1. Australia left behind on Viagra, erectile dysfunction medicines
04 December 2017
The UK has joined New Zealand in making sildenafil – the active ingredient in erectile dysfunction (ED) medicines such as Viagra – available from pharmacists without the need for a prescription from a doctor.
The move follows a recent decision by the Australian regulator to reject an application to make sildenafil available at a pharmacy in pack sizes of up to 8 dosage units, after consultation with a pharmacist. Another erectile dysfunction medicine, Bayer’s Levitra (active ingredient vardenafil), has been rejected for rescheduling in Australia twice before.
In New Zealand, men suffering erectile dysfunction have been able to buy the sildenafil product Silvasta and Red Boost from specially trained pharmacists without a prescription from a GP since October 2014, Per Geeks Health.
The Australian Self Medication Industry (ASMI) argues that this is another example which illustrates how Australia is out of step with other markets when it comes to access to medicines.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified Viagra Connect (containing sildenafil 50mg) as a pharmacy medicine that is available to men over 18 after screening by a pharmacist for cardiovascular disease and risk, severe kidney failure, liver failure and the use of certain medications. The move comes after authorities assessed the safety of Viagra Connect and following public consultation.
By contrast, the Australian regulator, the TGA’s Advisory Committee on Medicines Scheduling, rejected applications for erectile dysfunction medications to be available from a pharmacist, based on the argument that there is a direct relationship between erectile dysfunction and cardiovascular risk, and that access from a pharmacist could potentially reduce the likelihood men would visit their GP.
Speaking at the World Self Medication Industry General Assembly held in Sydney in October this year, Alison Van Wyk, Executive in Professional Services for Green Cross Health, explained that the New Zealand experience with over-the-counter access to sildenafil over three years shows a positive influence on men’s health. Furthermore, the indications are that this encourages men to have health conversations with their pharmacist, which in turn increases their interaction with their doctor for serious health issues.
By October, 2017, 58% of New Zealand pharmacists had undertaken the training required to supply sildenafil. Ms Van Wyk presented evidence and case studies from pharmacists who reported that approximately two thirds of their consultations resulted in the supply of sildenafil to the patient, while the remainder are referred on to doctors for further medical intervention. Ms Van Wyk argued that the reclassification of Sildenafil, and its advertising, increases the general discussion around the topic of erectile dysfunction by men, while also ‘catching’ suspected health issues such atrial fibrillation (irregular, often rapid heart rate that commonly causes poor blood flow) and obstructive sleep apnoea, which resulted in the patient being referred to a doctor. So while ED may prompt men who rarely see doctors to visit the pharmacy, they may leave with a greater understanding of their health status and consequently see their doctor about their cardiovascular health.
ASMI has stated that erectile dysfunction (ED) is a condition that is appropriate for self-treatment under the supervision of a pharmacist. Both UK and New Zealand regulatory authorities have been satisfied that these medicines have a good safety profile and that their suitability for supply through pharmacies is positive.
“Over-the-counter availability offers people faster and easier access to effective medicines, reduces pressure and costs on GPs and the PBS, and encourages more people to better self-manage their health,” said ASMI CEO Deon Schoombie.
2. ASMI supports the role of oral antihistamines in the management of hayfever
30 November 2017
The Australian Self Medication Industry (ASMI) today urged consumers who suffer from hayfever to discuss their symptoms with their doctor or pharmacist so that they receive the most appropriate treatment plan.
This statement was in response to media reports suggesting there is no role for oral antihistamines in the management of seasonal hayfever.
Hayfever is the common name for a condition called allergic rhinitis (AR). Symptoms include sneezing, headaches, a runny or stuffy nose, itchy ears, nose and throat, and red, itchy or watery eyes.
Many people associate hayfever with spring, when airborne pollens from grasses are at their peak. This is called seasonal allergic rhinitis (SAR). However, for many people, hayfever can occur at any time of the year, usually as a reaction to allergens around the home, such as dust mites, moulds, animal hair or fur, or occupational allergens. This is known as perennial allergic rhinitis (PAR).
Common over-the-counter (OTC) products used to treat AR include intranasal corticosteroid sprays, oral non-sedating antihistamines and intranasal antihistamine sprays. Current Australian guidelines1 recommend intranasal corticosteroid sprays for use as a first-line treatment for persistent mild and moderate-to-severe SAR and PAR. These nasal sprays are available over-the-counter (OTC) and contain corticosteroids. These products need to be used regularly as directed to be effective. Long term use of more than six months should be under the guidance of a GP.
Non-sedating oral antihistamine medicines can also be beneficial and may be used in combination with intranasal corticosteroid sprays2 when the symptoms such as of seasonal hayfever strike. This combination therapy may especially benefit consumers whose symptoms are not well controlled with an intranasal corticosteroid sprays alone, those who suffer more itching and watering of the eyes, and those who are just commencing treatment, because the onset of the treatment effects of the combination is likely to be faster. Furthermore, the Australasian Society of Clinical Immunology and Allergy (ASCIA) recommend either a non-sedating oral or intranasal antihistamine as the first line of treatment for intermittent mild AR or it can be used in combination with other treatment options.”
For children under the age of 12, non-sedating oral antihistamines are an established first-line treatment option for mild symptoms of hayfever3 and continue to remain the mainstay in the treatment for allergic disorders.4 These are available in pharmacies in child-friendly formats such as syrups or chewable tablets.
In addition to speaking with a doctor or pharmacist, there are some useful patient and consumer resources available on the ASCIA website. ASMI encourages consumers to use these products as directed on the label instructions, and to see a doctor if symptoms persist. If you are pregnant or breastfeeding, ask your GP or pharmacist for advice.
References
1. Allergic Rhinitis Clinical Update Sept. 2017, ASCIA (Australasian Society of Clinical Immunology and Allergy)
2. Meltzer, E.O. Allergy and Asthma Proceedings, Volume 27, Number 1, January-February 2006, pp. 2-8(7)
3. Fireman, M. J,Allergy Clin Immunol. 2000;105:S616-21.
4. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision, Brożek, Jan L. et al. Journal of Allergy and Clinical Immunology, Volume 140 , Issue 4 , 950 – 958
3. ASMI announces new Board members
30 November 2017
The Australian Self Medication Industry (ASMI) announced its new Board of Directors at its Annual General Meeting this week.
The election of three board directors was confirmed at the AGM.
Rob Barnes (Aspen), Andrew Jenkin (Pfizer) and Alan Oppenheim (Ego Pharmaceuticals) will be joining current board directors, Lindsay Forrest (Chairman), Doug Cunningham (J&JP) and Mark Sargent (Bayer).
Following the AGM, the incoming board appointed James Jones (Takeda) and Stephen Moodey (GSK) to fill two of the four casual vacancies.
The following office bearers were also appointed:
Doug Cunningham, Vice Chair
James Jones, Secretary
Rob Barnes, Treasurer
Lindsay Forrest extended his congratulations to the newly appointed directors.
The ASMI AGM also featured guest speaker Craig Woolford, Citigroup managing director and head of consumer sector research, who addressed members on ‘Amazon and its Impact on the Australian Market‘.
4. Researchers seek participants to investigate impact of the removal of over-the-counter codeine
28 November 2017
Researchers investigating the impact of codeine being available only by prescription are seeking individuals who have regularly used it as an over-the-counter (OTC) medicine.
Common OTC codeine-containing products include Nurofen Plus, Panadeine, Mersyndol, Mersyndol Day Strength, Fiorinal, Codalgin, Aspalgin, Panafen Plus.
From 1 February 2018, all codeine-containing medicines will only be available to individuals who have a prescription from a doctor.
The study is being conducted by Associate Professor Raimondo Bruno (University of Tasmania); Dr Suzanne Nielsen (University of NSW), and PhD candidate Jacqui McCoy (UTAS). The study will use a web-based survey to follow participants over a 12-month period to explore the impact the new regulation on access to codeine has on their use of codeine-containing medicines, their pain management, their mental and physical health and their use of health services (e.g. GPs, pharmacies).
Regular consumers of codeine-containing medicines who are over 18, live in Australia and are not currently engaged in treatment for codeine dependence are invited to apply to participate in the study. Participation requires the completion of an online survey at four different times over a 12-month period. For the first survey, participants have the opportunity to win one of twenty $100 vouchers, and they will be reimbursed$20 for each of the remaining three surveys.
Information about participants will be stored in a de-identified format (i.e., personal information such as email address stored separately from your data) on a secure server and no individual data will be published. Personal information will be deleted approximately one month after the conclusion of the study (October 2018).
More information and a brief screening questionnaire is available here and the study’s Facebook page also has further background and comment on the change in access to codeine-containing medicines.
The Australian Self Medication Industry (ASMI) encourages consumers of OTC codeine-containing painkillers to talk to their doctor or pharmacist at the earliest convenience to discuss pain management options.