The use of herbal medicinal products and supplements has increased tremendously over the past three decades with not less than 80% of people worldwide relying on them for some part of primary health care. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use are either poorly monitored or not even monitored at all. The consequence of this is an inadequate knowledge of their mode of action, potential adverse reactions, contraindications and interactions with existing orthodox pharmaceuticals and functional foods to promote both safe and rational use of these agents. Since safety continues to be a major issue with the use of herbal remedies, it becomes imperative, therefore, that relevant regulatory authorities put in place appropriate measures to protect public health by ensuring that all herbal medicines are safe and of suitable quality. This review discusses toxicity related-issues and major safety concerns arising from the use of herbal medicinal products and also highlights some important challenges associated with effective monitoring of their safety.

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The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety

Objectives: To provide guidance for the management of mood disorders, based on scientific evidence supplemented by expert clinical consensus and formulate recommendations to maximise clinical salience and utility. Methods: Articles and information sourced from search engines including PubMed and EMBASE, MEDLINE, PsycINFO and Google Scholar were supplemented by literature known to the mood disorders committee (MDC) (e.g., books, book chapters and government reports) and from published depression and bipolar disorder guidelines. Information was reviewed and discussed by members of the MDC and findings were then formulated into consensus-based recommendations and clinical guidance. The guidelines were subjected to rigorous successive consultation and external review involving: expert and clinical advisors, the public, key stakeholders, professional bodies and specialist groups with interest in mood disorders. Results: The Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders (Mood Disorders CPG) provide up-to-date guidance and advice regarding the management of mood disorders that is informed by evidence and clinical experience. The Mood Disorders CPG is intended for clinical use by psychiatrists, psychologists, physicians and others with an interest in mental health care.

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Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders

The use of herbal medicinal products and supplements has increased tremendously over the past three decades with not less than 80% of people worldwide relying on them for some part of primary healthcare. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use are either poorly monitored or not even monitored at all. The consequence of this is an inadequate knowledge of their mode of action, potential adverse reactions, contraindications, and interactions with existing orthodox pharmaceuticals and functional foods to promote both safe and rational use of these agents. Since safety continues to be a major issue with the use of herbal remedies, it becomes imperative, therefore, that relevant regulatory authorities put in place appropriate measures to protect public health by ensuring that all herbal medicines are safe and of suitable quality. This review discusses toxicity-related issues and major safety concerns arising from the use of herbal medicinal products and also highlights some important challenges associated with effective monitoring of their safety.

Background: Herbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information. Methods: Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John’s wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St John’s wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions). Results: Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John’s wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St John’s wort) contained at least 85% of the safety messages. Conclusions: Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John’s wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products.

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Buyer beware? Does the information provided with herbal products available over the counter enable safe use?

Administration errors in the hospital setting 32 Medication incidents within hospital units 35 Hospital emergency departments 36 Palliative care 36 Anaesthesia 36 Factors associated with medication-related errors during admission 37 The accuracy of discharge summaries 39 Medication safety and transition to aged care 41 Medication-related problems after discharge 42 Medication safety within hospital in the home 42 Medication-related problems in aged care 43 Medication-related problems 43 Potentially inappropriate medicine use 44 Dose administration aid errors 45 Medication-related problems in the community 45 Adverse medication events in general practice 45 Medication-related problems 46 Potentially inappropriate medicine use 48 Adverse reactions and complementary therapies 50 Patient self-reported problems with medicines 51 4 Literature Review: Medication Safety in Australia 2013 Factors contributing to problems in the community 52 Accuracy of electronic medication histories in general practice 52 Reading prescription labels 52 Patient reported risk factors 53 Systems to improve medicine administration and dispensing 54 Improved medicines packaging, storage and administration equipment 54 Standardising medication charts 56 Systems to improve prescription writing 57 Standardising medication charts 57 Electronic prescribing/medication management 61 Education and training 64 Academic detailing 66 Systems providing pharmacy services 66 Pharmacy services to improve medication reconciliation and information transfer between different healthcare settings 66 Pharmacist prescribing and dosing services 81 Pharmacist services in the community setting 83 Systems promoting multidisciplinary care 85 Medication management review services: the evidence 85 Systems-based approaches to understanding and preventing medication errors 88 Systems to allow hospitals to assess medication systems and performance 88 USA Agency for Healthcare Research and Quality (AHRQ) systematic review of practices to improve patient safety 94 The report 94 Medication safety topics included in the review 94 Methods used in the AHRQ systematic review 94 Summary tables for patient safety practices relevant to medication safety from AHRQ review 96 Strategies considered 'ready for adoption' 97 Recommendations for future research 97 Evidence for specific patient safety practices in the AHRQ report to reduce adverse medication events (AMEs) 97 Other practices reviewed by AHRQ relevant to medication safety 104 Medication safety intervention strategies: the international evidence and implications for the Australian healthcare setting 111 Patient safety practices encouraged for adoption now 111 Interventions recommended as priorities for future research 113 5 Literature Review: Medication Safety in Australia 2013

Literature Review: Medication Safety in Australia

Background: Complementary medicines (CMs) are popular amongst Australians and community pharmacy is a major supplier of these products. This study explores pharmacy customer use, attitudes and perceptions of complementary medicines, and their expectations of pharmacists as they relate to these products. Methods: Pharmacy customers randomly selected from sixty large and small, metropolitan and rural pharmacies in three Australian states completed an anonymous, self administered questionnaire that had been pre-tested and validated. Results: 1,121 customers participated (response rate 62%). 72% had used CMs within the previous 12 months, 61% used prescription medicines daily and 43% had used both concomitantly. Multivitamins, fish oils, vitamin C, glucosamine and probiotics were the five most popular CMs. 72% of people using CMs rated their products as ‘very effective’ or ‘effective enough’. CMs were as frequently used by customers aged 60 years or older as younger customers (69% vs. 72%) although the pattern of use shifted with older age. Most customers (92%) thought pharmacists should provide safety information about CMs, 90% thought they should routinely check for interactions, 87% thought they should recommend effective CMs, 78% thought CMs should be recorded in customer’s medication profile and 58% thought pharmacies stocking CMs should also employ a complementary medicine practitioner. Of those using CMs, 93% thought it important for pharmacists to be knowledgeable about CMs and 48% felt their pharmacist provides useful information about CMs.

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Perceptions, use and attitudes of pharmacy customers on complementary medicines and pharmacy practice

Objectives The primary aim was to determine the prevalence of adverse reactions to over-the-counter complementary medicines and their severity, as described by consumers. Secondary aims were to identify consumers' reporting behaviours and understanding of the AUST L designation on product labels.



Methods  An anonymous, self-administered survey was completed by randomly selected pharmacy customers at 60 community pharmacy locations between August 2008 and February 2009.



Key findings  Of the 1121 survey participants (response rate 62%), 72% had used a complementary medicine product in the previous 12 months, and 7% of this group (n = 55) reported having experienced an adverse reaction at some time. Of these, 71% described the reaction as mild and not requiring treatment, 22% as moderate and/or requiring advice from a healthcare professional and 7% (n = 4) described it as severe and requiring hospitalisation. If they were to report the reaction, it was most commonly to a medical practitioner. Most (88%) of complementary medicine consumers had never noticed the term ‘AUST L’.



Conclusions  Complementary medicines are widely used by pharmacy customers. Adverse reactions to these products are under-reported to healthcare authorities. Most adverse reactions are mild and serious reactions are rare. Customers have little awareness of the designation AUST L.

Evelyn Tiralongo

Papers

Perceptions, use and attitudes of pharmacy customers on complementary medicines and pharmacy practice

Adverse reactions to complementary medicines: the Australian pharmacy experience.