This paper will apply risk management system with some approaches that I adopted from several guidelines from European Medicines Agency (EMEA, 2005), Medicines and Healthcare Products Regulatory Agency (MHRA, 2008), risk management approached from several countries. I also adopt one of the most powerful tools, Root-Cause Analysis (RCA) as a technique for undertaking a systematic investigation (Baker, 2005); see appendix 1-5.
Based on Dutch pharmacist experiences (De Smet, 2006) of herb-drug interactions is mainly consists of 3 steps: (i) risk identification and assessment; (ii) development and execution of risk reduction strategies; and (iii) evaluation of risk reduction strategies.
(i) RISK IDENTIFICATION AND ASSESSMENT
This first step of risk management requires that incidents are identified and assessed. Risk rating tool will assist the process. (See Appendix 1 and Table 2)
No Standardization
The growth of Jamu market is inhibited by a very basic problem, which is lack of modernization and specialization. There is no standardization in sourcing, processing (extraction, decoction, encapsulation, etc.), packing, storing, and also distributing. The other technical problems comprise equipments, human resources and quality control.
So far, Indonesia has 1600 jamu industry, 25 big manufacturers, 415 medium scales and the rest are home industries. The government set a guideline about Jamu Good Manufacturing Practice (GMP) in 2003. Ironically, until now only 17 jamu manufactures that meet the criteria for jamu GMP. There is no urgency to obtain it as to get a registration number for a jamu product is very easy and does not require jamu GMP certificate.
It has been reported that some Jamu is contaminated by heavy metals from soil. Currently, there is no limitation on heavy metals contaminants for the herbal plants to be officially regulated. Some other cases, jamu contains aflatoxin from fungi due to improper storage. Both of these contaminants is known to have accumulative effect and can cause long term condition. A research in Indonesia conducted toward pregnant woman who consumed jamu that was contaminated shows that aflatoxin had significantly caused abortion, while a study toward breast feeding women showed that aflatoxin can harm the baby as it is transmitted to mother’s milk.
Lack of Funding in Jamu Clinical Research
The risks of jamu might be increased due to lack of research into herb-drug interactions and under-reporting. Unlike the chemical therapeutic drugs that have gone through clinical trials, Jamu’s safety and efficacy are only based on empirical study. Most of Jamu manufacturers do not establish clinical studies about the proper dosage, potency of interactions and side effects, especially when it is taken together with other medications.
Study about herbal medicines has never been easy, as in an herbal plant contains hundreds and thousands active compounds that support or inter-act each other. In the last 5 years, there have been an increasing number of informations published in some journals. However most of them are in vitro study that can be bias or not relevant when applied to clinical conditions. Few case and incidents reports make it difficult to infer the causality.
The progress of good research and study is very slow due to limited funding from government. It means that the manufacturers themselves have to spare budget for research and development, which raised the price of Jamu become unaffordable. Alternative solution is need to solve these dilemmas.
The General Herb-Drug Interactions
Consumers often think that herbal products are safe and advantageous for health; however there are several risks have been associated with the use of herbal medicines. Herbs-Drugs interactions are likely to happen if consumers use prescribed drugs at the same time. The interactions can be pharmacodynamic or pharmacokinetic.
The use of uncontrolled chemical agents as excipients and also as additional active constituents has been happened for years. This problem linked to uncontrolled dose and usage. Many consumers with limited knowledge tend to take double or more than suggested dosage to get instant effect of jamu. This means double up the risk of over dose. Chemical drugs is harmful to health if they are not taken as suggested, especially the combined used with Jamu.
Lack of Law Enforcement
Indonesia Department of Health issued a regulation in 1983, revised in 1992, about traditional medicines production. The regulation stated that traditional medicines must not be adulterated with western chemical medicines as the uncontrolled usage may harm the health, damage organ, cause unwanted side effects and long term chronic condition and further more can be lethal.
Lack of law enforcement within Indonesia government has given space to jamu manufacturers to produce harmful products for the sake of profit. BPOM has tried to eliminate this violations but it did not work as expected, because the structure of Indonesian governance practice disabled BPOM to give sanctions or penalties or prosecute them. This is the duties of police department, however there is no collaboration between BPOM and police department after handling over the cases. Besides, police department is the most corrupt organization in Indonesia. It is very easy for the stake holders who did violation to bribe.
As long as there is no law enforcement, all the regulations will become useless, especially when the regulations are not supported by audit system and regular inspection. There is not much we can do as healthcare professionals to address the solution for this root problem because this is high political agenda. However, some risk management plan that is discussed in the next section, may have good impact to reduce jamu violation.
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DEVELOPMENT AND EXECUTION OF RISK REDUCTION STRATEGIES
The next step of risk management will look at the development and execution of risk reduction strategies to maximize benefits, minimize risks and protecting the health of general public. I set several strategies that are feasible to be implemented.
Implement Jamu GMP to All Manufacturers and Restrict Registration
In my opinion, the current regulation about jamu GMP and product registration is not good enough. First because it is not accompanied by relevant guidelines; second it is not strict enough. I tried to compare and contrast with other countries regulation, and found that as Indonesia key requirements to register a product are too easy in the sense of not considering patient safety at all. For instance: product registration can be obtained by manufacturers that are not granted jamu GMP certification; there is no requirement for labeling and leaflets for products and to include information and instructions about the safe use.
The implementation of Jamu GMP to all manufacturers is a must. BPOM needs to revise the regulation to support the business as well as protect the consumers, workers and environment. Jamu GMP also needs to be re-socialized and BPOM need to act as consultant in this case to provide clear guidelines, to train some poor quality jamu manufacturers, which may be categorised as high risk in causing contamination, product defect and failure to meet specification standards. Training can also be collaboration between multi disciplinary professionals, ie: government as the regulators, traditional healers, pharmacists, herbalists, academics, etc.
The risk management strategies for unlicenced medicines and specials adopted from MHRA 2008, is shown in table 3 as a brief checklist of the risk management strategies that can to be applied for jamu in Indonesia.
Table 3. Risk management strategies check list.
Set off Pharmacovigilance Activities and Interventions
As has been discussed in previous section, one of the root problems is about funding to conduct good quality researches. Alternative affordable solution for this problem to minimize risk is setting off pharmacovigilance activities and interventions; which are clearly designed to identify, characterise, prevent or minimise risks relating to medicinal products. A well documented case reports can be a good option when clinical trials, controlled interaction studies and higher level of evidences are difficult to obtain.
To raise consumers’ awareness of Jamu, it is needed to develop pharmacovigilance activities, such as continuation process of evaluating risks and benefits, minimising risk through appropriate interventions, evaluating interventions as new knowledge gathered and revising them accordingly. Most of the jamu in Indonesia lack of formal surveillance. Adverse reactions and potential interactions with other medicines should be spontaneously reported routinely. Currently, reporting system has not been established, major incident will be brought to attention only if media published them.
In Canada, adverse events including drug interactions are voluntarily and spontaneously reported through the Canadian Adverse Drug Reaction Monitoring Program. Similar function in the UK is through MHRA; In Singapore is through Health Sciences Authority (HSA). While in Indonesia, BPOM duties do not cover adverse reactions reporting. Learning from several countries, Indonesia government should found a pharmacovigilance centre within BPOM to put in place the reporting culture. MHRA yellow card system is excellent to be adopted for public to report adverse experience, hospitalisation and life threatening reactions.
General public should be educated that jamu may not be safe and encourage them to use as suggested. For healthcare professionals, self-learning is highly suggested through published data from other countries. It is a big work for BPOM to ensure that the use of jamu is covered by a guidance and information.
Classify Jamu According to the Risk
Generating solution for the third root problem is to classify jamu. Similar to chemical therapeutic drugs, jamu is considered as medicines, therefore should also be classified according to risk, which is interactions and the potential toxicity. Regulatory authorities may classify jamu using easy spotted labelling system. For example ‘green dot’ as safe and can be treated like OTC medicines by attaching information about the usage, normally used to promote health or prevent illness. ‘Blue dot’ is for jamu that used to cure minor ailment; need sufficient information printed on the packaging about the dose and usage. ‘Red dot’ is marked for jamu with high risk. Supposedly, green dot and blue dot jamu can be sold in any shop; this red dot jamu can only be sold in ‘licensed- drug store’* or pharmacy only medicines.
(* ‘licensed-drug store’ known as ‘toko obat’ in Indonesia, is actually a pharmacy that can sell any medicines, except controlled drug. The qualified person in charge is pharmacy technician only, due to insufficient pharmacist in the country, especially for small town and sub urban area.)
In the UK, medicines is categorised using letter “P” or “POM”, this system more difficult to implement for jamu because in Indonesia there are still 10% (out of 200 million) uneducated people. The colour dotted system is easier and more eye-catching for general public to take precaution. To keep the production cost low so can be affordable for low or middle class people; I think only jamu with red dot that need to be accompanied by patient information leaflet (PIL).
Incomplete medical records and insufficient knowledge of doctors or pharmacists about herb-drug interactions can drive jamu to be dangerous for the consumers. The worse part is the lack of communications between doctors-patients, consumers of herbal remedy would not consult their doctors of pharmacists following adverse reactions. (Barnes et al, 1998) The beneficial aspect by classifying jamu is facilitating regulatory authority in communicating risks and safety concerns. Besides PIL, to supply red dot jamu, consumers need to be asked or consulted to prevent interactions; that is the reason why this red dot jamu can only be obtained in licensed-drug store or pharmacy.
Learning from MHRA website about herbal medicines, there are plenty more strategies that can be adopted for jamu in Indonesia to increase safety. For example, safety advise for red dot jamu consumers, precaution for pregnant, breast feeding woman, children and elderly, also for patient with certain condition who consume jamu as supplementary medication. This website not only will educate consumers but also important for healthcare professionals.
Another type of classification that comes in my mind is to classify jamu according to the therapeutic indication. However I don’t think this is feasible to implement because there is no sufficient study about how jamu works. On the reverse way, we can use drug classification to predict herb-drug interactions. A simple qualitative prediction of the potential for herb-drug interaction may be made based on the properties of drugs and the herbs of interest. The latter may cause synergistic or antagonistic effects. Jamu with red dot need to publish the herb-drug predicted interactions for healthcare professionals to assist them in consulting patients and consumers.
(iii) EVALUATION OF RISK REDUCTION STRATEGIES
The third step in risk management is the evaluation of risk minimisation strategies, to examine whether the strategies implemented can work effectively and efficiently.
Implement Jamu GMP to All Manufacturers and restrict registration
Jamu GMP regulation and product registration scheme is crucial for manufacturers who produce and distribute jamu to the mass public, but how about the home made jamu for family or local consumption? Which way is the most effective to educate them about toxicity and ensure safety?
Is it enough to restrict registration scheme? As I described in the introduction, jamu is part of tradition (see appendix 4), how to apply product registration restriction without restrict the culture itself? Most of jamu manufacturers are running traditionally, is it possible to implement jamu GMP due to financial matters? Is there any other solution, such as merger or soft loan? If yes, does it work well to support them? This strategy need to be carefully evaluated.
Set off Pharmacovigilance Activities and Interventions
Parmacovigilance centre, does it work effectively as expected? How many customers actually report the adverse reactions? Consider feedback to key opinion leaders and healthcare professionals, are they alert enough? For the incoming case reports, which criteria is considered as serious to be targeted follow up? To convert the raw data gathered into reliable case report or higher level of evidence, is it any other possibility to share data with other authorities to pool safety data and monitor risk pro-actively? How to make sure the findings is useful for jamu utilization study?
Classify Jamu according to the risk
The classification of jamu according to the risk, need to be objectively judge. With insufficient data about the safety, is it objective enough to use empirical data to set the criteria? For put red dot jamu as pharmacy only medicines, how often customers will come for jamu to pharmacy? And to what extend do they ask and receive counseling from healthcare professional about the herb-drug interaction? Knowledge and skill about jamu is inherited through generation, it is not part of the curriculum at the moment. Are doctors and pharmacists and other healthcare professionals eligible enough to conduct the councelling?
- FUTURE DIRECTION
Indonesia is the second richest country in botanical biodiversity after Brazil. However, from the total number of 9.000 species of herbal plants, only 350 species that are identify and used commercially as jamu. If risk management plan is applied properly, fewer incidents will happen in the future and consumer safety can be assured. This is the time to move on the focus to maximize the potential use of Indonesian richness of botanical biodiversity for healthcare innovation by.modernize jamu while maintaining the culture and tradition.
Knowledge in jamu is crucial to be taught as a specialized module in higher education. Further study on scientific proof of the mechanism of actions, optimal dosage, efficacy and safety is urgently needed. It is highly beneficial for herb-drug interaction to be taught in the university in the future because it is actually part of risk minimization. Knowledge in jamu will empower healthcare professionals to ensure the use of jamu widely among Indonesian people is safe and effective.
- CONCLUSION
From generation to generation, Indonesian ancestors have inherited the art of traditional medication through herbal medicines. It needs sustainable development to activate the Jamu industry in Indonesia to establish.
The incident that jamu caused adverse reactions, can be prevented in the future by applying risk management strategies. There are four main problems identified by using root analysis tool that cause this incident: no standardization, lack of funding in jamu research, general herb-drug interactions, and lack of law enforcement.
Risk reduction strategies that are implemented to encounter this problem are: implement jamu GMP for all manufacturers and restrict product registration, set off pharmacovigilance activities and intervention, classify jamu according to the risk. Also the evaluation is crucial step in risk management plan to know whether risk reduction strategies is working effectively and efficiently.
It is not very easy to eliminate errors and incidents; however by implementing risk management plan, we can minimize the harm of jamu to consumers. All of us: government, police department, professionals, manufacturers, distributors, farmer as raw material suppliers, general public need to be hand in hand to do something. Otherwise, jamu tradition will remain as history forever.
REFERENCES:
BMJ 2000; 320 ( Themed issue on error / risk management in British hospitals )
Doing Less Harm. http://www.npsa.org.uk/admin/publications/docs/draft.pdf. [10th January, 2003]
Lugon M, Secker-Walker J, 1999, Clinical Governance : Making it Happen, The Royal Society of Medicine Press, London.
Middleton, W., Clyne, A. and Harris, P. (1999). Risk assessment and decision making In Messer, D. and Jones, F. (eds). Psychology and Social care. JKP.
NHS Executive Health Service Circular 1999/123 Governance in the New NHS: Controls Assurance Statements 1999/2000 : Risk Management and Organisational Controls
Risk Management at University College Hospital. http://www.doh.gov.uk/pub/docs/doh/riskuclh.pdf. [10th January, 2003]
Vincent C (ed ), 1995 , Clinical Risk Management, BMJ Publishing Group. London
Vincent C, Taylor- Adams S, Stanhope N, 1998, Framework for analysing risk and safety in clinical medicine, BMJ, 316: 1154-1157
RECOMMENDED:
Beck U. 1992 Risk Society: Towards a New Modernity. Sage Publications
Berwick D, A primer on leading the improvement of systems, BMJ, 1996; 312: 619-622
Department of Health, 2000, An Organisation With A Memory: Report of an Expert Group on Learning from Adverse Events in the NHS chaired by the Chief Medical Officer, HMSO, London
Douglas M. 1986. Risk Acceptability According to the Social Sciences. Routledge Press
Giddens A. 1990 The Consequences of Modernity. Polity Press
Health Act 1999 Section 18 (1)
Lord Cullen 1990 The Public Inquiry into the Piper Alpha Disaster HMSO, London
Department of Health, 1999, Making a Difference, Strengthening the Nursing, Midwifery and Health Visiting Contribution to Health and Healthcare, HMSO, London
Department of Health NHS Executive, 1999, Guidelines on Implementing Controls Assurance in the New NHS, HMSO, London
Dewar S, 1999, Clinical Governance Under Construction: Problems of Design and Difficulties in Practice, Kings Fund, London
Kelmshall H. 1998. Risk in Probate Practice. Aldershot: Ashgate
Kelmshall H & Pritchard J. 1997. Good Practice in Risk Assessment and Risk Management. London: Jessica Kingsley
Monahan J & Steadman HJ, eds. 1994. Violence and Mental Disorder: Developments in Risk Assessment. University of Chicago Press
Nash M. 1999. Police, Probation & Public Protection. Blackstone
Parsloe P (ed.). 1999. Risk Assessment in Social Care and Social Work. Jessica Kingsley
Prins H. 1999. Will They Do it Again? Routledge
Reason J, 1997, Managing the Risks of Organisational Accidents, Ashgate, Aldershot
Royal College Nursing, 2000, Guidance for Nurses on Clinical Governance, RCN, London
Royal Society Study Group. 1992. Sir Fred Warner (chair). Risk Analysis, Perception and Management. London: Royal Society
Swage T, 2000, Clinical Governance in Health Care Practice, Butterworth Heinemann, Oxford
Walshe K, 2000, Accreditation in Primary Care : Towards Clinical Governance, radcliffe, Abingdon
Wilson J, Tingle J, (eds.), 1999, Clinical Risk Modification : A Route to Clinical Governance, Butterworth Heinemann, Oxford
OTHER USEFUL SOURCES :
The National Patient Safety Agency. Includes links for root cause analysis tools and other useful and relevant websites related to risk management and patient safety.
National Clinical Assessment Service. Centre for looking at professional practice of doctors and dentists.
. Central Office for Research Ethics Committees. Ensuring research meets the need of patients and public.
. National Confidential Enquiry intoPatient Outcome and Death.
. Confidential Enquiry into Maternal and Child Health.
. The National Confidential Inquiry into Suicide and Homicide by People with Mental Illness.
. Department of Health. Downloads for key documents.
- Kings Fund library reading list
– provides examples of good practice involving patients
– guidelines for those carrying out or commissioning reviews
