Management of Adverse! Experiences from the Use of! Herbal Medicines:!

Transcription

1 Management of Adverse! Experiences from the Use of! Herbal Medicines:! The Consumers Perspectives Chuenjid Kongkaew Faculty of Pharmaceutical Sciences, Naresuan University, Thailand

2 Funding and conflicts of interest Funded by the Annual Thai government statement of expenditure 2017 which had no influence on data collection not any part of this presentation. Chuenjid Kongkaew has no conflicts of interest to declare

3 Introduction Herbal medicines used worldwide Projected global market $140 billion % of Asian use herbal medicines (Thailand 33%) Herbal medicines in Thai vigilance database gastrointestinal problems most common adverse events. serious adverse events, e.g., Andrographis paniculata including: Stevens-Johnson syndrome anaphylactic shock exfoliative dermatitis Safety of herbal medicines is worrying

4 Introduction Current reporting mechanisms for herbal medicines, but: spontaneous reporting rates low probably under-reported (Debbie, S., et.al., 2012) Consumer engagement improve such reporting crucial to understand consumer perception of adverse events and how they act

5 Objectives Explore how consumers manage adverse experiences related to herbal medicines

6 S t u d y period: March/April 2017 setting: sub-district, south-east Thailand 2 0 k m

7 Background of participants Questionnaire Participant demographics Participant usage of herbal medicines Access to herbal medicines and services Knowledge, attitude, and beliefs of herbal medicines Knowledge and understanding of drug allergies Participant opinion about self-care

8 Participant demographics 270 participants recruited Aged yr, 56% Female, 70% Education: < primary school, 73% Marital status: married, 68% Occupation: agrarian, 57%

9 Herbal medicine usage of cohort Herbal medicines used Commonly: Andrographis paniculata Curcuma longa Thunbergia laurifolia Purposes: treatment or symptom relief (62%) disease prevention/health promotion (38%) Duration: >1 yr. (56%) Perceived benefits of herbal medicines (94%)

10 Access to herbal medicines and services Access to herbal medicines Health centre/pharmacy/community hospital (30%) Home-grown/foraging (37%) Grocery shop/market/temple/direct sale (16%) Neighbour (11%) Traditional healer (6%) Access to medical services Paramedic/nurse care : < 5 km (74% participants) Community hospital : > 10 km (78%)

11 Knowledge, attitude & beliefs Knowledge about herbals as medicines: (scored low) Attitude: favour over standard medicines (47%) Beliefs: herbal medicines provide benefits (56%) Knowledge and understanding about drug allergy (80%)

12 Participant opinion about self-care of a severe adverse experience Action N % Influencing factor 1. self-care self-care by self talk to family pharmacy seek-care hospital primary care Continue to use of herbal medicine Total ! Consumers living close (6-10 km) to a hospital would seek care from hospital (66%) rather than self-care. Reference group: consumers living >10km from hospital. odds ratio 0.34, C.I. =

13 Participant opinion about self-care of a mild/moderate adverse experience Action N % Influencing factor 1. self-care self-care by self talk to family pharmacy seek-care hospital primary care centre Continue to use of herbal medicine Total Participants who perceived benefits from herbal medicines Reference group: consumers who were uncertain about benefits of herbals odds ratio 3.45, C.I. = Good knowledge and understanding of drug allergies Reference group: poor knowledge and understanding of drug allergies odds ratio 3.05, C.I. =

14 Study Method A Multiple Case Study Data collection as in-depth interviews Criterion sampling Inclusion criteria Participants who had adverse experiences from herbal medicines Age 20 yr living in the area Consent to participate 9 informants fitted criteria

15 Age Sex Herbal medicine 1 55 M Stachytarpheta jamaicensis (L.) Vahl + Andrographis paniculata Adverse experience (or diagnosis) Dizziness 2 78 M Schefflera leucantha Muscle spasms 3 66 F Yellow powder medicinal herbs Dyspepsia 4 42 F Moringa oleifera Dizziness 5 62 F Chlorophyll Body Pain 6 56 F Ganoderma lucidum Dizziness 7 42 F Helicteres isora L. Frequent urination 8 55 F Medicago sativa Dizziness 9 79 F Herbal Capsule (Unknown) Impaired renal function

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17 Management of adverse experiences from the use of herbal medicines The perceived adverse reactions were managed by: (a) taking no action if symptoms were mild and that herbal medicines were believed to be safe (b) self-care including dose moderation or discontinuation, sleeping, drinking a lot to increase excretion, or taking laural clock vine (Thunbergia laurifolia) to promote toxin loss (c) seeking advice/care at sub-district health promoting hospital o r d r u g s t o r e a n d (d) perform both self-care and care-seeking behaviours

18 Discussion Suspected adverse experiences was verified by: ( i ) r u l i n g - o u t o t h e r p o t e n t i a l c a u s e s ( i i ) d e - c h a l l e n g e a n d ( i i i ) r e - c h a l l e n g e Some participants use reactions from herbal medicines, e.g., aches/ feeling warm, to indicate the herbal is effective ( Sai symptom) Unbiased information about herbals is needed especially about indication, dose, duration, adverse effect, and precautions to be a c c e s s i b l e v i a a m o b i l e p h o n e Need a dedicated user-friendly database for consumers to report a d v e r s e e v e n t s f r o m h e r b a l m e d i c i n e s

19 Challenges! Ambiguity of preparation contents! Different names for same herbal medicine! Poorly defined and erratic doses! Unclear definition of efficacy! Differentiating therapeutic effects from adverse events! No easy way of identifying long-term life threatening events, e.g: Carcinogenesis Renal, liver failure

20 Conclusion Consumers of herbal medicine are at risk of adverse events Vigilance systems for herbal medicines could be established by p r o m o t i n g c o n s u m e r r e p o r t i n g Healthcare professionals can still contribute Improving the safe use of herbal medicines by providing unbiased information for users and long-term follow-up Contact detail: chuenjid@googl .com

21 Method s Sequential mixed method research design using both quantitative and q u a l i t a t i v e s t u d y Study settings: A sub-district, in the south-east of Thailand during March/ A p r i l Show a map of this

22 Phase1: A Cross-Sectional Observational Study Sample'size'270;'sampled'people'registered'with'the'primary'centre Tool:'Interview'ques@onnaire' Inves@gate:'(1)'consumer'characteris@cs;' (2)'the'usage'behaviour'of'herbal'medicines;'(3)'access'to'herbal'medicines,'(4)' knowledge'about'herbal'medicines;'(5)'aktudes'about'the'use'of'herbal' medicines;'(6)'beliefs'about'the'use'of'herbal'medicines;'(7)'knowledge'and' understanding'about'drug'allergy;'(8)'opinions'about'selfncare'when'they' encountered'adverse'experiences' To'determine'factors'influencing'opinions'about'selfNcare'when'experienced' adverse'events'using'binary'logis@c'regression

23 Patterns of adverse experiences 9 key informants perceived the adverse experiences either severe or not severe during a course of herbal medicine treatment It s severe, I never got this with other medications. Starting with muscle pain, feel like having fever, sore tendon, pain all over my body, I quickly closed my shop, thinking I m dying that day Code A05 They performed self-diagnosis of the adverse experiences and observed abnormalities of the body using their own experiences. muscles are jerking and then got cramped (demonstration and pointing at the area, which got cramped Code A02 Not sure about any of this Some of them did not know if the experience was an adverse reaction to herbal medicines. They perceived the reaction from herbal medicines (e.g., feeling hot) after use and called the reactions as Sai symptom, which can be good or bad effects. Verifying the suspected experiences from herbal medicines was deduced by (i) ruling-out other potential causes (ii) de-challenge and (iii) re-challenge