evolve more rapidly, and genes, including those for antibiotic resistance, can be shared more easily. Extreme temperatures may induce genetic changes in bacteria, making them more resistant to antibiotics.13

Researchers are studying the interactions between climate, human behaviour, and antibiotic resistance. Factors such as increased indoor activities during extreme temperatures might contribute to the spread of resistant strains.13

Ongoing surveillance, combining weather data with monitoring antibiotic-resistance genes in wastewater, could improve forecasts and aid in tracking the spread of antibiotic-resistant bacteria.13

While efforts to reduce antibiotic resistance include improving water and sanitation access, awareness about proper antibiotic use remains crucial, concluded Wong.13

Conclusion

The annual toll of influenza-related complications is substantial, with 290 000 to 650 000 global fatalities reported. South Africa faces 7000 to 12 000 annual deaths due to influenza complications. A study by Motlogeloa et al found that the influenza season in South Africa begins in autumn (April) rather than winter (June). Accurate onset data is extremely important for timely vaccinations and healthcare preparedness. Influenza, distinct from the common cold, exhibits sudden onset symptoms such as fever, myalgia, and cough. Vaccination plays and important role in prevention and is recommended by the NICD – especially for high-risk groups like pregnant women, individuals with chronic diseases, and the elderly.

The severity of secondary bacterial infections during influenza such as CAP necessitates timely and appropriate antibiotic treatment. The threat of antibiotic resistance, exacerbated by climate change, requires a holistic approach involving improved surveillance, targeted vaccination strategies, and heightened awareness to mitigate the impact on public health.

References are available on request. SF

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Up to 46 % cost saving vs. the originator and 32 % vs. the clone 4

Daily CYFIL allows continuous PDE-5 inhibition for men whose sexual satisfaction is impaired by planning and timing of treatment5

20 mg CYFIL gets to work after just 16 minutes, and lasts up to 36 hours with a single dose2,3

May be taken any time of the day6

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ACCORD – QUALITY PRODUCTS MADE ACCESSIBLE AND AFFORDABLE TO MORE SOUTH AFRICANS

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cyfil tadalafil

References: 1. Based on internal analysis by Accord Healthcare using data from the following source: IQVIA Dispensed Data for the period MAT/01/2024, Script Lines, ATC3 G04B (Tadalafil-containing brands only) reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved. 2. CYFIL (Film coated tablet) prescribing information, March 2021. 3. Levine SB. Erectile Dysfunction: Why drug therapy isn’t always enough. Cleve Clin J Med 2003;70(3):241- 246. 4. Accord data on file. 5. Wrishko R, Sorsaburu S, Wong D, Strawbridge A, McGill J. Safety, efficacy, and pharmacokinetic overview of low-dose daily administration of tadalafil. J Sex Med 2009;6:2039-48. DOI: 10.1111/j.1743-6109.2009.01301.x. 6. Tolrà JR, Campaña JMC, Ciutat LF, Miranda EF. Prospective, randomized, open-label, fixed-dose, crossover study to establish preference of patients with erectile dysfunction after taking three PDE-5 inhibitors. J Sex Med 2006;3:901- 909. DOI: 10.1111/j.1743-6109.2006.00297.x. 7. Accord Data on File. S4 CYFIL 5 (film-coated tablet). Each 5 mg film-coated tablet contains 5 mg tadalafil and 91,572 mg lactose (as monohydrate). Reg No.: 50/7.1.5/0772. S4 CYFIL 20 (film-coated tablet). Each 20 mg film-coated tablet contains 20 mg tadalafil and 367,584 mg lactose (as monohydrate). Reg No.: 50/7.1.5/0773. For full prescribing information please refer to the professional information approved by the Regulatory Authority (SAHPRA). Accord Healthcare (Pty) Ltd. Reg. No.: 2004/011257/07. Tel: +27 11 234 5701/2/3. Building 31, Woodlands Office Park, 20 Woodlands Drive, Woodmead, 2191, Gauteng, SOUTH AFRICA. Postnet Suite 182,

CYF/002/MAR24/AD.

Multidisciplinary approach in fertility care:

Highlights from SASREG congress 2024

TThe South African Society for Reproduction and Gynecological Endoscopy (SASREG) recently concluded its highly anticipated national conference in Umhlanga, KwaZulu-Natal. The congress took place from 8-10 March. including psychological support for infertile couples and the emerging trends in carrier screening and gender diversity.

his three-day event brought together reproductive specialists, scientists, embryologists, geneticists, nursing coordinators and psychologists in the field of reproductive medicine to delve into the latest developments and practices shaping modern fertility care.

With an impressive turnout of 284 delegates, the conference boasted an excellent scientific programme designed to shed light on the multifaceted approach to contemporary fertility care.

From enhanced diagnostics to surgical innovations and discussions on reproductive genetics and legal frameworks, the agenda encompassed various dimensions of reproductive health.

The Friday workshops set the tone for the conference by delving into advanced skills in gynaecological ultrasound and operative hysteroscopy. These hands-on sessions provided attendees with practical insights and techniques to enhance their proficiency in these critical areas of reproductive medicine.

Saturday’s programme was marked by insightful discussions and presentations on infertility care, covering a spectrum of topics ranging from polycystic ovary syndrome management to fertility-sparing surgical techniques for conditions like endometriomas and adenomyosis.

The debate over the evidencebased management of freeze-all cycles sparked discussions on the potential impacts on obstetrical outcomes and epigenetic considerations.

A notable highlight was lessons learned

in fertility preservation in oncology patients over the past 10 years. Prof Michael Grynberg’s presentation on the latest European Society of Human Reproduction and Embryology guidelines underscored the evolving landscape of fertility preservation and its implications for patient care.

The embryology sessions were largely focused on the much-debated topic ‘addons’ and the implementation of these procedures into the in vitro fertility (IVF) laboratory. Experts in the field of both embryology and andrology discussed the current trending literature and studies pertaining to these novel techniques, that are taking over the market globally.

Furthermore, students in the field of reproductive biology presented their latest research studies and findings. A group of esteemed judges evaluated each presentation, and Samantha Bhengu received a generous sponsorship by LoRuMiR D for her presentation on In vitro embryonic diapause: The predictive potential of seminal oxidative stress in human embryo development.

The Reproductive Health Group from the University of Kwazulu Natal under the guidance and leadership of Prof Donrich Thaldar presented pressing topics currently under debate in South African law.

These discussions included, establishing a dedicated assisted reproductive technology (ART) statutory authority, access of ART to LGBTQ+ patients, and choosing gamete donor.

Sunday’s sessions delved into the often-neglected aspects of fertility care,

Prof Graham Howarth’s insights into medicolegal pitfalls in fertility clinics served as a sobering reminder of the ethical and legal considerations inherent in reproductive medicine.

The conference also provided a platform for stakeholders in egg donation agencies to address challenges and underscore their crucial role in facilitating fertility care. Updates on recent legal judgments and court applications in reproductive law, presented by Prof Donrich Thaldar, shed light on the evolving regulatory landscape governing fertility practices.

Acknowledgment was also given to individuals like Prof Carin Huyser and Dr Marie-Lena de Beer, who were honored with lifetime achievement awards for their contributions to embryology training. Additionally, the significance of initiatives like the ANARA registry, spearheaded by Dr Paversan Archary and Prof Silke Dyer, in monitoring and improving IVF outcomes in South Africa was duly recognised. Lydia Els-Smith was also acknowledged for her leading role in establishing the SASREG accreditation standards document.

The conference’s overarching message: Fertility care is multidisciplinary, continually evolving, and aligned with international best practices. The event served as a testament to the commitment of professionals in advancing reproductive health and ensuring equitable access to quality care for all. SF

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15,6 μg tiotropium