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Australian Journal of Pharmacy : March 2005
letters your say OTCs and generics: a wider appreciation Editor, The poor counselling, especially with pseudoephedrine, variable access, and the generally higher prices experienced with OTCs in many countries by pharmacist Kitty Tse (AJPJan 2005, p8) and your edi- torial on the prices of generics (AJP Feb 2005, p67) are timely additions to the growing evidence supporting Australia’s current system of OTCs and particularly pharmacist-only medicines. First, on counselling of OTCs. Some of the recommendations arising from the Galbally review of drugs, poisons and controlled substances legislation (2000) may have narrowed pharmacy’s approach to evaluating OTCs.1 The key objective sought by the review was ‘Free- dom from harm to the individual and the community as a whole’, but pharmacy was tied to a requirement to show improved health and other outcomes from OTCs issued according to PSA stan- dards. The subsequent research led to the world’s biggest study using the modified ‘mystery shopper’ or ‘pseudo patron’ technique. It resulted in the unique assess- ments of pharmacy practice, designed to raise the Australian standards referred to by Ms Tse.2 Second, regarding the variable access to OTCs encountered by Ms Tse. We used data from the Association of the Euro- pean Self-Medication Industry’s (AESPG) latest report, ‘The legal status of selected ingredients worldwide’ (2004), to analyse the scheduling of 217 OTC agents in Eng- lish-speaking countries.3 We found that New Zealand and Australia had many more effective agents than the UK, Canada, while the US ranked lowest. This finding seriously challenges the presump- tion that deregulation along the lines of the two-class US system (medically pre- scribed and general classes) facilitates bet- ter access to non-medically prescribed medicines.4 Third, the issue of OTC prices noted by Ms Tse has now been expanded by the AESPG to national health savings calcu- lated for European countries by ‘switch- ing’ a sample of medically-prescribed to 144 ? THE AUSTRALIAN JOURNAL OF PHARMACY VOL 86 MARCH 2005 OTCmedicine.5 The US’s healthcare costs are nearly 15 per cent of GDP whereas the UK’s, Australia’s and New Zealand’s are under 10 per cent. The National Pharmacy Database Pro- ject (NPDP) estimated more than 78 mil- lion primary and self-care cases in phar- macies. This equalled more than 80 per cent of all GP consultations in 2002.6a It is possible, therefore, that national health costs may be lowered in countries like Australia which have a combination of consumer access to a larger number of effective OTCs, a substantial pharmacist- only class of drugs and relatively high pharmacist involvement in self and pri- mary healthcare in the population. On the Galbally objective of population safety and deregulated OTCs, Ms Tse noted the widespread uninhibited access to Sudafed. In the US, a number of states have tightened access to this and other OTC agents because of the ‘front-of- counter’ access through a range of retail outlets and many reports of misuse, diver- sion into illegal manufacture and a sharp rise in OTC cases reported by US poisons centres. The size of pharmacists’ custodi- anship role is quantified by the NPDP. Pharmacies in Australia estimated 863,000 clients in 2002 with suspected misuse of OTCs, and they refused supply to 631,000 or notionally in 73 per cent of cases. This compared with about 13,500 clients with forged prescriptions for S4 and S8 drugs of dependence, and another 23,300 doctor shoppers detected in phar- macies in 2002.6b These results are con- siderably higher than figures collated from pharmacists’ reports overseas and earlier in Australia.6b References available upon request. Pharmacy concerns with falling gener- ics prices need to be tempered by the alternative strategies using OTCs in devel- oped countries to improve the financial circumstances of stakeholders. The switching of drugs to OTCs is now used by non-generics pharmaceutical companies to combat lost revenue from drugs com- ing off patent and by governments and health insurers to lower the costs of pre- scribed medicines. In 2004, for example, a UK drug manufacturer initiated the reclassification of simvastatin 10mg to OTC. A national agency in Sweden which administers a system similar to Australia’s PBS approved the switch of omeprazole 10mg and a US health insurer petitioned the switch of loratadine 10mg to lower costs.7 The American Pharmacists Association in August 2004 convened a ‘Pharmacy OTC Task Force’ in response to the switching of potent drugs and OTC safety concerns in the USA. An early recom- mendation was the creation of a new cat- egory of non-prescription medicines enti- tled ‘Pharmacy care OTCs’.8 The OTC stakes have risen sharply worldwide since 2000. The approaches to evaluating OTCs have also broadened for pharmacy and other stakeholders in Aus- tralia since the Galbally report. Con Berbatis Lecturer, School of Pharmacy Curtin University of Technology of Western Australia Letter to the editor competition A THE WINNER this month is Con Berbatis. S a joint initiative to reward readers for taking the time to write letters to the editor to the AJP, Therapeutic Guidelines Limited has agreed to sponsor a 12-month subscription to eTG complete—the electronic version of the familiar book series—to be awarded to the writer of the best letter submitted each month. When sending a letter to the editor, please limit your letter to 300 words, and include your name, address and a contact telephone number should the editor require clarification.